bioihbjkbjnl/mcl2 huggingface dataset:
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy, safety, and tolerability of
      canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes
      mellitus with inadequate control despite treatment with metformin.
    

Detailed description: 
      Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that
      presents patients with a significant risk of complications including heart disease,
      retinopathy, nephropathy, and neuropathy. Various classes of orally administered
      antihyperglycemic agents have been developed for the treatment of diabetes and although
      individual agents may be highly effective for some patients, it is still difficult to
      maintain optimal glycemic control in most patients, thereby resulting in high rates of
      morbidity and mortality in the diabetic population. This is a randomized, double-blind,
      active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the
      efficacy, safety, and tolerability of canagliflozin compared with a sulfonylurea
      (glimepiride) in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally
      controlled on metformin monotherapy. The primary study hypothesis is that the study drug will
      be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from
      baseline. The patients will receive capsules taken by mouth of canagliflozin (either 100 or
      300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum
      dose of 6 or 8 mg once daily for a total duration of 104 weeks.
    

Intervention name(s): Glimepiride; Canagliflozin (JNJ-28431754); Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Glimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.; Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.; Metformin will be given orally at the protocol-specified dose for 104 weeks.
Other intervention name(s): sulfonylurea
Intervention MeSH terms: Metformin; Glimepiride; Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Metformin; Glimepiride; Hemoglobin A1c; Type 2 diabetes mellitus; Canagliflozin
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647
Condition: Cytomegalovirus Infection
MeSH terms: Infections; Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to evaluate the safety, reactogenicity, and
      immunogenicity of the mRNA-1647 vaccine administered according to a 3-study injection
      schedule in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive Japanese adults
      18 to 40 years of age in the United States.
    


Intervention name(s): mRNA-1647; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Lyophilized product that is reconstituted with saline; 0.9% sodium chloride (normal saline) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Moderna; mRNA-1647; Cytomegalovirus; CMV; Cytomegalovirus Vaccine; Cytomegalovirus Infections; Cytomegalovirus Congenital; Virus Diseases; Infection Viral; Messenger RNA
Music and Essential Oil in Agitation
Condition: Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional

Summary: 
      The study aims to assess the effect of using music and essential oil on agitation in
      mechanically ventilated patients. Listening to classical relaxation music, and inhalation to
      bergamot oil will be used in this study.
    

Detailed description: 
      Agitation in critically ill patients is a phenomenon that can compromise patient safety and
      assistance during intensive care unit (ICU) hospitalizations. This trial will be conducted in
      five general intensive care unit. One hundred and twenty patients will be enrolled in this
      study divided into three equal groups (40 patients in each group). Group A is the control
      group. Group B is music group. Group C is essential oil group. Agitated mechanically
      ventilated patients will be randomly assigned to one of the three groups. Each group will be
      subjected to its specific intervention and they will be monitored for seven days. Agitation
      score and frequency outcome will be assessed at the end of the study.
    

Intervention name(s): Music; Essential oil; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property; Bergamot oil inhalation through a piece of cotton gauze (2 × 2 cm square shape) with 0.5 cc of bergamot oil. It will be attached to the collar of the patient's clothes gown, approximately 15 cm below their nose.; The routine intensive care unit sedation protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three-group pre-test and repeated post-test study
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Mechanical ventilation; Music therapy; Essential oil; Bergamot oil
Multicenter, Open-Label, Randomised, Haloperidol-controlled Study to Evaluate Seroquel as Mono-Therapy in the Treatment of Agitated Symptoms in the Patients With Acute Episode of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study attempts to observe the efficacy (response time) and safety of the
      second-generation antipsychotic agent-quetiapine versus the first-generation antipsychotic
      agent-haloperidol, in treating acute schizophrenia episode and to evaluate the effect of the
      effectiveness of acute schizophrenia episode on long-term tolerability.
    

Detailed description: 
      Both medication and patient can affect the compliance of patients to treatment. The control
      of schizophrenia syndromes effectively and rapidly will build up the confidence of patients
      on treatments. These early effects may influence the long-term compliance and prognosis of
      patients. And the antipsychotic medications with neuroprotection effect can significantly
      improve the long-term prognosis of patients, too.In the past, we always think that there is
      "delayed onset of antipsychotic" by antipsychotic medications. Recently, a large sample study
      indicated that the onset of antipsychotic effect was as early as the first day after
      administration (in 24 hours). This study was carried out in order to compare the
      second-generation antipsychotic agent- quetiapine with the first-generation antipsychotic
      agent- haloperidol on the onset time of treatment.
    

Intervention name(s): Quatiapine Fumarate; Haloperidol
Intervention type(s): Drug; Drug
Intervention description(s): 600-750mg/day; 12-20mg/day
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PANSS; Acute Episode of Schizophrenia
Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate the possible effect of multiple oral doses of
      25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and
      levonogestrel (LNG) (Microgynon®).
    


Intervention name(s): levonorgestrel; levonorgestrel; Ethinylestradiol; Microgynon + BI 10773; Ethinylestradiol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): multiple doses; multiple doses; multiple doses; multiple doses BI 10773; multiple doses
Intervention MeSH terms: Empagliflozin; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment
Condition: CHRONIC SPONTANEOUS URTICARIA
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the proportion of patients with an urticaria control test [UCT] score of greater
      than or equal to 12 at Week 12.
    


Intervention name(s): OMALIZUMAB
Intervention type(s): Drug
Intervention description(s): sub cutaneous injections of 300 mg every 4 weeks until Week 8.
Intervention MeSH terms: Omalizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CHRONIC SPONTANEOUS URTICARIA; OMALIZUMAB; URTICARIA CONTROL TEST; IGE025
Computer Assisted Orthognathic Surgery. Facial Asymmetry
Condition: Facial Asymmetry
MeSH terms: Facies; Facial Asymmetry
Study type: Interventional

Summary: 
      The specific aims of the study were to measure and compare the rates of alignment and cant
      reduction of the dental and facial midlines among the two groups.
    

Detailed description: 
      The purpose of this randomized, controlled, clinical study, was to evaluate the most accurate
      procedure for orthognathic correction of facial asymmetry. The investigators compared two
      different methods of surgical planning: classical (esthetic analysis of the face,
      cephalometric study of the skull in lateral and posteroanterior cephalograms, analysis and
      surgical simulation of plaster casts mounted in semi-individual articulators, development of
      a surgical acrylic resin intermediate splint) and digital planning (cone-beam computed
      tomography, data acquisition, software-assisted virtual surgery -Maxilim; Medicim, Mechelen,
      Belgium- and CAD/CAM processing of the surgical intermediate splint).
    

Intervention name(s): classic procedure of planning; computer assisted orthognathic planning and surgery of asymmetric patients
Intervention type(s): Procedure; Procedure
Intervention description(s): analysis of pictures, 2D radiographs and aesthetics; model surgery and acrylic splint
Other intervention name(s): CBCT, data acquisition and processing; virtual surgery and CAD/CAM intermediate splint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: computer-assisted orthognathic surgery; facial asymmetry
Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease of abnormal carbohydrate
      metabolism which is related with high morbidity and mortality rates caused by its
      complications. One of the major diabetes-related arterial phenotypes thought to be
      responsible for development of cardiovascular disease is endothelial dysfunction. Nitric
      oxide (NO) is a potent molecule derived of endothelium, which plays key role in control of
      vascular tone. In T2DM present endothelial dysfunction due to reduced NO bioavailability.
      Fish protein hydrolysates (FPH) have been showed to present antioxidant peptides (and high
      value of ACE inhibition activity. Therefore, the present study aimed to examine whether
      single dose of FPH ingestion would reversal macro- and microvascular endothelial dysfunction
      in T2DM.
    


Intervention name(s): Placebo; Fish protein hydrolysates
Intervention type(s): Other; Other
Intervention description(s): 5g of the sucralose administered as white plastic capsules; 5g of the FPH dissolving in 100 mL of water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vascular function; Type 2 diabetes mellitus; Fish protein hydrolysates
Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer
Condition: Small Cell Lung Carcinoma
MeSH terms: Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen
      etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly
      diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).
    


Intervention name(s): Etoposide + cisplatin; Irinotecan + cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle; irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle
Intervention MeSH terms: Cisplatin; Irinotecan; Etoposide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
Condition: Foramen Ovale, Patent
MeSH terms: Ischemic Attack, Transient; Ischemic Stroke; Foramen Ovale, Patent
Study type: Interventional

Summary: 
      The primary objective of this study is to demonstrate the safety and efficacy of the PFX
      Closure System when utilized for patent foramen ovale (PFO) in patients suffering from
      cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief
      neurological dysfunction), migraine or decompression illness.
    

Detailed description: 
      Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic
      stroke, transient ischemic attack, and right to left gas embolism in severe decompression
      illness. An association between patent foramen ovale and severe migraine headaches has also
      been reported. Several implantable devices are being used for percutaneous closure of patent
      foramen ovale; we propose to use a non-implantable system to safely effect closure.
    

Intervention name(s): PFX Closure System
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Subcutaneously CM310/Placebo in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CROWNS-1)
Condition: Chronic Rhinosinusitis (Diagnosis); Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the
      efficacy, safety, PK, PD and immumogenicity of CM310 in comparison to placebo in addition to
      a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic
      rhinosinusitis with nasal polyposis (CRSwNP).
    

Detailed description: 
      The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind
      Treatment Period (16 weeks, till End-of-Treatment Visit) and a Safety Follow-up Period (8
      weeks, till End-of-Study Visit).

      56 patients who meet eligibility criteria will be randomized 1:1 to receive either CM310
      300mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All
      patients will receive MFNS on a daily basis as a background treatment throughout the study.
      MFNS is required to use no less than 14 days during Screening/run-in Period.

      Central reading will be implemented to nasal endoscopic nasal polyp score (NPS) , CT scans to
      Lund-Mackay score and volume of the involved area of nasosinusitis on 3D-construction images,
      and nasal polyp biopsy tissue analysis to eosinophil counts & percentage.
    

Intervention name(s): CM310; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 300 mg every two weeks; 300 mg every two weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Rhinosinusitis with Nasal Polyps
Enhancing Uptake of Family Planning Services by HIV-Infected Women Attending the PMTCT Program
Condition: Contraception
Study type: Interventional

Summary: 
      A specific organized program utilizing peers in the PMTCT clinic who provide family planning
      information and support to HIV infected mothers was compared to providing standard family
      planning messages currently used in the clinic.
    

Detailed description: 
      A planned group education structural intervention utilizing peers in the PMTCT clinic who
      provide family planning information and support to HIV infected mothers was compared to the
      standard of care which consisted of providing standard family planning messages to women
      attending the PMTCT Clinic. The study had two phases.

      The Formative Phase consisted of six focus group discussions and six in depth interviews.

      In the Implementation Phase, patient attendance and family planning uptake summaries for
      during implementation were monitored and summarized daily. Weekly average summaries were
      considered as time points.
    

Intervention name(s): Group Education
Intervention type(s): Behavioral
Intervention description(s): Structured group education on family planning facilitated by Peer Champions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV; PMTCT
Visuo-Tactile Integration and Body Ownership in the Human Brain
Condition: Behavior and Behavior Mechanisms; Body Representation
Study type: Interventional

Summary: 
      The present project exploits brain imaging and neuroscience robotics to investigate the role
      of quantifiable visual input on the relationship between visuo-tactile integration and body
      ownership (the feeling that "this" body belongs to "me").
    

Detailed description: 
      Observational study, fundamental research, multicentric, national. The analysis of
      questionnaires, self-reports, and brain imaging associated with the RHI is used to understand
      the influence of visual input on body ownership. To this aim, participants lay down in the
      magnetic resonance (MR) scanner (Figure 1B), are presented with visual stimuli (videos of the
      virtual rubber hand - visual stroking) simultaneously in real time with tactile stimuli
      (robotic stroking of the participant's hand - tactile stroking), and in combination or not
      with the measurement of autonomic arousal (GSR) associated with the observation of a video
      showing the virtual rubber hand in a threatening situation (e.g. a knife approaching the
      virtual hand - unconscious RHI effects). By means of structured questionnaires and
      semi-structured self-reports, participants (i) evaluate eventual sensations felt during the
      visuo-tactile stimulation and (ii) report the personal feelings and impressions about body
      ownership for the virtual rubber hand (conscious RHI effects).
    

Intervention name(s): Visuo-tactile stimulations of the right hand
Intervention type(s): Behavioral
Intervention description(s): Participants lay down in the magnetic resonance (MR) scanner are presented with visual stimuli (videos of the virtual rubber hand - visual stroking) simultaneously in real time with tactile stimuli (robotic stroking of the participant's hand - tactile stroking). An MR-compatible robot systematically provides the tactile stroking on the participant's hand. MR-compatible goggles show the visual stroking. Patterns of long and short robotic movements will be provided.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Oral Morphine Versus Ibuprofen
Condition: Upper Extremity Fractures; Analgesia Post Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or
      ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine
      as needed for pain relief for the first 24 hours following discharge from the emergency
      department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We
      hypothesize that oral morphine will result in greater pain relief than ibuprofen.
    


Intervention name(s): Oral morphine; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours; Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department
Intervention MeSH terms: Ibuprofen; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fracture; pediatric; oral morphine; ibuprofen