bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis
Condition: Healthy Subjects; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1/2a study is a double-blinded (subject and Investigator), randomized,
      placebo-controlled, dose-escalation study to evaluate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of single and multiple nebulized doses of IONIS-ENaCRx.
    

Detailed description: 
      This study will be conducted in 3 parts: a single ascending dose (SAD) leading to a multiple
      ascending dose (MAD) in healthy volunteers, followed by a MAD in patients with cystic
      fibrosis. The study will enroll up to 88 participants.

      The study will consist of 4 single-dose randomized cohorts. Participants enrolled will
      receive a single inhaled dose of the Study Drug (IONIS-ENaCRx or placebo) on Day 1.
    

Intervention name(s): IONIS-ENaCRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single and multiple doses of IONIS-ENaCRx inhaled or nebulized.; Placebo comparator calculated volume to match active comparator inhaled or nebulized.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ION-827359; ENaC
Relative Bioavailability of Meloxicam 2 x 7.5 mg Tablets Compared to 15 mg Tablet and Dose Proportionality Over a Dose Range of 7.5 mg and 15 mg in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type)
      compared to one 15 mg meloxicam tablet (American type), and to investigate
      dose-proportionality over the dosage range 7.5 mg to 15 mg
    


Intervention name(s): Treatment 1; Treatment 2; Treatment 3
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)
Condition: Allergic Rhinoconjunctivitis; Chronic Urticaria
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The conduct of this clinical trial is aimed at determining the most suitable dose regimen for
      children in different age groups, and secondarily to assess the safety and tolerability of
      bilastine in this paediatric population subset.
    

Detailed description: 
      The objective of this study is to assess the pharmacokinetics of bilastine in children (aged
      2 to <12 years) with allergic rhinoconjunctivitis (seasonal allergic rhinitis [SAR] and/or
      perennial allergic rhinitis [PAR]) or chronic urticaria (CU) in order to ascertain that the
      systemic exposure attained with a dose of 10 mg/QD or lower is comparable to that achieved in
      adults and adolescents administered with a dose of 20 mg/QD.

      Additional objectives are to describe the safety and tolerability of a repeated
      administration of bilastine in children with AR or CU.
    

Intervention name(s): Bilastine
Intervention type(s): Drug
Intervention description(s): 10 mg/qd/ 7 days.Oral dispersible tablets
Other intervention name(s): Bilaxten
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic Rhinitis; Seasonal Allergic Rhinitis; Perennial Allergic Rhinitis; Urticaria; Chronic Idiopathic Urticaria; Allergy; Sneezing; Nasal Itching; Rhinorrhea; Nasal Congestion; Wheals; Hives; Skin itching; Flare; Erythema
Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice
Condition: Uveitis
MeSH terms: Uveitis; Panuveitis; Inflammation
Study type: Observational

Summary: 
      This study aims at evaluating real life effectiveness of originator adalimumab (Humira®)
      participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU)
      despite high-dose corticosteroid therapy; including effect on ocular inflammation,
      health-related quality of life, health resource utilization, work ability and medication
      burden, as well as describe the characteristics of NIIPPU participants treated with Humira®
      in the real-life setting.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with diagnosed active non- infectious intermediate, posterior or panuveitis
        (NIIPPU) that are being treated with Humira® as per locally approved label and prescription
        guidelines.
      
Keywords: Humira®; Adalimumab; Ocular inflammation; Active non-infectious intermediate, posterior and panuveitis
Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional

Summary: 
      Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations
      in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of
      adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal,
      nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and
      transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the
      membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and
      postpartum endometritis. Several studies have documented increased postpartum complications
      in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite
      common despite treatment. Documented recurrence rate of up to 30% within three months are
      reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic
      regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic
      therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an
      acidifying gel will decrease the chance of recurrence of BV within 3 months.
    

Detailed description: 
      Women with recurrent BV will be randomly assigned to standard care of metronidazole vs
      metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at
      followup.
    

Intervention name(s): Vaginal acidifying gel (RepHresh); Metronidazole control
Intervention type(s): Drug; Drug
Intervention description(s): placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH.; oral metronidazole therapy alone
Other intervention name(s): RepHresh vaginal gel.; metronidazole
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bacterial vaginosis; vaginal acidifying gel; recurrence
Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% /
      Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in
      Subjects with acne vulgaris after a 12-week treatment period.
    


Intervention name(s): Adapalene BPO
Intervention type(s): Drug
Intervention MeSH terms: Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium
Condition: Hyperactive Delirium
MeSH terms: Delirium; Hyperkinesis; Psychomotor Agitation
Study type: Interventional
Phase: Phase 3

Summary: 
      In population of intensive care unit (ICU), most studies compared atypical antipsychotics
      such as quetiapine with the traditional haloperidol in delirious patients of various forms
      and etiologies. The role of such agents in patients with hyperactive is not fully understood.

      This study compares the effectiveness of quetiapine with haloperidol in treating the
      hyperactive form of delirium in terms of their effects on morbidity, length of stay in the
      intensive care unit, and mortality in critically ill patients.
    

Detailed description: 
      A common complication in the intensive care unit (ICU) that has recently been identified is
      delirium. Defining delirium as a "sudden deterioration in attention, awareness, and
      cognition, which is not explained by any pre-existing neurocognitive disorder, but because of
      another medical condition," the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
      clarified the definition of delirium.

      A dibenzothiazepine derivative with a novel and distinctive pharmacologic profile is
      quetiapine. The limbic system is overactive in delirium, which is one of its
      pathophysiologies. By obstructing the mesolimbic dopamine D2 receptors specifically,
      quetiapine may be able to regulate this hyperactivity.

      The objective of this study is to compare the effectiveness of quetiapine with haloperidol in
      treating the hyperactive form of delirium in terms of their effects on morbidity, length of
      stay in ICU, and mortality in critically ill patients.

      This research will not receive any grants, funding, or financial aid (NOT FUNDED STUDY).
      Collaborators declare that they have no conflicts of interest.
    

Intervention name(s): Quatiapine; Haloperidol
Intervention type(s): Drug; Drug
Intervention description(s): Atypical antipsychotic; Antipsychotic
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel random assignment to receive either oral quetiapine (25-50 mg/day) or haloperidol (1-2 mg/day)
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Critical Care; Hyperactive Delirium; antipsychotics; Haloperidol; Quetiapine
A New Treatment Approach for Major Depressive Disorder Based Upon Targeting Monoamine Oxidase A (MAO-A)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators will be looking at MAO-A density before and after seven weeks of treatment
      with an antidepressant and dietary supplement. MAO-A is an enzyme that breaks down brain
      chemicals that regulate mood. MAO-A density is elevated in patients with major depressive
      episodes (MDE) secondary to major depressive disorder (MDD). Many remain treatment resistant
      with common antidepressant treatments and we think it may be due to poor targeting of brain
      pathologies. We want to test if adding a dietary supplement may normalize MAO-A.
    

Detailed description: 
      All subjects are getting the combined treatment of a selective serotonin reuptake inhibitor
      and the dietary supplement. There are two possible selective serotonin reuptake inhibitor
      treatments but the dietary supplement remains the same. No subjects are receiving the
      selective serotonin reuptake inhibitor alone and no subjects are receiving the dietary
      supplement alone. The dietary supplement is called n-acetylcysteine.
    

Intervention name(s): Sertraline; Citalopram; N-acetylcysteine (NAC); Existing depression medication treatment
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): selective serotonin reuptake inhibitor; selective serotonin reuptake inhibitor; natural health product; Continuation of depression medication treatment already taken prior to study enrollment except for drugs with affinity for MAO-A or potentially influencing MAO-A levels, including phenelzine, tranylcypromine, moclobemide, cytomel and lithium
Other intervention name(s): Zoloft; Celexa
Intervention MeSH terms: Acetylcysteine; Sertraline; Citalopram; N-monoacetylcystine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Skin Incision Adhesive in Pediatrics
Condition: Wounds
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™
      Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure
      of the topical skin in children presenting in the Emergency Department (ED).
    

Detailed description: 
      Subjects had SurgiSeal™ applied to their topical skin incisions in the ED. Subjects' wounds
      were evaluated for bleeding and closure of the incision/wound before patient discharge and 48
      hours after the procedure. Further follow up wound closure evaluations were conducted via
      telephone interview at 5-10 days and 14 days after the ED visit.
    

Intervention name(s): Surgiseal
Intervention type(s): Device
Intervention description(s): surgical glue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Wounds
A Study of SHR-1210 in Combination With Pemetrexed and Carboplatin in Subjects With Non-squamous NSCLC
Condition: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Disease; Neoplasms by Site; Neoplasm, Bronchial; Carcinoma, Bronchogenic
MeSH terms: Carcinoma; Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasms by Site; Thoracic Neoplasms; Respiratory Tract Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a randomized,Phase III,
      multicenter ,open-label study designed to evaluate the safety and efficacy of SHR-1210 with
      carboplatin and pemetrexed versus carboplatin-pemetrexed in subjects who are chemotherapy
      naive and have Stage IIIB/IV non-squamous NSCLC.

      The primary hypothesis is that SHR-1210 combined with carboplatin and pemetrexed prolongs
      Progression Free Survival (PFS) in per RECIST 1.1 by blinded independent central review (ITT
      population and population was indicated by high PD-L1 expression) compared to carboplatin and
      pemetrexed treatment .
    

Detailed description: 
      In this study, subjects will be randomly assigned to receive either carboplatin and
      pemetrexed for 4-6 cycles followed by pemetrexed maintenance until progression or
      unacceptable toxicity, OR receive SHR-1210 combined with carboplatin and pemetrexed
      chemotherapy for 4-6 cycles followed by pemetrexed maintenance with SHR-1210 until
      progression or unacceptable toxicity (SHR-1210 for a maximum of 2 years).

      Subjects assigned to the chemotherapy arm will have the opportunity to crossover to receive
      SHR-1210 monotherapy once they experience progression of disease (PD) defined by RECIST 1.1
      and meet all the crossover criteria.
    

Intervention name(s): SHR-1210; Carboplatin; Pemetrexed
Intervention type(s): Biological; Drug; Drug
Intervention description(s): SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.; Carboplatin; Pemetrexed
Intervention MeSH terms: Carboplatin; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PD-1; PD-L1; SHR-1210; Carboplatin; Pemetrexed
Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection
Condition: Myeloma; Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether the addition of the drug plerixafor to treatment
      with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the
      chances of transplant. The study will look for the activation of a certain type of blood
      cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The
      investigators will follow the number of patients that achieve the target numbers of CD34+
      cells. The number of patients achieving the target level of CD34+ cells, and the total number
      of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy
      and G-CSF, without plerixafor.

      The investigators will also test the safety of the combination of plerixafor with
      chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
    


Intervention name(s): Plerixafor
Intervention type(s): Drug
Intervention description(s): 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Other intervention name(s): Mozobil; AMD3100
Intervention MeSH terms: Plerixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myeloma; Lymphoma; Stem cell transplantation
Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in
      patients with mild to moderate persistent asthma.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone
      Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to
      moderate persistent asthma. Patients are randomised to receive either Beclomethasone
      Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or
      Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.
    

Intervention name(s): Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Intervention type(s): Drug
Intervention description(s): Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Intervention MeSH terms: Beclomethasone; Norflurane; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to look at brain function in order to understand how different
      treatments work to help people quit smoking. In this study, the investigators will look at
      the effects of nicotine patches, Chantix alone or Chantix paired with Zyban.
    


Intervention name(s): Varenicline; Bupropion; Nicotine patches; Placebo varenicline; Placebo bupropion; Placebo patch
Intervention type(s): Drug; Drug; Drug; Other; Other; Other
Other intervention name(s): Chantix; Zyban; Nicoderm
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Nicotine addiction; Cigarette smoking; Smoking cessation; Zyban; Chantix; Nicotine patches; varenicline; bupropion; fMRI
Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
Condition: Leprosy
MeSH terms: Leprosy
Study type: Interventional
Phase: Phase 2

Summary: 
      Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy

      Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line
      drug in patients with Type 1 Reactions who have not responded to a 12 week course of
      Prednisolone.
    


Intervention name(s): ciclosporin
Intervention type(s): Drug
Intervention description(s): Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Intervention MeSH terms: Cyclosporine; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leprosy; Type 1 Reaction; Prednisolone; Ciclosporin
Shelter Cat Adoption in Families of Children With Autism (Feline Friends)
Condition: Social Skills; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The overall purpose of this study is to investigate the effect of the introduction of a
      shelter cat into the family of a child with Autism Spectrum Disorder on the social skills and
      anxiety of the child, and to examine stress in the cat.
    

Detailed description: 
      Many families in the United States live with cats as companion animals, including families of
      children with Autism Spectrum Disorder (ASD). One in 68 children are diagnosed with ASD.
      There is no cure for ASD, and no one treatment works for all children. Symptoms of ASD
      include a lack of social skills and anxiety. Companion animals have been helpful for children
      with ASD. However, no one has studied stress of cats living in families of children with ASD.
      This study will place 64 pre-screened shelter cats in pre-screened homes and monitor the
      stress of the cats. Cats ages 10 months to four years that have been screened for calm
      behavior using a temperament, test will be adopted by families in the study. Families will
      also be screened for pet issues. No cat will be placed in a home with a child who has a
      history of aggression to animals. The study will also examine the social skills and anxiety
      of the children with ASD, and bonding of the parents and children with their cats. Five to
      eight million dogs and cats are relinquished to animal shelters in the United States each
      year. Thirty-eight percent of cats are given up for behavioral reasons. Studying cat stress
      and the placement of cats, with calm and non-aggressive characteristics into homes of
      families of children with ASD may help shed light on the likely success of the relationships
      between shelter cats and these families.
    

Intervention name(s): shelter cat
Intervention type(s): Other
Intervention description(s): families will adopt a shelter cat
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study uses a two-group randomized, repeated measures design with a delayed treatment control group.
Masking: None (Open Label)
Primary purpose: Other