bioihbjkbjnl/mcl2 huggingface dataset:
Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care
Condition: Conscious Sedation
Study type: Interventional

Summary: 
      The general objective of the study is to compare the efficacy of administering midazolam
      orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure:
      1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum
      working time.
    

Detailed description: 
      -  Prospective, parallel design

        -  Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative
           (Frankl 1-2), that needs at least two similar dental treatments. Exclusion criteria:
           enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 =
           >75% airway obstruction), upper respiratory tract infection or nasal discharge.

        -  Randomization: At the first appointment the subjects will assigned randomly to receive
           oral midazolam or nasal midazolam;

        -  Sedation: oral midazolam dose is 0.5mg/kg. Nasal midazolam dose is 0.2mg/kg. During
           treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

        -  Acceptability of the medication: compliance in taking the medication will be assessed
           and recorded as: willingly, coaxed, forced, or failed (not administered).

        -  Behavior during dental treatment: Houpt scale measures behavior by rating sleep,
           movement, crying and overall behavior. The degree of alertness, movement and crying will
           be assessed before, during (every 5 min) and after the operative procedure. The rating
           will be done by one observer blind to the route of administration. This blind observer
           will also monitor the pulse and oxygen saturation.
    

Intervention name(s): oral midazolam; nasal midazolam
Intervention type(s): Drug; Drug
Intervention description(s): administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.; administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
Other intervention name(s): oral dormicum; nasal dormicum
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Sublingual vs IV Atropine Bioavailability Study
Condition: Toxic Effect of Organophosphate and Carbamate Insecticides
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, three-sequence, three-period, phase 1 study is designed to assess the
      bioavailability and pharmacokinetics (PK) of sublingually administered atropine sulfate
      ophthalmic solution 1% USP (at 0.5 mg and 1.0 mg; test) compared to atropine sulfate
      injection administered IV (1.0 mg; reference).
    

Detailed description: 
      This is a randomized, three-sequence, three-period crossover study to assess the
      bioavailability and PK of a single dose of atropine administered sublingually in healthy
      adult volunteers. At least 15 healthy male and female volunteers will be enrolled to obtain
      approximately 12 evaluable subjects in the per protocol population. Eligible subjects will be
      randomized at a 1:1:1 ratio to receive one of three treatment dosing sequences (A, B, or C).

      Subjects assigned to treatment dosing sequence A will receive a low dose sublingually at
      Visit 1; Day 1 (Period 1), a high dose sublingually at Visit 2; Day 8 (Period 2) and an IV
      dose at Visit 3; Day 15 (Period 3).

      Subjects assigned to treatment dosing sequence B will receive a high dose sublingually at
      Visit 1; Day 1 (Period 1), an IV dose at Visit 2; Day 8 (Period 2) and a low dose
      sublingually at Visit 3; Day 15 (Period 3).

      Subjects assigned to treatment dosing sequence C will receive an IV dose at Visit 1; Day 1
      (Period 1), a low dose sublingually at Visit 2; Day 8 (Period 2), and a high dose
      sublingually at Visit 3; Day 15 (Period 3).
    

Intervention name(s): Atropine Sulfate Ophthalmic Solution; Atropine Sulphate Injection
Intervention type(s): Drug; Drug
Intervention description(s): Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anti-muscarinic indicated for cyclopegia, mydriasis, and penalization of the healthy eye in the treatment of amblyopia. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains active ingredient: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactive ingredients include benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection, USP.; Atropine sulfate injection, USP, 8mg/20mL (0.4 mg per mL) is a sterile, nonpyrogenic, isotonic, clear solution of atropine sulfate in water for injection with sodium chloride sufficient to render the solution isotonic. Each mL contains atropine sulfate, 0.4 mg; benzyl alcohol, 9 mg; sodium chloride 9 mg; and may contain sulfuric acid for pH adjustment, pH 3.5 (3.0 to 3.8).
Intervention MeSH terms: Atropine; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute
      exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to
      evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic
      obstructive pulmonary disease; (2) to observe the clinical efficacy of Qingcheng Pingxian
      Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease, to
      provide an effective medication and solution for the treatment of acute exacerbation of
      chronic obstructive pulmonary disease, and to provide data for the development of the further
      application of Qingcheng Pingxian Granules.
    


Intervention name(s): Qingkepingchuan Granules; conventional treatment
Intervention type(s): Drug; Other
Intervention description(s): Qingkepingchuan Granules,Take it three times a day with water after meals.; Oxygen intake, selection of appropriate antibiotics based on lab results, and other treatments
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Qingkepingchuan Granules
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Egg Consumption on Cardiometabolic Health in Prediabetic Subjects.
Condition: PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The objective of this trial is to assess the effects of whole egg consumption (12 per week),
      compared to energy-matched typical breakfast control foods, on insulin sensitivity and other
      markers of metabolic health, including fasting lipoprotein lipid levels and resting blood
      pressure.
    

Detailed description: 
      This is a randomized, crossover study that includes two screening visits and two 4-week test
      periods separated by a 4-week washout. Subjects will consume two eggs/day (12 eggs/week
      consumed over 6 days per week, provided as breakfast foods such as burrito-type roll-up, egg
      sandwich and omelet) or non-egg based control foods (provided as breakfast foods such as
      English muffins, bagels, ready-to-eat cereal, and flavored muffins). The background diet will
      be a habitual diet. The nutritional profiles of the egg and control breakfast foods will be
      designed such that the energy from eggs will be substituted for a mixture of carbohydrate,
      protein and fat in the control foods.

      Study foods will be dispensed with instructions to consume the assigned breakfast food
      starting on day 1. Subjects will be instructed to consume the breakfast foods in their
      entirety each day, for the duration of the 28 day test period, and to record daily study food
      intake. Subjects will receive diet instruction on the incorporation of food substitutions
      during the test period to maintain habitual energy intake. Compliance will be assessed using
      the Daily Log intake and number of foods consumed based on returned foods.

      An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of
      each treatment period for evaluation of insulin sensitivity. Blood will be collected for a
      fasting lipid profile (at all visits), glucose and insulin, high-sensitivity C-reactive
      protein (hs-CRP), vertical auto profile (VAP) for cholesterol carried by lipoprotein
      fractions (at baseline and end of each treatment period), with additional blood samples
      collected for storage and archived for possible future analysis of non-genetic indicators of
      metabolism. Assessments of vital signs and body weight, review of concomitant
      medication/supplement use and inclusion and exclusion criteria for relevant changes, and
      evaluation of adverse effects will be performed throughout the study.
    

Intervention name(s): Egg based breakfast foods; Non-egg based breakfast foods
Intervention type(s): Other; Other
Intervention description(s): Two eggs/day, 6 days per week provided as breakfast foods such as burrito-type roll-up, egg sandwich and omelet.; Non-egg based control foods provided as breakfast foods 6 days per week such as waffles, ready-to-eat cereal, fruits and cheeses.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Prognostic Value of Biomarkers Associated With Endothelial Progenitor Cells Mobilization in Acute Coronary Syndromes
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      This prospective study aimed to validate a new prognostic approach of endothelial progenitor
      cells associated biomarkers in patients with acute coronary syndromes . Recruitment is made
      prospectively by two centers of Inter -region South Mediterranean,
    


Intervention name(s): blood sample
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of
      life and increased economic burden. Current research has focused on expensive, invasive
      treatments, whereas inexpensive conservative treatments have received less attention. One
      such treatment is the use of orthotics to reduce pain and increase function in people with
      knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and
      contradictory, and could benefit from more research taking into account foot posture. This
      study aims to compare the use of two orthotics designs in people with knee OA.
    


Intervention name(s): Lateral wedge; Lateral wedge plus medial arch support
Intervention type(s): Device; Device
Intervention description(s): This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.; This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; knee; biomechanics; treatment; symptoms
Phase II Study to Evaluate the Efficacy of AMG 317
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317
      compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom
      scores from baseline to week 12.
    


Intervention name(s): AMG 317 75 mg; AMG 317 150 mg; AMG 317 300 mg; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 75 mg SC weekly injection; 150 mg SC once weekly injection; 300 mg weekly SC injection; Placebo SC once weekly injection
Other intervention name(s): AMG 317 300 mg dose
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Allergy; IL-13; IL-4; IL-4R
Feasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for
      reducing discomfort associated with Ultherapy™ treatment.
    

Detailed description: 
      All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes
      prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the
      face and neck and a placebo cream with similar consistency and color will be applied to the
      other side of the face and neck, in a randomized fashion. The subject and investigator or
      sub-investigator performing Ultherapy™ treatment will be blinded to the side to which the
      topical anesthetic is applied. Pain scores will be collected following treatment of each
      section of the face and neck on both sides. Subjects will return for a 90-day post-treatment
      visit to assess improvement in skin laxity, and overall lifting and tightening of skin.
    

Intervention name(s): L.M.X.4.® cream; A placebo cream; Ulthera System Treatment
Intervention type(s): Drug; Other; Device
Intervention description(s): A lidocaine topical anesthetic cream; Placebo cream containing no anesthetic properties.; Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): A lidocaine topical anesthetic cream; Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Intervention MeSH terms: Lidocaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Targeting FMO-Mediated TMAO Formation in Kidney Disease (TMAO) Study
Condition: Kidney Diseases; Cardiovascular Diseases
MeSH terms: Kidney Diseases; Cardiovascular Diseases
Study type: Interventional

Summary: 
      The project will investigate the modulation of flavin-containing monooxygenase (FMO)
      formation of the CVD risk factor trimethylamine-N-oxide (TMAO) in patients with kidney
      disease.
    

Detailed description: 
      Twelve patients with stage 3 to 4 kidney disease will receive an intervention for four weeks
      and a matching placebo in a crossover study design. Reduction of serum TMAO from baseline to
      end of intervention will be the primary endpoint.
    

Intervention name(s): Commercially available Diindolylmethane; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Commercially available Diindolylmethane is a compound derived from cruciferous vegetables (e.g. broccoli); A matching placebo capsule will be compounded by the UPMC Investigational Drug Service
Intervention MeSH terms: 3,3'-diindolylmethane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study
Condition: Cystinuria
MeSH terms: Urolithiasis; Urinary Calculi; Cystinuria
Study type: Interventional

Summary: 
      The goal of this research project is to establish that in short-term use, tolvaptan is a safe
      and potentially effective new therapy for cystinuria, by conducting a short-term pilot study
      of the safety and tolerability of this drug, and assess impact on urinary stone risk
      parameters, among adolescent and young adult patients with clinical cystinuria.
    


Intervention name(s): Tolvaptan
Intervention type(s): Drug
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystinuria; Kidney Stones
Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma
Condition: Part A and B: Advanced Solid Malignancies; Part C: Malignant Mesothelioma
MeSH terms: Neoplasms; Mesothelioma; Mesothelioma, Malignant; Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and
      Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab
      in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when
      given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese
      Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma
    

Detailed description: 
      Primary objectives Part A: To investigate the safety and tolerability of tremelimumab when
      given to Japanese patients with advanced solid malignancies and define the dose(s) for
      further clinical evaluation.

      Part B: To investigate the safety and tolerability of tremelimumab in combination with
      MEDI4736 when given to Japanese patients with advanced solid malignancies and to define the
      dose(s) for further clinical evaluation.

      Part C: To investigate the safety and tolerability of tremelimumab when given to Japanese
      patients with unresectable pleural or peritoneal malignant mesothelioma.
    

Intervention name(s): Tremelimumab; MEDI4736
Intervention type(s): Drug; Drug
Intervention description(s): Tremelimumab administered intravenously; MEDI4736 administered intravenously.
Intervention MeSH terms: Durvalumab; Tremelimumab
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Other
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
Condition: Migraine Disorders
MeSH terms: Migraine Disorders; Cluster Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg
      kit product for the treatment of migraine or cluster headache attacks in clinical settings,
      to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness)
      and rate of successful self-injection.
    


Intervention name(s): Sumatriptan Succinate
Intervention type(s): Drug
Intervention description(s): Sumatriptan Succinate
Intervention MeSH terms: Sumatriptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Sumatriptan Succinate Injection Kit; Cluster Headache; self-injection
Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
Condition: Sporadic Inclusion Body Myositis
MeSH terms: Myositis; Myositis, Inclusion Body
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study evaluated the efficacy, safety and tolerability of multiple doses of
      bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function,
      muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).
    


Intervention name(s): BYM338/bimagrumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.; Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sporadic inclusion body myositis,; myositis,; muscle wasting,; controlled clinical trial,; randomized,; body mass,; muscle function,; strength,; performance,; physical function
Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The investigators will compare tumor marker levels, including PSA, in samples taken from a
      peripheral upper limb vein and the internal iliac veins. These will be collected from
      patients who are scheduled for prostatectomy as part of their standard of care for prostate
      cancer. A selective internal iliac vein sampling procedure will be performed in
      Interventional Radiology. Venous samples will be correlated with prostatectomy specimens. The
      aim is to predict the side of the prostate containing tumor.
    


Intervention name(s): Obtaining biospecimen
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy
Condition: Diabetic Neuropathies; Diabetes Mellitus; Exercise Training
MeSH terms: Diabetic Neuropathies
Study type: Interventional

Summary: 
      This study examined the effects of balance exercises performed with the Biodex Balance System
      (BBS) on nerve conduction, sensory symptoms, and muscle strength in patients with
      diabetes-related neuropathy.
    

Detailed description: 
      We enrolled twenty-seven patients in this study. Patients in the intervention group (n=14)
      performed exercises using the computerized BBS. The control group (n=13) was just informed
      about diabetes self-management. All patients underwent pretest and posttest peripheral nerve
      conduction studies. Sensory examination performed by using 5.07 Semmes-Weinstein
      monofilaments and 128-Hz tuning fork. Muscle strength measurements obtained with manual
      dynamometer
    

Intervention name(s): Biodex Balance Exercise System
Intervention type(s): Device
Intervention description(s): Patients in the intervention group (n=14) performed exercises using the computerized BBS. The control group (n=13) was just informed about diabetes self-management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening