bioihbjkbjnl/mcl2 huggingface dataset:
Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in Japanese healthy volunteers to determine the safety and tolerability of
      the compound, AZD5069. It will also assess how the body handles the drug and how it responds
      to the drug following single and multiple doses up to 11 days.
    


Intervention name(s): AZD5069; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral suspension; Oral suspension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase I; Japanese healthy volunteer; AZD5069
Guideline vs Usual Treatment in Schizophrenic Adolescents
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the applicability and usefulness of the guideline
      treatment for diagnosis and treatment of adolescents with schizophrenia, also to evaluate the
      compliance to the treatment according to the guidelines, and to compare the treatment
      compliance, severity of illness and social functioning of patients treated according to
      guideline treatment vs patients with the treatment as usual on a six month follow up.
    

Detailed description: 
      The drug treatment of patients on the Guideline Treatment group followed an algorithm, where
      an atypical antipsychotic must be maintained during 6 weeks before the evaluation of
      medication change if the PANSS score did not show a reduction of 30% and the patients did not
      show functional improvement. Clozapine could be administered if two trials of antipsychotics
      were not effective. Benzodiazepines, antidepressants, anticholinergics or anticonvulsants
      were allowed for the treatment of comorbid disorders or side effects.

      The psychosocial treatment included psychoeducation (three 90 min sessions with the family
      and two 45 min sessions with the patients), followed by a seven 45 min sessions training on
      social skills which focused on verbal and non-verbal communication, as well as in
      conversation skills. Patients were also trained in healthy life style habits and were
      included on a 30 min of exercise in group.

      TAU included an antipsychotic and the psychosocial treatment decided by the clinician
    

Intervention name(s): Guideline treatment (Risperidone, administered orally); "Psychosocial treatment"; Treatment as Usual (any other antipsychotic)
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Participants will receive the Guideline Treatment (risperidone, administered orally) plus Behavioral Intervention: "psychosocial treatment" included "psychoeducation" "social skills" "healthy life style habits" "exercise in group"; Participants will receive the Guideline Treatment (risperidone, administered orally) plus Behavioral Intervention: "psychosocial treatment" included "psychoeducation" "social skills" "healthy life style habits" "exercise in group"; Participants will receive the Treatment as Usual (atypical antipsychotic) plus Behavioral Intervention: psychosocial treatment assigned by clinician.
Other intervention name(s): Atypical antipsychotic; "Psychoeducation"; "Social Skills"; "Healthy Life style"; "Exercise in group"; Any other antipsychotic assigned by clinician
Intervention MeSH terms: Risperidone; Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Adolescents; Treatment; Guidelines
Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD
Condition: ADHD; PMS
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This work will assess the prevalence in the general population of the ineffectiveness of the
      anesthetic Lidocaine compared to males with ADHD and females with ADHD with or without PMS.
    

Detailed description: 
      Using a non-invasive, pain-free, taste-based approach to assess lidocaine effectiveness, the
      study will assess the frequency of ineffectiveness in the target population. We will use an
      identical protocol at two sites: Jacobi hospital and Boston Clinical Trials.

      The controlled trial will assess the ability of lidocaine oral gel to block taste (e.g.,
      sweet) in 100 teens and adults, half with a history of ADHD, and for females, we will compare
      the sub-groups with and without premenstrual syndrome (PMS).

      This study will also be compared with a similar assessment among a specialized ADHD
      population (NCT03563573), that does not respond to existing medication..
    

Intervention name(s): Lidocaine gel
Intervention type(s): Drug
Intervention description(s): Lidocaine gel (0.75 g premeasured dose of Septodont 5% oral gel NDC 0362-0221-10)
Other intervention name(s): Intervention
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Intervention model description: A group of 100 subjects will be assessed.
Masking: None (Open Label)
Primary purpose: Health Services Research
Inflammation and the Host Response to Injury (In Healthy Volunteers)
Condition: Immune System
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The body's immune response to injury or infection is very complex.Endotoxin is a man-made
      substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few
      hours. This study is designed to determine whether certain proteins, genetics, or heart rate
      variability change affects the body's response to endotoxin.
    

Detailed description: 
      The body's immune response to injury or infection is very complex.Immune cell activity, the
      release of specific mediators(such as proteins, genetics(Deoxyribonucleic acid or DNA), the
      body's "instructions" for making proteins (Ribonucleic Acid or RNA) and heart rate
      variability (HRV,the intervals between heartbeats) may affect the body's clinical response to
      stress such as infection.Endotoxin is a man-made substance, which causes the body to "mimic"
      sickness (fever,chills, and achiness)for a few hours. This study is designed to determine
      whether any of the above (proteins,genetics,or HRV, etc.) correlate with or affect the body's
      response to endotoxin.This will enable the investigator to better understand the mechanisms
      involved in the immune response as well as potential therapeutic strategies to improve
      outcomes in patients.
    

Intervention name(s): Endotoxin, Lipopolysaccharide, LPS
Intervention type(s): Biological
Intervention description(s): Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes)
Other intervention name(s): Sodium Chloride Solution
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy Immune System
Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12
      healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered
      together have any significant impact on the pharmacodynamic effects of UFH and the
      pharmacokinetics of Bendavia.
    


Intervention name(s): Unfractionated heparin (UFH); Bendavia; Saline (0.9%, sterile, for infusion)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): UFH solution for infusion Initially 60U/kg bolus followed by intravenous infusion (12U/kg/hr) for approximately 11 hours; Bendavia for infusion Constant intravenous infusion (Bendavia 0.25mg/kg/hr) for 4 hours; Saline (placebo) Constant IV infusion for 4 hours
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety, Tolerability and Pharmacokinetics of 0.5% and 2.5% Cis-UCA Eye Drops in Adult Healthy Volunteers (Phase I)
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this two-part study is to evaluate safety, tolerability and pharmacokinetics
      of 0.5% and 2.5% cis-UCA eye drops in comparison to placebo in adult healthy volunteers.
    

Detailed description: 
      This is a Phase I single-centre, double-blind, placebo-controlled, single and multiple dose
      study to evaluate safety, ocular tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA
      eye drops in healthy volunteers for up to 15 days. After the single day dose (three times) on
      day 1 and the subsequent 7 (± 1) days wash-out period, a multidose phase with three times a
      day administration for 14 days will start

      Primary objectives:

        -  Part 1: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye
           drops and placebo for cis-UCA eye drops when administered on a randomized eye three
           times during a single day, assessed up to 7 (± 1) days following dosing in healthy
           volunteers

        -  Part 2: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye
           drops and placebo for cis-UCA eye drops when administered on both eyes three times a day
           for 14 days, assessed up to 7 days following the last dosing in healthy volunteers

      Secondary objectives:

        -  To evaluate single dose pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when
           administered on a randomized eye in adult healthy volunteers

        -  To evaluate the pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on
           both eyes three times a day for 14 days in adult healthy volunteers

      Healthy male or female volunteer, 18-65 years of age, with no history of significant eye
      disease or any current eye disease that would affect the pharmacokinetics of cis-UCA.
      Subjects without any treatment-emergent adverse events during Part 1 may continue to Part 2
      of the study.
    

Intervention name(s): cis-urocanic acid 0,5% eye drops; cis-urocanic acid 2.5% eye drops; Placebo for cis-UCA, eye drops
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2; one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2; one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: eyes; cis-urocanic acid; safety; tolerability; pharmacokinetics
Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).
Condition: Epstein Barr Virus (EBV) Infection
MeSH terms: Epstein-Barr Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety, immune-response and efficacy of GSK Biologicals' EBV vaccine in a
      population at risk of developing infectious mononucleosis. Each subject will receive three
      doses of vaccine or placebo during the study period.
    


Intervention name(s): EBV vaccine (268664)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Epstein Barr Virus; Belgium; Infectious mononucleosis
Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective :

      To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then
      after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type
      I diabetes mellitus.

      Secondary objective :

        -  Recording the average daily dose of both insulin Glulisine & insulin Glargine in type I
           DM.

        -  Recording adverse events.
    


Intervention name(s): insulin glargine; insulin glulisine
Intervention type(s): Drug; Drug
Intervention description(s): in combination with insulin Glulisine as bolus regimen; in combination with insulin Glargine as bolus regimen
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers.
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To evaluate the absorption and elimination of varenicline Formulation A transdermal
           delivery system [TDS (patch)] compared to varenicline immediate release tablet
           (CHANTIX®).

        2. To evaluate the adhesion of the varenicline Formulation A patch.

        3. To evaluate the safety and tolerability of a single application of the varenicline patch
           and a single oral dose of the varenicline immediate release tablet (CHANTIX®).
    


Intervention name(s): varenicline tartrate; varenicline free base
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation; A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.
Other intervention name(s): varenicline, Chantix, Champix; varenicline
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: varenicline bioavailability transdermal smoking cessation
ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery
Condition: Lung Diseases
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      A randomized prospective trial to test the non-inferiority of erector spinae plane block
      (ESPB) in comparison with intercostal nerve block combined with patient-controlled
      intravenous analgesia in Thoracoscopic lung surgery
    

Detailed description: 
      For patients undergoing thoracic surgery, postoperative pain greatly limited their
      recovery.Multimodal analgesia have shown good efficacy but without reaching full pain relief.

      The primary goal of this study is to observe the effect of ultrasound-guided erector spinae
      plane block in comparison with intercostal nerve block combined with patient-controlled
      intravenous analgesia in video assisted thoracic lung surgery.
    

Intervention name(s): Intercostal Nerve Block with PCIA; Erector Spinae Plane Block (ESPB)
Intervention type(s): Drug; Drug
Intervention description(s): Intercostal nerve block consists in the injection of Ropivacaine (4 ml,0.5%) in related intercostal spaces. Patient-controlled intravenous analgesia regimen is conducted with sufentanil.; Erector Spinae Plane Block consists in the injection of Ropivacaine (20ml, 0.5%), in the anatomical plane between the Erector Spinae muscles and transverse process, laterally to the spinous process of T5 . The catheter was inserted and secured in place under ecographic guidance, and a patient-controlled regional anesthesia regimen was conducted with 0.2% ropivacaine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Erector spinae plane block; Video-assisted thoracic surgery;; Intercostal nerve block; Patient-controlled intravenous analgesia
Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound
Condition: Acute Rupture of Achilles Tendon
MeSH terms: Rupture
Study type: Observational

Summary: 
      This is a prospective randomized controlled study carried out between May 2016 and December
      2020. It included 98 patients presented with acute rupture of Achilles tendon The patients
      were randomly distributed by closed envelop technique (49 in each group). Group A included
      those managed with the assistant of an intra-operative ultrasound. Group B included those
      done without ultrasound assistant
    

Detailed description: 
      A preoperative prophylactic dose of antibiotic was given intravenously in the form of 2gm of
      cephalosporin one hour before operation. Under general or regional anesthesia, the patient
      laid in prone position without a tourniquet and both feet out of the table for easily
      mobilization of the ankle joint. In group A, an intraoperative ultrasound was done by a
      radiologist before the repair for identification the course of sural nerve and outline the
      medial and lateral edges of torn tendon. Then ultrasound was repeated after repair for
      confirmation of adequate contact of both stumps and satisfactory strength of the repair by
      visualization of the tendon with passive motion of the ankle. For patients in group B, the
      course of the sural nerve was determined according to the technique described by Blackmon et
      al. This technique depends on the leg length for location the point where the nerve crosses
      the lateral edge of the tendon. The medial and lateral borders of both stumps were outlined
      by palpation with identification of the gap in-between. The technique of repair was
      standardized for all patients in both groups. We used the technique described by Maffulli et
      al
    

Intervention name(s): percutaneous repair with an intraoperative assisted ultrasound; percutaneous repair without an intraoperative assisted ultrasound
Intervention type(s): Other; Other
Intervention description(s): Under general or regional anesthesia, the patient laid in prone position In group A, an intraoperative ultrasound was done by a radiologist before the repair .; For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al.The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. We used the technique described byMaffulli et al with six stab incisions, one cm each. Four incisions were on medial and lateral edge of the proximal stump and the other two were around distal stump.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        a prospective randomized control study
Storytelling With or Without Social Contextual Information in Children With Autistic Spectrum Disorder and Typical Development
Condition: Autism Spectrum Disorder; Healthy
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study was to examine the effects of storytelling with or without contextual information
      on children with autism spectrum disorder (ASD) and typical development (TD).
    

Detailed description: 
      This was a 2 x 2 x 2 randomized controlled trial with 52 children (26 with ASD and 26 with
      TD) recruited in the community and randomized into four groups: 1) ASD Group 1 - storytelling
      with contextual information; 2) ASD Group 2 - storytelling without contextual information; 3)
      TD Group 1 - storytelling with contextual information; 4) TD Group 2 - storytelling without
      contextual information. All stories were photo-based and static in nature. The only
      difference between Group 1 and Group 2 was that the stories included and did not include
      social contextual information, respectively. Training was delivered in small groups, with
      eight sessions across four weeks, two sessions per week, and 30 minutes per session.
      Participants' total fixation duration (TFD), total visit duration (TVD), and total fixation
      count (TFC) on human faces from 20 photos and a video were recorded using the Tobii eye
      tracker.
    

Intervention name(s): Storytelling with social contextual information; Storytelling without social contextual information; Children with ASD; Children with TD
Intervention type(s): Behavioral; Behavioral; Other; Other
Intervention description(s): Four out of 100 stories from a storytelling app (SAHK, 2013) that incorporated social contextual information, and inter-personal skills were selected. The intervention was in small group format, consisted of eight sessions across four weeks, two sessions per week, 30 minutes per session.; Four out of 100 stories from a storytelling app (SAHK, 2013) without social contextual information, and inter-personal skills were selected. The intervention was in small group format, consisted of eight sessions across four weeks, two sessions per week, 30 minutes per session.; Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with ASD.; Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with TD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose was to assess the safety and tolerability of a single intravenous (IV)
      administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia
      A.
    


Intervention name(s): Advate (Low Dose); Advate (High Dose); BIVV001 (Low Dose); BIVV001 (High Dose)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Participants received a single IV low dose of Advate 25 IU/kg.; Participants received a single IV high dose of Advate 65 IU/kg.; Participants received single IV low dose of BIVV001 25 IU/kg.; Participants received single IV high dose of BIVV001 65 IU/kg.
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other