bioihbjkbjnl/mcl2 huggingface dataset:
The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of empagliflozin on oxidative stress
      in patients with type 2 diabetes. The association is examined by comparing the difference in
      oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared
      to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each
      treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are
      measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and
      8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment
      with placebo. The results will be published in a peer-review journal.
    


Intervention name(s): Empagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Empagliflozin; Oxidative stress; Oxidative nucleic acid modifications; 8-oxo-7,8-dihydro-2'-deoxyguanosine; 8-oxo-7,8-dihydroguanosine
Short Term Topical Tetracaine is Safe and Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions
Condition: Corneal Abrasion
MeSH terms: Corneal Injuries
Study type: Interventional

Summary: 
      The objective of this study was to show that patients with corneal abrasions would experience
      more pain relief with short term topical tetracaine than placebo, have similar complication
      rates, and take less hydrocodone for breakthrough pain.
    

Detailed description: 
      Corneal abrasions are among the most common eye-related injuries seen in the emergency
      department (ED). Topical anesthetic drops are routinely used prior to slit-lamp examination
      for diagnosis of corneal abrasions and often provide immediate pain relief. Patients are then
      sent home with oral analgesics and topical antibiotics. The use of topical anesthetics for
      outpatient treatment of corneal abrasions is discouraged by most emergency medicine textbooks
      due to concerns over safety. Case reports of abuse and misuse as well as animal studies have
      suggested that long term use of topical anesthetics may lead to rare complications. Two
      clinical trials showed no delayed healing after a short course of topical anesthetics
      following PRK surgery. Whether this could be applied to nonsurgical patients in the ED was
      investigated by two small clinical trials that showed similar efficacy and safety but were
      underpowered to prove a statistical difference. In 2014, a larger randomized trial
      demonstrated the safety of tetracaine for ED patients with corneal abrasions but failed to
      show a significant difference in patient visual analogue scale (VAS) pain ratings over time.
      More recently, a retrospective cohort study of 444 ED patients given tetracaine for 24 hours
      reported no serious complications or uncommon adverse events. If topical anesthetics could be
      safely prescribed for short term use in the management of corneal abrasions, it is possible
      that this would decrease use of systemic opioids for this purpose. The aim of this
      randomized, double-blind trial was to compare the effectiveness of topical tetracaine versus
      placebo in ED patients with corneal abrasions as measured by a reduction in the VAS score.
    

Intervention name(s): topical tetracaine hydrochloride 1%; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): topical ophthalmologic anesthestic; Placebo
Intervention MeSH terms: Tetracaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA
      9-1067 or 1 hour after.
    

Detailed description: 
      Single-centre, open-label, randomized, gender-balanced, crossover study with four consecutive
      single-dose treatment periods.
    

Intervention name(s): BIA 9-1067; Sinemet® 100/25 mg
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg of BIA 9-1067 (single-dose); immediate-release levodopa/carbidopa 100/25 (single-dose).
Other intervention name(s): OPC, Opicapone; levodopa 100 mg /carbidopa 25 mg
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination; Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson Disease; BIA 9-1067
Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional

Summary: 
      Mindfulness training, relaxation training, and cerebellar electrical stimulation were used to
      intervene in the cognitive function of healthy individuals and individuals with first episode
      depression
    

Detailed description: 
      In this proposed study,the investigators will evaluate the effects of different
      non-pharmacological interventions (physical/psychological) on emotion-related cognitive
      function.This project will use a variety of intervention methods to conduct research in
      healthy individuals and patients with mood disorders. The main intervention methods include:
      (1) mindfulness training;(2) relaxation training;(3) cerebellar electrical stimulation.

      The study will recruit 80 healthy subjects and 40 first-episode depression patients. The
      study consisted of three steps: First, subjects filled in personal data and completed the
      first screening, randomly assigned groups, and filled in the pre-intervention
      questionnaire;Second, give a one-time non-drug intervention (mindfulness training, relaxation
      training or cerebellar electrical stimulation);Step 3: After the intervention, the subjects
      filled in the post-intervention questionnaire and completed the cognitive task test.Clinical
      efficacy and safety assessment will be done at first time. The specific aims are to evaluate
      the effect of non-drug therapy on cognitive function in healthy individuals and patients with
      first episode depression. and the behavior was evaluated by cognitive function task.
    

Intervention name(s): non-drug intervention
Intervention type(s): Other
Intervention description(s): mindfulness training, relaxation training, or electrical cerebellar stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase one study to evaluate the safety and dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET
      Imaging in healthy human volunteers.
    

Detailed description: 
      This study aims to assess the safety and evaluate the dosimetry of CSB-111. This study will
      estimate organ dosimetry and the overall effective dose, a requirement for expanding the
      human use of a radiopharmaceutical.
    

Intervention name(s): CSB-111
Intervention type(s): Drug
Intervention description(s): [68Ga]-NOTA-hGZP is a PET imaging agent.
Other intervention name(s): [68Ga]-NOTA-hGZP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
RDEA3170 and Allopurinol Combination Study in Gout Subjects
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male
      subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics
      (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.
    


Intervention name(s): RDEA3170 10 mg; allopurinol 300 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Allopurinol; Verinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia
Condition: Von Willebrand Disease
MeSH terms: Menorrhagia; Von Willebrand Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of rhIL-11, when given
      subcutaneously for six consecutive months, in reducing menstrual blood loss in women with
      type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by
      subjective bleeding severity scale and pictorial bleeding chart. Safety will be measured by
      the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias,
      fluid retention, or edema.
    

Detailed description: 
      This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in women with
      type 1 VWD and menorrhagia refractory to estrogen, hormones, or hemostatic agents. It is
      anticipated that 10 subjects who meet eligibility criteria will enroll and complete this
      study. All aspects of this study, including the rhIL-11 injections and the screening,
      hemostatic and safety monitoring, and coagulation testing, are considered experimental. The
      specific objectives are to determine the efficacy and safety of rhIL-11 in reducing menstrual
      blood loss in adult women with type 1 VWD during six consecutive menstrual cycles, and to
      determine the mechanism of the hemostatic response of rhIL-11.
    

Intervention name(s): Oprelvekin, Interleukin 11, IL-11
Intervention type(s): Drug
Intervention description(s): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
Other intervention name(s): Neumega (Oprelvekin, Interleukin 11, IL-11)
Intervention MeSH terms: Oprelvekin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: IL-11; von Willebrand disease; von Willebrand factor; VWFmRNA; menorrhagia
Effects of Exercise on Glymphatic Functioning and Neurobehavioral Correlates in Parkinson's Disease
Condition: Parkinson's Disease and Parkinsonism; Glymphatic System
MeSH terms: Parkinson Disease; Parkinsonian Disorders
Study type: Interventional

Summary: 
      This study is designed to measure the change in patients diagnosed with Parkinson's disease
      (PD) before, during and after a 12 week exercise program.The focus of this study is the
      glymphatic system. The glymphatic system is a recentlydiscovered novel waste clearance
      pathway, in patients with Parkinson's Disease (PD).The glymphatic system acts as a
      waste-clearance system in the brain of vertebrate animals.The glymphatic system has been
      proposed in which new clearance pathways involving communication between paravascular spaces,
      interstitial fluid, and ultimately meningeal and dural lymphatic vessels exists, and we have
      provided evidence that this system may be dysfunctional in patients with Parkinson's disease
      with cognitive disorders. Early research suggest glymphatic function increases following
      exercise, this response is believed to clear beta-amyloid in the brain and may mediate the
      neurobehavioral response to exercise in PD.

      This study will use cognitive exams, neurological exams as well as specialized imaging to
      record data points and evaluate the glymphatic function after exercise.
    


Intervention name(s): Exercise--Rock Steady Boxing class
Intervention type(s): Behavioral
Intervention description(s): Rock Steady Boxing is a class designed specifically for those with Parkinsonism and movement difficulty using explosive and fine tuned movements as well as cognitive learning skills.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Parkinson's; Glymphatic System
Westlake N-of-1 Trials for Macronutrient Intake
Condition: Postprandial Hyperglycemia; Metabolic Disorder, Glucose
MeSH terms: Hyperglycemia; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      This is a dietary intervention study in students and staff of Westlake University, which is
      designed to provide evidence in support of N-of-1 methods as an approach to advance
      personalized nutrition. The primary aim is using a series of N-of-1 trials to determine the
      impacts of a high fat, low carbohydrate diet (HF-LC) on glucose metabolism and gut microbiota
      in subjects versus a low fat, high carbohydrate diet (LF-HC) at both the individual and group
      level.
    

Detailed description: 
      This study will employ a series of individual N-of-1 trials comparing a high fat, low
      carbohydrate diet (HF-LC) to a low fat, high carbohydrate diet (LF-HC). Participants will
      enter the study on a usual diet and will have a 6-day run in period for diet planning and
      baseline data collection before beginning their intervention. The HF-LC or the LF-HC will be
      randomized as the starting intervention followed by a wash-out period lasting for 6 days with
      normal diet between two interventions to eliminate previous intervention effects. Then the
      participants will be provided with the other diet. Both HF-LC and LF-HC last for 6 days in
      each set which consists of two wash-out periods and two intervention periods. There will be 3
      sets in this study and investigators will aggregate the results of the completed N-of-1
      trials across all participants to estimate the group level impacts of HF-LC compared to
      LF-HC.
    

Intervention name(s): High fat low carbohydrate diet; Low fat high carbohydrate diet
Intervention type(s): Other; Other
Intervention description(s): Throughout the 6-day intervention, participants are provided with a high fat, low carbohydrate diet (HF-LCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25% respectively while the three macronutrients in the other 3-day diet account for 70%, 15% and 15% respectively. The sequencing of the two diets will be randomized.; Throughout the 6-day intervention, participants are provided with a low fat, high carbohydrate diet (LF-HCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 20%, 15% and 65% respectively while the three macronutrients in the other 3-day diet account for 10%, 15% and 75% respectively. The sequencing of the two diets will be randomized.
Other intervention name(s): HF-LCD; LF-HCD
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Personalized Nutrition; Glucose Metabolism; Gut Microbiota
Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children
Condition: Pharyngitis
MeSH terms: Pharyngitis
Study type: Observational

Summary: 
      Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic
      challenge in pediatric emergency departments, since isolated signs and clinical prediction
      rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid
      antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing
      for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity
      is not optimal. The aim of the present study is to test the accuracy of a new fluorescent
      immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children
      3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the
      gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).
    


Intervention name(s): Sofia Strep A FIA
Intervention type(s): Diagnostic Test
Intervention description(s): Patients who presented with sore throat will be performed throat swab for the new fluorescent immunoasssay (Sofia Strep A FIA), for a standard RADT (Alere Testpack Strep A) and for culture and backup PCR in case of discrepant results.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 3 to 15 years old presenting to the PED with pharyngitis and Mc Isaac score ≥ 2
      
Keywords: GAS; pharyngitis; children; RADT
Effect of Sand on Knee Load and Muscle Activity During a Single Leg Landing Task
Condition: Single Leg Hop Sand Surface; Single Leg Hop Grass Surface; Single Leg Hop Firm Surface
Study type: Interventional

Summary: 
      This study evaluates the effect of different surfaces on the load experienced by the knee
      when landing from a single leg hop. A sand, pliable grass and firm (hard floor) surface will
      be compared when hopping from a 30 cm height. Each subject will complete 5 hops on each
      surface in a random order. The muscle activity in selected muscles of the lower limb will
      also be investigated to see how this differs in the landing leg, when landing on the
      different surfaces.
    

Detailed description: 
      The aim of this study is twofold: 1) To investigate the effect of sand on landing kinematics
      and kinetics at the knee joint when performing a single leg jump landing task (dominant leg),
      comparing sand with a firm surface and pliable grass control. 2) To investigate the sEMG
      activity of the hamstring, quadriceps and gastrocnemius muscles of the dominant leg during
      the jump landing task on these different surfaces (from take off through to terminal knee
      flexion at the end of the landing phase).
    

Intervention name(s): Sand; artificial grass; firm ground
Intervention type(s): Other; Other; Other
Intervention description(s): sand surface; grass surface; firm surface
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, repeated measures crossover design.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sand; knee valgus; knee abduction moment; electromyography
Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
    


Intervention name(s): ALV003; ALV003 placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Celiac Disease; Coeliac Disease; Celiac Sprue; Keliakia Disease
Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      We investigate the potential pharmacokinetic drug-drug interaction between metformin extended
      release and rosuvastatin in healthy male volunteers who receive metformin extended release
      alone, rosuvastatin alone, and both together in a 3 period repeatedly.
    


Intervention name(s): Glucophage SR tablet 750 mg, Crestor tablet 20 mg
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics after a single dose of
      dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.
    

Detailed description: 
      The drug being tested in this study is called Dexlansoprazole. This study will assess the
      pharmacokinetics, safety and tolerability of a single oral dose of Dexlansoprazole 30 mg and
      60 mg delayed-release capsules in healthy participants.

      The study will enroll approximately 40 participants, 20 participants in each parallel arm.
      Participants will be randomly assigned (by chance, like flipping a coin) to one of the two
      treatment groups:

        -  Group 1: A single oral dose of Dexlansoprazole 30 mg delayed-release capsule

        -  Group 2: A single oral dose of Dexlansoprazole 60 mg delayed-release capsule

      All participants will be asked to take single dose of study drug on Day 1.

      This single center trial will be conducted in China. The overall time to participate in this
      study is approximately 40 days. Participants will be contacted by telephone or will make a
      final visit to the clinic 5 to 10 days after receiving their last dose of study drug for a
      follow-up assessment.
    

Intervention name(s): Dexlansoprazole
Intervention type(s): Drug
Intervention description(s): Dexlansoprazole delayed-release capsule.
Other intervention name(s): TAK-390 Modified Release (TAK-390MR) dexlansoprazole
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy