bioihbjkbjnl/mcl2 huggingface dataset:
Agitation in the Acute Psychiatric Department
Condition: Mental Disorders
MeSH terms: Psychomotor Agitation; Mental Disorders
Study type: Observational

Summary: 
      Agitation is associated with a number of acute psychiatric conditions, and frequent in acute
      psychiatric admissions. It is associated with violence towards others, and strongly
      associated with in-patient suicides.

      The main aims of the study are to assess different clinical presentations of agitation at
      admittance, and to assess the consequences of these different clinical presentations during
      the first three days of the stay.
    

Detailed description: 
      The patients are assessed with three rating scales (Components of agitation, The PANSS-EC,
      The Brøset Violence Checklist) measuring agitation at admittance and day three thus providing
      a measurement of the differences during three days of in-patient stay. Therapeutic measures
      and interventions taken are assessed daily with a 18-item checklist. Threatening and violent
      incidents are recorded with The SOAS-R.

      Blood samples for immunological parameters are taken at admittance and discharge giving
      opportunity to assess changes through the acute psychiatric condition. Urine and blood
      samples are taken at admittance to assess substance use and medications.

      The patients are assess with two self-rating VAS-scales at discharge assessing the suicidal
      intentions they have had during the stay, aspects of clinical history and assessment for
      personality disorders.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All acutely admitted psychiatric in-patients from a defined catchment area.
      
Biospecimen description: 
      Blood samples are collected for storage and analyses both at admittance and discharge from
      the psychiatric acute department.
    
Keywords: Emergency services, psychiatric; Psychomotor agitation; Suicide; Violence
Different Doses of Tyrosine Adsorbed Grass Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Grass Pollen
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 2

Summary: 
      Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities
      of an allergen extract to an allergic patient, is a curative approach which directly treats
      the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal
      specific immunotherapy for patients with an allergy to grass pollen (hay fever). The purpose
      of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of
      different doses of GrassMATAMPL in volunteers allergic to grasses and rye pollen.
    


Intervention name(s): Grass MATAMPL
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Allergy; Specific Immunotherapy
The Bioseal Vascular Study
Condition: Cardiovascular Bleeding; Vascular Bleeding; Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective
      vascular surgery.
    


Intervention name(s): Bioseal Fibrin Sealant; Manual Compression
Intervention type(s): Biological; Other
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study for Patients With Relapsing Remitting Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to test if dirucotide is safe and effective in treating patients
      with relapsing remitting multiple sclerosis.
    


Intervention name(s): dirucotide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500mg, intravenous, every 6 months for 15 months; intravenous, once every six months for 15 months
Other intervention name(s): MBP8298; LY2820671
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial of SHR8735 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 open-label study.
    

Detailed description: 
      This is a phase 1 open-label study. The objective of this study is to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR8735 in healthy
      subjects
    

Intervention name(s): SHR8735
Intervention type(s): Drug
Intervention description(s): SHR8735 is an thrombopoietin receptor agonist to promote platelet production.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Relative Bioavailability of Pacritinib Following Oral Administration as Capsule and Solution Formulations in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a randomized, 2-period, 2-treatment-sequence crossover study to determine the
      relative bioavailability of pacritinib following administration as a 400 mg oral dose of four
      100 mg pacritinib capsules and an 80 mg dose of an oral solution and to characterize the PK
      and major human metabolites of pacritinib.
    

Detailed description: 
      Twelve healthy subjects will be enrolled in the study (6 subjects per sequence) at a single
      clinical site with the intent that 12 subjects complete Periods 1 and 2 in the study.
      Subjects will be randomly assigned to 2 possible sequences (6 subjects per sequence) on Day 1
      of Period 1. Subjects will be randomly assigned to 2 possible sequences. Each subject
      received 2 treatments (a 400 mg oral dose of four 100 mg pacritinib capsules and an 80 mg
      oral solution dose of pacritinib) in a 2-period crossover design. Each treatment will be
      administered as monotherapy during 1 of 2 treatment periods with a 7-day washout period
      between administrations of each study medication.
    

Intervention name(s): (Treatment A); (Treatment B)
Intervention type(s): Drug; Drug
Intervention description(s): Four 100-mg capsules of pacritinib administered as a single oral dose; A single 80-mg oral solution dose of pacritinib
Other intervention name(s): Pacritinib 400 mg Capsule; Pacritinib 80 mg Solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Immune and Hormone Response to Influenza Vaccine
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this pilot research project is to look at the effect of the inactivated
      influenza vaccine (seasonal flu shot) on early signs of immune or germ-fighting response
      known as cytokines or signal molecules. The investigators also want to see if the timing of
      vaccine administration has any effect on women's reproductive hormones. The investigators
      hypothesis is that influenza vaccine given right before ovulation may change the hormone
      levels usually seen after ovulation. Thi
    

Detailed description: 
      This study is an open-label, longitudinal study of healthy young women of reproductive age,
      not on hormonal contraception who receive seasonal inactivated influenza vaccine (IIV). The
      women will be followed for one menstrual cycle to measure luteinizing hormone surge,
      estradiol, and progesterone, and then vaccinated with the seasonal inactivated influenza
      vaccine prior to ovulation during a second month. At the investigator's discretion, or if
      there is active circulation of influenza virus in Baltimore, the investigators will vaccinate
      during the first menstrual cycle (prior to ovulation) and then follow for a second menstrual
      cycle for comparison. After vaccination, they will be followed for cytokine and chemokine
      responses as well as changes in the concentrations of steroid hormones. This study will
      evaluate the effect of IIV on inflammatory cytokines and hormonal responses before and after
      ovulation. Each woman will have 13 visits in addition to a screening visit, and will be
      followed for 2 complete menstrual cycles.
    

Intervention name(s): Seasonal Inactivated Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
Other intervention name(s): FluZone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: influenza vaccine; cytokines; hormones; progesterone
Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Childre
Condition: Early Childhood Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To determine the optimal application time of silver diamine fluoride (38% SDF) in arresting
      dental caries in the primary teeth of preschool children.
    

Detailed description: 
      Methods: The randomized double blinded clinical trial will recruit 414 healthy kindergarten
      children aged 3-5 years old with caries and with parental consent. The sample size is
      sufficient for the appropriate statistical analyses. The children will receive 0.004 mL 38%
      SDF (typical amount applied per manufacturer's instructions) to treat each caries lesion. The
      children will be classified into high and low caries rates and equably allocated into nine
      groups of SDF application time: 3, 5, 15, 30, 45, 60, 120 and 180 seconds. The children will
      be followed up for 6-months in their kindergartens. Clinical examinations after 6-months will
      be conducted to assess whether the caries is arrested. Information on confounding factors,
      such as oral hygiene habits and the use of other fluoride agents, will be collected through a
      parental questionnaire at the baseline and 6-months follow-up. The examiner, the children and
      the children's parents will be blind to the treatment allocation. The analysis will determine
      the significance of differences between the means of arrested caries at the various
      follow-ups; and Cochran-Armitage test will be used to evaluate the exposure (SDF-application
      time) to response relationship.

      Significance: This study will help determine the optimal application time in SDF treatment.
      The study provides an evidence-based protocol for the use of silver diamine fluoride to
      arrest tooth decay in primary teeth of young children.
    

Intervention name(s): 3-second SDF application; 5-second SDF application; 10-second SDF application; 15-second SDF application; 30-second SDF application; 45-second SDF application; 60-second SDF application; 120-second SDF application; 180-second SDF application
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Dosage: 3-second 38% SDF solution application; Dosage: 5-second 38% SDF solution application; Dosage: 10-second 38% SDF solution application; Dosage: 15-second 38% SDF solution application; Dosage: 30-second 38% SDF solution application; Dosage: 45-second 38% SDF solution application; Dosage: 60-second 38% SDF solution application; Dosage: 120-second 38% SDF solution application; Dosage: 180-second 38% SDF solution application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: silver diamine fluoride; application time; preschool children; early childhood caries
Split-face Comparison Study to Assess ELAPR Compared to Juvéderm® for the Treatment of Nasolabial Folds
Condition: Aging
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will
      be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial
      fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold.
    

Detailed description: 
      The treatment will be repeated on Day 29 (if required) and Day 57 (if required) to achieve
      optimum cosmetic results (OCR).

      Each treatment will consist of up to 15 injections in total, each consisting of up to 0.1 ml
      of product, delivered to the mid to deep dermis of the skin of each Nasolabial fold using a
      27G needle.

      Each patient will receive the same preparation implanted as a bolus of 0.1mL at Day 1 into
      the mid-deep dermis of the skin of the medial aspect of the upper arm using a 27G needle, and
      two 2mm biopsies will be taken at the same visit on Day 57, Day 85 or Day 169 depending on
      randomisation for histopathology assessment.
    

Intervention name(s): Juvéderm® Ultra Plus; ELAPR002
Intervention type(s): Device; Device
Intervention description(s): Patients will receive either ELAPR002b or ELAPR002d for the treatment of one NLF, and Juvéderm® Ultra Plus for the treatment of the second, opposite NLF. Treatments will be provided on Day 1 and repeated on Day 29 (if required at the discretion of the investigator) Day 57 (if required at the discretion of the investigator)to achieve OCR.; Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient.
Other intervention name(s): Tropelastin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Aging
Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
Condition: Chronic Hepatitis B; Nonalcoholic Fatty Liver Disease
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The changes in liver function, body mass index, controlled attenuation parameters, liver
      stiffness and HBV-DNA at different time points in each group before and after treatment were
      counted to explore the clinical efficacy of Ganshuang granules combined with tenofovir in the
      treatment of CHB complicated with NAFLD.
    

Detailed description: 
      92 patients included in the study were randomly divided into 2 groups, 42 patients in the
      control group and 50 patients in the treatment group. Both groups of patients received
      conventional basic treatment such as liver protection. Moreover, in both groups, patients
      were instructed to change their dietary structure to control low-fat and low-sugar, and were
      instructed to perform appropriate aerobic exercise.

      The control group was treated with silymarin glucosamine tablets (Jiangsu Zhongxing
      Pharmaceutical Co., Ltd.; National medicine permission number: H32026233; Production batch:
      200304) and tenofovir (QILU Pharmaceutical Co., Ltd.; National medicine permission number:
      H20173185; Production batch: 1L0694DF6). The use of silymarin glucosamine tablets was 0.2g/d,
      3 times/d for 24 weeks; the use of tenofovir was 300mg/d, 1 time/d for 24 weeks.

      The treatment group was treated with Ganshuang granules (Baoding Tianhao Pharmaceutical Co.,
      Ltd.; National medicine permission number: Z20027671; Production batch: 200326 ) combined
      with silibinin meglumine tablets and tenofovir. Libribin meglumine tablets and tenofovir were
      used in the same way as in the control group, and Ganshuang granules were used 3 g/time, 3
      times/d, and the course of treatment was 24 weeks.
    

Intervention name(s): Chronic Hepatitis B
Intervention type(s): Drug
Intervention description(s): 92 patients included in the study were randomly divided into 2 groups, 42 patients in the control group and 50 patients in the treatment group. Both groups of patients received conventional basic treatment such as liver protection. Moreover, in both groups, patients were instructed to change their dietary structure to control low-fat and low-sugar, and were instructed to perform appropriate aerobic exercise.
Other intervention name(s): Nonalcoholic Fatty Liver Disease
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy Study of the Combination Mometasone + Salicylic Acid in Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of the combination of mometasone furoate 0.1% and Salicylic Acid 5%
      in patients of both sexes who presented clinical symptoms of psoriasis of mild to moderate.
    

Detailed description: 
      Phase III clinical trial, systematic sampling, open-label study that evaluated the efficacy
      of the combination of mometasone furoate 0.1% and 5% salicylic acid in 71 patients with
      lesions of mild to moderate psoriasis treated for up to 45 days or less than this, at the
      discretion of the investigator. The results were statistically analyzed and investigational
      data and their conclusions are referred to in this report.
    

Intervention name(s): memotasone + salicylic acid
Intervention type(s): Drug
Intervention description(s): mometasone 0,1% + salicylic acid 5%.
Intervention MeSH terms: Salicylic Acid; Salicylates
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriasis, mometasone, salicylic acid.
The Trauma of Betrayal: Treating Adjustment Disorder With Reconsolidation Blockade Under Propranolol
Condition: Adjustment Disorders; Posttraumatic Stress Disorder; Trauma and Stressor Related Disorders
MeSH terms: Stress Disorders, Post-Traumatic; Adjustment Disorders; Trauma and Stressor Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Attachment injuries are events occurring within couple relationships that involve betrayal or
      abandonment by a significant other during times of need (e.g., infidelity). They can be
      understood as relationship traumas, which can lead to debilitating symptoms consistent with
      posttraumatic stress disorder (PTSD), depression, and generalized anxiety for the injured
      partner. Research has demonstrated that the presence of an attachment injury represents a
      barrier to empirically effective couple's therapy. However, disrupting memory reconsolidation
      with the beta-blocker propranolol has been shown to alleviate PTSD symptoms by attenuating
      the salience of the emotional trauma memory, representing an interesting avenue for the
      treatment of adjustment disorders stemming from attachment injuries. Moreover, evidence
      suggests that a certain degree of mismatch, or an error between what is expected/predicted to
      occur and what actually occurs, must be present in order for a memory to destabilize and
      enter the reconsolidation phase following retrieval. Here, the investigators aim to extend
      the conditions under which reconsolidation therapy with propranolol can be used in a clinical
      setting, as well as assess whether incorporating mismatch enhances treatment effects. The
      investigators hypothesize that, compared to a wait-list control, 4-6 sessions of memory
      reactivation under propranolol will significantly reduce trauma-related and general
      anxio-depressive symptoms, associated with an attachment injury. Moreover, the investigators
      hypothesize that participants randomized to the mismatch group will improve significantly
      more than the standard treatment group on all variables of interest.
    


Intervention name(s): Propranolol Pill
Intervention type(s): Drug
Intervention description(s): 1mg/kg of propranolol 60 minutes prior to memory reactivation
Other intervention name(s): Inderal
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experiment 1: Repeated measures open-label clinical trial with time-series analysis.
Experiment 2: Randomized clinical trial (mismatch vs. no mismatch) with within-group wait-list.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Reconsolidation; Propranolol; Infidelity; Attachment injury; Romantic relationships
Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
Condition: Stress-related Changes in Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to examine the effects of fish oil on immune function and mood in
      medical students.
    

Detailed description: 
      This study will examine how supplementation with omega-3 polyunsaturated fatty acids (key
      fish oil components) affects immune and mood responses to examination stress. This study will
      examine these outcomes in medical students during academic examination periods as well as
      less stressful non-exam periods. Participants will take fish oil supplements or placebo pills
      for approximately 3 months during which time relevant mood, endocrine, and immune measures
      will be assessed.

      For detailed information about the study, please visit our website at
      http://www.stressandhealth.org
    

Intervention name(s): omega-3 supplementation; Oral omega-3 fish oil placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2.5 g/day omega-3; to match experimental dosage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: affect; inflammation