bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment
Condition: Dental Sedation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the current study is to compare the effect of intranasal versus nebulized route of
      administration of midazolam as moderate sedative agents in preschoolers undergoing dental
      treatment.
    


Intervention name(s): Nebulized Midazolam; Intranasal Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): All the drug solutions will be freshly prepared on the day of sedation session. Depending on the dosage calculated from the weight of each child The sedative drug, the dosage will be diluted with an equal volume by adding distilled water.
The child will be seated in an upright position on the dental chair. Before placing the mask of the nebulizer, the child will be coached into proper breathing pattern; All the drug solutions will be freshly prepared on the day of sedation session. Depending on the dosage calculated from the weight of each child, For children who will receive midazolam using the atomization device attached to a three-ml syringe, the child sitting reclined in knee-to-knee position. Half of the dose will be sprayed in the right nostril and the other half will be sprayed in the left nostril to double the absorptive surface area by short and quick puffs
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and tolerability of single ascending doses of
      UCB4019 administered by subcutaneous injection in healthy subjects.
    


Intervention name(s): PR1; PL1
Intervention type(s): Drug; Other
Intervention description(s): Active substance: UCB4019
Route of Administration: subcutaneously; Active substance: Placebo
Concentration: 0.9 % saline
Route of Administration: subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: First in human; Healthy volunteers
Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis
Condition: Pulmonary Sarcoidosis; Lung Function
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Sarcoidosis is a granulomatous disease for which the molecular and immunologic association
      with mycobacteria continues to strengthen. The investigators are interested in conducting a
      proof-of-concept investigation of the effects of antibiotics on sarcoidosis resolution. The
      investigators hypothesize that pulmonary sarcoidosis will improve faster if patients are
      given antimycobacterial therapy, in addition to their standard therapy.
    


Intervention name(s): levaquin; ethambutol; rifampin and azithromycin.
Intervention type(s): Drug
Intervention description(s): Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD
**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway.
Intervention MeSH terms: Azithromycin; Rifampin; Ethambutol; Levofloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: sarcoidosis; mycobacteria; lung; pulmonary; radiographic improvement
Telephone-Based Support for Caregivers of Patients With Dementia
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to develop an effective, low-cost, telephone-based intervention
      to reduce anxiety, depression, and feelings of burden and stress in caregivers of patients
      with dementia. This study will also determine whether the intervention can alter the course
      of dementia.
    

Detailed description: 
      Caregivers are randomized to receive either telephone-based intervention or standard medical
      care. Both groups receive a resource packet containing information about caring for someone
      with dementia and a list of local resources. Caregivers in the intervention group also
      receive a series of telephone calls over 12 months, during which education, emotional
      support, and training in problem-solving skills are provided by trained therapists.
      Caregivers in the standard care group receive no additional psychosocial intervention.
      Participants are assessed pre-treatment, mid-treatment (6 months), post-treatment, and at a
      3-month follow-up.
    

Intervention name(s): Cognitive-Behavioral Family Systems Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Tibial Nerve Versus Sciatic Nerve Block
Condition: Post Operative Analgesia
Study type: Interventional

Summary: 
      The purpose of this study is to analyse the ability to selectively block the posterior tibial
      nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking
      the posterior tibial nerve will give the same post-operative pain relief after total knee
      surgery compared to a sciatic nerve block.
    


Intervention name(s): Selective Tibial Nerve block; Sciatic Nerve Block
Intervention type(s): Procedure; Procedure
Intervention description(s): Use of selective pain block.; Use of Sciatic Nerve Block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether two different fermented dairy drinks
      consumed daily could have an effect on the intestinal immune response in healthy subjects.
    


Intervention name(s): 1- Dairy drink containing probiotics A; 2- Dairy drink containing probiotics B; 3- Dairy drink without probiotics (control)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1- Dairy drink containing probiotics A; 2- Dairy drink containing probiotics B; 3- Dairy drink without probiotics (control)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Probiotics; intestinal immune system; human; healthy subjects; dairy drink; Healthy adults
A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants
      with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the
      target sample size is 60 individuals.
    


Intervention name(s): Peginterferon alfa-2a
Intervention type(s): Drug
Intervention description(s): 180 uG in 0.5 mL solution administered once weekly for 48 weeks
Other intervention name(s): Pegasys
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
Condition: Fish Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to investigate the safety and tolerability of Subcutaneous
      Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish
      parvalbumin (mCyp c 1) quantified in mass units:

      To establish a safe dose of the candidate hypo-allergen in human subjects and To study the
      pharmaco-dynamics of the hypo-allergen administered to human subjects.

      The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish
      allergic patients allocated into three different groups of eight.
    

Detailed description: 
      The aim of the FAST project in general is to develop novel recombinant allergen-based
      therapeutics for the treatment of food allergy. The chosen approach is to modify recombinant
      allergens into hypo-allergenic molecules to decrease the risk of anaphylactic side-effects
      and to allow administration of higher doses leading to better efficacy.
    

Intervention name(s): mCyp c 1
Intervention type(s): Biological
Intervention description(s): 2 patient groups with different doses of allergen.
Other intervention name(s): A modified hypo-allergenic Parvalbumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fish allergy; immunotherapy; hypoallergen
VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo (CellspermVIH)
Condition: HIV-1-infection
Study type: Interventional

Summary: 
      The objective of our project is to determine the infected seminal cell types and the
      molecular mechanisms involved in HIV cell-associated transmission in the colo-rectal mucosa,
      using conditions as close as possible to real life, i.e. seminal leukocytes and seminal
      plasma from HIV-infected donors and tissue explants
    

Detailed description: 
      This project relies on:

        -  our expertise of HIV in semen and male genital tract and our experience in organotypic
           cultures;

        -  a network of infectious diseases and reproductive biology clinicians to collect, analyze
           and process seminal cells and seminal plasma from HIV+ donors;

        -  the expertise in confocal microscopy and ex vivo colo-rectal model. State of the art
           culture of colo-rectal tissues, primary cell culture and infection, confocal microscopy,
           flow cytometry, Polymerase Chain Reaction and Luminex assays for cytokine measurements
           will be the methodologies primarily used in this project.
    

Intervention name(s): blood sample; sperm sample
Intervention type(s): Other; Other
Intervention description(s): A sample of HIV-1 infected patients's blood is collected; A sample of HIV-1 infected patients's sperm is collected
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV-1; Colo-rectal transmission; seminal plasma
A Study to Investigate the Impact of Fortified Malt Based on Immunity Outcomes in School Children
Condition: Growth and Development
Study type: Interventional

Summary: 
      This study will test the hypothesis that a fortified malt based food may improve immunity
      outcomes in 7-10 year old school age children.
    

Detailed description: 
      This will be a single centre, multiple sites, open label, two-arm, parallel-group, stratified
      by gender, matched pair cluster randomised, controlled study in children aged 7-10 years.
    

Intervention name(s): Fortified malt based food
Intervention type(s): Dietary Supplement
Intervention description(s): Fortified malt based food
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment
Condition: Hypertension With Moderate Renal Impairment
MeSH terms: Renal Insufficiency; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To examine antihypertensive effect and safety of administration of CS-3150 in combination
      with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.
    


Intervention name(s): CS-3150
Intervention type(s): Drug
Intervention description(s): CS-3150 1.25 to 2.5, 5mg, orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mineralocorticoid receptor antagonist; Moderate renal impairment; Hypertension
A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to gather preliminary data regarding the angiographic
      efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during
      balloon angioplasty for heart attacks.

      We hypothesize that low-dose IC tenecteplase will enhance the breakdown of blood clots at the
      site of the culprit lesion leading to reduced damage to the heart muscle.
    

Detailed description: 
      The primary objective of this study is to gather preliminary data regarding the angiographic
      efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during
      primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial
      infarction (STEMI). Efficacy will be assessed by measurements of both the angiographic
      characteristics of the culprit lesion as well as by measurements of epicardial flow and
      myocardial perfusion in the territory of the infarct-related artery. This study will also
      evaluate the safety of administering low-dose IC tenecteplase to subjects undergoing primary
      PCI for STEMI treated with standard therapy (aspirin, clopidogrel, and glycoprotein IIb/IIIa
      inhibitors). Safety endpoints include the incidence of death, recurrent myocardial infarction
      (MI), abrupt vessel closure, subacute stent thrombosis, and TIMI major and minor bleeding
      events.

      Prompt reperfusion therapy with primary PCI in patients with STEMI improves clinical outcomes
      through salvage of myocardial tissue. The proposed pilot trial is a randomized,
      placebo-controlled trial to evaluate the effectiveness and safety of adjunctive low-dose IC
      tenecteplase in conjunction with standard medical therapy during primary PCI for STEMI. We
      hypothesized that low-dose IC tenecteplase will enhance fibrinolysis at the site of the
      culprit lesion leading to reduced microvascular dysfunction. As reduced dose tenecteplase
      will be injected directly into the coronary artery increasing local concentration of the drug
      with minor systemic effects, an improved safety profile is also expected from this mode of
      administration.
    

Intervention name(s): Tenecteplase; Sterile Saline
Intervention type(s): Drug; Drug
Intervention description(s): Intracoronary injection of IV tenecteplase.; Intracoronary injection of IV sterile saline
Intervention MeSH terms: Tenecteplase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ST-Elevation Myocardial Infarction; Acute Myocardial Infarction; No Reflow
Comparison of IV Fluid Loading and Ondansetron in Reduction of PONV After LC
Condition: Postoperative Nausea; Postoperative Vomiting; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      This study is designed to examine the incidence of postoperative nausea and vomiting during
      24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative
      intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor
      ondansetron or control group (group C).
    

Detailed description: 
      This study is a prospective randomized control trial. It is designed to examine the incidence
      of postoperative nausea and vomiting during 24 hours after elective laparoscopic
      cholecystectomy in patients receiving preoperative intravenous fluid loading (group F),
      ondansetron (group O) and receiving neither fluid nor ondansetron or control group (group C).
      This study is hypothesized that the incidence of PONV in patients receiving preoperative
      intravenous fluid loading (group F) and patients receiving ondansetron (group O) will be
      similarly reduced from the control group (receiving neither fluid nor ondansetron).
    

Intervention name(s): Fluid loading; Ondansetron
Intervention type(s): Other; Drug
Intervention description(s): Patients in the preoperative intravenous fluid loading group (group F) will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation.; Patients in the ondansetron group (group O) will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation
Other intervention name(s): Preoperative IV loading; Zetron
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Modulation of the Brain Excitatory/Inhibitory (E/I) Balance in Autism Spectrum Disorder (ASD)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      This study investigates the brain response to a single acute dose of Arbaclofen, the
      R-enantiomer of the GABA-B agonist Baclofen, compared to a single dose of placebo in healthy
      men with and without autism spectrum disorder.
    

Detailed description: 
      Previous research suggests that GABAergic drug compounds could shift brain excitation and
      inhibition (E-I) in the healthy brain and in neurodevelopmental psychiatric conditions, such
      as autism spectrum disorder (ASD) - where this balance is disrupted. A study by Ajram et al.
      (2017) has shown an E-I shifted towards more GABA in individuals with ASD, and not in
      controls, after a single dose of the anti-glutamatergic and pro-GABAergic drug Riluzole.
      Moreover, brain connectivity patterns in ASD patients where shifted towards the ones observed
      in the control group. However, it was unclear whether this changes could be driven by GABA
      receptors, thus more specific probes may help to clarify the mechanism underlying the E-I
      coordination in ASD. Therefore, this study will use neuroimaging and electrophysiology to
      investigate the brain E-I coordination in ASD compared to control participants when the
      system is responding to a single dose of the specific GABA-B (STX209) receptor agonist. 50
      adult individuals with ASD and 50 neurotypical adults (25 males and 25 females per group)
      will be invited to participate. Each participant will receive a single dose of the drug (15mg
      or 30mg Arbaclofen) or matched placebo). Brain activity and neurochemistry will be
      investigated using magnetic resonance imaging. Further data will be collected through
      questionnaires, behavioural tasks, blood samples, and sensory tasks using
      electroencephalography and retinal imaging.
    

Intervention name(s): Arbaclofen_15; Arbaclofen_30; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose (15mg); Single oral dose (30mg); Single oral dose placebo (oral tablet)
Other intervention name(s): r-baclofen, STX209; r-baclofen, STX209; Placebo oral tablet
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Repeated-measures cross-over study, where each subject received each one of the three pharmacological probes in separate visits (i.e., placebo, arbaclofen low dose and arbaclofen high dose), with the order of tablet administration being pseudorandomized.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Autism Spectrum Disorder; Arbaclofen; E-I balance; pharmacological imaging; GABA
Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
Condition: HER2-normal
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the feasibility of dose-dense doxorubicin and
      cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast
      cancer.
    

Detailed description: 
      This is a multicenter, single-arm Phase II trial to assess the feasibility of dose-dense
      adjuvant chemotherapy in subjects with early stage (I-III), HER-2 normal breast cancer. A
      total of 80 adult subjects will be enrolled in order to have 73 subjects who start the
      eribulin portion of the adjuvant study regimen. After completion of 4 cycles of AC, each
      subject will begin 4 cycles of eribulin mesylate 1.4 mg/m2 intravenously over 2 to 5 minutes
      on Days 1 and 8 of every 21 day cycle.
    

Intervention name(s): eribulin mesylate
Intervention type(s): Drug
Intervention description(s): Dose dense doxorubicin and cyclophosphamide for 4 cycles during the first 8 weeks followed by eribulin mesylate 1.4mg/m2 for 4 cycles during the next 12 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; HER2-normal Stage I to III invasive breast cancer