bioihbjkbjnl/mcl2 huggingface dataset:
Signatures of N-Ac for Non-Suicidal Self-Injury in Adolescents
Condition: Self-Harm; Depression; Suicide
MeSH terms: Suicide; Self-Injurious Behavior
Intervention: N-acetyl cysteine; Placebo oral tablet
Intervention description: 3600 or 5400 mg/day N-acetyl cysteine; Placebo
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: Female
Minimum age: 16 Years
Maximum age: 24 Years
Healthy volunteers: No

Summary:

      To measure NAC-induced changes to concentrations of glutathione (GSH) in the anterior
      cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS) in 36 adolescents
      and young adults with NSSI (12 in each group: high, low, and placebo).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current frequency of at least one NSSI episode in the past 2 months

          -  ≥ 5 past episodes of NSSI with significant tissue damage (e.g. scars present)

          -  Psychotropic medications are dose-stable for 1 month

          -  Ability to understand study procedures and to comply with them for the entire length
             of the study

        Exclusion Criteria:

          -  Any MRI contraindications (e.g. metal plates, claustrophobia, braces, implanted
             devices)

          -  Any current serious medical illness as defined by medical history

          -  Current Substance Use Disorder (except Tobacco Use Disorder)

          -  Primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder,
             schizophreniform disorder)

          -  Neurodevelopmental disorder such as mental retardation or autism

          -  Changes in psychotropic medications in past 1 month

          -  Taken NAC or glutathione on a regular basis in the past 6 months

          -  Currently pregnant, planning to become pregnant, currently breastfeeding, or
             unwillingness to use contraception throughout the study.

          -  Allergy/sensitivity to N-acetylcysteine.

          -  Inability or unwillingness of individual or legal guardian/representative to give
             written informed consent.
Study of Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in HCT Recipients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Intervention: Propranolol
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Recipients

Summary:

      This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic
      antagonist propranolol is effective in decreasing gene expression of stress-mediated
      beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic
      stem cell transplant (HCT) for multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with multiple myeloma receiving an autologous HCT are eligible when the following
        criteria are met:

          1. 18-75 years of age

          2. ≤ 1 year since initiation of systemic anti-myeloma therapy

          3. Patient is scheduled for autologous hematopoietic stem cell transplant as the upfront
             therapy for their multiple myeloma

          4. Karnofsky Performance Status of ≥90 %; patients eligible for HCT are eligible for the
             study

          5. All men and women must agree to practice effective contraception during the study
             period if not otherwise documented to be infertile.

        Exclusion Criteria:

          1. Prior autologous HCT

          2. Non secretory multiple myeloma

          3. Concurrent beta-blocker therapy at or within 3 weeks of study entry.

          4. Previous intolerance to beta-blocker therapy

          5. Any medical contraindications to beta-blocker therapy including, but not limited to,
             symptomatic hypotension; drug hypersensitivity; sinus bradycardia, sick sinus
             syndrome, or 2nd or 3rd degree atrioventricular block without a pacemaker;
             uncompensated heart failure; or uncontrolled asthma

          6. Active, untreated depression screened for by the HCT physician (Patients who screen
             positive will be offered a referral to the Medical College of Wisconsin
             Psycho-Oncology program for further evaluation and treatment)

          7. Concurrent use of medications as specified in the protocol throughout the study or
             within one week of study entry.

          8. Pregnant or lactating women
Enhancing Medication-based Analgesia in Humans
Condition: Pain; Cannabis; Opioid Use, Unspecified
Intervention: Within-subject test of blinded study medications
Intervention description: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Intervention model description: Each participant completed each of the 5 study conditions (identified here as arms).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clinical Trial, Phase II; Analgesia; Abuse Potential

Summary:

      This is a single-group, within-subject, double-blind, double-dummy, placebo and
      active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol)
      would enhance analgesia, subjective reports, and cognitive performance when compared to the
      FDA-approved opioid hydromorphone (Dilaudid).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-75

          -  Urine sample tests negative for common illicit substances of abuse, including cannabis

          -  Medically cleared to take study medications

          -  Are not pregnant or breast feeding

          -  Willing to comply with the study protocol.

        Exclusion Criteria:

          -  Meet DSM-5 criteria for alcohol/substance use disorder

          -  Taking opioids for pain

          -  Previous adverse reaction to a cannabinoid product

          -  Prescribed and taking stimulants or benzodiazepines

          -  Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain

          -  Self-report any illicit drug use in the past 7 days

          -  Presence of any clinically significant medical/psychiatric illness judged by the
             investigators to put subject at elevated risk for experiencing an adverse event

          -  History of seizure disorder

          -  Have a known allergy to the study medications or sesame seed oil

          -  Taking medications contraindicated with hydromorphone or dronabinol

          -  Have a history of clinically significant cardiac arrhythmias or vasopastic disease

          -  Have an abnormal and clinically-significant ECG
Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis; Psoriasis; Skin Diseases
MeSH terms: Psoriasis; Skin Diseases
Intervention: JTE-451 Tablets; Placebo Tablets
Intervention description: Active drug tablets containing JTE-451; Placebo tablets matching in appearance to the active drug tablets
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: Double-blind
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: JTE-451; Psoriasis; Plaque psoriasis; IMPACT-PS

Summary:

      Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects
      with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a history of moderate to severe plaque psoriasis for at least 6 months prior
             to Visit 1;

          -  Subjects with moderate to severe plaque psoriasis covering ≥10% body surface area
             (BSA), with a psoriasis area and severity index (PASI) ≥12 and static Physician's
             Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2

        Exclusion Criteria:

          -  History of discontinuation of biologic therapies (including marketed and
             investigational drugs) directly targeting Interleukin (IL)-17A, IL-17A/F, IL-17
             receptor A, IL-12/IL-23p40 or IL-23p19 due to lack of efficacy, according to the
             Investigator's judgment;

          -  Prior exposure to retinoid-related orphan receptor (ROR)-γ inhibitors;

          -  Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
             medication-induced psoriasis or other skin conditions (e.g., clinically-significant
             eczema or severe acne) at Visit 1;

          -  History or presence of itch due to underlying conditions other than plaque psoriasis
             which cause or influence pruritus of the skin within 12 months prior to Visit 1.
Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Euthyroid Group
Intervention description: Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: thyroid cancer; PET scan; recombinant thyrotropin; thyroglobulin; Thyroid cancer, differentiated epithelial

Summary:

      The purpose of this study is to determine [for patients with previously treated
      well-differentiated thyroid cancer and evidence of residual disease based on serum
      thyroglobulin (Tg) level] whether positron emission tomography-computed tomography (PET-CT)
      fusion scanning performed after recombinant thyroid-stimulating hormone (TSH) (rTSH,
      thyrotropin alfa for injection) will be more sensitive for the detection of disease sites
      than PET-CT scanning without rTSH. The study will also determine if this information will
      significantly alter the therapeutic approach in some patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (aged ≥ 18 years) with history of treated well-differentiated epithelial
             thyroid carcinoma (papillary, follicular or Hurthle cell), for which total or near
             total thyroidectomy plus postoperative radioiodine remnant ablation with 131-I has
             either been performed or found to be unnecessary by radioiodine imaging after TSH
             stimulation.

          -  Serum thyroglobulin (Tg) concentration ≥ 10 ng/mL (in the absence of interfering Tg
             autoantibodies).

          -  No findings of a "qualifying" radioiodine whole body scan that are sufficient to
             localize the disease suspected on the basis of the serum Tg.

          -  Inconclusive disease localization despite clinical assessment, cervical sonography, CT
             or magnetic resonance (MR) of the chest, and when appropriate other imaging and biopsy
             procedures. Patients must have no more than three foci of known or suspected
             extra-cervical metastasis.

          -  Must be in stable medical condition.

          -  Must be able to fully understand the protocol and be compliant with instructions.

        Exclusion Criteria:

          -  Diabetes mellitus, due to interference with fluorodeoxyglucose (FDG) PET scanning.

          -  Claustrophobia, inability to lay supine, or other factors preventing cooperation with
             scanning procedures.

          -  Withdrawal of thyroid hormone or rTSH administration within the preceding month.

          -  Presence of circulating Tg autoantibodies interfering with serum Tg measurement.

          -  Women who are pregnant or breastfeeding
Niclosamide for Mild to Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Niclosamide; Placebo; Telehealth monitoring
Intervention description: Participants in the treatment arm will receive Niclosamide 2 grams orally once daily for 7 days in addition to current standard of care treatment. Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14. Fecal samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14, 21. A baseline fecal and oropharyngeal sample will be obtained on Day 1 prior to starting dosing of Niclosamide/ placebo.; The collection of oropharyngeal samples will be observed by a Study Team member via the telehealth platform.; In addition to Niclosamide or placebo treatments, all enrolled patients will be provided a home thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. The collection of oropharyngeal samples will be directly observed by a Study Team member via the telehealth platform.
Intervention MeSH terms: Niclosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded randomized controlled trial.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: As all members of the Study Team will be blinded, Tufts Investigational Drug Services (IDS) will be unblinded and will dispense both the Niclosamide and placebo. The study intervention (Niclosamide) and placebo will be packaged and as indistinguishable as possible.
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; Coronavirus; Treatment; Pill; Telehealth; Viral shedding

Summary:

      This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for
      mild to moderate coronavirus disease 2019 (COVID-19).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive SARS-CoV-2 test by PCR

          -  No requirement of oxygen supplementation

          -  Ability to take oral medication

        Exclusion Criteria:

          -  Known allergic reactions to any components of Niclosamide medication

          -  Participation in another trial or use of any experimental treatment for COVID-19,
             including chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir

          -  Hospitalization or requirement of hospitalization at the time of enrollment
Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous Access
Condition: Stroke; Intracranial Hypotension; Cerebral Edema
MeSH terms: Brain Edema; Intracranial Hypotension; Hypotension
Intervention: Intraosseous; Hypertonic saline
Intervention description: Intraosseous administration of hypertonic saline; Intraosseous administration of hypertonic saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: prospective case series
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Hypertonic saline is used to treat elevated intracranial pressure. Intraosseous vascular
      access has been used to administer fluids and medications. This study combines these to
      administer 3% hypertonic saline via IO.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NCCU patients in which osmotherapy with HTS is planned (standard of care

          -  Does not already have a CVC or PICC.

        Exclusion Criteria:

          -  <18 years old

          -  Known pregnancy

          -  Long bone fracture in the targeted site

          -  Proximity to prosthetic joint

          -  Excessive tissue/absence of anatomical landmarks

          -  History of osteopetrosis

          -  Previous significant orthopedic procedure at site

          -  Prosthetic limb or joint

          -  IO catheter use in the past 48 hours of the target bone

          -  Infection at the area of insertion

          -  Hypersensitivity to lidocaine
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: ACT-128800 Dose 1; Placebo; ACT-128800 Dose 2; ACT-128800 Dose 3
Intervention description: ACT-128800 (Dose 1) administered orally once daily; Matching placebo administered orally once daily; ACT-128800 (Dose 2) administered orally once daily; ACT-128800 (Dose 3) administered orally once daily
Intervention MeSH terms: Ponesimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 464.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with
      relapsing-remitting multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males and females

          -  Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for
             Multiple Sclerosis (MS).

          -  Signed inform consent prior to initiation of any study-mandated procedure.

        Exclusion Criteria:

          -  A diagnosis of MS categorized as primary progressive or secondary progressive or
             progressive relapsing.

          -  Patients currently treated for an autoimmune disorder other than MS.

          -  Contraindications for MRI.

          -  Ongoing bacterial, viral, or fungal infection.

          -  History or presence of malignancy.

        Additional inclusion and exclusion criteria apply with respect to medical conditions and
        concomitant treatments which could affect patients' risk from participating in the study.
A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BMS-986036; Placebo (Matching with BMS-986036)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 219.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults
      with type-2 diabetes.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Diagnosed with type-2 diabetes mellitus with HbA1c ≥6.5% to less than 10.0%

          -  Body mass index 30.0 to 50.0

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Inability to self-administer subcutaneous injections

          -  Inability to be venipunctured

          -  Evidence of organ dysfunction beyond what is consistent with the target population

          -  History of allergy to PEGylated compounds or Fibroblast growth factor 21 (FGF21)
             related compounds
Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Broccoli sprout extract; Mango juice
Intervention description: 100 µmols of sulforaphane (dissolvable); 150 mL of mango juice
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Broccoli Sprout Extract; Breast Cancer

Summary:

      The purpose of this research is to examine the effect of a broccoli sprout preparation on
      specific factors in breast tissue that are related to breast cancer risk and to assess
      whether sulforaphane a key component of broccoli sprouts increases the levels of protective
      enzymes in breast tissue. In addition, the investigators will also examine how acceptable the
      broccoli sprouts preparation is to the study participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female 18 + years of age

          -  Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for
             definitive surgery

          -  Pre or Post menopausal women reporting no use of hormone replacement therapy,
             tamoxifen or raloxifene within the prior 6 months to eligibility screening

          -  Agree to avoid cruciferous vegetable/condiment intake for 14 days

          -  Agree to sign an informed consent and allow use of some tissue (slides) from biopsy
             and definitive surgery for research purposes

        Exclusion Criteria:

          -  Prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma
             in-situ

          -  Used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months
             prior to eligibility screening

          -  Used antibiotics within 10 days prior to beginning cruciferous free diet (day -14
             prior to surgery)

          -  Smoked within the past 12 months prior to eligibility screening;

          -  Active infection or inflammation of the breast at time of eligibility screening

          -  Has baseline comprehensive metabolic panel (CMP) [Glucose, Calcium, Albumin, Serum
             total protein (TP), Sodium, Potassium, Carbon dioxide, Chloride, Blood urea nitrogen
             (BUN), Creatinine, Alkaline phosphatase (ALP), Alanine amino transferase (AST),
             Aspartate amino transferase (SGOT), and Bilirubin], prothrombin time (PT) and ,
             complete blood count (CBC) values that are 1.5 times in either direction the reported
             normal range