bioihbjkbjnl/mcl2 huggingface dataset:
Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared
      with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic
      low back pain requiring around-the-clock opioid analgesia for an extended period of time.
    


Intervention name(s): Oxycodone DETERx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h; Placebo, divided into 2 doses, q12h
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low back pain; Chronic back pain; Back pain; Opioid; Oxycodone; DETERx; Chronic pain; Chronic low back pain; CLBP; Xtampza
Use of a Modified Propofol Emulsion in Adults
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether a modified propofol preparation shows any
      effect on the incidence of injection pain in adults undergoing elective surgery under general
      anesthesia.

      Study hypothesis: The use of a modified propofol preparation will reduce the incidence of
      injection pain in the study group.
    

Detailed description: 
      Pain on injection is a most frequently reported side effect associated with the use of
      propofol for induction of anesthesia. Various measures have been taken to reduce the pain on
      injection, e.g. administration of lidocaine or fentanyl prior to propofol administration,
      mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on
      injection had been reduced with some of the above mentioned methods, they may not be regarded
      as a satisfactory solution of the problem.
    

Intervention name(s): Propofol; Propofol 1%
Intervention type(s): Drug; Drug
Intervention description(s): Propofol (drug), intravenous, induction of anesthesia; Propofol (drug), intravenous, induction of anesthesia
Other intervention name(s): Modified propofol; Propofol-Lipuro 1%
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Anesthesia; Induction; Pain
Comorbidities and Indirect Health State Utility in Hip and Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      National cohort study aimed to investigate the impact of comorbidities (number and type of
      comorbidities) on health utility state change in lower lim osteoarthritis (hip and knee OA).
    

Detailed description: 
      The concept of health utility state was developed by economists to explain individual choices
      and preferences for health states. It is expressed as the "desirability or preference that
      individuals exhibit for the condition". This health utility state can be measured indirectly
      using health-relation quality of life questionnaires.

      Chronic diseases such as OA are known to be associated with impairment of quality of life.
      Given that OA prevalence increases with age, OA is often associated with other diseases
      (comorbidities). A cross-sectional study showed that comorbidities are associated with lower
      health utility state in OA. Investigation of longitudinal impact of comorbidities on health
      utility state change is need.

      Main objective: Determine the impact of comorbidities on change in health utility state among
      patients with lower limb OA.

      Secondary objective: Determine the Minimal Clinically important Difference in health utility
      state among patients with lower limb OA.

      The COMUTAR study uses longitudinal data from the Knee and Hip Osteoarthritis Longitudinal
      Assessment (KHOALA) cohort study. Health utility state is measured indirectly using Medical
      Outcome Study Short Form-36 quality of life questionnaire Comorbidities are assessed using
      the Functional Comorbidity Index
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Population-based
DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the systemic bioavailability of DHEA and its
      metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA
      concentration.
    

Detailed description: 
      Humans, are unique among animal species in having adrenals that secrete large amounts of the
      inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S.
      The marked reduction in the formation of DHEA-S by the adrenals during aging results in a
      dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a
      situation that has been proposed to be associated with age-related diseases including skin
      atrophy, insulin resistance and obesity. Much attention has been given to the benefits of
      DHEA administered to postmenopausal women, especially on the bone, skin, vagina and well
      being after oral as well as percutaneous administration of the precursor steroid.

      Therefore, this study proposes to evaluate the systemic bioavailability and the effectiveness
      of 1.3 mL vaginal suppositories of DHEA at 4 different concentrations (0.0%, 0.5%, 1.0% et
      1.8%) following 1 week administration of vaginal suppositories in post-menopausal women with
      vaginal atrophy. This is a phase I, randomized, placebo-controlled, double-blind study.
    

Intervention name(s): DHEA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DHEA; Placebo
Other intervention name(s): dehydroepiandrosterone; prasterone
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vaginal atrophy; DHEA; Prasterone; Menopause
Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Interventional

Summary: 
      This research study will look at the safety (e.g., the occurrence of side effects) and
      efficacy (how well the drug works in reducing trigeminal neuralgia attacks) of a drug called
      lamotrigine in adults with trigeminal neuralgia.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, add-on study of lamotrigine in trigeminal
      neuralgia. Thirty-eight eligible patients with trigeminal neuralgia will be enrolled;
      nineteen will be randomized to the active medication group and nineteen to the placebo group.
      Using a daily diary, all patients will document their overall pain level and attack frequency
      and intensity for four weeks. After the four week baseline period, patients will initiate
      medication (lamotrigine or placebo). Patients will titrate until either they reach the
      maximum dose of 400mg per day and up to 700mg for patients on enzyme-inducing anti-epileptic
      drugs (EIAED's), their side effects inhibit further increases (known as maximum tolerated
      dose (MTD)), or their trigeminal neuralgia pain resolves (referred to as pain free dose
      (PFD)) over eight weeks. Patients will remain on a constant dose of prior medications
      throughout the study. Patients will remain on maximum dose, MTD, or PFD for a maintenance
      period of at least eight weeks, and at the end of the maintenance period patients who opt to
      stay on the medication will be unblinded as to medication and dosage. Primary outcome will be
      average intensity of daily pain.
    

Intervention name(s): lamotrigine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal). This drug is an anti-seizure medication.; The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
Other intervention name(s): Lamictal; Lamictal XR
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Double-Blind; Placebo-Controlled
Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects
Condition: Prediabetic State
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The goal is to assess the long-term effect of Pep2Dia® compared to placebo intake on blood
      glucose homeostasis. Respective improvements will be assessed by changes in glycated
      haemoglobin (HbA1c) before and after the 12-weeks intervention.
    


Intervention name(s): Pep2dia; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 700 mg Pep2Dia® 15 min prior to breakfast and 700 mg Pep2Dia® 15 min prior to dinner; 700 mg placebo 15 min prior to breakfast and 700 mg placebo 15 min prior to dinner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effect of Ankle-foot Orthoses Trim Line Modifications on Ankle and Knee Motion and Force.
Condition: Lower Extremity Biomechanics
Study type: Observational

Summary: 
      The purpose of this study is to quantify changes in ankle and knee motion and force resulting
      from five progressive modifications to the anterior-posterior trim lines of thermoformed
      ankle-foot orthoses (AFO). It is hypothesized that the AFO with the most anterior trim line
      will prevent the most plantar flexion during loading response (the first 10% of the gait
      cycle)and prevent the most dorsiflexion at terminal stance (from 30 to 50% of the gait cycle)
      as compared to the non-device condition. This will be evidenced by the sagittal plane ankle
      motion and ground reaction force magnitude and location during loading response and terminal
      stance. Additionally, the angular velocity of knee flexion will increase during these same
      periods. By contrast, as the trim lines are moved more posterior this will result in lowering
      the effective stiffness of the device which will result in progressive increases in
      dorsiflexion and allow increasing amounts of knee flexion during terminal stance.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study seeks to recruit younger, healthy (non-pathological) individuals over 18 years
        of age.
      
Keywords: Ankle; Knee; Orthosis; Kinematics; Kinetics
Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis
Condition: Hysterical Simulation of Disease
Study type: Interventional

Summary: 
      The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after
      central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve
      the patient's walking floor by removing the STEPPAGE, reducing the effort of walking,
      facilitating the flow and removing anomalies compensatory (such as the mowing of the hip).
      Its objective is to improve the patient's autonomy locomotor.

      The aim of this study is to compare the results of the implementation of an implanted
      stimulator in the levator muscles of the foot to the results obtained by wearing a
      splint-type reliever, which is considered standard treatment, in order to determine if the
      implanted stimulation may be proposed in the treatment of foot drop off a neurological
      center.
    

Detailed description: 
      The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after
      central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve
      the patient's walking floor by removing the STEPPAGE, reducing the effort of walking,
      facilitating the flow and removing anomalies compensatory (such as the mowing of the hip).
      Its objective is to improve the patient's autonomy locomotor.
    

Intervention name(s): Functional electrical stimulator; feet orthosis
Intervention type(s): Device; Device
Intervention description(s): The stimulator is surgically implanted; feet orthosis specifically mold
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: feet STEPPAGE of central neurological origin; implanted functional electrical stimulation; feet orthosis
Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction
Condition: Type 2 Diabetes Mellitus Related Endothelial Dysfunction
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether atazanavir use is of influence on the
      endothelial dysfunction associated with type 2 diabetes mellitus.
    


Intervention name(s): placebo + atazanavir; atazanavir + placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo treatment first, atazanavir treatment second
4 day treatment; Atazanavir treatment first, placebo treatment second
4 day treatment
Intervention MeSH terms: Atazanavir Sulfate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the speed of absorption and onset of action
      of BIOD-105 and BIOD-107 and compare them to Humalog®.
    

Detailed description: 
      The secondary objectives of this study are to assess other pharmacokinetic characteristics of
      BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic
      characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the
      safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.
    

Intervention name(s): Insulin LISPRO; recombinant human insulin
Intervention type(s): Drug; Drug
Intervention description(s): Single doses of: 0.15 U/kg; Single doses of: 0.15 U/kg
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to evaluate the bioequivalence (is the amount same in both the
      pills) of metformin component of the canagliflozin and metformin immediate release (IR) fixed
      dose combination (FDC) tablet compared with the metformin IR tablet co-administered with
      canagliflozin tablet in healthy fed and fasted participants.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), open-label
      (identity of study drug will be known to volunteer and study staff), single-center,
      single-dose, 4-treatment, 4-way crossover (method used to switch participants from one study
      group to another in a clinical trial, like the flip of a coin) study in healthy adult
      participants. The study will have 3 phases: Screening Phase (approximately 3 weeks, Day -22
      to Day -2), Open-Label Treatment Phase (consisting of 4 single-dose treatment periods of 3
      days each [Day -1 to Day 2], each separated by a washout period of 7 days) and Follow-up
      Phase (5 to 7 days after last study-related procedure on Day 2 of treatment period 4). All
      eligible participants will be randomly assigned to 1 of 4 treatment sequences and will
      receive 2 treatments under fasting and 2 treatments under fed conditions. Blood samples will
      be collected at pre-dose and post-dose of study treatment, for understanding the
      pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how
      it is removed from the body over time). Participants' safety will be monitored throughout the
      study.
    

Intervention name(s): Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC); Canagliflozin; Metformin IR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.; Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.; Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Metformin; Canagliflozin; JNJ-28431754
Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation
Condition: Pharyngitis; Endotracheal Intubation; Pain
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      Postoperative sore throat (POST) is a common problem following the use of endotracheal
      intubation during general anaesthesia. It leads to dissatisfaction and discomfort after
      surgery and can delay a patient's return to normal routine activities. POST has been rated by
      patients as the eighth most adverse effect in the postoperative period. The incidence of sore
      throat after endotracheal intubation varies from 14.4-90%. Laryngoscopy and tracheal
      intubation also leads to hemodynamic stress response. The response can be deleterious in
      patient with or without cardiac disease. It is related to the degree of manipulation of the
      airway during endotracheal intubation and has been studied during intubation for some
      equipment used for endotracheal intubation
    


Intervention name(s): Endotracheal intubation
Intervention type(s): Device
Intervention description(s): Endotracheal intubation will be done with any of these equipments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Measurement
Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this pilot study is to investigate whether gait specific robotic supported
      bodyweight supported treadmill training and lower extremity strength training have similar
      beneficial effects on walking function and other outcomes.
    

Detailed description: 
      Although task-specific training has been promoted during the last years to improve function,
      recent studies showed that after an incomplete spinal cord injury, strength, but not complex
      movement coordination, is affected. In this randomized cross-over trial we investigate the
      effectiveness of a task-specific 4 week Lokomat training with a 4 week (unspecific) lower
      extremity muscle strength training on walking-related and other outcomes.
    

Intervention name(s): RAGT; Strength Training
Intervention type(s): Device; Other
Intervention description(s): 16 sessions / 4 times/week / 45 minutes Lokomat training; 16 sessions / 4 times/week / 45 minutes lower extremity strength training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ASIA C and D
Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data
Condition: Atrial Fibrillation; Atrial Fibrillation Ablation; Pulmonary Vein Isolation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is
      catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation
      catheter to deliver targeted burns on the inner surface of the heart. The aim of this
      approach is to cause electrical isolation of the pulmonary veins. The purpose of this study
      is to evaluate whether the information which can be derived from the latest catheter
      technologies - on the degree of contact force between the catheter and the heart - affects
      the time to perform the procedure, or the outcomes as a result of it. Patients undergoing
      pulmonary vein isolation will be randomised to having their procedure performed with the
      contact force information available to the operator, or not available. The time taken to
      achieve pulmonary vein isolation is the primary end-point of the study.
    


Intervention name(s): Pulmonary vein isolation using contact force sensing catheter
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment
Keywords: Atrial fibrillation; Contact force; Ablation
Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness.
Condition: Range of Motion
Study type: Interventional

Summary: 
      The purpose for this protocol is to perform a double-blind, randomized, placebo-controlled,
      parallel-arm clinical study in healthy subjects to evaluate the efficacy of a nutraceutical
      product on physical and mental energy levels and overall wellness.
    


Intervention name(s): Prickly pear juice; Pear-flavored juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 ounces daily for 8 weeks.; 3 ounces daily for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blinded, randomized, placebo-controlled, parallel-arm clinical study design will be used.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science