bioihbjkbjnl/mcl2 huggingface dataset:
Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective: To examine whether the switch to paliperidone ER from risperidone improves
      cognitive function in stabilized patients with schizophrenia.

      Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after
      switching to paliperidone ER from risperidone
    

Detailed description: 
      This is a 12-week, randomized, parallel-group, open labeled, flexible-dose study. The
      patients will be randomized to the risperidone-continuation group in which they continue to
      receive risperidone, or to the paliperidone-switch group in which they are switched from
      risperidone to paliperidone. In the paliperidone-switch group, risperidone will be tapered
      off during the first 4 weeks of the study, while paliperidone is titrated simultaneously. The
      doses of both drugs will be adjusted according to the clinical judgment of each research
      psychiatrist, within 6 mg/day of risperidone and 12 mg/day of paliperidone.
    

Intervention name(s): Paliperidone ER; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): 3mg to 12mg of Paliperidone ER once a day; 1 to 6 mg of risperidone once or twice a day
Other intervention name(s): Invega; Risperdal
Intervention MeSH terms: Risperidone; Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
Condition: Treatment of Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at Vega Baja, versus
      Zwickau.
    


Intervention name(s): Fesoterodine; Fesoterodine
Intervention type(s): Drug; Drug
Intervention description(s): A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg; A fesoterodine extended-release tablet (ER) formulation once daily administration of 4 mg
Other intervention name(s): Toviaz 4 mg; Toviaz 4 mg
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence
TRIAD Project: Qualitative Study of Adolescent Depression and Smoking
Condition: Adolescent - Emotional Problem; Smoking
MeSH terms: Depression
Study type: Observational

Summary: 
      It has been shown in the adult literature that smoking is related to depression and visa
      versa. Not much is known about how this relationship is started or if one perhaps leads to
      the other. We are performing 1 hour long interviews with adolescents ages 12-19 who meet
      criteria for major depression and who smoke. They are interviewed along with their parent.
      Questions center around their view of depression and their history of depression as well as
      questions around their smoking as well as the interrelationships between the two. Transcripts
      are made of the interview and are being analyzed for themes.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents ages 12-19 who live with their parental guardian who meet criteria for major
        depression and who smoke cigarettes.
      
Keywords: Adolescent depression; Adolescent smoking
Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes
Condition: Type 2 Diabetes; Hypogonadism
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to investigate how well Androgel, when tested against placebo gel, helps to
      control blood sugar levels in males with type 2 diabetes who have low testosterone (the main
      male hormone) blood levels and are taking oral diabetic medicines alone or in combination
      with insulin.
    


Intervention name(s): Androgel (testosterone gel)
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 diabetes; hypogonadism; testosterone; glycosylated hemoglobin A1C
Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type
      1 diabetes that are currently using an insulin pump.
    

Detailed description: 
      This study is a non-randomized, uncontrolled feasibility study that looks to enroll people
      with type 1 diabetes who are currently using an insulin pump. During the subject's
      participation, the study staff will closely monitor the study subject in a clinical research
      center environment for approximately 30 hours, while controller algorithm determined insulin
      doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
    

Intervention name(s): Predictive Low Glucose Minimizer
Intervention type(s): Device
Intervention description(s): This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Other intervention name(s): type 1 diabetes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Type 1 diabetes; Insulin Pump
Research Study to Assess New Chikungunya and Zika Vaccines in Healthy Adults in Mexico.
Condition: Chikungunya; Zika
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase Ib, single centre, double-blind, double-dummy placebo-controlled, randomised, stepwise
      dose escalated, vaccine trial to assess the safety and immunogenicity of the candidate
      ChAdOx1 Chik and ChAdOx1 Zika vaccines, given as a standalone vaccines or in
      co-administration. Healthy volunteers aged 18-50 years old, residents of the metropolitan
      area of Monterrey (Mexico), will be recruited as participants
    

Detailed description: 
      This trial consists of 4 intervention arms according to the vaccination product: 1) ChAdOx1
      Chik, 2) ChAdOx1 Zika, 3) ChAdOx1 Chik and ChAdOx1 Zika as contralateral co-administration,
      and 4) placebo. There will be a total of 120 participants divided in ten study groups with 12
      participants per group (Table 5.1). Groups 1 to 3 will receive ChAdOx1 Chik + placebo
      administered contralaterally, Groups 4 to 6 will receive ChAdOx1 Zika + placebo administered
      contralaterally, and Groups 7 to 9 will receive both ChAdOx1 Chik and ChAdOx1 Zika
      administered contralaterally. Group 10 will receive placebo in both arms.

      Enrolment into this study will be implemented in a step-wise dose escalation manner.
      Participants will be first recruited into the vaccination groups at the lowest dose (Groups
      1, 4 and 7). It is only after completion of these low dose groups and upon satisfactory
      interim clinical safety reviews that participants will be enrolled into the mid dose groups
      (Groups 2, 5 and 8). Participants in the high dose groups (Groups 3, 6 and 9) will be
      enrolled last, after completion and interim clinical safety reviews from the mid dose groups.
      Participants allocated to the Placebo group (Group 10) will be evenly distributed across the
      dose escalation model.

      Randomisation procedures will be implemented accordingly, at a ratio of 3:3:3:1 for each of
      the four intervention arms.

      The study involves a total of 9 visits (screening inclusive) and follow up will be undertaken
      for 6 months after vaccination day

      Innovate UK (project number 971557)
    

Intervention name(s): CHIK low dose; CHIK mid dose; CHIK high dose; ZIKA low dose; ZIKA mid dose; ZIKA high dose; Saline placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): A single dose of 5x10^9 vp ChAdOx1 Chik; A single dose of 2.5x10^10 vp ChAdOx1 Chik; A single dose of 5x10^10 vp ChAdOx1 Chik; A single dose of 5x10^9 vp ChAdOx1 Zika; A single dose of 2.5x10^10 vp ChAdOx1 Zika; A single dose of 5x10^10 vp ChAdOx1 Zika; A single dose of isotonic saline solution (0.9%)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Vaccine; ChAdOx1; Chikungunya; Zika; Mexico
Effects of Low-level Laser Therapy on Global Gene Expression of Young Males Submitted to Physical Strength Training
Condition: Healthy
Study type: Interventional

Summary: 
      Muscle performance is largely influenced by modulations in gene expressions of muscle tissue.
      In this context, low-level laser therapy has been used to improve muscle performance in
      experimental models and human researches. Thereby, the investigators examined modulations on
      global gene expression of muscle tissue influenced by exercise associated to low-level laser
      therapy.
    

Detailed description: 
      This study assessed muscle performance in isokinetic dynamometry and leg press device; global
      gene expression of muscle tissue by microarray analysis
    

Intervention name(s): Low-level laser therapy and training; Training
Intervention type(s): Device; Other
Other intervention name(s): Laser; Laser therapy; Low-level laser therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low-level laser therapy; muscle performance; strength training; gene expression; microarrays
Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when
      given as single oral ascending doses to Japanese healthy male volunters. This will be done by
      comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption,
      distrubution and disappearance of AZD4017 in the body. Information about plasma
      concentrations of AZD4017 vs time after dose intake will also be collected. The future
      indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.
    


Intervention name(s): AZD4017; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ascending single doses (start dose 2 mg), oral suspension; placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: safety; tolerability; pharmacokinetics; AZD4017Japanese
Irofulven in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with
      relapsed or refractory non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate to 6-hydroxymethylacylfulvene (HMAF) as salvage
      chemotherapy in patients with relapsed or refractory non-small cell lung cancer. II.
      Determine the duration of response to this regimen in this patient population. III. Determine
      the effect of prior response to chemotherapy on the response to HMAF in these patients. IV.
      Determine the survival and failure-free survival of patients treated with HMAF. V. Evaluate
      the toxicity profile of HMAF as salvage therapy in these patients.

      OUTLINE: Patients are stratified into relapsed or refractory patient groups based on results
      achieved with prior therapy. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes
      daily for 5 days. Courses repeat every 28 days. Patients with stable or responding disease
      are treated for a minimum of 6 courses (2 courses beyond optimal response) in the absence of
      unacceptable toxic effects or disease progression. Patients are followed at least every 3
      months for 1 year, then every 6 months until death.

      PROJECTED ACCRUAL: A total of 66 patients (33 for each stratum) will be accrued for this
      study within 12-18 months.
    

Intervention name(s): 6-hydroxymethylacylfulvene
Intervention type(s): Drug
Intervention description(s): 11mg/sq m IV infusion over 5 min q day for 5 days each 28 day cycle
Other intervention name(s): irofulven
Intervention MeSH terms: Irofulven
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer
A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the movement of Belatacept drug products, whose active pharmaceutical
      ingredient has been manufactured by 2 different processes, into, through and out of the body
      (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned
      to one of two groups, and will receive a single dose of a belatacept product once during a
      4-day stay at a study site.
    


Intervention name(s): belatacept
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers
Imagery-based CBT for Social Anxiety Disorder: Piloting a Treatment Augmentation Protocol
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The purpose of this pilot study is to explore whether there is a differential impact of
      verbal versus imagery-based cognitive behavioural therapy (CBT) as a treatment augmentation
      strategy for individuals with social anxiety disorder (SAD). Clients who have not
      demonstrated clinically significant change following group CBT for SAD will receive four
      additional sessions of either verbal-based CBT or imagery-based CBT. We hypothesize that that
      individuals who receive imagery-based CBT will experience even stronger improvements and be
      more satisfied with their treatment than individuals who received traditional
      verbal-linguistic CBT.
    

Detailed description: 
      Social Anxiety Disorder (SAD) is a debilitating disorder, marked by significant functional
      impairment and high personal distress for those who suffer. Psychological treatment for SAD
      has traditionally been verbal-linguistic cognitive behavioural therapy (CBT). However, a
      significant number of individuals who complete CBT for SAD do not achieve full response and
      continue to struggle with significant residual symptoms. One innovation that has received
      attention recently in the literature is using imagery-based CBT as a way to augment treatment
      outcome in SAD. Results from a pilot and benchmarking study suggest that participants who
      received imagery-based CBT were more likely to complete treatment than those who received
      traditional CBT and treatment outcome was strong for both groups, but stronger in the
      imagery-based CBT group.

      However, before re-training hundreds of practitioners in using a completely novel treatment
      approach, it is important to see if a brief augmentation of traditional CBT programs is
      effective in producing further change for individuals with residual symptoms after group CBT.
      It is possible that individuals just require a few more sessions of the same
      verbal-linguistic CBT to consolidate treatment gains or work on lingering triggers of
      anxiety. It is also possible that more of the same is not as valuable as offering therapy
      using a different modality, such as imagery. Therefore, we propose to evaluate a brief
      imagery-based augmentation of traditional group CBT to explore its effects on further symptom
      reduction.
    

Intervention name(s): Verbal-linguistic CBT; Imagery-based CBT
Intervention type(s): Other; Other
Intervention description(s): Participants will receive 4 sessions of individual therapy focused on traditional cognitive restructuring and exposure therapy.; Participants will receive 4 sessions of individual therapy focused on imagery-based cognitive work and behavioural experiments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Behavioural Therapy
Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The investigators are seeking people who have been exposed to a traumatic event in the past
      and have symptoms of posttraumatic stress disorder (PTSD) currently. A person with PTSD may
      feel significant distress when reminded of a traumatic event or feel depressed, anxious or
      jumpy.

      As a part of this study, participants will receive brain MRIs and office assessments before
      and after psychotherapy. The investigators provide the gold-standard psychotherapy for PTSD,
      "Prolonged Exposure", free of charge; additionally participants are compensated for their
      time during assessment procedures. This study is exploring the brain circuitry involved in
      improvement in response to psychotherapy.
    


Intervention name(s): Prolonged exposure
Intervention type(s): Behavioral
Intervention description(s): PE will be delivered in 9-12 90-minute sessions. Therapy will be delivered by PhD-level therapists at Stanford and Palo Alto VA. PE consists of four components: psychoeducation about PTSD symptoms and the behavioral or cognitive factors maintaining it, a brief breathing retraining that can be used as a stress management tool, prolonged imaginal exposure to the trauma memory both within-session and repeated as homework, and prolonged in vivo exposure to avoided scenarios in patients' day-to-day lives.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Posttraumatic Stress Disorder (PTSD); Psychotherapy; non-medication treatment; Prolonged Exposure; Transcranial Magnetic Stimulation (TMS); Anxiety Disorders; emotion; emotion regulation; functional MRI; Affective Symptoms
Immunogenicity and Safety Trial of the HIV-1 Tat Vaccine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a randomized, open label, phase II clinical trial directed at evaluating the
      immunogenicity (as a primary end-point) and the safety (as a secondary end-point), of the
      recombinant HIV-1 Tat vaccine in HIV-1 infected adult subjects, anti-Tat antibody negative,
      HAART-treated with chronic suppressed HIV-1 infection, CD4+ T cell counts >= 200
      cells/microliter, levels of plasma viremia < 50 copies/ml in the last 6 months prior to the
      screening and without a history of virologic rebound. The immunogenicity of 3 or 5
      immunizations of the two different vaccine doses (7.5 and 30 micrograms) of the Tat vaccine
      has been evaluated.
    

Detailed description: 
      This phase II clinical trial was directed at evaluating the immunogenicity and the safety of
      the HIV-1 Tat protein-based vaccine. Anti-Tat antibody negative, HIV-1 positive subjects
      treated successfully with HAART have been screened and recruited for a 48-weeks study,
      including a period of 16 or 8 weeks treatment phase and a period of 32 or 40 weeks follow-up
      phase, in arm A or Arm B, respectively. One hundred sixty-eight subjects have been randomized
      1:1:1:1 to one of the 2 arms (Arm A and Arm B) and each arm has been divided in the following
      groups:

      Arm A - Group I: 5 immunizations with Tat (7.5 microg) at weeks 0, 4, 8, 12, 16; Arm A -
      Group II: 5 immunizations with Tat (30 microg) at weeks 0, 4, 8, 12, 16; Arm B - Group I: 3
      immunizations with Tat (7.5 microg) at weeks 0, 4, 8; Arm B - Group II: 3 immunizations with
      Tat (30 microg) at weeks 0, 4, 8.

      Four vaccination regimens have been tested by intradermal administration of the Tat vaccine
      at two different doses (7.5 microg or 30 microg) in 5 or 3 immunizations.
    

Intervention name(s): Tat protein
Intervention type(s): Biological
Intervention description(s): Biologically active recombinant Tat protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Tat protein; Therapeutic vaccine; HAART; HIV Therapeutic Vaccine; Treatment Experienced
A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome
Condition: Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920
      (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).
    

Detailed description: 
      The study will enrol 2 SS populations: Population 1 will include participants with moderate
      to high systemic disease activity defined by European League Against Rheumatism (EULAR)
      Sjögren's Syndrome Disease Activity Index (ESSDAI) >= 5; Population 2 will include
      participants with moderate to severe subjective symptoms defined by EULAR Sjögren's Syndrome
      Patient Reported Index (ESSPRI) score >= 5 and residual stimulated salivary flow but with
      mild systemic disease activity defined by ESSDAI score < 5. This study will include 3
      periods: screening (4 weeks), treatment period (40 Weeks) and follow-up period (12 weeks). In
      the treatment period, participants from each of the populations will be randomized at 1:1
      ratio to receive intravenous (IV) dose of VIB4920 or placebo (Stage I). After completion of
      Stage I, participants randomized to VIB4920 in Stage I will receive placebo and participants
      randomized to placebo in Stage I will receive VIB4920 (Stage II). Participants who had study
      drug discontinuation will not be eligible for treatment during Stage II. All participants
      will be followed for at least 12 weeks after their last dose of study drug administration.
    

Intervention name(s): VIB4920; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous Dose 1.; Intravenous dose matched to VIB4920.
Other intervention name(s): Dazodalibep
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sjögren's Syndrome; SS; VIB4920; MEDI4920