bioihbjkbjnl/mcl2 huggingface dataset:
fMRI Study Examining Effects of D-cycloserine in Specific Phobia
Condition: Phobias
MeSH terms: Phobic Disorders
Intervention: D-cycloserine; Placebo
Intervention description: D-cycloserine; Placebo
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The research team hopes to use brain imaging and mental testing to learn more about specific
      phobias and the treatment of phobia. When given directly prior to therapy sessions,
      D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify
      reasons why D-cycloserine has this effect by measuring brain activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Right-handed

          -  Adults between 18 and 55 years of age

          -  Subjects in the phobic group will additionally meet diagnostic (DSM-IV) criteria for
             spider phobia.

          -  Individuals of both genders and all races will be included

        Exclusion Criteria:

          -  Women who are breastfeeding or pregnant

          -  Individuals with medical conditions unsuitable for MR scanning

          -  Individuals reporting a history of epilepsy or seizures

          -  Individuals reporting an allergy to cycloserine

          -  Individuals diagnosed with asthma or who report previous anaphylactic reaction to
             insect stings/bites, medication, food, or other material and/or event

          -  Individuals reporting present or past diagnosis of a developmental disorder,
             neurological disorder, or head injury *Individuals found to have Axis I
             psychopathology as defined by the DSM-IV (other than spider phobia)

          -  Individuals currently taking any psychotropic medication
Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children
Condition: Neurologically Impaired; Irritable Mood; Signs and Symptoms, Digestive; Sleeplessness; Chronic Pain
MeSH terms: Sleep Initiation and Maintenance Disorders; Chronic Pain; Signs and Symptoms, Digestive
Intervention: Gabapentin; placebo
Intervention description: The active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period.; The placebo is a glycerin-based clear solution that is flavored similarly to the commercial product. The placebo will be given orally or through a gastrointestinal tube.
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No
Keywords: chronic irritability; chronic pain; Neurologically impaired; gabapentin

Summary:

      This study is a prospective, randomized, double blind, placebo controlled, crossover clinical
      trial looking at whether gabapentin can provide symptom relief for chronic irritability in
      neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and
      safe for children with chronic irritability that persists despite identification and
      appropriate management of symptom sources.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female

          -  1 month to 16 years of age at enrollment

          -  neurological impairment defined as subnormal (-2 S.D.) motor and/or cognitive ability
             from a variety of etiologies

          -  chronic irritability defined as symptoms suggesting pain to the child's caregiver
             recurrently over a 4-week of greater time period

          -  Subject must have an acceptable surrogate capable of giving consent on the subject's
             behalf

        Exclusion Criteria:

          -  Children with resolved symptoms after treatment of identified sources of pain

          -  Identified potential source of irritability without adequate trial of appropriate
             management

          -  Ketogenic diet

          -  Renal insufficiency or failure

          -  Current treatment with gabapentin or pregabalin for another existing condition.
Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients
Condition: Atrial Fibrillation; Coronary Artery Disease
MeSH terms: Atrial Fibrillation; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Regadenoson MRI; Gadobenate dimeglumine
Intervention description: AF patients will be provided with a regadenoson stress MRI to see if coronary artery disease can be detected with more sensitivity /specificity.; Resting perfusion with Multihance Gd-BOPTA contrast agent will be performed first, then a regadenoson injection will be given and MR imaging performed with a Gd-BOPTA contrast agent bolus 60-100 seconds later.
Intervention MeSH terms: Regadenoson
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: MRI; Atrial Fibrillation

Summary:

      Atrial fibrillation (AF) is growing into an epidemic affecting 1 in 4 adults. There is a need
      for research to elucidate the prevalence of ischemic cardiomyopathy in patients diagnosed
      with AF. The objective of this study is to demonstrate the utility of MRI in assessment of
      coronary artery disease. The specific objective is to demonstrate sensitivity/specificity
      comparable to that reported in meta-analyses of non-AF patients and adenosine (90% /80%) in
      an AF population using the time-efficient vasodilator regadenoson that requires only a single
      intravenous (IV).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with confirmed persistent or paroxysmal AF and suspected coronary artery disease
        who will undergo catheterization X-ray angiography

        Exclusion Criteria:

          1. Critically ill patients, patients on ventilators patients with hypotension,
             asthmatics, and other patients whose medical care or safety may be compromised from
             undergoing an MRI examination will be excluded.

          2. Patients with claustrophobia will also be excluded since MRI is conducted in a closed
             environment.

          3. Patients with contraindications to MRI (pacemaker, metal implants).

          4. Pregnant subjects (or women who may become pregnant), minors, and prisoners will be
             excluded from this study.

          5. Subjects are over 60 or have any suspicion of abnormal kidney function (a blood test
             to determine Glomerular filtration rate (GFR) will be performed prior to imaging.
             Subjects with GFR<30 will be excluded from the study. This is standard practice for
             clinical scans in Radiology due to the extremely small but not negligible relationship
             between gadolinium contrast agent and nephrogenic systemic fibrosis in patients with
             severely impaired renal function.
A Study to Test if TEV-48574 is Effective in Relieving Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: TEV-48574; Placebo
Intervention description: subcutaneous infusion; Matching Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T2 low, non-T2 asthma

Summary:

      The primary objective of the study is to evaluate the effect of TEV-48574 compared with
      placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe
      asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA).

      The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo
      on a range of clinical measures of asthma control.

      The duration of participant participation in the study is planned to be up to approximately
      30 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has a diagnosis of asthma for at least 12 months prior to the initial
             screening visit.

          -  The participant is able to perform technically acceptable and repeatable spirometry,
             including with a hand-held spirometer, after training

          -  The participant has had at least one documented clinical asthma exacerbation in the 18
             months prior to (but not within 30 days of) the initial screening visit.

          -  The participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years,
             with no current ecigarette or marijuana use.

        NOTE- Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  The participant has any concomitant conditions or treatments that could interfere with
             study conduct.

          -  The participant is currently pregnant or lactating or is planning to become pregnant
             during the study.

          -  The participant has received any live or attenuated vaccine within 15 days of the
             initial screening visit.

        NOTE- Additional criteria apply, please contact the investigator for more information
A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; semaglutide; semaglutide; semaglutide; semaglutide; semaglutide; placebo; placebo; placebo; placebo; placebo; liraglutide; liraglutide
Intervention description: 0.1 mg, once weekly, s.c. injection; 0.2 mg, once weekly, s.c. injection; 0.4 mg, once weekly, s.c. injection; 0.8 mg, once weekly, s.c. injection; 0.8 mg with titration, once weekly, s.c. injection; 1.6 mg with titration, once weekly, s.c. injection; 0.1 mg, once weekly, s.c. injection; 0.2 mg, once weekly, s.c. injection; 0.4 mg, once weekly, s.c. injection; 0.8 mg with titration, once weekly, s.c. injection; 1.6 mg, once weekly, s.c. injection; 1.2 mg with titration, once daily, s.c. injection; 1.8 mg with titration, once daily, s.c. injection
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 415.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly
      to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or
      liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was
      double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy
      parameter was HbA1c and the treatment duration was 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at
             least three months

          -  Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise
             alone for at least three months

          -  HbA1c: 7.0-10.0 % (both inclusive)

          -  Body weight between 60 kg and 110 kg

        Exclusion Criteria:

          -  Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl
             peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any
             investigational drug, within the last three months

          -  Impaired liver or kidney function

          -  Proliferative retinopathy or maculopathy requiring acute treatment

          -  Clinically significant active cardiovascular disease and uncontrolled
             treated/untreated hypertension

          -  Recurrent major hypoglycaemia or hypoglycaemic unawareness

          -  Present or planned use of any drug which could interfere with the glucose levels (e.g.
             systemic corticosteroids)
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg
Condition: Advanced Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant
Intervention description: intramuscular injection 250 mg & 500 mg
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 144.0
Sex: Female
Minimum age: 45 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: oncology; cancer; breast cancer

Summary:

      This study will assess the relationship between fulvestrant dose and efficacy in
      postmenopausal women with oestrogen receptor positive advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast Cancer has continued to grow after having received treatment with an
             anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor.

          -  Requiring hormonal treatment.

          -  Postmenopausal women (woman who has stopped having menstrual periods)

        Exclusion Criteria:

          -  Treatment with more than one previous regimen of systemic anticancer therapy other
             than endocrine therapy for advanced BC.

          -  Treatment with more than one previous regimen of endocrine therapy for advanced BC.

          -  An existing condition that prevents compliance.
Phase 2 Study of Rituximab-ABVD in Classical Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Bleomycin; Rituximab; Dacarbazine; Doxorubicin; Vinblastine
Intervention MeSH terms: Rituximab; Doxorubicin; Dacarbazine; Bleomycin; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in
      different ways to stop the growth of cancer cells, either by killing the cells or by stopping
      them from dividing. Giving rituximab together with combination chemotherapy may kill more
      cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with combination
      chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV
      Hodgkin's lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed classical Hodgkin's lymphoma

               -  No lymphocyte-predominant histology

               -  Stage II, III, or IV disease

               -  Newly diagnosed disease

        PATIENT CHARACTERISTICS:

          -  Performance status 0-2

          -  Creatinine < 2.0 mg/dL

          -  Bilirubin < 5 mg/dL

          -  Not pregnant or nursing

          -  No HIV positivity

          -  Hepatitis B surface antigen negative

          -  No active concurrent malignancy except for superficial nonmelanoma skin cancer or
             cervical carcinoma in situ

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for Hodgkin's lymphoma

          -  Steroids allowed if medically required before chemotherapy initiation
SI-613 Study for Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: SI-613; Placebo
Intervention description: SI-613 will be repeated intra-articularly administered.; Placebo will be repeated intra-articularly administered.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Knee; Osteoarthritis; Intra-articular injection

Summary:

      The objective of the study is to evaluate the efficacy and safety of intra-articular
      injections of SI-613 compared with placebo for knee OA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provides their written informed consent.

          -  Has a diagnosis at the time of screening of OA of the knee according to American
             College of Rheumatology (ACR) criteria

          -  Is willing to switch to using acetaminophen as a rescue medication

        Exclusion Criteria:

          -  Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.

          -  Secondary OA

          -  Is a female subject who is pregnant or lactating.

          -  Is currently hospitalized or has a planned hospitalization during the life of the
             study.
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: RSLV-132; Placebo
Intervention description: RNase Fc fusion protein; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The present study will examine the role of circulating RNA complexed with autoantibodies and
      immune complexes and its role in activation of inflammatory pathways in patients with primary
      Sjogren's syndrome. The study will be conducted in a subset of Sjogren's patients who have
      elevated levels of autoantibodies and a pattern of elevated interferon-stimulated gene
      expression in blood cells. A number of biochemical and clinical parameters will be analyzed
      to determine the potential therapeutic utility of nuclease therapy in Sjogren's syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meet 4 of 6 criteria of 2002 American-European Consensus Group (AECG) criteria for
             Primary Sjogren's Syndrome

          2. Presence of anti Ro autoantibodies

          3. Presence of interferon signature

        Exclusion Criteria:

          1. Use fo hydroxychloroquine within 30 days of baseline

          2. Use of cyclophosphamide within 180 days of baseline

          3. Use of oral corticosteroids greater than 10 mg/day

          4. Known IgG4-related disease
Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib
Condition: Multiple Indications Cancer
Intervention: Dasatinib
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to continue to provide dasatinib to patients that are currently
      participating in another dasatinib trial that is ending and for which there is no other
      option to provide dasatinib.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participated in and completed a previous dasatinib protocol (including but not limited
             to CA180056, CA180363 or CA180227) and is deemed by the investigator to be deriving
             benefit from dasatinib as defined by the previous protocol

          -  Receiving dasatinib at the time of signature of informed consent

          -  Males and Females, ages 18 and older

        Exclusion Criteria:

          -  All patients previously discontinued from a dasatinib study for any reason

          -  Any serious or uncontrolled medical disorder or active infection that would impair the
             ability of the subject to receive protocol therapy

          -  History of allergy to dasatinib
Efficacy and Safety Study of SUNPG1622
Condition: Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Intervention: SUNPG1622 I dose; Placebo dose
Intervention description: Injection; Injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the
      efficacy and safety of SUNPG1622.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed written consent

          -  Subject is ≥ 18 years of age at time of Screening

          -  Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of
             investigational product

          -  Subject has a negative test for TB within 4 weeks before initiating IMP

        Exclusion Criteria:

          -  Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes

          -  Active uveitis or symptomatic inflammatory bowel disease requiring therapy at
             screening

          -  Radiographic evidence of total ankylosis of the spine

          -  Subject has a planned surgical intervention between Baseline and the Week 24
             evaluation for a pre-treatment condition