bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy
      to an assigned open label antidepressant therapy (ADT) in the proposed subject population
      with MDD.
    

Detailed description: 
      This is a trial designed to assess the safety and efficacy of brexpiprazole (flexible dose)
      as adjunctive therapy to an assigned known anti-depressant in depressed subjects. The trial
      consists of a continuous 18-week double-blind treatment period with a 30-day follow-up.
      Subjects who complete all trial visits through the Week 18 visit may be offered entry into an
      optional open-label rollover trial.
    

Intervention name(s): Brexpiprazole; Seroquel XR; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet/capsule; tablet/capsule; tablet/capsule
Other intervention name(s): OPC-34712
Intervention MeSH terms: Quetiapine Fumarate; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment
A Study of DLX105-DMP in Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Pilot, Open-Label Study in Subjects with Mild-to-Moderate Plaque Psoriasis to Investigate
      the Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of
      DLX105-DMP Administered to a Target Lesion
    


Intervention name(s): DLX105-DMP
Intervention type(s): Drug
Intervention description(s): 1mg applied to target lesion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Compare between the analgesic efficacy of diclofenac sodium and ketorolac tromethamine in
      post-tonsillectomy pain management.and Compare between the effect of diclofenac sodium and
      ketorolac tromethamine on post-tonsillectomy bleeding
    

Detailed description: 
      patients will be randomly allocated to two groups of 50 patients each Group (A): will receive
      intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously.

      Group (B): will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg
      intravenously.

      Then the two groups will continue postoperatively on the same drug received intra-operative

      I. Intra-operative data:

      Bleeding score will be assessed by the surgeon at the end of the operation using the
      following Scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding
      more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous).

      II. Early Post-operative data:

        1. Post- tonsillectomy bleeding assessments;

             -  Bleeding score will be recorded immediately postoperative and 3, 6, 12 and 24h
                postoperatively.

             -  Hospital re-admission because of bleeding.

             -  Re-operation because of bleeding.

        2. Post- tonsillectomy pain assessments; Pain intensity will be assessed postoperatively by
           the verbal rating scale (VRS; 0 = no pain, 1 = mild pain, 2 = moderate pain, 3= severe
           pain, and lastly 4= excruciating pain). VRS assessment will be performed immediately
           postoperative and 3, 6, 12 and 24h postoperatively. Analgesia will be given if requested
           or if the VRS≥3. Patients in Group A will receive diclofenac sodium 0.3 mg/kg iv, while
           patients in Group B will receive ketorolac tromethamine 0.5 mg/kg.

      The total consumption of analgesics used in each group in the first 24 h postoperative will
      be calculated and the time of the first request for analgesia will be recorded.

      - Time needed to restore normal dietary habits.

      IV. Late Post-operative data:

      As aweekly follow up for 2 weeks :

        1. bleeding tendency

        2. Dysphagia.

             -  Time needed to restore normal dietary habits
    

Intervention name(s): diclofenac; ketorolac
Intervention type(s): Drug; Drug
Intervention description(s): non steroidal anti-inflammatory drug; non steroidal anti-inflammatory drug
Other intervention name(s): Voltaren; Tromethamine
Intervention MeSH terms: Diclofenac; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tonsillectomy; post operative analgesia; diklofanic; ketorolac
Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach
Condition: Hernia, Inguinal; Chronic Pain
MeSH terms: Chronic Pain; Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      The objective of this study is to evaluate chronic pain after inguinal hernia repair
      involving mesh placement with the Onstep-technique compared to mesh placement using a
      laparoscopic approach. The study hypothesis is that an even or smaller proportions of
      patients operated the Onstep technique will have chronic pain that impairs daily function.
    


Intervention name(s): Onstep; Laparoscopic repair
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hernia, Inguinal; Laparoscopy; Onstep
Efficacy and Safety of NFC-1 in Adolescents With Genetic Disorders Impacting mGluR and ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Genetic Diseases, Inborn; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel-group study of NFC-1 versus
      placebo in adolescents with ADHD who have genetic disorders impacting mGluRs.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group study of adolescents
      with ADHD who have genetic disorders impacting mGluRs. Approximately 90 subjects will receive
      randomized treatment with NFC-1 or placebo. Dosing will be optimized during the first 4 weeks
      of treatment, based on clinical response and tolerability, and maintained for an additional 2
      weeks.
    

Intervention name(s): NFC-1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NFC-1 is supplied as size 2 hard gelatin capsules.; Matching placebo capsules
Other intervention name(s): NFC1; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial of Weaning of Nasal Continuous Positive Airway Pressure (CPAP)
Condition: Preterm Neonates
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or
      less
    

Detailed description: 
      Objective: To study the weight and the post menstrual age (PMA) at the time of nasal CPAP
      (NCPAP) wean utilizing the method of sudden wean as compared to gradual wean. . Methods: A
      prospective randomized trial was conducted comparing sudden weaning with gradual weaning from
      NCPAP in neonates with gestational age (GA) <32 weeks. The patients were randomized to one of
      the two methods of weaning from NCPAP and their success was compared.
    

Intervention name(s): Gradual weaning from Nasal CPAP in preterm neonates
Intervention type(s): Procedure
Intervention description(s): Nasal CPAP for gradual wean group it was cycled off for 3 hours alternating with 3 hours on for first 48 hours, if successful the cycle was extended to 6 hours off and 3 hours on for the next 48 hours. If the baby tolerated this regime the prongs were removed and CPAP was kept off.
Other intervention name(s): Nasal CPAP; Weaning; Preterm neonates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neonatal; Nasal CPAP; Randomized controlled trial; Weaning
Feasibility Study Focusing on Fit of Made-to-measure Compression Garments in Healthy Subjects
Condition: Product Use Issue
Study type: Interventional

Summary: 
      Fit of made-to-measure compression garments in healthy subjects will be tested on one day,
      simulating daily activities.
    

Detailed description: 
      Lower and upper extremities of 36 health subjects will be measured be trained experts to
      collect measures for made-to-measure compression garments.

      Fit of made-to-measure compression garments, which are not on the market yet, among healthy
      subjects will be tested on one day, simulating daily activities. Fit will be assessed
      directly after donning and after a wearing period of maximum 7 hours at the study site by
      trained experts. Healthy subjects will give back study products at the end of the wearing
      period. AEs will be documented throughout the study.
    

Intervention name(s): Made-to-measure compression garment
Intervention type(s): Device
Intervention description(s): Made-to-measure compression garment
Intervention model: Single Group Assignment
Intervention model description: Healthy subjects will test made-to-measure compression garments. No comparator group due to exploartive design
Masking: None (Open Label)
Primary purpose: Other
A Study of CSL112 in Healthy Adults and in Adults With Moderate Renal Impairment
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 multicenter, randomized, double-blind, placebo-controlled, ascending dose
      study to investigate the pharmacokinetics (PK), safety, and tolerability of CSL112 in adult
      subjects with moderate renal impairment and in healthy adult subjects with normal renal
      function.
    


Intervention name(s): CSL112; Placebo
Intervention type(s): Biological; Other
Intervention description(s): CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.; 0.9% weight/volume sodium chloride solution (ie, normal saline)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients
Condition: Gastric Distention
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high
      flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations
      of oxygen via nasal cavity.

      The purpose of this study is to investigate the effect of HFNO on gastric insufflation in
      paralyzed anesthetized patients undergoing laryngologic surgery.
    

Detailed description: 
      HFNO can be used during intraoperative period. HFNO reduces the risk of desaturation and
      prolongs the safe apnea time, compared with conventional oxygenation.

      In laryngeal microsurgery, HFNO therapy make possible to perform tubeless anesthesia,
      providing perfect exposure of structure of the vocal cords.

      HFNO have a risk for low level of positive pressure can make gastric distension, but gastric
      reflux or aspiration were not occurred during rapid sequence induction for emergency
      operation.

      The purpose of this study is to investigate the effect of HFNO on gastric insufflation in
      paralyzed anesthetized patients undergoing laryngologic surgery.
    

Intervention name(s): THRIVE
Intervention type(s): Device
Intervention description(s): Patients will receive HFNO therapy during laryngomicrosurgery. Patients will undergo a gastric ultrasound examination after HFNO therapy.
Other intervention name(s): Optiflow
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a
      primary hypothesis of comparing the handling of each lens. Additional secondary markers are
      measured looking at subjective comfort and vision of the lenses.
    


Intervention name(s): delefilcon A; etafilcon A
Intervention type(s): Device; Device
Intervention description(s): Daily wear soft contact lens for bilateral distance vision correction use.; Daily wear soft contact lens for bilateral distance vision correction use.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Colorectal Polyp Resection Adequacy
Condition: Polyp Resection Adequacy
MeSH terms: Polyps
Study type: Observational

Summary: 
      The purpose of this study is to determine the best way to ensure that polyps are completely
      removed by evaluating the borders of the removed polyp. If a polyp is found that meets the
      size requirements for the study, the investigators will take extra biopsies of the margin to
      determine if there is any abnormal tissue or cancer at these borders.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults aged 40 to 80 who are undergoing screening or surveillance colonoscopy for
        colorectal adenomatous polyps.
      
Biospecimen description: 
      Polyp margins will be biopsied and retained.
    
Keywords: Colorectal Cancer Screening; Colon Cancer Screening; Polyps; Colonoscopy
Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to find out if bone marrow treatment (bone marrow
      aspiration and infusion of stem cells) can be safely used in adults who have recently (within
      24-72 hours)suffered an acute ischemic stroke.
    

Detailed description: 
      Our primary hypothesis is that autologous bone marrow mononuclear cell transplantation by
      intravenous administration is feasible and safe after acute ischemic stroke. Our secondary
      hypothesis is that autologous transplantation is associated with improved outcome after acute
      stroke.
    

Intervention name(s): Autologous Bone Marrow Mononuclear Cells
Intervention type(s): Biological
Intervention description(s): Harvest of bone marrow from ischemic stroke patients, isolation of bone marrow mono-nuclear cells, and peripheral IV infusion of autologous bone marrow mono-nuclear cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be
      compared when given either intrathecally or epidurally in primiparous parturients during
      early phase of the labour.
    


Intervention name(s): Spinal analgesia for labour pain; Epidural analgesia for labour pain
Intervention type(s): Drug; Drug
Intervention description(s): Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique; Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
Other intervention name(s): labor epidural; labour epidural
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Socio-aesthetic Intervention on Body Image and Quality of Life in Women With Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The aim of this study is to evaluate the impact of a socio-aesthetic intervention on body
      image and quality of life in post-surgical patients with mastectomy or tumorectomy for breast
      cancer.Two groups of randomized subjects were constituted. Patients of the experimental group
      received 2 or 3 aesthetic care during the first post-surgical week, whereas those of the
      control group not. Body image, quality of life and diverse other personality variables were
      assessed at three different times: surgical operation day before, exit day before of
      hospitalization and three months afterwards. Our general hypothesis is that subjects who
      receive aesthetic care report levels significantly higher of corporal satisfaction and of
      quality of life at the end of the hospitalization and three months later than patients of the
      control group.
    


Intervention name(s): Aesthetic care
Intervention type(s): Behavioral
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Breast cancer
      
Keywords: Aesthetic care,; Mastectomy,; Breast cancer,; Quality of life,; Body image,; Psychological adjustment
Memantine and Cognitive Dysfunction in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see whether memantine improves memory function in
      participants with bipolar disorder who have minimal symptoms. Secondary analyses will test
      the role of memantine in improving residual mood symptoms (depression and mania) in
      participants with bipolar disorder.

      We hypothesize that in participants with bipolar disorder who have minimal symptoms memantine
      will be effective in improving cognitive functions, as measured by the difference in
      neuropsychological test scores at the beginning and at the end of the trial.
    

Detailed description: 
      A large proportion of participants with bipolar disorder experience significant cognitive
      dysfunction, even when euthymic, after adequate treatment. The cognitive deficits in
      asymptomatic patients with bipolar disorder are very important for the participant's
      psychosocial function. In this population, cognitive deficits have been associated with poor
      psychosocial functioning, such as inability to hold a job. Memantine is a glutamate
      N-methyl-D-aspartate (NMDA) receptor antagonist which has shown efficacy in cognitive
      dysfunction due to moderate to severe Alzheimer disease.

      Demonstrating the role of memantine in reducing cognitive dysfunction in minimally
      symptomatic participants with bipolar disorder promises to provide important clinical
      information, which could lead to improvements in well-being and functional status for large
      populations of participants with bipolar disorder.
    

Intervention name(s): Memantine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Week 0: 5 mg memantine or placebo once a day (q.d.) Week 1: 5 mg memantine or placebo twice a day (b.i.d.) Week 2-3: 5 mg memantine or placebo once in the morning (q.a.m.)/10 mg once in the evening (q.p.m.) Week 4-12: 10mg Memantine or placebo b.i.d.; Inactive comparator. Placebo-matching memantine tablet.
Other intervention name(s): Namenda; Sugar pill
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar disorder; Cognitive dysfunction; Memantine; NMDA antagonist
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical
      response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER
      (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.
    


Intervention name(s): 60 mg/kg azithromycin ER; 30 mg/kg azithromycin IR
Intervention type(s): Drug; Drug
Intervention description(s): subjects taken 60 mg/kg azithromycin ER; subjects taken 30 mg/kg azithromycin IR (Immediate Release)
Other intervention name(s): Zithromax; Zithromax
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: azithromycin, pharmacokinetics, pediatrics
Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
Condition: Plantar Sensation; Balance; Distorted; Fall; Gait Disorders, Neurologic
MeSH terms: Nervous System Diseases; Gait Disorders, Neurologic; Schizophrenia
Study type: Interventional

Summary: 
      Cerebellar vermis anomalies are present in schizophrenic individuals. This condition leads to
      postural balance problems. Foot and ankle complex have a special role for maintaining
      balance. However, there is no study about this topic in schizophrenic individuals.
    


Intervention name(s): Correlation / Observational
Intervention type(s): Other
Intervention description(s): correlation between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Glooko mHealth Advantage Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to compare HbA1c of insulin-treated subjects with type 2
      diabetes managed via usual care alone and usual care augmented with remote monitoring using
      Glooko
    

Detailed description: 
      In this study, the investigator wants to evaluate if diabetes self-management supported by a
      mobile application, which captures a subject's blood glucose readings, lifestyle and
      medication information and shares it with the subject's certified diabetes educator (CDE) to
      enable remote monitoring, improves their glycemic control compared to standard of care.
    

Intervention name(s): Glooko's mobile application
Intervention type(s): Device
Intervention description(s): Standard of care and Remote monitoring
Other intervention name(s): Glooko's Population Tracker, Meter Sync Blue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glooko; Mobile health application; Insulin treated; Type 2 Diabetes; Remote patient monitoring; Certified diabetes educator; mHealth Advantage; Population health