bioihbjkbjnl/mcl2 huggingface dataset:
A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: INCB054707; Placebo
Intervention description: INCB054707 tablet administered orally once daily at the protocol-defined dose.; Placebo tablet administered orally once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hidradenitis suppurativa; Janus kinase (JAK) inhibitor; skin disease

Summary:

      The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment
      period in men and women with moderate to severe hidradenitis suppurativa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6
             months before screening.

          -  Stable course of HS for at least 90 days before screening, as determined by the
             investigator.

          -  HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley
             Stage II or Hurley Stage III at screening.

          -  Total AN count of at least 3 at screening and baseline.

          -  Willingness to avoid pregnancy or fathering children.

        Exclusion Criteria:

          -  Women who are currently pregnant or lactating.

          -  Presence of > 20 draining fistulas at screening and baseline.

          -  Participants with protocol-defined concurrent conditions or history of other diseases.

          -  Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF),
             defined as ≥ 450 msec.

          -  Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB
             test at screening.

          -  A history of active tuberculosis (treated or untreated) or a history of untreated
             latent tuberculosis.

          -  Positive serology test results for HIV, hepatitis B surface antigen, hepatitis B virus
             core antibody, or hepatitis C virus (HCV antibody with positive HCV-RNA) at screening.

          -  Decreased blood cell counts at screening per protocol-defined criteria.

          -  Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or
             aspartate aminotransferase levels ≥ 1.5 × upper limit of normal at screening.

          -  Impaired renal function with serum creatinine > 1.5 mg/dL at screening.

          -  Use of protocol-prohibited medications.

          -  Known or suspected allergy to INCB054707 or any component of the study drug.

          -  Known history of clinically significant drug or alcohol abuse in the last year before
             baseline.
Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Dronabinol; Placebo
Intervention description: Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects will receive either 2.5 mg bid, or 5 mg bid, taken orally with water for 2 days.; Placebo will match study drug; taken orally with water twice per day for two days.
Intervention MeSH terms: Dronabinol
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: anandamide; cannabinoid; fatty acid amide hydrolase; gastric; motility; small bowel

Summary:

      Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no
      effective and safe medications approved for the treatment of abdominal pain associated with
      bowel symptoms in IBS. This study will investigate the effects of an approved medication,
      Dronabinol, on the movement of food through the stomach and colon in subjects with a history
      of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).

      Dronabinol is a synthetic medication (a medication made in a laboratory) related to the
      active ingredient of "cannabinoid or marijuana". Dronabinol is approved by the Food and Drug
      Administration (FDA) for preventing nausea and vomiting in patients with cancers undergoing
      chemotherapy. It is also used in AIDS patients with excessive weight loss for improvement in
      appetite and weight gain.

      The hypothesis in this study is that dronabinol will slow down the movement of food through
      the colon, and that this effect is regulated by the genes controlling the body messengers
      (receptors) that respond to medicinal marijuana or synthetic medicines that work on the same
      messengers that are present in the gastrointestinal tract and pain nerves.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-75 years

          -  Positive for IBS symptoms by Rome III criteria

          -  No prior abdominal surgery (except appendectomy or cholecystectomy)

          -  Baseline Geometric Center at 24 hours is greater/equal to 2.0

          -  Baseline Geometric Center at 48 hours is greater/equal to 3.9

        Exclusion Criteria:

          -  Patients with significant depression (score of greater than 10 on Hospital and Anxiety
             Inventory)

          -  Patients with anxiety (score of greater than 10 on Hospital and Anxiety Inventory)
             will not be allowed to participate. However, patients on stable doses of selective
             serotonin re-uptake inhibitors (SSRIs) or low dose of tricyclic antidepressants will
             be eligible.
A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas
Condition: Brainstem Glioma
MeSH terms: Glioma
Intervention: Capecitabine; Radiation therapy
Intervention description: Capecitabine was supplied as film-coated tablets.; Local irradiation using conformal, volume-based delivery techniques. The nominal energy of the X-rays was ≥ 4 MV.
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study evaluated the effect of capecitabine and concomitant radiation therapy in children
      with newly diagnosed brainstem gliomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric and adolescent patients ≥ 3 to < 18 years of age.

          -  Patients must have a newly diagnosed non-disseminated intrinsic infiltrating brainstem
             glioma.

          -  Karnofsky Performance Scale (if > 16 years of age) or Lansky Performance Score (if ≤
             16 years of age) ≥ 50% assessed within 2 weeks prior to registration to study.

          -  Patients must not have received any prior chemotherapy or bone marrow transplant for
             the treatment of brainstem glioma. Prior dexamethasone and/or surgery are allowed.

          -  Adequate organ function.

        Exclusion Criteria:

          -  Patients receiving any other anticancer or experimental drug therapy.

          -  Patients with uncontrolled infection.

          -  Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children
Condition: Pandemic H5N1 Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: Adjuvanted H5N1 pandemic influenza vaccine
Intervention description: Comparison of two doses of aH5N1c vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 662.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza, Pandemic, H5N1, Children

Summary:

      Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived
      influenza vaccine in children.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy pediatric subjects 6 months to 17 years of age,

          2. Individuals' parent(s) or legal guardian(s) willing to provide written informed
             consent,

          3. Individuals in good health,

          4. Individuals/Individuals' parent(s)/legal guardian(s) willing to allow for serum
             samples to be stored beyond the study period,

          5. Individuals willing to provide informed assent (where applicable).

        Exclusion Criteria:

          1. Individuals' parent(s)/legal guardian(s) not able to understand and follow study
             procedures,

          2. History of any significant illness,

          3. History of any chronic medical condition or progressive disease,

          4. Presence of medically significant cancer,

          5. Known or suspected impairment/alteration of immune function,

          6. Presence of any progressive or severe neurologic disorder,

          7. Presence of any bleeding disorders or conditions that prolongs bleeding time,

          8. History of allergy to vaccine components,

          9. Receipt of any other investigational product within 30 days prior to entry into the
             study,

         10. History of previous H5N1 vaccination,

         11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into
             the study,

         12. Receipt of any other vaccine within 2 weeks prior to entry into the study,

         13. Body temperature ≥38°C (≥100.4° F) and/or acute illness within 3 days of intended
             study vaccination,

         14. Pregnant or breast feeding,

         15. Females of childbearing potential refusing to use acceptable method of birth control,

         16. Body mass index (BMI) ≥ 35 kg/m2,

         17. History of drug or alcohol abuse,

         18. Any planned surgery during study period,

         19. Individuals conducting the study and their immediate family members,

         20. Individuals with behavioral or cognitive impairment or psychiatric diseases,

         21. Individuals diagnosed with any growth disorders.
Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?
Condition: Myelodysplastic Syndrome
MeSH terms: Myelodysplastic Syndromes
Intervention: Maitake
Intervention description: Patients will receive the oral mushroom extract 3mg/kg by mouth twice daily for 3 months. Patients will serve as their own controls, with blood counts after Maitake compared with baseline counts. Rather than a wait list control, at study entry we will obtain from MDS patient charts 2 CBC/differential/platelet values drawn within 12-24 weeks prior to starting the protocol.
Healthy control volunteers will be recruited to this study as participants for expanding the baseline normal values for neutrophil and monocyte function as measured by the respiratory burst test.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: MDS; Maitake; mushroom; 09-094

Summary:

      Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York
      Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of
      a medicinal mushroom extract called Maitake (pronounced my-tock-e).

      Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake
      does not kill cancer cells directly. It is believed to work through the immune system (the
      body's defense system against infection). Our test tube, animal and human dose determining
      studies show that Maitake can enhance immune function. We are conducting this study to see
      whether Maitake improves the neutrophil count and function in patients with MDS. The
      neutrophils are white blood cells which help to fight infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MSKCC patients age 18 or older able to sign informed consent

          -  Absolute Neutrophil count >0.5 K/mcL

          -  Diagnosis of MDS by bone marrow biopsy

          -  Patient not a candidate for aggressive standard treatment

        Exclusion Criteria:

          -  IPSS (High risk)

          -  History of AML

          -  History of Stem Cell transplant

          -  Known history of HIV+

          -  Allergy to mushrooms

          -  Bone Marrow blasts >10%

        HEALTHY CONTROL ELIGIBILTY CRITERIA

        Inclusion Criteria

          -  Age ≥55 years

        Exclusion Criteria

          -  Currently taking corticosteroids or other immunosuppressants

          -  Known history of HIV+

          -  Current or previous malignancy or hematology disorder except adequately treated
             non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other
             solid tumors curatively treated with no evidence of disease for > 3 years
A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: Setipiprant; Placebo; Finasteride
Intervention description: Setipiprant tablets, orally, BID for 24 weeks.; Placebo tablets, orally, BID for 24 weeks.; Finasteride tablet, orally, once daily for 24 weeks.
Intervention MeSH terms: Finasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 169.0
Sex: Male
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability and efficacy of the oral administration of
      setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males
      with androgenetic alopecia (AGA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has androgenetic alopecia (AGA)

          -  Participant agrees to maintain current hair care regimen, refraining from hair
             weaving, hair colorants or dyes and non-study hair growth products during the study.

        Exclusion Criteria:

          -  History of hair loss for reasons other than AGA

          -  Scarring of the scalp or any condition or disease of the scalp, hair or hair shaft

          -  Use of products within 6 months of study start used continuously for at least 1 month
             that could impact hair growth

          -  Hair-weaving within 6 months

          -  Use of hair colorants or dyes within 6 months.
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Premature Birth; Syndrome
Intervention: Aerosolized lucinactant; Aerosolized lucinactant
Intervention description: Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours.; Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour.
Intervention MeSH terms: Pulmonary Surfactants
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 15 Minutes
Maximum age: 30 Minutes
Healthy volunteers: No
Keywords: Lucinactant; Nasal continuous positive airway pressure (nCPAP); Respiratory distress syndrome (RDS); Pediatric; Premature

Summary:

      To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by
      nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress
      syndrome (RDS) in premature infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age 28-32 completed weeks, inclusive

          -  Placement of arterial line

          -  Successful initiation of nCPAP

          -  Informed Consent

        Exclusion Criteria:

          -  Heart rate that cannot be stabilized >100 bpm within 5 minutes of birth

          -  Five (5) minute Apgar score ≤ 3

          -  Major congenital malformation(s) diagnosed antenatally or noted immediately after
             birth

          -  Other disease(s) or conditions potentially interfering with cardiopulmonary function

          -  Mother with prolonged rupture of membranes > 2 weeks

          -  Known or suspected chromosomal abnormality

          -  Need for chest compressions or administration of epinephrine, bicarbonate, or fluid
             boluses in the delivery room

          -  Need for mechanical ventilation within 30 minutes of birth
Pilot Study of Duloxetine in Psychological Resilience
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Duloxetine
Intervention description: Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Pharmacotherapy; Duloxetine

Summary:

      The purpose of this study is to explore benefits of duloxetine in enhancing psychological
      resilience and to understand the relevance of inhibiting of both serotonin (5HT) and
      norepinephrine (NE)to therapeutic responses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 18-65

          -  primary diagnosis of MDD based on Diagnostic Standard Manual(DSM-IV) criteria and
             assessed by the MINI International Neuropsychiatric Interview

          -  Montgomery-Asberg Depression Rating Scale (MADRS)score of at least 20 on baseline

          -  Minimum Clinical Global Impressions of Severity (CGS) severity score of 4

          -  Ability to provide written consent form

          -  A negative serum pregnancy test for women of childbearing potential

        Exclusion Criteria:

          -  Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic
             disorder, mental retardation or other pervasive developmental disorder or cognitive
             disorder due to a general medical condition

          -  History of substance abuse or dependence within the last 6 months

          -  Suicide risk or serious suicide attempt within the last year

          -  Clinically significant medical condition or laboratory abnormality

          -  Women of childbearing potential who are unwilling to practice an acceptable method of
             contraception

          -  Subjects needing concurrent use of psychotropic medications

          -  History of sensitivity to duloxetine

          -  History of failure to respond to an adequate trial of duloxetine (at least 60mg/day
             for 4 weeks)

          -  Subjects taking monoamine oxidase inhibitors (MAOIs)

          -  Subjects with uncontrolled narrow-angle glaucoma
The Role of Endothelin in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: BQ-123
Intervention description: 6-120 µg/min
Intervention MeSH terms: cyclo(Trp-Asp-Pro-Val-Leu)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: primary pulmonary hypertension; secondary pulmonary hypertension due to left heart failure; secondary pulmonary hypertension due to other causes; patients without pulmonary disease or pulmonary hypertension

Summary:

      The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123,
      an investigational compound which is not approved by the FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers or known diagnosis of pulmonary hypertension

        Exclusion Criteria:

          -  hypertension due to other reasons (not pulmonary)
A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)
Condition: Constipation Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: RDX5791
Intervention description: Capsule, QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of
      RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition
      of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery
      of screening procedures to determine eligibility for the trial.

      The study will consist of a 2-week treatment-free screening period, a 4-week blinded
      treatment period, and a 2-week treatment-free follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject meets Rome III criteria for IBS-C

          -  If > 50 years old, colonoscopy evaluation within 10 years

          -  All ages, negative colonoscopy if any "warning symptoms"

          -  Active disease during 2-week screening period

          -  Compliant with IVRS

        Exclusion Criteria:

          -  Subjects has IBS-D, IBS-M or un-subtyped IBS according to Rome III criteria

          -  Diagnosis or treatment of any clinically symptomatic biochemical or structural
             abnormality of the GI tract

          -  Use of medications that are known to affect stool consistency

          -  Subject has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments or prevent completion of study