bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis
Condition: Nonallergic Irritant Rhinitis
MeSH terms: Rhinitis
Intervention: Capsaicin; Placebo
Intervention MeSH terms: Ethanol; Capsaicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nonallergic irritant rhinitis; nasal congestion; rhinorrhea

Summary:

      The proposed study seeks to investigate the effect of intranasal capsaicin treatment in
      patient with Non-allergic irritant rhinitis (NAIR), as well as evaluate optical rhinometry
      (ORM) as a means to quantify symptomatic improvement in NAIR patients during and after
      treatment.
    

Eligibility criteria:

        Inclusion criteria:

          -  Non-allergic irritant rhinitis (NAIR) patients as defined by history (symptoms of
             nasal congestion, rhinorrhea, nasal itching or sneezing upon exposure to nasal
             irritants)

          -  Patients with positive optical rhinometer (ORM) response with intranasal challenge
             with 0.5 millimolar (mM) capsaicin as described by Lambert et al 2012

          -  Confirmed negative skin prick test to common allergens (which rules out allergic
             rhinitis)

        Exclusion Criteria:

          -  History of sinonasal surgery

          -  Chronic rhinosinusitis

          -  Inflammatory or granulomatous diseases

          -  Asthma

          -  Allergic rhinitis

          -  Immunocompromised state

          -  Radiation to the head and neck

          -  Intranasal steroid use >4 wks

          -  Intranasal or systemic antihistamine x 3 days

          -  Intranasal or systemic decongestants x 3 days
A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 318.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of investigational doses of
      dulaglutide in participants with type 2 diabetes on metformin monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had type 2 diabetes (T2D) for ≥6 months according to the World Health
             Organization (WHO) classification

          -  Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory

          -  Have been treated with stable doses of metformin for at least 3 months

          -  Have a body mass index (BMI) ≥25 kilograms per square meter

        Exclusion Criteria:

          -  Have type 1 diabetes (T1D)

          -  Have used any glucose-lowering medication other than metformin 3 months prior to study
             entry or during screening/lead-in period or have used any glucagon-like peptide-1
             receptor agonists (GLP-1 RAs) at any time in the past

          -  Have had any of the following cardiovascular conditions: acute myocardial infarction
             (MI), New York Heart Association Class III or Class IV heart failure, or
             cerebrovascular accident (stroke)

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
             than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level
             >2.5 times the upper limit of the reference range, as determined by the central
             laboratory at study entry; participants with NAFLD are eligible for participation in
             this trial

          -  Have had chronic or acute pancreatitis any time prior to study entry

          -  Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square
             meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation

          -  Have serum calcitonin ≥20 picograms per milliliter, as determined by the central
             laboratory at study entry
Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome)
Condition: 22q13 Deletion Syndrome; Phelan-McDermid Syndrome
MeSH terms: Chromosome Disorders; Syndrome; Chromosome Deletion
Intervention: Insulin-Like Growth Factor-1 (IGF-1); Normal saline
Intervention description: IGF-1 and placebo will each be administered for 3 months with a four-week washout period in between. IGF-1 will be administered for 3 months subcutaneously.; Saline solution will be administered for three months subcutaneously.
Intervention MeSH terms: Mitogens; Mecasermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: SHANK3; IGF-1; Autism

Summary:

      The purpose of this study is to pilot the use of Insulin-Like Growth Factor-1 (IGF-1)
      treatment in 22q13 Deletion Syndrome (Phelan-McDermid Syndrome) caused by SHANK3 gene
      deficiency in order to evaluate safety, tolerability, and efficacy. IGF-1 is an injection
      under the skin that contains human IGF-1. IGF-1 is approved by the FDA under the brand name
      Increlex for the treatment of children with short stature due to primary IGF-1 deficiency. It
      is being used off-label in the current study and is not FDA approved, nor has it yet been
      studied in humans for the treatment of SHANK3 deficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  5 to 12 years old

          -  pathogenic deletions or mutations of the SHANK3 gene

          -  stable medication regimens for at least three months prior to enrollment

        Exclusion Criteria:

          -  closed epiphyses

          -  active or suspected neoplasia

          -  intracranial hypertension

          -  hepatic insufficiency

          -  renal insufficiency

          -  cardiomegaly / valvulopathy

          -  history of allergy to IGF-1 or any component of the formulation (mecasermin)

          -  history of extreme prematurity (<1000 grams) with associated early neo-natal
             complications, e.g. intra-cerebral hemorrhage, prolonged hypoxia, prolonged
             hypoglycemia

          -  patients with comorbid conditions deemed too medically compromised to tolerate the
             risk of experimental treatment with IGF-1
A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
Condition: Multiple Myeloma; Solid Tumors
MeSH terms: Multiple Myeloma
Intervention: Carfilzomib
Intervention description: Carfilzomib dose levels ranged from 11 to 27 mg/m² for 2- to 10-minute infusions and 36 to 56 mg/m² for 30-minute infusions. Carfilzomib doses were administered on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Dose level reduction to a minimum dose of 11 mg/m² for toxicity was permitted.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple myeloma; proteasome; Hematological; carfilzomib; PR-171

Summary:

      This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and
      efficacy of long-term or continuing carfilzomib therapy for patients who previously completed
      a primary carfilzomib treatment study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previous completion of a carfilzomib study within 90 days prior to first dose of
             maintenance study drug.

          2. Disease Assessments performed within 30 days prior to first dose of maintenance study
             drug.

          3. Written informed consent in accordance with federal, local, and institutional
             guidelines

          4. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test, with a sensitivity of at least 50 mIU/mL, within 3 days prior to first dose of
             maintenance study drug.

          5. Subjects must agree to adhere to the study visit schedule and other study requirements
             and receive outpatient treatment and laboratory monitoring at the institution that
             administers the drug.

        Exclusion Criteria:

          1. Administration of an intervening chemotherapy between the time of previous carfilzomib
             study termination and first dose of maintenance study drug.

          2. Pregnant or lactating females

          3. Diagnosis of a new malignancy of a different tumor type.
CAP-Ketamine for Antidepressant Resistant PTSD
Condition: PTSD; Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Ketamine; Placebo/Saline
Intervention description: FDA approved anesthetic medication with rapid acting antidepressant effects.; This is a saline placebo/non-active solution.
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PTSD; Ketamine; Veteran; Military; Clinical Trial

Summary:

      The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as
      compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an
      active duty military and Veteran population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female Veterans or active duty military personnel between the ages of 18 and
             70 years

          -  diagnosis of PTSD

          -  history of trialing one or more antidepressant medications with little to no PTSD
             symptom improvement

          -  ability to provide written informed consent

        Exclusion Criteria:

          -  females who are currently pregnant or breastfeeding

          -  current high risk for suicide

          -  history of severe head injury
Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant
Condition: Acute Myeloid Leukemia
Intervention: Fludarabine; Melphalan; Pembrolizumab
Intervention MeSH terms: Pembrolizumab; Fludarabine; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: AML

Summary:

      AML is the most common acute leukemia in adults. Most patients can undergo allogeneic stem
      cell transplantation as a possible cure; however, many patients are not candidates for
      allogeneic transplant due to age, overall health, psychosocial factors, and/or lack of
      available donors. Therefore, these patients are unable to receive the therapeutic benefits of
      the "graft-versus-leukemia" effect of donor immune cells. The aim of this study is to
      hopefully break immune tolerance to AML cells to provide better outcomes in patients with
      non-favorable risk AML.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-favorable risk AML

          -  In CR-1 or subsequent CR

          -  Completed at least one cycle of consolidation chemotherapy

          -  Collection of at least 2x106/kg CD34+ cells

          -  KPS of 70% or greater

        Exclusion Criteria:

          -  Received investigational agent within 4 weeks of first dose

          -  Prior chemotherapy, radiation therapy within 2 weeks of first dose

          -  Hypersensitivity to pembrolizumab or any of its excipients

          -  Received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children
Condition: Respiratory Syncytial Virus
MeSH terms: Respiratory Insufficiency
Intervention: Azithromycin 10 mg; Azithromycin 20mg; Placebo
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Participant, clinical providers and study staff are masked to the intervention. The random assignment of treatment was determined by random permutation. A statistician generated the randomization schedule and provided the randomization schedule (with randomization IDs) in an excel file to the study pharmacist in charge of dispensing the appropriate treatment.
Enrollment: 48.0
Sex: All
Maximum age: 16 Years
Healthy volunteers: No
Keywords: RSV; respiratory support; ICU; Azithromycin

Summary:

      This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single
      tertiary pediatric intensive care unit (PICU). The study will include children with RSV
      infection who were admitted to the pediatric intensive care unit and require respiratory
      support via positive pressure ventilation (invasive and noninvasive).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission to the PICU with RSV infection

          -  Need for positive pressure ventilation (invasive and non-invasive)

          -  Randomization and drug/placebo initiation within 48 hours of admission to Pediatric
             Intensive Care Unit

        Exclusion Criteria:

          -  Azithromycin use within 7 days of PICU admission

          -  Contraindication to azithromycin use including:

               -  Patients with electrocardiogram QT interval corrected for heart rate (Qtc) ≥ 450
                  ms

               -  Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)

               -  Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide
                  drug

               -  Cardiac arrhythmia

          -  History of pyloric stenosis

          -  Immunocompromised children (any cause)

          -  Current use of any medication known to cause QT prolongation
Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)
Condition: Glucose Intolerance
MeSH terms: Glucose Intolerance
Intervention: Placebo for Sitagliptin 25 mg; Placebo for Sitagliptin 50 mg; Sitagliptin 25 mg; Sitagliptin 50 mg
Intervention description: 1 tablet orally once daily before breakfast for 8 weeks; 1 tablet orally once daily before breakfast for 8 weeks; 1 tablet orally once daily before breakfast for 8 weeks; 1 tablet orally once daily before breakfast for 8 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 242.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin
      (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose
      tolerance who have inadequate glycemic control using diet and exercise therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Impaired glucose tolerance

          -  On diet/exercise therapy

          -  Unlikely to conceive

          -  Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society
             value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g
             oral glucose tolerance test ≥140 mg/dL and <200 mg/dL

        Exclusion Criteria:

          -  History of diabetes mellitus

          -  Disease or condition of clear or likely glucose tolerance disorder

          -  Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug
A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
Condition: Bacterial Enteritis
MeSH terms: Enteritis
Intervention: OPS-2071 tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 19 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial
      Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient provides written, informed consent before the clinical trial is initiated

          -  The patient has distinctive symptoms and findings of bacterial enteritis

          -  The patient has bacterial enteritis with one or more of the following causative
             pathogens either proven or presumed: C. difficile, Salmonella, Campylobacter,
             pathogenic E. coli, and other bacteria estimated to cause bacterial enteritis

          -  The patient and his/her partner are willing to take contraceptive measures from
             initiation of investigational medicinal products (IMPs) to 4 weeks after
             administration of IMPs

        Exclusion Criteria:

          -  The patient has severe or progressive underlying disease or complication, making it
             difficult to ensure safety in the study or proper efficacy assessment

          -  The patient has a current diagnosis or history of convulsive disorders, such as
             convulsion and epilepsy

          -  The patient has a severe hepatic dysfunction

          -  The patient has a severe cardiac dysfunction

          -  The patient has cardiac arrhythmia or congenital or sporadic long QTc syndrome. Or the
             patient is treated with a drug reported to prolong QTc interval

          -  The patient has a moderate or severe renal dysfunction

          -  Women with confirmed or suspected pregnancy or breast-feeding women

          -  Patients judged to be ineligible by the investigator for any other reasons
A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; GDC-0810
Intervention description: Fulvestrant at a dose of 500 mg as two intramuscular injections will be administered on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle.; GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily.
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of
      GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic
      estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-)
      breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the
      Sponsor and the enrollment in this study has been discontinued. Participants currently
      enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810
      as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity,
      withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the
      Sponsor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with histologically or cytologically confirmed invasive, ER+/HER-
             (defined by local guidelines) metastatic or inoperable, locally advance breast cancer

          -  Participants for whom endocrine therapy is recommended and treatment with cytotoxic
             chemotherapy is not indicated at time of entry into the study

          -  Participants must have measurable disease by RECIST v1.1 or non-measurable, evaluable
             disease with atleast one evaluable bone lesion by RECIST v1.1 based on radiologic
             scans within 28 days of Day 1 of Cycle 1

          -  Participants with radiologic/objective evidence of breast cancer recurrence or
             progression while on or within 6 months after the end of adjuvant treatment with an
             AI, or progression while on or within 1 month after the end of prior AI treatment for
             locally advanced or metastatic breast cancer

        Exclusion Criteria:

          -  HER2-positive disease

          -  Prior treatment with fulvestrant

          -  Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen or >2 endocrine
             therapies for advanced or metastatic disease