bioihbjkbjnl/mcl2 huggingface dataset:
Olfactory Disfunction and Co-ultraPEALut
Condition: Anosmia; Covid19; Hyposmia; Parosmia; Treatment Compliance
MeSH terms: COVID-19; Anosmia; Olfaction Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Olfactory dysfunction is common among patients with Corona-Virus-Infection-Disease
      (COVID)-19, and up to 30% of patients may report persistent disorders of smell or taste as a
      long-term sequelae. This randomized-controlled study has addressed to compare the efficacy of
      neuro-protective and anti-inflammatory agents palmitoylethanolamide (PEA) and
      Luteolin(Treatment) with control (olfactory training) in a cohort of patients who present
      persistent smell disorders after resolution from Covid-19 and negative swab for 4 months at
      least.
    

Detailed description: 
      Patients ages 18 to 70 years with confirmed history of COVID-19 (positive nasopharyngeal swab
      for SARS-CoV-2) and subjective olfactory dysfunction persisting ≥ 90 days after follow-up
      negative COVID-19 nasopharyngeal swab are eligible.

      All patients will undergo nasal endoscopic examination to look for presence of polyps,
      masses, anatomic blockage, or other pathology which presence will require exclusion from the
      study. Patients then will be evaluated at the baseline with Sniffin' Sticks (Burghardt®,
      Wedel, Germany) prior to initiating olfactory training and/or supplement treatment (T0). One
      group received daily olfactory training, patients in the supplement group additionally
      received a daily oral tablet that contained PEA 700 mg and Luteolin 70 mg (Glialia ®, Epitech
      pharmaceutical, Milano, Italy), or 1 dose of PEA-LUT only or aTwo Dose of PEA-LUT.

      Assessment of olfactory function will be repeated at 30 days, 60 and 90 and 120 days
    

Intervention name(s): co-ultraPEALut; Olfactory Rehab; PEA-LUT 1 sachet; PEA-LUT 2 sachet day
Intervention type(s): Combination Product; Procedure; Drug; Drug
Intervention description(s): Olfactory rehab 10 minutes twice a day for all the observation period + co-ultraPEALut (700 PEA + 70 Luteolin) 1 dose daily.; Olfactory Rehabilitation10 minutes twice a day for all the observation period; Only 1 sachet day of PEA-LUT no olfactory training; 2 sachets day of PEA-LUT no olfactory training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blinded randomized clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Brain Emotion Circuitry-Targeted Self-Monitoring and Regulation Therapy (BE-SMART)
Condition: Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      New treatments to help to reduce the emotional dysregulation of mood disorders are critically
      needed. This is a study of an emotional dysregulation psychotherapy treatment in which
      participants will learn skills to help to down-regulate maladaptive emotional responses and
      learn beneficial, healthy habits. Investigators will perform symptom and behavioral
      assessments and scanning prior to the treatment and will then repeat scanning, symptom and
      behavioral assessments at the midpoint, and after the psychotherapy is completed. This
      collected information will assess whether the treatment can improve functioning of emotion
      regulation brain circuitry.
    

Detailed description: 
      Aim: To use functional magnetic resonance imaging (fMRI), before, at mid point, and after an
      emotional regulation intervention, to assess intervention-associated changes in brain
      circuitry responses to emotional stimuli.

      Hypothesis : The emotional regulation psychotherapy treatment will be associated with changes
      in emotional regulation circuitry.
    

Intervention name(s): BE-SMART
Intervention type(s): Behavioral
Intervention description(s): Participants will take part in 12 therapy sessions, at a rate of about 1 session every one to two weeks. Sessions are anticipated to last about 1 hour each. Sessions may be focused on teaching skills to regulate emotions or regularize sleep and activity. These therapy sessions may be videotaped and audiotaped (only with the expressed written consent of the participant, and when appropriate, the participant's parent or guardian). Participants will be asked to complete worksheets and practice the skills learned from these sessions and will be asked questions about feelings. There will be an interview, assessments and scanning performed prior to treatment and at the midpoint and end to assess progress. The intervening 9 sessions may be by video telecommunication. Participants may be given devices to track actigraphy and ecological momentary assessments.
Intervention model: Single Group Assignment
Intervention model description: It is planned that 72 of the 86 participants who meet criteria for bipolar disorder (BDI, BDII, BD-OS) will complete this combined psychotherapy (BE-SMART) and imaging study. There will be variation of therapies, but no comparison between groups. Actigraphy and ecological momentary assessments on 20 participants will be integrated as part of the supplement to parent grant.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psychotherapy
A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is a 6-week, double-blind, randomized, active and placebo-controlled
      parallel-group study with a primary objective of comparison of starting doses of pramipexole
      fixed-dose (0.25 mg daily) and pramipexole titrated-dose (0.125 mg qd for 1 week, then 0.25
      mg qd for the remaining 5 weeks) with placebo to evaluate efficacy and safety in treating RLS
      symptoms in patients diagnosed with idiopathic RLS.

      The secondary objectives of this study will be to assess the onset of action of symptomatic
      relief of RLS for pramipexole with daily assessment of PGI and modified IRLS during two
      intervals of the first 2 weeks (Days 2, 3 and 4 and Days 9, 10, and 11) and assessment of
      IRLS, PGI and CGI-I at Weeks 1, 2, 4 and 6 (CGI-I additionally on Day 3).
    


Intervention name(s): Pramipexole
Intervention type(s): Drug
Intervention MeSH terms: Pramipexole
Intervention model: Parallel Assignment
Primary purpose: Treatment
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic
      exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult
      participants with various degrees of renal function (mildly, moderately, or severely
      impaired, or end-stage renal disease [ESRD] with or without hemodialysis) compared to adult
      participants with normal renal function.
    


Intervention name(s): JNJ-64041575
Intervention type(s): Drug
Intervention description(s): All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.
Other intervention name(s): ALS-008176, lumicitabine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Repetitive Transcranial Magnetic Stimulation in Drugs Addiction
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study also aims to develop and apply a standard repetitive transcranial magnetic
      stimulation (rTMS) protocol on drug users. The investigators want to focus on the effects of
      rTMS on amphetamine and cocaine as they are the most commonly used types of illicit drugs in
      Hong Kong.

      The primary research question is:

      • To examine if rTMS can reduce craving and consumption of the most commonly used illicit
      drugs (amphetamine, cocaine) among people with drug use disorders in Hong Kong?

      The secondary research questions are:

        -  What is the association between rTMS protocol (frequency, intensity) and drug craving
           and consumption?

        -  Would there be gains in executing functioning among participants who have received rTMS
           treatment?

        -  Would there be a reduction in depressive and anxiety symptoms among participants who
           have received rTMS treatment?

      The investigators would use a cross-over design (figure 1) to investigate the effects of
      rTMS. The investigators would recruit participants through community drug rehabilitation and
      youth outreach services. Participants who meet the selection and exclusion criteria will be
      invited to join. Upon obtaining their written consent, the investigators would randomize
      participants to a treatment (rTMS) group and a sham stimulation (placebo) group. Upon
      completing the first phase (2 weeks), there would be a washout period of 2 weeks. The two
      groups will swap (treatment becomes sham, and vice-versa) and the second phase will proceed.
      A double-blinded procedure will be implemented. Outcome measures will be conducted at
      baseline, after Phase I, at the start of Phase II, and at the end of Phase II.
    


Intervention name(s): Transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): Transcranial Magnetic Stimulation (TMS) uses magnetic fields to stimulate nerve cells in the brain. TMS uses a small electromagnetic coil controlled by a computer program to deliver short, powerful pulses of magnetic energy focused precisely on parts of the brain's pre-frontal cortex. High-frequency repetitive TMS can enhance the excitability of the stimulated region.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation; Substance Use Disorders; Craving
Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men
      with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and
      physiotherapy.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients are treated with daily olsalazine. The dose is increased each week
      until the protocol dose is reached.

      Supplemental acetaminophen is allowed; nonsteroidal anti-inflammatory drugs continue
      unchanged. Concurrent sulfasalazine is prohibited.
    

Intervention name(s): olsalazine
Intervention type(s): Drug
Intervention MeSH terms: Olsalazine
Primary purpose: Treatment
Keywords: ankylosing spondylitis; genetic diseases and dysmorphic syndromes; rare disease
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral
      activity of an investigational regimen including FDA approved HIV drugs in HIV-infected
      pediatric subjects, ages 4 weeks to < 2 years old.
    

Detailed description: 
      A 48 week, Phase II, open-label, 2-cohort, multicenter study to evaluate the
      pharmacokinetics, safety, tolerability and antiviral activity of GW433908 and GW433908/RTV
      when administered to HIV-1 infected protease inhibitor (PI) naive and PI-experienced
      pediatric subjects aged 4 weeks to <2 years.
    

Intervention name(s): GW433908; ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Fosamprenavir suspension bid; Ritonavir solution bid
Other intervention name(s): GW433908
Intervention MeSH terms: Ritonavir; Fosamprenavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; ritonavir; amprenavir; AGENERASE; HIV; Lexiva; protease inhibitors; HIV Infection; fosamprenavir
A Non-Pharmacological Method for Enhancing Sleep in PTSD
Condition: PTSD; Sleep Problems
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Sleep disturbance is nearly ubiquitous among individuals suffering from PTSD and is a major
      problem among service members returning from combat deployments. The proposed study aims to
      test a novel, inexpensive, and easy to use approach to improving sleep among service members
      with PTSD.

      Primary outcome measures will include not only PTSD symptom improvement but also include
      neuroimaging of brain structure, function, connectivity, and neurochemistry changes. The
      proposal is firmly grounded in the emerging scientific literature regarding sleep, light
      exposure, brain function, anxiety, and resilience. Prior evidence suggests that bright light
      therapy is effective for improving mood and fatigue, and our pilot data further suggest that
      this treatment may be effective for improving daytime sleepiness and brain functioning in
      brain injured individuals. Thus, this intervention, in our own research and in the work of
      others, has been shown to affect critical sleep regulatory systems. Improving sleep may be a
      vital component of recovery in these service members. Our approach would directly address
      this issue. Our preliminary data have shown that this approach is extremely well tolerated
      and is effective for improving sleep, mood, cognitive performance, and brain function among
      individuals with brain injuries.

      Finally, the potential impact of this study is high because of the capability of
      transitioning the research to direct clinical application almost immediately. If the bright
      light treatment is demonstrated as effective, this approach would be readily available for
      nearly immediate large-scale implementation, as the devices have been widely used for years
      in other contexts, are already safety tested, and commercially available from several
      manufacturers for a very low cost. Thus, the impact of this research on treating PTSD would
      be high and immediate.
    


Intervention name(s): PTSD wavelength-1 bright light; PTSD wavelength-2 bright light
Intervention type(s): Device; Device
Intervention description(s): 6 weeks of daily light exposure, 30 minutes per morning.; 6 weeks daily light exposure, 30 minutes per morning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Stress; Sleep Problems; Brain imaging; fMRI
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
Condition: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Healthy
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate
      the safety, pharmacokinetics (how the trial drug is distributed in the body) and
      pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021
      administered intravenously and subcutaneously to healthy male subjects and subjects with
      haemophilia A or B
    


Intervention name(s): NNC 0172-0000-2021; NNC 0172-0000-2021; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose; Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.; Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
High Doses of Candesartan Cilexetil on the Reduction of Proteinuria
Condition: Proteinuria
MeSH terms: Proteinuria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effects of high doses of candesartan cilexetil and
      also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction
      of proteinuria.
    


Intervention name(s): candesartan cilexetil
Intervention type(s): Drug
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hypertension
ARTS - AVODART After Radical Therapy For Prostate Cancer Study
Condition: Neoplasms, Prostate; Prostate Cancer After a Radical Treatment
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial
      assessing the efficacy and safety of dutasteride in extending time to prostate specific
      antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer
      (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage
      radiotherapy) with curative intent but who experience a biochemical failure (PSA rise)
      afterwards without signs or symptoms of metastases.
    

Detailed description: 
      A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of
      Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men with Prostate
      Cancer and Biochemical Failure (PSA increase) after Radical Therapy with Curative Intent
      (ARTS - AVODART after Radical Therapy for prostate cancer Study)
    

Intervention name(s): Avodart; placebo
Intervention type(s): Drug; Other
Intervention description(s): 0.5 mg administered orally once daily; Patients will be randomized at Visit 2 in 1:1 ratio to receive either 0.5 mg dutasteride or placebo
Other intervention name(s): Avodart/placebo
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prostate Cancer; AVODART; PSA; dutasteride; PSADT; Prostate specific antigen; radical therapy; doubling time
Quantification of Exhaled Particles to Identify Airborne Transmission Risks of COVID-19
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the aerosols emitted during various respiratory activities will be quantified
      in healthy subjects. The differences in aerosol size spectrum and number during tidal
      breathing, speaking, coughing and singing will be assessed. Subjects with an endogenously
      high aerosol emission will repeat the respiratory activities wearing face masks with varying
      particle filter capacity to investigate the aerosol emission reduction.
    


Intervention name(s): Community Mask; Surgical Mask; FFP2 respirator; FFP3 respirator
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Fabric mask, no medical device; Medical face mask (personal protective equipment), CE-certified; Filtering Face Piece with no less than 94% filtering capacity, CE-certified; Filtering Face Piece with no less than 99% filtering capacity, CE-certified
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: In part A of the study, aerosol emission of subjects will be characterized. From this population, the 10 highest-emitting subjects will enter part B of the study to investigate the effect of face masks on aerosol emission down to the submicron range.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Aerosols; Exhaled particles; Face mask
The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess the pharmacodynamic properties of drug-drug of
      SHR4640, Febuxostat and Colchicine interaction in patients with gout.
    


Intervention name(s): Colchicine; Febuxostat; SHR4640
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Day-14~Day16 qd; Day1 and Day8 qd; Day3~Day8 qd
Intervention MeSH terms: Colchicine; Febuxostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SHR4640 Febuxostat Colchicine pharmacodynamics
Sulfur Amino Acids, Energy Metabolism and Obesity
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The primary objective of the trial is to establish the effects of dietary sulfur amino acid
      (SAA) restriction on body weight, body composition and energy expenditure in humans.
    

Detailed description: 
      Dietary SAA restriction is an established model for increasing lifespan and improving
      metabolic health in animal studies. Data from human studies are limited.

      In this study the investigators will perform an 8-week dietary intervention with SAA
      restriction to characterise the effects on several parameters related to metabolic health
      including body weight, body composition, energy expenditure, lipid profile and gene
      expression profiles in adipose tissue. The aim is to translate findings from previous animal
      experiments to humans
    

Intervention name(s): Low SAA diet; High SAA diet
Intervention type(s): Other; Other
Intervention description(s): Diet with low content of methionine and cysteine; Diet with high content of methionine and cysteine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Methionine; Cysteine; Sulfur amino acids; Dietary intervention; Plant-based diet
A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study to determine whether high dose vitamin D has positive effect on
      behavior of autistic children.
    

Detailed description: 
      Double blinded placebo controlled study to determine effect of two different doses of vitamin
      D on Behavioral domains in autistic children.
    

Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Drug; Other
Intervention description(s): vitamin D drops for paediatrics; glucose syrup with same taste and color to vitamin D3 drops
Other intervention name(s): vitamin D drops; glucose syrup
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment