bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: CTP-692; Placebo
Intervention description: Administered as powder for oral solution.; Administered as powder for oral solution.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the safety and efficacy of 3 different doses of
      CTP-692 administered once daily (QD) for 12 weeks to adult participants with schizophrenia on
      stable dopaminergic antipsychotic medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of
             schizophrenia for the past 2 years

          -  Patients with clinically stable schizophrenia with residual symptoms defined as
             positive and negative syndrome scale (PANSS) total score of 70-110

          -  Patients currently treated with one antipsychotic medication

        Exclusion Criteria:

          -  Patients who, in the opinion of the Investigator, have a history of antipsychotic
             treatment resistance

          -  Patients currently taking clozapine

          -  History of meeting DSM-V5 criteria for moderate to severe alcohol or substance use
             disorder (other than nicotine or caffeine) within the 6 months before the first
             Screening Visit

          -  Patients with positive blood screen for human immunodeficiency virus (HIV) antibody
             and/or hepatitis B virus surface antigen

          -  Patients with history of renal disease or those taking medications to treat renal
             disease
Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Acetaminophen 1000mg IV; Hydromorphone 0.5 mg IV
Intervention description: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push; 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push
Intervention MeSH terms: Acetaminophen; Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments
      (ED) across the country. Acetaminophen, given orally, has also been used for treatment of
      mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely
      used in Europe for more than 20 years as post-surgical analgesia and received full FDA
      approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize
      treatment of pain among elderly ED patients, this randomized study will compare efficacy and
      safety of IV acetaminophen to IV hydromorphone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age equal to 65 or greater

          2. Pain onset within 7 days with severe pain

          3. Has capacity to provide informed consent

          4. Understanding English or Spanish

        Exclusion Criteria:

          1. Use of tramadol or opioids within 7 days

          2. Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours

          3. Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis,
             fibromyalgia, and peripheral neuropathies

          4. Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis
             (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or
             severe dehydration

          5. Alcohol intoxication

          6. Systolic blood pressure: < 100 mmHg

          7. Heart rate: < 60 beats per minute

          8. Oxygen saturation: < 95% on room air

          9. Use of monoamine oxidase (MAO) inhibitors in the past 30 days

         10. Use of transdermal pain patch or oral opioid > 10 days in the prior month

         11. Prior enrollment in the same study
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
Condition: Diabetic Macular Edema; Non-proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema
Intervention: dexamethasone intravitreal implant; intravitreal bevacizumab
Intervention description: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5); Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Intervention MeSH terms: Dexamethasone; Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Macular Edema; DME; PDR; NPDR; Ozurdex; Dexamethasone; Avastin; Bevacizumab

Summary:

      The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone
      implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant
      diabetic macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of NPDR or PDR as confirmed by fluorescein angiography

          -  Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 4
             weeks

          -  < 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit
             and following treatment with >= 2 intravitreal anti-VEGF injections

          -  Age 18 years or older

          -  ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25
             to 20/800)

          -  Ability to provide written informed consent

          -  Capable of complying with study protocol.

        Exclusion Criteria:

          -  Intraocular injection of steroid medication within prior 3 months

          -  Evidence of significant geographic atrophy on fluorescein angiography in the opinion
             of the treating physician

          -  Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual
             acuity in the opinion of the treating physician

          -  Prior vitrectomy surgery

          -  Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or
             extensive dermal) within 1 month prior to day 1.

          -  Known history of IOP elevation in response to steroid treatment in either eye that
             resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid
             injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to
             keep IOP below 21 mm Hg.

          -  Patients who are pregnant.

          -  Unwilling or unable to follow or comply with all study related procedures
Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Zilucoplan (RA101495)
Intervention description: Subjects will continue to receive the final maintenance dose they were receiving in the qualifying study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to enable continued access to zilucoplan (RA101495) for patients
      with paroxysmal nocturnal hemoglobinuria (PNH) after they complete a zilucoplan clinical
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of a qualifying Ra Pharmaceuticals sponsored zilucoplan (RA101495) PNH
             study

          -  Evidence of ongoing clinical benefit in the opinion of the Investigator

        Exclusion criteria:

          -  History of meningococcal disease

          -  Current systemic infection or suspicion of active bacterial infection
Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
Condition: Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Intervention: SD-101 dermal cream (6%)
Intervention description: SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: Amicus Therapeutics; Scioderm, Inc.; Recessive Dystrophic; Junctional non-Herlitz; Epidermolysis Bullosa; Simplex; SD-101 6%; SD-101-6.0; Allantoin 6%; Zorblisa

Summary:

      The purpose of this study was to assess the continued safety of topical use of SD-101 cream
      (6%) in participants with Epidermolysis Bullosa (EB).

      Funding Source: FDA Office of Orphan Products Development
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent form signed by the participant or participant's legal representative;
             if the participant is under the age of 18 but capable of providing assent, signed
             assent from the participant.

          -  Participant (or caretaker) must be willing to comply with all protocol requirements.

          -  Participant must have successfully completed the SD-003 study.

        Exclusion Criteria:

          -  Participants who do not meet the inclusion criteria.

          -  Pregnancy or breastfeeding during the study. A urine pregnancy test will be performed
             at the final visit for SD-003 for female participants of childbearing potential.

          -  Females of childbearing potential who are not abstinent and not practicing a medically
             acceptable method of contraception.
A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ZPL389 30mg; ZPL389 50mg; TCS and/or TCI
Intervention description: 30mg of ZPL389; once daily; 50mg of ZPL389; once daily; Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atopic dermatitis; AD; eczema; itch; pruritus; H4R; ZPL389

Summary:

      This extension study (CZPL389A2203E1) was designed as a 2-year (100 weeks) extension to the
      core study (CZPL389A2203/ NCT03517566) which is disclosed separately. It aimed to assess the
      short-term and long-term safety of (blinded) 30 mg o.d and 50 mg o.d ZPL389 with concomitant
      or intermittent use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors
      (TCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must give a written, signed and dated informed consent

          -  Subjects with atopic dermatitis who have participated in and completed 16 weeks of
             treatment in CZPL389A2203 study.

          -  Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
             diary completion and other study procedures.

        Exclusion Criteria:

          -  Inability to use TCS and/or TCI due to history of important side effects of topical
             medication (e.g., intolerance or hypersensitivity reactions).

          -  Treatment discontinued subject from CZPL389A2203 study.

          -  Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis
             disease activity.
Treatment With Mecamylamine in Smoking and Non-smoking Alcohol Dependent Patients
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: mecamylamine; Placebo
Intervention description: mecamylamine 10mg/day; Placebo
Intervention MeSH terms: Mecamylamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: mecamylamine; treatment; alcohol dependence; smoking

Summary:

      The purpose of the study will be to evaluate the efficacy of mecamylamine in reducing alcohol
      consumption in smoking and non-smoking alcohol dependent patients.

      We hypothesize that mecamylamine will result in a greater reduction of alcohol consumption
      than placebo. We further hypothesize that mecamylamine will be effective in reducing both
      alcohol consumption and smoking in a subset of alcoholics who also smoke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  individuals with DSM-IV diagnosis of alcohol dependence

          -  smokers and non-smokers

          -  patients who do not require psychotropic medication for the management of their
             psychiatric symptoms

          -  individuals with a history of substance dependence (other than alcohol and tobacco)
             but have not met criteria for substance dependence in the past 30 days

          -  women with acceptable method of contraception

        Exclusion Criteria:

          -  pregnant women

          -  medications thought to influence drinking behavior including: acamprosate, disulfiram,
             naltrexone and ondansetron

          -  underlying medical conditions

          -  history of glaucoma, prostatic hypertrophy, urethral obstruction, cerebral
             arteriosclerosis, pyloric stenosis, or a history of hypersensitivity to mecamylamine

          -  DSM-IV diagnosis of bipolar disorder, schizophrenia, and schizophrenia-type disorders

          -  unstable medical conditions

          -  patients who require psychotropic medication for the management of an active
             psychiatric disorder

          -  patients on pharmacological treatment for alcohol and/or nicotine dependence
Treating Smokers With Mental Illness
Condition: Smoking Cessation; Cigarette Smoking; Schizophrenia; Psychotic Disorders; Major Depressive Disorder; Bipolar Disorder I; Bipolar II Disorder; Mental Illness
MeSH terms: Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Intervention: Nicotine patch; Nicotine lozenge; Therapy; Information
Intervention description: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use; Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use; In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase; Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: The outcomes assessor will not be made aware of the participant's study status, although it may become obvious during the assessments.
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mental illness; tobacco treatment

Summary:

      This is a smoking cessation study that will enroll smokers who have been diagnosed with a
      severe mental illness. The study will use a combination of intensive tobacco treatment
      counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting
      smoking over the course of six months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  have a severe mental illness diagnosis

          -  be a daily smoker

          -  be willing to reduce the number of cigarettes smoked per day leading to a quit attempt

          -  want to try to quit smoking

          -  be willing to use nicotine replacement therapy

          -  be able to communicate in English

        Exclusion Criteria:

          -  anyone who has had an active psychotic episode or been hospitalized due to suicidal
             ideation in the last six months

          -  pregnancy

          -  taking Chantix or Clozapine

          -  having a terminal illness
Safety and Efficacy of BKM120 in Relapsed and Refractory NHL
Condition: Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Buparlisib
Intervention description: 100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diffuse large B-cell lymphoma, Mantle cell lymphoma, Follicular lymphoma, PI3K inhibitor, Non-Hodgkin lymphoma, NHL

Summary:

      This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in
      patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell
      lymphoma (MCL) or follicular lymphoma (FL).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular
             lymphoma, or diffuse large B cell lymphoma.

          2. Patient had relapsed or refractory disease and received at least one prior therapy.

          3. Patient with diffuse large B cell lymphoma had received or was ineligible for
             autologous or allogeneic stem cell transplant.

          4. Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria
             (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the
             long axis at baseline, then the patient must have had at least one measurable
             extra-nodal lesion.

          5. Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

          6. Patient had adequate bone marrow and organ function.

        Exclusion Criteria:

          1. Patient had received previous treatment with PI3K inhibitors

          2. Patient had evidence of graft versus host disease (GVHD).

          3. Patient had active or history of central nervous system (CNS) disease.

          4. Patient had a concurrent malignancy or had a malignancy within 3 years of study
             enrollment (with the exception of adequately treated basal or squamous cell carcinoma
             or non-melanomatous skin cancer).

          5. Patient had a score ≥ 12 on the PHQ-9 questionnaire.

          6. Patient had a GAD-7 mood scale score ≥ 15.

          7. Pregnant or nursing women

          8. Patient who did not use highly effective contraception methods to avoid becoming
             pregnant or conceiving offspring.
Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Nitrous Oxide
Intervention description: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation
Intervention MeSH terms: Nitrous Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: PTSD

Summary:

      The purpose of this study is to understand nitrous oxide effects in post traumatic stress
      disorder (PTSD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-80

          -  Veterans of the United States Uniformed Services

          -  primary diagnosis of PTSD

          -  sufficient severity of PTSD symptoms

          -  fluency in English

          -  capacity to provide informed consent

        Exclusion Criteria:

          -  psychiatric or medical conditions that make participation unsafe

          -  pregnant or nursing females

          -  allergy to nitrous oxide
Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
Condition: Infantile Colic
MeSH terms: Colic
Intervention: Simethicone Solution; Vivatlac Baby
Intervention description: Oral daily treatment for four weeks; Oral daily treatment for four weeks
Intervention MeSH terms: Simethicone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 3 Weeks
Maximum age: 6 Weeks
Healthy volunteers: No

Summary:

      Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in
      babies diagnosed for infantile colic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed for infantile colic according to Wessel's criteria

        Exclusion Criteria:

          -  previous treatment with probiotic or synbiotic

          -  previous treatment with antibiotics