bioihbjkbjnl/mcl2 huggingface dataset:
Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, randomised, double-blind, placebo-controlled, multiple ascending
      dose study of MEDI0618 in healthy male and female volunteers.

      Subjects will receive MEDI0618 or placebo administered by intravenous infusion or
      subcutaneous injection.

      Safety, tolerability and pharmacokinetics of multiple ascending doses of MEDI0618 will be
      assessed.
    


Intervention name(s): MEDI0618; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.; Four doses of IV placebo or SC placebo administered once every two weeks.
Other intervention name(s): Protease-Activated Receptor 2 Antagonist
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Protocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic pain
Masking: Double (Participant, Investigator)
Primary purpose: Other
Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q
Condition: Myelodysplastic Syndromes
MeSH terms: Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine
      and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is
      currently tested in non del 5q MDS patients. Preliminary results have been recently presented
      at ASH meeting (Sekeres et al, 2007).

      Overall, the combination of Lenalidomide and Azacitidine is well-tolerated and early results
      suggest some efficacy in advanced MDS without del 5q.

      In this trial, we will combine Lenalidomide to Azacytidine in higher risk MDS with del (5q).

      Patients will receive azacitidine( 75mg/m2/day for 5 days every 28 days) combined to
      escalating doses of lenalidomide (starting at relatively low dose).

      For patients in hematological CR, PR, HI or marrow CR after cycle 2 or 4, it is mandatory to
      continue on Azacitidine + Lenalidomide as long as there is no unacceptable toxicity or overt
      progression, with the schedule that yielded response.

      In patient still responding after 52 weeks, the drug will continue to be supplied, and follow
      up until death will be continued in all patients.
    


Intervention name(s): Azacitidine combined to Lenalidomide
Intervention type(s): Drug
Intervention description(s): Azacitidine: 75mg/m2/d for 5 days per cycle of 28 days. Lenalidomide: 5mg/day during 14 days for cohort 1. Lenalidomide: 5mg/day during 21 days for cohort 2. Lenalidomide: 10mg/day during 21 days for cohort 3.
Other intervention name(s): Vidaza.; Revlimid.
Intervention MeSH terms: Lenalidomide; Azacitidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar.
Condition: Anesthetic Effectiveness
Study type: Interventional
Phase: Phase 4

Summary: 
      Infiltration (injecting next to the tooth) injections are common in dentistry and a number of
      studies have shown that articaine anesthetic, when injected next to a lower molar, is more
      effective than a local anesthetic injection of lidocaine. However success rates have not been
      as high as hoped for. No objective study has addressed the success rate of buffering
      articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the
      purpose of this prospective, randomized, double-blind, crossover study is to compare the
      degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine
      solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary
      infiltration in the mandibular first molar. The investigators will also record the pain of
      injection and postoperative pain.
    

Detailed description: 
      Using a crossover design, 80 adult subjects will receive two injections consisting of a
      primary mandibular first molar infiltration of 1.8 mL of non-buffered 4% articaine with
      1:100,000 epinephrine, and 1.8 mL of buffered 4% articaine with 1:100,000 in two separate
      appointments spaced at least one week apart. With the crossover design, 160 infiltrations
      will be given for the first molar and each subject will serve as his or her own control.
      Eighty infiltrations will be administered on the mandibular left side and 80 administered on
      the mandibular right side. The order of the two injections will be assigned randomly and the
      dentist and subject will be blinded about which anesthetic the subject is given. The
      anesthetics used in this study are not experimental. An electric pulp tester (EPT) will be
      used to test the lower first molar for anesthesia starting 30 seconds after the injection;
      and testing every 30 seconds for the first five minutes. After five minutes the EPT will be
      used to test the lower first molar every minute and the contralateral control canine every 5
      minutes for a grand total of sixty minutes. The pain of injection and postoperative pain will
      be recorded in a survey. Patients will report any postoperative pain or discomfort on a
      Visual Analog Scale (VAS) for three days following each appointment. The data will be
      statistically analyzed.
    

Intervention name(s): Articaine Hydrochloride + Epinephrine; Buffered Articaine Hydrochloride + Epinephrine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Epinephrine; Racepinephrine; Carticaine; Epinephryl borate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Degree of pulpal anesthesia obtained.; Primary infiltration in the lower first molar.; Buffered local anesthetic.
Procedural Pain in Children: Intervention With the Hospital Clown
Condition: Pain, Acute; Venous Puncture; Children, Adult
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      This study evaluates the effect of an intervention with a hospital clown compared to standard
      care on pain experience for acute hospitalized children receiving venipuncture. Half of the
      children will receive an intervention with the hospital clown while the other half will
      receive standard care.
    

Detailed description: 
      Background: Hospitalized children describe the pain associated with painful procedures as one
      of the worst experiences during hospitalization. These experiences can be traumatic for
      children and their families. Most children are acutely hospitalized with no chance to prepare
      the child for painful procedures, while others experience repeated hospitalizations. Previous
      negative pain experiences are known to have major consequences for future admissions and
      procedures. Therefore, there is a need for different interventions for pain relief. In 2004,
      hospital clowns became a part of the team on pediatric wards in Denmark. International
      studies have shown positive effects of hospital clowns on preoperative anxiety in children,
      but there is limited knowledge of the impact on the child's experience related to painful
      procedures.

      The overall purpose of this study is to investigate the effect and impact of the hospital
      clown as a non-pharmacological intervention on hospitalized children's pain experience and
      ability to cope during painful procedures in both short and long-term treatment and care.

      Methods: A two-faced mixed methods study design with merging and connecting results and
      findings.

        1. A prospective, randomized open-label trial to identify whether exposure to the hospital
           clown has an effect on pain experience in acute hospitalized children receiving
           venipuncture.

        2. An ethnographic study to uncover the pain experience and ability to cope during painful
           procedures in short-term hospitalization.

        3. An ethnographic study to uncover the influence related to repeated painful procedures,
           as well as uncover if a relationship may have a potential long-term impact.
    

Intervention name(s): Hospital clown; No hospital clown intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Presence of the hospital clown; Presence of pediatric nurses and biomedical laboratory technologists in the venipuncture procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pain assessment; Self report; Hospital clown intervention
Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics
Condition: Periodontal Diseases; Periimplantitis
MeSH terms: Periodontal Diseases; Peri-Implantitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in
      the treatment of periimplantitis is needed.
    

Detailed description: 
      This study will give the opportunity to draw scientifically based conclusions on the
      recommendations of the use of adjunctive systemic antibiotics in the treatment of
      peri-implantitis. This study will also be able to determine the ecological impact on the
      oropharyngeal and intestinal microflora between different antibiotic treatments. The lack of
      knowledge in this area has been highlighted by the Food and Drug Administration and The
      Swedish Council on Health Technology Assessment (SBU)
    

Intervention name(s): Placebo; Amoxicillin Sandoz; Metronidazole Sanofi; Phenoxymethylpenicillin Meda
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Place capsule to mimic antibiotics; Tablet 500 mg amoxicillin Sandoz three times a day; 400 mg metronidazole Sanofi administered three times a day (TID); 1600 mg phenoxymethylpenicillin Meda, three time a day (TID)
Intervention MeSH terms: Amoxicillin; Metronidazole; Penicillin V
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Participatory Intervention Among Construction Workers (IRMA11)
Condition: Musculoskeletal Disorders
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      There is high prevalence of back pain and neck-shoulder pain among blue collar workers.
      Physical excessive exposures such as heavy lifting or working with a bended or twisted back
      are independent risk factors for back pain among workers in the construction industry.
      Participatory ergonomic initiatives increase the success of interventions aimed at reducing
      physical excessive exposures.

      The objectives are in two phases to; 1) determine which work-tasks in selected job-groups
      involve the highest load of the back and shoulders during a normal working day (using EMG,
      Actigraphs, Video). 2) investigate whether a participatory intervention can reduce physical
      workloads, drawing on information from objective measurements from phase 1.
    


Intervention name(s): Participatory Intervention; Control
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Quetiapine in Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to examine the effectiveness and tolerability of quetiapine for
      the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be
      effective and well-tolerated for patients with social anxiety disorder.
    

Detailed description: 
      This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine
      (100-400 mg/day)in social anxiety disorder.
    

Intervention name(s): quetiapine
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: quetiapine; social anxiety disorder; antipsychotic; pilot study
Colonoscope Insertion Trial Protocol
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This research study is about determining how well a Technically Improved Colonoscope from
      Olympus works in helping the doctor in guiding the scope through the large bowel or colon.
      When a doctor performs a colonoscopy he guides or inserts the scope from the rectum to the
      appendix where the small bowel ends and the large bowel begins. There are points during this
      insertion where there are turns in the colon which can create a loop in the colonoscope.
      These loops can stretch the colon and create some discomfort and also require special
      maneuvers by the nurse or patient to help reduce or minimize the loop. Thus, reducing the
      looping will make it more comfortable for the patient and more efficient for screening for
      polyps. The purpose of the study is to examine this colonoscope and compare it to the
      traditional adult colonoscope (Olympus CF-H180). The investigators hypothesis is that this
      colonoscope will function better with regard to insertion of the scope from the rectum to the
      cecum.
    

Detailed description: 
      There will be two arms to the study, the CF-H180 adult colonoscope (Control Arm) and the
      Olympus Technically Improved Colonoscope (Olympus). (Control Arm). In this protocol the
      investigators will randomize patients to either the adult colonoscope or to the Olympus
      Technically Improved Colonoscope (Olympus) arm. The name of the arm (CF-H180 adult
      colonoscope or Technically Improved Colonoscope) will be in a sealed envelope and opened by
      the nurse. The endoscopist will be blinded to the scope that will be used.
    

Intervention name(s): Colonoscopy with Olympus Technically Improved Colonoscope; Control with standard colonoscope Olympus CF-H180
Intervention type(s): Device; Device
Intervention description(s): The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.; Standard colonoscopy using the adult scope, Olympus CF-H180.
Other intervention name(s): Olympus Technically improved colonoscope; Olympus CF-H180
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: colonoscopy
A Study to Investigate the Safety and Tolerability of a New Inhaled Formulation of RV568 in Healthy Volunteers
Condition: COPD; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      RV568 is being developed as a possible treatment of smoking related lung disease (also known
      as Chronic Obstructive Pulmonary Disease - COPD).

      The main purpose of this study is to examine the safety and tolerability of a new inhaled
      formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and
      Part B. Part A (Cohorts 1, 2 & 3) will investigate 6 different dose levels of RV568 given as
      a single dose and Part B (Cohorts 4 & 5) will investigate 2 different dose levels of RV568
      given once a day for 14 days.
    


Intervention name(s): RV568 single dose; RV568 matching placebo single dose; RV568 repeat dose; RV568 matching placebo repeat dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Safety and tolerability of single escalating doses in normal human volunteers; Safety and tolerability of escalating repeat doses in normal human volunteers.; Safety and tolerability of escalating repeat doses in normal human volunteers.; Safety and tolerability of escalating repeat doses in normal human volunteers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pandemic Influenza Plasmid DNA Vaccines (Needle)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled
      in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations
      with a needle and will be followed for 6 months to evaluate the safety of and the immune
      system's response to the vaccine. The safety and immune system response will be studied
      throughout the trial.
    


Intervention name(s): VCL-IPT1; VCL-IPT1; VCL-IPT1; VCL-IPM1; PBS
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): IM, 0.1 mg/mL, 2 injections, 0 and 21 days; IM, 0.5 mg/mL, 2 injections, 0 and 21 days; IM, 1 mg/mL, 2 injections, 0 and 21 days; IM, 1 mg/mL, 2 injections, 0 and 21 days; IM, 1 mL, 2 injections, 0 and 21 days
Other intervention name(s): Phosphate Buffered Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Pandemic Influenza; Avian Influenza; DNA Vaccines; Antibody; T Cells; HA/NP/M2
Safety and Efficacy of Triptolide Wilfordii in New Onset HIV-1 Infection
Condition: HIV-infection/AIDS
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The traditional Chinese herbal medicine Triptolide Wilfordii has displayed remarkable effect
      on the treatment of autoimmune diseases such as rheumatoid arthritis. Now that
      immunosuppression therapy has recently become a new strategy for HIV infection, it's
      reasonable to expect the anti-inflammatory effect of Triptolide Wilfordii in HIV infected
      patients. So we designed a randomized, double-blinded, placebo-controlled study to explore
      the efficacy and safety of Triptolide Wilfordii in new-onset HIV infection.
    

Detailed description: 
      Acquired immune deficiency syndrome(AIDS) is a severe fatal disease caused by HIV infection.
      Despite viral suppression achieved, antiretroviral therapy(ART) cannot ameliorate HIV-induced
      immune activation and the consequent non-AIDS complications including cardiovascular, renal,
      hepatic diseases. Recently, immunosuppression therapy has become the focus since it can
      suppress exorbitant immune activation and inflammation so as to reduce the risk of non-AIDS
      cardiovascular and central neural system complications. Triptolide Wilfordii is a traditional
      Chinese herbal remedy and has long been used in the treatment of autoimmune diseases such as
      rheumatoid arthritis. Moreover, a recent study has shown that Triptolide Wilfordii combined
      with ART is associated with increased CD4 T cell counts and reduced immune activation in
      immunological non-responders, who were defined as patients with CD4 cell counts<350 cells/μl
      despite over 2 years of ART. Hence we expect Triptolide Wilfordii to bring up similar
      improvement in treatment naïve HIV infection. This randomized, double-blinded,
      placebo-controlled study is designed to investigate the safety and efficacy of Triptolide
      Wilfordii and hopefully provide evidence for a new treatment strategy.
    

Intervention name(s): Triptolide Wilfordii; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): In addition to appropriate ART, Triptolide Wilfordii will be given to patients in the experimental group at a dosage of 20mg three times a day per os for 12 months.; In addition to appropriate ART, placebo oral tablets will be given to patients in the experimental group at a dosage of 2 pills three times a day per os for 12 months.
Intervention MeSH terms: Triptolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CD4 cell recovery; immune activation; anti-inflammation
Serious Games for Training in Oral Rehabilitation
Condition: Health Knowledge, Attitudes, Practice
Study type: Interventional

Summary: 
      Coronavirus disease-19 (COVID-19) dramatically changed the learning conditions of dental
      students, with restricted access to training sessions and clinical practice. The "Playdent"
      project proposed the integration of serious games (SGs) in the third-year curriculum, based
      on tailor-made scenarios questioning the first dental visit of edentulous patients, and
      examined whether training with the games would advance students' learning outcomes.
    

Detailed description: 
      Three Serious games proposed in addition to conventional lectures and practical exercises in
      oral rehabilitation of edentulous patients were supposed to improve knowledge and skills of
      undergraduates. However, in order to assess the influence of SGs on students' learning
      outcomes and subsequent satisfaction, a single-blind controlled protocol was designed. The
      null hypothesis was that SGs had no impact on the learning outcomes of undergraduate
      students.
    

Intervention name(s): Playing Serious Games during a four-week test period in addition to conventional lectures
Intervention type(s): Device
Intervention description(s): Playing SGs during a four-week test period in addition to conventional lectures in oral rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were allocated either to a "test" group which accessed Serious games during a four-week test period in addition to conventional lectures or to a "control" group which benefited solely from conventional lectures
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: health education