bioihbjkbjnl/mcl2 huggingface dataset:
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed
      fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin & metformin
      extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR
      administered simultaneously.
    


Intervention name(s): High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed; 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR; High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted; 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR; Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed; 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet; 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets; High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet; 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets; Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet; 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
Intervention MeSH terms: Metformin; Empagliflozin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Nutritional Intervention for Migraines-2
Condition: Migraines
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to assess whether, in individuals with migraines, a low-fat,
      vegan diet improves pain more effectively than a control supplement or a placebo. The
      principal measures are pain as measured by Visual Analog Scale (VAS) and the change in
      migraines frequency. The study duration is 36 weeks.This study also tests that a low fat,
      plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using
      the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck
      Depression Inventory II (BDI-II).
    

Detailed description: 
      Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional
      supplements can help reduce pain and also reduce the need for pain medications for some
      people. The investigators will ask about 100 people to participate. All of them will get a
      low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a
      placebo), although some will get the diet first, and others will get the supplement first.
      This order in which they will get the diet and the supplement will be determined randomly,
      that is, by chance (like the toss of a coin). The principal measures are pain as measured by
      Visual Analog Scale (VAS)and the change in migraines frequency.

      Mood change will be measured using the Center for Epidemiologic Studies Depression
      Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
    

Intervention name(s): Plant based diet; an unrestricted diet
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Migraines, diet, vegan, vegetarian, plant-based
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.
    

Detailed description: 
      The purpose of this clinical investigation is to evaluate the safety and performance of the
      Doraya catheter in patients admitted with AHF, presenting persistent volume over load and
      poor response to diuretic treatment.
    

Intervention name(s): Doraya catheter
Intervention type(s): Device
Intervention description(s): Temporary deployment of the Doraya catheter in AHF patients.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Eluting Stents Versus Bare Metal Stents for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis
Condition: Ischemic Stroke; Vertebral Artery Stenosis
MeSH terms: Ischemic Stroke; Vertebrobasilar Insufficiency; Constriction, Pathologic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Stroke is one of the important causes of disability and death in the world, in which more
      than half were ischemic strokes. About 1/4 of the ischemic stroke occurred in the vertebral
      basilar artery system, especially when in the presence of extracranial proximal vertebral
      artery stenosis. Vertebral artery stenting is a minimally invasive method for the
      reconstruction of vertebral artery stenosis and the early clinical studies showed that it was
      feasible, safe and effective, but the high rate of restenosis has become a bottleneck
      restricting its development. Previous systematic review had suggested that the drug eluting
      stent might reduce the incidence of restenosis of vertebral artery. However, prospective
      randomized controlled trials comparing the efficacy of bare metal stents and drug eluting
      stents on the prevention of restenosis remains absent.
    

Detailed description: 
      60 patients were randomly assigned into DES and BES group to compare the safety and efficacy
      in the treatment of symptomatic extracranial vertebral artery stenosis with drug eluting
      stents (YINYI) and bare metal stents (Express SD), especially the stent restenosis rate after
      6 months.
    

Intervention name(s): Drug eluting stent (DES); Bare metal stent (BES)
Intervention type(s): Device; Device
Intervention description(s): Polymer-free paclitaxel eluting stents; Bare metal stent
Other intervention name(s): YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.); Express SD (Bosten Scientific)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vertebral Artery Stenosis; Ischemic Stroke; Stent
Combined Versus Successive Macular Hole and Cataract Surgery
Condition: Macular Hole; Visual Acuity
MeSH terms: Cataract; Retinal Perforations
Study type: Observational

Summary: 
      The purpose of this study is to compare functional and anatomical results of a combined
      surgery and two time surgery for macular hole and cataract extraction in one hundred and
      twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic
      centers.
    

Detailed description: 
      Main outcome measures were the assessment of visual acuity at 6 and 12 months,and the rate of
      closure of MH by OCT (optical coherence tomography).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with symptomatic visual loss and needed vitrectomy for Macular Hole treatment.
      
Keywords: Macular Hole; Cataract surgery; Vitreoretinal surgery; Combined surgery; Idiopathic
Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)
Condition: Tooth Discoloration
MeSH terms: Tooth Discoloration
Study type: Interventional

Summary: 
      This study is a single blind, prospective study aimed to evaluate the safety and efficacy of
      the Silk'n ToothWave Powered Toothbrush for stains reduction and improvement of teeth shade.
    

Detailed description: 
      The study includes a total of 84 treatment sessions, twice a day, and 4 clinic visits over a
      period of 6 weeks.

      One treatment group (Silk'n powered toothbrush - ToothWave) and 1 control group (an ADA
      approved powered toothbrush (PTB)) will participate in the study.

      For each patient, efficacy assessment data will be collected at baseline, 4 weeks, and at 6
      weeks. The average stain data will be calculated for each group.

      Treatment is defined as a timed, 2 minute brushing of the teeth according to the
      manufacturer's instructions, twice daily (morning and evening). Brushing will be undertaken
      using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use an
      ADA accepted PTB and standard fluoride toothpaste.
    

Intervention name(s): ToothWave; powered toothbrush
Intervention type(s): Device; Device
Intervention description(s): RF-utilizing powered toothbrush for teeth whitening; regular powered toothbrush with no RF
Other intervention name(s): RF toothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double arm, single blind prospective study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot
Condition: Tetralogy of Fallot With Pulmonary Stenosis
MeSH terms: Tetralogy of Fallot; Pulmonary Valve Stenosis; Ventricular Remodeling
Study type: Interventional

Summary: 
      Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at
      35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or
      pulmonary regurgitation (PR). It is well established that these lesions can lead to
      irreversible sequelae such as right ventricle dilatation and dysfunction. Pulmonary valve
      replacement technique was developed to avoid long term right ventricular dysfunction.
      Pulmonary valve replacement indications are based upon the presence of symptoms at exercise
      and/or morphological or functional parameters such as severe pulmonary regurgitation with
      right ventricle dilatation/dysfunction. The best timing of such intervention is still
      underdebate with the main aim of having the right balance between avoiding long term sequelae
      of PR or PS and being the latter possible to push ahead the need for new intervention. Recent
      publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration
      of myocardial contractility. Quantification of diffuse fibrosis by magnetic resonance imaging
      is feasible and could help the physician to best determine the right timing for PVR in this
      population of patients. Cardiac function assessment at rest and during exercise is possible
      using MR and our centre has developed a program for cardiac exercise during MRI. This could
      help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise.
    


Intervention name(s): MRI
Intervention type(s): Other
Other intervention name(s): assesment RV and LV ejection fraction after PVR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pulmonary valve replacement; tetralogy of Fallot
Effects of Red Light LED Therapy on Body Contouring
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether red light therapy using LED 650nm red light
      for body contouring of the waist, hips and thighs is as effective as red light therapy using
      Laser 635nm red light.
    

Detailed description: 
      Red light laser therapy using 635nm red light laser technology has previously been shown to
      cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body
      contouring. This study hypothesizes that red LED light therapy using 650nm red light LED
      (light emitting diode) technology produces similar results to the laser device (red LASER
      635nm) when preformed using a specified treatment protocol.

      Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after a
      single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward
      Photonics) achieves its results after one 32 minute therapy program.

      The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light
      therapy. This multi-site study reviews results from 66 randomly selected patients after a
      single treatment using the Vevazz LED device.
    

Intervention name(s): Vevazz LED
Intervention type(s): Device
Intervention description(s): Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      The purpose of this study is to develop an Auditory Brainstem Response (ABR) based
      neurological screening method to detect increased risk for Autism Spectrum Disorders (ASD)
      and other neurological conditions in newborns.
    

Detailed description: 
      In the proposed study, a screening method for neurological deficits, with an emphasis on its
      application to ASD, will be developed and its feasibility demonstrated. The proposed method
      will utilize high rate stimulation to acquire Auditory Brainstem Responses in order to
      determine peak latency and amplitude differences in children with ASD compared to non-ASD.
      Similarly to newborn hearing screening, the output of the screening method will provide an
      automated pass or refer outcome that can be used by a physician to determine if the child
      needs further evaluation.
    

Intervention name(s): No Intervention Provided
Intervention type(s): Other
Intervention description(s): No Intervention Provided
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children with autism spectrum disorders and normally developing age- and gender-matched
        controls
      
Keywords: Autism Spectrum Disorder
Immune Monitoring in Sensitized Patients at Risk of Rejection
Condition: Kidney Failure
MeSH terms: Renal Insufficiency
Study type: Observational

Summary: 
      The purpose of this study is to test the effect of anti-rejection medications on your immune
      system
    

Detailed description: 
      Recipients of deceased or living donor transplants with calculated percent reactive antibody
      (cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled
      in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained
      pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be
      obtained at the same true intervals including pre-transplant in patients who still produce
      urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core)
      of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for
      gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and
      urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior
      to treatment intensification and procedure. Patient's who are treated for rejection, will
      have additional samples obtained 2-4 weeks after treatment of rejection and at the time of
      any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have received a kidney transplant and will be taking immunosuppressive
        medications.
      
Biospecimen description: 
      Blood and urine
    
Keywords: Kidney transplant recipient
Integrating the Genetic and Metabolic Faces of Obesity
Condition: Insulin Resistance; Obesity; Metabolic Syndrome
MeSH terms: Obesity; Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to determine why some obese individuals develop insulin resistance
      and others do not. We hypothesize that an impairment in differentiation of fat cells
      (adipocytes) is responsible for the development of insulin resistance in select obese
      individuals. This study will evaluate obese individuals at baseline with respect to
      characteristics of adipocytes, including gene expression, and will then entail randomizing
      subjects to either weight loss or treatment with an insulin sensitizing drug (pioglitazone).
      Changes in insulin resistance will be associated with changes in adipocyte morphology and
      gene expression.
    

Detailed description: 
      Healthy overweight/obese individuals will be screened for insulin resistance. Both insulin
      resistant individuals and insulin sensitive individuals (to serve as controls) will be
      eligible to enroll. Fat cel biopsy and CT scan of the abdomen is required at baseline and
      after an intervention with either weight loss or pioglitazone (drug to improve insulin
      resistance). Subjects will repeat insulin resistance test after the intervention as well.
      Subjects will learn much about their metabolism in this study, and will have an opportunity
      to improve their insulin resistance.
    

Intervention name(s): weight loss; thiazolidinedione
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: 2,4-thiazolidinedione
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: obesity; insulin resistance; thiazolidinedione; weight loss; adipose tissue; metabolic syndrome; diabetes prevention; cardiovascular disease prevention
Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD
Condition: Postmenopausal
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized,
      Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150,
      and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with
      Low Bone Mineral Density.
    


Intervention name(s): risedronate; risedronate; risedronate; experimental
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablet, 5 mg risedronate daily for 6 months; tablet, 100 mg risedronate monthly for 6 months; tablet, 150 mg risedronate monthly for 6 months; tablet, 200 mg risedronate monthly for 6 months
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers
Condition: Alcohol-induced Disorders; Drug Users; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Alcohol-Induced Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to examine the implementation of two evidence-based intervention
      strategies of SBIRT (Generalist vs. Specialist) for adolescent alcohol, tobacco, other drug
      use, and HIV risk behaviors.
    

Detailed description: 
      Guided by Proctor's conceptual model of implementation research, the proposed study is a
      multi-site, cluster randomized trial to compare two principal strategies of SBIRT delivery
      within adolescent medicine. In the Generalist Strategy, the primary care provider delivers
      brief intervention (BI) for substance misuse. In the Specialist Strategy, BIs are delivered
      by behavioral health counselors. The 7 study sites, primary care clinics operated by a large,
      urban Federally Qualified Health Center in Baltimore, will be randomly assigned to implement
      SBIRT for adolescents using either the Generalist or Specialist strategies. Staff at each
      site will be trained in the assigned implementation strategy, and quarterly booster trainings
      will be provided during the implementation period. Implementation outcomes, including:
      penetration, costs/cost-effectiveness, acceptability, timeliness, fidelity/adherence, and
      patient satisfaction will be assessed during the 18-month-long implementation period using a
      complementary combination of administrative service encounter data, provider and patient
      surveys, and qualitative interviews. At the end of the active implementation period, all
      training and technical support activities will cease for 12 months in order to measure
      relative sustainability. The study will also examine the effectiveness of integrating HIV
      risk screening within an SBIRT model.
    

Intervention name(s): The brief interventions are delivered by behavioral health counselors (Specialist); The brief interventions are delivered by the primary care provider (Generalist)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral Health Specialists perform the brief intervention. The screening and referral to treatment processes remain the same as with the Generalist condition.; Primary care providers perform the brief intervention. The screening and referral to treatment processes remain the same as with the Specialist condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: implementation; SBIRT; alcohol screening; drug screening; Brief Intervention; Referral to Treatment; adolescents; Federally Qualified Health Centers
Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital
Condition: Acute Cholecystitis
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
Study type: Observational

Summary: 
      The aim of this retrospective study was to assess the different outcomes of early (performed
      on the patient's first admission for acute cholecystitis) and delayed cholecystectomy (done
      on a second admission) at King Abdulaziz University Hospital in Jeddah, Saudi Arabia.
    

Detailed description: 
      This study was conducted retrospectively through reviewing patients medical records
    

Intervention name(s): Cholecystectomy
Intervention type(s): Procedure
Intervention description(s): Cholecystectomy (removal of the gallbladder) for acute cholecystitis
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The data were collected retrospectively from the electronic medical records data system at
        KAUH. We included all adult patients who presented to the Emergency Department of KAUH with
        an acute cholecystitis between January 2010 and April 2018
      
Keywords: Acute cholecystitis; Cholecystectomy; overweight; BMI; early; delayed