bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study to Evaluate Plasma Treatment of Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety of treating human toenails with
      atmospheric plasma (MOE Antimicrobial Plasma Treatment System) and get an initial evaluation
      of the efficacy of this treatment for toenail fungus (onychomycosis).
    


Intervention name(s): MOE Antimicrobial Plasma Treatment System
Intervention type(s): Device
Intervention description(s): Plasma applied to great toenail 1X/week for three weeks
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I, Open-label Study of Absorption, Metabolism, and Excretion of Defactinib (VS-6063) in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assesses the mass balance recovery, pharmacokinetics, metabolite profile and
      metabolite identification of defactinib.
    


Intervention name(s): defactinib
Intervention type(s): Drug
Intervention description(s): Single oral dose of 400 mg [14C]-defactinib
Other intervention name(s): VS-6063
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficiency of Intercoat (Oxiplex/AP Gel)in Decreasing Intrauterine Adhesions
Condition: Asherman Syndrome
MeSH terms: Gynatresia; Tissue Adhesions
Study type: Interventional

Summary: 
      This is a prospective single blind randomized controlled pilot study was designed to
      investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of
      intrauterine adhesions following hysteroscopic treatment for retained products of conception.
    

Detailed description: 
      Thirty women randomly divided equally into those who received Intercoat following
      hysteroscopic treatment for retained products of conception (study group) and those who did
      not receive the gel (controls). Safety and efficacy of the preparation were evaluated.
    

Intervention name(s): Oxiplex/AP gel; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Intrauterine application of Intercoat following hysteroscopy; No intrauterine application of Intercoat following hysteroscopy
Other intervention name(s): Intercoat; Distention media
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Oxiplex/AP gel; Prevention of Asherman's syndrome; Intra uterine adhesions
Low-Dose Coronary Computed Tomographic Angiography for Early Triage of Acute Chest Pain
Condition: Chest Pain
MeSH terms: Chest Pain
Study type: Interventional

Summary: 
      This study is to see whether the low-dose coronary computed tomographic angiography (CCTA)
      protocol is as safe and efficacious as conventional-dose protocol in early triage of acute
      chest pain.
    

Detailed description: 
      Currently, CCTA is a valuable tool for early triage of low to intermediate risk acute chest
      pain patients in emergency department. However, it has been criticized for causing
      unnecessary radiation exposure in the population where its majority has no coronary lesion. A
      low-dose CCTA protocol comprised with 1) dedicated cardiac imaging protocol (rather than
      triple rule-out protocol), 2) prospective gating and 3) without additional imaging for
      calcium scoring will be used to implement the low-dose imaging. We hypothesized that the
      low-dose CCTA protocol will be as safe and efficacious as conventional dose protocol while
      decreasing the amount of radiation exposure significantly.
    

Intervention name(s): Low-dose Cardiac CT protocol; Conventional cardiac CT protocol
Intervention type(s): Other; Other
Intervention description(s): A cardiac CT protocol modified for reduction of radiation exposure
Prospective gating
Range: dedicated imaging (below carina to heart base); Conventional CCTA protocol
Retrospective gating with tube current modulation
Range: dedicated imaging (below carina to heart base)
Intervention MeSH terms: Cytarabine; Thioguanine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Acute coronary syndrome; Cardiac computed tomographic angiography; Radiation dose reduction; Medical radiation exposure
Accu-Chek® CONNECT at School (CATS) Pediatric Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This interventional, 6-month post-marketing study is designed to evaluate the change in
      diabetes-related distress among parents/caregivers of school-age children and adolescents
      with type 1 diabetes (T1D) who are receiving multiple daily injections (MDI) therapy.
      Investigational sites will be assigned using cluster randomization, with approximately 10 to
      20 children at each site. In order to maintain a true control group for comparison, the
      investigational sites will be randomly assigned to the Accu-Chek® CONNECT Diabetes Management
      System (DMS) or usual care/continued use of current DMS devices.
    


Intervention name(s): Accu-Chek® CONNECT DMS; DMS
Intervention type(s): Device; Device
Intervention description(s): SMBG will be performed during the 6-month study using the Accu-Chek® Aviva CONNECT monitoring device, and corresponding Smartphone app and online tracking tool.; SMBG will be performed during the 6-month study according to usual care, using the participant's current DMS (other than Accu-Chek® CONNECT DMS).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism
Condition: Idiopathic Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Study type: Observational

Summary: 
      The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with
      insulin resistance and influence of testosterone treatment on this cytokine in patients with
      idiopathic hypogonadotropic hypogonadism.
    


Intervention name(s): Sustanon 250 mg ampule (Testosterone esters)
Intervention type(s): Drug
Intervention description(s): Drug used for treatment of hypogonadism
Other intervention name(s): No name
Intervention MeSH terms: Testosterone
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with hypogonadotrophic hypogonadism
      
Keywords: hypogonadism; Retinol binding globulin 4; Testosterone treatment
Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
Condition: Gastroesophageal Reflux Disease; Heartburn; Regurgitation
MeSH terms: Gastroesophageal Reflux; Heartburn
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being carried out to see whether AZD3355 is an effective treatment as an add-on
      to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial
      response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another
      goal of the study is to examine which of the investigated doses of AZD3355 is optimal for
      treatment of these patients. This study will also measure levels of drug in the blood and see
      how well it is tolerated.
    


Intervention name(s): lesogaberan (AZD3355); lesogaberan (AZD3355); lesogaberan (AZD3355); lesogaberan (AZD3355); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 60 mg, oral, capsules, bid for 4 w; 120 mg, oral, capsules, bid for 4 w; 180 mg, oral, capsules, bid for 4 w; 240 mg, oral, capsules, bid for 4 w; oral,capsules, bid for 4 w
Intervention MeSH terms: Lesogaberan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GERD treatment; Acid and non-acid Reflux; Heartburn; Regurgitation; Add-on treatment to PPI
Deep Brain Stimulation (DBS) for Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75
      million people in the US and Canada. People with AD have difficulty remembering general facts
      and previously experienced autobiographical events. Animal and human research demonstrates
      that this type of memory depends on neural function within specific brain areas, and that it
      may be possible to enhance memory with electrical stimulation of these brain areas. We have
      recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances
      memory in a human.

      Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by
      activating memory circuits in the brain.

      Methods: Six early AD patients will take part in a phase I clinical study over a 1-year
      period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and
      neurological testing, and brain imaging to detect alterations in brain activity induced by
      stimulation. These assessments will occur one month before surgery, then again at one month,
      6 months, and 12 months after surgery.
    


Intervention name(s): Bilateral fornix DBS implantation,
Intervention type(s): Procedure
Intervention description(s): Fornix DBS for Alzheimer Disease
Other intervention name(s): DBS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      In vitro maturation (IVM) is a technique for obtaining potentially fertilizable oocytes from
      immature oocytes. An oocyte must be mature both nuclearly and cytoplasmically in order to be
      competent in the reproductive process. Nuclear maturation involves an oocyte in metaphase II
      stage and is easily evaluated for its morphology. However, cytoplasmic maturation can only be
      evaluated by in vitro fertilization of that oocyte A mature nuclear and cytoplasmic oocyte is
      one capable of producing a viable embryo. This study aims to fine-tune the in vitro
      maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up
      to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried
      out to check the cytoplasmic maturation of the oocytes, avoiding the generation of
      potentially viable embryos.

      The aim of this study is to evaluate the response to the strategy stimulation with highly
      purified human menopausal gonadotropin (hMG-HP) administered for three days, in association
      with a standard methodology of in vitro oocyte maturation (IVM), to be performed on oocyte
      donors.

      The correct functioning of this IVM technique would mean a reduction in the costs of ovarian
      stimulation treatments, as lower doses and shorter stimulation times are required, which
      implies lower risks for women derived from the medication and less stress for them.
    


Intervention name(s): IN VITRO MATURATION AND OOCYTE ACTIVATION
Intervention type(s): Procedure
Intervention description(s): This study aims to fine-tune the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.
Intervention model: Single Group Assignment
Intervention model description: Prospective and unicentric cohort pilot study
Masking: None (Open Label)
Primary purpose: Other
Keywords: OOCYTE ACTIVATION; IN VITRO MATURATION; OOCYTE RETRIEVAL; DONNOR; hMG-HP
Comparison of Two NN1250 Formulations in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in North America. The aim of this clinical trial was to investigate
      if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the
      body.
    


Intervention name(s): insulin degludec; insulin degludec
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin); Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect Of Maraviroc On The Pharmacokinetics Of Digoxin
Condition: Healthy; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of
      digoxin, a probe for p-glycoprotein.
    


Intervention name(s): Digoxin; Digoxin; Maraviroc
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Digoxin 0.25 mg single dose; Oral Digoxin 0.25 mg single dose on Day 5; Oral Maraviroc 300 mg twice daily for 6 days
Other intervention name(s): Selzentry, Celsentri
Intervention MeSH terms: Maraviroc; Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Maraviroc; Digoxin; P-glycoprotein; Pharmacokinetics; Drug Interaction; HIV
Treatment of Unilateral Complicated Zygomatic Complex Fractures Using Computer-Assisted Navigation System
Condition: Zygomatic Fractures
MeSH terms: Zygomatic Fractures; Fractures, Bone
Study type: Observational

Summary: 
      Many studies show that computer-assisted navigation system have been available to treat
      zygomatic-complex fractures. However, most of them are case reports or clinical experiences
      lacking multiple variables and controlled design. The aim of this study was to evaluate the
      accuracy of the computer-assisted navigation system by a randomized controlled trial with
      multiple variables.
    

Detailed description: 
      In this prospective randomized controlled trial, twenty patients with unilateral complicated
      zygomatic fractures were divided into experimental and control groups. Patients in the
      experimental group were treated with open reduction and internal fixation with the assistance
      of surgical navigation technology, and patients in the control group without it. Preoperative
      and postoperative CT data were obtained to measure surgical landmarks discrepancy between the
      2 groups. The Chi-square Test and t-test were conducted to test whether there was significant
      difference in the accuracy between the two groups. Evaluating the effect of fixation by the
      data and clinical symptoms.

      Twenty patients with unilateral complicated zygomatic-complex fractures received operation.
      All patients healed and their function and facial contour were improved obviously.
      Postoperative clinical symptoms were not significantly different between the two groups
      (P>0.05). Compared with the control group, discrepancy of surgical landmarks measured by
      software Geomagic studio 11, Brainlabiplan CMF 3.0 were significantly low in the experimental
      group (P<0.05). Software measurement showed the symmetry of zygomatic area and the effect of
      the fixation in the experimental group were more satisfactory than the control group.
    

Intervention name(s): computer-assisted navigation system
Intervention type(s): Procedure
Intervention description(s): The computer-assisted navigation system was applied in treatment of unilateral complicated zygomatic fractures
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with unilateral complicated zygomatic-complex fractures
      
Keywords: computer-assisted navigation system
Sleep at 30 Degrees in Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      This study is designed to investigate the effect of body posture (particularly when sleeping)
      on the pressure in the eye. The effect of body posture on progressive glaucoma (glaucoma
      where a significant change i.e. a disc hemorrhage has occurred) is not known.

      The study will involve being admitted to the Sleep Unit of the University Health Network at
      Toronto Western Hospital for 1 night (14 hours). IOP will be measured in both eyes every 2
      hours with a Tonopen, along with brachial blood pressure (BP), in the sitting position until
      the patients reach their normal sleep cycle time. Patients will then be asked to sleep in
      either lying down or reclining at a 30 degrees position and have the IOP measurements and
      brachial BP every 2 hours in that position.

      The same cohort of patients will then be invited for a repeat 14 hour IOP and BP measurement
      but will change their position, i.e. sitting before will now be supine and vice versa.
    


Intervention name(s): Sleeping position in glaucoma patient
Intervention type(s): Behavioral
Keywords: progressive glaucoma despite controlled IOP
Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to determine the safety, efficacy and the way sitagliptin works in patients
      with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.
    


Intervention name(s): Comparator: sitagliptin phosphate; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin tablet 100 mg, administered once daily before the morning meal.; Matching placebo tablet, administered once daily before the morning meal.
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Osseodensification Versus Motor-Driven Expanders' Techniques for Increasing Bone Density With Simultaneous Implant Placement
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The aim of this study was to compare and measure the amount of bone density and ridge width
      gained with motor driven expanders and densifying burs with simultaneous dental implant
      placement.
    

Detailed description: 
      Seven patients were treated by the osseodensification technique and another seven were
      treated by the motor-driven expanders' technique with simultaneous implant placement.
    

Intervention name(s): Osseodensification technique; Motor driven expanders' technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Implant bed preparation will be performed according to the manufacturer's guidelines, densifying burs (Densah® Burs) will be used sequentially in densifying mode (counterclockwise drill speed 800-1500 rpm with copious irrigation) to achieve the planned osteotomy diameter and desired ridge expansion. The implant will be then placed in the prepared osteotomy; The technique consisted of preparing the implant bed by progressively increasing the size of the osteotomes until the desired expansion will be achieved. At the planned implant site, a pilot drill 1000 rpm with irrigation until the desired length, then expansion with the series of ridge spreaders and finally using the final drill. The implant will be then placed in the prepared osteotomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endosseous implants; Osseodensification
The Impact of Acute (2 h) and Short-term (4 Days) Nitrate Supplementation in the Form of Red Beet Root Juice on Intense Intermittent Exercise Performance.
Condition: Exercise Performance
Study type: Interventional

Summary: 
      Both acute ingestion (1-3 h) and chronic supplementation (3-30 days) with dietary nitrate has
      been shown to increase nitric oxide activity and, in some studies, to improve exercise
      economy, exercise tolerance, and endurance exercise performance. In addition, more recent
      evidence suggests that dietary nitrate has the potential to enhance team-sport-specific
      high-intensity intermittent exercise performance. Indeed, chronic dietary nitrate
      supplementation (2-6 days) has been reported to increase the distance covered before
      exhaustion during the Yo-Yo intermittent recovery level 1 test, a well-established and
      ecologically valid test widely used to mimic the high-intensity running bouts of soccer
      match-play. However, while these findings suggest that nitrate may be an effective ergogenic
      aid for team-sport players when consumed daily, it is currently unclear if the improvement in
      team-sport specific intermittent exercise performance can be achieved following a single
      bolus of dietary nitrate. Given the increasing interest and use of dietary nitrate as an
      ergogenic aid by team-sport players, establishing the shortest period of supplementation
      required to elicit an ergogenic effect is important in order to guide athletes on optimal
      supplementation strategies.

      Given that a single bolus of dietary nitrate has previously been shown to improve exercise
      tolerance and endurance exercise performance, and an improved Yo-Yo IR1 performance has been
      observed after chronic nitrate supplementation, the investigator hypothesizes that acute (2
      h) and short-term (4 days) nitrate supplementation will significantly elevate nitric oxide
      activity (measured as an increase in plasma nitrite concentration and skeletal muscle nitrate
      concentration) and improve performance during the Yo-Yo IR1 test (measured as an increased in
      distance covered (m) during the test at the point of volitional exhaustion) to a similar
      extent, when compared to a placebo.
    


Intervention name(s): Test Beet Shot; Placebo Beverage
Intervention type(s): Other; Other
Intervention description(s): Active supplement containing 6.2 mmol nitrate; Placebo supplement containing negligible nitrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science