bioihbjkbjnl/mcl2 huggingface dataset:
Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      - To compare the 3-year progression free survival (PFS) in the two treatment arms.

      Secondary Objectives:

        -  Overall survival (OS).

        -  Postoperative pathological stage and R0 (complete) resection rate.

        -  Safety: Toxicities associated with neoadjuvant chemotherapy, surgery,
           morbidity/mortality, toxicity of adjuvant chemotherapy.
    

Detailed description: 
      Participants in the neoadjuvant chemotherapy arm were treated for 3 cycles (1 cycle is 21
      days) before surgery and treated for a year with S-1. Participants in the adjuvant
      chemotherapy arm underwent surgery and were treated for a year with S-1. All participants
      were followed during and after the study treatment until death or disease progression,
      whichever comes first.
    

Intervention name(s): Docetaxel (XRP6976); Oxaliplatin (SR96669); S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solution for infusion Route of administration: intravenous; Pharmaceutical form:solution for infusion Route of administration: intravenous; Pharmaceutical form:Tablet Route of administration: Oral
Intervention MeSH terms: Docetaxel; Fluorouracil; Oxaliplatin; Tegafur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D and Grass Pollen Specific Immunotherapy
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced
      allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is
      limited by a long treatment time and high non-responder frequency. Based on experimental and
      epidemiological evidences we hypothesize that vitamin D can act as an effective
      immunomodulatory adjuvant to overcome these limitations.
    


Intervention name(s): Cholecalciferol; middle-chain fatty acids (carrier)
Intervention type(s): Drug; Other
Intervention description(s): given orally, once daily, before grass pollen season; given orally, once daily, before grass pollen season
Other intervention name(s): Vitamin D; neutral oil
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vitamin D; SIT; Grass pollen; allergic rhinoconjunctivitis
Bioequivalence Study of Ibuprofen 200 mg Gel Capsules of Dr. Reddy's Laboratories Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of ibuprofen 200 mg
      gelcaps (test) versus Advil liquigels (reference) administered as 1 x 200 mg gelcap under
      fasting conditions.
    

Detailed description: 
      Randomized, 2-way crossover, bioequivalence study of Ibuprofen 200 mg gel capsules and Advil
      liquigels 200 mg gel caps administered as 1 x 200 mg gel capsule in healthy subjects under
      fasting conditions.
    

Intervention name(s): Ibuprofen
Intervention type(s): Drug
Intervention description(s): Ibuprofen 200 mg gel capsules of Dr. Reddy's Laboratories Limited
Other intervention name(s): Advil liquigels 200 mg gel capsules
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Ibuprofen
Exercise in Methamphetamine Use Disorder Upregulation and Neural Function
Condition: Methamphetamine Abuse
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this research study is to determine the effects of an exercise intervention
      and health-education program on brain dopamine receptors and on cognitive functions that have
      been linked to these receptors.
    

Detailed description: 
      After completing baseline assessments within 2 wks after admission, participants will be
      randomized to one of two interventions: Exercise (EX, active intervention), consisting of
      3x-weekly 50-min aerobic + resistance-training sessions for 8 wk; Health Education (control
      intervention, CON), consisting of 50-min health education sessions 3x-weekly for 8 wk.
      Participants will undergo positron emission tomography (PET) and functional magnetic
      resonance imaging (fMRI) scans while performing the stop signal task (SST) and the reversal
      learning task (RLT) (cognitive computer tasks) at baseline and after completing the 8-wk
      protocol.
    

Intervention name(s): EX; CON
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An individualized aerobic and resistance-exercise program will be developed for each participant on the basis of a maximal incremental exercise test and strength assessments performed at baseline. This test will measure aerobic capacity (VO2 max) and the metabolic or lactate threshold (VO2θ) (i.e., the level of O2 uptake that defines one's ability to perform prolonged work), using indirect calorimetry with an automated metabolic-measurement system. The intervention will comprise 24 sessions over 8 wk (3x/wk), supervised by a credentialed exercise specialist. Each session will consist of a 5-min warm-up, 30-40 min of aerobic activity on a treadmill, 15-20 min of resistance training, and a 5-min cool-down.; Participants attend 50-min sessions 3x/wk matched to EX for staff contact. A counselor will facilitate integrative group discussions, and will conduct a multimedia program addressing various health, wellness and lifestyle topics, such as nutrition, dental care, stress relief, sleep hygiene, relationships, immunizations, health screening, smoking, environmental health, and time management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: exercise; methamphetamine
Controlling Post-extraction Complications of Impacted Mandibular Third Molar
Condition: Preventing Postextraction Complication
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      Impacted mandibular 3rd molar will be extracted in all patients, then patients will be
      divided, according to material placed in extraction socket into 3 groups: control, hyaluronic
      acid and honey. Then post extraction complications will be evaluated
    

Detailed description: 
      Impacted Mandibular third molar will be extracted under local anesthesia Through standard
      surgical flap elevation, after extraction and wound irrigation a material facilitate healing
      will be placed. According to material will be placed patients will be divide into 3 group:
      control ( no material, second group hyaluronic acid, third group ( honey).. then wound will
      be closed. Postoperative pain ( through visual analog scale) , edema, total dose of
      analgesic, mandibular movement (interincisal distance in mm) will be evaluated preoperative,
      1,2,3,7, and 10 day after extraction
    

Intervention name(s): Normal saline; Hyaluronic acid; Methylprednisolone; Methylprednisolone and Hyaluronic acid
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Normal saline irrigation and No other drug placed after extraction; Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket; Methylprednsolone will be injected half an hour preoperatively; Methylprednisolone will be injected half an hour preoperatively and Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket
Other intervention name(s): Gengigel
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Ergometer Training With Telemonitoring in Patients With Chronic Obstructive Pulmonary Disease (COPD) After Exacerbation
Condition: COPD
Study type: Interventional

Summary: 
      Home ergometer training combined with online monitoring and regular telephone support could
      prove to be a cost-effective method to improve physical performance and quality of life in
      COPD patients.

      The primary objective of the study is to demonstrate a significantly higher daily workout
      time in patients that are monitored during home ergometer training with telephone support
      compared to conventional home ergometer training. Consequently we expect an increased quality
      of life related to the illness and a decreasing BODE-Index. A post-interventional lower
      BODE-Index correlates with a reduced risk of hospitalisation and mortality.
    

Detailed description: 
      Hypothesis: There will be an increased prevalence, morbidity and mortality of COPD during the
      next decades. On the other hand there is a clear correlation between life expectancy and
      physical activity in this disease. Telemedicine concepts promise new treatment strategies
      with favourable impact on the long-term process of COPD.
    

Intervention name(s): Ergometer Training; Motivation
Intervention type(s): Other; Other
Other intervention name(s): Ergometer; Telemonitoring; Phone Calls
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; telemonitoring; training; ergometer; telemedicine
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
Condition: Infections; Child
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules)
      1g filling sachet in children with infections (Respiratory tract infections, Dermatological
      infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections).

      Secondary objectives are to assess the clinical efficacy, bacteriological efficacy and
      acceptability of telithromycin (20% fine granules) 1g filling sachet in children with
      infections.
    


Intervention name(s): telithromycin (HMR3647)
Intervention type(s): Drug
Intervention MeSH terms: Telithromycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Respiratory Tract Infections; Skin Diseases; Sinusitis
A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether mobile-based virtual reality exposure
      treatement can reduce the symptoms of panic disorder and the symptoms of depression and
      anxiety than the waitlist group
    


Intervention name(s): Arm I (Prepectoral); Arm II (Subpectoral)
Intervention type(s): Procedure; Other
Intervention description(s): Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.; Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Aerobic Exercise on Learning After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine if attaining aerobic fitness is beneficial in producing cortical neuroplasticity in
      individuals with chronic stroke.
    

Detailed description: 
      Crossover clinical trial. Experimental group undergoes 3x/wk/6 months of aerobic
      conditioning. Control group performs usual daily activities. All participants will be
      assessed with cognitive and motor behavioral testing at baseline, 3, 6, 9 and 12 months.
    

Intervention name(s): Rehabilitation exercise
Intervention type(s): Behavioral
Intervention description(s): Rehab therapy is delivered for 8 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
Condition: Convergence Insufficiency
MeSH terms: Ocular Motility Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare the use of special prism glasses to placebo treatment for
      children with symptomatic convergence insufficiency.
    

Detailed description: 
      The Base-in for Convergence Insufficiency Treatment Trial (BI-CITT) is a multi-center,
      placebo-controlled, masked, clinical trial designed to compare the benefits of base-in prism
      for patients with convergence insufficiency (CI).

      The goals of this clinical trial are:

        -  To compare the effectiveness of Base-in prism and Placebo eyeglasses for the treatment
           of CI in children

        -  To study the long-term effect of these treatments for CI

        -  To identify factors that may be associated with successful treatment of CI with base-in
           prism
    

Intervention name(s): Base-in prism glasses for reading; Placebo reading glasses
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: convergence insufficiency; base-in prism; orthoptics; vision therapy
Comparison 1 Plane-2 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block
Condition: Radius Fractures
MeSH terms: Radius Fractures
Study type: Interventional

Summary: 
      The supraclavicular block can provide effective surgical anesthesia of the forearm and hand.
      There have been many different approaches to ultrasound-guided supraclavicular brachial
      plexus block (US-SCBPB) according to the needle injection site (e.g. corner pocket approach,
      cluster approach) or number of needling (single or double injection). Numerous studies
      demonstrates good results (e.g. faster onset time) when using double injections rather than
      single injection. But double injection does not guarantee complete sensory block because
      ulnar nerve tends to be spared by its anatomical location.
    

Detailed description: 
      The investigators hypothesized that double injection in different plane (we call this new
      approach as a 2 plane-2 injection approach;2P2I) would overcome the weakness of the existing
      double injection in same plane (we call this approach as a 1 plane-2 injection approach;1P2I)
      like "ulnar nerve sparing effect", and could have a good results (e.g. shortening the onset
      time or increasing rate of all four nerves block). Because 2P2I can achieve an effect of a
      "tridimensionally administered LA", rather 1P2I only achieve an effect of a "
      two-dimensionally administered LA".
    

Intervention name(s): stimuplex insulated needle; lidocaine mixed with epinephrine
Intervention type(s): Device; Drug
Intervention description(s): 2P2I group: nerve stimulating needle is advanced twice with the up-down direction at the different puncture site and LA is injected 15 mL at a time.
1P2I group: nerve stimulating needle is advanced twice with the up-down direction at the same puncture site and LA is injected 15 mL at a time.; 2P2I group and 1P2I group use the same LA (1.5% lidocaine mixed with 1:200,000 epinephrine). But 2P2I group is injected LA at equally divided doses (15 mL at a time) with the up-down direction at the different puncture site. 1P2I group is injected LA at equally divided doses with the up-down direction at the same puncture site.
Other intervention name(s): D Plus B.Braun; 1.5% lidocaine mixed with 1:200,000 epinephrine
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: brachial plexus block; nerve stimulator; ultrasound
A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants
Condition: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type B
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined
      vaccine in support of registration of this product in China

      Primary Objectives:

        -  To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4
           and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria,
           Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine
           given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP)
           antigens, one month after the three-dose primary vaccination.

        -  To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine
           administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis
           Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with
           Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose
           primary vaccination.

      Secondary Objectives:

        -  To describe the safety after administration of the study vaccines.

        -  To describe in each group the immunogenicity of the study vaccines one month after the
           primary vaccination and before and one month after the booster vaccination.
    

Detailed description: 
      Participants will receive a primary vaccination consisting of three doses of ACTACEL at
      either 2, 3, and 4 months of age or at 3, 4, and 5 months of age; or Wuhan DTaP and Act-HIB
      vaccines at 3, 4, and 5 months of age. All participants will receive a single booster dose at
      18-20 months of age and will be followed up for one month after the last dose of study
      vaccine.
    

Intervention name(s): DTaP//PRP-T Combined Vaccine; DTaP//PRP-T Combined Vaccine; DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular (each vaccine)
Other intervention name(s): ACTACEL; ACTACEL; Act-HIB™
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B
Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective
      compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative
      symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks
      and will then return for a follow-up visit 2 weeks later. About 275 patients with
      schizophrenia will be enrolled in this study.
    


Intervention name(s): Talnetant; placebo; risperidone
Intervention type(s): Drug; Other; Other
Intervention description(s): talnetant; Placebo Comparator; Active Comparator
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: paranoid; catatonic; undifferentiated types; disorganized
DNA of Oral Cytobrush in Three Means Conservation
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to analyze genomic DNA of buccal cytobrush stored in three means
      conservation.
    

Detailed description: 
      Blood samples are an excellent source of large amounts of genomic DNA. However, alternative
      sources are often needed in epidemiological studies because of difficulties in obtaining
      blood samples.
    

Intervention name(s): samples collected by buccal cytobrush
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Buccal Mucosa; DNA; Polymerase Chain Reaction
Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the bioequivalence between two compounds (phenytoin and epamin) by a
      randomized, single dose study under fasting conditions in healthy volunteers.
    

Detailed description: 
      Bioequivalence study in healthy volunteers
    

Intervention name(s): Phenytoin; Epamin
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V.; Single dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC
Intervention MeSH terms: Phenytoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; EPAMIN; PHENYTOIN
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP4058 Following Single Oral Doses
Condition: Pharmacokinetics of ASP4058; Healthy Subjects; Food Effect of ASP4058
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK) of
      single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects. This
      study will also explore the effect of food on the PK of ASP4058.The food-effect crossover
      group was open-label treatment with no placebo control.
    

Detailed description: 
      Subjects will remain in the clinic for 9 days. Subjects will return to the clinic for
      follow-up on days 12 and 30 to collect additional safety information.
    

Intervention name(s): ASP4058; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: ASP4058; healthy subjects