bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery
Condition: Tachycardia; Hypertension; Myocardial Ischemia
MeSH terms: Tachycardia; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      It was hypothesized that the use of esmolol as an alternative to remifentanil with
      sevoflurane inhalation anesthesia during intracranial surgery, could provide better
      hemodynamic conditions and cause lesser side effects in the perioperative period. It was the
      main objective of this study to compare the effect of esmolol and remifentanil on the
      incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The
      comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes
      were the secondary objectives.
    

Detailed description: 
      During neurosurgical procedures intubation, insertion of the head pins, extubation and the
      early postoperative period are the time lines in which cerebral autoregulation can be
      impaired by changes in heart rate and blood pressure. Several anesthetic regimens have been
      implied to overcome this problem. Remifentanil is used in neurosurgery since it allows early
      recovery and neurologic evaluation. Esmolol on the other hand is also very short acting,
      effective to blunt cardiovascular responses during surgery and has no significant effect on
      intracranial pressure and cerebral blood flow. In addition esmolol is addressed to reduce
      perioperative ischemia during noncardiac surgery.

      It was hypothesized that the use of esmolol as an alternative to remifentanil with
      sevoflurane inhalation anesthesia during intracranial surgery, could provide better
      hemodynamic conditions and cause lesser side effects in the perioperative period. It was the
      main objective of this study to compare the effect of esmolol and remifentanil on the
      incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The
      comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes
      were the secondary objectives.
    

Intervention name(s): Esmolol; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Esmolol 50 mcg/kg/min; Remifentanil 0.5 mcg/kg/min
Other intervention name(s): Brevibloc; Ultiva
Intervention MeSH terms: Remifentanil; Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Remifentanil; Esmolol; Intracranial surgery; Heart rate; Blood pressure
Onnit Labs New Mood Supplementation in Healthy College Students
Condition: Mental Health Wellness 1
Study type: Interventional

Summary: 
      The primary purpose of this study is to assess the effectiveness of ONNIT Lab's New Mood™
      dietary supplement in supporting optimal mood balance and reducing daily stress among
      collegiate-aged men and women. To be considered for this study, the participant must meet the
      following criteria: (1) current undergraduate student at the University of Idaho between
      18-24 years of age, (2) have no known allergies to the ingredients of New Mood™ (Niacin,
      Vitamin B6, Magnesium, Valerian Extract, Lemon Balm Extract, L-Tryptophan.
      5-Hydroxytryptophan, and Inositol) or the placebo (rice bran and maltodextrin), (3) not
      currently taking any mood/sleep supplementation or medications, (4) not currently seeking
      therapy or diagnosed with a psychological disorder, (5) not regularly using cigarettes,
      marijuana, or other illicit drugs, and (6) not pregnant or breastfeeding.
    


Intervention name(s): Multi-Ingredient Herbal Supplement; Placebo Supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Weeks 0-2 all participants consumed a placebo lead-in period and weeks 2-6 were intervention weeks. Throughout the 8 weeks (2 weeks placebo lead-in and 6 weeks intervention) participants were asked to consume 2 capsules (multi-ingredient supplement) upon waking in the morning and 2 capsules (multi-ingredient supplement) before bed.; Weeks 0-8 all participants consumed a placebo. Throughout the 8 weeks participants were asked to consume 2 capsules (placebo) upon waking in the morning and 2 capsules (placebo) before bed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: cortisol; mood
Bone Graft in Aseptic Subtrochanteric Nonunion
Condition: Subtrochanteric Nonunion
Study type: Observational

Summary: 
      This study aimed to compare the radiologic results between closed nailing without bone graft
      (BG) and open nailing with BG for subtrochanteric nonunion and to determine when open BG
      should be considered.
    

Detailed description: 
      In this retrospective study, we investigated the patients who underwent surgical intervention
      for subtrochanteric nonunion between January 2008 and March 2018 in two institutions. The
      cases with infection, large bone defect, pathologic fracture, open fracture, previous surgery
      using plate, and follow-up less than 1 year were excluded. We compared the demographic
      details and radiologic results between patients who underwent the open procedure with BG (BG
      group) and the closed procedure without BG (non-BG group) as a historical control, and risk
      factors for the failure of revision surgery were evaluated.
    

Intervention name(s): Revision surgery with / without open bone graft
Intervention type(s): Procedure
Intervention description(s): Removal of previous implant and re-alignment and re-fixation using intramedullary nail with (bone graft group) / without (non bone graft group) open bone graft
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who visited our institutions for surgical treatment of subtrochanteric nonunion
        and underwent surgical intervention in the institutions.
      
Keywords: subtrochanteric nonunion; intramedullary nail; bone graft
A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients
Condition: Non-Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in
      comparison to docetaxel for the treatment of unresectable non-small cell lung cancer
      (NSCLC)patients
    

Detailed description: 
      A randomized-controlled, three-arm, phase II study of lurbinectedin (PM01183) alone or in
      combination with gemcitabine and a control arm with docetaxel as second-line treatment in
      unresectable non-small cell lung cancer (NSCLC)patients to evaluate the antitumor activity as
      progression-free survival at four months (PFS4) of PM01183 alone or in combination with
      gemcitabine as using single agent docetaxel as a reference in the control arm as current
      standard of care and to analyze overall survival (OS), overall survival rate at 1-year
      (OS12), duration of response (DR), antitumor activity, as response rate (RR), safety and
      efficacy profiles of PM01183 alone and in combination with gemcitabine, to be preliminary
      compared with docetaxel, patients' quality of life (QoL), pharmacokinetics (PK) of PM01183,
      pharmacokinetic/pharmacodynamic (PK/PD)correlation and pharmacogenomics (PGx)to explore
      potential correlations between clinical outcomes and molecular parameters found in tumor and
      blood samples
    

Intervention name(s): Docetaxel; Gemcitabine; Lurbinectedin (PM01183)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Powder for solution for infusion; Powder for solution for infusion; Powder for concentrate for solution for infusion
Intervention MeSH terms: Gemcitabine; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of TG103 Injection in Overweight/Obese Subjects Without Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the safety and tolerability of multiple doses of
      TG103 injection in overweight/obese subjects without diabetes
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, multiple-doses, parallel-group
      study to characterize the safety (including the anti-drug antibodies (ADA)), tolerability,
      pharmacokinetics (PK) and pharmacodynamics (PD) of TG103 injection. The study will consist of
      3 periods: an approximately 4-week screening period, followed by a 12-week treatment period,
      and a 3-week safety follow-up period. Eligible subjects will be enrolled into three
      paralleled dose groups (15 mg, 22.5 mg and 30 mg) with 16 subjects in each group. Within each
      group, subjects will be randomized in a 3:1 ratio to receive TG103 injection or placebo
      subcutaneously (SC) once a week (QW) over a period of 12 weeks. Each group will be started at
      a low dose of 7.5 mg and gradually up-titrated at weekly intervals until the target dose.
    

Intervention name(s): TG103 injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TG103 injection, SC, once weekly; Placebo control, SC, once weekly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis
Condition: Kidney Diseases; Lupus Nephritis; Tacrolimus; Induction Phase; Maintenance Phase
MeSH terms: Kidney Diseases; Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous
      cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V).

      To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy
      of LN(III,IV,V).
    


Intervention name(s): tacrolimus (FK506); cyclophosphamide or azathioprine
Intervention type(s): Drug; Drug
Intervention description(s): Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;; Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.
Intervention MeSH terms: Cyclophosphamide; Azathioprine; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; lupus nephritis
Effectiveness of Chest Physiotherapy in Infants With Acute Viral Bronchiolitis
Condition: Viral Bronchiolitis
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Study type: Interventional

Summary: 
      The purpose of this study is to verify the effectiveness of chest physiotherapy (actual
      versus conventional) on respiratory distress in infants with acute viral bronchiolitis.
    

Detailed description: 
      The infants were random in three groups: Conventional techniques, actual techniques and
      suction of upper airways On the first two groups the infants were evaluated on
      admission,48,72hours and before hospital discharge. On third group was evaluated only on
      admission when SRV was collected.

      Respiratory distress was evaluated with Wang's score by the physiotherapists and nurses not
      participating in the research.
    

Intervention name(s): Chest physiotherapy - Conventional; Chest physiotherapy - actual techniques; 3-Airway suction
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Percussion Postural Drainage and thorax compression; Slow prolonged expiration and clearance rhinopharynx retrograde; Airway suction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Chest physiotherapy
M0001 Effects on Oral Contraceptive Plasma Levels
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, two-way cross-over drug-drug interaction Phase I trial.

      The objectives of this phase I trial are to investigate in healthy female subjects:

        -  the effect of prucalopride on the absorption of ethinylestradiol and norethisterone
           acetate, the active constituents of several oral contraceptives, after the first dose of
           prucalopride.

        -  the effect of multiple oral dosing of 2 mg prucalopride, for 6 days o.d. (steady state),
           on the pharmacokinetics of ethinylestradiol and norethisterone acetate.

      This trial will be conducted in healthy females of child bearing potential, i.e. females aged
      between 18 and 45 years (pre-menopausal).
    


Intervention name(s): prucalopride
Intervention type(s): Drug
Intervention description(s): prucalopride 2 mg oral dosing o.d. for 6 days
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SENSIMED Triggerfish
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The purpose of the investigation is to investigate the relationship between the study device
      output and tonometric assessments.
    

Detailed description: 
      60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8
      device groups of 6 subjects each or into the control group containing 12 subjects. Patients
      in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with
      SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all
      patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During
      SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be
      taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP
      measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the
      control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours
      in both eyes.
    

Intervention name(s): SENSIMED Triggerfish; Tonometer
Intervention type(s): Device; Device
Intervention description(s): Soft contact lens-based device for the continuous monitoring of IOP fluctuations; Tonometric assessment of IOP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
Condition: INSOMNIA
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to determine whether eszopiclone (Eurofarma) is
      non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of
      insomnia.
    

Detailed description: 
      The primary objective of the study is to determine whether eszopiclone (Eurofarma) is
      non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of
      insomnia. To that end, the latency to persistent sleep (LPS) will be used as a primary
      endpoint at the end of the treatment, measured by polysomnography.

      The secondary objectives and endpoints of this study are as follows:

        -  To evaluate the efficiency of eszopiclone compared to zopiclone by means of the
           patient's clinical history, using as secondary endpoints:

        -  Variables of the sleep diary of the Associação Fundo de Incentivo à Psicofarmacologia
           (see Appendix A), namely:

        -  Latency time to the beginning of the sleep;

        -  Frequency of night wake-ups;

        -  Time awake during bedtime;

        -  Early morning awakening;

        -  Total time in bed;

        -  Sleep efficiency;

        -  Sleep variables measured by actigraph;

        -  Insomnia Severity Index (see Appendix B);45

        -  Pittsburgh Sleep Quality Index (see Appendix C);46

        -  To evaluate the safety of eszopiclone compared to zopiclone by means of adverse events
           in each study arm.
    

Intervention name(s): Eszopiclone; Zopiclone
Intervention type(s): Drug; Drug
Intervention description(s): Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment); Zopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
Intervention MeSH terms: Eszopiclone; Zopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: INSOMNIA; FOR THE TREATMENT OF INSOMNIA
Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite all efforts, malaria remains a public health concern, in particular in the Democratic
      Republic of the Congo (DRC). The National Malaria Control program recommends
      artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or
      artemether-lumefrantrine for the treatment of uncomplicated malaria. Previous studies
      indicated that ACTs are still effective, with efficacy above the required threshold of 90%.
      It is required to assess regularly the efficacy of antimalarial drugs. I In case of
      increasing failure rates, alternative options can be decided ontime.

      The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ
      Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 in the treatment of
      uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.
    

Detailed description: 
      This is a phase IV, randomized, open label, 2-arm trial. It will be performed in six malaria
      sentinel site around the Democratic Republic of the Congo. Children aged 6 to 59 months with
      confirmed Plasmodium falciparum uncomplicated malaria will be enrolled after informed consent
      granted by a parent or guardian. They will be randomized to receive either
      artesunate-amodiaquine or artemether lumefrantrine during 3 days (directly observed
      treatment) and then followed up until day 28. At each visit, clinical examination will be
      done and malaria testing as well. Hemoglobin level will be measured on recruitment day and
      then every two weeks until day 28.
    

Intervention name(s): Artesunate-amodiaquine; Artemether-lumefantrine
Intervention type(s): Drug; Drug
Intervention description(s): Artemisinin-based combination treatment; Artemisinin-based combination treatment
Other intervention name(s): ASAQ Winthrop®; Coartem dispersible®
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Reminding to Improve Medication Adherence in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study is being done to look at how people manage their heart failure. The investigators
      are testing two medication reminder systems and the investigators want to know which one
      people like better. The investigators also want to see if they have any effect on ease of
      managing medication in individuals with heart failure.
    

Detailed description: 
      A pilot and feasibility randomized trial of two medication reminder systems for patients with
      heart failure (HF). The investigators believe that medication reminder systems will improve
      adherence and will reduce the effects of cognitive impairment on medication adherence. The
      investigators believe that patients will accept and use a medication reminder system, but the
      investigators cannot specify which system will be preferred. Each has different features
      which may be perceived as more or less desirable.

      The investigators will enroll 60 patients with HF and randomize them to four conditions in a
      2 (device 1 versus device 2) by 2 (Active versus Passive) design. After enrollment in the
      trial, patients will be consented and will complete pretesting at Summa Health System in the
      Center for Clinical Trials. They will primarily undergo brief computerized cognitive testing,
      complete self-report measures (e.g., quality of life, depression, self-management related
      social support), and will give consent for medical information to be collected from their
      electronic medical record. They will then be randomized to condition. In-home training will
      be provided regarding how to use the equipment. Medication adherence will be monitored for 28
      days, followed by an in-home post-test (all pre-test measures) during which the equipment is
      returned.
    

Intervention name(s): iPhone or pillbox; Non-reminding
Intervention type(s): Device; Behavioral
Intervention description(s): People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.; As a comparison, the devices will collect medication taking information without providing reminders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Heart Failure