bioihbjkbjnl/mcl2 huggingface dataset:
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ALX-0061; Placebo; Methotrexate
Intervention description: Stable background dose of commercially available methotrexate (not provided by the Sponsor).
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061
      administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with
      active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo.

      To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics
      (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061,
      based on safety and efficacy, for further clinical development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA for at least 6 months prior to screening, and American College of
             Rheumatology (ACR) functional class I-III

          -  Subjects treated with and tolerating MTX

          -  Active RA

          -  Others as defined in the protocol

        Exclusion Criteria:

          -  Have been treated with disease-modifying antirheumatic drugs (DMARDs)/systemic
             immunosuppressives other than MTX.

          -  Have received approved or investigational biological or targeted synthetic DMARD
             therapies for RA less than 6 months prior to screening.

          -  Have a history of toxicity, non-tolerance, primary non-response or inadequate response
             to a biological therapy, or targeted synthetic DMARDs, for RA.

          -  Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.

          -  Others as defined in the protocol
A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: PF-06826647 or Placebo; PF-06826647
Intervention description: Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period; Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This multicenter study is being conducted to provide additional PF-06826647 safety and
      tolerability data, and to further explore the clinical efficacy of PF-06826647 in the
      treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to
      enable selection of oral dose and dosing regimen for the future clinical development of
      PF-06826647.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the ages of 18 and 75 years.

          -  Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6
             months.

          -  Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3
             (moderate) or 4 (severe).

          -  Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).

        Exclusion Criteria:

          -  Have non-plaque forms of psoriasis.

          -  Drug-induced psoriasis.

          -  Current active infection.

          -  Infected with Mycobacterium tuberculosis (TB).

          -  Have any history of malignancies.

          -  Require treatment with prohibited concomitant medications(s).

          -  Positive for hepatitis B or C, or human immunodeficiency virus (HIV).
PNT2258 for Treatment of Patients With Richter's Transformation (Brighton)
Condition: Richter's Transformation
Intervention: PNT2258
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
Healthy volunteers: No
Keywords: PNT2258; Richter's Transformation; NHL; Non-Hodgkin's Lymphoma; Lymphoma; DLBCL; Diffuse Large B-cell Lymphoma; Lymphoma, Large B-cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, B-cell

Summary:

      This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a
      multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to
      characterize anti-tumor activity and collect safety data on patients with Richter's
      Transformation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed Richter's transformation (RT) from chronic lymphocytic
             leukemia/small lymphocytic lymphoma (CLL/SLL).

          2. Availability of fresh or archived tumor tissue.

          3. FDG PET-CT (disease) positive baseline scan with measurable disease.

          4. ECOG performance status of 0-1.

          5. Evidence of disease progression at study entry.

          6. Discontinuation of prior anticancer therapy for ≥ 7 days prior to C1D1 and recovered
             to ≤ CTCAE grade 2 (or baseline) from any acute or chronic toxicity associated with
             prior therapy.

          7. Must have previously received at least one prior chemotherapeutic regimen for RT.

             - Previously untreated RT patients deemed ineligible for, or that refuse, intensive
             chemotherapy are eligible.

          8. Adequate bone marrow, renal, and hepatic function.

          9. Normal Coagulation profile.

         10. Agreement to use acceptable methods of contraception during the study and for ≥ 120
             days after the last dose of PNT2258 if sexually active and able to bear or beget
             children.

         11. Ability to participate in the clinical study for a minimum of at least 2 cycles (6
             weeks).

        Exclusion Criteria:

          1. Concurrent non-hematologic malignancies requiring treatment.

          2. No more than 2 prior regimens for DLBCL.

          3. Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma,
             interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or
             prolymphocytic transformation.

          4. Ongoing risk of bleeding.

          5. CNS or leptomeningeal involvement of lymphoma

          6. Concurrent clinically significant illness, medical condition, surgical history,
             physical finding, electrocardiogram or laboratory finding that, in the opinion of the
             investigator, could adversely affect the safety of the subject or impair the
             assessment of the study results.

          7. Pregnancy or breast-feeding.

          8. Previous exposure to PNT2258.
Statin Therapy in Acute Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Atorvastatin; Placebo
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Influenza (the 'flu') is a common virus infecting approximately 5-20% of the population in
      the United States and causing as many as 500,000 deaths worldwide each year. Currently, there
      are only a few treatments for influenza infection and none of these target inflammation that
      can be caused by the virus. This study will test whether the anti-inflammatory effects of
      statins, a class of drugs most often used to treat high cholesterol, will decrease the
      severity of illness in patients who are infected with influenza by testing markers of
      inflammation in the blood and recording resolution of influenza illness.
    

Eligibility criteria:

        Inclusion Criteria:(all must be present):

          1. Adult patient (age > 18 years)

          2. Positive influenza DFA/RAT test result

          3. <12 hours from positive influenza test result

        Exclusion Criteria:

          1. Prior statin medication use (within 30 days of positive influenza test result)

          2. Comfort measures only designation or anticipated withdrawal of life-support

          3. Atorvastatin specific exclusions:

               1. Documented liver cirrhosis or liver dysfunction (AST or ALT greater than 240)

               2. Known allergy or intolerance to statins

               3. Rhabdomyolysis (CPK elevation > 6x normal)

               4. Patients taking the following medications: cyclosporine, HIV protease inhibitors,
                  hepatitis C protease inhibitor telaprevir, fibric acid derivatives (gemfibrozil),
                  niacin, azole antifungals (itraconazole, ketoconazole) clarithromycin and
                  colchicine

          4. Patients unable to take oral or nasogastric medications or plan for no oral intake as
             part of medical course (eg. emergent surgical intervention)

          5. Known pregnancy or active breastfeeding

          6. Inability to provide written informed consent for any reason
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Condition: Body Dysmorphic Disorders
MeSH terms: Body Dysmorphic Disorders
Intervention: Psilocybin
Intervention description: A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
Intervention MeSH terms: Psilocybin
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
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded
      to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with
      a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will
      be conducted over a 3 month period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body dysmorphic disorder of at least moderate severity, non-delusional subtype, for >6
             months

          -  History of intolerance of, or nonresponse to, a prior adequate trial of a serotonin
             reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)

          -  Currently in psychotherapy (other than cognitive behavioral therapy (CBT) for body
             dysmorphic disorder

        Exclusion Criteria:

          -  Current major depressive disorder of greater than moderate severity

          -  Other significant psychiatric or medical comorbidity or conditions that could
             interfere with safety of participation or interpretation of outcomes

          -  Use of: investigational medication within 3 months of baseline; depot antipsychotic
             within 6 months of baseline; serotonergic medication within 2 weeks of baseline (6
             weeks for fluoxetine).

          -  Females who are pregnant, breastfeeding, or sexually active and not willing to use
             adequate contraception

          -  Enrollment in any investigational drug or device study in past 30 days

          -  Prior adverse effects from psilocybin
Harm Reduction With Pharmacotherapy (HaRP)
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: XR-NTX; Placebo; HRC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Masking of the double-blind portion of the study was quadruple until after all data had been collected, when they were unblinded.
Enrollment: 308.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: harm reduction, naltrexone, alcohol use disorder, homelessness

Summary:

      The goal of this study is to test the efficacy of extended-release naltrexone and harm
      reduction counseling in reducing alcohol-related harm among homeless people with alcohol
      dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  being a registered client at one of the named partnering sites

          -  being at least 21 years of age (for legal reasons)

          -  agreeing to use an adequate form of birth control (if female and in childbearing
             years) fulfilling criteria for current alcohol dependence according to DSM-IV-TR
             criteria as determined by the SCID-I/P

        Exclusion Criteria:

          -  refusal or inability to consent to participation in research

          -  constituting a risk to safety and security of other clients or staff

          -  known sensitivity or allergy to naltrexone/XR-NTX

          -  current treatment with naltrexone/XR-NTX

          -  being pregnant or nursing

          -  suicide attempts within the past year

          -  renal insufficiency/serum creatinine level > 1.5

          -  current opioid dependence according to the DSM-IV-TR criteria

          -  liver transaminases (AST, ALT) > 5 times the upper limit of normal (ULN)

          -  clinical diagnosis of decompensated liver disease
Pharmacokinetics of Advantage Arrest
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: 38% silver diamine fluoride
Intervention description: Topical application of SDF to teeth
Intervention MeSH terms: Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label exposure--response study
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adult; fluoride; silver; silver diamine fluoride; pharmacokinetics

Summary:

      The study aim is to characterize the kinetics of silver and fluoride after topical
      application of silver diamine fluoride.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older, minimum 20 teeth, healthy, not taking prescription or OTC
             medications

        Exclusion Criteria:

          -  pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known
             sensitivity to silver or fluoride
Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Standard of care ADT + (HMB + arginine + glutamine); Standard of care ADT
Intervention description: 1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.
Take one packet twice daily for 3 months; Patient will receive standard of care androgen deprivation therapy (ADT) alone
Intervention MeSH terms: Androgens
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Men; Androgen Deprivation Therapy; Elderly; Geriatric; Nutritional supplementation

Summary:

      This is a study of HMB plus amino acids in older men with prostate cancer starting androgen
      deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional
      supplementation will decrease the loss of muscle mass and strength that occurs when men start
      ADT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed adenocarcinoma of the prostate

          2. Age 60 years or older

          3. Patients with asymptomatic or minimally symptomatic prostate cancer for which they are
             about to start androgen deprivation therapy (ADT) per provider recommendation

               -  Asymptomatic or minimally symptomatic (as judged by treating physician)
                  metastases allowed

               -  Men receiving ADT for localized prostate cancer are allowed

          4. Patient able to give informed consent.

        Exclusion Criteria:

          1. Patient already on ADT

          2. Patients who are visiting clinic for a second opinion only

          3. Patients with a diagnosis of dementia

          4. Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis)
Use of Convalescent Plasma for COVID-19
Condition: COVID
Intervention: Convalescent Plasma
Intervention description: 200-425mL convalescent plasma donated by patients previously positive for COVID-19
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe
      whether this will result in a significant improvement in clinical outcome in comparison to
      historical experience.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented COVID-19 infection by nasal pharyngeal sampling

          -  COVID-19 disease falling into one of the following groups:

          -  Critical disease: respiratory failure requiring mechanical ventilation, pressor
             support, or multiple organ dysfunction/failure

          -  Severe disease: tachypnea >/=30 per min, O2 sats </=93% at rest, PaO2/FiO2 index
             </=300mmHg

          -  High Risk: upper respiratory symptoms but no radiographic evidence of disease,
             immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate
             to severe asthma history, severe COPD, morbid obesity (BMI >/=40, age >/=65 years

          -  Health Care Providers: health care providers at risk to exposure to COVID-19 infection
             or those with mild to non-severe disease

        Exclusion Criteria:

          -  History of IgA deficiency

          -  History of anaphylatic reaction to blood product transfusion including
             hypersensitivity to immunoglobulin therapy
Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: IVT aflibercept; Sham SC; SC CLS-TA
Intervention description: IVT aflibercept [2 mg/0.05 mL]; sham SC; CLS-TA [4 mg/100 μL] SC injection
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Aflibercept; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Diabetic Retinopathy; Microneedle; Mircoinjection; Triamcinolone; Choroid; Choroid Injection; Aflibercept; Suprachoroidal; Triamcinolone acetonide

Summary:

      The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA
      used with intravitreal aflibercept in subjects with DME.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of type 1 or type 2 DM

          -  DME with central involvement (> 300 µm in the central subfield on spectral-domain
             optical coherence tomography [SD-OCT], in the study eye

          -  ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye

          -  Naïve to local pharmacologic treatment for DME in the study eye

        Exclusion Criteria:

          -  IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded
             if IOP is <22 mmHg in the study eye with no more than 1 IOP lowering medication

          -  Any previous treatment in the study eye with an ocular corticosteroid implant

          -  Has significant media opacity precluding evaluation of retina and vitreous in the
             study eye.

          -  History of glaucoma or optic nerve head change consistent with glaucoma damage

          -  History of glaucoma surgery

          -  History of clinically significant IOP elevation in response to corticosteroid
             treatment ("steroid responder")
Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma
Condition: Recurrent Melanoma; Stage IV Skin Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab; Laboratory Biomarker Analysis; Pharmacological Study; Stereotactic Body Radiation Therapy
Intervention description: Given IV; Correlative studies; Correlative studies; Undergo SBRT
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in
      treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able
      to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal
      antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor
      cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of melanoma

          -  Previously treated or previously untreated stage IV melanoma by American Joint
             Committee on Cancer (AJCC) staging criteria

          -  Presence of an index lesion between 1 and 5 cm

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

          -  Signed informed consent document

          -  Adequate renal, hepatic, and hematologic indices for ipilimumab therapy

          -  Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold
             position for treatment)

        Exclusion Criteria:

          -  Prior systemic therapy within 14 days of study enrollment; patients must be adequately
             recovered from prior systemic therapy side effects as deemed by the treating
             investigator

          -  Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic
             sclerosis, active inflammatory bowel disease if bowel is within target field, etc)

          -  Presence of central nervous system metastasis (including active brain metastasis);
             active brain metastasis would be defined as untreated brain metastases; if the brain
             metastases have received prior treatment (usually either with surgery or radiation),
             they are no longer active

          -  Long-term use of systemic corticosteroids; patients with replacement steroids and not
             immunosuppressive steroids may enroll in the study

          -  Prior radiation therapy (RT) that precludes the delivery of SBRT