bioihbjkbjnl/mcl2 huggingface dataset:
Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet)
Condition: Pain Management
Intervention: Morphine Sulfate; Oxycodone; Acetaminophen
Intervention description: 15mg PO morphine sulfate; 10mg Oxycodone; 650 mg Acetaminophen
Intervention MeSH terms: Acetaminophen; Morphine; Oxycodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      Oxycodone and Hydrocodone are the most commonly used oral opioid analgesics in the emergency
      department and in outpatient settings. Both medications have a very high potential for abuse
      due to the prominence of the euphoric effect (abuse liability) and relative lack of "bad "or
      "negative" effects (likeability). The highly addictive properties of these medications lead
      to recurrent ED visits for repetitive dosing and prescribing that may lead to abuse, misuse,
      development of dependence and addiction, and, most importantly, death due to overdose. In
      contrast, several research papers demonstrated that administration of MSIR results in similar
      analgesic efficacy to Oxycodone and Hydrocodone but with significantly less euphoric and
      rewarding associated effects. In addition, consumption of large doses of MSIR leads to
      dysphoria, vomiting and sedation ("negative effects"). To the investigators' knowledge, there
      are no randomized controlled trials in the ED that directly compared analgesic efficacy of
      MSIR to Percocet
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 18-64,

          -  present to the Emergency department with moderate-to-severe acute pain that warrants
             an oral opioid analgesic.

          -  pain score is above 5 and are deemed to require oral opioid at the discretion of the
             attending physician.

          -  Painful conditions will include but will not be limited to acute
             traumatic/non-traumatic musculoskeletal pain, renal colic pain, dental pain.

        Exclusion Criteria:

          -  age <18, age >64,

          -  subjects who received long acting opioids within 24 hours of presenting to ED

          -  received short acting analgesics within 4 hours,

          -  chronic pain,

          -  pregnant patients,

          -  patient refusal,

          -  altered mental status,

          -  known allergy to either morphine or oxycodone or acetaminophen,

          -  history of substance and opioid abuse,

          -  unstable vital signs, acute psychosis or incarceration.

          -  subjects who received long acting opioids within 24 hours of presenting to ED;

          -  chronic pain"
Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds
Condition: Invasive Fungal Infections
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Intervention: fosmanogepix
Intervention description: IV and oral fosmanogepix
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: APX001; APX001A; fosmanogepix; manogepix; aspergillus; aspergillosis; covid; covid19; mold; mould; pulmonary aspergillosis; pulmonary aspergillus; galactomannan; Karius; SARS-CoV-2; fusarium; mucorales; mucor; rhizopus; scedosporium; fungal disease; invasive fungal disease; EORTC

Summary:

      This is a Phase 2, multicenter study to evaluate APX001 for the treatment of invasive fungal
      infections caused by Aspergillus spp. or rare molds (eg, Scedosporium spp., Fusarium spp.,
      and Mucorales fungi).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, 18 years or older.

          -  Patients with proven or probable IMI caused by Aspergillus spp. Patients who present
             with IMI due to other filamentous fungi (eg, Scedosporium spp., Fusarium spp., and
             Mucorales fungi such as Mucor spp. or Rhizopus spp.) may also be enrolled.

          -  Have limited or no treatment options due to documented or anticipated resistance,
             contraindication, intolerance, or lack of clinical response to SOC antifungal therapy,
             as advocated by the relevant regional/country treatment guidelines.

          -  Patients where the Investigator considers that there is a potential advantage of using
             APX001 over current SOC (eg, broad spectrum of activity, emergence of IMI during
             antifungal prophylaxis, activity against resistant mold pathogens, IV and PO
             formulations, favorable DDI profile, favorable hepatic and renal safety profile, wide
             tissue distribution including brain), and/or where the SOC antifungal therapy carries
             significant risk of toxicity or treatment failure (eg, DDI risk, safety/toxicity risk,
             site of infection not accessible by SOC).

        Exclusion Criteria:

          -  Refractory hematologic malignancy.

          -  Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.

          -  Treatment with systemic (PO, IV, or inhaled) mold active antifungal therapy for 120
             hours immediately before initial dosing. Note: patients with invasive fungal infection
             caused by a mold with documented resistance to or lack of coverage by the prior SOC in
             question, may have received >120 hours prior treatment and remain eligible for the
             study.

          -  Evidence of significant hepatic dysfunction.
Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Condition: Choroidal Neovascularization; Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: hI-con1; ranibizumab; Sham injection
Intervention description: Intravitreal injection of hI-con1 0.3 mg; Intravitreal injection of ranibizumab 0.5 mg; No injection is given, a needleless syringe is used to mimic an injection.
Intervention MeSH terms: Ranibizumab; hI-con1; Immunoconjugates
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic
      effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in
      combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating
      patients with choroidal neovascularization (CNV) secondary to age-related macular
      degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females of any race at least 50 years of age

          -  Active primary Choroidal Neovascularization (CNV) secondary to Age-Related Macular
             Degeneration (AMD) in the study eye

          -  Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 up to
             20/320) in the study eye

        Exclusion Criteria:

          -  Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in
             the better seeing eye

          -  Any prior treatment of CNV or advanced AMD in the study eye, except for dietary
             supplements or vitamins

          -  Any intraocular or ocular surface surgery (including cataract surgery and laser
             procedures) in the study eye within 3 months

          -  Vitrectomy in the study eye

          -  Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
Assessment of LBR-101 In Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: LBR-101 High Dose; LBR-101 Low Dose; Placebo
Intervention description: Subcutaneously Administered LBR-101 Monthly x 3; Subcutaneously Administered LBR-101 Monthly x 3; Subcutaneously Administered Placebo (Vehicle) Monthly x 3
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Headache; Migraine; Chronic Migraine

Summary:

      The purpose of the study is to determine whether monthly subcutaneous administration of
      LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic
      migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 to 65 years of age.

          -  A signed and dated informed consent document indicating that the subject has been
             informed of all pertinent aspects of the study including any known and potential risks
             and available alternative treatments.

          -  Chronic migraine meeting the diagnostic criteria listed in the International
             Classification of Headache Disorders (ICHD-III beta version, 2013)

          -  Body Mass Index (BMI) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and
             120 kg inclusive.

          -  Demonstrated compliance with the electronic headache diary during the run-in period
             headache data on a minimum of 22/28 days (80% diary compliance)

        Exclusion Criteria:

          -  Onset of chronic migraine after the age of 50 years.

          -  Subject has received onabotulinum toxin A for migraine or for any medical or cosmetic
             reasons requiring injections in the head, face, or neck during the 6 months prior to
             study entry.

          -  Subject is using medications containing opioids (including codeine) or barbiturates
             (including Fiorinal®, Fioricet®, or any other combination containing butalbital) on
             more than 4 days per month for the treatment of migraine or for any other reason.

          -  Failed > 2 medication categories or > 3 preventive medications (within two medication
             categories) due to lack of efficacy for prophylactic treatment of episodic or chronic
             migraine after an adequate therapeutic trial

          -  Treatment with an investigational drug or device within 30 days of study entry or any
             prior exposure to a monoclonal antibody targeting the CGRP pathway.
Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection
Condition: SARS-CoV-2 Infection; Acute Kidney Injury
MeSH terms: COVID-19; Acute Kidney Injury
Intervention: Placebo; Nicotinamide riboside
Intervention description: Placebo capsule containing inert ingredient; 250 mg Nicotinamide riboside capsules
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, double-blind, placebo-controlled clinical interventional trial
Masking: Double (Participant, Investigator)
Masking description: The study drug (NR or placebo) packaging and labeling will be designed to maintain the blinding of the investigator's team and the participants.
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An interventional clinical trial using oral nicotinamide riboside (NR) in hospitalized
      patients with COVID-19 infection and acute kidney injury to determine the effect of NR on
      whole blood nicotinamide adenine dinucleotide (NAD+) levels and to evaluate safety of the use
      of NR.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of signed and dated informed consent form from a participant or legally
             authorized representative (LAR);

          2. Male or female, >18 years old;

          3. Hospitalized participants with a laboratory diagnosis of COVID-19 infection

          4. Evidence of persistent AKI as defined by the Kidney Disease: Improving Global Outcomes
             (KDIGO) guidelines (Table 3);

          5. Willing to adhere to the study intervention regimen;

        Exclusion Criteria:

          1. Hypersensitivity to nicotinamide riboside (NR);

          2. Pregnant or lactating women confirmed with positive laboratory pregnancy tests as per
             local requirements;

          3. eGFR <15 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration
             equation at admission lab;

          4. Maintenance renal replacement therapy or initiation of renal replacement therapy
             before randomization

          5. Currently on NR or nicotinamide or vitamin B3 (niacin) supplementation (multivitamins
             are allowed);

          6. Concomitant cirrhosis of liver or acute liver failure;

          7. Any medical history or condition that might, in the opinion of the attending
             physician, put the participant at significant risk if he/she were to participate in
             the trial;

          8. Individuals with kidney transplant;

          9. Individuals with blood platelet count <100,000/microL
Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Certolizumab Pegol; Placebo
Intervention description: Pharmaceutical Form: solution for injection in pre-filled syringe
Route of Administration: subcutaneous use; Matching Placebo to Certolizumab Pegol
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic plaque psoriasis, anti TNFα; CDP870, Cimzia

Summary:

      A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo,
      administered during 12 weeks, to patients suffering from moderate to severe chronic plaque
      psoriasis, extended by a 12 to 24 week follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men and women > 18 years

          -  Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to
             severe for at least 6 months

          -  Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area
             (BSA) ≥ 10 %

          -  Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or
             photochemotherapy

        Exclusion Criteria:

          -  Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form
             of psoriasis

          -  A history of chronic infection, recent serious or life-threatening infection (within
             six months, including herpes zoster), or any current sign or symptom that may indicate
             an infection (e.g. fever, cough);

          -  White blood cell counts less than 4000/mm^3 or more than 20000/mm^3

          -  Suspected or diagnosed demyelinating disease of the central nervous system (e.g.
             multiple sclerosis or optic neuritis)

          -  Systemic Lupus

          -  Non respect of adequate wash out periods for treatments that might have an impact on
             the disease

          -  Any associated disease that could be impacted by the study treatment intake

          -  Any other condition, which in the Investigator's judgment would make the subject
             unsuitable for inclusion in the study
Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis
Condition: Focal Segmental Glomerulosclerosis
MeSH terms: Glomerulosclerosis, Focal Segmental
Intervention: Voclosporin
Intervention description: Voclosporin softgel capsules. Up to 10 subjects will be enrolled into Cohort 1 and take up to 3 capsules twice daily (BID).
The dose of voclosporin for Cohort 2 (at least 10 subjects) will be determined by analysis of efficacy and safety data at Week 12 from the first 5 or 6 subjects in Cohort 1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: calcineurin inhibitors; Focal Segmental Glomerulosclerosis

Summary:

      Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission
      of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Primary FSGS diagnosed by renal biopsy.

          2. Urine protein creatinine ratio (UPCR) ≥2.0 mg/mg, serum albumin ≤3.2 g/dL and can be
             immunosuppressant treatment-naïve, or receiving treatment with steroids.

          3. Stable proteinuria, renal function, and BP.

        Exclusion Criteria:

          1. Clinical or histologic evidence of secondary FSGS.

          2. Histologic evidence of collapsing variant FSGS.

          3. eGFR as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
             equation of ≤30 mL/minute/1.73 m2 at initial screening assessment or ≤45
             mL/minute/1.73 m2 at last qualifying assessment.

          4. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected
             to require dialysis during the study period.

          5. Current or medical history of:

               -  Congenital or acquired immunodeficiency.

               -  In the opinion of the Investigator, clinically significant drug or alcohol abuse
                  within 2 years prior to screening.

               -  Malignancy within 5 years of screening, with the exception of basal and squamous
                  cell carcinomas treated by complete excision.

               -  Current or past lymphoproliferative disease or previous total lymphoid
                  irradiation.

               -  Severe viral infection within 3 months of screening, or known HIV infection.
                  Severe viral infection is defined as active disease requiring antiviral therapy.

               -  Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking
                  prophylaxis with isoniazid.
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Condition: Anemia; Dialysis Dependent Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Vadadustat; Placebo
Intervention description: Daily oral dose; Daily oral dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Anemia; kidney; dialysis dependent chronic kidney disease; CKD; DD; renal; vadadustat; AKB-6548; hypoxia-inducible factor; Akebia (AKB); hypoxia-inducible factor (HIF); HIF; prolyl-hydroxylase inhibitor (PHI); PHI; Japan; Japanese

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess
      the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally
      administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent
      Chronic Kidney Disease (DD-CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female Japanese participants ≥20 years of age

          -  Receiving chronic maintenance hemodialysis for end-stage kidney disease

          -  Hemoglobin (Hb) <10.0 grams per deciliter (g/dL)

        Exclusion Criteria:

          -  Anemia due to a cause other than chronic kidney disease (CKD) or presence of active
             bleeding or recent blood loss

          -  Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic
             malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia

          -  Red blood cell transfusion within 4 weeks prior to or during screening

          -  Anticipated to recover adequate kidney function to no longer require hemodialysis
             during study participation