bioihbjkbjnl/mcl2 huggingface dataset:
Rapid Antidepressant Effects of Leucine
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: L-Leucine; Maltodextrin
Intervention description: L-leucine is an essential amino acid which will be provided as an effervescent powder mixture to participants.; Maltodextrin is a nonsweet carbohydrate which will be provided as an effervescent powder mixture similar in taste and appearance to the L-leucine containing effervescent powder mixture
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Antidepressant; Inflammation; Biomarker; Depression; Treatment Resistant Depression; Leucine

Summary:

      This randomized double-blind placebo-controlled crossover study seeks to evaluate the
      antidepressant effect of L-leucine, an essential amino acid, in patients with Major
      Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current primary diagnosis of nonpsychotic major depressive disorder.

          -  Stable antidepressant dose of no more than one antidepressant medication for 4 weeks
             and no anticipated changes during the study period.

          -  Stable doses of all concomitant medications for over 6 weeks.

          -  No more than two failed antidepressant trials of adequate dose and duration, as
             defined by ATRQ, in the current episode.

        Exclusion Criteria:

          -  Psychiatric co-morbidity posing safety risk.

          -  Pregnant or breastfeeding or plan to become pregnant over the ensuing 2 months
             following study entry or are sexually active and not using adequate contraception

          -  Exclusionary psychiatric conditions (such as substance dependence in the last 6
             months, substance abuse in the last 2 months, or lifetime history of psychotic
             disorders.

          -  Unstable or terminal general medical condition (GMC).

          -  Concomitant medications that interact with L-leucine (e.g. sildenafil).

          -  Vagus nerve stimulation, ECT, or rTMS, or other somatic antidepressant treatment
             during current episode

          -  Inadequately controlled hypothyroidism.

          -  Therapy that is depression specific, such as CBT or Interpersonal Psychotherapy of
             Depression.

          -  Hypersensitivity to L-leucine

          -  Have Maple Syrup Urine Disease.
Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Bepotastine Besilate Nasal Spray 2% Twice a day; Bepotastine Besilate Nasal Spray 3% Twice a day; Bepotastine Besilate Nasal Spray 4% Twice a day; Placebo Nasal Spray
Intervention description: nasal spray; nasal spray; nasal spray; nasal spray
Intervention MeSH terms: Bepotastine besilate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 601.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 12 years of age with a history of mountain cedar allergy

        Exclusion Criteria:

          -  No active nasal infection or nasal abnormality that would affect subject safety or
             symptom assessments
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF/VEL/VOX; RBV
Intervention description: 400/100/100 mg FDC tablet administered orally once daily with food; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
      the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination
      (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV)
      infection and prior treatment experience with a direct acting antiviral (DAA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals with chronic HCV genotype 1 infection

          -  Documented as treatment experienced with a direct acting antiviral-containing regimen
             without achieving sustained viral response

          -  Absence of cirrhosis or presence of compensated cirrhosis

          -  Screening laboratory values within defined thresholds

          -  Must use specific contraceptive methods if female of childbearing potential or
             sexually active male

        Key Exclusion Criteria:

          -  Co-infection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with individual's treatment, assessment or compliance with the protocol

          -  Pregnant or a nursing female

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Oxytocin, Alcohol Craving, and Intimate Partner Aggression
Condition: Alcohol Use
MeSH terms: Aggression
Intervention: Oxytocin; Placebo
Intervention description: 40 IU oxytocin nasal spray; Saline
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Couples; Oxytocin; Aggression; Alcohol

Summary:

      Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There
      are significant health and economic burdens associated with AUD and co-occurring IPA, and
      little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate
      both AUD and IPA. However, clinical data examining oxytocin's effects on human aggression is
      scant. The proposed study is designed to address these gaps in the literature by utilizing a
      human laboratory paradigm to test the effects of oxytocin on craving and aggression among
      couples with AUD and co-occurring IPA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria indicate that participants must

          -  aged 18 or over

          -  fluent in English

          -  endorse at least one instance of mild or moderate physical IPA with their partner in
             the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2)

          -  both partners must be willing to participate

          -  one or both partners must meet Diagnostic and Statistical Manual of Mental Disorders
             (DSM-V) criteria for an alcohol use disorder (AUD). Concurrent substance use disorders
             (e.g., marijuana) is acceptable provided alcohol is the participant's primary
             substance of choice.

        Exclusion Criteria:

          -  Exclusion criteria include

          -  pregnancy or breastfeeding

          -  current or history of psychiatric or medical condition that could interfere with
             neuroendocrine function (e.g., hematological, endocrine, renal, or pulmonary disease;
             synthetic glucocorticoid or exogenous steroid therapy; psychotic, bipolar, eating
             disorders)

          -  Body Max Index (BMI) ≥ 39

          -  current suicidal ideation and intent

          -  severe physical or sexual IPA in the past six months as defined by the Conflict
             Tactics Scale (CTS-2)

          -  initiation of psychotropic medication in the past 4 weeks

          -  acute alcohol withdrawal as indicated by a score of 8 or greater on the Clinical
             Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar).
A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: V565; Placebo
Intervention description: Daily dosing of V565 three times a day orally for 6 weeks; Daily dosing of placebo three times a day orally for 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of V565 in participants with
      active Crohn's Disease (CD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of Crohn's Disease of at least 3 months duration prior to screening

          -  Crohn's Disease Activity Index (CDAI) score of ≥220 to ≤450 during screening

          -  C-reactive protein (CRP) ≥5 mg/L (or, if CRP is normal, faecal calprotectin (FCP) ≥250
             µg/g) at screening

          -  Permitted CD medication regimen expected to remain stable during the period of the
             study

        Exclusion Criteria:

          -  Previous lack of response or current contra-indication to an anti-tumour necrosis
             factor α (anti-TNFα) agent

          -  Certain complications of Crohn's Disease that would make it hard to assess response to
             study drug

          -  Known history or suspicion of inflammatory bowel disease other than Crohn's disease

          -  History of tuberculosis (TB) or latent TB infection that has not been treated

          -  Any significant illness or condition which would preclude effective participation in
             the study

          -  GI infection as demonstrated by presence of enteric pathogens

          -  Pregnant or lactating women

          -  Abdominal surgery in the previous 6 months

          -  Unsuitable for inclusion in the study in the opinion of the investigator or sponsor
             for any reason that may compromise the subject's safety or confound data
             interpretation
Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
Condition: Blunt Chest Wall Trauma; Rib Fracture; Sternal Fracture
MeSH terms: Fractures, Bone; Wounds and Injuries; Rib Fractures
Intervention: Liposomal bupivacaine; 0.9% sodium chloride
Intervention description: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position; 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall
      trauma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Anticipated length of stay of at least 72 hours

          -  Blunt chest wall trauma with two or more rib or sternal fractures

          -  Demonstrated ability to achieve > 50% predicted inspiratory capacity based on ideal
             body weight using IS within the first 24 hours of admission

        Exclusion Criteria:

          -  Known allergy to bupivacaine

          -  Respiratory failure requiring intubation within 24 hours prior to enrollment

          -  Known or suspected atrioventricular nodal blockade process requiring cardiology
             evaluation or pacemaker placement

          -  Hemodynamic instability (defined as new intravenous vasopressor or inotrope
             requirement or mean arterial pressure < 55 mmHg)

          -  Signs of active myocardial ischemia or non-ST elevation MI

          -  > 20 rib fractures

          -  Weight < 50 kg or > 150 kg

          -  Pregnancy

          -  Incarceration
Cannabidiol on Reward- and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: Cannabidiol 100 MG/ML [Epidiolex]; Placebo
Intervention description: 600mg; Matching placebo
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a double-blind, placebo-controlled, cross-over trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: This is a double-blind cross-over trial, in which the research staff and participants will be blinded.
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the impact of cannabidiol on reward- and
      stress-related neurocognitive processes among individuals with opioid use disorder on
      buprenorphine or methadone treatment.
    

Eligibility criteria:

        Inclusion Criteria

          -  English speaking

          -  DSM5 diagnosis of opioid use disorder

          -  Receiving buprenorphine or methadone for treatment of opioid use disorder

          -  Agreeable to abstaining from using any cannabis or CBD products for the duration of
             the trial.

        Exclusion Criteria:

          -  Any self-reported use of cannabis or CBD products in the past 30 days

          -  Baseline depression (PHQ9) or anxiety (GAD7) scores of greater than 10

          -  Currently pregnant

          -  Hepatic liver enzymes greater than 3x upper normal limit

          -  Hypersensitivity to cannabinoids or sesame oil (CBD solution comes in sesame oil
             emulsion)

          -  Currently taking any medications with known significant pharmacokinetic interactions
             with CBD
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Abemaciclib
Intervention description: Administered orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to examine the side effects that participants with
      metastatic breast cancer experience when taking abemaciclib with or without food.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).

          -  Have all of the following:

               -  Recurrent, locally advanced, unresectable or mBC with disease progression
                  following anti-estrogen therapy.

               -  Prior treatment with chemotherapy for locally advanced or metastatic disease.

               -  No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.

          -  Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.

          -  Have discontinued all previous treatments for cancer and recovered from the acute
             effects of therapy.

          -  Have adequate organ function.

          -  Women of child-bearing potential must have a negative pregnancy test.

          -  Are able to swallow tablets/capsules.

        Exclusion Criteria:

          -  Are currently receiving treatment in a clinical study involving an investigational
             product.

          -  Have a serious concomitant systemic disorder.

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis.

          -  Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic
             activated/reactivated hepatitis A, B, or C.

          -  Have a personal history of syncope of either unexplained or cardiovascular etiology,
             ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.

          -  Have a history of any other cancer.

          -  Had major surgery within 14 days prior to randomization.

          -  Are breastfeeding.

          -  Have received treatment with a drug that has not received regulatory approval for any
             indication within 14 or 21 days of the initial dose of study drug for a
             nonmyelosuppressive or myelosuppressive agent, respectively.
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Selatogrel 8 mg; Selatogrel 16 mg
Intervention description: Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water and further diluted with 1 mL sodium chloride (NaCl) 0.9%.; Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can
      prevent platelets from binding together. This study will also help to find out more about the
      safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses
      (8 mg or 16 mg) and will be administered in the thigh.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Informed consent obtained prior to any study-mandated procedure,

          -  Males aged from 18 to 85 and postmenopausal females aged up to 85 years,

          -  Onset of symptoms of AMI of more than 30 min and less than 6 hours prior to
             randomization,

          -  Subjects presenting a type I AMI including STEMI or NSTEMI.

        Main Exclusion Criteria:

          -  Cardiogenic shock or severe hemodynamic instability,

          -  Cardiopulmonary resuscitation,

          -  Loading dose of any oral P2Y12 receptor antagonist prior to randomization,

          -  Planned fibrinolytic therapy or any fibrinolytic therapy administered within 24 h
             prior to randomization,

          -  Known platelet disorders (e.g., thromboasthenia, thrombocytopenia, von Willebrand
             disease).

          -  Active internal bleeding, or bleeding diathesis or conditions associated with high
             risk of bleeding.

          -  Known clinically important anemia.

          -  Oral anticoagulation therapy within 7 days prior to randomization
Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency
Condition: Alpha-1-antitrypsin Deficiency; Liver Cirrhosis
MeSH terms: Liver Diseases; Liver Cirrhosis; Alpha 1-Antitrypsin Deficiency
Intervention: Drug-Carbamazepine (Tegretol XR); Carbamazepine (Tegretol XR) Placebo
Intervention description: To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated..; Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine.
Intervention MeSH terms: Carbamazepine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 14 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Carbamazepine (Tegretol) use; severe liver disease; alpha-1-antitrypsin deficiency

Summary:

      The primary objective is to determine if the medication Carbamazepine, can be used as a
      therapy for patients with severe liver disease due to Alpha-1-Antitrypsin Deficiency .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 14 years to less than or equal to 80 years of age.

          -  Alpha-1-Antitrypsin deficiency confirmed by ZZ or SZ phenotype & serum level

          -  < 83mg/dl.

          -  HVPG greater than or equal to 10 mmHg unless collateral vessels are visualized via
             transvenous biopsy.

        Exclusion Criteria:

          -  Child Pugh Score greater than or equal to 12. Serum total bilirubin > 5 mg/dl. INR >
             2.2.