bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain
Condition: Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain
Intervention: Corticosteroid; Placebo Injection
Intervention description: 40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine; A placebo injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to receive either an injection of methylprednisolone acetate plus lidocaine or to receive an injection of saline with lidocaine using a randomized block design with a 1:1 allocation.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: Female
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Sciatica; Pelvic girdle pain

Summary:

      The purpose of this study is to see if pelvic girdle pain can be more effectively treated
      with the use of injectable anti-inflammatory medication plus physical therapy compared with
      physical therapy and a saline injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who are not doing other therapies for pain (physical therapy, chiropractic
             management, pool)

          -  Women between age 21 and 50 who plan to deliver at Loyola or Gottlieb

          -  Pain Numeric Rating Scale (NRS) on average of greater than or equal to 5/10 at Visit 1

          -  Pain must be between the upper level of the iliac crests and the gluteal folds in
             conjunction with or separately from pain in the pubic symphysis and influenced by
             position and locomotion

          -  2/4 positive physical examination tests on the symptomatic side including the P4 test,
             the LDL test, pubic symphysis palpation and the acute straight leg rise (ASLR)

        Exclusion Criteria:

          -  Women presenting with PGP in the first or third trimester (<13 weeks gestation or >28
             weeks gestation)

          -  Women with pubic symphysis (anterior) pain alone

          -  Women who do not plan to deliver a baby at Loyola or Gottlieb

          -  Pain above the upper level of the iliac crest

          -  History of lumbar or pelvic fracture, neoplasm, inflammatory disease, active
             urogenital infection or active gastrointestinal illness, current physical therapy or
             other therapies for PGP, or previous surgery of the lumbar spine, pelvic girdle, hip
             joint or femur

          -  History or signs of radiculopathy or other systemic neurologic disease

          -  Women with diabetes or gestational diabetes
An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis
Condition: Cholangitis, Sclerosing
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Intervention: All-trans retinoic acid
Intervention description: Fixed low dose of ATRA 10 mg twice daily for 24 weeks.
Intervention MeSH terms: Tretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to determine whether a low dose of ATRA will improve
      laboratory tests of liver and bile duct inflammation in patients with PSC. The investigators
      will also look for changes to other blood tests which are related to inflammation, scarring,
      and the immune system.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ages 18-80

          -  Diagnosis of large-duct PSC based on ERCP or MRCP, or liver biopsy findings without
             alternative explanation for findings, for at least 6 months.

          -  Serum ALP levels persistently more than 1.5 x upper limit of normal over the past 6
             months.

          -  Ursodeoxycholic acid therapy must be discontinued for at least 3 months.

          -  At least 2 forms of barrier protection for males and females of child-bearing age.

        Exclusion Criteria:

          -  Small duct PSC, overlap with autoimmune hepatitis, IgG4 disease or secondary
             sclerosing cholangitis.

          -  Any malignancy, presently or within the past 5 years, except adequately treated
             non-melanoma skin cancer, carcinoma in situ of the cervix or in situ prostate cancer.

          -  Viral hepatitis including hepatitis A, B, C, D, E.

          -  Decompensated cirrhosis, or planned liver transplantation.

          -  Recent diagnostic or therapeutic biliary manipulation (endoscopic, radiologic) within
             the past 3 months.

          -  Ascending Cholangitis requiring antibiotics within the past 3 months.

          -  Uncontrolled IBD, or IBD requiring the use of steroids.

          -  Acute or Chronic Kidney Disease with serum creatinine > 2 mg/dL.

          -  Allergy to ATRA or vitamin A compounds.
Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19
Condition: Virus Diseases; Infection Viral; Corona Virus Infection
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Coronavirus Infections
Intervention: Azithromycin; Hydroxychloroquine; Placebo oral tablet; Placebo oral tablet
Intervention description: Azithromycin; Hydroxychloroquine; Placebo Azithromycin; Placebo Hydroxychloroquine
Intervention MeSH terms: Azithromycin; Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Healthy volunteers: No

Summary:

      This study explores whether patients acutely hospitalized may have shorter hospitalization
      and fewer admittances at Intensive Care Units by treatment with azithromycin and
      hydroxychloroquine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient admitted to a Danish emergency department, lung medical department or medical
             department

          -  Age >18 years

          -  Hospitalized <48 hours

          -  Positive COVID-19 test/diagnosis during the hospitalization

          -  Signs informed consent

        Exclusion Criteria:

          -  If the patient uses > 5 LO2/min at time of recruitment

          -  Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to
             quinine or 4-aminoquinolinderivates

          -  Pregnancy

          -  Breastfeeding

          -  Neurogenic hearing loss

          -  Psoriasis

          -  Retinopathy

          -  Maculopathy

          -  Changes in vision field

          -  Severe liver disease other than amoebiases

          -  Severe gastrointestinal, neurological or haematological disorders

          -  eGFR < 45 ml/min/1.73m2

          -  Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc
             interval

          -  Myasthenia Gravis

          -  Uses Digoxin

          -  Glucose-6-phosphate dehydrogenase deficiency

          -  Porphyria

          -  Hypoglycemia at any time since hospitalization

          -  Severe mental illness which significantly impedes cooperation

          -  Severe linguistic problems that significantly impedes cooperation

          -  Treatment with sickle alkaloids
Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Intervention: BI 671800; Placebo
Intervention description: BI 671800; Placebo matching BI 671800
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening
      (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid
      in symptomatic asthma patients.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed informed consent consistent with International Conference on Harmonisation
             (ICH) - Good Clinical Practice (GCP) (ICH-GCP)

          2. Three month history of reversible (12% with 200 mL) asthma according to [Global
             Initiative for Asthma (GINA)] with following spirometry at randomization:forced
             expiratory volume in 1 second (FEV1) 60%-85%.

          3. Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.

          4. Diagnosis of asthma prior to 40 years.

          5. Asthma Control Questionnaire (ACQ) at least 1.5 at randomization.

          6. Male or female, 18 to 65 years.

          7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine
             screen.

          8. Able to perform pulmonary function test (PFT).

        Exclusion criteria:

          1. Significant diseases other than asthma or allergic rhinitis.

          2. Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).

          3. Hospitalizations for asthma or asthma related intubation within 3 months.

          4. Uncontrolled asthma on ICS + another controller.

          5. Respiratory tract infection or exacerbation within 4 weeks.

          6. FEV1 less than 40%, more than 12 puffs of short acting beta agonists (SABA) on more
             than two consecutive days or asthma exacerbation during the run-in period.

          7. Participation in another interventional study.

          8. Pregnant or nursing women.

          9. Women of child bearing potential nor using appropriate methods of birth control as
             defined by protocol.
Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy
Condition: Unspecified Adult Solid Tumor, Protocol Specific; Vascular Access Device Complications
Intervention: vascular access device placement
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vascular access device complications; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Giving chemotherapy drugs through an implanted port reduces the need for multiple
      needle sticks. It is not yet known whether one type of port is more effective than another in
      reducing infections and other side effects associated with long-term port use.

      PURPOSE: This randomized clinical trial is comparing two types of ports in patients with
      cancer receiving intravenous chemotherapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of malignancy requiring intravenous chemotherapy for ≥ 6 months

               -  Must undergo entire course of chemotherapy at the Mayo Clinic in Jacksonville,
                  unless the outside treating institution agrees to submit the research data sheet
                  to Mayo Clinic

          -  Scheduled time frame for regular use of the vascular access port ≥ 3 months after port
             insertion

        PATIENT CHARACTERISTICS:

          -  Life expectancy ≥ 6 months

          -  No active skin condition implicating an elevated risk of local or systemic infectious
             or non-infectious complications, including any of the following:

               -  Current skin infection

               -  Cutaneous lymphoma

               -  Auto-immune disorders

               -  Active vasculitis

               -  Connective tissue diseases

          -  No known active infection requiring antibiotic therapy at the time of port
             implantation

               -  Patients without an active infection who are on chronic antibiotic suppressive
                  therapy are eligible

          -  No concurrent illness requiring chronic anticoagulation

               -  Patients who develop other comorbidities requiring chronic anticoagulation during
                  the study period are eligible

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics
Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age
Condition: Meningitis, Meningococcal, Serogroup B
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: rLP2086
Intervention description: 0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086
      vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6
      schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work
      directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086
      vaccine development program. The study will provide descriptive safety and immunogenicity
      data following vaccination of these individuals with bivalent rLP2086 vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic
             Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development
             program.

          2. Male or female subject aged ≥18 to ≤65 years at the time of enrollment.

          3. Negative urine pregnancy test.

        Exclusion Criteria:

          1. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
             allergen immunotherapy with a licensed product and are not on stable maintenance
             doses.

          2. A known or suspected defect of the immune system that would prevent an immune response
             to the vaccine, such as subjects with congenital or acquired defects in B cell
             function or those receiving immunosuppressive therapy. Subjects with terminal
             complement deficiency are excluded from participation in this study.

          3. Significant neurological disorder or history of seizure (excluding simple febrile
             seizure).

          4. Current chronic use of systemic antibiotics.

          5. Received any investigational drugs, vaccines, or devices within 28 days before
             administration of the first study vaccination.

          6. Any neuroinflammatory or autoimmune condition, including, but not limited to,
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

          7. Prior receipt of any vaccine specifically targeting fHBP or LP2086 antigens.

          8. History of microbiologically proven disease caused by Neisseria meningitidis.
A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo
Condition: Asthma
MeSH terms: Asthma
Intervention: budesonide; placebo
Intervention description: pMDI, inhalation, bid, 6 weeks; pMDI, inhalation, bid, 6 weeks
Intervention MeSH terms: Budesonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: asthma, children, budesonide pMDI

Summary:

      This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6
      weeks is effective and safe in treating asthmatic children aged 6 to <12 years
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 2
             that has required daily inhaled corticosteroid in the low dose range OR LTRA as
             monotherapy for at least 30 days prior to Visit 2.

          -  Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last
             dose of inhaled short acting beta agonist of greater than or equal to 70% and less
             than or equal to 95% of predicted normal

          -  Demonstrated reversibility of FEV1 of ≥12% from pre short acting beta agonist level
             within 15 to 30 minutes after administration of a standard dose of short acting beta
             agonist OR has a documented reversibility of ≥ 12 % within 12 months prior to Visit 2.

        Exclusion Criteria:

          -  Has been hospitalized at least once or required emergency treatment (was seen in the
             emergency room or had an urgent care visit) more than once for an asthma-related
             condition during the 6 months prior to Visit 2

          -  Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal)
             for any reason within the 12 weeks prior to Visit 2
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: OPA-15406; Vehicle ointment
Intervention description: OPA-15406 topical ointment; OPA-15406 1%-matching placebo topical ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 10 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis, Eczema

Summary:

      The purpose of this study is to investigate the effectiveness and safety of 2 concentrations
      of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants 10-70 years of age

          -  Diagnosis of AD

          -  History of AD for at least 3 years

          -  AD affecting greater than or equal to 5% and less than or equal to 40% of total body
             surface area (BSA) at Baseline

          -  Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate)
             in the selected treatment area(s)

        Exclusion Criteria:

          -  Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.

          -  Concurrent diseases/conditions and history of other diseases/conditions in the
             selected treatment area(s) that may have an impact on the study assessments.
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients
Condition: Hepatitis C Infection
MeSH terms: Infections; Hepatitis C; Hepatitis
Intervention: BMS-790052; BMS-790052; Placebo; Peginterferon alfa-2b; Ribavirin
Intervention description: Tablets, Oral, 10 mg, daily, 24-48 weeks; Tablets, Oral, 60 mg, daily, 24-48 weeks; Tablets, Oral, 0 mg, daily, 48 weeks; Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks; Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well
      tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the
      treatment of hepatitis C virus genotype 1 in chronically infected patients who are
      treatment-naïve and nonresponsive to the standard of care
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients chronically infected with hepatitis C virus (HCV) genotype 1

          -  HCV RNA viral load ≥10*5* IU/mL at screening

          -  Naïve or nonresponsive to the current standard of care

        Key Exclusion Criteria:

          -  Cirrhosis

          -  Hepatocellular carcinoma

          -  Coinfection with hepatitis B virus, HIV-1 or HIV-2
Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: AZD1305; Placebo
Intervention description: Intravenous (iv) single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes; iv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 228.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: AZD1305; intravenous cardioversion of Atrial Fibrillation

Summary:

      This study is being carried out to see which dose of AZD1305 is safe and effective in
      cardioverting atrial fibrillation into normal heart rhythm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical indication for cardioversion of Atrial Fibrillation, ie a correction of
             irregular heart rhythm to normal heart rhythm

          -  Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3
             months at randomisation

          -  Adequate anticoagulation according to international guidelines (ACC/AHA/ESC, 2006) or
             national guidelines

        Exclusion Criteria:

          -  Potassium level below 3.8 mmol/L measured in serum or plasma

          -  QTcF interval >440 ms