bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc
Condition: Healthy Volunteers; Diabetes Mellitus, Type 2; Overweight; Obesity
MeSH terms: Overweight; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study in healthy men and women looks at the injection site experience of semaglutide and
      dulaglutide given subcutaneously (s.c., under the skin). Participants will receive 1 dose of
      semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day. The 2 injections will
      be given at least 30 minutes apart, one in each side of the stomach. Participants will be in
      the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5
      weeks after the injections were given.
    


Intervention name(s): Semaglutide; Dulaglutide
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.; Subjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.
    

Detailed description: 
      Prospective functional Magnetic Resonance Imaging study involving a group of participants
      with Mild Cognitive Impairment due to AD and a control participants group matched for age,
      education level, verbal Intelligence Quotient as assessed through the French version of the
      National Adult Reading Test and income group following National Institute of Statistics and
      Economics Studies classification.
    

Intervention name(s): Neuropsychological tests; A cranial MRI; Experimental procedure
Intervention type(s): Other; Device; Other
Intervention description(s): Scales and tests to evaluate:
Global cognitive performance
Handedness
Memory functions performance
Gestural praxis functions performance
Lexical and semantic functions performance
Executive functions performance
Memory disorders
Way of life
Mood
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI
Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax
Condition: Primary Spontaneous Pneumothorax
MeSH terms: Pneumothorax
Study type: Interventional
Phase: Phase 3

Summary: 
      For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb
      obliteration with pleural adhesive procedure is generally accepted as a standard. But
      additional pleurodesis is potentially useless procedure on the parietal pleura for treating
      visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural
      physiology and cause chronic pain. According to our previous study, stapling resection of the
      bulla without pleurodesis gave comparable result in recurrence comparing with articles with
      additional pleurodesis. The purpose of this study is to evaluate surgical outcome of
      thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure
      is essential in the management of PSP.
    


Intervention name(s): thoracoscopic surgery
Intervention type(s): Procedure
Intervention description(s): stapled wedge resection of the lung mechanical pleural abrasion
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pneumothorax, thoracoscopy, pleurodesis
Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
Condition: Dermatomyositis; Polymyositis
MeSH terms: Dermatomyositis; Polymyositis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of an active rehabilitation program on
      disability and quality of life of patients affected by dermatomyositis and polymyositis.
    

Detailed description: 
      Dermatomyositis (DM) and polymyositis (PM) are inflammatory disabling neuromuscular
      disorders. Despite partial benefit of pharmacological treatments, muscle strength, functional
      status and quality of life remain impaired. Although the use muscle exercises in (DM) and
      (PM) have been reported, its efficacy on disability and quality of life has not been proved.

      Te aim of the study is to evaluate the benefit at mid term (12 months) of an active
      rehabilitation program administrated to patients affected by PM and DM.

      Method: a 3 year prospective, multicentric, randomized controlled trial A program of 12
      individual exercise sessions (3 per week during 4 weeks) is compared to conventional care.
      Patients are followed 12 month after the inclusion.
    

Intervention name(s): Active rehabilitation
Intervention type(s): Other
Intervention description(s): A program of 12 individual exercise sessions (3 per week during 4 weeks)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: rehabilitation; exercise; efficacy; functional status
Docetaxel and Cetuximab in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some
      block the ability of tumor cells to grow and spread. Others find tumor cells and help kill
      them or carry tumor-killing substances to them. Cetuximab may also stop the growth of
      prostate cancer by blocking blood flow to the tumor. Giving docetaxel together with cetuximab
      may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with
      cetuximab and to see how well it works in treating patients with metastatic prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To assess the efficacy and safety of docetaxel and cetuximab in patients with
           docetaxel-resistant hormone-refractory prostate cancer

      OUTLINE: This is a multicenter study.

      Patients receive cetuximab IV once weekly and docetaxel IV on day 1 (3-week courses) or on
      days 1, 8, and 15 (4-week courses). Treatment repeats every 3 weeks for up to 8 courses or
      every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed at 4 weeks and then every 3 months
      thereafter.
    

Intervention name(s): cetuximab; docetaxel
Intervention type(s): Biological; Drug
Intervention description(s): Cetuximab: 400 mg/m2 initial dose on day 1, then 250 mg/m2 weekly starting on day 8
--- for max. 24 weeks or until progression or unacceptable toxicity ---; 75 mg/m2 day 1 of a 21 day cycle or 35 mg/m2 day 1,8,15 of a 28 day cycle
--- for max. 24 weeks or until progression or unacceptable toxicity ---
Other intervention name(s): Erbitux; Taxotere
Intervention MeSH terms: Docetaxel; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer
Promoting Intrafamily Accountability for Reducing Cellphone Use While Driving in Adults and Their Teen Children
Condition: Teen Drivers; Motor Vehicle Accidents
Study type: Interventional

Summary: 
      Research participants and their parents will be recruited to take part in a randomized
      control trial. Participants' and their parents' cellphone use will be observed during an
      initial baseline period. Participants and their parents will then be randomly assigned to one
      of two conditions: opt-out blocking with parental notification, opt-out blocking with
      bidirectional notification.
    

Detailed description: 
      In 2012, 3,328 people were killed and an additional 421,000 were injured in crashes involving
      a distracted driver. Adults aged greater than 40 years old accounted for 44% of these
      fatalities. Teen driving behavior is heavily influenced by parental driving behaviors with a
      recent study showing the proportion of teens that text while driving is 14% higher if they
      have observed their parents doing the same. The proportion of adults who text while driving
      has recently surpassed teen rates with a 2013 national poll finding 49% of adult car
      commuters admit to texting while driving, most stating that they did it out of habit. Based
      on previous findings, it is unlikely that teens will reduce their texting while driving
      unless their parents do the same.

      The objective of this study is to compare measures of acceptance and feasibility across
      teen-parent dyads randomized to bidirectional teen-parent (teen monitors parent and parent
      monitors teen) vs. teen only (parent monitors teen) cellphone use while driving.

      Research participants will be recruited to take part in a randomized control trial.
      Participants' cellphone use will be observed during an initial baseline period. Participants
      will be randomly assigned to one of two conditions (bidirectional teen-parent monitoring or
      parental monitoring of the teen only). An exit survey and interview will be administered to
      both the parent and teen separately at the end of the study.
    

Intervention name(s): CellControl
Intervention type(s): Device
Intervention description(s): Technology that blocks incoming and outgoing calls and texts. CellControl Drive ID will monitor all cellphone use while driving (without blocking) for 3 weeks during baseline measurement period. During the intervention period (5 weeks) cellphone use will be monitored and blocking of incoming calls and texts will be active.
Other intervention name(s): DriveID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Driving; Teens; Texting; Cellphone; DriveID; Motor vehicle accident
Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil
Condition: Anesthesia
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is designed to quantify the pharmacodynamic (PD) and pharmacokinetic (PK)
      interaction(s) between an anaesthetic drug (remimazolam) and an opioid (remifentanil).
      Remimazolam is a new anaesthetic drug with a sedative effect, which, in combination with an
      opioid can be used to achieve general anaesthesia. To date, however, no clinical trials have
      been conducted to specifically assess the potential for drug-drug interactions between
      remimazolam and remifentanil. Greater understanding of the potential for such interactions
      will help define more appropriate dosing regimens with less over-sedation and associated side
      effects.
    


Intervention name(s): Remimazolam; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Remimazolam is an intravenous anaesthetic and sedative drug. Remimazolam exhibits its anaesthetic effects via the benzodiazepine binding site at the GABAA receptor.; Remifentanil is a commonly used opioid in anaesthetic practice. It is a potent and fast-acting analgesic.
Other intervention name(s): Byfavo, CNS7056; Ultiva
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible
      patients will receive open-label treatment with rivastigmine capsules plus memantine tablets
      as add on therapy. This study is designed to evaluate the safety and tolerability of add on
      therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)
    


Intervention name(s): Rivastigmine, memantine
Intervention type(s): Drug
Intervention MeSH terms: Memantine; Rivastigmine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dementia,; Alzheimer's,; Rivastigmine,; Memantine
Family Networks Project Study One: An Efficacy Study of Stepping Stones Triple P for Children Under Age Two
Condition: Prevent Child Maltreatment
Study type: Interventional

Summary: 
      The purpose of the project is to assess the initial efficacy of Stepping Stones Triple
      P-Positive Parenting Program (SSTP) with parents of children below age two with developmental
      disabilities to strengthen families and prevent child maltreatment.
    

Detailed description: 
      This study is an initial efficacy trial of SSTP for parents of children below age 2. The
      target population consists of 50 families of young children ages 11-23 months with
      developmental disabilities who are eligible to receive IDEA Part C (Individuals with
      Disabilities Education Act Part C) services in one region of South Carolina. Families will be
      randomly assigned to one of two conditions (1) IDEA Part C services as usual or (2) IDEA Part
      C services plus SSTP. Project goals are to strengthen parent competence, enhance parent
      confidence, and strengthen child social, emotional and behavioral functioning. Ultimately,
      this should result in a reduced likelihood of child maltreatment
    

Intervention name(s): Stepping Stones Triple P; BabyNet Services As usual
Intervention type(s): Behavioral; Other
Intervention description(s): 10-12 session manualized intervention delivered in client homes; BabyNet services as usual based on IFSP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention; evidence-based parenting intervention; children; disabilities; IDEA Part C; Stepping Stones Triple P
Study to Test Safety, Tolerability and Blood Levels of GSK971086 After 1 Dose & 7 Days of Dosing in Healthy Adult Males
Condition: Healthy Subjects; Androgen Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is the first administration of GSK971086 in humans. The purpose of this
      study is to assess the safety and tolerability of GSK971086, as well as, how much GSK971086
      is in your blood after different doses
    


Intervention name(s): placebo; GSK971086
Intervention type(s): Drug; Drug
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: SARM,; FTIH,; pharmacokinetics
Butorphanol in Pain Following Ablation for Hepatic Tumor
Condition: Visceral Pain; Microwave Ablation; Hepatic Tumor
MeSH terms: Liver Neoplasms; Visceral Pain
Study type: Interventional

Summary: 
      The objective of this investigation was to evaluate the influence of Butorphanol on
      postoperative pain mitigation in patients undergoing microwave ablation for hepatic tumor.
      Employing a rigorously designed multicentral, randomized, and placebo-controlled format,
      patients subjected to microwave ablation were assigned randomly to either Butorphanol
      (experimental group) or normal saline (control group). Primary outcomes encompassed
      intraoperative pain levels assessed through patient-driven evaluation utilizing a 10-point
      visual analog scale (VAS). Secondary outcomes included postoperative pain levels at the
      6-hour mark (VAS) and comprehensive pain assessment outcomes.
    


Intervention name(s): Butorphanol; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): The pharmacological attributes of Butorphanol, characterized by its mild impact on cardiopulmonary dynamics and demonstrated efficacy in attenuating mechanical traction-induced discomfort, culminate in an ameliorative effect on postoperative nausea and vomiting rates. Importantly, it substantively attenuates visceral postoperative pain. However, sedation can also cause dizziness, drowsiness, and other adverse reactions during recovery; normal saline contain 0.9% NaCl sodium.
Intervention MeSH terms: Butorphanol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Auditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW)
Condition: Procedural Anxiety; Procedural Pain; Adenotonsillitis
MeSH terms: Psychomotor Agitation; Pain, Procedural
Study type: Interventional

Summary: 
      Adenotonsillectomy (AT) is one of the most common pediatric surgical procedures. The
      management of postoperative pain and agitation after AT is still a controversial issue.
      Safety considerations limit the use of opioids and non-steroidal anti-inflammatory drugs,
      leading to inadequate control of the high levels of postoperative pain experienced by AT
      patients. Along with pain killers, non-pharmacological strategies have remarkable impact on
      pain management in children. A systematic review and meta-analysis published in The Lancet in
      2015 on adult patients suggest that auditory stimulation with music in the perioperative
      setting, and even when patients are under general anaesthesia, can reduce postoperative pain,
      anxiety, and analgesia needs. The authors concluded that there is sufficient evidence to
      implement auditory stimulation in the treatment of all adult surgical patients, regardless of
      the mode of administration. Up to now, no research has investigated the effects of
      intraoperative auditory stimulation on pain and agitation upon awakening after AT in the
      pediatric population. Objective of this study is to determine the effects of intraoperative
      auditory stimulation on pain and agitation upon awakening after pediatric AT.
    


Intervention name(s): Music; Mother's lap; Soundproof earplugs
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 45 dB SL, normalized, high-frequency sampled W.A. Mozart Symphony n°4 in D K19 and n°5 in B-flat K22 (from Mozart Symphonies Vol. I - Adam Fisher, Dacapo Records, Frederiksberg C., Denmark, 2013); 45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped; Disposable foam earplugs with a noise attenuation of at least 30 dB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Auditory stimulation; adenotonsillectomy; pain; agitation; awakening
Repeat Dose Safety and Efficacy Study for Compound to Treat Anemia
Condition: Kidney Disease
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to characterize the safety and efficacy of repeat doses of
      compound 1278863A in subjects with anemia.
    

Detailed description: 
      Compound 1278863A is a novel small molecule agent, which stimulates erythropoiesis through
      inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is
      being developed for the treatment of anemia. This study, PHI112844, will be the first
      administration of compound 1278863A to investigate the pharmacodynamics/efficacy, safety,
      tolerability, and pharmacokinetics of repeat oral doses in anemic pre-dialysis patients with
      moderate or severe renal impairment and in hemodialysis-dependent patients.
    

Intervention name(s): 1278863A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25mg, 50mg, 100mg; matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hemodialysis; tolerability; pharmacokinetics; safety; anemia; renal impairment; repeat dose
Effect of Low-Level Laser Therapy Following Direct Pulp Capping on Postoperative Sensitivity by Thermal Stimulus
Condition: Low-level Laser Therapy
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      The aim of this study was to investigate the effect of low-level laser therapy (LLLT) on
      postoperative pain provoked by thermal stimulation in direct pulp capping. All the patients
      who received consent form in this retrospective study were retrieved from the records of
      patients attended for routine dental treatment at the Ordu University, Faculty of Dentistry,
      Department of Endodontics between 01.10.2017-01.10.2018. Study subjects were recruited from
      the pool of patients who performed direct pulp capping by a single operator. A total of 123
      pre-treated teeth of 123 patients who referred to Ordu University, Faculty of Dentistry were
      examined. Follow-up examinations were carried out at postoperative 6th hours, 1st and 7th
      days with visual analog scale (VAS), and treatment outcome were assessed. Participants were
      allocated to the laser and control group which consist of 42 patients in each group. 6
      patients were excluded from the study due to missing data in both groups. Thus, data from 72
      patients who had been carried out direct pulp capping were assessed.
    


Intervention name(s): Low-level laser therapy
Intervention type(s): Device
Intervention description(s): The low-level laser was applied to each patient in low-level laser therapy group.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All the participants in this study were retrieved from the pool of patients who attended
        for routine treatment at the Department of Endodontics at the University Hospital of Ordu
        between October 2017 and October 2018. Those patients who had received DPC treatment by a
        single operator were selected.
      
Keywords: direct pulp capping; low level laser therapy; thermal stimulus; biostimulation