bioihbjkbjnl/mcl2 huggingface dataset:
A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to compare the pharmacokinetic characteristics of
      GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.

      GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.
    


Intervention name(s): Oxycodone; Oxycodone; Oxycodone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oxycodone XL 20mg(20mg once a day, fasted); Oxycodone XL 20mg/day(20mg once a day, after high fat meal); Oxycodone 20mg/day (10mg twice a day, fasted)
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Oxycodone, controlled release formulation
A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the drug levels of BMS-986166 in healthy male
      participants.
    


Intervention name(s): BMS-986166; Bisacodyl
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Other intervention name(s): Dulcolax®
Intervention MeSH terms: Bisacodyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, open-label, multicenter, pilot study of the safety and efficacy of two
      Docetaxel-based regimens plus bevacizumab for the adjuvant treatment of participants with
      node positive or high risk node negative breast cancer.

      The primary objective of this study was to evaluate the cardiac safety, and the secondary
      objectives were to evaluate safety and toxicity of participants treated with bevacizumab ±
      trastuzumab administered with 2 different docetaxel-based combination regimens.

      This study was originally designed to also evaluate disease-free survival (DFS) and overall
      survival (OS); however, based on a protocol amendment, follow-up was shortened from 10 years
      to 2 years, and the efficacy endpoints of disease free survival and overall survival were
      deleted from the protocol.
    


Intervention name(s): Docetaxel; Doxorubicin; Carboplatin; Cyclophosphamide; Trastuzumab; Bevacizumab
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 75 mg/m^2 administered IV on Day 1 for Cycles 1-6
All participants received a prophylactic steroid regimen prior to each dose of docetaxel - Dexamethasone 8 mg orally 12 hours prior to docetaxel, dexamethasone 10 mg IV just prior the docetaxel infusion and 8 mg orally 12 hours after docetaxel administration. If a participant had not taken their oral dexamethasone the evening prior to receiving docetaxel, the dose of the pre-docetaxel infusion of dexamethasone was increased from 10 mg IV to 15 mg IV. A Dexamethasone 8 mg equivalent may have been used (dexamethasone 8 mg = methylprednisolone 40 mg = prednisone 50 mg = prednisolone 50 mg).; 50 mg/m^2 administered IV on Day 1 for Cycles 1-6; 6 mg/mL/min (target area under the curve [AUC] dose) administered IV on Day 1 for Cycles 1-6; 500 mg/m^2 administered IV on Day 1 for Cycles 1-6; A single loading dose of 8 mg/kg administered IV on Day 2 for Cycle 1, and 6 mg/kg administered IV on Day 1 for Cycles 2-6 and for maintenance therapy; 15 mg/kg administered IV on Day 1 for Cycles 1-6, and for maintenance therapy
Other intervention name(s): Taxotere®; Gemzar®
Intervention MeSH terms: Cyclophosphamide; Bevacizumab; Carboplatin; Docetaxel; Doxorubicin; Trastuzumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Compression Anastomosis Using the Compression Anastomotic Ring-locking Procedure (CARP)
Condition: Cancer; Polyp
Study type: Interventional
Phase: Phase 1

Summary: 
      The intestinal ends must be rejoined after colonic resection. Conventional methods include
      sutured and stapled anastomoses, which is associated with 3-6% leakage after colonic surgery.
      The leakage of an anastomosis can cause serious consequences, such as abdominal infections
      and/or sepsis. Early detection of anastomotic leakage is the best way to avoid serious
      abdominal infections. The methods that are used today to detect leaks are unfortunately not
      very accurate. These methods include monitoring symptoms, temperature, and CRP-levels, and
      performing abdominal examinations and tomography scans. Because of the difficulties in
      objectively assessing these parameters, the anastomotic leaks are often diagnosed late. When
      reoperation is required, a permanent stoma may be made at the level of the sigmoid colon. The
      CARP system has been developed to achieve a safe anastomosis. The CARP is designed to
      providing an improved contact surface between the two intestinal ends and the ability to
      precisely investigate the anastomosis during and after surgery using the catheters of the
      CARP system. Standardized use of the CARP to anastomose the large intestine may provide
      significant advantages in the field of colorectal surgery.
    


Intervention name(s): Compression anastomotic ring-locking procedure (CARP)
Intervention type(s): Device
Intervention description(s): The Compression anastomotic ring-locking procedure (CARP) device is based on a set of rings to make a compression anastomosis between the intestinal ends.
Other intervention name(s): The rings are called RapAn
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anastomosis; Compression; Colon
A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of esketamine compared with placebo in
      improving symptoms of depression in patients with treatment resistant depression.
    

Detailed description: 
      This is a double-blind (neither physician nor patient knows the treatment that the patient
      receives), double-randomization (the study drug is assigned by chance), placebo-controlled
      (placebo is an inactive substance that is compared with a drug to test whether the drug has a
      real effect in a clinical trial), multiple dose titration study in adult patients with
      treatment resistant depression (TRD). The study will assess the efficacy of esketamine at 24
      hours after dosing on Day 1, administered as a 0.40 mg/kg and 0.20 mg/kg intravenous (i.v.)
      infusion, compared with placebo in improving symptoms of depression in patients with TRD,
      using the Montgomery-Asberg Depression Rating Scale (MADRS). The study will consist of 3
      phases: a screening phase of up to 2 weeks, a 7-day double-blind treatment phase (Day 1 to
      Day 7), and a 4-week posttreatment (follow up) phase. The interval between the first and last
      dose of study medication is 3 days. The total study duration for each patient will be a
      maximum of 7 weeks.
    

Intervention name(s): Esketamine; Esketamine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Type= exact number, number= 0.20, unit= mg/kg, form= intravenous infusion, route= intravenous use. One single intravenous infusion of esketamine 0.20 mg/kg administered on Day 1 and Day 4.; Type= exact number, number= 0.40, unit= mg/kg, form= intravenous infusion, route= intravenous use. One single intravenous infusion of esketamine 0.40 mg/kg administered on Day 1 and Day 4.; Form= intravenous infusion, route= intravenous use. One single placebo intravenous infusion administered on Day 1 and Day 4.
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Major depressive disorder; Treatment resistant depression; Depression; Esketamine
Using Short Message Service as a Means of Clinical Engagement in Early Psychosis
Condition: Psychotic Disorders
MeSH terms: Psychotic Disorders
Study type: Interventional

Summary: 
      Engagement with clinical services for youth with early psychosis represents a significant
      challenge, with up to 40% of patients dropping out of treatment in the first year. This has
      been linked to worse illness outcomes and represents a significant barrier to recovery for
      these patients. This study aims to evaluate the efficacy of short message service (SMS) as a
      means of improving clinical engagement in early-episode psychosis populations by bridging
      contact between appointments with weekly check-ins/reminders. These weekly check-ins during
      the first year of treatment will serve as an additional opportunity to reach out to patients
      and give them a chance to do the same with their care teams, with patient responses
      triggering clinician follow-up if necessary.
    


Intervention name(s): SMS text messaging - interactive check-in; SMS text messaging - inactive control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interactive SMS text message check-ins delivered once weekly to participants.; Minimally interactive SMS text message delivered once weekly to participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SMS text messaging; Clinical engagement
Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
Condition: Lumbosacral Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and effectiveness of a new pain medication in
      development, clonidine micropellet. Participants will receive a single injection of either
      clonidine micropellet or sham injection for the treatment of low back and leg pain from
      sciatica.
    


Intervention name(s): Clonidine Micropellets; Sham
Intervention type(s): Combination Product; Other
Intervention description(s): Injection; Injection
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clonidine Micropellet vs Sham-Control
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study was to evaluate the safety and efficacy of multiple doses of
      upadacitinib monotherapy versus placebo in the treatment of adults with moderate to severe
      atopic dermatitis (AD).
    

Detailed description: 
      The study was to include a 16-week double-blind treatment period (Period 1) and a 72-week
      double-blind treatment period (Period 2) for a total of 88 weeks of treatment. Participants
      who met eligibility criteria were to be randomized in a 1:1:1:1 ratio to one of the four
      treatment groups. Participants who completed Period 1 were re-randomized at Week 16 into a
      72-week double-blind, placebo-controlled treatment period (Period 2) in a 1:1 ratio:

        -  Group 1: Upadacitinib 7.5 mg once daily (QD) (Day 1 to Week 16) → upadacitinib 7.5 mg QD
           or placebo (Week 16 - and thereafter)

        -  Group 2: Upadacitinib 15 mg QD (Day 1 to Week 16) → upadacitinib 15 mg QD or placebo
           (Week 16 and thereafter)

        -  Group 3: Upadacitinib 30 mg QD (Day 1 to Week 16) → upadacitinib 30 mg QD or placebo
           (Week 16 - and thereafter)

        -  Group 4: Matching placebo (Day 1 to Week 16) → upadacitinib 30 mg QD or placebo (Week 16
           and thereafter)

      In Period 1, discontinuation from study drug was mandatory for any participant with an Eczema
      Area and Severity Index (EASI) score worsening of 25% or more compared with their Baseline
      EASI score at any 2 consecutive scheduled study visits from Week 4 to Week 12.

      In Period 2, blinded rescue therapy with upadacitinib 30 mg QD was provided after the first
      instance of a < EASI 50 response starting at the Week 20 visit (4 weeks after
      re-randomization into Period 2) for the remainder of the study.
    

Intervention name(s): Upadacitinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet for oral use; Tablet
Other intervention name(s): RINVOQ™; ABT-494
Intervention MeSH terms: Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ABT-494; Atopic Dermatitis
Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD
Condition: Substance Use Disorders; Attention Deficit Hyperactivity Disorder
MeSH terms: Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effectiveness and safety of atomoxetine in the
      treatment of adolescents with coexisting alcohol or substance use disorders and Attention
      Deficit Hyperactivity Disorder (ADHD).
    


Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Substance Use
Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine
Condition: Pertussis; Whooping Cough
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety and immunogenicity of a higher dose formulation of a new live
      attenuated vaccine, BPZE1, intended to prevent Bordetella pertussis nasopharyngeal
      colonization and pertussis disease, and investigates whether higher doses of BPZE1 induce the
      live vaccine to colonize subjects' nasopharynx. The study is a Phase Ib (high dose), single
      centre, dose-escalating, placebo-controlled study of the live attenuated B. pertussis strain
      BPZE1 given as a single intranasal dose to healthy adult volunteer.
    


Intervention name(s): BPZE1; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Intranasal live, attenuated vaccine; Diluent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pertussis; Colonization; Vaccine; Immune response; BPZE1; Infection; Bordetella pertussis; B. pertussis; respiratory Tract Infection
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)
Condition: Breast Diseases
MeSH terms: Breast Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multicenter, Randomized, Open-label, Parallel, Phase 3 Clinical Trial in 8
      weeks for screening, once Investigational product injection, Follow up visit.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy and safety of LuminoMark inj. (Conc.
      for fluorescence) localization in patients with nonpalpable breast lesions.
    

Intervention name(s): LuminoMark inj.(Conc. for fluorescence); Charcotrace Inj.
Intervention type(s): Drug; Drug
Intervention description(s): Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.; Injection Charcotrace Inj. about 0.3~1mL once in this study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonpalpable Breast Lesions
Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)
Condition: Inguinal Hernia; Femoral Hernia
MeSH terms: Hernia; Hernia, Inguinal; Hernia, Femoral
Study type: Interventional

Summary: 
      In this study the researchers want to compare fibrin glue versus tacked fixation in fixation
      of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the
      first 3 days postoperative days. Moreover, the researchers investigate general well-being,
      fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are
      investigating chronic pain and clinical recurrence.
    


Intervention name(s): Fibrin glue; Tacks
Intervention type(s): Procedure; Procedure
Intervention description(s): Tissucol 2 ml; Protacks
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tapp; Early pain; well-being; Seroma; Haematoma; Fibrin glue; tacks
COVID-19 Vaccine Confidence Among Pregnant Women and Mothers
Condition: Pregnancy Related; Mothers
Study type: Observational

Summary: 
      The purpose of this study is to assess the level of vaccine confidence and influencers among
      pregnant women and mothers of school-aged children during the COVID-19 pandemic.
    

Detailed description: 
      The WHO has listed "vaccine hesitancy" as one of the top threats to global health.

      The COVID-19 pandemic has triggered the need to vaccinate worldwide as soon as a safe and
      efficacious vaccine becomes available. However preliminary data show that, on average, only
      50% to 66% of US adults would be willing to receive COVID-19 vaccination when it becomes
      available, a percentage lower than what is required for herd immunity to control the
      pandemic. Furthermore, there is a pressing need to vaccinate children to reopen schools and
      keeping them safe, as well as to immunize pregnant women through vaccination programs since
      they constitute a vulnerable population. Vaccine confidence among pregnant women and mothers
      of school-aged children during the period of COVID-19 pandemic is unknown, leading to an
      important gap of knowledge that may hinder the upcoming global COVID-19 vaccination scale-up
      effort. It is therefore of critical importance to assess the level of vaccine confidence and
      influencers among pregnant women and mothers of school-aged children during the COVID-19
      pandemic.

      The international nature of the proposed survey will allow the evaluation of vaccine
      confidence and its influencers among pregnant women and mothers of school-aged children on a
      global level. Therefore, social and geographic characteristics from different countries and
      cultures will be available for comparison. The resulting knowledge will be relevant to a
      large percentage of the world's population. Any country in the world can participate.
    

Intervention name(s): This is an online survey with no intervention.
Intervention type(s): Other
Intervention description(s): As this is an online survey about health and wellbeing, there is no intervention.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women or women who have at least one child younger than 18 years of age.
Pentostatin for High Risk and Refractory Chronic Graft Versus Host Disease in Children
Condition: Graft vs Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter trial through the Pediatric Blood and Marrow Transplant Consortium.

      The Primary hypothesis of this study is that because of its effect as a potent
      immunosuppressive agent targeting lymphocytes, pentostatin will show a sustained response in
      pediatric subjects with severe chronic GVHD. Secondary hypotheses include that the infection
      and toxicity rate of pentostatin in this setting will be acceptable given its lack of severe
      myelosuppression, and subjects with refractory chronic GVHD will have significant QOL
      impairment and symptomatology. These may change as subjects are being treated for their
      chronic GVHD with pentostatin.
    

Detailed description: 
      To participate in this study, subjects must have diagnosed chronic Graft versus Host Disease
      that is refractory to therapy or that is considered high risk (i.e. low platelet count,
      progressive onset and greater than 50% of body surface area affected). Subjects must have not
      failed more than 2 immunosuppressive regimens in order to be considered for this trial.
      Eligible subjects will receive intravenous pentostatin every 2 weeks for 24 weeks. If the
      subject has had a complete response, the therapy will end at 24 weeks. If the subject has had
      a partial or mixed response or stable disease, they will continue on study receiving
      pentostatin for 52 weeks.
    

Intervention name(s): Pentostatin
Intervention type(s): Drug
Intervention description(s): The drug, Pentostatin, is given every 2 weeks. This drug will be given by intravenous (IV) infusion.
Intervention MeSH terms: Pentostatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic graft versus host disease; graft; host; transplant; stem cell; pediatric; GVH0313; leukemia
Multimodal Analgesia After Shoulder Arthroscopy
Condition: Analgesia; Arthroscopy; Shoulder Joint
MeSH terms: Agnosia
Study type: Observational

Summary: 
      This proposal aims to measure the quality of recovery and quality of pain management after
      shoulder surgery before and after implementation of a multimodal pain protocol.
    

Detailed description: 
      Pain management after shoulder surgery remains to be a major challenge. Reliance on a single
      agent (most commonly opioids) results in increased incidence of side effects. Multimodal pain
      management refers to the use of multiple drugs that target different components of pain
      pathway.
    

Intervention name(s): multimodal perioperative pain protocol (MP3)
Intervention type(s): Combination Product
Intervention description(s): administration of gabapentionoid, acetaminophen, non steroidal anti-inflammatory drugs around the clock in addition to the peripheral nerve block offered before surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients scheduled for shoulder arthroscopy
      
Keywords: multimodal analgesia; quality of recovery; quality of pain management