bioihbjkbjnl/mcl2 huggingface dataset:
Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use
Condition: Cocaine Use Disorder; Anxiety
Intervention: suvorexant; Placebo (for suvorexant)
Intervention description: Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM.; Subjects will receive placebo capsules once daily at 10 PM.
Intervention MeSH terms: Suvorexant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: cocaine; sleep; anxiety; craving; addiction; orexin; cue reactivity; suvorexant; Belsomra

Summary:

      The purpose of this study is to determine the effectiveness of a medication called suvorexant
      in reducing anxiety, improving sleep, and reducing cocaine cravings or cocaine use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meet current DSM-5 criteria for cocaine use disorder (CUD) of at least moderate
             severity (≥4 symptoms)

        Exclusion Criteria:

          -  current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine,
             marijuana, or nicotine

          -  have a DSM-IV axis I psychiatric disorder or neurological disease or disorder
             requiring ongoing treatment and/or making study participation unsafe

          -  significant current suicidal or homicidal ideation

          -  medical conditions contraindicating administration of suvorexant (e.g., severe
             pulmonary disease, severe cardiovascular disease or clinically abnormal EEG, severe
             liver or kidney disease, seizure disorder, or sleep disorder - particularly
             narcolepsy)

          -  taking medications known to have significant drug interactions with the study
             medication(s) (e.g., MAO inhibitors, anticonvulsants, haloperidol, phenothiazines,
             anesthetics, and all sedatives)

          -  currently or recently (last 3 months) treated for substance use [other than cocaine or
             nicotine] or another psychiatric condition

          -  conditions of probation or parole requiring reports of drug use to officers of the
             court; (8) impending incarceration

          -  pregnant or nursing for female patients

          -  inability to read, write, or speak English [required for lab tasks and psychometric
             scales]

          -  unwillingness to sign a written informed consent form

          -  subjects with alcohol use disorders or are drinking > 7 alcoholic drinks per week. All
             subjects who are excluded will be given referral information to other local treatment
             programs.
Gabapentin for Alcohol Relapse Prevention
Condition: Alcohol Use Disorder; Alcohol Withdrawal
MeSH terms: Alcoholism
Intervention: Gabapentin; Placebo
Intervention description: gaba potentiating medication; a pill that looks exactly like the active medication but does not contain medication
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol
      dependence will get medication, which might help them to reduce or stop their drinking, or a
      placebo ( placebo is a capsule that looks the same as the investigational drug, but has no
      real medication. It is a "sugar pill").
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meets criteria for alcohol use disorder based on DSM-5 criteria

          2. Meets criteria for history of alcohol withdrawal based on DSM-5 criteria

          3. Able to maintain abstinence for a minimum of 3 days prior to randomization as verified
             by self report, urine ETG, and breathalyzer.

        Exclusion Criteria:

          1. Significant psychiatric or medical illness

          2. No other substance abuse

          3. Taking other medications known to treat alcohol use disorder

          4. Unstable living arrangements

          5. Significant legal problems pending
An Open Label Extension Study of the Efficacy of MORAb-003
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: MORAb-003
Intervention description: Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks.
Intervention MeSH terms: Farletuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Extension study; Epithelial ovarian cancer

Summary:

      An open label extension of the MORAb-003-002 study in order to continue the active patients
      in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of Informed consent.

          -  Subjects must have been enrolled in and have met the inclusion/exclusion criteria of
             the MORAb-003-002 study.

          -  Subjects must have achieved a normalization of CA 125 levels and/or CR or PR (or
             stable disease and an investigator's assessment of a clinical benefit) after MORAb-003
             in combination with standard chemotherapy and have not yet met the criteria for
             disease progression during participation in the MORAb-003-002 study.

          -  Subjects must be currently receiving single-agent MORAb-003 maintenance therapy.

        Exclusion Criteria:

        • Subjects that discontinued the MORAb-003-002 study for any reason.
SMART Trial: Intrapersonal and Interpersonal Stigma Reduction
Condition: Stigma, Social; Opioid Use; Opioid-use Disorder; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Intervention: Intrapersonal Stigma Reduction; Interpersonal Stigma Reduction
Intervention description: Brief intervention for stigma reduction; Brief intervention for support persons of intrapersonal intervention participants.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: opioid use disorder; substance use disorder; stigma

Summary:

      The goal of this project is to develop a multicomponent stigma reduction intervention to
      address intrapersonal (individual) stigma regarding Opioid Use Disorder (OUD). The
      intervention will address this cost/benefit evaluation among individuals known to face
      intersecting stigma of OUD and African American race, with treatment elements chosen
      explicitly to increase the value of treatment using salient forms of reward, and to ease
      perceived costs through explicit services in an effort to encourage the occurrence of the
      first treatment visit for OUD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Identify as African American, Black, or mixed race

          -  Identify as someone with a substance use disorder who is not currently in treatment OR
             a support person of someone enrolled

          -  Access to a telephone for follow-up assessment

          -  Reside in the Memphis, TN area

        Exclusion Criteria:

          -  Unable to understand consent procedures
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Condition: Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: AKB-6548; Placebo
Intervention description: Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.; Oral Placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 82 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; erythropoietin; kidney; oral anemia treatment; hemoglobin; hypoxia-inducible factor; HIF; hypoxia-inducible factor prolyl-hydroxylase inhibitor; HIF-PHI; efficacy; safety; pharmacokinetics

Summary:

      The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and
      tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease
      (pre-dialysis) with anemia with dosing for 20 weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 to 82 years of age, inclusive

          -  Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis

          -  eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2

          -  Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol

          -  Iron replete with ferritin and TSAT levels as defined per protocol

        Key Exclusion Criteria:

          -  BMI > 44.0 kg/m2

          -  Red blood cell transfusion within 11 weeks prior to the Screening visit

          -  Androgen therapy within the previous 21 days prior to the Screening visit

          -  Intravenous iron within the past 4 weeks prior to the Screening visit

          -  AST or ALT >1.8x ULN, alkaline phosphatase >2x ULN, or total bilirubin >1.5x ULN

          -  Screening ECG with QTc > 500 msec

          -  Uncontrolled hypertension

          -  Class III or IV congestive heart failure

          -  Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the
             Screening visit
A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
Condition: Active Non-segmental Vitiligo
MeSH terms: Vitiligo
Intervention: PF-06651600; PF-06651600; PF-06651600; PF-06651600; PF-06651600; placebo; PF06700841; narrow-band UVB phototherapy
Intervention description: Induction dose 1. Oral tablet taken QD; Induction dose 2. Oral tablet taken QD; Maintenance dose A. Oral tablet taken QD; Maintenance Dose B. Oral tablet taken QD; Maintenance Dose C. Oral tablet taken QD; placebo; Oral tablet taken QD; Phototherapy will be combined with PF-06651600
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose ranging period is a parallel design. Extension period is a sequential design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Dose ranging period is blinded. The partially blinded extension period includes open arms and blinded arms.
Enrollment: 366.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b, randomized, double blind, parallel group, multicenter study with an
      extension period. The study will have a maximum duration of approximately 60 weeks. This
      includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week
      extension period and a 8 week Follow up Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18-65 years of age, inclusive, at time of informed
             consent.

          -  Must have moderate to severe active non-segmental vitiligo.

        Exclusion Criteria:

          -  History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

          -  Infected with hepatitis B or hepatitis C viruses.

          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis (TB)
A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: LY2157299; Sorafenib; Placebo
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: transforming growth factor beta (TGF-β)

Summary:

      The main purpose of this study is to evaluate the safety and effectiveness of the study drug
      known as LY2157299 in participants with hepatocellular carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological evidence of a diagnosis of HCC not amenable to curative surgery.

          -  Have Child-Pugh Class A.

          -  Have the presence of measurable disease.

          -  Have adequate organ function.

          -  Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG)
             scale.

          -  If male or female with reproductive potential, must agree to use medically approved
             contraceptive precautions during the trial and for 3 months following the last dose of
             study drug.

          -  If females with childbearing potential, must have had a negative serum pregnancy test
             7 days prior to the first dose of study drug.

          -  Are able to swallow capsules or tablets.

          -  Have available diagnostic or biopsy tumor tissue.

        Exclusion Criteria:

          -  Have received previous systemic treatment for advanced disease.

          -  Have known HCC with fibro-lamellar or mixed histology.

          -  Have presence of clinically relevant ascites.

          -  Have had a liver transplant.

          -  Have moderate or severe cardiac disease.

          -  Have active or uncontrolled clinically serious hepatitis B virus or hepatitis C virus
             infection.

          -  Have experienced Grade 3 or 4 gastrointestinal bleeding or any variceal bleeding
             episode in the 3 months prior to enrollment requiring transfusion or endoscopic or
             operative intervention.

          -  Have esophageal or gastric varices that require immediate intervention or represent a
             high bleeding risk.

          -  Had major surgery within 4 weeks prior to the study randomization.
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis
Condition: Exocrine Pancreatic Insufficiency (EPI); Cystic Fibrosis (CF)
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: MS1819; Porcine PERT
Intervention description: MS1819 in enteric capsules. It contains is a yeast-derived (non-porcine) lipase pancreatic enzyme replacement.; Porcine PERT is being used a comparator to MS1819 as a second drug/intervention.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2, 2x2 Crossover
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Exocrine Pancreatic Insufficiency; EPI; Cystic Fibrosis; CF

Summary:

      The primary objectives of this study are to assess the safety and efficacy of MS1819 in
      enteric capsules vs porcine pancreatic enzyme replacement therapy (PERT) in patients with
      exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The exploratory
      objective of the extension phase (EP) is to find a dose of MS1819 in immediate release
      capsules that is safe and results in CFA values in a therapeutic range.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Cystic fibrosis, based on 2 clinical features consistent with CF, plus either a
             new/historic sweat chloride ≥60 mmol/L (measured while not on a CFTR modulator) or
             genotype.

          2. Under stable dose of porcine PERT

          3. A fair or better nutritional status

          4. Fecal elastase <100 µg/g

          5. Standard-of-care medications including CFTR modulators are allowed

        Exclusion Criteria:

          1. History or diagnosis of fibrosing colonopathy

          2. Any chronic diarrheal illness unrelated to pancreatic insufficiency

          3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥5 ×upper
             limit of normal (ULN), or total bilirubin level ≥1.5 ×ULN at the Screening visit

          4. Feeding via an enteral tube during 6 months before screening

          5. Forced expiratory volume ≤30% at the Screening visit
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: alpelisib; buparlisib; Placebo
Intervention description: BYL719 + Letrozole; BKM120 + Letrozole; Placebo (of BYL719 or BKM120) + Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 340.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BYL719; alpelisib; Breast Cancer; BKM120; buparlisib; Pathological Complete Response; neoadjuvant; hormone receptor-positive; HER2 negative; Objective Response Rate

Summary:

      The purpose of the study was to determine whether treatment with a PI3K inhibitor plus
      letrozole led to an increase in pathologic clinical response and Objective Response Rate
      compared to treatment with placebo plus letrozole in patients with Breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is an adult, female ≥ 18 years old at the time of informed consent

          2. Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer

          3. Patient is postmenopausal.

          4. Patient has T1c-T3, any N, M0, operable breast cancer

          5. Patients must have measurable disease

          6. Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67
             level.

          7. Patient has estrogen-receptor and/or progesterone positive breast cancer as per local
             laboratory testing

          8. Patient has HER2 negative breast cancer defined as a negative in situ hybridization
             test or an IHC status of 0 or 1+ as per local laboratory testing

        Exclusion Criteria:

          1. Patient has locally recurrent or metastatic disease

          2. Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy,
             immunotherapy) or radiotherapy for current breast cancer disease before randomization.

          3. Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes
             mellitus

          4. History of acute pancreatitis within 1 year of study entry

          5. Uncontrolled hypertension
CHOCOlate MeLatonin for AdolescenT MigrainE
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Melatonin
Intervention description: melatonin
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Existing treatments for acute migraine are not effective for all children and adolescents,
      and can cause side effects. Investigator propose a dose-finding study of melatonin for acute
      migraine treatment in children and adolescents to determine the best dose to bring forward in
      a future fully-powered efficacy trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meet ICHD criteria for episodic migraine in children and adolescents, with at least 1
             migraine attack per month on average.

          2. Age 3-17 years

          3. Dissatisfaction with previous acute treatments, for one or more of the following
             reasons: a) One or more previously tried acute medications have not been effective, or
             adequately effective, b) previously tried acute treatments have caused side effects,
             or C) patient/family would prefer a natural supplement for acute treatment over
             medication treatment

          4. If of driving age, teen participant agrees not to drive for at least 8 hours after
             treating with melatonin.

        Exclusion Criteria:

          1. Allergy or intolerance to melatonin, or to chocolate.

          2. Opioid or barbiturate overuse as defined in ICHD

          3. Pregnant/lactating
Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Interleukin-2
Intervention description: Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days
Intervention MeSH terms: Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acute myelogenous leukemia; interleukin-2

Summary:

      Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment
      during lymphocyte recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed hematopathology diagnosis of AML receiving marrow suppressive treatment

          -  Total WBC recovery of 500 mm3 prior to IL-2 treatment

          -  Platelet count of at least 20,000 mm3 prior to starting IL-2 treatment

          -  Active infection controlled prior to starting IL-2 treatment

          -  Stable systolic blood pressure > 90mm Hg prior to starting IL-2 treatment

          -  O2 saturation >90% prior to starting treatment

          -  Stable cardiopulmonary status prior to starting IL-2 treatment

          -  Serum creatinine < or equal to 2.0 mg/dl

          -  Total bilirubin and AST <3x upper limits normal

        Exclusion Criteria:

          -  Acute Promyelocytic Leukemia

          -  Active thrombocytopenic bleeding

          -  Cardiac ejection fraction below 45%

          -  Pregnancy and/or lactation