bioihbjkbjnl/mcl2 huggingface dataset:
Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Naltrexone
Intervention description: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: alcohol; veterans

Summary:

      The over-arching goal of the proposed project is to understand the impact of medication
      adherence upon engagement in behavioral treatment for alcohol use disorders. The proposed
      project is a pilot feasibility study of inpatient veterans with problem alcohol use at the
      William S. Middleton VA Hospital (Madison, WI). Participants will be randomized to one of two
      parallel study conditions: (1) an initial 50 mg oral dose of naltrexone prior to hospital
      discharge plus a 30-day prescription for oral naltrexone, or (2) a single 380 mg
      intramuscular injection of naltrexone administered prior to discharge and a second injection
      one month later. The central hypothesis is that hospital-administered injectable naltrexone,
      when compared to daily oral naltrexone taken at home, will reduce alcohol use in the days
      immediately following hospitalization. Injectable naltrexone has been efficacious vs. placebo
      in addition to behavioral treatment in several studies. However, it has yet to be examined in
      head-to-head comparison with oral naltrexone, or in the hospital setting as an intervention
      that might facilitate behavioral treatment follow up after discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  diagnostic criteria for alcohol dependence or abuse

          -  women of childbearing potential who have a negative screening urine pregnancy test and
             are willing to use reliable birth control methods throughout the duration of the study

        Exclusion Criteria:

          -  active or recently active (less than 1 year) opioid dependence or daily use of opioid
             analgesics

          -  acute hepatitis or liver failure

          -  pregnancy

          -  women who are currently breastfeeding

          -  active suicidality

          -  inability to provide written informed consent as determined by study comprehension
             questions
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: placebo for risankizumab IV; risankizumab SC; risankizumab IV
Intervention description: placebo for risankizumab administered as intravenous (IV) infusion.; risankizumab administered by subcutaneous (SC) injection; risankizumab administered as intravenous (IV) infusion.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 618.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ABBV-066; BI 655066

Summary:

      The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus
      placebo during induction therapy in participants with moderately to severely active CD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to
             local regulations, at the Baseline Visit. Where locally permissible, participants 16
             to < 18 years of age who meet the definition of Tanner stage 5 for development at the
             Baseline Visit.

          -  Confirmed diagnosis of CD for at least 3 months prior to Baseline.

          -  Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.

          -  Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
             abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).

          -  Demonstrated intolerance or inadequate response to biologic therapy for CD.

          -  If female, participant must meet the contraception recommendations.

        Exclusion Criteria:

          -  Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

          -  Participants with unstable doses of concomitant Crohn's disease therapy.

          -  Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab,
             certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab
             within 12 weeks prior to Baseline), or any investigational biologic or other agent or
             procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is
             longer.

          -  Prior exposure to p19 inhibitors (e.g., risankizumab).

          -  Complications of Crohn's disease.

          -  Having an ostomy or ileoanal pouch.

          -  Known active Coronavirus Disease 2019 (COVID-19) infection.
Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: desvenlafaxine succinate sustained release; Genotyping
Intervention description: 50 mg/day oral tablet for 12 weeks; CYP2D6 genotyping at randomization
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 437.0
Sex: All
Minimum age: 19 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder

Summary:

      This is a multicenter study to assess the health and well-being in subjects who are
      outpatients with major depressive disorder that take desvenlafaxine succinate sustained
      release (DVS SR) or placebo for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient men and women, between the ages of 18 to 75 years, fluent in both written
             and spoken English.

          -  Employed for 20 hours or more for a minimum of 1 month prior to baseline.

          -  Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days
             prior to baseline.

        Exclusion Criteria:

          -  Treatment with desvenlafaxine succinate sustained release at any time in the past
             and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.

          -  Treatment-resistant defined as any of the following failed treatments in the past 3
             years: 3 or more previous adequate trials of >=2 classes of antidepressant medication,
             electroconvulsive therapy, or psychotherapy (2 adequate trials).

          -  Current (within 12 months prior to the screening visit) psychoactive substance abuse
             or dependence (including alcohol), manic episode, posttraumatic stress disorder,
             obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic
             disorder.

          -  Clinically important abnormalities on physical examination, electrocardiogram (ECG),
             or laboratory evaluations.
Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Condition: Pneumococcal Vaccines
Intervention: 13-valent Pneumococcal Conjugate Vaccine
Intervention description: 1 dose at 2,3,4 and 12 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 269.0
Sex: All
Minimum age: 41 Days
Maximum age: 99 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of
      manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale
      13vPnC in healthy infants when given with routine pediatric vaccines.
    

Eligibility criteria:

        Inclusion criteria:

          1. Aged 2 months (42 to 98 days) at time of enrollment.

          2. Available for entire study period and whose parent/legal guardian can be reached by
             telephone.

          3. Healthy infant as determined by medical history, physical examination, and judgment of
             the investigator.

          4. Parent/legal guardian must be able to complete all relevant study procedures during
             study participation.

        Exclusion criteria:

          1. Previous vaccination with licensed or investigational pneumococcal, Hib conjugate,
             diphtheria, tetanus, pertussis, or polio vaccines.

          2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

          3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
             polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.

          4. Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          5. Known or suspected immune deficiency or suppression.

          6. History of culture-proven invasive disease caused by S pneumoniae.

          7. Major known congenital malformation or serious chronic disorders.

          8. Significant neurological disorder or history of seizure including febrile seizure, or
             significant stable or evolving disorders such as cerebral palsy, encephalopathy,
             hydrocephalus, or other significant disorders. Does not include resolving syndromes
             due to birth trauma such as Erb palsy.

          9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and
             monoclonal antibodies; eg, Synagis®).

         10. Participation in another investigational or interventional trial. Participation in
             purely observational studies is acceptable.

         11. Infant who is a direct descendant (child or grandchild) of a member of the study site
             personnel.
Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation
Condition: Invasive Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Eucerin; Mometasone Furoate 0.1%
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Status post mastectomy; plan to receive PMRT; Topical; steroid cream; emollient skin care; Eucerin; Mometasone Furoate 0.1%

Summary:

      The purpose of this study is to find out if the effect of mometasone furoate is any different
      from Eucerin in decreasing the severity of redness of the skin during irradiation, preventing
      the skin from peeling, or reducing the amount of irritation the patient reports during
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC

          -  Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary
             lymph node dissection) to receive PMRT

          -  ECOG Performance Status of 0 or 1

        Exclusion Criteria:

          -  Male

          -  Patients with clinical evidence of gross disease

          -  Patients who are pregnant or breastfeeding

          -  Prior radiation therapy to the ipsilateral chest wall or thorax

          -  Patients requiring a chest wall boost

          -  Concurrent chemotherapy (biologic agents are allowed)

          -  Psychiatric illness that would prevent the patient from giving informed consent

          -  Inability or unwillingness to comply with skin care instructions and follow-up

          -  Allergy to either Eucerin or MF

          -  Residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at
             intended site of study drug application at the time of the start of RT

          -  Medical condition such as uncontrolled infection (including HIV), uncontrolled
             diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other
             collagen vascular diseases)

          -  Treatment with palliative or pre-operative radiation
Study of BHV-3241 in Participants With Multiple System Atrophy
Condition: Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Intervention: Verdiperstat; Placebo
Intervention description: 300mg 2 oral tablets, twice daily; Matching placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-blind to Sponsor, Investigator and Subject
Enrollment: 421.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Multiple System Atrophy (MSA)

Summary:

      The purpose of this study is to compare the efficacy of verdiperstat (BHV-3241) versus
      placebo in participants with Multiple System Atrophy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of probable or possible MSA according to consensus clinical criteria (Gilman
             et al 2008), including participants with MSA of either subtype (MSA-P or MSA-C).

          2. Able to ambulate without the assistance of another person, defined as the ability to
             take at least 10 steps. Use of assistive devices (e.g., walker or cane) is allowed.

          3. Anticipated survival of at least 3 years at the time of Screening, as judged by the
             Investigator.

        Exclusion Criteria:

          1. Any condition that would interfere with the participant's ability to comply with study
             instructions, place the participant at unacceptable risk, and/or confound the
             interpretation of safety or efficacy data from the study, as judged by the
             Investigator.

          2. Diagnosis of neurological disorders, other than MSA.
An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: bion
Intervention description: battery powered bion microstimulator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urgency-Frequency; Syndrome; Urinary; Refractory; Stimulation; Nerve; Neuromodulation; Microstimulator; bion; Pudendal; Overactive bladder

Summary:

      The goal of this study is to investigate the safety and effectiveness of a new implanted
      device designed to treat Urinary Urgency-Frequency Syndrome.
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Age 18 years and above.

          -  Diagnosed with urinary urgency-frequency syndrome.

          -  Have no reported history of urethral obstruction/stricture, bladder calculi or bladder
             tumor.

          -  Have normal upper urinary tract function.

          -  Be capable of giving informed consent.

          -  Be capable and willing to follow all study related procedures.

        Key Exclusion Criteria:

          -  Have any active implantable device regardless of whether stimulation status is ON or
             OFF.

          -  Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during
             the following 12 month period.

          -  Less than one year post partum and/or are breast-feeding.

          -  Have any large passive implant that contains metal located within 30 cm of the chair
             pad while seated (e.g., hip replacement).

          -  Have conditions requiring magnetic resonance imaging (MRI) evaluation.

          -  Have conditions requiring diathermy procedures.

          -  Have an inability to operate the bion Remote Control and bion Recharging System either
             by self or caregiver.

          -  Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.

          -  Have history of coagulopathy or bleeding disorder.

          -  Have pelvic pain in the absence of voiding dysfunction.

          -  Have anatomical restrictions such that the study device placement is not possible.

          -  Are currently participating or have participated within the past 30 days in any
             clinical investigation involving or impacting urinary or renal function.

          -  Cannot independently comprehend and complete the questionnaires.
A Study Evaluating Epoetin Alfa 40,000 IU (International Units) Every Week or 80,000 IU Every Week Compared to Placebo in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes at Risk for Transfusion
Condition: Myelodysplastic Syndromes; Anemia
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Placebo; Epoetin alfa; Placebo; Epoetin alfa
Intervention description: Matching volume 2 mLfor 48 weeks; 40,000 IU subcutaneously once every week (1 mL dose) for 48 weeks; Matching volume 1 mL for 48 weeks; 80,000 IU subcutaneously once every week (2 mL dose) for 48 weeks
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MDS; Myelodysplastic syndromes; Anemia; Epoetin alfa; EPO

Summary:

      The purpose of this study is to demonstrate that Epoetin alfa treatment reduces red blood
      cell transfusions in anemic patients with myelodysplastic syndromes (MDS). Myelodysplastic
      syndromes are a group of disorders characterized by progressive bone marrow failure and an
      increased risk of development of leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of MDS according to protocol-specified criteria via bone marrow studies
             performed within 12 weeks before randomization

        Exclusion Criteria:

          -  No prior or concurrent treatment with epoetin alfa or any other approved or
             experimental erythropoietin stimulating agents (ESAs) within the previous 12 months
             before randomization

          -  No prior use of approved or experimental agents for the treatment of MDS or recent
             treatment with granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage
             colony stimulating factor (GM-CSF) for the treatment of neutropenia

          -  Patients must not have secondary MDS or anemia caused by factors other than MDS
             (including iron deficiency, vitamin B12 or folate deficiencies, hemolysis, chronic
             renal failure, or gastrointestinal bleeding)

          -  No history (within 12 months) of deep venous thrombosis

          -  or history (within 6 months) of stroke, acute coronary syndrome or other arterial
             thrombosis

          -  Not currently receiving therapeutic anticoagulants or have uncontrolled hypertension

          -  No uncontrolled disease or dysfunction deemed clinically significant by the
             Investigator not attributable to MDS
A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Intervention: NPSP558
Intervention description: All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: PTH 1-84; Hypoparathyroidism; Parathyroid Hormone 1-84; NPSP558

Summary:

      This study is a long-term, open-label study using NPSP558 for the treatment of adult patients
      with Hypoparathyroidism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously completed the rhPTH[1-84] RELAY study (8 weeks of active therapy) and/or
             previously completed the rhPTH[1-84] REPLACE study (Visit 18).

          -  Able to perform daily SC self-injections of study medication (or have a designee
             perform injection).

          -  Women who are (1) postmenopausal; (2) surgically sterilized; or, (3) of childbearing
             potential with a negative pregnancy test and who consent to use two acceptable methods
             of contraception for the duration of the study.

          -  Males who have female partners of childbearing potential must use two acceptable forms
             of contraception for the duration of the study.

          -  Serum creatinine <1.5 mg/dL at enrollment.

          -  Total serum calcium less than or equal to upper limit of normal (ULN) based on local
             laboratory result prior to enrollment.

          -  Serum 25 hydroxy (OH) vitamin D less than or equal to 1.5 times the ULN within
             approximately 16 weeks prior to enrollment.

        Exclusion Criteria:

          -  Any condition that, in the investigator's opinion after consultation with the sponsor,
             would preclude the safe use of parathyroid hormone (PTH).

          -  Pregnant or lactating women.

          -  Any disease or condition which has a high probability of precluding the subject from
             completing the study or where the subject cannot or will not appropriately comply with
             study requirements.