bioihbjkbjnl/mcl2 huggingface dataset:
Web-based Support for People With Schizophrenia and Their Families
Condition: Relapse Rates Related to Website Usage
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      This study will assess the feasibility of using the internet and in-home computers to provide
      advice from health care professionals, social support, and health information to people with
      schizophrenia and their families.
    

Detailed description: 
      The objective of this study is to assess the feasibility of using the World Wide Web (Web)
      and in-home computers to provide patients suffering from schizophrenia and their families
      advice from health care professionals, social support, and information.

      The purposes of this intervention are to improve: 1) the availability, convenience and use of
      needed mental health services; 2) family support for their ill family members; and 3) patient
      and family outcomes.
    

Intervention name(s): (relapse rate)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Keywords: Schizophrenia; Relapse; Psychological distress
Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis
Condition: Rh Disease
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The correlation of circulating serum miR-125ba and miR-146a expression and clinical response
      to green tea therapy were analysed in RA patients.Clinical response to green tea therapy for
      24 weeks was calculated from DAS28 scores. Whereas , a decrease of 1.2 points or above in
      DAS28 scores at 24 weeks of treatment compared with baseline was defined as clinical response
      according to the EULAR response criteria.A ready-made solutions containing the primers and
      probes for human miR-146a and miR-125ba (Applied Biosystems, Foster City, CA) and real-time
      RT-PCR was estimated using an ABI 7300 system (Applied Bio systems).
    

Detailed description: 
      1. participants: A total of 100 subjects (aged 18-65 years) who were diagnosed as RA with
           moderate to severe activity at the division of rheumatology and clinical immunology at
           Mansoura University were evaluated in this study.

        2. patients were evaluated for therapeutic response at baseline and 12, and 24 weeks of
           green tea therapy. All patients with RA were subjected for estimation of ESR, CRP,
           disease activity score in 28 joints (DAS28), patient's global assessment (PGA), and
           health assessment questionnaire damage index (HAQ-DI) at each visits (0 week, 12 weeks,
           and 24 weeks).

        3. Pain intensity was assessed by using a standard VAS of 100 mm previously validated to
           chronic and acute pains.

        4. Clinical response to green tea therapy for 24 weeks was calculated from DAS28 scores.

        5. human miR-146a and miR-125ba were isolated and subjected to RT-PCR analysis
    

Intervention name(s): Green tea group
Intervention type(s): Dietary Supplement
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A total of 100 subjects (aged 18-65 years) who were diagnosed as RA with moderate to severe
        activity at the division of rheumatology and clinical immunology at Mansoura University,
        between 20 January/2015 and 20 September 2015 were recruited in this prospective study.
        According to the diagnostic criteria of the American College of Rheumatology (Arnett et
        al., 1988), all patients classified as showing established RA for more than 8 years.
      
Biospecimen description: 
      For each subject, total RNA was extracted from serum samples using the TRIzol LS reagent
      (Invitrogen, Carlsbad, CA), and subjected to RT-PCR analysis. A ready-made solutions
      containing the primers and probes for human miR-146a and miR-125ba (Applied Biosystems,
      Foster City, CA) and real-time RT-PCR was estimated using an ABI 7300 system (Applied Bio
      systems) (Mazloom et al.,2015).
Pain Index Extracted From EEG in Monitoring Chronic Pain
Condition: Chronic Pain; Pain Assessment
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      Pain is a subjective feeling,and pain experts have been trying to assess it using objective
      methods. Pain index (PI) is extracted from electroencephalographic as an objective diagnostic
      tool for chronic pain. This study is a diagnostic test aims to explore the reliability and
      validity of PI, with numerical rating scale(NRS) as the gold standard.
    

Detailed description: 
      Chronic pain outpatients between 18 and 80 years old, NRS ≥4 at first visit and receive
      injection or shockwave therapy will be included. After informed consents signed, the age,
      gender, dominant hand and hospital anxiety and depression scale (HADS) will be collected.
      Each patient will be connected with a multifunctional monitor HXD-1 for 8 minutes to access
      EEG in a quiet environment before pain treatment and 30 minutes after pain treatment. NRS
      will also be recorded before pain treatment and 30 minutes after pain treatment. PI will be
      extracted from EEG by analysts.

      In order to reduce environmental effects, the same quiet research environment will be used
      throughout the study. All data will be obtained and recorded by the same person, and all PI
      will be analyzed and calculated by the same person.

      SPSS 20.0 will be used to analyze the data, Pearson's correlations and Kappa consistency test
      to analyze the validity and reliability of PI. The receiver operating characteristic curve
      will be use to analyze the sensitivity and specificity of PI to evaluating moderate and
      severe pain(NRS≥4). A multiple linear regression equation with PI as dependent variable and
      anxiety score and depression score as independent variables will be used to evaluate the
      influence of anxiety and depression on PI.
    

Intervention name(s): Pain index
Intervention type(s): Diagnostic Test
Intervention description(s): Record the patients' EEG and extract pain index before and after pain treatments
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The sample capacity calculation is based on the sensitivity/specificity of the diagnostic
        test allowed a minimum sensitivity of 80%, a minimum specificity of 80%, a significance
        level α of 0.01, an allowable error of 0.1 strictly.The estimated sample is 107 patients.
        Considering a predicted shedding rate of 10%, 118 patients will be enrolled.
      
Keywords: Pain assessment; electroencephalographic; numerical rating scale; pain index
Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main objective of this study is to investigate the effect of a 4-weeks intake of berry
      peel powder on fasting and postprandial glucose metabolism and inflammatory markers. The
      berry peel product will be compared with a placebo in a single-blind, cross-over design.
      Furthermore, inflammation-related peripheral blood mononuclear cells (PBMCs) genes
      expression, appetite and cognitive performance will be included as a pilot study.
      Investigators hypothesize that long-term consumption of polyphenols and fibres of berry peel
      will exhibit both direct and indirect actions in healthy overweight subjects by improvement
      of glucose-associated markers as well as ameliorating inflammation. Moreover, above metabolic
      markers will correlated with improvements in inflammation-related PBMCs genes expression,
      subjective appetite and cognitive performance after long-term consumption of berry peel as a
      source of polyphenols.
    


Intervention name(s): Berry peel drink; Control drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Berry; Inflammation; Cognition; Polyphenols; Appetite; Glucose metabolism
Dose-Related Inflammatory Effects of Intravenous Endotoxin in Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate 4-dose levels of CCRE Lot 94332B1 (0.6, 1.0, 2.0,
      and 4.0 ng/kg). This study is known as, an "endotoxin challenge." Thousands of healthy
      subjects worldwide over the last 20 years have participated in endotoxin challenge studies as
      part of clinical research and clinical drug development programs. This study will only test
      the safety and tolerability of CCRE Lot 94332B1.
    

Detailed description: 
      Normal healthy subjects will be recruited and consented for the study. Following completion
      of the study, the bio-marker samples will be sent to Dr. Anthony Suffredini a collaborator
      and Deputy Chief & Senior Investigator Department of Critical Care Medicine at the National
      Institutes of Health (NIH). All samples will be de-identified and analyzed at the NIH; the
      results of which will be reviewed by both Drs. Suffredini and Noveck. Statistical analysis
      will be performed at the NIH by the Department of Statistics from which manuscripts will be
      written for publication.
    

Intervention name(s): Endotoxin; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Reference Endotoxin is a purified LPS prepared from Escherichia coli O:113 (US Standard Reference Endotoxin); Clinical Center Reference Endotoxin (CCRE) Lot #94332B1 manufactured and vialed under GMP guidelines by List Biological Labs, Inc., 540 Division St., Campbell, CA 95008, for the Pharmacy Development Service, Clinical Center, National Institutes of Health, Bethesda, MD, USA. The material has been approved by the FDA (Food and Drug Administration) for 'Investigational Use Only'. This specific Lot from List Biological Labs specified for use in this study contains 1 mcg/vial.; Normal saline will be administered as the control to evaluate the effects on the biomarkers over time and to compare the responses following LPS to those following the control injection of normal saline.
Other intervention name(s): LPS; Lipopolysaccharide; Reference Endotoxin; CCRE; CCRE Lot 94332B1; Normal Saline (NS); Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Endotoxin; healthy; volunteers; males; females
Cannabinoids, Neural Synchrony, and Information Processing
Condition: Cannabis; Psychotic Disorders
MeSH terms: Psychotic Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active
      ingredient of cannabis, on neural synchrony. Neural synchrony is studied using
      electroencephalography (EEG).
    


Intervention name(s): THC; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.; • Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
P3 Study in Acne Comparing Once Daily SB204 and Vehicle
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel
      group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
    

Detailed description: 
      This is a double-blind, placebo controlled study in subjects with moderate to severe acne.
      Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD
      in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and
      inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline
      evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).
    

Intervention name(s): SB204 4%; Vehicle Gel
Intervention type(s): Drug; Drug
Intervention description(s): Once daily; Placebo comparator
Other intervention name(s): NVN1000; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression (SAINT-TRD)
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial
      magnetic stimulation device for treatment-resistant depression. In a double-blind fashion,
      half the participants will receive accelerated theta-burst stimulation while half will
      receive sham treatment.
    

Detailed description: 
      Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for
      treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40
      min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been
      effective in real world situations. The limitations of this approach include the duration of
      the treatment (approximately 40 minutes per treatment session, 5 days per week, for 4-8
      weeks). Recently, researchers have pursued modifying the treatment parameters to reduce
      treatment times with some preliminary successes. This study aims to further modify the
      parameters to create a more rapid form of the treatment and look at the change in
      neuroimaging biomarkers.
    

Intervention name(s): Active TBS-DLPFC; Sham TBS-DLPFC; Open label TBS-DLPFC
Intervention type(s): Device; Device; Device
Intervention description(s): Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
Stimulation will be delivered to the L-DLPFC using a MagPro stimulator.; The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.; All patients will have the option to receive active, open label aTBS treatment after the 1-month mark, following the blinded phase.
Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial magnetic stimulation; theta burst
A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare two different preparations of an antibiotic called
      cephalexin to determine if they are essentially the same. The study has two periods.
      Participants will receive one preparation of cephalexin in each period. At least 7 hours will
      pass between the study periods. The study is expected to last about 2 days for each
      participant, not including screening or follow-up.
    


Intervention name(s): Cephalexin
Intervention type(s): Drug
Intervention description(s): Administered Orally
Other intervention name(s): Keflex®
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2
Condition: Lung Cancer
Study type: Interventional

Summary: 
      The Archimedes System is an image-guided navigation system used to access tissue samples in
      the lungs. This study is being conducted to confirm the performance of the Archimedes System
      in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung
      cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor
      is conducted.
    


Intervention name(s): Archimedes System
Intervention type(s): Device
Intervention description(s): The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Microvascular Injury and Blood-brain Barrier Dysfunction as Novel Biomarkers and Targets for Treatment in Traumatic Brain Injury
Condition: Traumatic Brain Injury; Blood Brain Barrier Defect
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      Traumatic brain injury (TBI) is a leading cause of death and disability around the world. The
      social and economic burden of TBI is tremendous and the cost of TBI is estimated at $1
      billion per year in Canada- $650 million in care and $580 million in lost productivity. Novel
      interventions aimed at TBI-linked molecular targets have been successful in limiting injury
      and improving neurologic recovery in animal models, thus providing compelling evidence that
      effective intervention is possible after injury. This study proposes to investigate traumatic
      microvascular injury (TMI) and specifically blood-brain barrier dysfunction (BBBD) as a
      candidate biomarker and therapeutic target in TBI.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will recruit mild (n=40), moderate (n=40) and severe (n=40) TBI patients with a
        TBI-linked abnormality (e.g. epidural & subdural hematomas, subarachnoid hemorrhage,
        contusions). TBI will be classified by severity using the Glasgow Coma Scale (GCS); mild
        TBI (GCS13-15), moderate TBI (GCS 9-12), and severe TBI (GCS <8).
      
Biospecimen description: 
      Serum tau protein (sTau), von Willebrand factor (vWF), brain derived neurotrophic factor
      (BDNF), glial fibrillary acidic protein (GFAP),S100β, and serum neurofilament light (sNFL).
Community-based Post-exposure Prophylaxis for COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Specifically identified Ayurvedic preparations is recommended by ministry of AYUSH as
      post-exposure prophylaxis to efficaciously prevent a negative person who has come into
      contact with COVID-19-positive. Traditionally, recommended Ayurvedic preparations have been
      used as antioxidants, antimicrobial and anti-inflammatory properties. Particularly, Guduchi
      Ghanvati has been recognised with its ability to control viral attachment, viral replication
      and induce immune response in pre clinical settings, and found to be one among the most
      important drugs in Ayurveda to fight against COVID-19.

      However, known gap in guideline implementation and its impact on preventing active infection
      in exposed cases is unclear. Study aimed to increase the use of recommended AYUSH guidelines
      by having registered AYUSH physicians provide these medications, when indicated, in community
      based participants after known exposure to the SARS-CoV-2 coronavirus.
    


Intervention name(s): Guduchi Ghanvati; Standard guidelines
Intervention type(s): Other; Other
Intervention description(s): 500 mg of Samshamani vati or Giloy Ghanavati (Aqueous extract of Tinospora cordifolia) twice daily; Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Post Exposure Prophylaxis
Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)
Condition: Gastroenteritis; Rotavirus
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      To observe the safety, tolerability and immunogenicity of the administration of 3 doses of
      rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
    


Intervention name(s): Rotavirus Vaccine, Live, Oral, Pentavalent
Intervention type(s): Biological
Intervention description(s): Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.
Other intervention name(s): RotaTeq™ Vaccine; V260
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
An Open-label DDI Study of Omaveloxolone in Healthy Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-sequence, 2-period crossover study in healthy subjects.

      In this study, 20 subjects will be enrolled to allow at least 16 evaluable subjects.

      Subjects will receive a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) on Day
      1 (Period 1) and on Day 29 (Period 2), and 600 mg efavirenz once a day from Days 15 through
      42 (Period 2).
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Omaveloxolone; Efavirenz
Intervention type(s): Drug; Drug
Intervention description(s): Omaveloxolone Capsules, 150 mg, administered orally; Efavirenz Tablet, 600 mg, administered orally once daily
Other intervention name(s): RTA 408
Intervention MeSH terms: Efavirenz
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: omaveloxolone; DDI