bioihbjkbjnl/mcl2 huggingface dataset:
Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to evaluate whether saxagliptin or (and vitamin D3) with
      metformin (and insulin) therapy can better protect islet β cell function than metformin(and
      insulin) .
    

Detailed description: 
      LADA is actually a form of type 1 diabetes, which is caused by autoimmune damage of islet β
      cells and triggered by environmental factors based on genetic susceptibility. LADA shows some
      characteristics of type 2 diabetes at its onset, which develops slowly and latent, and easily
      be misdiagnosed as type 2 diabetes due to slowly β cell function deterioration. This is a
      multi-center, open- label, 1:1:1 randomized controlled trial to investigate the protective
      effects of saxagliptin and vitamin D3 in LADA patients. The study comprises the 0-6weeks of
      screening period and the 104-week intervention period. After obtaining the informed
      consent，the screening will find out the eligible patients according to the
      inclusion/exclusion criteria, then the patients will be randomized to the 104-week
      intervention period. Subjects will be randomized into one of the three groups(arms) through
      central dynamic randomization: metformin (and insulin), metformin(and insulin) +saxagliptin,
      metformin(and insulin) +saxagliptin+vitamin D3. Our previous randomized- controlled pilot
      study showed that dipeptidyl peptidase 4 (DPP-4) inhibitors could significantly improve islet
      β-cell function in patients with LADA. The main purpose of this study: To evaluate whether
      saxagliptin (and vitamin D3) with metformin (and insulin) therapy can better protect islet β
      cell function than metformin (and insulin).
    

Intervention name(s): Saxagliptin; Vitamin D3; Insulin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Take saxagliptin tablet 5mg p.o. qd. for 104 weeks after randomization.; Take vitamin D drops 2000 IU p.o. qd. for 104 weeks after randomization.; For optimal control of patients' glucose, researchers can initiate insulin therapy at any time in this trial, choose any brands of insulin after discussion with the patient.; Take Metformin tablet 1.5g p.o. per day for 104 weeks (adjust the dose between 1-1.7g per day according to subject's specific situation) before or after randomization.
Other intervention name(s): Onglyza; Dipeptidyl peptidase 4 (DPP-4) inhibitor; Cholecalciferol; Recombinant Human Insulin, Insulin analogue.; Metformin Hydrochloride tablet
Intervention MeSH terms: Vitamin D; Cholecalciferol; Insulin; Insulin, Globin Zinc; Metformin; Saxagliptin; Dipeptidyl-Peptidase IV Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LADA; saxagliptin; vitamin D3; C-Peptide
Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
Condition: Trigger Finger
MeSH terms: Trigger Finger Disorder
Study type: Interventional

Summary: 
      The purpose of the study is to investigate which strategy is superior in trigger finger
      Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid
      injections.
    


Intervention name(s): Corticosteroid injections; Open surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Corticosteroid injections in and around A1-pulley.; Open A1-pulley release
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quinell grade; Open surgery; corticosteroid injections; randomized controlled trial; Trigger finger
Use of Prineo in Breast Reduction Surgery
Condition: Efficiency of Surgical Incision Closure; Post-operative Scar
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with
      subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the
      final skin layer of one breast will be closed with subcuticular suture while the other breast
      will be closed with Prineo™. The treatment will be randomized to left or right breast.
      Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™
      group, with each patient serving as her own control. For this study, the resident will close
      one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this
      study of incision closure under conditions as similar to normal conditions of closure.
    

Detailed description: 
      Wound closure with dermal sutures is time consuming and may increase risk of infection and
      inflammation. Moreover, appearance of the resulting scar depends largely on surgeon
      technique. Use of the Prineo™ wound closure system may decrease operative time, decrease
      incidence of infection and inflammation, and improve aesthetics of the resulting scar.
      Prineo™ has been shown to hold as well as sutures for the first 12-25 days and may reduce
      closure time of the final skin layer up to 75% in abdominoplasty and breast procedures. The
      system provides excellent coverage of the wound edge, protecting the incision with a
      microbial barrier. Cosmetic results in abdominoplasty and breast procedures appear to be
      equivalent to sutures.

      The main endpoints will be operative time to closure of the final skin layer and
      patient-rated and blinded observer-rated scar quality. The investigators hypothesize that
      operative time to closure of the final skin layer using Prineo™ will be faster than operative
      time to closure using subcuticular suture. The investigators also hypothesize that subjective
      and objective scar quality of incisions closed with Prineo™ will be better than those closed
      with subcuticular suture.
    

Intervention name(s): Prineo
Intervention type(s): Device
Intervention description(s): After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.
Other intervention name(s): Prineo wound closure system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: wound closure; prineo; scar
Study of the Safety, Tolerability, Pharmacokinetics and Pharmcodynamics of ILV-094 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group
      study of ascending single IV doses of ILV-094, an investigational drug, administered to
      healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow
      the 25 mg IV dose.
    


Intervention name(s): ILV-094
Intervention type(s): Drug
Intervention MeSH terms: Fezakinumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion
Condition: Healthy Volunteers
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative potency of multiple oral doses of LUM001
      and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight and
      obese adult subjects. This study is designed to address the relative potency question for the
      first time in the same.
    


Intervention name(s): Placebo; Maralixibat; Volixibat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive placebo matched to maralixibat/volixibat orally for 7 days.; Participants will receive maralixibat in 10 mg, 20 mg, 50 mg or 100 mg doses.; Participants will receive volixibat in 10 mg and 20 mg doses.
Other intervention name(s): LUM001; SHP626
Intervention MeSH terms: Volixibat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Volunteer
The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
Condition: Pain
Study type: Interventional

Summary: 
      The investigators propose to assess whether intra-operative intercostal cryoanalgesia using
      the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior
      post-operative analgesic efficacy as compared to current pain management in patients
      undergoing unilateral thoracotomy cardiac procedures.
    

Detailed description: 
      Completion of the proposed study will for the first time demonstrate efficacy of intercostal
      cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore,
      results of this study may have a pivotal role in supporting future clinical outcome trials
      for intercostal cryoanalgesia therapy.
    

Intervention name(s): Cryoanalgesia; Standard of Care
Intervention type(s): Device; Drug
Intervention description(s): AtriCure® cryoICE cryo-ablation system; Institutional SOC for pain management will be followed.
Other intervention name(s): cryoICE; SOC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CryoAnalgesia; Thoracotomy; Forced Expiratory Volume (FEV1); Visual Analog Scale (VAS)
Effect of an H1 Receptor Antagonist on Exercise Performance in Hypoxia
Condition: Hypoxia, Altitude
MeSH terms: Altitude Sickness; Hypoxia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study seeks to determine whether a simple, single intervention of Cetirizine / Zyrtec®
      use can improve exercise performance of active individuals when acutely exposed to altitude.
      For this project, healthy subjects will perform steady state and progressive work rate
      exercise, endurance performance time trials, and repeated sprint performance time trials in
      the laboratory at a simulated altitude of 3000m (9900ft) after dosing with 10 mg of
      Cetirizine or a placebo in a repeated measures design.
    

Detailed description: 
      This study seeks to determine whether a simple, single intervention of Cetirizine / Zyrtec®
      use can improve exercise performance of active individuals when acutely exposed to altitude.
      For this project, healthy subjects will perform steady state and progressive work rate
      exercise, endurance performance time trials, and repeated sprint performance time trials in
      the laboratory at a simulated altitude of 3000m (9900ft) after dosing with 10 mg of
      Cetirizine or a placebo in a repeated measures design. Non-invasive techniques (pulse
      oximetry, near-infrared spectroscopy [NIRS]) will be utilized to measure changes in arterial
      oxyhemoglobin saturation and skeletal muscle oxygenation at the level of the microvasculature
      during exercise. It is expected that after Cetirizine, blood and muscle microvascular
      oxygenation during heavy exercise will improve compared to placebo, ultimately improving
      exercise performance at altitude. Subjects will be asked to report to the laboratory on a
      three occasions, separated by a minimum of 48 hours and a maximum of 14 days. For each
      subject, all testing sessions will be performed at the same time of day. Prior to each
      testing session, subjects will be asked to abstain from caffeine consumption for 12 hours.
      Subjects will also be asked to avoid alcohol consumption for 24 hours before testing, be at
      least 3-hour post prandial and avoid high-intensity exercise during the 24 hours leading to
      the exercise testing. Finally, subjects will be asked to consume a similar diet the night
      before, and the morning of, Sessions 2 and 3.
    

Intervention name(s): Cetirizine; Placebo oral capsule; Hypoxia
Intervention type(s): Drug; Drug; Other
Intervention description(s): Cetirizine tablet 10 mg; Gelatin placebo; Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft
Other intervention name(s): Zyrtec; altitude, low-oxygen environment
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Team-based Virtual Pediatric Cochlear Implant Clinic
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      The purpose of this study is to see if remote visits for pediatric cochlear implant patients
      are possible. The investigator will be assessing whether a multi-disciplinary team approach
      can be achieved remotely for patients both undergoing the cochlear implant (CI) process and
      for those who have already been implanted.
    


Intervention name(s): Virtual team-based clinic; Remote cochlear implant programming
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Virtual team-based clinic will include consultation, counseling, and education from pediatric audiology, psychology, auditory verbal therapy, and education. Each session lasts approximately 30 minutes with a total of 3 sessions within the year.; Remote cochlear implant programming will be provided via Zoom on a study-provided encrypted laptop.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People
Condition: Fitness
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the effect of daily supplementation of a
      combined orange- and pomegranate extract for a period of 4 weeks on physical fitness compared
      to placebo.

      In this crossover study, participants will daily receive either a placebo or Actiful®, a
      supplement containing 500 mg orange extract and 200 mg pomegranate actives, for 4 weeks
      followed by a wash-out period of 4 to 8 weeks. Subsequently, the second intervention period
      of 4 weeks (active product or placebo) will take place. The product and placebo will be
      supplied in capsules that participants can ingest with a glas of water (daily, prior to
      breakfast).
    

Detailed description: 
      Dietary habits and physical activity are two important components of a healthy lifestyle.
      Targeted nutritional interventions may improve health and stimulate physical activity. Both
      orange extracts and pomegranate concentrate have been shown to exert beneficial effects on
      health and exercise performance. However, the effects of a combination of the two extracts on
      exercise and physical activity have not been investigated yet. It is expected that this
      combination may be an effective dietary way to improve exercise performance, physical
      activity in the free-living state, and quality of life in a middle aged population.
    

Intervention name(s): Actiful; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): supplement containing 500 mg orange extract and 200 mg pomegranate actives; Maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Performance; Polyphenols; Nutrition; Sports
Effects of Kinesio Taping on Hip Abductor Muscle Strength and EMG Activity
Condition: Chronic Ankle Instability
Study type: Interventional

Summary: 
      Athletes with chronic ankle instability tend to develop Glutei muscle weakness. This weakness
      makes the lower limb prone to injuries. Kinesio Tape (KT) may assist this muscle in
      performing its functions thus preventing injuries.
    

Detailed description: 
      The aim was to study the effects of Kinesio Tape on hip abductor muscle strength and EMG
      activity. Pretest-posttest experimental design was used. The study was conducted in the
      research lab of the University. Thirty-four athletes with a mean age of 22.08 years
      participated in the study. For the experimental group Kinesio Tape and for the control group
      Micropore Tape (MT) was applied over Gluteus Medius (GM) muscle. GM muscle's strength and EMG
      activity were noted in supine and during the Single-Leg Squat Test (SLST) respectively before
      and after the intervention. Hip abductor muscle strength measured through a maximum voluntary
      isometric contraction (MVIC) and GM activation measured through EMG. Handheld dynamometer
      (Lafayette manual muscle test system), Power Lab EMG system.
    

Intervention name(s): Kinesio Tape; Micropore Tape
Intervention type(s): Other; Other
Intervention description(s): Kinesio Tape; Micropore Tape
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two parallel groups pretest-posttest design.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Chronic ankle instability; Hip abductors; Kinesio Taping; Muscle strength; EMG
Effects of Acipimox on Mitochondrial Function in Obesity
Condition: Abdominal Obesity; Insulin Resistance; Hypertriglyceridemia
MeSH terms: Obesity; Insulin Resistance; Hypertriglyceridemia; Obesity, Abdominal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to examine whether a medication called acipimox can improve your
      body's mitochondria. Mitochondria are the "power house" of the cell and make energy for your
      body.

      Obesity is associated with increased risk for developing diabetes. However, the investigators
      do not know how obesity leads to diabetes. Previous studies have shown levels of fat in the
      blood (free fatty acids or FFA) are higher in obesity, and elevated FFA can affect how our
      body uses glucose and responds to insulin. Recent studies have shown that changes in
      mitochondria may be involved in the development of diabetes and may be affected by FFA. The
      investigators propose to improve the function of mitochondria in obese people with
      pre-diabetes by treating with acipimox, a medication which decreases FFA. The investigators
      will use state of the art techniques to evaluate the mitochondria, including a new magnetic
      resonance imaging (MRI) technique to measure function of mitochondria in muscle.
    


Intervention name(s): Acipimox; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 250 mg by mouth (PO) three times daily; 0 mg by mouth (PO) three times daily
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Use of Mucograft® to Treat Gingival Recession
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Twenty patients with gingival recession will be enrolled in this trial. Gingival recession
      will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while
      on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.

      Patients will be followed for 3 and 6 months by measuring the clinical indexes and
      statistical analyses will be performed to compare the results and to assess the success of
      Mucograft®.
    

Detailed description: 
      Many surgical techniques have used to treat gingival recession such aas repositioned flaps,
      autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts
      like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft®
      (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue
      regeneration and considered the ideal solution to autogenous soft tissue grafts and it
      provides an ideal matrix for blood vessel and soft tissue ingrowth.
    

Intervention name(s): Mucograft; Connective Tissue Graft
Intervention type(s): Procedure; Procedure
Intervention description(s): This method of grafting will be used to treat the gingival recession using coronally advanced flaps.; This will be used in the traditional manner to correct gingival recession
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingival graft; free gingival graft; coronally advanced flap; reduced keratinized gingiva
A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma
Condition: Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or
      3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than
      placebo in improving lung function in patients with eosinophilic asthma as assessed by the
      overall change from baseline in forced expiratory volume in 1 second (FEV1).
    


Intervention name(s): Reslizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3.0 mg/kg or 0.3 mg/kg doses administered intravenously (iv) by qualified site personnel once every 4 weeks, for a total of 4 doses.; Placebo administered by iv infusion by qualified study personnel every 4 weeks for a total of 4 doses.
Other intervention name(s): Cinquil; humanized monoclonal antibody; CEP-38072
Intervention MeSH terms: Reslizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment