bioihbjkbjnl/mcl2 huggingface dataset:
Ventilatory Weaning Guided by a New Index
Condition: Respiration, Artificial
Study type: Interventional

Summary: 
      Mechanical ventilation (MV) is an essential therapy for patients with acute respiratory
      failure. The ventilatory weaning process should be started when the precipitating causes of
      the use of the ventilatory prosthesis are resolved. Inappropriately slow weaning exposes the
      patient to unnecessary discomfort, increases the risk of complications and increases the cost
      of hospital treatment. In this sense, indices that can predict successful weaning are of
      great value.
    

Detailed description: 
      Mechanical ventilation (MV) is an essential therapy for patients with acute respiratory
      failure. The ventilatory weaning process should be started when the precipitating causes of
      the use of the ventilatory prosthesis are resolved. Inappropriately slow weaning exposes the
      patient to unnecessary discomfort, increases the risk of complications and increases the cost
      of hospital treatment. In this sense, indices that can predict successful weaning are of
      great value. Our study aimed to evaluate the performance of a new ventilatory weaning index,
      the timed inspiratory effort index (TIE index), as a weaning predictor in comparison with the
      traditionally used spontaneous breathing test (SBT). The study is a randomized controlled
      trial of a cohort of mechanically ventilated patients over 24 hours admitted to the ICU of
      Hospital e Clínica São Gonçalo (HCSG), located in the city of São Gonçalo, State of Rio de
      Janeiro, Brazil. The TIE index is calculated as the ratio of the maximum inspiratory pressure
      developed in the last 30 seconds of a 60 second period of unidirectional airway occlusion by
      the time required to reach this value.
    

Intervention name(s): Timed Inspiratory Effort (TIE index)
Intervention type(s): Device
Intervention description(s): Conventional clinical treatment and using the Timed Inspiratory Effort (TIE index), which guided the decision to ventilate weaning and extubation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Mechanical Ventilator; Ventilator Weaning; Spontaneous Breath Test; Predictive Index
Single-dose/Multiple-doses Incremental Intravenous Injection of SY-005 （Recombinant Human Annexin A5）in Healthy Subjects
Condition: Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose/multiple-doses incremental, randomized, double-blind, parallel,
      placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic
      study of a single-dose/multiple-doses incremental intravenous injection of SY-005（recombinant
      human annexin A5） in healthy subjects. Six sigle-dose group trials are planned: 0.75mg,
      2.5mg, 5mg, 10mg, 15mg,and 20mg and three multiple-doses groups are planned: 5mg, 10mg and
      20mg. Single-dose groups are planned to enroll 64 subjects and multiple-doses groups are
      planned to enroll 30 subjects.
    

Intervention name(s): SY-005
Intervention type(s): Drug
Intervention description(s): This single-dose group will be initiated in healthy subjects at a 0.75mg dose that is the maximum recommended starting dose(MRSD). Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are2.5mg, 5mg, 10mg, 15mg, 20mg successively. The dose of multiple-doses groups are depending on the results of single-dose groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients
Condition: Dental Anesthesia; Anesthesia, Local; Anesthesia, Reversal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether OraVerse is safe and effective for the
      reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.
    

Detailed description: 
      This Phase 4 clinical study is designed as a multicenter, randomized, double-blinded,
      controlled study to evaluate the safety and efficacy of OraVerse in approximately 150
      children 2 to 5 years of age. OraVerse or sham injection is administered at the completion of
      a dental procedure requiring local anesthesia with lidocaine 2% with 1:100,000 epinephrine.
      The dental procedure(s) comprising restoration/fillings shall be performed in a single
      quadrant of the mouth.

      The primary endpoint is safety and tolerability of OraVerse as measured by adverse events,
      vital signs, oral cavity assessments, nerve injury, and analgesics for intraoral pain.
      Secondary objectives in subjects 4 and 5 years of age include the safety and tolerability of
      OraVerse as measured by pain assessments using W-B PRS and evaluation of efficacy assessed by
      a pediatric Functional Assessment Battery (pFAB) and standardized lip and tongue palpation
      procedure.
    

Intervention name(s): OraVerse; Sham injection
Intervention type(s): Drug; Other
Intervention description(s): 1.8mL dental cartridge delivered in doses of either 1/4, 1/2 or 1 cartridge depending on subject weight; No drug administered, simulation of injection used in same manner as drug
Intervention MeSH terms: Phentolamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OraVerse; Safety; Efficacy; Pediatric; Reversal of dental anesthesia
Dose Escalation Study to Evaluate the Safety and Tolerability of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP)
Condition: Hypophosphatasia
MeSH terms: Hypophosphatasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine tolerability, PK/PD and preliminary efficacy of
      BPS804 in adult patients with HPP treated with multiple escalating doses of BPS804.

      This study will allow a comparison of several doses of the study drug within the first two
      weeks after administration and after a longer assessment period for the highest dose level to
      enable selection of dose ranges to be tested in subsequent studies in the HPP indication.
    

Detailed description: 
      This study was conducted and previously posted by Novartis. The record was transferred to
      Ultragenyx in February 2021.
    

Intervention name(s): BPS804
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypophosphatasia; HPP; Rathbun's disease
Caudal Versus Intravenous Dexmedetomidine for Caudal Analgesia in Children
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this prospective randomized double-blind study was to compare the analgesic
      efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine
      for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.
    

Detailed description: 
      Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration
      of action of caudal block with a local anesthetic agent.But which route of administration of
      dexmedetomidine is the most beneficial remains unknown.

      The investigators performed prospective randomized double-blind study to compare the effects
      of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after
      caudal bupivacaine in children undergoing infra-umbilical surgery.

      75 children (ASAⅠorⅡ,aged 1-6 yr) undergoing infra-umbilical surgery were included in this
      study. Anesthesia was induced with sevoflurane via a facemask, followed by placement of a
      laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in
      oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups.
      Group B-Dcau (n = 25): Caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml
      normal saline i.v.;Group B-Div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine
      1µg/kg(10 ml)i.v.;Group B(n = 25): bupivacaine 0.25% and 10 ml normal saline intravenous
    

Intervention name(s): Caudal Dexmedetomidine; Intravenous dexmedetomidine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug:Caudal bupivacaine 0.25% 1ml/kg
Drug: Caudal dexmedetomidine 1µg/kg
Intravenous: 10 ml normal saline
sevoflurane Induction and maintenance of anesthesia; Drug:Caudal bupivacaine 0.25% 1ml/kg.
Drug:Intravenous dexmedetomidine1 μg /kg in a total volume of 10 ml
sevoflurane Induction and maintenance of anesthesia; Drug:Caudal bupivacaine 0.25% 1ml/kg
Intravenous: Normal saline 10 ml
sevoflurane Induction and maintenance of anesthesia
Other intervention name(s): dexmedetomidine; Precedex; precedex; normal saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cognitive-Behavioral Therapy for Irritability in Adolescents With High Functioning Autism Spectrum Disorder
Condition: Autism; Autism Spectrum Disorder (ASD; Asperger's Disorder; Pervasive Developmental Disorder (PDD-NOS)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Developmental Disabilities; Asperger Syndrome
Study type: Interventional

Summary: 
      In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder
      (ASD) often exhibit disruptive behavior problems including irritability, tantrums,
      noncompliance, and aggression. This is a pilot study of Cognitive-Behavioral Therapy, also
      known as Anger Control Training, in adolescents with high-functioning ASD. CBT teaches
      children to recognize antecedents and consequences of problem behavior and to use emotion
      regulation and problem-solving skills to reduce irritability, aggression and noncompliance.
      This form of CBT has been well-studied in typically developing children with disruptive
      behavior and we are investigating if this treatment can be feasible and helpful, with
      appropriate modifications, for irritability and disruptive behavior in ASD.
    


Intervention name(s): Cognitive-Behavioral Therapy (CBT) for Irritability
Intervention type(s): Behavioral
Intervention description(s): CBT is an individually administered behavioral interventions aimed at reducing irritability and disruptive behavior. There are 10 to 12 weekly sessions that are conducted with the child and the parent. During these sessions children are taught to recognize antecedents and consequences of problem behavior and to use emotion regulation and problem-solving skills to reduce irritability, aggression and noncompliance.
Other intervention name(s): Anger Control Training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; Irritability; Disruptive Behavior; Aggression; Behavior Therapy; Cognitive Behavioral Therapy
Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation
Condition: Inflammation, Brain; Emotional Problem
MeSH terms: Encephalitis; Inflammation
Study type: Interventional

Summary: 
      Major Depression Disorder is one of the most common psychiatric disease and has affecting
      approximately 350 million people in the world. According to World Health Organization's
      report, it may be the first burden of disease in 2030. Due to the high morbidity and low
      acceptance in the treatment, it is necessary to find some nature compounds to prevent the
      disease.

      Cordyceps militaris, one of the most treasure Chinese herbs in Asia, contains many kinds of
      component such as cordycepin, polysaccharide, mannitol. In winter, it appears as an worm in
      the soil, afterwards, it grows out of the soil and convert into grass in summer. A previous
      study has demonstrated that Cordyceps militaris has anti-depressive effect in mouse tail
      suspension test, and in this study we will explore its effect in human subjects.
    


Intervention name(s): beverage containing mushroom-extracts
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A triple-blind, randomized-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining paclitaxel with radiation therapy may kill more tumor cells.

      PURPOSE: This trial is to study the effectiveness of concurrent administration of
      chemotherapy and radiation therapy in treating women who have stage II or stage III breast
      cancer by examining the complications and cosmetic effects.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with
           stage II or III breast cancer who have had primary breast conserving surgery and
           adjuvant chemotherapy.

        -  Assess the cosmetic results of breast conservation after this treatment in these
           patients.

        -  Determine the pulmonary toxicity of this regimen in these patients.

      OUTLINE: Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3
      weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen.
      Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.
      Treatment continues in the absence of disease progression or unacceptable toxicity.

      Patients are followed at 1 month, every 3 months for 1 year, every 6 months for the next 5
      years, and then annually thereafter.

      PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 12-18
      months.
    

Intervention name(s): paclitaxel; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Procedure; Radiation
Intervention description(s): Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen.; doxorubicin and cyclophosphamide adjuvant regimen; Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer
Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
      Amifostine may protect normal cells from the side effects of chemotherapy.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, amifostine,
      and peripheral stem cell transplantation in treating patients who have stage II, stage III,
      or stage IV breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the feasibility of high dose doxorubicin, cyclophosphamide,
      paclitaxel, and amifostine in patients with high risk stage II/III and responsive stage IV
      advanced breast cancer. II. Determine the pharmacokinetic profile of paclitaxel administered
      with amifostine in this regimen in these patients. III. Assess the toxicity of this treatment
      regimen in this patient population.

      OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously twice daily on days 1-4 for
      peripheral blood stem cell (PBSC) mobilization and continuing through days 5-10 during PBSC
      collection. At least 2 weeks following mobilization, patients receive doxorubicin IV as a
      continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on day
      -5 and amifostine IV over 15 minutes, and paclitaxel IV over 24 hours on day -4. On day -2,
      25% PBSC are reinfused and 75% are reinfused on day 0, followed by daily G-CSF subcutaneously
      or IV beginning on day 1. Patients are followed every 3 months for 2 years, then periodically
      thereafter.

      PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6-8 months.
    

Intervention name(s): filgrastim; amifostine trihydrate; cyclophosphamide; doxorubicin hydrochloride; paclitaxel; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Amifostine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; stage IIIB breast cancer
Tai Chi in Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis
Study type: Interventional

Summary: 
      Our hypothesis is that tai chi sessions would increase physical activity of patients with
      Spondyloarthitis. The main objective is to study the effect of tai chi sessions (16 vs.0) on
      global physical activity of Spondyloarthitis patients, compared to a control group without
      tai chi.
    

Detailed description: 
      Selection and inclusion of patients will be done by principal investigator of Rheumatology
      Department. After verification of inclusion and non-inclusion criteria by principal
      investigator and signature of consent, patients will be randomized by 1: 1 randomization
      (centralized randomization by statistician into 2 groups at M0). They will participate in
      sessions in a deferred manner due to two per week for each group:

        -  Interventional "A" group: 32 sessions (on average 2/week) performed from M0 to M4 in 15
           patients.

        -  Control "B" group: 16 sessions (on average 2/week) performed from M2 to M4 in 15
           patients.

      Patients of "B" group will be not performing sessions with "A" group patients. Sessions
      lasting about 45 minutes will be proposed from Monday to Friday in a room planned from this
      activity within the CHU. Exercises will be adapted and personalized according to each one.
      Evaluations will be carried out at M0, M2 and at the end of the protocol at M4.

      Assessment of pain and stress will be done before and after each session. Final assessment
      will be done at 4 months after randomization. Fitness assessment and tai chi sessions will be
      conducted by APA student.
    

Intervention name(s): Tai Chi 2 month; Tai Chi 4 month
Intervention type(s): Other; Other
Intervention description(s): Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breathing, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.; Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breathing, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SPONDYLOARTHITIS; TAI CHI CHUAN; PHYSICAL ACTIVITY
Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      The study aims to develop a questionnaire that can be used to help uncover a child's risk of
      developing dental caries (also known as tooth decay or a cavity). The aim is to develop a
      practical and easily-scored risk tool that a primary medical care provider can use to help
      find young children with the highest risk for developing cavities.
    

Detailed description: 
      The duration of expected time to participate is 3 years (which includes 3 dental
      examinations).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy children aged 12 months (± 3 months) at baseline stratified by Medicaid status
        and/or race/ethnicity to ensure a diverse representation. Each child will be paired with
        the primary caregiver, whom the investigators expect to most likely be the adult parent or
        legal guardian.
      
Keywords: dental caries; high risk; dental cavities; children dental care
Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited, Under Non-Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is

        -  To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to
           that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under non-fasting
           conditions and to assess the bioequivalence.

        -  To monitor the safety of the subjects.
    

Detailed description: 
      A Two-way open label crossover experimental evaluation of relative bioavailabilities of
      Ramipril 10 mg capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg capsules of King
      Pharmaceuticals in healthy adult human male subjects under non-fasting conditions.
    

Intervention name(s): Ramipril; Altace
Intervention type(s): Drug; Drug
Intervention description(s): Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited; Altace@ 10 mg capsules of Kings Pharmaceuticals, USA
Other intervention name(s): Altace@10 mg Capsules
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Crossover; Ramipril