bioihbjkbjnl/mcl2 huggingface dataset:
Neurophysiological and Acute Pharmacological Studies in FXS Patients
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to utilize neurophysiologic assessments, behavioral measures and
      clinical measures to assess how much deficits associated with Fragile X Syndrome from
      pre-dose to post-dose using pharmacology.
    


Intervention name(s): Acamprosate; Lovastatin; Minocycline; Placebo; Baclofen
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): two 666mg pills; two 20mg pills; two 135mg pills; placebo pill; one 30mg pill
Intervention MeSH terms: Minocycline; Acamprosate; Baclofen; Lovastatin; L 647318; Dihydromevinolin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study was designed as a 4-intervention crossover, with all study participants receiving all possible interventions. These were originally placebo, acamprosate, minocycline, and lovastatin. Midway through the study (n=16) it was determined that acamprosate was undetectable in serum and this intervention was replaced by baclofen. Remaining participants (n=13) received baclofen and 5 participants were re-enrolled to receive baclofen or a second round of placebo, so investigators and participants would remain blinded to drug status during the baclofen visit. The second round of placebo was not analyzed.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Investigate Pharmacodynamics and Pharmacokinetics of OPC-41061 in Patients With Hepatic Edema
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to
      cirrhosis patients with ascites despite having received treatment with conventional diuretics
      and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.
    


Intervention name(s): OPC-41061; OPC-41061
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days; Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cirrhosis; ascites; Tolvaptan; OPC-41061
Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the necessary cause
      of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and
      thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical
      cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent
      vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and
      safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18
      L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.
    


Intervention name(s): HPV Vaccine (GSK580299) Cervarix TM; Engerix B
Intervention type(s): Biological; Biological
Intervention description(s): IM administration; IM administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Co-administration; HPV vaccine; Cervical cancer
VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Objective:

        1. To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program in
           reducing anxiety disorder symptoms in at-risk public school children.

        2. To determine whether parent education and involvement improves outcome in anxious
           children treated with CBT.

        3. To determine the ability of school personnel in a) recognizing classroom behaviors as
           anxiety disordered after targeting training of observable child behaviors e.g.,
           avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and

        4. To evaluate a new measure of teacher-rated anxiety disorder symptoms in children.

      Hypothesis:

        1. A CBT oriented intervention as delivered by school personnel will be superior to an
           attention control procedure in reducing anxiety symptoms in at-risk children.

        2. Children who have parental involvement will post stronger and more enduring treatment
           gains.
    


Intervention name(s): Cognitive Behaviour Treatment
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Anxiety; Therapy; Behaviour
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy
Condition: Narcolepsy
MeSH terms: Narcolepsy; Cataplexy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible
      treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of
      this study is to learn how well the study drug works and how safe the study drug is compared
      to placebo.
    

Detailed description: 
      This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to
      evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SUVN-G3031 compared
      to placebo in participants with narcolepsy with and without cataplexy. Participants will be
      randomized at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Each
      participant will receive study drug once daily, in a tablet formulation, for 14 days.
    

Intervention name(s): SUVN-G3031; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SUVN-G3031 Tablets; Placebo Tablets
Other intervention name(s): Samelisant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SUVN-G3031; Narcolepsy with and without cataplexy; Cataplexy; Narcolepsy Type 1; Narcolepsy Type 2; Excessive Daytime Sleepiness (EDS); Histamine H3 receptor; Samelisant
Haskap and Endurance Running Performance
Condition: Exercise Performance
Study type: Interventional

Summary: 
      This study will employ a randomised, double-blind, placebo-controlled, independent groups
      experimental design. Submaximal, maximal and 5 km time trial running performance will be
      assessed before and after supplementation with haskap berry or a placebo.
    

Detailed description: 
      Participants will consume haskap berry powder or an isocaloric placebo for 7 days. They will
      be required to run on a treadmill before and after supplementation to asses the influence on
      the intervention on aerobic performance parameters. Other performance parameters such as
      blood lactate, heart rate, ratings of perceived exertion and respiratory variables will also
      be monitored throughout the various elements of the exercise trials.
    

Intervention name(s): Haskapa; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Haskapa Ltd, Oxford, UK; isocaloric to the haskap powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: berry; running; time trial
Tai Chi, Physiologic Complexity, and Healthy Aging
Condition: Healthy Aging
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effects of Tai Chi-a mind-body exercise--on age-related loss of physiological
      complexity (using fractal and entropy based measures), and to understand the relationship
      between complexity, function and adaptability, we will conduct a two-arm prospective
      randomized clinical trial. Our overarching goal is to evaluate if six months of Tai Chi
      training, compared to a waitlist control receiving standard medical care, can enhance
      physiological complexity and adaptability in older Tai Chi-naïve adults. Secondary goals of
      the study are to characterize the relationship between complexity biomarkers, measures of
      function, and resilience. This pilot study will inform a future more definitive trial by
      providing information on recruitment and retention, compliance, dose-dependent effects,
      preliminary estimates of effect size, and the optimal biomarkers of complexity, function, and
      adaptive capacity.
    

Detailed description: 
      Specific Aim #1: To determine if 6 months of Tai Chi training can increase complexity,
      function, and adaptive capacity of multiple physiological systems in older healthy adults.
      Specific Aim #2: To determine the relationships between biomarkers of physiological
      complexity, conventional measures of function and adaptive capacity. Statistical regression
      models will be used to determine relationships, both at baseline and overtime, between a)
      complexity biomarkers and measures of physical and cognitive function, and b) complexity
      biomarkers and adaptive capacity. Elucidating these relationships will further inform the
      interpretation of complexity biomarkers and provide insights into underlying component
      mechanisms contributing to complex physiological dynamics.
    

Intervention name(s): Tai Chi Exercise; Tai Chi
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Practicing Tai Chi exercise 4 times a week for 6 months - twice in a classroom and twice independently; Usual care, individuals attend testing sessions for 6 months with testing at times 0, 3, and 6 months. Individuals in Usual Care receive 3 months of Tai Chi at the study end.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of
      Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).
    


Intervention name(s): Efavaleukin Alfa; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Efavaleukin Alfa will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.; The placebo will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This phase 1b study is a double-blind, placebo controlled multiple ascending dose (MAD) study to evaluate the safety and tolerability of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE) and to determine the recommended phase 2 dose(s). Participants will be treated for a total of 12 weeks followed by a 6 week follow-up period. Five dosing cohorts are planned for the study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Efavaleukin Alfa; Systemic lupus erythematosus; Phase 1b
Smoking by IV Pulsed Nicotine
Condition: Smoking Cessation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine
      dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches
      nicotine delivery by inhaled tobacco use.
    

Detailed description: 
      Both sub-studies will enroll male and female tobacco cigarette smokers. This study will
      examine the feasibility of the proposed study parameters in a total of 10 completers. In a
      crossover design, participants will be tested under 5 conditions: 0.2 mg nicotine delivered
      over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20
      pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine
      deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). The
      main outcome measures will be self-report drug effects and urges to smoke cigarettes.

      The investigators hypothesize that the abuse potential and alleviation of smoking urges are
      produced by nicotine as a function of nicotine dose and delivery rate.

      This study is complete with 13 enrolled and 10 completers
    

Intervention name(s): Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s
Intervention type(s): Drug
Intervention description(s): Nicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries).
Other intervention name(s): nicotine infusion
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: placebo-controlled, mixed-design with nicotine dose as a between-subject and nicotine delivery rate as a within-subject factor.
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
A Clinical Trial to Examine Effects of Atomoxetine in the Treatment of Negative Symptoms in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study proposes to examine the effect of atomoxetine on quality of life and negative
      symptoms such as social withdrawal, lack of interest in things, lack of thought content, flat
      emotions, slowed body movements and lack of drive and motivation in patients with
      schizophrenia or schizoaffective disorder. This study also examines the safety of using
      atomoxetine along with the conventional antipsychotic in these patients.
    

Detailed description: 
      This study proposes to examine the effect of Atomoxetine (Strattera), a selective
      norepinephrine reuptake inhibitor on Negative Symptoms and Quality of Life and its safety
      when used in conjunction with an atypical antipsychotic agent in remitted community dwelling
      subjects with Schizophrenia or Schizoaffective disorder. Atomoxetine was recently approved by
      the FDA for the treatment of Attention Deficit Hyperactivity Disorder in children and adults.
      All subjects will receive various psychometric assessments at 2-week intervals for a period
      of 26 weeks. It is hypothesized that subjects treated with Atomoxetine in this 26 week random
      assignment, parallel-group, double-blind, placebo-controlled study, will have a significantly
      greater improvement in quality of life and social functioning.
    

Intervention name(s): Atomoxetine (Strattera)
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Schizo-Affective Disorder; Negative Symptoms; Atomoxetine; Strattera
Improving Asthma Care Through Parental Empowerment
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The overall aim of this study will be to perform a prospective randomized clinical trial of
      an enhanced version of the IMPACT DC intervention involving short-term case management to
      facilitate PCP follow-up appointments and to provide education for parents about how to
      communicate more effectively with their children's PCPs as a means (1) to improve the rate of
      utilization of primary care services for ongoing asthma care and (2) to enhance the
      self-efficacy of parents in their interactions with their children's provider regarding the
      child's asthma care needs in 150 parents of high risk children referred within the IMPACT DC
      Asthma Clinic.
    

Detailed description: 
      Asthma is the most common chronic disease of childhood, and it disproportionately affects
      urban, minority, and disadvantaged children. When implemented correctly, existing
      evidence-based guidelines from the National Heart, Lung, and Blood Institute (NHLBI) improve
      pediatric asthma care and outcomes. One key component of these guidelines is the importance
      of longitudinal care as part of a partnership among patient, parents, and a healthcare
      provider. Such a partnership depends on effective communication of healthcare status by
      parents to providers. Improving the communication skills of inner-city parents may improve
      their ability to obtain more effective longitudinal asthma care within their primary care
      homes and thereby to improve their child's asthma health outcomes. IMPACT DC ("Improving
      Pediatric Asthma Care in the District of Columbia") is a locally validated emergency
      department (ED) based intervention that improves multiple measures of asthma care and
      outcomes through an intensive short-term program of asthma education, medical care, and care
      coordination. In spite of these successes, achieving increased subsequent contact and
      partnership with primary care providers (PCPs) for asthma care after the intervention has not
      been successful. Therefore, for the current study, we propose to assess the effectiveness of
      an enhanced version of the existing IMPACT DC intervention consisting of short-term case
      management by trained asthma educators.
    

Intervention name(s): PEPAC
Intervention type(s): Behavioral
Intervention description(s): The proposed enhancement of the IMPACT DC intervention will consist of three key components: (1) an enhanced IMPACT DC Asthma Clinic visit; (2) short-term case management to increase the rate of primary care follow-up visits in the first month after the IMPACT DC Asthma Clinic visit; and (3) training in an "asthma care toolkit" to improve communication around asthma care with the child's primary care provider.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: parental empowerment; parent self-efficacy
Synbiotics in Advanced HIV Infection
Condition: HIV Infection Asymptomatic
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a
      greater risk of clinical progression. Gut bacteria metabolism appears to impact immune
      recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and
      probiotics seem to exert immunological effects, the clinical implications in this key
      population remain unknown. This is a pilot multicenter randomized placebo-controlled, double
      blind clinical trial in HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS.
      Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341
      or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be
      safety and immunological recovery. Secondary outcomes will include changes in fecal
      microbiota structure and plasma inflammatory markers.
    


Intervention name(s): PMT25341; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HIV; immunologic recovery; microbiota; prebiotics; probiotics; synbiotics
Study to Evaluate Biomarkers and Clinical Manifestations in Individuals With Glycogen Storage Disease Type III (GSD III)
Condition: Glycogen Storage Disease Type III
MeSH terms: Glycogen Storage Disease; Glycogen Storage Disease Type III; Metabolic Diseases; Disease
Study type: Observational

Summary: 
      The primary objective of this study is to evaluate potential biomarkers of GSD III.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No Intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with a confirmed diagnosis of GSD III
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and
      Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping
      Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic
      Rhinitis/Rhinoconjunctivitis
    


Intervention name(s): AllerT; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacodynamic Study of Cilostazol in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to investigate the effects of Cilostazol,
      Acetylsalycylic acid and Clopidogrel alone as well as combinations of
      Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF)
      testing.
    


Intervention name(s): Cilostazol; Acetylsalicylic acid; Clopidogrel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Cilostazol; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers