bioihbjkbjnl/mcl2 huggingface dataset:
A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor
      over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age
      14 - 75 years.
    

Detailed description: 
      This study is a multi-center, randomized, prospective single-sample correlational design
      without controls. Up to 72 subjects will be enrolled in order to have approximately 60
      subjects complete the study. Three investigational centers in China will be used during this
      study.

      Each subject will wear the following devices:

      • Two Enlite Sensors each connected to an iPro2 for approximately 6 days

      Sensor Location:

      • The 2 Enlite Sensors will be worn in the abdomen area. Investigational center staff will
      insert sensors and connect to the iPro2s.

      During the study, each subject will be randomized and undergo one Yellow Springs Instrument
      (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6).

      During the study, subjects will continue with their current diabetes regimen independent of
      the study devices. Subjects will be instructed by the investigational center that they are
      not to use the study devices (except for the study meter) for the management of their
      diabetes. The Study Meter may be used for treatment decisions and calibration of Enlite
      Sensor.
    

Intervention name(s): Enlite 1 connected to iPro2 recorder
Intervention type(s): Device
Intervention description(s): Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Type I Type II
Snore Positive Airway Pressure Trial
Condition: Non-Apnoeic Snorers
Study type: Interventional

Summary: 
      This study will aim to assess the acceptance of the Snore PAP system as a treatment concept
      for snore. The study will subjectively assess participant and bed partner acceptability and
      usability of the Snore PAP system and objectively assess participant compliance with the
      Snore PAP system.
    


Intervention name(s): Snore PAP System
Intervention type(s): Device
Intervention description(s): The Snore PAP system delivers a set Continuous Positive Airway Pressure (CPAP) and consists of a CPAP flow generator and an approved pillows mask.The system will deliver a fixed positive airflow to the participant via approved tubing and pillows mask.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Vitamin D in Female Reproductive Tract Immunity
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the impact of approximately 8 weeks of Vitamin D
      (VitD) and calcium supplementation, using daily versus weekly supplementation regimens, on
      female reproductive tract immunity.
    

Detailed description: 
      This outpatient open label study will assess the impact of 8 weeks of daily versus weekly
      VitD and calcium supplementation on measures of cervicovaginal (CV) innate immune function,
      including antimicrobial and proinflammatory gene expression, Toll-like receptor
      (TLR)-mediated responses, immunohistochemical (IHC) analysis of immune cell markers, and
      microbiota in premenopausal women with insufficient serum VitD levels at baseline.

      Women will be seen in 3 study visits and will be contacted by one scheduled follow-up
      telephone call after their final study visit. Volunteers will be consented at Visit 1 and
      undergo procedures to confirm they are eligible to continue in the study.

      Once it has been confirmed that the participant meets all of the inclusion criteria and none
      of the exclusion criteria, baseline blood and genital samples will be taken in the luteal
      phase at Visit 2. The participant will then be given their first dose of VitD 4000 IU daily
      or 50,000 IU weekly in capsule form, which they will then administer for 8 weeks.
      Participants will also administer 1000 mg of calcium daily. Participants will return upon
      completion of supplementation for repeat of blood and genital samples (Visit 3).
    

Intervention name(s): Vitamin D and Calcium
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Novel Alpha Glucan GI Tolerability Study (Loris Chronic)
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study aims to evaluate the gastrointestinal tolerance of chronic consumption (7 days) of
      a novel alpha glucan compared to a rapidly available carbohydrate (glucose syrup).
    

Detailed description: 
      This study will be randomized, double blind, placebo-controlled, single-center, and 3x3
      crossover in design.

      Eligible participants will be randomized to receive the below products in single dose and in
      different random sequence, as determined by the randomization system:

        1. novel alpha glucan (80 g/day)

        2. novel alpha glucan (180 g/day)

        3. glucose syrup (180 g/day)
    

Intervention name(s): Drinkable solution
Intervention type(s): Dietary Supplement
Intervention description(s): The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3x3
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture
Condition: Laryngeal Mask Airway
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      In surgery under general anesthesia due to nasal bone fracture, laryngeal mask airway or
      tracheal intubation has been used. However, it has not been investigated that the difference
      of recovery profiles according to use of laryngeal mask airway or tracheal intubation in
      nasal bone fracture surgery. The aim of study is to evaluate the efficacy of the laryngeal
      mask airway regarding recovery profiles and airway complications, compared to tracheal
      intubation.
    


Intervention name(s): Laryngeal mask airway; Endotracheal tube
Intervention type(s): Device; Device
Intervention description(s): LMA Flexible is a supraglottic airway device, which can be moved out of the surgical field without displacement of the cuff, or loss of seal for the anesthetist; Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.
Other intervention name(s): LMA Flexible,Teleflex Co., Westmeath, Ireland; Portex, Smiths Medical International Ltd., South East England, United Kingdom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laryngeal mask airway; Intubation; nasal bone fracture; recovery
Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)
Condition: Silent Stroke; Pulmonary Embolism; Patent Foramen Ovale
MeSH terms: Pulmonary Embolism; Stroke; Embolism; Foramen Ovale, Patent
Study type: Observational

Summary: 
      Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in
      patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the
      incidence of clinically silent brain infarction is unknown. We will assess the rate of
      clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE)
      in relation to the presence or not of a PFO.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive series of patients with a pulmonary embolism
      
Keywords: stroke; PFO; embolism
CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial
Condition: Locally Advanced Breast Cancer; Circulating Tumor Cell
MeSH terms: Breast Neoplasms; Neoplastic Cells, Circulating
Study type: Interventional

Summary: 
      The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE
      approved. The purpose of this clinical trial is to evaluate the predictive value of CTC in
      neoadjuvant chemotherapy among locally advanced breast cancer patients.
    


Intervention name(s): GILUPI CellCollector®
Intervention type(s): Device
Intervention description(s): Use of GILUPI CellCollector® to detect CTC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Botulinum Toxin at Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe glabellar
      lines.
    


Intervention name(s): ATGC-100 100U; Botox 100U
Intervention type(s): Biological; Biological
Intervention description(s): Clostridium botulinum toxin type A; Clostridium botulinum toxin type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Supplementary Food for Moderate Acute Malnutrition in Children
Condition: Moderate Acute Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Children with moderate acute malnutrition will be recruited in order to receive an
      intervention which consists in the consumption of a single serving of SF-cookies daily,
      7-days a week for 12 months and 12 educational sessions on health and nutrition.
    


Intervention name(s): Nutritional Oats Cookie
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients
Condition: Type 2 Diabetes; Diabetic Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia,
      promotes the development of coronary heart disease. Secondary dyslipidemia is often
      associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase
      inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading
      to a significant reduction of cardiovascular risk. More recently, revisions to guidelines
      have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring
      the administration of higher dose of statin. However, it is unclear whether high dose statin
      therapy could affect glycemic control in diabetic patients. Moreover, data regarding the
      effects of statins on insulin-resistance and endothelial function are controversial.
    


Intervention name(s): Simvastatin; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg/day in one oral administration; 20 mg/day in one oral administration.
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Statins administration in diabetic dyslipidemia
Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to investigate if a drug-drug interaction occurs with
      the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of
      dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition
      (components of Aggrenox®) when administered every 12 hours at steady state.
    

Detailed description: 
      Purpose:
    

Intervention name(s): Aggrenox alone; Aggrenox and omeprazole; Aggrenox and omeprazole; Omeprazole alone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Aggrenox 1 capsule twice daily for 7 days; Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days; Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days; omeprazole 80 once daily for 7 days
Intervention MeSH terms: Omeprazole; Aspirin, Dipyridamole Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of fluorouracil (5-FU),
      levofolinate calcium (l-LV), oxaliplatin (L-OHP) and irinotecan hydrochloride hydrate
      (CPT-11) (FOLFOXIRI) plus bevacizumab in untreated metastatic colorectal cancer patients who
      harbor Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1) *1/*1, *1/*6 or
      *1/*28.
    


Intervention name(s): Oxaliplatin (L-OHP); Irinotecan hydrochloride hydrate (CPT-11); Continuous intravenous infusion of fluorouracil (CIV 5-FU); Levofolinate calcium (l-LV); Bevacizumab (Bmab)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Oxaliplatin; Irinotecan; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bevacizumab; oxaliplatin; irinotecan; hydrochloride hydrate; fluorouracil; levofolinate calcium
Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants
Condition: Intermittent Claudicants
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators are conducting a randomised controlled trial to investigate the clinical
      and cost effectiveness of Ramipril which is an anti-hypertensive medication in patients with
      intermittent claudication. The investigators aim to recruit 78 participants in total. The
      investigators will randomise the 78 participants into two groups: Ramipril group with 39
      participants and Placebo group with 39 participants. The investigators will measure
      Ramipril's effect on walking by doing a simple treadmill test and measuring the maximum
      walking distance the participant can walk. The investigators also want to examine Ramipril's
      effect on arterial function, cardiovascular prognosis, quality of life and cost
      effectiveness.
    


Intervention name(s): Ramipril
Intervention type(s): Drug
Intervention description(s): 5 mg/day for 2 weeks then 10 mg/day for 22 weeks
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ACE inhibitors; Intermittent claudication; Ramipril
Electroconvulsive Therapy Amplitude Titration
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study is focused on advancing ECT treatment for older adults with depressive disorders
      by refining neuromodulation stimulus parameters to improve efficacy and cognitive safety.
    

Detailed description: 
      Amplitude titration, as proposed in this current proposal, can reduce the variability related
      to fixed amplitude dosing and optimize clinical and cognitive outcomes. The goal of this
      project is to change standard ECT parameter selection from a fixed amplitude to an
      individualized and empirically determined amplitude. To achieve this goal, the investigators
      will focus on the relationship between amplitude titration and treatment-responsive changes
      in hippocampal neuroplasticity with RUL fixed amplitude ECT. Fixed amplitude ECT results in
      variable E-field or ECT dose. Over the course of an ECT series, the variable ECT dose will
      result in inconsistent changes in hippocampal neuroplasticity. In contrast, pre-translational
      investigations have demonstrated that amplitude titration results in a consistent E-field or
      ECT "dose". Seizure titration amplitudes (based on historic data, 233 to544mA) are below the
      amplitude range of FDA-approved ECT devices (500 to 900mA) and will require an adaptor to
      reduce the output amplitude (Investigational Device Exemption). Amplitude titration will also
      be below the hippocampal neuroplasticity threshold and insufficient for antidepressant
      response. The difference between RUL amplitude titration and RUL fixed amplitude (800mA) ECT
      will determine the degree of target engagement with the hippocampus. To illustrate, subjects
      with low amplitude titration of ~250 mA (800/250, high fixed/titration amplitude ratio) will
      have significant changes in hippocampal neuroplasticity. Subjects with high amplitude
      titration ~500mA (800/500, low fixed/titration ratio) will have minimal changes in
      hippocampal neuroplasticity. The relationship between amplitude titration and fixed amplitude
      hippocampal neuroplasticity will be used to develop the amplitude multiplier required for
      consistent and clinically effective ECT dosing.
    

Intervention name(s): Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface
Intervention type(s): Device
Intervention description(s): The Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD-ECT Multi-Channel Stimulation Interface will reduce ECT current amplitude for amplitude-seizure titration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Electroconvulsive Therapy; Depressive Episode; Cognition
The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with
      involving compression of the median nerve in the carpal tunnel. Rather than other progressive
      disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease
      the entrapment of nerve to restore blood supply. In addition, the hyaluronic acid was proved
      to decrease adhension of soft tissue and nerve during operation. The investigators design a
      randomized, double-blind, controlled trial to assess the effect after ultrasound-guided
      hydrodissection with hyaluronic acid in patients with CTS.
    

Detailed description: 
      After obtaining written informed consent, patients with bilateral CTS will been randomized
      into intervention and control group. Participants in intervention group received one-dose
      ultrasound-guided hydrodissection with hyaluronic acid and control side received one-dose
      ultrasound-guided injection with normal saline. No additional treatment after injection
      through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire
      (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA)
      of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch
      strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th
      month and one year after the treatment.
    

Intervention name(s): Sono-guided injection with hyaluronic acid; Sono-guided injection with normal saline
Intervention type(s): Procedure; Procedure
Intervention description(s): Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2.5 ml) between carpal tunnel and median nerve; Sono-guided injection with 2.5cc Normal saline (0.9%) between carpal tunnel and median nerve
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hydrodissection; hyaluronic acid
Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data
    

Detailed description: 
      Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized,
      Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection
      Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide
      Symptomatic Relief of Osteoarthritis of the Knee
    

Intervention name(s): Cingal; Monovisc; Triamcinolone Hexacetonide
Intervention type(s): Combination Product; Device; Drug
Intervention description(s): Hyaluronic Acid with Triamcinolone Hexacetonide; Hyaluronic Acid; Triamcinolone Hexacetonide
Other intervention name(s): HA + TH; HA; TH
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the 16-02 study, subjects were randomized in a 4:4:1 ratio into the Cingal, Monovisc (hyaluronic acid) or TH (triamcinolone hexacetonide) arm. The 17-02 study is a 39-week follow-up to the 16-02 study.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Intra-articular Injection; Hyaluronic Acid; Triamcinolone Hexacetonide
A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients
Condition: Pediatric Pateints; Amnesic Properties of Propofol
Study type: Interventional

Summary: 
      The goal of this study is to extend findings of propofol's effects on memory, as measured in
      volunteer research studies, to a clinical setting.
    


Intervention name(s): memory test; Propofol
Intervention type(s): Other; Drug
Intervention MeSH terms: Propofol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Amnesic; Propofol; 12-006
Evaluate Different Extended-release (ER) Tablets/Capsules of AZD1305
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.
    


Intervention name(s): AZD1305; AZD1305
Intervention type(s): Drug; Drug
Intervention description(s): Extended release capsules, oral single doses; Extended release capsules, oral single doses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AZD1305; pharmacokinetics; Properties of different ER formulations