bioihbjkbjnl/mcl2 huggingface dataset:
Stabilizing Behavioral Rhythms to Improve Mental Health
Condition: Depressive Symptoms; Anxiety Symptoms; Sleep Symptoms
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      In order to assess the efficacy of the Rhythm Stabilization component of HealthRhythms'
      product, investigators will recruit 128 outpatients between the ages of 18 and 65, presenting
      to the University of Utah Department of Psychiatry outpatient clinics with a current mood
      and/or anxiety disorder. Sixty-four of these individuals will be randomly allocated to
      receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm
      Stabilization) on their smartphones, while 64 will be asked to consent to Rhythm Sensing
      only. Participants in both arms will receive treatment as usual (TAU) for their mood and/or
      anxiety disorders, as typically provided at the University of Utah clinics. The duration of
      the study will be 16 weeks.

      The primary outcome measures of the RCT will be the PROMIS Depression, the PROMIS Anxiety and
      the PROMIS Sleep Disturbance computerized adaptive testing (CAT) measures. The investigators
      hypothesize that those receiving the full package will demonstrate lower levels of
      depression, anxiety and sleep disturbance. In addition, investigators will explore the
      relationship between sensed rhythm stability and scores on patient-reported outcome measures
      of mood, anxiety and sleep disturbance (PROMIS). The investigators hypothesize that positive
      changes in the PROMIS measures will be mediated by positive changes in rhythm stability.

      The primary outcome analyses will be based on random regression models, while the mediation
      analyses will follow the approach described by Helena Kraemer and colleagues.
    


Intervention name(s): Full Package
Intervention type(s): Behavioral
Intervention description(s): Individuals will be randomly allocated to receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm Stabilization) program on their smartphones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether DuPont Experimental Dietary Fibre products
      1 and 2 are digested using glycaemic and insulinaemic response as markers.
    

Detailed description: 
      DuPont Experimental Dietary Fibre products 1 and 2 glycaemic and insulinaemic response will
      be compared against that of polydextrose and dextrose when given to adult healthy volunteers.
    

Intervention name(s): Experimental Dietary Fibre 1; Experimental Dietary Fibre 2; Polydextrose; Dextrose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 22.17 g of product diluted in 250 ml of water taken once orally.; 21.84 g of product diluted in 250 ml of water taken once orally.; 21.48 g of product diluted in 250 ml of water taken once orally.; 23.89 g of dextrose diluted in 250 ml of water taken once orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Glycemic Index; Dietary Fiber
A Phase 1 Study to Assess the Pharmacokinetics of AZD9977 Administered Alone and in Combination With Itraconazole in Healthy Volunteers
Condition: Heart Failure With Preserved Ejection Fraction (HFpEF)
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, non-randomized, fixed sequence study conducted at a single study
      center with primary aim to assess the pharmacokinetics (PK) of AZD9977 in healthy volunteers
      when administered alone and in combination with multiple doses of itraconazole.
    

Detailed description: 
      This is an open-label, non-randomized, fixed sequence study conducted at a single study
      center with primary aim to assess the pharmacokinetics (PK) of AZD9977 in healthy volunteers
      when administered alone and in combination with multiple doses of itraconazole. Two types of
      treatments (treatment period 1 and treatment period 2) will be administered in a fixed order
      separated by a washout period of 3 days or more. Treatment period 1 will be single dose of
      AZD9977 (Dose 1) administration, in the fed state, on Day 1 followed by at least 3 days
      washout period. For treatment period 2, Itraconazole will be administered daily (Dose 2) from
      Day 4 to Day 8 plus AZD9977 (Dose 1, fed state) will be administered as a single dose on Day
      7. Dose of itraconazole has to be taken at -1 hour (1 hour prior to AZD9977 dosing) when
      co-administered with AZD9977.
    

Intervention name(s): AZD9977; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single AZD9977 (Dose 1) capsule orally once daily in fed state, on Day 1 followed by at least 3 days washout period.; Participants will receive Itraconazole daily (Dose 2) capsule orally once daily from Day 4 to Day 8 plus will be administered AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole has to be taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977.
Other intervention name(s): Sporanox
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Congestive heart failure; Healthy volunteers; Itraconazole; Drug-drug interaction; Pharmacokinetics; Open-label non-randomized
Validation of Hausa Oswestry Disability Index, Numeric Pain Rating Scale, Roland-Morris Disability Questionnaire, SF-12 Health Survey, Pain Catastrophizing Scale, Fear-Avoidance Beliefs Questionnaire,Global Rating of Change Scale and Back Beliefs Questionnaire in Low Back Pain Patients
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Oswestry Disability Index (ODI), Numeric Pain Rating Scale, Roland-Morris Disability
      Questionnaire (RMDQ), SF-12 Health Survey, Pain Catastrophizing Scale (PCS), Fear-Avoidance
      Beliefs Questionnaire (FABQ), Global Rating of Change Scale and Back Beliefs Questionnaire
      (BBQ) are important and widely used validated patient self-reported measures commonly used in
      clinical trials and health research involving patients with low back pain (LBP). However, to
      date, validated Hausa versions of these tools are unavailable for use despite not only Hausa
      language is commonly spoken in Nigeria but in other parts of the world.

      The purpose of this study is to perform, using evidence-based guidelines, translation,
      cultural adaptation and validation of the ODI, NPRS, RMDQ, SF-12 health survey, FABQ, PCS,
      GROC and BBQ into Hausa language among patients with LBP in Northern Nigeria.
    

Detailed description: 
      This study will test the psychometric properties (i.e validity; reliability, and ceiling
      effect) of the ODI-H, NPRS, RMDQ-H, SF-12-H, FABQ-H, PCS-H, GROC and BBQ-H in Hausa-speaking
      patients with LBP. Rural and urban participants with LBP will be recruited purposively.
      Copies of the translated Hausa versions of the NPRS, ODI, RMDQ, SF-12, FABQ, PCS, BBQ as well
      as VAS for pain and disability will be self or interviewer-administered. Lumbopelvic mobility
      using finger-floor distance test (FFD) will be also measured. The Hausa versions of the ODI,
      NPRS, RMDQ, SF-12, FABQ, PCS, GROC and BBQ will be administered again a week after.

      Data will be analysed using descriptive, correlation, and factorial analysis on IBM SPSS
      (version 23.0) at alpha level of 0.05.
    

Intervention name(s): Application of the initial evaluation; Final application of instruments
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Initial evaluation involves the application of Hausa ODI, NPRS, RMDQ, SF-12, PCS, GROC, BBQ, VAS for pain and disability, and FFD.; Application of the Hausa versions of ODI, NPRS, RMDQ, SF-12, PCS, GROC and BBQ one week after initial evaluation
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults with CLBP attending either rural or urban physiotherapy clinics in Kano State,
        Northern Nigeria.
      
Keywords: Chronic Low Back Pain; Oswestry Disability Index; Numeric Pain Rating Scale; Roland Morris Disability Questionnaire; SF-12 Health Survey; Fear-Avoidance Beliefs Questionnaire; Pain Catastrophizing Scale; Global Rating of Change Scale; Back Beliefs Questionnaire
Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will look at differences in bioanalytical measures among different groups of MS
      patients and Healthy Volunteers, when administered interferon beta-1a.
    


Intervention name(s): Interferon beta-1a (Avonex)
Intervention type(s): Drug
Intervention description(s): 30 mcg by intramuscular injection once a week
Other intervention name(s): Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Multiple Sclerosis
Effects of a Whole Grain Cereal Product on Blood Glucose Response After 3 Consecutive Meals
Condition: Blood Glucose
Study type: Interventional

Summary: 
      In this pilot study it will be investigated if a whole grain product will improve the glucose
      response not only when it is eaten at breakfast, but also at the two following meals; lunch
      and dinner (2nd and 3rd meal effect) in a healthy population.
    


Intervention name(s): Breakfast product: Whole grain; Breakfast product: Reference
Intervention type(s): Other; Other
Intervention description(s): This intervention is a whole grain-based breakfast product containing oats and barley.; This intervention is a rice-based breakfast product.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this clinical trial is to investigate the
      pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog
      alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.
    


Intervention name(s): turoctocog alfa
Intervention type(s): Drug
Intervention description(s): Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.
Other intervention name(s): N8; recombinant factor VIII
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Baclofen on Marijuana Withdrawal and Relapse
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's
      direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.
    

Detailed description: 
      Only a small percentage of dependent-marijuana smokers who are seeking treatment for their
      marijuana use are able to achieve sustained abstinence. The objective of this study is to
      investigate the interaction between marijuana and the potential treatment medication,
      baclofen, with the direct goal of using this information to improve marijuana treatment
      outcome. GABAB agonists such as baclofen have been shown to attenuate the self-administration
      of cocaine, heroin, alcohol and nicotine (see Cousins et al., 2002; Haney et al., 2006).
      Baclofen also appears to decrease withdrawal symptoms in heroin and alcohol abusers
      (Akhondzadeh et al., 2000; Addolorato et al., 2000). The purpose of this study is to
      determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of
      marijuana withdrawal and thus decreases marijuana relapse in our laboratory model. For the
      purposes of this model, relapse is defined as a return to marijuana use after a period of
      abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with
      each participant maintained on each of three medication conditions for 16 days: placebo and
      baclofen (60, 90 mg/day). Participants will begin taking capsules during the outpatient phase
      so that the dose can be incremented up to the maintenance dose prior to the first inpatient
      day. Further, clinical studies have shown that baclofen is most effective at decreasing
      cocaine's effects when administered for several weeks. During the inpatient study phases,
      participants will have the opportunity to self-administer placebo or active marijuana 6 times
      per day. This study will provide important information of the effect of baclofen as a
      potential treatment medication for marijuana dependence.
    

Intervention name(s): Baclofen; Marijuana; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).; Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.
Other intervention name(s): Lioresal; cannabis
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Baclofen; Marijuana Dependence; Marijuana Withdrawal
Escitalopram (Lexapro) for Depression MS or ALS
Condition: Major Depression; Multiple Sclerosis; Amyotrophic Lateral Sclerosis
MeSH terms: Multiple Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major
      depressive disorder in patients who have ALS or MS.
    

Detailed description: 
      This eight-week study aims to assess the effectiveness and tolerability of escitalopram in
      improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS)
      or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess
      improvement in the quality of life in patients with Major Depression and ALS or MS.
    

Intervention name(s): escitalopram
Intervention type(s): Drug
Intervention description(s): After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; ALS; Multiple Sclerosis; MS; Major Depression; Depression; Major Depressive Disorder; antidepressants; Escitalopram; Lexapro
A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study to evaluate the safety and tolerability of single ascending
      doses of IW-3300. The study drug will be administered rectally as a low-volume (20 mL) enema.
      Study participants will be randomized in a 3:1 ratio to receive a single dose of IW-3300 or
      placebo. Up to 5 different doses of IW-3300 will be studied. Safety reviews will be conducted
      before proceeding to each higher dose.
    

Detailed description: 
      This is a Phase 1, single-center, randomized, double-blind, placebo-controlled,
      single-ascending-dose study assessing the safety, tolerability, and pharmacokinetics (PK) of
      IW 3300 administered rectally as a low-volume enema in healthy adult volunteers. This
      first-in-human study will assess participants for safety, tolerability, and PK.

      The study includes up to 6 treatments: placebo and up to 5 dose levels of IW-3300 which will
      be determined after safety reviews of previous cohorts.

      This study will enroll a maximum of 40 participants (up to 5 cohorts of 8 participants each).
      The 8 participants within each cohort will be randomized in a double-blind manner to receive
      a single dose of IW-3300 (6 participants) or placebo (2 participants), administered rectally
      as a low-volume [20 mL] enema. Each cohort will progress through a Screening Period, Clinic
      Period, and Follow-up Period. Treatment duration will be 1 day. Participants will remain in
      the Phase 1 unit for approximately 24 hours after dosing and will be contacted by phone for
      follow-up approximately 2 weeks after dosing. Total participation will be 22 to 45 days,
      including the Screening, Clinic, and Follow-up Periods.
    

Intervention name(s): IW-3300; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of IW-3300 administered rectally (as a low-volume [20 mL] enema) following a fast of at least 6 hours.; A single dose of placebo administered rectally (as a low-volume [20 mL] enema) following a fast of at least 6 hours.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteers
HOPE Social Media Intervention for HIV Testing and Studying Social Networks
Condition: HIV
Study type: Interventional

Summary: 
      This study [HOPE: Harnessing Online Peer Education] seeks to determine the efficacy of using
      online social networks to scale peer community leader models to increase HIV prevention
      within African-American and Latino men who have sex with men. The peer community leader
      model, which teaches community popular opinion leaders about how to disseminate behavior
      changes messages throughout the community, has been proven to increase HIV prevention
      behaviors. Social media and online communities, such as Facebook, may be a cost-effective
      platform for scaling these models. Primarily upper middle-class White populations used the
      Internet in its early years, however, Internet use within African-American and Latino
      households has recently increased dramatically, especially on social media. People using the
      Internet may be at the highest risk for contracting HIV and are using novel Internet
      approaches to find sex partners, such as through social media. This is the first study to
      examine the effectiveness of the HOPE social media intervention to increase HIV testing among
      at-risk groups in the United States.
    


Intervention name(s): social media intervention
Intervention type(s): Behavioral
Intervention description(s): social media intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is:

        -  to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616)
           given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in
           pediatric and adult participants

        -  to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants,
           and to evaluate the safety of sugammadex in pediatric and adult participants.
    


Intervention name(s): Sugammadex 0.5 mg/kg; Sugammadex 1 mg/kg; Sugammadex 2 mg/kg; Sugammadex 4 mg/kg; Placebo; Rocuronium bromide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): IV infusion; IV infusion; IV infusion; IV infusion; IV infusion; IV infusion
Other intervention name(s): Org 25969; MK-8616; SCH 900616; Org 25969; MK-8616; SCH 900616; Org 25969; MK-8616; SCH 900616; Org 25969; MK-8616; SCH 900616; sodium chloride 0.9% solution; ESMERON®
Intervention MeSH terms: Bromides; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate T-20 in children.
    

Detailed description: 
      Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples
      for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the
      selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin
      a "new" optimized antiretroviral regimen based on the patients' prior treatment history,
      historical resistance testing results, and the results of the testing performed at screening.
      Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly
      through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study
      visits are performed.
    

Intervention name(s): Enfuvirtide
Intervention type(s): Drug
Intervention MeSH terms: Enfuvirtide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-HIV Agents; pentafuside