bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Pharmacokinetics of hzVSf-v13 in Healthy Adults (Intravenous and Subcutaneous Administration)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the safety, tolerability and pharmacokinetics (PK) characterization of
      hzVSF-v13 with single and multiple doses (intravenous and subcutaneous) compared to placebo
      in healthy subjects.
    

Detailed description: 
      A phase I, double-blind, placebo-controlled, single and multiple dose
    

Intervention name(s): hzVSF-v13 (intravenous, single dose); hzVSF-v13 (subcutaneous, single dose); hzVSF-v13 (intravenous, multiple dose); Placebo (intravenous, single dose); Placebo (subcutaneous, single dose); Placebo (intravenous, multiple dose)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dosage form: 50mg / 100mg / 200mg / 400mg / 800mg /1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Intravenous Frequency: Dose at Day 1 (single administration); Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration); Dosage form: 100mg / 400mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration); Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration); Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration); Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)
Other intervention name(s): a humanized monoclonal antibody (mAb); a humanized monoclonal antibody (mAb); a humanized monoclonal antibody (mAb); 0.9% Normal saline; 0.9% Normal saline; 0.9% Normal saline
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cerebrovascular Response to Acute Exercise
Condition: Healthy; Physical Activity
Study type: Interventional

Summary: 
      Cerebrovascular function and peripheral vascular function will be measured in healthy young
      adults, before and after acute bouts of aerobic exercise at various intensities.
    

Detailed description: 
      Acute bouts of aerobic exercise have been shown to enhance vascular reactivity of the
      peripheral circulation; however, the effects of a single exercise session on the cerebral
      circulation are unknown. This study will measure cerebrovascular function and peripheral
      vascular function before and after aerobic exercise at high and low intensities.

      The research aims are:

        1. To determine if a single bout of aerobic exercise acutely enhances cerebrovascular
           function

        2. To determine the effect of aerobic exercise intensity and dose on cerebrovascular
           function in healthy adults.

        3. To determine if the acute exercise-induced changes in cerebrovascular function are
           associated with acute exercise-induced changes in peripheral vascular function in
           healthy adults.
    

Intervention name(s): Control; Aerobic Exercise
Intervention type(s): Other; Other
Intervention description(s): Ultrasound
Blood Pressure
Heart Rate
Oxygen Saturation; Ultrasound
Blood Pressure
Heart Rate
Oxygen Saturation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise; Treadmill; Vascular Function; Intensity
Efficacy of Er,Cr:YSGG Laser in Partial Pupotomy
Condition: Laser; Tooth; Pulpotomy
Study type: Interventional

Summary: 
      The aim of this study was to compare the efficacy of partial pulpotomy treatment using MTA
      and Er,Cr:YSGG + MTA in permanent immature molar teeth with deep dentin caries. The study was
      performed in children aged between 6-15 who had at least one deep dentine caries in permanent
      immature molar tooth. The patients' therapies were completed in Kırıkkale University, Faculty
      of Dentistry, Department of Pediatric Dentisry. A total of 90 teeth (caries exposed) were
      included in the study. According to the treatment, the teeth were randomly divided into two
      groups: 1. MTA group (n=45), 2. Laser+MTA group (n=45). In the MTA group, after removing
      caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25%
      NaOCl. In the same session, the tooth was restored with resin modified glass ionomer cement
      and composite resin. In the laser+MTA group, the treatment procedures were the same as the
      MTA group, and before the MTA condensation, Er, Cr: YSGG laser was applied to the exposure
      area after bleeding control to provide biostimulation. Patients were called for followup
      appointments at 1, 3, 6 and 12 months after treatment and control radiographs were taken.
    


Intervention name(s): Partial pulpotomy with laser+MTA; Partial pulpotomy with MTA
Intervention type(s): Procedure; Procedure
Intervention description(s): After removing caries, laser+MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl.; After removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl.
Intervention MeSH terms: Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Double-Blind Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression (TRD)
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine if the opioid properties of ketamine are responsible
      for its antidepressant effects. Since naltrexone can block opiate actions, the investigators
      will determine if naltrexone can effectively block ketamine's effects.
    

Detailed description: 
      The primary goal is to determine if the antidepressant effects of Ketamine are mediated by an
      opiate mechanism.

      Primary Objective:

      To determine if the opioid properties of Ketamine are responsible for it's antidepressant
      effects by potentially blocking the antidepressant effects with a opioid antagonist
      naltrexone.

      We will measure this objective by looking at the response on a scale called the 6- item
      Hamilton Rating Scale for Depression (HAM-D-6). Response is defined as a statistically
      significant greater decrease on the overall score on this scale, post infusion.

      Secondary Objective:

      This includes comparing a scale called Clinician Administered Dissociative States Scale
      (CADSS) on both of our patient groups, one group receiving Ketamine plus Naltrexone compared
      to the other group receiving Ketamine plus placebeo, to determine if naltrexone has any
      effect on CADSS as well as to determine if CADSS is associated with antidepressant response

      Another secondary objective is to assess ketamine craving using the Visual Analog Craving
      Scale for Ketamine (VASK), after infusion and determine if there is a change in level of
      craving for the group that receives naltrexone.

      Number of Subjects:

      i) 30

      ii) The subjects will be drawn from an outpatient sample of patients with MDD, diagnosed with
      the use of the Structured Clinical Interview for DSM-IV Axis I Disorders(SCID-I/P), currently
      on a stable, adequate dose of antidepressant therapy, as defined by the MGH ATRQ, for at
      least 4 weeks or a history of intolerance to at least 2 antidepressant treatments.
    

Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention description(s): adding naltrexone (or placebo) to a ketamine infusion to potentially block the effects of ketamine as an anti depressant.
Other intervention name(s): Revia
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ketamine; Naltrexone; Treatment-Resistant; TRD
Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System
Condition: Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of this study are to assess the safety and effectiveness of the Journey Deuce
      Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to
      total knee replacement using the Genesis II Total Knee System. The hypothesis is that the
      Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total
      Knee System at the 2-year. The null hypothesis is that there is no difference between the
      groups.
    


Intervention name(s): Total Knee Replacement; Deuce
Intervention type(s): Device; Device
Intervention description(s): Smith and Nephew Total Knee Replacement; Smith and Nephew Bicompartmental Knee Replacement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; Bicompartmental Knee Arthroplasty
Alignment Efficiency of Two Thermal Activated Orthodontic Archwire Sequences
Condition: Crowding
Study type: Interventional

Summary: 
      The aim of the present study was to compare the effectiveness of two alignment sequences with
      thermal activated archwires with different Af temperatures applied for the correction of
      mandibular anterior crowding
    

Detailed description: 
      A parallel randomized clinical trial was conducted involving 42 patients ages 15 to 25 years
      (mean: 19.5 years) who required orthodontic treatment including the correction of mandibular
      anterior crowding. Eligibility criteria were no active caries, exemplary hygiene, non-
      extraction in the lower arch and no significant tooth size or shape abnormalities. Outcome:
      The primary outcome was the degree of crowding measured on plaster casts using Little's
      Irregularity Index. The secondary outcome was crowding survival time until the occurrence of
      correction in a six-month period. Randomization: The patients were randomly allocated to the
      different groups using sealed opaque envelopes. Blinding: The patients were blinded to the
      group to which they were allocated. Intervention: Patients were treatment with a pre-adjusted
      appliance (0.022 in- Roth prescription). Two nickel-titanium alignment and leveling sequences
      were employed - NiTi archwire: 0.012 in and 0.019 X 0.025 in; and thermal activated NiTi
      archwires: 0.018 in and 0.016 X 0.022 in with different austenite finish temperatures (37ºC
      and 35ºC), which formed the different study groups.
    

Intervention name(s): Fixed orthodontics appliance and arch wire
Intervention type(s): Device
Intervention description(s): Two nickel-titanium alignment and leveling sequences were employed
Other intervention name(s): the alignment of mandibular anterior crowding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Orthodontics; Nitinol
In Vitro Interaction Between Ticagrelor and Its Active Metabolite and Their Effects on Salicylic Acid
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and
      its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic
      acid. The study consist of two parts of in-vitro study as follows;

        -  Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor
           and its active metabolite.

        -  Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor
           and its active metabolite and their effect on the pharmacodynamics of salicylic acid on
           platelet aggregation tests with the agonist of arachidonic acid.
    

Detailed description: 
      This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and
      its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic
      acid. The study consist of two parts of in-vitro study as follows;

        -  Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor
           and its active metabolite. Platelet aggregation tests with the agonist of adenosine
           diphosphate(ADP) will be assessed on the in-vitro mixtures of blank plasma and
           randomized paired concentrations of ticagrelor + AR-C124910XX.

        -  Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor
           and its active metabolite. Platelet aggregation tests with the agonist of arachidonic
           acid will be assessed on the in-vitro mixtures of blank plasma plus randomized paired
           concentrations of ticagrelor and AR-C124910XX and the invitro mixtures with blank plasma
           and ticagrelor + AR-C124910XX + salicylic acid.
    

Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Biospecimen description: 
      Plasma and white blood cells
    
Keywords: Platelet Aggregation; Cardiovascular Diseases; Salicylic Acid
Safety and Pharmacokinetics of HU6
Condition: Obese
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Twelve subjects will
      be randomized (1:1) to treatment sequence to determine the order in which they will receive
      the tablet or capsule formulation in Period 1 and Period 2.

      Part 2 is an open-label study of up to 4 single, ascending dose levels of HU6 administered as
      the tablet formulation. Eight subjects will be enrolled to participate in all of the
      ascending study periods.
    

Detailed description: 
      Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Twelve subjects will
      be randomized (1:1) to treatment sequence to determine the order in which they will receive
      the tablet or capsule formulation in Period 1 and Period 2. There will be a minimum 10 day
      washout period between dosing in Period 1 and Period 2.

      Part 2 is an open-label study of up to 4 single, ascending dose levels of HU6 administered as
      the tablet formulation. Eight subjects will be enrolled to participate in all of the
      ascending study periods. There will be a minimum 14-day washout period between dosing in each
      study period. The washout is longer in Part 2 to allow time for pharmacokinetic analyses and
      data review between study periods.
    

Intervention name(s): HU6 Tablet; HU6 Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Six subjects will receive a tablet formulation.; Six subjects will receive the capsule formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Part 2 is an open-label study of up to 4 single, ascending dose levels.
Masking: None (Open Label)
Primary purpose: Treatment
Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation
Condition: Alveolar Ridge Enlargement
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Thirty-six patients (19 females and 17 males) that required implant placement in esthetic
      zone participated in this study and were blindly allocated 12 patients per group, all
      patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the
      sockets were sealed with free gingival graft harvested from the palate.
    

Detailed description: 
      The aim of this study was to compare injectable platelets rich fibrin (I-PRF) versus
      hyaluronic acid (HA) in combination with xenografts for ARP. Methods: Thirty-six patients (19
      females and 17 males) that required implant placement in esthetic zone participated in this
      study and were blindly allocated 12 patients per group, all patients had ARP either with
      I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free
      gingival graft harvested from the palate. The assessment was done by cone beam CT
      preoperative and 4 months postoperative to assess radiographic bone gain and crestal bone
      loss. Clinical parameters were soft tissue thickness, keratinized gingiva and clinical bone
      width that were assessed preoperative, 4 months and 1 year postoperative. Histological
      assessment of core bone biopsies 4 months postoperatively was performed by histomorphometric
      analysis of newly formed bone %, mature bone% and residual graft%
    

Intervention name(s): Alveolar ridge augmentation with injectable platelets rich fibrin; Alveolar ridge augmentation with hyaluronic acid; Alveolar ridge augmentation with xenograft
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Injectable platelets rich fibrin is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption; Hyaluronic is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption; Xenograft is added alone as a active compatator
Other intervention name(s): Socket augmentation with injectable platelets rich fibrin; Socket augmentation with hyaluronic acid; Socket augmentation with xenograft
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Austria
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a National, Multicentre, Observational Registry to study adherence and long term
      outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth
      hormone treatment from hospitals in Austria and to assess the level of adherence of subjects
      receiving SAIZEN® via Easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter, longitudinal observational registry.
      Parents/subjects will provide their Informed Consent/assent to upload their data for
      populationbased analyses and optionally to adhere to a patient adherence support program
      designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will
      be primarily derived from the Easypod™ device combined with physician data entry of outcome
      measures. Data will be collected retrospectively and prospectively. This will allow the
      establishment of adherence profiles and explore the hypothesis that patient adherence support
      programs improve adherence and subsequent clinical outcomes. Collected data will be also
      analyzed in a multinational pooled analysis of comparable national studies.

      Primary Objective:

      - To assess the level of adherence of subjects receiving SAIZEN® via Easypod™

      Secondary Objectives:

        -  To identify adherence subject profiling

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via Easypod™

        -  To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)
    

Intervention name(s): Easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™
Other intervention name(s): Saizen; Somatotropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        Easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
Aggressive Weight Loss Program in Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis; Weight Loss
Study type: Interventional

Summary: 
      Chronic plaque psoriasis is frequently associated with obesity and previous studies have
      shown that a calorie-controlled diet inducing body weight loss improves symptoms and
      increases the response to pharmacologic treatment. Besides, clinical improvement has been
      directly correlated with the amount of weight loss. Short-term very low-calorie ketogenic
      diets are responsible for substantial weight loss and attenuate systemic inflammation to a
      higher extent than moderately hypocaloric diets. This intervention has been recently
      demonstrated to restore, after only 4 week, the response to biological therapy in a patient
      suffering from relapsing moderate-to-severe plaque psoriasis and obesity-related metabolic
      syndrome. We investigated the efficacy of an aggressive weight loss program with a ketogenic
      induction phase in a single-arm trial that could provide the rationale for a large randomized
      trial.
    


Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment