bioihbjkbjnl/mcl2 huggingface dataset:
Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade
Condition: Underdosing of Unspecified General Anesthetics
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: remifentanil's optimal dose for children intubation without neuromuscular
      blockade is unknown. Method: phase IV adaptative trial using Dixon's up-and-down method for
      modeling remifentanil's dose-response curve for adequate intubation conditions as defined by
      previous studies.
    

Detailed description: 
      Introduction: remifentanil's optimal dose for children intubation without neuromuscular
      blockade is unknown.

      Method: phase IV adaptative trial using Dixon's up-and-down method for modeling
      remifentanil's dose-response curve for adequate intubation conditions as defined by previous
      studies. Remifentanil doses starting from 2mg/kg will be infused before intubation. When a
      success occurs next patient's dose will be decreased by 0.25mg/kg/h. When a success does not
      occur the next patient's dose will be increased by 0.25mg/kg/h. Intubation will be considered
      adequate if patient does not cough, does not move, if vocal cords are open, if larigocsocpic
      Cormack grade I or II.
    

Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): Remifentanil for intubation without neuromuscular blockade
Other intervention name(s): Ultiva
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Remifentanil; Intubation; Children
The Pathogenesis of OSA in People Living With HIV
Condition: Obstructive Sleep Apnea; HIV/AIDS
MeSH terms: Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to help us understand how HIV and/or Anti-Retroviral Therapy
      (ART) may predispose individuals to Obstructive Sleep Apnea (OSA). The traditional risk
      factors for OSA are weight and age. However, people living with HIV on ART seem to have OSA
      even when they are thin and young. The study involves a detailed physiological sleep study
      and an MRI of the head and neck to understand the underlying cause of OSA in those with and
      without HIV.
    

Detailed description: 
      Participants who have sleep apnea and are using positive airway pressure (PAP) with and
      without HIV will be enrolled if they otherwise meet all the inclusion criteria, and none of
      the exclusion criteria.

      Subjects will undergo two overnight sleep studies (polysomnograms, PSGs) and a MRI scan of
      the upper airway. The first sleep study will evaluate the severity of sleep disordered
      breathing and will be identical to a clinical PSG. The second sleep study will measure the
      physiological traits most important for OSA, such as upper airway anatomy, control of
      breathing, sleep stability, and upper airway muscle activation. These measurements are
      performed while subjects sleep using PAP, but the PAP level is adjusted during the night, and
      the subject's response is measured. The MRI scan will be of the head and neck and will occur
      during the evening time. Subjects will be encouraged to sleep during this portion of the
      study, as well.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women with physician-diagnosed OSA who have been prescribed and are using positive
        airway pressure (e.g. CPAP). Also, men and women with physician-diagnosed HIV who achieved
        viral suppresion.
Vertical Bone Gain and Neurosensory Affection in Computer Guided vs Conventional Sandwich Osteotomy
Condition: Bone Loss
Study type: Interventional

Summary: 
      The aim of this study was to assess the efficiency of the computer-guided interpositional
      sandwich osteotomy for the vertical bone gain and effects on vital structures (inferior
      dental nerve bundle) compared to free hand interpositional osteotomies.
    

Detailed description: 
      in this research a full digital sandwich osteotomy protocol was conducted to be compared with
      the conventional protocol. the investigators were seeking to determine the significance of
      using surgical computer software in sandwich interpositional bone grafting at atrophied
      posterior mandibles and how efficiently can it affect this technique.
    

Intervention name(s): sandwich interpositional bone grafting computer guided; conventional interpositional bone grafting
Intervention type(s): Procedure; Procedure
Intervention description(s): performing the 2 vertical and the 1 horizontal osteotomies using a cutting patient specific guide and fixation of the vertically elevated bony segment after gap calculation using patient specific fixation guides; performing the conventional interpositional sandwich osteotomies free-hand and fixation of the mobilized bone segment free-hand
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor
      Administered Orally to Patients With Sickle Cell Disease
    

Detailed description: 
      This is a randomized, placebo-controlled, double blind, parallel group, multicenter study of
      participants, age 12 to 65 years, with SCD. The key purpose for the study is to establish
      efficacy and safety of voxelotor as compared with placebo.
    

Intervention name(s): voxelotor; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): GBT440
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Genes Associated With Hereditary and Drug-Induced Gingival Overgrowth
Condition: Gingival Overgrowth
MeSH terms: Gingival Overgrowth
Study type: Observational

Summary: 
      This study will examine common features of gingival overgrowth (excessive growth of the gums
      around the teeth) that develops in patients with the hereditary form of the condition and in
      those who develop the condition as a side effect of medications. A better understanding of
      gingival overgrowth may help scientists develop medications with fewer oral side effects.

      Patients of any age with hereditary gingival fibromatosis and their blood relatives, and
      patients of any age with gingival overgrowth who are taking medications associated with
      development of the disorder, including phenytoin (diphenylhydantoin or Dilantin),
      cyclosporine, and calcium-channel blockers, may be eligible for this study.

      Participants undergo a medical and dental history, including a history of medication use;
      detailed examination of the teeth, periodontium, head, and neck; photographs of teeth with
      gingival overgrowth; dental x-rays; and blood tests. DNA is extracted from a blood sample to
      look for genes related to gingival overgrowth.

      Patients with gingival overgrowth are offered two options, as follows:

        -  Tissue biopsy: A tissue sample is taken from each affected site, with a maximum of three
           biopsies. For the procedure, lidocaine is first injected into the gum to numb the
           tissue. Then, a cookie-cutter instrument is pushed into the numbed skin, and a small
           piece of tissue is removed.

        -  Gingivectomy: Surgical removal of the overgrown gingival.
    

Detailed description: 
      The purpose of this protocol is twofold: 1) to continue identification of genes associated
      with hereditary gingival fibromatosis (HGF), a type of gingival overgrowth 2) to investigate
      the genes up-regulated by medications that induce gingival overgrowth. These studies will
      establish if common mechanisms are involved in the hereditary and drug-induced processes. If
      a common pathway is identified, it could lead to the development of assays that could be used
      to screen new medications for their potential deleterious effects on periodontal tissues. In
      addition, understanding the mechanisms involved in gingival overgrowth could lead to the
      development of tissue engineering approaches to repair gingival defects. Genes will be
      identified from DNA samples collected from patients with hereditary gingival fibromatosis.
      These will be compared with DNA and tissue samples taken from patients taking medications
      known to induce gingival overgrowth (phenytoin, cyclosporine and calcium channel blockers).
    

Keywords: Periodontal Disease; Dilantin; Cyclosporin; Calcium-Channel Blockers; Genetics; Hereditary Gingival Fibromatosis; HGF; Gingival Overgrowth; Gum Overgrowth
Pharmacokinetic and Pharmacodynamic Profiles of Aliskiren in Japanese Patients With Mild to Moderate Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetic profile, the effect of rennin inhibition and the
      relationship among pharmacokinetics, renin-angiotensin system (RAS) biomarkers, and blood
      pressure lowering effects of oral doses of SPP100 in Japanese patients with mild to moderate
      essential hypertension. Safety will also be evaluated.
    


Intervention name(s): SPP100 (aliskiren)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pharmacokinetics, pharmacodynamics, safety, RAS profile, SPP100, aliskiren, Japanese, essential hypertension; Mild to moderate essential hypertension
Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BEA 2180 BR in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral
      doses of BEA 2180 BR
    


Intervention name(s): BEA 2180 BR - rising dose; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Safety and Efficacy of Single Therapy Versus Double and Triple Therapy of the Pellevé™ Wrinkle Treatment System for the Treatment of Moderate Facial Wrinkles
Condition: Appearance of Facial Wrinkles
MeSH terms: Facies
Study type: Interventional

Summary: 
      The study will enroll and treat a patients to assess improvement in the appearance of facial
      wrinkles.
    

Detailed description: 
      The study will enroll and treat a total of 44 subjects (23 in treatment Group A receiving a
      single treatment and 21 in treatment Group B receiving two treatments) with moderate facial
      wrinkles corresponding to a grade of 4-6 on the validated Fitzpatrick Wrinkle Assessment
      Scale.
    

Intervention name(s): Pelleve Wrinkle Treatment System
Intervention type(s): Device
Intervention description(s): comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: wrinkle; rhytide
Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms
Condition: Depressive Symptoms; Anxious Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      Emerging adults (EA; 18 to 29 years old) in Canada are among the age group with highest risk
      of developing mental health issues. Despite this, they experience especially long wait-times
      for mental health services. To date, there has been minimal research into developmentally
      appropriate treatment options for the EA population. Mindfulness-based interventions (MBIs)
      are emerging as a potential treatment to address this need. MBIs are group-based
      psychological treatments for coping with distress, with the goal of improving mental health.
      Unfortunately, these 'traditional' MBIs are very demanding in terms of time and homework and
      are therefore not sufficiently feasible for the demanding schedules of EA university
      students. Instead, recent studies suggest a role for briefer MBIs in addressing mental health
      symptom burden, well-being and reducing acute stress symptoms. The brevity of these
      interventions make them theoretically better suited for EA university populations. High
      quality research, including controlled clinical trials are needed to demonstrate whether MBIs
      can provide efficacious treatment to improve the lives of EA university students. The current
      study will test the efficacy of a five-week MBI baseline within-subject controlled trial.
    


Intervention name(s): Mindfulness-based Intervention
Intervention type(s): Behavioral
Intervention description(s): MBI will be delivered in group format, 90 minutes per week, for 5 consecutive weeks with 6-15 participants per group.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness; Well-being; Emotion Regulation; Perceived Stress; Self-Compassion
Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the potential pharmacokinetic (PK) interactions of bumetanide and dapagliflozin
      following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects
    


Intervention name(s): Bumetanide; Dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 1 mg, Single Dose, 7 Days; Tablets, Oral, 10 mg. Single Dose, 7 Days
Other intervention name(s): Bumex; BMS-512148
Intervention MeSH terms: Dapagliflozin; Bumetanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sonographic Venous Doppler Imaging in Acute Kidney Injury
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      The first presentations of patients with acute kidney injury (AKI) are usually to the
      emergency departments. While the mortality rate is 5-10% in uncomplicated AKI, it is between
      40-90% in patients hospitalized in the intensive care unit. Therefore early diagnosis and
      treatment of AKI in the emergency department is important in terms of morbidity and
      mortality.

      Sonographic evaluation of the venous system (hepatic, portal and renal vein) may be useful
      for diagnosis. Studies conducted so far have generally been based on predicting cardiorenal
      AKI and renal poor outcomes and have been designed in general ICU conditions.

      In this study, the investigators aimed to determine the diagnostic value of sonographic
      venous Doppler imaging in terms of distinguishing subgroups of AKI in patients presented to
      the emergency department with AKI.
    


Intervention name(s): Sonography
Intervention type(s): Diagnostic Test
Intervention description(s): Sonographic Venous Doppler Imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Emergency department patients with acute kidney injury
Myeloid-Related Protein in Evaluation of Acute Chest Pain in the Emergency Departement
Condition: Myocardial Ischemia; Acute Coronary Syndrome; Myocardial Infarction; Coronary Occlusion; Coronary Thrombosis
MeSH terms: Myocardial Infarction; Thrombosis; Acute Coronary Syndrome; Myocardial Ischemia; Coronary Occlusion; Coronary Thrombosis; Infarction; Chest Pain
Study type: Observational

Summary: 
      The purpose of the study is the evaluation of multiple biomarkers related to acute coronary
      syndromes, including myeloid-related protein 8/14 (MRP 8/14), along with established clinical
      markers, for early diagnosis and risk stratification in patients presenting with acute chest
      pain at the emergency department.

      Study hypothesis: MRP 8/14, alone or together with other established or new biomarkers,
      increases the earliness, sensitivity, and specificity of diagnosing acute coronary syndromes.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients - systematic sampling - presenting with acute chest pain at the
        emergency room in which determination of cardiac biomarkers is indicated for clinical
        diagnostics
      
Keywords: Acute Coronary Syndrome; Myocardial Infarction; Coronary Artery Disease
Is Meniscal Volume Critical to Post-meniscectomy Symptoms?
Condition: Meniscal Tear
Study type: Observational

Summary: 
      With this study we would like to investigate whether a certain, critical loss of meniscal
      volume, is critical to the development of pain.
    

Detailed description: 
      1. Background and rationale It is known that a partial meniscectomy of the knee is a risk
           factor to the development of early osteoarthritis with complaints of pain.

        2. Trial objectives and Design 2.1 Trial objectives With this study we would like to
           investigate whether a certain, critical loss of meniscal volume, is critical to the
           development of pain.

           2.2 Primary endpoints How much volume can be resected peroperatively without developing
           postoperative pain.

           2.3 Secondary endpoints A possible correlation between the resected volume and the
           severity of the pain.

        3. Selection and withdrawal of subjects

      3.1 Inclusion criteria

        -  All patients who were treated with a partial meniscectomy for a meniscal tear and have
           postoperative MRI's.

        -  Age between 14 and 50 years old

        -  Women of child bearing age can be included: the study has no effect on their methods of
           contraception.

      3.2 Exclusion criteria

        -  A history of a tibia plateau fracture or severe deformity of the knee

        -  Rupture of the ACL/PCL/collateral ligaments of the knee

        -  Focal cartilage defects of the knee
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        -  All patients who were treated with a partial meniscectomy for a meniscal tear and have
             postoperative MRI's.

          -  Age between 14 and 60 years old

          -  Women of child bearing age can be included: the study has no effect on their methods
             of contraception.
      
Keywords: meniscectomy; volume; pain
Comparing Rehabilitation Programs for Patellofemoral Pain Syndrome
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Interventional

Summary: 
      Patellofemoral pain syndrome (PFPS) is a common knee disorder affecting physically active
      people. Despite the growing base of support for the early introduction of hip strengthening
      exercises into the rehabilitation of PFPS, there have been few randomized clinical trials
      comparing isolated hip to isolated quadriceps strengthening. The purpose of this study is to
      determine how different exercises affect pain, strength, muscle activity, and function in
      female subjects with patellofemoral pain. The researchers hypothesize that females diagnosed
      with PFPS who initially participate in a hip strengthening program will report a greater
      perceived level of function, greater strength, less pain, and improved neuromuscular activity
      than those who participate in a progressive quadriceps strengthening intervention.
    

Detailed description: 
      Methods: Thirty-three females with PFPS will perform either initial hip strengthening (hip
      group) or initial quadriceps strengthening (quad group) for 4 weeks, prior to 4 weeks of a
      similar program of functional weight-bearing exercises. Self-reported pain, function, and
      functional strength were measured. Isometric strength was assessed for hip abductors,
      external rotators, and knee extensors. A mixed-model analysis of variance will be used to
      determine group differences over time.
    

Intervention name(s): Hip Progressive Resistive Exercise; Quad Progressive Resistive Exercises
Intervention type(s): Other; Other
Intervention description(s): Hip Progressive Resistance Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening hip abduction ad external rotation musculature.; Quad Progressive Resistive Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening quadriceps musculature with straight leg raises and quadriceps isometrics.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Knee pain; Rehabilitation
Use of Mobile-based Technologies to Improve Diabetes Self-management and Postprandial Glucose Control
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The project involve evaluation of a web-based nutrition education program and pilot-testing
      of a new smartphone app for real-time data logging to identify factors causing glycemic
      variability.
    

Detailed description: 
      The intervention will be three (3) months in duration and will entail use of a smart phone
      app for real-time data logging to identify factors causing glycemic variability, as well as
      use of a web-based nutrition education program. The investigators postulate that the
      interactive nutrition education curriculum - which will provide feedback to patients about
      the inter-relationship between their food intake and postprandial glucose profiles, as well
      as practical guidance for improvements - will lead to a change in food choices and improved
      post-prandial glucose control.
    

Intervention name(s): Sugar Sleuth
Intervention type(s): Behavioral
Intervention description(s): Educational module and use of smart phone app ("Sugar Sleuth")
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care