bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
Condition: Diabetes Mellitus, Type 2; Noninsulin-Dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the efficacy and safety of the Fractyl duodenal
      mucosal resurfacing (DMR) Procedure using the Revita System compared to a sham procedure for
      the treatment of uncontrolled type 2 diabetes.

      Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham
      treatment arm will cross over to receive the DMR treatment at 24 weeks with background
      medications held constant from 24-48 weeks of follow up.
    

Detailed description: 
      The study is a multi-center, randomized, prospective, double-blinded (subject and
      endocrinologist) trial of type 2 diabetes patients sub-optimally controlled on 1 or more oral
      anti-diabetic medications comparing the Fractyl DMR procedure to sham procedure.
      Randomization will be 1:1 DMR treatment to sham. All subjects will participate in a 4 week
      oral anti-diabetic medication run-in period before the index procedure to confirm lack of
      blood glucose control in conjunction with medication compliance and nutritional counseling.
      The Sham treatment arm will cross-over to receive the DMR treatment at 24 weeks with
      background medications held constant 24weeks of follow up after the cross-over DMR procedure.
      The DMR treatment arm will be managed according to current diabetes standard of care.

      Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham
      treatment arm will cross over to receive the DMR treatment at 24 weeks with background
      medications held constant from 24-48 weeks of follow up.
    

Intervention name(s): DMR Procedure; Sham Procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System; The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
Other intervention name(s): DMR; Revita
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes, Revita System, DMR
Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
Condition: Seizures
MeSH terms: Seizures; Epilepsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety,
      tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral
      Solution in a sequential fashion.

      Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant
      seizures, and satisfy all inclusion/exclusion criteria.
    


Intervention name(s): Cannabidiol Oral Solution
Intervention type(s): Drug
Intervention description(s): An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Intervention MeSH terms: Cannabidiol
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment-resistant seizures
Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      Anti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of
      diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid
      and or vascular endothelial growth factor (VEGF) antibodies into the vitreous cavity or slow
      release drug capsules surgically implanted in the eyes run the risk of surgical complications
      including infections, hemorrhages and cataracts and place a huge demand on eye care resources
      significantly increase the risk of cardiovascular events and death.

      A non-invasive drug delivery platform with steroid eye drops, reaching the back of the eye to
      treat DME and other retinal diseases would circumvent most of these problems.

      A novel drug delivery platform is required for ocular therapy. Oculis ehf. has developed a
      drug delivery platform, which is based on cyclodextrin nanoparticles that dissolve in the
      tear fluid to form water-soluble drug/cyclodextrin complex nanoparticles. Animal and initial
      clinical testing has shown the potential for this technology to increase the drug
      concentration in the eye tissues including the retina and therefore treat retinal diseases
      like DME.
    


Intervention name(s): Dexamethasone nanoparticles eye drops
Intervention type(s): Drug
Intervention description(s): DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks
Intervention MeSH terms: Dexamethasone; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bortezomib (Velcade®), Lenalidomide (Revlimid®) and IV Busulfan (Busilvex®) in Patients Under 65 Years Old
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol is a national, multicenter, comparative, open-label, randomized trial comparing
      the progression free survival (PFS) of two pre-transplant conditioning regimens (BUMEL
      versus. MEL-200).

      A total of 460 patients will be enrolled in the study. Scheduled evaluations and study visits
      will take place during the pre-treatment, treatment and follow-up periods.

      The pre-treatment period includes the screening visit in which participants provide informed
      consent in writing in order to take part in the study. The patient is then assessed to
      determine his/her eligibility. The selection process will begin 21 days before the first dose
      of medication is administered (days -21 to 0). During the treatment period, eligible patients
      will be included in the study and given six cycles of induction treatment with bortezomib/
      lenalidomide / dexamethasone (VRD-GEM). Each cycle will last 28 days, during which SC
      bortezomib will be administered on days 1, 4, 8 and 11, oral lenalidomide on days 1-21 of
      each cycle, and oral dexamethasone on days 1-4 and 9-12 of the cycle.

      After the first three induction cycles, and in the absence of progression or unacceptable
      toxicity, peripheral blood hematopoietic stem cells will be mobilized and collected using
      G-CSF for later autologous transplantation. Patients will be randomized in a 1:1 allocation
      ratio to receive conditioning treatment with MEL-200 versus BUMEL. Randomization will take
      place at the beginning of the study, once the screening is complete and the patient's
      eligibility verified. Three months after transplantation, patients will receive two cycles of
      consolidation treatment with VRD-GEM at the same doses administered during induction
      treatment.

      Once the treatment phase is complete, patients will begin the follow-up phase in which they
      will be visited every three months to evaluate disease progression and survival
    


Intervention name(s): bortezomib (Velcade ®); lenalidomide (Revlimid®); busulfan (Busilvex ®); Dexamethasone acetate; Melphalan
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Bortezomib; Melphalan; Busulfan; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; MEL200; BUMEL
Effects Whole Body Vibration in Ergospirometrics Parameters and Quality of Life
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study makes sure that the training of whole body vibration induces changes in
      ergospirometric parameters, in strength and influence in quality of life in healthy elderly.
      A case that is run like a vibration training combined, increasing strength and VO2.
    

Detailed description: 
      The search use the spirometric values after whole body vibration training and resistance
      training
    

Intervention name(s): WHOLE BODY VIBRATION
Intervention type(s): Procedure
Intervention description(s): 03 MONTHS, TWICE PER WEEK
Other intervention name(s): POWER PLATE, MODEL MY3
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: WHOLE BODY VIBRATION; AGED; VO2; muscle strength
Acoustical Properties of Speech as Indicators of Suicidal Risk
Condition: Depression
MeSH terms: Depression
Study type: Observational

Summary: 
      This project is focused on acoustical, sound, analysis of speech in order to identify vocal
      characteristics of speech that are associated with suicidality. Speech samples will be
      collected from four populations with different mental health status: suicidal, ideational
      suicidal, depressed and those in remission from depression, (the control group). Speech of
      subjects will be recorded during routine diagnostic interview sessions. The speech samples
      will be acoustically analyzed via digital computer algorithms. The acoustical differences
      among those groups will be determined based on the statistical analysis.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Acutely suicidal depressed patients; non-suicidal depressed patients;
      
Keywords: depression; suicide; voice
An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed
      by:

        -  Subject self-examination skin irritation scores

        -  Adverse events

        -  Changes in vital signs and ECG parameters

      The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:

        -  Headache pain free at two hours after patch activation for all initial acute migraine
           attacks treated with NP101

        -  Headache pain relief at two hours after patch activation for all initial acute migraine
           attacks treated with NP101

        -  Nausea free at two hours after patch activation for all initial acute migraine attacks
           treated with NP101

        -  Phonophobia free at two hours after patch activation for all initial acute migraine
           attacks treated with NP101

        -  Photophobia free at two hours after patch activation for all initial acute migraine
           attacks treated with NP101

        -  Migraine free at two hours after patch activation for all initial acute migraine attacks
           treated with NP101

      This study will use an open-label design to assess the long term safety of NP101 (sumatriptan
      iontophoretic transdermal patch).

      Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not
      contraindicated) and received treatment (patch activation) with the study patch for a
      qualifying migraine under study NP101-007 will be considered eligible for enrollment into the
      open-label study. Subjects will be expected to remain in the study for up to 12 months.
    


Intervention name(s): NP101
Intervention type(s): Drug
Intervention description(s): NP101 study patch 4 hour application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane
Condition: Patients in Good Health
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the profile of cytokines IL-1beta, IL-6, IL-8, IL-10,
      IL-12 and TNF-alpha under inhalation anesthesia with isoflurane and intravenous anesthesia
      with propofol in healthy patients subjected to minimally invasive elective surgeries.
    

Detailed description: 
      Twenty ASA-I patients, subjected to otorhinolaryngology surgery, were randomly allocated in
      one group to receive anesthesia with isoflurane 1 MAC (minimum alveolar concentration) (n =
      20). Other group with twenty ASA-I patients received propofol 2 to 4 microgram mL-1 (n = 20).

      Fentanyl 5 mg kg-1 and rocuronium bromide 0.6 mg kg-1 were also administered to all patients.
      Venous blood (10 mL) was collected from each patient at each of the following times: before
      the beginning of surgery and anesthesia (T1), 2 h after the beginning of surgery (T2), and on
      the day after the anesthetic-surgical procedure (T3).

      Plasma concentrations of interleukins IL-1beta, IL-6, IL-8, IL-10 and IL-12 and tumor
      necrosis factor (TNF-alpha) were measured in each sample through flow cytometry technique by
      using the method Cytometric Bead Array (CBA). Venous blood samples from fifteen volunteers
      not subjected to stress were also collected as control, and the same cytokines were measured.
    

Intervention name(s): Propofol and isoflurane
Intervention type(s): Drug
Intervention description(s): Comparison of two anesthetic drugs
Other intervention name(s): Diprivan; isoflurane
Intervention MeSH terms: Propofol; Isoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: cytokines; propofol; isoflurane; flow cytometry; Types of General Anesthesia
Role of the MET Oncogene in Human Colorectal Cancer - A Translational Study
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The MET oncogene is known to sustain the Trousseau's syndrome in murine experimental models,
      featuring association of carcinogenesis with a blood procoagulant disorder. MET is frequently
      overexpressed in colorectal cancer, a tumor where venous thromboembolism (VTE) may occur in
      association with poor prognosis, but the biological and genetic factors that cause VTE are
      still obscure.

      The Investigators propose to study whether in patients harboring a surgically resectable
      colorectal cancer the MET oncogene is expressed and may be associated with a blood
      thrombophilic condition that favors the onset of VTE.

      These data would have two main implications: (i) for the first time, a direct genetic link
      between the MET oncogene and a procoagulant disorder would be demonstrated in humans; (ii)
      the procoagulant alterations would have diagnostic/prognostic significance for the
      identification of patients at risk for poor outcome, and implementation of appropriate
      therapeutic protocols.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with resectable colorectal tumor with survival prognosis>6 month
      
Keywords: resectable colorectal cancer
Safety Study to Evaluate Bilateral CNTF Implants in Subjects With MacTel Type 2
Condition: Macular Telangiectasia Type 2
MeSH terms: Telangiectasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, open-label, 6-month study to evaluate the safety of bilateral CNTF
      implants in participants with Macular Telangiectasia Type 2.
    


Intervention name(s): NT-501 CNTF implant
Intervention type(s): Combination Product
Intervention description(s): Single implantation of CNTF-secreting NT-501 device into one eye
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular Telangiectasia Type 2; CNTF; Mactel
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)
Condition: Recurrent Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back
      pain.
    


Intervention name(s): MK0663, Etoricoxib / Duration of Treatment : 12 Weeks; Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
Condition: Pharmacokinetics; Renal Impaired; Healthy Volunteer
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and
      its metabolites in subjects with severe renal impairment compared to matched healthy subjects
      with normal renal function
    


Intervention name(s): LCZ696A; LCZ696A
Intervention type(s): Drug; Drug
Intervention description(s): once daily administration of 400 mg LCZ696 for 5 days
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LCZ696; pharmacokinetics
Vilazodone for Menopausal Hot Flashes
Condition: Hot Flushes
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      This is a pilot study to determine proof in principle that vilazodone, a selective serotonin
      reuptake inhibitor and 5HT1a agonist, reduces the frequency and severity of menopausal hot
      flashes relative to placebo. A secondary aim is to evaluate improvement in menopause-related
      quality of life.
    

Detailed description: 
      This is a proposal to conduct a small clinical trial for proof in principle that vilazodone
      reduces the frequency and severity of menopausal hot flashes. An additional exploratory aim
      is to identify improvement in menopause-related quality of life. Healthy, perimenopausal
      women ages 45-60 with an average of 4 or more moderate or severe hot flashes/night sweats per
      day for 3 screening weeks will be randomized to 8 weeks of treatment in a 2:1 ratio of
      vilazodone or matching placebo pills. Flexible dosing of vilazodone will start at 10 mg
      once/day for 7 days, increase to 20 mg/day for 1 more week and increase to 40 mg once/day at
      week 3 if unimproved. The primary outcome assessments are the frequency and severity of hot
      flashes at week 4 and week 8 as assessed by prospective daily diaries (using 7-day mean
      scores from the daily diaries). The secondary outcome is clinical improvement, defined as hot
      flash frequency >=50% decrease from baseline. Treatment-emergent adverse events will be
      monitored and patient ratings of tolerability will be obtained.
    

Intervention name(s): vilazodone; placebo capsules
Intervention type(s): Drug; Drug
Intervention description(s): capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved.; placebo capsules matched to drug capsules.
Other intervention name(s): viibryd
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: menopause; hot flashes; vilazodone
Organization in Acute Atrial Fibrillation Post Open Heart Surgery
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      A form of irregular heart rate called, Atrial Fibrillation (AF) is a major clinical problem.
      It afflicts about 2 million Americans and is the single largest heart related cause of
      stroke. However, despite 120 years of speculation and research, the mechanisms that cause AF
      are poorly understood. Acute AF is also the most common irregular heart rate after open-heart
      surgery in patients. This is seen in as many as 30% of such patients and often results in a
      longer hospital stay.

      In this study we would like to study the pattern of atrial fibrosis (scar tissue in the
      heart) and an associated blood marker (a protein called pro-collagen-1) in those patients
      concurrently having open heart surgery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any person over 18 years having an elective valve, CABG or combination procedure
      
Biospecimen description: 
      Tissue sample for the right and left sid eof the heart.
    
Keywords: Atrial Fibrillation post open heart surgery
Effects of Parental Holding on Pain Response in Young Children During Cystometry
Condition: Vesico-Ureteral Reflux; Filum Terminale Lipoma
MeSH terms: Vesico-Ureteral Reflux
Study type: Interventional

Summary: 
      Cystometry is essential for diagnosis and treatment plans by identifying the causes of lower
      urinary tract symptoms and objectively evaluating bladder functions in diseases such as
      neurogenic bladder, voiding dysfunction, and vesicoureteral reflux. Children may experience
      pain during this invasive procedure of inserting the urethra catheter. Furthermore, infants
      aged ≥ 6 months may feel pain from an unfamiliar and unnatural environment as they experience
      stranger anxiety. This experience can have a negative physical and emotional impact on
      children, and uncooperative behavioral reactions caused by pain can hinder the procedure. In
      this regard, parental holding is known as effective non-pharmacological procedural pain
      management in children. Although the International Children's Continence Society has advised
      performing cystometry while holding the infant as an effective non-pharmacological pain
      management method, there is insufficient evidence to support this. So, this study aimed to
      analyze the effect of parental holding on reducing pain in children during cystometry.
    

Detailed description: 
      This is an experimental study in a randomized controlled pre-posttest design. During
      cystometry, participants in the experimental group are placed on the parents' laps and held
      in the parents' arms. Participants in the control group are laid down on the examination
      table. The behavioral (FLACC scale) and physiological (oxygen saturation and heart rate) pain
      responses are measured at three time points (immediately, 3 min, and 10 min after urethral
      catheter insertion).
    

Intervention name(s): Lying; Holding
Intervention type(s): Behavioral; Behavioral
Intervention description(s): After the urethral catheter is inserted, the participant lies on an examination table lined with paper towels and diapers.; Holding is performed as a non-pharmacological intervention to relieve pain in children during cystometry. After the urethral catheter is inserted, the participant's parent sits in the chair, placing a paper towel and diaper on their lap. The researcher lifts the participant by the shoulder and puts them on their parent's lap, and the parent holds the participant in their arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cystometry; children; parental holding; procedural pain; pain response; pain management