bioihbjkbjnl/mcl2 huggingface dataset:
High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
Condition: Cancer
MeSH terms: Dyspnea
Intervention: High-flow Oxygen; Low-flow Oxygen; High-flow Air; Low-flow Air
Intervention description: Optiflow Respiratory Humidifier used to deliver HFOx. Oxygen flow will be maximized (set between 20 and 60 L/min), if tolerated, to minimize dyspnea. FiO2 will be set at 100%.; Low-flow Oxygen will be delivered by Optiflow in an identical manner to high flow, except provided at 2 L/min using a nasal cannula identical to that used for high-flow devices.; Two level air flow (high and low) will be delivered by Optiflow in an identical manner to oxygen air flows, except that researchers will use pressurized air instead of oxygen. LFOx and LFAir will be provided at 2 L/min using a nasal cannula identical to that used for high-flow devices.; Two level air flow (high and low) will be delivered by Optiflow in an identical manner to oxygen air flows, except that researchers will use pressurized air instead of oxygen. LFOx and LFAir will be provided at 2 L/min using a nasal cannula identical to that used for high-flow devices.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: shortness of breath; oxygen; breathing therapies

Summary:

      The goal of this clinical research study is to compare high-flow oxygen, low-flow oxygen,
      high-flow air, and low-flow air in helping to decrease shortness of breath in cancer
      patients. Researchers also want to learn if these therapies can help to improve lung function
      and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of cancer

          2. Patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency
             care at MD Anderson Cancer Center

          3. Dyspnea Numeric Rating Scale at rest >/=3 of 10 (average over last 24 hour)

          4. Non-hypoxemic (i.e. oxygen saturation >90% on ambient air)

          5. Able to communicate in English or Spanish

          6. Age >/= 18 years

          7. Able to tolerate high-flow oxygen/air

        Exclusion Criteria:

          1. Memorial Delirium Rating Scale >13

          2. Hemodynamic instability

          3. Respiratory failure requiring mechanical ventilation or non-invasive ventilation

          4. Frequent use of rescue opioids >8x/day or rescue bronchodilators >8x/day over last 24
             hours

          5. Currently requiring high flow oxygen for oxygenation
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-561; IVA; Placebo; Placebo
Intervention description: VX-561 tablets for oral administration.; 150-mg film-coated tablet for oral administration.; Placebo matched to IVA.; Placebos matched to VX-561.
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and
      pharmacokinetic (PK) effect of VX-561.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have 1 of the following 9 CFTR mutations on at least 1 allele: G551D, G178R,
             S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D

          -  On ivacaftor therapy

          -  FEV1 value ≥40% and ≤100% of predicted mean for age, sex, and height

        Key Exclusion Criteria:

          -  History of clinically significant cirrhosis with or without portal hypertension

          -  History of solid organ or hematological transplantation

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

        Other protocol defined Inclusion/Exclusion criteria may apply
A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas
Condition: Cancer of the Pancreas
MeSH terms: Pancreatic Neoplasms
Intervention: Pioglitazone
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to determine whether or not addition of the oral medication,
      pioglitazone to standard chemotherapy, results in improvement of blood tests that measure the
      body's ability to utilize sugar (glucose and insulin metabolism). In addition the
      investigators want to determine whether or not treatment with pioglitazone results in (1)
      improvement in the size of the tumor, (2) weight gain, (3) improved ability to function
      during the day and (4) quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Histologically proven adenocarcinoma of the pancreas

          -  Radiologically measurable disease

          -  ECOG functional status 0-2

        Exclusion Criteria:

          -  Prior radiation therapy for pancreatic cancer If chemotherapy is planned, new
             chemotherapy regimen should have started more than 14 days prior to enrollment

          -  Surgery or radiation planned within 8 weeks of starting therapy

          -  Prior exposure to Thiazolidinedione (TZD) therapy in the past 12 months

          -  Hypersensitivity of TZD

          -  New York heart association class III/IV heart failure.

          -  Known HIV positive

          -  Pregnant or lactating women

          -  History of, or active bladder cancer

          -  Inadequate hepatic function documented within 14 days of enrollment

          -  Total bilirubin level > 1.5 x ULN

          -  AST and ALT > 2.5 x ULN, unless there are liver metastases in which case AST and ALT
             or > 5 x ULN
Ganaxolone Treatment in Children With Fragile X Syndrome
Condition: Fragile x Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Intervention: Ganaxolone; Placebo
Intervention description: oral suspension, given in 3 divided doses; oral suspension, given in 3 divided doses
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: fragile x syndrome; ganaxolone; anxiety; attention; pediatric

Summary:

      This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled,
      crossover study to investigate ganaxolone treatment in children with fragile x syndrome
      (FXS). The objective of the study is to assess the safety, tolerability and efficacy of
      ganaxolone in the treatment of anxiety and attention in subjects with FXS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  molecular documentation of FMR1 full mutation

          -  ages 6-17 yrs, inclusive

          -  sexually active subjects are required to use a medically acceptable form of birth
             control

        Exclusion Criteria:

          -  non-English or Spanish speaking subjects

          -  concomitant systemic steroid, vigabatrin, felbamate and ketoconazole

          -  changes in medications within last 2 months

          -  clinically unstable medical disease, progressive CNS disease/disorder

          -  history of recurrent status epilepticus

          -  unwilling to withhold grapefruit or grapefruit juice for the duration of the study

          -  actively suicidal
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
Condition: Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Intervention: BGS649; Placebo
Intervention description: Capsules were taken weekly for a maximum of 24 weeks; Capsules were taken weekly for a maximum of 24 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 271.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hypogonadotropic; hypogonadism; testosterone

Summary:

      The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese
      subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24
      weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a
      6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male subject aged 18 to 65 years inclusive

          -  BMI > 30 kg/m2 and < 50 kg/m2

          -  Serum total testosterone concentration below the normal range

          -  LH levels below the upper limit of normal

          -  Oestradiol levels within or above the normal range of approved assay

          -  At least two symptoms of androgen deficiency present for at least 2 months prior to
             the first Screening Visit, with at least one of these being a sexual dysfunction

        Exclusion Criteria:

          -  Evidence of clinically significant endocrinopathy at screening that may interfere with
             the study assessments

          -  Other types of hypogonadotropic hypogonadism or primary hypogonadism

          -  Any other pituitary or hypothalamic disease
Pharmacokinetics of Advantage Arrest in Children
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Silver Diamine Fluoride
Intervention description: 38% aqueous silver diamine fluoride [Ag(NH3)]2F, CAS RN 33040-28-7
Intervention MeSH terms: Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label exposure--response study
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 3 Years
Maximum age: 13 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: child; pharmacokinetics; silver diamine fluoride

Summary:

      The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy
      children to contribute to evidence for the safety of Advantage Arrest, consistent with
      Guidance for Industry--Exposure--Response Relationships (April 2003).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy.

          -  At least one carious lesion.

        Exclusion Criteria:

          -  Oral mucositis

          -  Any ulcerative lesions

          -  Hypersensitivity to silver

          -  Hypersensitivity to fluoride.

          -  SDF treatment within 3 months.
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Duavee
Intervention description: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Maximum age: 61 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn whether daily use of Duavee® is accepted and tolerated
      by peri- and post-menopausal women at moderate risk for development of breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with vasomotor symptoms with a uterus who are postmenopausal or in late
             menopause transition

          -  Body Mass Index (BMI) <36 kg/m2

          -  Class I-III mammogram within 6 months of Random Periareolar Fine Needle Aspiration
             (RPFNA); If Class 0 or 4, must be resolved with additional procedures

          -  If previously on oral contraceptives or hormone replacement, off for 8 weeks or more
             prior to baseline RPFNA; the exception is low dose vaginal hormones

          -  Confirmed moderate risk of developing breast cancer

          -  RPFNA results within study defined range

          -  Kidney and liver function within study defined range

          -  Willing and able to comply with study related procedures

        Exclusion Criteria:

          -  Previous biopsy showing evidence of breast cancer

          -  Have a predisposition to or prior history of thromboembolism, deep venous thrombosis,
             pulmonary embolism, or stroke

          -  History of renal or liver disease

          -  Prior ovarian or endometrial cancer

          -  Stopped or started hormone replacement within 8 weeks

          -  Any other condition or intercurrent illness that in the opinion of the investigator
             makes the woman a poor candidate for RPFNA

          -  Currently taking or have taken specific medications in the past 6 months

          -  Participation on any chemoprevention trial within 6 months

          -  Current illness which would make potential participant unsuitable for enrollment
A Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Intervention: Tc99m tilmanocept
Intervention description: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of
      lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single
      dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided written informed consent with HIPAA authorization

          -  Has cervical cancer and is a candidate for surgical intervention, with lymph node
             dissection being a part of the surgical plan.

          -  Is at least 18 years of age at the time of consent

          -  Has an ECOG performance status of Grade 0 to 2

          -  Has the following International Federation of Gynecology and Obstetrics (FIGO)
             IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still
             be considered eligible as consistent with FIGO guidelines.

          -  If of childbearing potential, the subject has a negative pregnancy test within 48
             hours before administration of Lymphoseek, has been surgically sterilized, or has been
             postmenopausal for at least 1 year

        Exclusion Criteria:

          -  The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy
             within the 30 days prior to Lymphoseek administration

          -  Has had previous surgery or radiation to node basins that would be involved in the ILM
             procedure

          -  Has a known allergy to dextran

          -  Is breast-feeding or pregnant

          -  Before the administration of Lymphoseek, has received any radiopharmaceutical within 7
             radioactive half-lives of that radiopharmaceutical

          -  Is scheduled for surgery and/or another invasive procedure other than the primary
             surgical intervention within the 3 days after Lymphoseek administration

          -  Has received an investigational product within the 30 days prior to Lymphoseek
             administration
A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
Condition: Acneiform Eruptions
MeSH terms: Acneiform Eruptions
Intervention: Imsidolimab; Placebo
Intervention description: Humanized monoclonal antibody; 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: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: IL-36 receptor; Interleukin 36; Imsidolimab

Summary:

      Efficacy and Safety of imsidolimab in participants with epidermal growth factor receptor
      inhibitor (EGFRi)/mitogen-activated protein (MAP)/extracellular signal-regulated kinase (ERK)
      kinase inhibitor (MEKi)-associated acneiform Rash
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has cancer

          -  Participant is treated with an oral or injectable Food and Drug Administration
             (FDA)-approved EGFRi or MEKi therapy

          -  Participant has EGFRi/MEKi-related acneiform rash of Grade ≥ 2 as per common
             terminology criteria for adverse events (CTCAE) version 5.0, and ≥ 20 inflammatory
             lesions on the face at screening and Day 1.

        Exclusion Criteria:

          -  Participant has infected EGFRi/MEKi-associated acneiform rash according to
             investigator's evaluation.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
BOTOX® for the Treatment of Platysma Prominence
Condition: Platysma Prominence
Intervention: BOTOX® purified neurotoxin complex; Placebo
Intervention description: BOTOX® superficial intramuscular injections.; Placebo injections.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma
      prominence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants willing to minimize the risk of inducing pregnancy for the
             duration of the clinical study and follow-up period

          -  A female participant is eligible to participate if she is not pregnant (has a negative
             urine pregnancy result prior to randomization), not breastfeeding, and at least one of
             the following conditions applies:

               1. Not a woman of childbearing potential (WOCBP) OR

               2. A WOCBP who agrees to follow the studies contraceptive guidance during the
                  treatment and follow-up period through study exit.

          -  Capable of giving signed informed consent, which includes compliance with the
             requirements and restrictions listed in the informed consent form (ICF) and in this
             study's protocol

        Exclusion Criteria:

          -  Any medical condition that may put the participant at increased medical risk with
             exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome,
             amyotrophic lateral sclerosis, or any other condition that might interfere with
             neuromuscular function

          -  Participant has an anticipated need for treatment with botulinum toxin of any serotype
             for any indication during the study (other than study intervention)

          -  Anticipated need for surgery or overnight hospitalization during the study

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of entry into this study

          -  Females who are pregnant, nursing, or planning a pregnancy during the study

          -  Known immunization or hypersensitivity to any botulinum toxin serotype

          -  History of alcohol or drug abuse within 12 months of the study

          -  Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure
             the neck
Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: REGN910-3; Intravitreal Aflibercept Injection (IAI)
Intervention description: Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to compare the efficacy of intravitreal
      (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in
      improving best corrected visual acuity (BCVA) in participants with diabetic macular edema
      (DME).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus who have
             clinically significant DME with central involvement in the study eye

          2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the
             study eye

          3. Willing and able to comply with clinic visits and study-related procedures

          4. Provide signed informed consent

        Key Exclusion Criteria:

          1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye

          2. IVT anti-VEGF in the study eye within 12 weeks of the screening visit

          3. Panretinal laser photocoagulation or macular laser photocoagulation in the study eye
             within 3 months of screening

        Note: Other inclusion/ exclusion criteria apply