bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
Condition: Vulvovaginitis; Yeast Infection; Yeast Infection Vaginal; Candidiasis, Vulvovaginal
MeSH terms: Infections; Communicable Diseases; Candidiasis; Candidiasis, Vulvovaginal; Mycoses; Vulvovaginitis
Intervention: Oral Encochleated Amphotericin B (CAMB); Fluconazole
Intervention description: lipid-crystal nano-particle formulation amphotericin B
Intervention MeSH terms: Fluconazole; Amphotericin B; Liposomal amphotericin B
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 137.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy
      of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the
      treatment of moderate to severe VVC.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Informed consent

        Clinical diagnosis of moderate to severe VVC

        Negative pregnancy test

        Vaginal pH less than 4.5

        Key Exclusion Criteria:

        Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole
        antifungal drugs

        Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections
        requiring antifungal therapy

        Has received treatment for VVC within the past 30 days or has experienced 4 or more
        episodes of VVC in the past 12 months

        Has another cause of vulvovaginitis

        Has other urogenital infection(s) that would potentially alter their response to disease

        Has another vaginal or vulvar condition that would confound the interpretation of clinical
        response

        Has significant laboratory abnormality at screening

        Has any known azole-resistant Candida infection;

        Has any other condition the Investigator believes would interfere with the subject's
        ability to provide informed consent, comply with study instructions, or puts the subject at
        undue risk
Milk Thistle in Trichotillomania in Children and Adults
Condition: Trichotillomania; Hair Pulling Disorder
MeSH terms: Trichotillomania
Intervention: Milk Thistle; Placebo
Intervention MeSH terms: Silymarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 10 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk
      thistle) in children and adults with trichotillomania. The hypothesis to be tested is that
      silymarin will be more effective and well tolerated in children and adults with
      trichotillomania compared to placebo. The proposed study will provide needed data on the
      treatment of a disabling disorder that currently lacks a clearly effective treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females ages 10-65.

          2. Diagnosis of current trichotillomania (TTM) based on DSM-5 criteria and confirmed
             using the clinician-administered Structured Clinical Interview for DSM-5 (SCID);

          3. Hair-pulling behavior within 2 weeks prior to enrollment;

          4. Child able and willing to provide active assent for participation;

          5. Legal guardian available to provide consent for participation.

        Exclusion Criteria:

          1. Infrequent hair-pulling (i.e. less than one time per week) that does not meet DSM-5
             criteria for trichotillomania;

          2. Unstable medical illness as determined by the investigator;

          3. History of seizures;

          4. Current use of stimulants coinciding with onset or exacerbation of trichotillomania
             symptoms or other current medications coinciding with exacerbation or onset or
             trichotillomania symptoms;

          5. Clinically significant suicidality (defined by the Columbia Suicide Severity Rating
             Scale);

          6. Baseline score of ≥17 on the Hamilton Depression Rating Scale (17-item HDRS);

          7. Lifetime history of bipolar disorder type I or II, schizophrenia, autism, any
             psychotic disorder, or any substance use disorder;

          8. Initiation of psychotherapy or behavior therapy within 3 months prior to study
             baseline;

          9. Previous treatment with milk thistle;

         10. Any history of psychiatric hospitalization in the past year.
Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
Condition: Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: E7777
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Peripheral T-cell lymphoma; Cutaneous T-cell lymphoma; E7777; Phase 2

Summary:

      The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in
      participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous
      T-cell lymphoma (CTCL).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants who have histological diagnosis as peripheral T-cell lymphoma (PTCL) and
             cutaneous T-cell lymphoma (CTCL).

          2. Participant who have measurable disease.

          3. Participant who had previous systemic chemotherapy.

          4. Participant who had disease progression (PD) or did not have response (complete
             response (CR) or partial response (PR)) in systemic chemotherapy, or relapsed or
             progressed after systemic chemotherapy.

          5. Participant with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0
             or 1.

          6. Participant with adequate renal, liver and bone marrow function.

          7. Male and female participants ≥20 years of age at the time of informed consent.

          8. Participants who have provided written consent to participate in the study.

        Exclusion Criteria:

          1. Participant with serious complications or histories.

          2. Participant with history of hypersensitivity to protein therapeutics.

          3. Participant who is positive for Human immunodeficiency virus (HIV) antibody, Hepatitis
             C virus (HCV) antibody, or Hepatitis B Surface (HBs) antigen.

          4. Participant with malignancy of activity other than PTCL or CTCL within 36 months
             before informed consent.

          5. Women of childbearing potential or man of impregnate potential who don't agree to use
             a medically effective method for contraception.

          6. Woman who is pregnant or lactating.

          7. Participant with allogeneic stem cell transplantation.

          8. Participant who were decided as inappropriate to participate in the study by the
             investigator or sub-investigator.
A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Elsubrutinib; Upadacitinib; Placebo for elsubrutinib; Placebo for upadacitinib
Intervention description: Elsubrutinib capsule will be administered orally.; Upadacitinib tablet will be administered orally.; Placebo capsule for elsubrutinib will be administered orally.; Upadacitinib placebo tablet will be administered orally.
Intervention MeSH terms: Upadacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Elsubrutinib; ABBV-105; Upadacitinib; ABBV-599; Rheumatoid Arthritis (RA); Long-term extension (LTE)

Summary:

      This was a long-term extension (LTE) study to assess the safety, tolerability, and efficacy
      of ABBV-105 (elsubrutinib [ELS]) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in
      participants with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has completed Study M16-063

          -  Participant has not developed any laboratory or clinical discontinuation criteria as
             defined in the Study M16-063 protocol

          -  Participant is willing and/or able to comply with procedures required in the current
             study protocol

        Exclusion Criteria:

          -  Participant is currently enrolled or planning to enroll in another interventional
             clinical study while participating in this study (except the preceding study M16-063)

          -  Participant requires vaccination with any live vaccine during study participation,
             including at least 30 days after the last dose of study drug
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4)
Condition: Healthy Volunteers
Intervention: PRT064445/Rivaroxaban; Placebo/Rivaroxaban; Placebo
Intervention MeSH terms: Rivaroxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.
Module 1, NCT01758432 (54 subjects with 7 cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of
      several blood thinner drugs on laboratory tests. The study also is evaluating the blood
      levels of PRT064445 given at different doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men or women between the ages of 18 and 45 years old

        Exclusion Criteria:

          -  History (including family history) or symptoms of, or risk factors for bleeding

          -  History (including family history) of or risk factors for a hypercoagulable or
             thrombotic condition

          -  Absolute/relative contraindication to anticoagulation or treatment with specific
             anticoagulants

          -  History of major surgery, severe trauma or bone fracture within 3 months prior to
             dosing; or planned surgery within 1 month after dosing.
Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
Condition: Pyoderma Gangrenosum
MeSH terms: Pyoderma; Pyoderma Gangrenosum
Intervention: vilobelimab
Intervention description: IV infusions of vilobelimab diluted in sodium chloride.
Intervention MeSH terms: Vilobelimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: IV infusions of vilobelimab diluted in sodium chloride
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is
      safe and effective in the treatment of pyoderma gangrenosum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator

        In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:

        History of

          -  Pathergy (ulcer occurring at the sites of trauma)

          -  Personal history of inflammatory bowel disease or inflammatory arthritis

          -  History of papule, pustule or vesicle that rapidly ulcerated

        Clinical examination (or photographic evidence) of

          -  Peripheral erythema, undermining border, and tenderness at site of ulceration

          -  Multiple ulcerations (at least 1 occurring on the lower leg)

          -  Cribriform or "wrinkled paper" scar(s) at sites of healed ulcers

        Subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening

        Exclusion Criteria:

          -  Pyoderma gangrenosum target ulcer for more than 3 years before screening

          -  Surgical wound debridement within the previous 2 weeks before screening

          -  Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents
             within 30 days before screening

          -  Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg),
             intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the
             exception of antibiotics for wound superinfection) used within a time of 5 half-lives
             of the drug before screening
Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
Condition: Thymoma; Thymic Carcinoma
MeSH terms: Carcinoma; Thymoma; Thymus Neoplasms
Intervention: Premetrexed (Alimta)
Intervention description: Pemetrexed will be 500 mg/m2 IV every 3 weeks
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Thymoma; Thymic Carcinoma

Summary:

      To study the efficacy of Alimta as a single agent in thymic cancers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma
             not amenable to potentially curative therapy by surgery. Original biopsy of tumor is
             sufficient for diagnoses unless otherwise clinically indicated.

          -  Patients must have measurable disease with at least one bidimensional measurable
             lesion. Any scans or x-rays used to document measurable disease must be obtained with
             6 weeks prior to registration.

          -  Patients may have had prior chemotherapy for metastatic disease

          -  Adequate organ function as defined by: bili </=1.5; calc. crt clr of >/=45;
             hematologic-granulocytes >/=1500 & plt >/=100K.

          -  Patients who are receiving a stable dose of corticosteroids for myasthenia gravis are
             eligible.

          -  ECOG performance status of 0 or 1

        Exclusion Criteria:

          -  Acute intercurrent infection or complications

          -  pregnancy or lactating patients

          -  Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a
             5-day period (8-day period for long-acting agents.

          -  Presence of clinically relevant third-space fluid collections that cannot be
             controlled by a procedure
Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Intervention: aliskiren; ramipril; Placebo to aliskiren; Placebo to ramipril
Intervention description: Aliskiren 150 mg once daily up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site; 2.5 mg , 5.0 mg or 10 mg once daily; matching placebo to aliskiren in double blind phase; Matching placebo to ramipril capsule in double blind phase
Intervention MeSH terms: Ramipril
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart failure; Systolic; Aliskiren; Ramipril; Angiotensin II; Ang II; Plasma Renin Activity; PRA; Plasma Renin Concentration; PR,; brain natriuretic peptide; BNP; urinary aldosterone; Escape; Pharmacokinetic; PK

Summary:

      In addition to the blood pressure lowering effects of aliskiren, it may have beneficial
      effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue
      level. An increase of angiotensin II is associated with progression of heart failure.
      Although the use of ACE-inhibitors in heart failure shows clinical benefit, an increase in
      angiotensin II due to an angiotensin II "escape" phenomenon is not desirable. It is not yet
      known if a direct renin inhibitor can reduce or even prevent the angiotensin II escape
      phenomenon associated with the use of an ACE-inhibitor. Therefore the study tested the
      effects of ramipril, aliskiren and the combination of both on levels of angiotensin II in the
      blood in patients with systolic heart failure
    

Eligibility criteria:

        Inclusion Criteria:

          -  Decompensated systolic heart failure, left ventricular ejection fraction ≤40%

          -  Brain natriuretic peptide (BNP) level ≥ 100 pg/mL

        Exclusion criteria:

          -  Use of Angiotensin Converting Enzyme(ACE) or Angiotensin Receptor Blocker (ARB)
             inhibitor treatment following the run-in period or requirement of both treatments

          -  Acute heart failure secondary to acute myocardial infarction, acute coronary syndrome
             or new tachyarrhythmia

          -  Occurrence of unstable angina or myocardial infarction within 12 weeks prior to
             screening

          -  History of cardiomyopathy such as postpartum, restrictive, infective, hypertrophic
             obstructive

          -  History of right heart failure due to pulmonary disease

          -  History of untreated second or third degree atrioventricular heart block

        Other protocol-defined inclusion/exclusion criteria applied
Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients
Condition: Long QT Syndrome
MeSH terms: Long QT Syndrome
Intervention: Placebo; Ranolazine
Intervention description: Matching Placebo will be given for first month.; Patients will receive ranolazine 1000mg bid for subsequent 5 months.
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Patients will receive placebo for 1 month and subsequently ranolazine 1000mg twice a day for 5 months.
Masking: Double (Participant, Outcomes Assessor)
Masking description: Matching placebo and ranolazine pills were used. Patients were blinded regarding administration of medication. ECG Core Lab reading ECGs was blinded regarding drug assignment.
Enrollment: 25.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: ranolazine; clinical trial

Summary:

      The purpose of this study is to determine whether late sodium channel blockade might be
      effective in shortening the QTc interval in various LQT3 mutations and be considered as a
      safe therapeutic option for LQT3 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotyped positive for LQT3 (SCN5A) mutation

          -  Age 21 years or older

          -  Not currently taking an antiarrhythmic drug (beta blockers are allowed)

          -  Enrolled in LQTS Registry

        Exclusion Criteria:

          -  Age less than 21 years

          -  Not confirmed to have an LQT3 mutation

          -  Significant co-morbidity that would preclude subject's safe participation in this
             study

          -  Females who are pregnant or nursing

          -  Females of childbearing age who are not using acceptable method of birth control

          -  Evidence of prior sensitivity to ranolazine

          -  Hepatic or renal disease that might adversely affect ranolazine excretion

          -  Currently taking strong CYP3A inhibitors

          -  Currently taking P-gp inhibitors

          -  Currently taking CYP3A inducers

          -  In vitro studies of specific mutation show no effect of ranolazine on late sodium
             current kinetics or show repolarization prolongation
Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Intervention: D-Amphetamine 30mg; D-Amphetamine 60mg; Modafinil 200mg; Modafinil 400mg; Therapy; Placebo
Intervention description: Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
Intervention MeSH terms: Modafinil; Amphetamine; Dextroamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Cocaine dependence is a major public health problem; an effective primary treatment for
      cocaine dependent individuals has yet to be found. The purpose of this study is to examine
      the effects of d-amphetamine and modafinil, when given alone and in combination, in treating
      cocaine dependent individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders-IV (SCID) criteria for cocaine abuse or dependence

          -  In general good health. Individuals who are HIV-positive will not be excluded if in
             good general health, unless medication interactions exist.

        Exclusion Criteria:

          -  Meets diagnostic criteria for psychiatric disorders, including other forms of drug
             dependence, other than nicotine

          -  Current cardiovascular disease, as determined by an electrocardiogram

          -  On probation or parole if the circumstances do not allow study completion or if
             ethical constraints of supervision do not allow confidentiality

          -  Previously received treatment with d-amphetamine, modafinil, or aripiprazole

          -  Currently receiving prescribed medication