bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics (how the medicine is changed and
      eliminated from your body after you take it) and pharmacodynamics (effects of the medicine in
      the body) of the study medicine (called Ritlecitinib) in children of 6 to <12 years of age
      with Alopecia Areata, a condition of scalp hair loss. 12 children with alopecia areata will
      be participating in this study. All participants will receive study medicine with a dose of
      20 milligram (mg) orally once daily for 7 days. 5 blood samples will be collected on day 7
      for pharmacokinetic evaluation and 2 blood samples each at screening and on Day 7 will be
      collected for pharmacodynamic evaluation. Participants will take part in the study for about
      10 weeks.
    

Detailed description: 
      This is an interventional, Pharmacokinetic (PK), Pharmacodynamic (PD), phase 1, open label
      study in children 6 to less than 12 years of age with ≥50% scalp hair loss due to severe
      alopecia areata. The purpose of the study is to collect data to support dose selection for
      subsequent studies in the same population.

      Participants will be screened and, if all eligibility criteria are met, will receive the
      first dose of Investigational product within 28 days after the screening visit.

      Participants will receive 20 mg ritlecitinib in one dose, daily, for 7 consecutive days.
      Blood samples for pharmacodynamic evaluation will be collected on screening and Day 7. Blood
      samples for pharmacokinetic evaluation will be collected on Day 7 at: 0 hr (pre-dose), 0.5
      hr, 1 hr, 3 hrs, and 8 hrs after dosing.

      At least 12 evaluable participants with respect to the primary endpoint will be enrolled in
      the study.

      Participants and their parents/legal guardians will be required to visit the study site 3
      times during the study (Screening, Day 1 and Day 7) A safety follow-up visit will be
      conducted by phone, 28 to 35 days after the last dose of ritlecitinib.
    

Intervention name(s): Ritlecitinib 20 mg
Intervention type(s): Drug
Intervention description(s): orally administered, Ritlecitinib 20 mg once daily (QD)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Tissue Alterations in Aggressive and Chronic Periodontitis
Condition: Localized Aggressive Periodontitis; Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Aggressive Periodontitis; Aggression
Study type: Observational

Summary: 
      Present study intended to compare diseased and healthy sites in chronic and aggressive
      periodontitis with healthy individuals. The investigators suggest that even unaffected
      healthy sites of both chronic and aggressive periodontitis patients exhibit subclinical
      inflammation and tissue destruction with decreased fibroblast cell counts and increased
      inflammatory cell counts. Investigators also suggest that a possible mechanism which might
      play a role in the disease progression might occur via a disbalance between matrix
      metalloproteinases and their inhibitors, and increased hypoxia in diseased sites.
    

Detailed description: 
      Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the
      production of collagen, the quality, and quantity of the connective tissue. The etiology and
      pathogenesis of chronic periodontitis are mostly revealed however, there are many dark points
      in the etiopathogenesis of aggressive periodontitis. The existence of periodontal destruction
      at even one tooth in the mouth increases the risk of further periodontal destruction.
      However, the incidence of progression of the disease to the unaffected teeth was not
      demonstrated. Yet, the progression of the disease from diseased sites to healthy sites is
      likely to occur but no evidence is present comparing healthy and diseased sites of chronic
      and aggressive periodontitis. Present study aimed to evaluate the histological changes in
      both diseased and healthy sites in both localized aggressive periodontitis (LAgP) and chronic
      periodontitis (CP) patients by determining fibroblast and inflammatory cell counts in
      histologic slides and immunohistochemical staining of enzymes and hypoxia markers in order to
      better understand the dimensions of this demolition in periodontal disease.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy individuals, chronic periodontitis patients, and localized aggressive periodontitis
        patients older than 30 years old and younger than 45 years old were enrolled. The age was
        specifically chosen because aging changes periodontal and gingival tissues independently of
        other variables. Any possible factor which might alter connective tissue metabolism were
        excluded.
      
Biospecimen description: 
      Gingival biopsies around teeth either affected by periodontal destruction or unaffected. And
      gingival biopsies of healthy individuals were also obtained.
A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine
      compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese
      participants with treatment-resistant depression (TRD), in improving depressive symptoms.
    


Intervention name(s): Placebo; Intranasal esketamine (28 mg); Intranasal esketamine (56 mg); Intranasal esketamine (84 mg)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.; Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes.; Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes.; Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes.
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in
      participants with persistent asthma.

      Secondary Objective:

      To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.
    

Detailed description: 
      The total study duration for each participant was between approximately 29 and maximum of 30
      weeks, consisting of a screening period of 5 weeks and optional up to 7 additional days, a
      treatment period of 12 weeks, and a post-treatment period of 12 weeks.

      Participants who completed the treatment period could be eligible to participate in an
      open-label extension study.
    

Intervention name(s): Placebo; Dupilumab SAR231893/REGN668; fluticasone propionate and salmeterol; budesonide and formoterol; mometasone furoate and formoterol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled; Pharmaceutical form:inhalation aerosol Route of administration: inhaled; Pharmaceutical form:inhalation aerosol Route of administration: inhaled
Other intervention name(s): Advair; Symbicort; Dulera
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Budesonide; Formoterol Fumarate; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (Italy)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      An unblinded, randomized, cross-over design with each patient participating in two 40-hour
      outpatient admissions: (a) Experimental involving automated Control to Range (CTR) and (b)
      Control using Continuous Glucose Monitor (CGM)- augmented insulin pump treatment outside of a
      hospital based clinical research center.
    

Detailed description: 
      The principal goal is to validate a smart phone-based control-to-range (CTR) system for
      ambulatory use and to estimate the effect of CTR vs. sensor-augmented pump therapy, thereby
      providing justification for further larger home-based trials of CTR.
    

Intervention name(s): Diabetes Assistant (DiAs)
Intervention type(s): Device
Intervention description(s): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Continuous Glucose Monitor; Artificial Pancreas; Insulin Pump; Closed Loop; Open Loop; Diabetes Assistant; DiAs; Cell Phone
Physiopathology, Diagnosis and Therapy of Primary Cephalalgia and Adaptive Disorders
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      The main aim of the present pilot study is to prove the possibility to use the Nitroglycerin
      (NTG) model to describe the pathophysiology of headache using task-free advanced Magnetic
      Resonance Imaging (MRI) techniques, in order to depict the static changes of the ictal and
      inter-ictal phase of migraine attacks vs the pain free state in healthy subjects and to
      compare that with the spontaneous headache attack experienced by chronic migraineurs.
    

Detailed description: 
      Resting state functional magnetic resonance imaging (rs-fMRI) has depicted cyclical
      functional connectivity changes during the ictal and inter-ictal phase of the migraine
      attack. In this pilot study, Functional Connectivity (FC) changes during nitroglycerin (NTG)
      induced migraine attacks were assessed vs the pain-free condition in healthy subjects.

      To this end, subjects with episodic migraine (EM) without aura were enrolled. NTG-triggered a
      spontaneous-like migraine attack in the subjects. They underwent 4 rs-fMRI scan repetitions
      during different phases of the attack (baseline, prodromal, full blown, recovery phase) with
      a 3 Tesla MR scanner. According to the pain field literature, several regions of interests
      were studied, in particular the thalamic areas and the salience network (SN) were selected as
      primary areas of interest for the analyses. Subjects' rs-fMRI data were first processed with
      a seed-based correlation analysis (SCA) to assess the static changes in FC between the
      thalamus and the rest of the brain during the experiment. The wavelet coherence approach
      (WCA) were also applied to test the changes in time-in-phase coherence between the thalamus
      and the salience network (SN).

      Healthy subject were administered nitroglycerin as well and scanned at a pain free baseline
      and after 3 hours in order to compare the response.

      The rebound headache that followed acute drug withdrawal were used as a surrogate paradigm of
      spontaneous attack. Patients with chronic migraine and medication overuse were hospitalized
      for a supervised withdrawal program at the Mondino Foundation; during the program if they
      experienced a rebound headache attack, they were scanned with a rs-fMRI acquisition.

      The acquired imagines were analyzed with the same procedure regarding the evaluation of
      static and dynamic functional connectivity fluctuation.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with episodic migraine without aura; patients with chronic migraine and medication
        overuse; healthy subjects
      
Keywords: Episodic migraine; Chronic migraine; Medication overuse; Nitroglycerin; fMRI
Total Intravenous Anesthesia: TCI Versus MCI
Condition: Test the Differences Between Schinder's TCI Model and MCI
Study type: Interventional

Summary: 
      test the following differences between Schinder's Target Controlled Infusion (TCI ) model and
      manually controlled infusion (MCI) :

        -  remifentanil and propofol total dose given

        -  incidence of awareness or inadequate anesthesia

        -  number of rescue dose given
    


Intervention name(s): Remifentanil and propofol administration using TCI; Remifentanil and propofol administration using MCI
Intervention type(s): Device; Device
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Suspension Training on the Balance of Healthy Young Adults
Condition: Healthy
Study type: Interventional

Summary: 
      Non-specific training through the use of devices in which the subject can be suspended is a
      technique that has aroused a growing interest in recent years. One of its advantages may be
      to enhance the balance, since it induces a high level of neuromuscular stimulation. Indeed, a
      suspension training suppose a high demand of the core musculature, require a high degree of
      postural control, precise response strategies , anticipatory capacity and muscular
      conditioning. However, current literature targeting healthy young adults and appraising the
      specifics effects of suspension training on balance is scarce or non-existent to the best of
      our knowledge. For this reason this interventional study will primarily assess the effects of
      suspension training on different balance components.
    


Intervention name(s): Suspension training
Intervention type(s): Other
Intervention description(s): Nine sessions of suspension training The suspension device will be TRX (R) The intervention will be administered in work:rest intervals (2:1) A global training approach will seek to train lower limbs, upper body and core musculature
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biochemical Factors for a Dry Eyed Population
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to compare various symptoms and signs of dry-eye as well as
      stratify characteristics of the tear film in a group of dry-eyed individuals in comparison to
      a group of non-dry-eyed people. Dry-eye is a condition that significantly impacts the quality
      of life of the sufferer. These are people who are predominantly female and in the older age
      groups. Determining what characterises a person with dry-eyes is of importance to
      understanding the disease process.
    

Detailed description: 
      Dry eye is a multifactorial disease that results in a wide variety of signs and symptoms,
      which are often poorly correlated. Recent work has shown that not only are there changes in
      the composition of the tear film (including cytokines and the presence of various mucin
      species and tear film proteins) but also quantifiable changes in both the structure and
      function of the ocular surface, including corneal sensitivity and the appearance of the
      epithelial cells and the sub-basal neural network. To-date, no published study has attempted
      to correlate various clinical and morphological changes found in dry eye with tear film and
      ocular surface biomarkers.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      Tears
    
Keywords: Postmenopausal; non dry eye
Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Adenocarcinoma of the Breast
Condition: Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study were to assess the safety and tolerability of
      intravenously (i.v.) administered 186Rhenium (186Re)-labelled bivatuzumab and to investigate
      the biodistribution and pharmacokinetics of 186Re-labelled bivatuzumab in patients with
      adenocarcinoma of the breast
    


Intervention name(s): BIWA 4
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intranasal Ketamine as a Sedative for Venipuncture
Condition: Respiratory Tract Disease; Acute Pain; Diseases of the Digestive System
MeSH terms: Digestive System Diseases; Respiratory Tract Diseases; Acute Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Randomized clinical trial, controlled, double-blind, parallel two-arm.
    

Detailed description: 
      Randomized, double-blind, placebo controlled study conducted at the Clinical Hospital of
      Porto Alegre between November / 15 and August / 16. This study was approved by the Ethics
      Committee of the Institution. Participated children requiring venipuncture randomized in the
      intervention group who received the ketamine IN 4 mg/kg and placebo saline group. The groups
      were compared: Puncture time, ease the nurse to perform the procedure, adverse events,
      changes in vital signs and perception of the companion.
    

Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): As indicated the use of sedative and after authorization of the person responsible, the child receives the intranasal solution. Before administration of the solution 2 hour and 24 hours after the procedure, must be recorded vital signs of the patient. A person with the help of a clock will make the time count. The nurse and the patient's family must respond to the study protocol questions; As indicated the use of sedative and after authorization of the person responsible, the child receives the intranasal solution. Before administration of the solution 2 hour and 24 hours after the procedure, must be recorded vital signs of the patient. A person with the help of a clock will make the time count. The nurse and the patient's family must respond to the study protocol questions
Other intervention name(s): Intervention group; Saline group
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ketamine; Intranasal administration; Pediatric nursing
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of repeated intravenous
      infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE)
      compared with people who receive a placebo.
    

Detailed description: 
      Study 990 is a Phase IIa, proof-of-concept study of BT063 in subjects with SLE. This study is
      divided into 2 parts. After Part I an interim analysis will be performed. Each Part will
      enrol 18 subjects. Subjects will be randomly assigned to receive BT063 or Placebo 8 times
      over 12 weeks and will be followed for 4 months after their last dose.
    

Intervention name(s): BT063; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12); Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SLE, Lupus; IL10, IL-10, BT063, BT-063
Study to Determine the Relative Bioavailability, Single and Repeat Dose Pharmacokinetics, Safety and Tolerability of BOS172767 Enantiomers in Healthy Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 of the study evaluates the safety and tolerability as well as pharmacokinetic
      properties of a single oral dose of BOS172767 enantiomer E1 and BOS172767 enantiomer E2
      following administration to healthy participants. Part 2 of the study was to be conducted to
      assess the safety and tolerability as well as pharmacokinetic properties of one selected
      enantiomer (BOS172767-Ex) following multiple ascending doses over 14 days of dosing in
      healthy participants.
    

Detailed description: 
      The study design of Part 1 was a double-blind, placebo-controlled, randomized, single-dose,
      two-way crossover, followed by two sequential ascending dose periods in 12 healthy
      participants.

      Part 2 was designed to be a double-blind, placebo-controlled, randomized multiple ascending
      dose (MAD) study in 36 healthy participants (12 per study cohort).

      Part 2 was to progress following completion of Part 1, but was not conducted.
    

Intervention name(s): BOS172767 enantiomer E1 or E2; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets; Oral tablets
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1 was a two-way crossover design, followed by two sequential ascending dose periods. Part 2 was designed to be a multiple ascending dose design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: BOS172767; enantiomer E1 and E2; relative bioavailability; pharmacokinetics; dose linearity; healthy participants