bioihbjkbjnl/mcl2 huggingface dataset:
Combined Spinal/Epidural (CSE) Saline Duration/Spread
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Sterile normal saline 0 mls; 15 mls sterile normal saline
Intervention description: at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.; After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: labor pain treatment; duration analgesia; Analgesic duration with normal saline injection.; Analgesic duration without normal saline injection

Summary:

      An attempt is being made to see if by injecting a set volume of sterile saline into the
      epidural space during the treatment of labor pain with a combined spinal/epidural (CSE)
      increases the amount of pain relief obtained and makes the labor analgesia lasts longer.
      Subjects are in the study from the time their CSE is placed until they request additional
      pain medication from the spinal dose of numbing medicine wearing off.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age greater than 12 years of age

          -  ASA status 1 or 2

          -  cervical dilation < 6cm

        Exclusion Criteria:

          -  ASA assigned 3 or 4

          -  advanced labor (> 6cm cervical dilated)

          -  distorted epidural anatomy
Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Povidone-Iodine; Essential oils; Tap water
Intervention description: Gargle; Gargle; Gargle
Intervention MeSH terms: Povidone-Iodine; Listerine; Povidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 arms
Gargle with povidone-iodine
Gargle with essential oils
Gargle with tap water
Control
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gargle; povidone-iodine; essential oils; tap water

Summary:

      The purpose of this study is to assess the ability of regular gargling to eliminate severe
      acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the throat and nasopharynx. This 4
      arms interventional study compares the effect of gargling using povidone-iodine, essential
      oils- based, tap water with control (no intervention) among Stage 1 coronavirus disease-2019
      (COVID-19) patients.

      Findings from this study will provide new insight into the importance of gargling in the
      treatment and prevention of COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. adult aged 18 years and above

          2. able to understand instructions

          3. Stage 1 COVID-19

          4. < 5 days of illness or diagnosis

        Exclusion Criteria:

          1. Less than 18 years old

          2. Unable to understand instructions

          3. Stage 2 & 3 COVID-19

          4. Respiratory symptoms or fever on admission

          5. Abnormal chest radiograph or computed tomography (CT) findings on admission
The Study of an Investigational Drug, Revusiran (ALN-TTRSC), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Whose Disease Has Continued to Worsen Following Liver Transplant
Condition: Transthyretin (TTR)-Mediated Amyloidosis; Familial Amyloidotic Polyneuropathy (FAP); ATTR Amyloidosis; Familial Amyloid Neuropathies
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Intervention: Revusiran
Intervention description: 500mg Revusiran by subcutaneous (sc) injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FAP; Familial Amyloidotic Polyneuropathy; ATTR Amyloidosis; Orthotopic Liver Transplant; RNAi therapeutic

Summary:

      The purpose of this study was to evaluate the safety and effectiveness of revusiran
      (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis (ATTR), whose disease has
      continued to worsen after liver transplantation. Dosing has been discontinued; patients are
      being followed-up for safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of FAP (familial amyloidotic polyneuropathy) with documented TTR mutation

          -  Received an orthotopic liver transplant ≥12 months before the date of informed consent

          -  An increase in polyneuropathy disability (PND) score post-transplant

          -  Polyneuropathy Disability score of ≤3b

        Exclusion Criteria:

          -  New York Heart Association (NYHA) classification of >2

          -  Other known causes of sensorimotor or autonomic neuropathy (eg, autoimmune disease)
Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: 67.5 mg oral insulin crystals daily; 500mg oral insulin crystals every other week
Intervention description: human insulin crystals in capsules; human insulin crystals in capsules
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Isophane; Methamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 3 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: oral insulin

Summary:

      The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to
      assess the effects of varying doses and schedules of oral insulin on immunological and
      metabolic markers in relatives at risk for type 1 diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is
             relative of proband with type 1 diabetes

          -  Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7
             with an abnormal OGTT

          -  Confirmed positive for insulin autoantibodies within previous six months

          -  Confirmed positive for one or more other autoantibodies on two separate occasions
             within the past six months

        Exclusion Criteria:

          -  Diagnosed with type 1 diabetes

          -  History of treatment with insulin or oral hypoglycemic agent

          -  History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids
             within the past two years for a period of more than three months

          -  Ongoing use of medications known to influence glucose tolerance

          -  Pregnant or intending to become pregnant while on study or lactating
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
Condition: Stasis Dermatitis
MeSH terms: Dermatitis
Intervention: crisaborole ointment; vehicle ointment
Intervention description: crisaborole ointment; vehicle ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Stasis Dermatitis; venous hypertension; venous insufficiency

Summary:

      This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of
      concept study that will include participants with stasis dermatitis without active skin
      ulceration, who will receive crisaborole ointment 2% or vehicle twice daily for 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are ≥45 years of age and in generally stable health

          -  Participants who are in generally stable health and have a known diagnosis of Stasis
             Dermatitis or newly diagnosed Stasis Dermatitis

          -  Participants whose mental and physical status allows them to be able to mostly perform
             their activities of daily living with minimal assistance

        Exclusion Criteria:

          -  Participants with clinically significant active or potentially recurrent dermatitis
             conditions and known genetic dermatological conditions that are not Stasis Dermatitis
             or overlap with Stasis Dermatitis

          -  Participants with active venous stasis ulceration on either lower extremity.

          -  Participants with current infection or suspected infection of any Stasis Dermatitis
             lesions

          -  Women of child bearing potential (WOCBP) are not eligible for this study
A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer
Condition: Hepatocellular Carinoma
MeSH terms: Vaccinia
Intervention: JX-594 recombinant vaccina GM-CSF
Intervention description: Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver Cancer; HCC; first line HCC; Pexa-Vec; JX-594

Summary:

      This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients
      with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with
      sorafenib, and the safe administration of JX-594 in five weekly IV infusions.
    

Eligibility criteria:

        KEY Inclusion Criteria:

          -  Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma
             (HCC)

          -  Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the
             arterial phase on CT scanning)

          -  ECOG performance status 0, 1 or 2

          -  Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites

          -  Platelet count ≥50,000 plts/mm3

          -  WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3

          -  Hemoglobin ≥10 g/dL

          -  Adequate liver function

        KEY Exclusion Criteria:

          -  Received sorafenib as previous treatment for HCC for more than 14 days

          -  History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis
             requiring systemic therapy for > 4 weeks)

          -  Prior treatment with JX-594

          -  Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or
             medication

          -  Severe or unstable cardiac disease

          -  Viable CNS malignancy associated with clinical symptoms

          -  Pregnant or nursing an infant

          -  Significant bleeding event within the last 12 months.
A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: SB-742457 15mg; SB-742457 35mg; Placebo; donepezil 5-10mg
Intervention description: SB-742457 - 15mg added to existing donepezil treatment; SB-742457 - 35mg added to existing donepezil; Placebo added to existing donepezil; existing donepezil treatment
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 682.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease cognition SB-742457

Summary:

      The study is designed to investigate the safety and efficacy of SB-742457 when added to
      stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects and their caregivers must provide informed consent prior to study entry.

          -  Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's
             disease with no evidence of disorders that are thought to be the cause of, or
             contributing to the severity of the subject's dementia and a documented history of at
             least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2
             months.

          -  Subjects must have a regular caregiver who is willing to attend visits, oversee the
             subject's compliance with the study and report on the subject's status.

          -  Female subjects of child-bearing potential must agree to abstinence or an approved
             form of birth control.

          -  Subjects must have adequate blood pressure and laboratory values.

        Exclusion Criteria:

          -  Subjects with a diagnosis of possible, probable or definite vascular dementia may not
             participate.

          -  Subjects with known hypersensitivity to sunlight or a history of seizures, previous
             exposure to SB-742457, taking agents for which there is a theoretical risk of
             interaction with SB-742457, or taking medication for Alzheimer's disease or centrally
             acting agents which might impact study outcomes may not participate.
18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy
Condition: Malignant Glioma
MeSH terms: Glioma
Intervention: Diffusion Weighted Imaging; Fluorine F 18 Fluorodopa; Intensity-Modulated Radiation Therapy; Perfusion Magnetic Resonance Imaging; Positron Emission Tomography; Quality-of-Life Assessment; Temozolomide
Intervention description: Undergo DTI; Undergo 18F-DOPA-PET; Undergo IMRT; Undergo pMRI; Undergo 18F-DOPA-PET; Ancillary studies; Receive temozolomide
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well fluorine F 18 fluorodopa (18F-DOPA)-positron emission
      tomography (PET) works in finding tumors in patients with newly diagnosed gliomas undergoing
      radiation therapy. Comparing results of diagnostic procedures done before and during
      radiation therapy may help doctors predict a patient's response to treatment and help plan
      the best treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed newly diagnosed grade IV malignant glioma; Note: grade III
             patients are no longer being enrolled

          -  Computed tomography (CT) simulation, immobilization, MRI and PET imaging, treatment
             planning, and all follow-up MRI and PET scans to be performed at Mayo Clinic
             Rochester; Note: the actual radiation therapy treatments and follow-up other than
             imaging can be performed at Mayo Clinic Rochester, Northfield, LaCrosse, Mankato, Eau
             Claire, or Albert Lea

          -  Provide written informed consent

          -  Ability to complete questionnaire(s) by themselves or with assistance

        Exclusion Criteria:

          -  Patients diagnosed with anaplastic oligodendroglioma

          -  Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator,
             kidney failure)

          -  Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson's disease, taking
             anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from
             discontinuance of dopamine agonists); NOTE: other potentially interfering drugs
             consist of: amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine,
             mazindol, methamphetamine, methylphenidate, norephedrine, phentermine,
             phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline; if a patient
             is on any of these drugs, list which ones on the on-study form

          -  Any of the following:

               -  Pregnant women

               -  Nursing women

               -  Men or women of childbearing potential who are unwilling to employ adequate
                  contraception
BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: BTRX-246040 oral capsule(s); Placebo oral capsule(s)
Intervention description: BTRX-246040 administered once daily to patients with MDD for 8 weeks; administered once daily to patients with MDD for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Anhedonia; antidepressant; Nociceptin; NOPR

Summary:

      This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of
      up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of MDD as defined by DSM-5 criteria and have had at least 1
             prior major depressive episode in the past 10 years

          -  Patients must present with a new current episode of MDD and the duration of the
             current episode must be at least 4 weeks but not longer than 18 months.

          -  At Visit 1 (screening) and Visit 2 (baseline), patients must have clinically
             significant depressive symptoms defined by tandem (investigator- and
             computer-administered) Montgomery-Asberg Depression Rating Scale (MADRS) total scores
             ≥ 26 with a difference of ≤ 7 points between the Investigator- and
             computer-administered MADRS total scores

          -  Patients must have a CGI-S score ≥ 4 at Visit 2 (baseline).

        Exclusion Criteria:

          -  Patients who present with any current DSM-5 disorder other than MDD which is the focus
             of treatment.

          -  Patients who are homicidal in the opinion of the Investigator or are at suicidal risk
             (any suicide attempts within 12 months prior to Visit 1 [screening] or any suicidal
             intent, including a plan, within 3 months prior to Visit 1 [screening]; C-SSRS answer
             of "YES" on item 4 or 5 [suicidal ideation]; Investigator- or computer-administered
             MADRS score of ≥ 5 on item 10 [suicidal thoughts]; by Investigator clinical
             evaluation).

          -  Patients cannot have any history of substance or alcohol use disorder within 12 months
             prior to Visit 1 (screening) per DSM-5 criteria

          -  Patients must not have a clinically significant comorbid disease.
Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
Condition: Vitamin d Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: Mongolian milk without vitamin D; Mongolian milk with vitamin D; UHT milk; Milk Substitute; Seasonal D supplement; Daily D supplement
Intervention description: 710ml per day for 49 days; 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.; 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.; 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.; Deliver dosage of 13,700 IU vitamin D over 7 days; Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 597.0
Sex: All
Minimum age: 9 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vitamin d; children; Mongolia

Summary:

      This intervention study will address the impact of vitamin D fortified milk and vitamin D
      supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone,
      academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for
      eczema) of Mongolian children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children in 3rd and 4th grade from selected Mongolian schools.

          -  School selection will consider:

               -  socioeconomic position;

               -  geographic location;

               -  school size;

               -  current lunch or supplementation program; and

               -  the interest and willingness to participate of the school's administration and
                  faculty.

        Exclusion Criteria:

          -  Allergy to milk or wheat products.
A Study of TRV130 for the Treatment of Pain After Abdominoplasty
Condition: Pain
Intervention: TRV130; Morphine; Placebo
Intervention description: Rescue: Ibuprofen, oxycodone; Rescue: Ibuprofen, oxycodone; Rescue: Ibuprofen, oxycodone
Intervention MeSH terms: Morphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain; abdominoplasty; PCA

Summary:

      The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with
      placebo in patients with acute postoperative pain following abdominoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >=18 and <=65 years of age.

          -  Plans to undergo an abdominoplasty procedure with no additional collateral procedures.

          -  Is able to understand and comply with the procedures and study requirements, and to
             provide written informed consent before any study procedure.

        Exclusion Criteria:

          -  ASA Physical Status Classification System classification of P3 or worse.

          -  Has surgical or post-surgical complications.

          -  Has clinically significant medical conditions or history of such conditions that may
             interfere with the interpretation of efficacy, safety, or tolerability data obtained
             in the trial, or may interfere with the absorption, distribution, metabolism, or
             excretion of drugs.

          -  Has previously participated in another TRV130 clinical study.