bioihbjkbjnl/mcl2 huggingface dataset:
Investigating Psychosocial Intervention Treatment Response in Justice-Involved Youth With Conduct Disorder
Condition: Conduct Disorder
MeSH terms: Conduct Disorder
Study type: Interventional

Summary: 
      This research focuses on youth with conduct disorder (CD), and a history of violence. CD is a
      youth neurodevelopmental disorder that is commonly associated with criminality. Although
      psychosocial interventions that address impulsivity and self-control have been shown to be
      effective at helping promote prosocial behavior in patients with CD, the biological changes
      that occur as a result of treatment are not well understood. This study will explore changes
      in the brain function of the anterior cingulate cortex (ACC) in response to a common
      psychosocial intervention (Stop, Now and Plan). This study will contribute to our
      understanding of biological mechanisms involved in therapeutic gains among children with
      behavioural problems and youth offenders; therefore, it will inform further development of
      treatment programs for children/youth with impulsive behaviours.
    

Detailed description: 
      CD is a youth-limited neurodevelopmental disorder characterized by impulsivity and
      dysfunctional social behavior. CD is associated with increased risks of mortality, lower
      educational and occupational achievement, criminal behavior and other psychosocial
      difficulties, and hence presents a significant burden to society. Impulsivity is a prominent
      predictor of violence in CD. Treatment programs targeting impulsivity in CD have been shown
      to be effective at increasing pro-social functioning in CD, but the biological mechanisms
      that underpin these therapeutic gains are not well understood. Past research suggests that
      the ACC play a role in CD and impulsivity. This study explores biological and behavioral
      changes in response to Stop, Now and Plan (SNAP), a validated 13-week psychosocial
      intervention addressing impulsivity and self-control in youth.

      The main hypotheses are:

      (1) CD youth who respond to SNAP treatment will exhibit greater post-treatment ACC activation
      during an fMRI imaging task compared with their baseline, pre-treatment ACC activation.

      The secondary hypotheses are:

      (1) CD youth will exhibit lower ACC activation at baseline during an fMRI imaging task
      compared with the baseline ACC activation exhibited by typically developing youth.
    

Intervention name(s): Stop, Now and Plan
Intervention type(s): Behavioral
Intervention description(s): SNAP program was developed to target justice-involved youth (6 years and older) who have problems with aggression, CD, and/or gang affiliation. SNAP focuses on engaging youth in interesting and creative learning modules by providing real life scenarios designed to improve self-control, impulsive behaviors, decision-making skills, and pro-social skills. SNAP treatment is delivered over a 13-week period.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nigella Sativa in COVID-19
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      Natural products with immunomodulation and antiviral activity showed a promising improvement
      in the outcomes of some viral infectious diseases both in preclinical and primitive clinical
      studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil
      towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study
      will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be
      supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary
      outcome will be the proportion of patients who clinically recovered on day 14. The secondary
      outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes
      occurred, NS supplementation may be recommended as an add-on to standard care protocol to
      enhance the recovery from COVID-19 disease in the current emerging situation.
    


Intervention name(s): Nigella sativa oil
Intervention type(s): Dietary Supplement
Intervention description(s): Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, open-label, controlled clinical study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; SARS-CoV-2; Nigella sativa; Herbal
B Vitamins in MTHFR Positive Patients With Major Depression: A Post Hoc Analysis of Findings
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized double-blind placebo controlled study of reduced B vitamins in patients with
      major depression who were positive for one or both of the common MTHFR polymorphisms was
      conducted between 8/1/2014 and 4/3/2015. Homocysteine levels and MADRS scores were used as
      primary measures. The study was designed to test safety and efficacy of reduced B vitamins in
      MDD associated with MTHFR. This study examines the data from the trial to see effects, effect
      sizes, and further, if demographic factors and other patient characteristics correlated with
      findings.
    

Detailed description: 
      This original study was designed to evaluate the efficacy and safety of reduced B vitamins as
      monotherapy in adults with major depressive disorder (MDD) who were also positive for at
      least 1 methylenetetrahydrofolate reductase (MTHFR) polymorphism associated with depression,
      and further test the hypothesis that reduced (metabolized) B vitamins will lower homocysteine
      (HCY) in a majority of clinically responding patients. 330 adult patients with MDD (DSM-5),
      and positive for MTHFR C677T and/or A1298C polymorphisms were enrolled in a trial conducted
      between August 1, 2014, and April 3, 2015. 160 patients received placebo, while 170 received
      a capsule containing a combination of reduced B vitamins. Plasma homocysteine levels were
      measured at baseline and week 8. The Montgomery-Asberg Depression Rating Scale (MADRS) was
      used to evaluate efficacy for MDD. This further analysis is conducted on the resultant data,
      with patient names withheld. It is an extensive look at the findings to determine if response
      is correlated with HCY reduction and if other factors may be associated with response or
      non-response.
    

Intervention name(s): Enlyte; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): gel cap of reduced B vitamins; identical to Enlyte
Other intervention name(s): reduced B vitamins; inert gel cap
Intervention MeSH terms: Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: MTHFR depression vitamins Homocysteine
Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study.
      This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This
      study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and
      400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive single
      dose of the study drug under fasted condition. Following 3 days of washout period, subject
      will receive the study drug once daily for 7 days starting on the fifth day from the single
      dose administration.

      For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period
      before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed
      condition, to evaluate food effect of the study drug.
    


Intervention name(s): E6007; E6007 matching placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: E6007; Healthy Japanese male subjects
Cosmetic Study of AO+Mist in Improving the Appearance of Skin Afflicted With Keratosis Pilaris
Condition: Keratosis Pilaris
MeSH terms: Keratosis, Actinic; Abnormalities, Multiple; Darier Disease; Keratosis
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the safety, tolerability and efficacy of AO+ Mist
      administered daily for 4 weeks to improve the appearance of skin afflicted with keratosis
      pilaris.
    

Detailed description: 
      This will be a single center, double-blind, placebo-controlled study in subjects with
      keratosis pilaris affecting both sides of the body.

      Subjects will be screened within 4 weeks of enrollment. Subjects will be seen at the research
      facility on for the baseline visit and will be asked to return to the site on weeks 1, 2, 3
      and 4 for assessments. Test product application will occur for four weeks starting with the
      day of the baseline visit.
    

Intervention name(s): Placebo; AO+Mist
Intervention type(s): Other; Other
Intervention description(s): Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
Subjects may not wash their body with soap and water AFTER the applications; Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
Subjects may not wash their body with soap and water AFTER the applications
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Bi-Lateral study
Masking: Double (Participant, Care Provider)
Primary purpose: Other
EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
Condition: Tobacco Smoking
Study type: Interventional
Phase: Phase 3

Summary: 
      Varenicline is the most effective smoking cessation therapy available. Nevertheless, most
      smokers using varenicline relapse within the first few months after quitting. Varenicline is
      hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking
      during the standard 1-week pre-quitting treatment phase. Learning theory and previous human
      and animal research support the hypothesis that a longer period of varenicline treatment
      prior to the target quit date (TQD) will lead to greater reductions in smoking before
      quitting, and higher long-term cessation rates, compared to standard varenicline treatment.
      Building on promising preliminary clinical data, the study tests these hypotheses with a
      full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized
      to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD
      varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will
      receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The
      primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks
      8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating
      mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and
      subjective measures assessed both in the lab and using real-world, real-time electronic
      momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking
      cessation will be improved among the extended run-in group compared to the standard run-in
      group. The investigators further predict the improved clinical outcomes with extended run-in
      varenicline will be explained (or mediated) by greater pre-quit reductions in smoking
      reinforcement among the extended run-in group compared to the standard run-in group. The
      significance of this work is clear: The project aims to make best available treatment for
      smoking cessation even better, using a method that is ripe for dissemination and an approach
      that will elucidate critical mechanisms to target in the next generation of treatment
      enhancement.
    


Intervention name(s): Varenicline; Brief smoking cessation counseling
Intervention type(s): Drug; Behavioral
Intervention description(s): oral varenicline tablets; ~10-minute individual counseling at each of 6 clinic visits
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending
      doses of GAP 134 administered as 6-day continuous IV infusions to healthy subjects.
    


Intervention name(s): GAP-134; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Multicomponent Therapy for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly
      evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent
      and multidisciplinary therapy gains importance and revealing promising results, the
      investigators aim to combine two well-known therapies in a program for patients with
      fibromyalgia.

      From clinical experience, a high drop-out rate has been stated. All data will be explored to
      analyse explanatory factors.
    


Intervention name(s): cognitive behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): exercise therapy
Other intervention name(s): physical therapy
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: multicomponent therapy
A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to examine the efficacy and tolerability of ziprasidone
      intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the
      treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin
      American population.
    


Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.
Other intervention name(s): Geodon, Zeldox
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of GLP-2 Mechanism of Action (GA-8)
Condition: Healthy
Study type: Interventional

Summary: 
      Glucagon-like peptide-2 (GLP-2) is a naturally occuring hormone secreted to the circulation
      in response to food ingestion. Previous studies have shown that GLP-2 and incretins inhibit
      the bone resorption. However, the mechanism is unknown. In the present study we will
      investigate the mechanism of action using a receptor specific inhibitor.
    


Intervention name(s): Inhibitor + GLP-2; Placebo + GLP-2; Placebo + GIP; Placebo + Saline
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Inhibitor and GLP-2 are used as study tools.; Placebo and GLP-2 are used as study tools.; Placebo and GIP are used as study tools.; Placebo
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Retinal Imaging in CNTF -Releasing Encapsulated Cell Implant Treated Patients for Early-stage Retinitis Pigmentosa
Condition: Retinitis Pigmentosa; Usher Syndrome Type 2; Usher Syndrome Type 3
MeSH terms: Usher Syndromes; Retinitis; Retinitis Pigmentosa; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial is a single-site, 30 patient study for participants who have early stage
      retinitis pigmentosa, or Usher syndrome (type 2 or 3). Funding Source - FDA OOPD and
      Foundation Fighting Blindness.
    

Detailed description: 
      This clinical trial is a prospective, randomized, double-masked, sham-controlled trial of 30
      study participants who have early-stage retinitis pigmentosa, or Usher syndrome (type 2 or
      3). The trial will be conducted at the University of California, San Francisco. Individuals
      with these diseases experience gradually worsening vision that ultimately may lead to
      blindness due to a genetic condition in which specialized cells in the eye's retina called
      photoreceptor cells cease functioning and/or die. The study is intended to use a relatively
      new, non-invasive technology called AOSLO (adaptive optics scanning laser ophthalmoscopy) in
      combination with a routine standard of care measurement called sdOCT (Spectral Domain Optical
      Coherence Tomography) to demonstrate that when a device that secretes an investigational drug
      called CNTF (Ciliary Neurotrophic Factor) is surgically placed in the patient's eye, one type
      of photoreceptor called "cone photoreceptors" is preserved such that the gradual loss of
      vision is halted.
    

Intervention name(s): NT-501; Sham
Intervention type(s): Drug; Procedure
Intervention description(s): Study participants will undergo surgery to have an NT-501 Encapsulated Cell Therapy implant placed into the study eye.; Non-penetrating sham procedure to mimic implant procedure in the other eye.
Other intervention name(s): CNTF, Encapsulated Cell Therapy, ECT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are considered in screening upon signing of the consent. Enrollment does not occur until participant is deemed eligible, as per screening, and randomized for implant. As such, there were 22 total participants enrolled in the study. There was a participant who died prior to screening procedures being conducted of which was captured in the AE section as the death occurred after consent to enter screening period. However, this participant was not enrolled as they had not completed screening or randomization for implant.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Retinitis pigmentosa; Usher syndrome type 2; Usher syndrome type 3; Cone photoreceptor; Vision; Blind
Arts and Movement Therapies for Trauma
Condition: PTSD; Depression; Anxiety; Stress; Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The current goal of this project is to subjectively and objectively assess the efficacy of
      arts and movement interventions--including dance/movement therapy, art therapy and mindful
      yoga for youth and adults exposed to trauma, including families resettled as refugees and
      families in high-risk, low-resource environments. The overarching aim is to measure the
      changes over time in self-reported symptoms of posttraumatic stress disorder, anxiety
      disorder(s), depression, and somatic symptoms, as well as changes in biological substrates
      representing pathophysiological processes involved in responses to stress, trauma, and the
      aforementioned disorders. These biological substrates include inflammatory proteins and the
      stress hormone cortisol. We hypothesize that given the emotional and physical components of
      arts and movement therapies, which are implemented in group settings and confer life-long
      coping skills to participants, participation in arts and movement therapies will result in
      reduction of self-reported severity of psyciatric symptoms and improved physiology.

      COVID-19: In March, the COVID-19 pandemic caused in person research to be halted in order to
      be in adherence to the stay at home order for the State of Michigan. The IRB overseeing the
      present project approved an amendment to allow data to be collected online via phone or
      email, based on participant preference, with a new consent form for this new method of data
      collection. Following this approval, we migrated our programming to virtual formats and began
      to serve both refugee commuities as well as school-aged youth with the intervention program
      and obtained consent followed by data from participants as part of this study. We have
      pivoted towards also looking at the benefits of creative arts and movement based
      interventions in reducing COVID-related distress, as well as building resilience.

      By collecting psychological and biomarker data the investigators seek concrete scientific
      evidence supporting these non-pharmacological, cost effective, and accessible programs as
      reliable treatment options.
    


Intervention name(s): Dance/Movement Therapy, Art Therapy, Mindful Yoga
Intervention type(s): Behavioral
Intervention description(s): Utilizing deep breathing, exercise modalities, and social support in all settings
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment