bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Urban Afforestation Activity on Mental Health
Condition: Healthy
Study type: Interventional

Summary: 
      This single-group pretest-posttest clinical trial aims to evaluate the effects of a
      single-session afforestation activity on affect and vitality levels in a sample of young
      adults.
    

Detailed description: 
      The participants will perform an afforestation activity for a single session of 90 minutes.
      The therapists will direct the participants' attention to the visual, auditory, olfactory,
      and tactile features of the surrounding environment.
    

Intervention name(s): Urban Afforestation Program
Intervention type(s): Other
Intervention description(s): An afforestation program based on land cultivation and transplantation of several plants for 90 minutes will be implemented.
Other intervention name(s): Nature-based activity; Afforestation activity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Green spaces; Nature-based activities; Urban afforestation; Horticultural therapy; Adults; Mental health; Affect; Vitality
Axis Length and Its Relationship With Refractive Error in Chinese University Students
Condition: Refractive Error - Myopia Axial
MeSH terms: Myopia; Refractive Errors
Study type: Observational

Summary: 
      To investigate the relationship between axis length (AL) and refractive error. eyes of low
      hyperopia to emmetropia subjects, comprising eyes with moderate to high myopia (-11.00D ≤ SE
      ≤ -4.00D) were analyzed in this cross-sectional study. Cycloplegic refractive error was
      measured with the autorefractor, AL was measured with the IOL master. Association between AL
      and refractive error were evaluated by linear regression analysis. The mean of AL and its
      correlation with SE, sex, and age were evaluated.
    

Detailed description: 
      To investigate the relationship between axis length (AL) and refractive error (RE). 894 eyes
      with low hyperopia to emmetropia (-0.50D ≤ spherical equivalent (SE) ≤ +2.00D), comprising
      1007 eyes with moderate to high myopia (-11.00D ≤ SE ≤ -4.00D) were analyzed in this study.
      Cycloplegic RE was measured with the autorefractor, AL was measured with the IOL master.
      Association between AL and refractive error were evaluated by linear regression analysis. The
      mean of AL and its correlation with SE, sex, and age were evaluated.
    

Intervention name(s): myopia or not myopia
Intervention type(s): Other
Intervention description(s): visual acuity, IOL master biometry, the anterior segment with slit lamp, dilated fundus examination and refraction.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The subject recruited for the study were 1935 students
      
Keywords: China; high myopia; hyperopia; emmetropia
Is Pentoxifylline Able to Improve Olfactory Sensitivity?
Condition: Olfaction Disorders
MeSH terms: Olfaction Disorders
Study type: Observational

Summary: 
      Signal processing in the olfactory neuron could be influenced by inhibition of enzymes like
      phosphodiesterase. Pentoxifylline is a unspecific phosphodiesterase inhibitor. The hypothesis
      is that pentoxifylline could lead to increased sensitivity to odors.
    

Detailed description: 
      Olfactory signal processing is conducted by a G-protein linked increase of intracellular
      concentration of adenosine 3´,5´-cyclic monophosphate (cAMP). In the cilia of olfactory
      sensory neurons (OSN) cAMP is degraded by phosphodiesterase 1C2 (PDE1C2). Inhibition of
      PDE1C2 could result in an increased response of OSN to chemical stimuli. Aim of the present
      prospective post-marketing surveillance study was to investigate the impact of
      pentoxifylline, an unspecific phosphodieasterase inhibitor, on olfactory function.
    

Intervention name(s): Pentoxifylline retard 400mg
Intervention type(s): Drug
Intervention description(s): Agapurin retard 400mg 3/day per os for 3 weeks
Other intervention name(s): Agapurin retard
Intervention MeSH terms: Pentoxifylline
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        hyposmic or functionally anosmic patients TDI-score <31; age: 18-50 years; odor threshold:
        better than 1; cause of smell loss: post traumatic, postinflammatory, idiopathic
      
Keywords: smell; olfaction; olfactory sensitivity; smell loss; chemoreception
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
Condition: Anemia, Sickle Cell; Pain
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if intranasal fentanyl can decrease the pain of
      patients with sickle cell disease who present to the pediatric emergency department with a
      vaso-occlusive crisis.
    

Detailed description: 
      Principles of therapy for treatment of vaso-occlusive crises include early aggressive
      analgesic therapy with opiates and non-steroidal anti-inflammatory agents as well as fluid
      administration. It is known that there is a significant delay in time to administration of
      analgesics in children with VOC in the ED. The most easily modifiable factor that contributes
      to delayed opiate administration is route of administration.

      Intranasal medication administration is an easy, rapid way to administer opiates with minimal
      discomfort as well as bypassing first past metabolism and the blood brain barrier. Intranasal
      fentanyl has been shown to be a safe and effective analgesic for treatment of acute pain in
      children, reaching therapeutic effect in 2-10 minutes after administration.

      The investigators believe that intranasal fentanyl therapy will be able to provide expedited
      and effective pain therapy to patients with sickle cell disease presenting to the pediatric
      emergency department with a vaso-occlusive crisis
    

Intervention name(s): Fentanyl Citrate; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device; A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fentanyl; intranasal; sickle cell; vasoocclusive crisis; pain crisis; pediatrics
Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)
Condition: Primary Immune Deficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether a long-term use of a new human
      immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary
      immunodeficiency.
    


Intervention name(s): IgPro20
Intervention type(s): Biological
Other intervention name(s): IgG with Proline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CVID; XLA
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week
      study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets)
      taken daily at bedtime for the treatment of fibromyalgia.
    


Intervention name(s): TNX-102 SL; Placebo SL Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.; Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain, Sleep, Fibromyalgia, FM
Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to compare the relative bioavailability (rate and extent of
      absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets
      (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablet) in healthy, adult
      subjects administered under fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence
      Statistical Methods
    

Intervention name(s): Drospirenone/Ethinyl Estradiol (Gianvi®); YAZ®
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg/0.02 mg Tablets; 3 mg/0.02 mg Tablets
Other intervention name(s): Gianvi®; Drospirenone/Ethinyl Estradiol (generic name)
Intervention MeSH terms: Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the effect of multiple doses of a uridine
      diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl
      estradiol and levonorgestrel) on the PK of BIIB074 at steady state; evaluate the effect of
      multiple doses of BIIB074 on the pharmacokinetics(PK) of an OC regimen (ethinyl estradiol and
      levonorgestrel) at steady state.

      The secondary objective of this study is to evaluate the safety and tolerability of BIIB074
      when administered alone and when coadministered with a UGT-inducing OC regimen containing
      ethinyl estradiol and levonorgestrel and to evaluate the effect of a UGT-inducing OC regimen
      (ethinyl estradiol and levonorgestrel) on the PK of the M13, M14, and M16 metabolites of
      BIIB074.
    


Intervention name(s): BIIB074; OC (ethinyl estradiol and levonorgestrel)
Intervention type(s): Drug; Drug
Intervention description(s): BIIB074 is administered as specified in the treatment arm.; OC is administered as specified in the treatment arm.
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral Contraceptive, Healthy Volunteers, Ethinyl Estradiol,; Levonorgestrel
Effects of EPA and Vitamin E on Leptin, Adiponectin and Enzymatic Antioxidants in Type 2 DM
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate efficacy and safety of EPA(Eicosapentaenoic
      Acid)alone and with VitE in diabetic patients.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled, parallel-group study design After a 12weeks,
      subjects with type II DM will be randomized to receive either 2000 mg pearl EPA per day plus
      a double-blinded matching placebo (1 corn oil pearls per day) for 12 weeks OR 400 mg VitE
      pearl plus double-blinded per day plus a double-blinded matching placebo (4 corn oil pearls
      per day) for 12 weeks OR 2000 mg pearl EPA per day plus a double-blinded matching 400 mg VitE
      pearl OR placebo(4corn oil pearls per day plus 1 corn oil pearls per day )for 12 weeks.The
      total dose of EPA pearl will be 2000 mg per day (with the EPA or matching placebo corn oil
      doses remaining at 4 pearls per day) and The total dose of VitE pearl will be 400 mg per day
      (with the VitE or matching placebo corn oil doses remaining at 1 pearls per day).
    

Intervention name(s): EPA, Vitamin E
Intervention type(s): Dietary Supplement
Intervention description(s): EPA pearls, 500 mg QID for 12 Weeks (2000 mg per day) Vitamin E pearls, 400 mg per day for 12 weeks
Other intervention name(s): Plus EPA
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: diabetes mellitus type 2; EPA; leptin; adiponectin
A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients
Condition: T Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell
      lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy
      (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other
      transformed T-cell lymphomas with the primary objective of studying the biological effects of
      the multikinase inhibitor, sorafenib.
    

Detailed description: 
      Primary objectives:

      • To study the biological effects of sorafenib 400mg BID on the mitogen-activated protein
      kinase (MAPK) pathway, specifically the inhibition of extracellular signal-regulated kinases
      (ERK) phosphorylation, and to correlate with clinical activity in patients with T-cell
      lymphoma.

      Secondary objectives:

        -  To observe the clinical activity of sorafenib 400mg BID by determining response rate,
           and progression free survival in patients with T-cell lymphoma. Duration of response and
           duration of stable disease will also be measured.

        -  To determine the tolerability of sorafenib in patients with T-cell lymphoma.

      Exploratory objectives:

        -  To observe the effects of sorafenib on T-cell subsets (CD4/CD8 ratio, and Tregs), and
           the effects of sorafenib on the monocytoid population.

        -  To observe the effects of sorafenib on the serum cytokine profile.

        -  To observe the effects of sorafenib on the T-cell receptor pathway, i.e. Lck, ZAP-70,
           and Syk.

        -  To observe changes in lymph node or skin morphology including tumor cell infiltrate,
           vasculature, and the tumor microenvironment in patients treated with sorafenib by
           performing serial biopsies of lymph nodes or skin.
    

Intervention name(s): Sorafenib
Intervention type(s): Drug
Intervention description(s): Intrapatient dose reduction to 400 mg once daily and then 400 mg every other day will be allowed depending on the type and severity of toxicity encountered provided that criteria for patient withdrawal from study treatment have not been met.
Intervention MeSH terms: Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: relapsed or refractory T cell lymphoma
A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The investigators hypothesize that breast cancer survivors participating in a prosocial
      online support group will have a significantly lower mean level of psychological symptoms
      (anxiety/depression) and higher mean level of sense of purpose post-intervention than
      participants in a standard online support group.
    

Detailed description: 
      Psychological distress is a significant problem among breast cancer survivors. Many survivors
      turn to the internet for information and support, yet few controlled studies have examined
      the effectiveness and safety of online support groups. The investigators are testing the
      potential efficacy, acceptability, and feasibility of an innovative theory-based online
      support group (OSG) for breast cancer survivors. Members of the control group will
      participate in a standard OSG that encourages self-expression. Members of the experimental
      condition will participate in a prosocial OSG that provides structured helping opportunities
      and coaching on how best to give support to others. Participants will complete two telephone
      interviews and six weekly online support group meetings.
    

Intervention name(s): prosocial online support group; Standard Online Support Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six weekly 1.5 hour online support group meetings facilitated by a Cancer Support Community staff member. This online support group will maximize opportunities to provide help to others.; Six weekly 1.5 hour online support group meetings facilitated by a Cancer Support Community staff member. This online support group will focus on encouraging self-expression.
Other intervention name(s): Life Beyond Cancer; Life Beyond Cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: breast cancer; breast tumor
A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis
Condition: Sepsis; Shock, Septic; Sepsis Syndrome; Septicemia; Infection
MeSH terms: Sepsis; Toxemia; Shock, Septic; Systemic Inflammatory Response Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Sepsis is a serious condition where there is inflammation and damage to body tissue, usually
      caused by an infection. This infection can lead to decreased function of vital body organs
      and in some cases may lead to permanent health problems or death.

      Much of the injury is due to endotoxin, a harmful substance produced by certain types of
      bacteria. An endotoxin antagonist is designed to block the effects of endotoxin.

      This study is designed to study the safety and efficacy when treating patients with severe
      sepsis.
    


Intervention name(s): E5564
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Sepsis; Shock; Septic; Sepsis Syndrome; Septicemia; Endotoxins; Endotoxemia; Infection
Transdiagnostic Group Intervention for Children With Behavior Problems
Condition: Behavioral Symptoms; Emotional Disturbances
MeSH terms: Problem Behavior; Behavioral Symptoms; Affective Symptoms
Study type: Interventional

Summary: 
      This study fills a notable gap in the transdiagnostic literature by evaluating whether an
      evidence-based transdiagnostic treatment for emotional disorders such as the Unified Protocol
      for Children (UP-C) is effective for treating childhood behavior problems.
    

Detailed description: 
      By participating in the study, child participants will learn emotion regulation skills and
      have opportunities to interact and practice skills with other children who have similar
      problems. In addition, parent participants will learn effective parenting skills, including
      appropriate limit-setting, use of praise and consequences, and empathy, that may help them
      effectively navigate the challenges of caring for a child with behavior concerns (1). Parents
      will also have the opportunity to interact with other parents who face similar challenges,
      providing validation and support. Upon completion of the study, investigators plan to share
      these findings at professional conferences and submit manuscripts to peer-reviewed journals.
      Collectively, this study will add to the literature in the pediatric mental health field and
      may also serve as a model for other outpatient clinics regarding implementation and provision
      of a transdiagnostic approach to treat children with behavior problems. Thus, the main goals
      of the current study are to examine the effectiveness of the UP-C group treatment in reducing
      childhood behavior problems, evaluate parents' satisfaction with this treatment, and
      determine the feasibility of implementing this treatment in a pediatric outpatient setting.
    

Intervention name(s): Group Therapy
Intervention type(s): Behavioral
Intervention description(s): Participating children and their caregivers will attend 90-minute weekly group therapy sessions for 10 consecutive weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Effect of JNJ-67953964 on Gastric Mucosal Integrity in Healthy Male and Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to investigate the upper gastro-intestinal (GI)-related
      safety and tolerability in healthy participants by gastroscopy and gastric biopsies after
      treatment with 25 milligram (mg) JNJ-67953964 once daily (QD) over 4 weeks.
    


Intervention name(s): JNJ-67953964; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-67953964 as oral capsules.; Participants will receive matching placebo oral capsules.
Other intervention name(s): Cerecor (CERC)-501
Intervention MeSH terms: Aticaprant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Non-Contact Air Tonometry (Topcon CT-1®) Versus Goldmann
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      In this prospective device comparison study with 58 healthy eyes, the Topcon CT-1® showed
      statistically significant elevated intraocular pressure measurements compared to the gold
      standard Goldmann application tonometry.
    

Detailed description: 
      Introduction:

      Intraocular pressure (IOP) measurement is crucial in glaucoma diagnosis and treatment. We
      compared a non-contact air tonometer (Topcon CT-1®) with the gold standard Goldmann
      Applikation tonometer (GAT).

      Methods:

      In this prospective, mono centric device comparison study, only healthy eyes were enrolled.
      IOP was measured three times with the Topcon CT-1® followed by three times GAT. Mean IOP was
      calculated and compared with a paired t-test, a linear regression and a Bland-Altman
      analysis.
    

Intervention name(s): Intraocular pressure measurement
Intervention type(s): Device
Intervention description(s): Pressure tip or air puff is applied on eye
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Keywords: Tonometry