bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Open-label Placebos on COVID-related Psychological Health
Condition: Stress; Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This project aimed to test the efficacy of a telehealth-administered placebo without
      deception intervention on stress, anxiety, and depression related to the COVID-19 pandemic.
      Participants were randomized into two groups (open-label placebo vs. no-treatment control).
      All participants received information on the impact of COVID-19 on psychological health.
      Participants in the open-label placebo group were instructed to watch an informational video
      on the beneficial effects of placebos without deception, remotely interact with an
      experimenter, and take open-label placebo pills twice a day for two weeks. Participants in
      the no-treatment control group did not receive any intervention. Instead, participants met
      with an experimenter and reported on their psychological and physical health. The
      investigators predicted that the placebo without deception group would exhibit substantially
      reduced stress, depression, and anxiety compared to a no-treatment control group.
    


Intervention name(s): Non-Deceptive Placebo
Intervention type(s): Behavioral
Intervention description(s): The placebos were ordered through Amazon from Zeebo® (Zeebo, Zeebo Effect, LLC, South Burlington, Vermont, USA). The placebos in this study were blue and white capsules containing Microcrystalline cellulose (an inert fiber). Ingredients include ones that are typically used to make pills including silica, gelatin, titanium dioxide, red #3 food coloring, and blue #1 food coloring. Placebo capsules were free of any active ingredients. These bottles were not branded specifically for the experiment, including the brand name ("Zeebo Relief"), description of the contents, directions, and a disclaimer. The investigators chose to not include a custom label for transparency and in order to increase "non-deceptive" placebo effects. Participants were instructed to take two pills a day, one in the morning and one in the evening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COVID-19; Non-Deceptive Placebos; Intervention; Telehealth; Stress; Anxiety; Depression
Concerta Treatment in Adults With ADHD NOS
Condition: ADHD NOS
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be an open label pilot study of Concerta in the treatment of adults with the
      diagnosis of Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS). We
      hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Concerta
      treatment in the short term and Concerta-associated response of ADHD symptomatology in adults
      with ADHD NOS will be sustained over the medium term.
    

Detailed description: 
      Concerta is a stimulant medication approved for the treatment of ADHD in children. We propose
      to study the safety and efficacy of Concerta therapy in adults with ADHD NOS. Adult ADHD NOS
      is operationalized by either

        -  An adult satisfying current diagnostic criteria for ADHD but with insufficient number of
           childhood symptoms to fulfill the required diagnostic threshold for this disorder set
           forth in DSM-IV

        -  An adult who has five current symptoms of inattention and/or five current symptoms of
           impulsivity/hyperactivity, but does not meet the full diagnosis criteria of six current
           symptoms within one of these categories.

      Our hypotheses will be examined in two phases of an open label, pilot study. Phase I of the
      study consists of a six-week acute effectiveness trial. Phase II consists of continuation for
      responders in which subjects who respond in Phase I will be re-assessed every four weeks for
      six months. Effectiveness will be measured by improvements in clinician-rated scales,
      including: ADHD Symptom Checklist, Clinical Global Impression: ADHD, and Global Assessment of
      Functioning.
    

Intervention name(s): atomoxetine (Strattera)
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD NOS; Adults; Concerta; Open-Label
Study to Analyze the Efficacy of Acute Intake With a β-alanine Supplement in Recreational Cyclists
Condition: Beta Alanine Supplementation
Study type: Interventional

Summary: 
      Randomized, controlled, double-blind, single-center, double-blind clinical trial with three
      parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and
      placebo product) to measure the efficacy of a sustained release beta alanine on physiological
      physical performance efficacy in recreational cyclists.
    

Detailed description: 
      Subjects meeting the selection criteria will be randomly assigned to each of the study groups
      (investigational product dose 1 or dose 2, or placebo, depending on the group to which they
      have been assigned).

      The product to be consumed is beta alanine. Participants will consume the product for 1 day.
      They will have to take four intakes every hour and a quarter, on the same day.

      The study subjects will have to make 2 visits to the laboratory. In the first one, they will
      have to perform a 10-minute time trial, without consumption. In the second visit, they will
      perform the same performance test but with acute consumption of the product. Their physical
      and physiological performance will be evaluated.

      The two tests will be separated by 7 days.
    

Intervention name(s): Beta Alanine high dose; Beta Alanine low dose; Control group
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 4 intakes of 5 g of beta alanine every 1 hour and 15 minutes.; 4 intakes of 2.5 g of beta alanine every 1 hour and 15 minutes.; 4 intakes of 2.5 g of wheat semolina every 1 hour and 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Acute effect; Beta Alanine
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
Condition: Shigellosis
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 2

Summary: 
      In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be
      tested for its ability to induce an immune response that protects healthy adult volunteers
      from infection with a wild-type Shigella flexneri 2a strain compared to subjects receiving
      placebo.
    

Detailed description: 
      Flexyn2a is a bioconjugate candidate vaccine that is able to induce an humoral immune
      response specific for the 2a-antigen of Shigella flexneri 2a bacteria. Healthy adult
      volunteers naïve for Shigella flexneri 2a infections at screening will receive two
      administrations of 10 micrograms Flexyn2a or placebo 4 weeks apart. Four weeks after the
      second vaccination, each subject will be challenged with 1500 cfu of the virulent Shigella
      flexneri 2a strain 2457T. In order to assess the ability of Flexyn2a to protect against
      infection with this strain, the attack rate of shigellosis in the group vaccinated with
      Flexyn2a will be compared to the group of the subjects who received placebo injections.
    

Intervention name(s): Flexyn2a; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart; 2 doses of TBS solution will be injected intramuscularly 4 weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Effectiveness of Enhanced Treatments for Drug Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this challenge grant is to conduct an initial test of a new, enhanced version
      of this protocol (telephone monitoring and counseling - enhanced, or TMAC-E), which has been
      modified to include the elements of our existing continuing care intervention plus
      patient-centered changes to boost patient involvement and community linkages. The
      investigators will recruit 150 cocaine dependent patients in publicly funded, community-based
      programs and randomize them to treatment as usual or the TMAC-E and follow them for 12
      months.
    


Intervention name(s): Telephone Monitoring and Counseling - Enhanced
Intervention type(s): Behavioral
Intervention description(s): Calls or in-person sessions, 1x weekly for first 8 weeks, then every other week up to a year. Step up session frequency if needed based on participants' ratio of protective and risk factors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks
Condition: Pain, Postoperative; Pain, Acute; Upper Extremity Injury
MeSH terms: Pain, Postoperative; Acute Pain; Arm Injuries
Study type: Interventional

Summary: 
      When used as perineural (PN) adjuvants to local anesthetics (LAs), dexamethasone (DX) and
      dexmedetomidine (DXD) have been well documented to prolong the duration of peripheral nerve
      blocks. These drugs have important differences in terms of cost and safety profiles. This
      randomized controlled trial (RCT) will compare PN DX and PN DXD for ultrasound-guided
      infraclavicular brachial plexus blocks (ICBs).

      Since analgesic and sensory duration can be influenced by factors different to block, motor
      block duration is the main outcome. The protocol is designed as an equivalency trial and
      hypothesize that both drugs result in similar durations. The equivalency margin is set at 3
      hrs.
    


Intervention name(s): Dexamethasone; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone as perineural local anesthetic adjuvant; Dexmedetomidine as perineural local anesthetic adjuvant
Intervention MeSH terms: Dexamethasone; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nerve block adjuvants; dexamethasone; dexmedetomidine; nerve block duration
Rhupus Syndrome and Efficacy of Etanercept Treatment
Condition: Rhupus Syndrome, Etanercept
MeSH terms: Syndrome
Study type: Observational

Summary: 
      between March 2013 and March 2014, Rhupus patients were enrolled to receive a 25-mg
      etanercept injection subcutaneously twice a week. The follow-up time of the study was 24
      weeks.
    

Detailed description: 
      between March 2013 and March 2014, patients who were unresponsive to therapy with
      corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity
      Score in 28 Joints (DAS28) >5.1 were enrolled to receive a 25-mg etanercept injection
      subcutaneously twice a week. The follow-up time of the study was 24 weeks.
    

Intervention name(s): etanercept
Intervention type(s): Drug
Intervention description(s): 25-mg etanercept injection subcutaneously twice a week
Other intervention name(s): TNFа blockade
Intervention MeSH terms: Etanercept
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who were unresponsive to therapy with corticosteroid and disease-modifying
        antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) >5.1 were
        enrolled
Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional

Summary: 
      According to recent research, microRNAs (miRNAs) may function as early disease indicators and
      contribute to the severity of a number of precancerous and malignant oral disorders. The aim
      of the present study, through a double-blind randomized controlled trial design, is to
      analyze in the gingival crevicular fluid (GCF) as a non-invasive approach the impact of
      topical clobetasol on miRNAs expression in subjects affected by oral lichen planus (OLP).
    

Detailed description: 
      A double-blind randomized controlled clinical trial is conducted in order to evaluate the
      impact of topical clobetasol on GCF miRNAs expression in subjects with OLP and determine the
      statistical significance of the outcome variables.

      At least 60 patients with OLP, randomly allocated in two groups: placebo group with a 4%
      hydroxyethyl cellulose adhesive gel and the clobetasol group with the same gel containing
      clobetasol propionate 0,05%.
    

Intervention name(s): Clobetasol Topical Gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topic Clobetasol gel applied locally on OLP lesions.; Placebo oral gel applied locally on OLP lesions.
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The main aim of the study is to analyze the impact of topical clobetasol on gingival crevicular fluid miRNAs expression in subjects affected by oral lichen planus.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Injuries; Pain, Postoperative; Tissue Adhesion
MeSH terms: Pain, Postoperative; Tissue Adhesions; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Although radial extracorporeal shock wave therapy (rESWT) has proven to be an effective
      treatment, the effectiveness of the treatment has so far been controversial. There are no
      studies using rESWT in rehabilitation after arthroscopic rotator cuff repair (ARCR).
      Therefore, in this study, there is evidence that rESWT promotes pain control and healing
      recovery, and through previous studies, we would like to investigate whether treatment with
      rESWT during the intensive rehabilitation period of patients after ARCR is more effective in
      controlling pain.
    


Intervention name(s): Radial extracorporeal shockwave therapy
Intervention type(s): Behavioral
Intervention description(s): Radial extracorporeal shockwave therapy group include Therapeutic modality(Transcutaneous electrical nerve stimulation [TENS], Microwave thermotherapy, and Superficial heat therapy), Range of motion exercise(Continuous passive motion and Active range of motion exercise).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Methadone in Pediatric and Adult Sickle Cell Patients
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      To determine the pharmacokinetics of methadone in children and adults with SCD who are
      experiencing a painful episode.
    


Intervention name(s): Morphine; Methadone
Intervention type(s): Drug; Drug
Intervention description(s): Standard of care for pain management of acute episode of pain; Compare to standard of care for pain management of acute episode of pain
Intervention MeSH terms: Morphine; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
Condition: Safety; Tolerability; Pharmacokinetics; Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate safety, tolerability and pharmacokinetics (PK) of AZD7503, following
      subcutaneous (SC) administration of single ascending doses of AZD7503 in healthy
      participants.
    

Detailed description: 
      This is a Phase I, First-in-Human, study in healthy males and females (non-childbearing
      potential) participants. In this study up to four dose levels of AZD7503 are planned to be
      evaluated.

      The planned doses of AZD7503 are dose 1, dose 2, dose 3, and dose 4. Eligible participants
      will be randomised to receive either AZD7503 or placebo. The study will include four single
      dose cohorts with an option to include two cohorts based on emerging data from planned
      cohorts in the study and two additional cohorts of Japanese participants and one cohort of
      Chinese participants will also be included.

      Dosing for each ascending dose cohort will be proceeded with sentinel dosing strategy. Here,
      sentinel sub-cohort will be included, such that 1 participant will be randomised to receive
      placebo and 1 participant will be randomised to receive AZD7503. The safety data from the
      sentinel participants up to 24 hours post-dose will be reviewed by the Principal Investigator
      (PI) before the remaining participants in the cohort are dosed

      The study will comprise:

        -  A Screening Period of maximum 28 days;

        -  A Treatment Period during which participants will be resident at the Study Centre from
           the day before study medication administration (Day -1) until at least 72 hours after
           study medication administration; discharged from the Study Centre on Day 4;

        -  Follow-up Visits on 1,2,4,6 and 8 weeks; and

        -  A Final Follow-up Visit 10 weeks after the last study medication dose. Each participant
           will be involved in the study for approximately 14 weeks.
    

Intervention name(s): AZD7503; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y).; Randomised participants will receive placebo by SC injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: First-in-Human; Placebo-controlled; AZD7503; Single Ascending Dose; Sentinel Dosing
Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
Condition: Partial Onset Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to provide short term efficacy and safety data of TRI476 in children
      with inadequately-controlled partial seizures. Patients will be randomized into either drug
      treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks.
      The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.
    


Intervention name(s): TRI476; Placebo to TRI476; Benzodiazepines
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TRI476 oral suspension doses, based on body weight twice daily; Placebo oral suspension, taken twice daily; Benzodiazepines could be used as needed as rescue medication during the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Seizures; oxcarbazepine; child
Supporting Cognitive Control Training With tDCS
Condition: Cognitive Control
Study type: Interventional

Summary: 
      Cognitive control (CC) is an important prerequisite for goal-directed behaviour and often
      associated with dysfunctional prefrontal activity within the cortex. This can be ameliorated
      by non-invasive brain stimulation. In this randomised single-blind study we compare effects
      of transcranial direct current stimulation (tDCS) on CC in healthy subjects. The study
      includes 162 subjects who undergo a two-week (six sessions) training of cognitive control
      (adaptive paced auditory serial addition task, PASAT) supported by tDCS. Subjects are
      randomised to receive either concurrent anodal, cathodal, or sham tDCS with an intensity of 1
      mA or 2 mA of their left (F3) or right (F4) PFC, resulting in eight stimulation groups.
      Stimulation effects on performance changes are compared to a sham control group.Changes in
      Affective state are measured by the positive and negative affect schedule (PANAS), possible
      transfer effects are assessed by the Eriksen Flanker task. Stability of effects is measured
      up to three months after the last intervention.
    


Intervention name(s): Effect of tDCS on cognitive control task performance
Intervention type(s): Behavioral
Intervention description(s): Added verum or sham tDCS while working on a cognitive control task.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Brain stimulation; Cognitive training; Cognition; Cognitive enhancement; Transcranial direct current stimulation
Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine
Condition: Elderly Person; Body Composition; Physical Exercise
Study type: Interventional

Summary: 
      Controlled clinical trial, randomized by strata (sex and period of the study), with 6
      parallel branches to the study depending on the type of product consumed and the type of
      physical exercise program performed, double-blind masked for the consumption of the product
      and single-center.
    

Detailed description: 
      The subjects that meet the selection criteria will make a total of seven visits to the
      research laboratory (two of them to collect product) and will carry out the pre-established
      tests in the protocol. Subsequently, a statistical analysis will be carried out with the
      variables measured in the study to obtain results.
    

Intervention name(s): dietary supplement consumption
Intervention type(s): Dietary Supplement
Intervention description(s): Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk).
In addition, 5 of the arms perform physical activity training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment