bioihbjkbjnl/mcl2 huggingface dataset:
Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: pTVG-HP; rhGM-CSF
Intervention description: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period; rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
Intervention MeSH terms: Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are trying to find new methods to treat prostate cancer. The approach the
      investigators are taking is to try to enhance patients' own immune response against the
      cancer. In this study the investigators will be testing the effectiveness of a vaccine that
      may be able to help the body fight prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of adenocarcinoma of the prostate

          -  Completion of local therapy by surgery and/or ablative radiation therapy at least 3
             months prior to entry, with removal or ablation of all visible disease, including
             seminal vesical and/or local lymph node involvement

          -  Rising prostate specific antigen (PSA) levels without scan evidence of metastatic
             disease

          -  Asymptomatic or mildly symptomatic and life expectancy of at least 4 months

        Exclusion Criteria:

          -  Small cell or other variant prostate cancer histology

          -  Evidence of immunosuppression

          -  Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly
             with radiation therapy or at time of prostatectomy. In this situation, no more than 24
             months of androgen deprivation must have been given and treatment must not have been
             within 12 months prior to screening for this study.

          -  Serum testosterone at screening < 50 ng/dL

          -  Known bone metastases or lymph node involvement as determined by bone scan or computed
             tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry

          -  Prior vaccine therapy for prostate cancer

          -  Known allergic reactions to granulocyte-macrophage colony-stimulating factor (GM-CSF)

          -  Severe intercurrent medical conditions or laboratory abnormalities that would impart,
             in the judgment of the Medical Monitor, excess risk associated with study
             participation or study agent administration
Hyperbaric VO2max Study
Condition: Exercise Training
Intervention: Hyperoxic hyperbaric interval exercise training; Normoxic, normobaric, interval exercise training; Oxygen
Intervention description: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.; Six 30-min high-intensity interval training sessions completed 3-times a week.; Used in Hyperoxic hyperbaric interval exercise training intervention
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: interval training; hyperbaric oxygen; VO2 max; altitude; exercise performance; mitochondrial oxidative capacity; mitochondrial biogenesis

Summary:

      This study seeks to examine the effectiveness of training while in a hyperoxic-hyperbaric
      environment for exercise performance at altitude. Subjects will complete a short,
      high-intensity interval training (HIT) program inside the hyperbaric chamber.Before and after
      this training phase, all subjects will be tested for maximum aerobic capacity at a simulated
      high altitude of 15,000ft in a hypobaric chamber, as well as for molecular markers of
      mitochondrial oxidative capacity in a skeletal muscle biopsy.

      A group of individuals of similar characteristics completing this training program in a
      normoxic-normobaric environment will serve as a control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy, recreationally active or sedentary individuals

        Exclusion Criteria:

          -  VO2max < 35 ml/kg/min - male 30 ml/kg/min - female

          -  chronic cardiovascular or pulmonary diseases

          -  history of pneumothorax

          -  active smoker

          -  pregnant women

          -  non-english speaking

          -  not in full mental capacity

          -  blind

          -  sickle cell trait or disease
Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk
Condition: Leukemia
MeSH terms: Preleukemia; Myelodysplastic Syndromes
Intervention: Decitabine; Azacitidine
Intervention description: 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.; 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.
Intervention MeSH terms: Azacitidine; Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Myelodysplastic syndromes; MDS; Low and Intermediate-1 Risk Disease; Decitabine; DAC; Dacogen; Azacitidine; AZA; 5-azacytidine; 5-aza; Vidaza; 5-AZC; AZA-CR; Ladakamycin; NSC-102816

Summary:

      The goal of this clinical research study is to compare how two different drugs, decitabine
      and azacitidine, when given on a shorter than standard dosing schedule can help to control
      MDS. The safety of the drugs will also be studied.

      Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause
      cancer cells to die.

      Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the
      function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting
      genes may be able to work better. This could cause the cancer cells to die.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Sign an Institutional Review Board (IRB)-approved informed consent document.

          2. Age >/= than18 years

          3. de novo or secondary International Prostate Symptom Score (IPSS) low- or
             intermediate-1 - risk MDS, including CMML

          4. Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.

          5. Organ function as defined: Serum creatinine </= 3 x Upper Limit of Normal (ULN), Total
             bilirubin </= 2 x ULN, Alanine transaminase (ALT) (SGPT) </= 2 x ULN

          6. Women of childbearing potential must have a negative serum or urine pregnancy test
             within 7 days and will also need to use contraceptives. Men must agree not to father a
             child and agree to use a condom if his partner is of child bearing potential.

        Exclusion Criteria:

          1. Breast feeding females

          2. Prior therapy with decitabine or azacitidine
A Study of OV101 in Individuals With Fragile X Syndrome
Condition: Fragile X Syndrome (FXS)
MeSH terms: Fragile X Syndrome; Syndrome
Intervention: OV101 (gaboxadol)
Intervention description: OV101 (gaboxadol)
Intervention MeSH terms: Gaboxadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: Male
Minimum age: 13 Years
Maximum age: 22 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety, tolerability and efficacy of oral OV101
      (gaboxadol) in subjects with Fragile X syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is male and 13 to 22 years old (inclusive) at the time of informed consent.

          -  Has a diagnosis of FXS with a confirmed FMR1 full mutation (≥200 CGG repeats).

        Exclusion Criteria:

          -  Concomitant disease or condition that are clinically significant and would limit study
             participation

          -  Clinically significant lab abnormalities or vital signs at the time of screening

          -  History of uncontrollable seizure disorder or seizure episodes within 6 months of
             screening or change in the anticonvulsant pharmacotherapy in the past 3 months.

          -  Unable or does not have a caregiver able to comply with study requirements.

          -  Enrolled in any clinical trial within the 30 days before screening.
Piloting Treatment With Intranasal Oxytocin in Phelan-McDermid Syndrome
Condition: Phelan-McDermid Syndrome
MeSH terms: Chromosome Disorders; Syndrome; Chromosome Deletion
Intervention: Oxytocin; Saline
Intervention description: Intranasal oxytocin; Placebo
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a pilot study examining the efficacy, safety and tolerability of intranasal oxytocin
      as a novel treatment in Phelan-McDermid syndrome (PMS). This study will utilize a randomized,
      placebo-controlled design for 12 weeks (phase 1), followed by an open-label extension for 12
      weeks (phase 2). The purpose is to evaluate the effect of intranasal oxytocin on impairments
      in attention, social memory, socialization, language, and repetitive behaviors.
    

Eligibility criteria:

        Inclusion criteria:

          -  Have a diagnosis of Phelan-McDermid syndrome defined by pathogenic deletion or
             mutation of the SHANK3 gene and confirmed by chromosomal microarray or sequencing.

          -  Must be between the ages of 5 and 17

          -  Must be on stable medication and psychosocial therapy regimens for at least three
             months prior to enrollment

        Exclusion criteria:

          -  Allergy to oxytocin

          -  Active cardiovascular disease, epilepsy, or renal disease that is not controlled by
             medication

          -  Pregnant, lactating or refuse to practice contraception if sexually active

          -  Have caretakers who are unable to speak English, be consistently present at visits to
             report on symptoms, or are otherwise judged unable to comply with the protocol by the
             study team

          -  Comorbid conditions such that the patient is too medically compromised to participate
A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Abicipar pegol
Intervention description: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate abicipar pegol for safety and treatment effects in
      participants with neovascular age-related macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants, 50 years of age or older at the time of informed consent

          -  Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen
             equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment)
             visits in the study eye

          -  BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to
             treatment) in the non-study eye

        Exclusion Criteria:

          -  Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)

          -  Previous or concurrent macular laser treatment (study eye)

          -  Cataract or refractive surgery within 3 months prior to baseline (study eye)
Translating Neuroprediction Into Precision Medicine Via Brain Priming
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Intervention: Oxytocin; Pivotal Response Treatment; Placebo
Intervention description: Oxytocin nasal spray.; An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.; Placebo nasal spray.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eighty children will be randomly assigned to receive PRT with either oxytocin (forty children) or a placebo (forty children).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 5 Years
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT)
      on the development of language, social, and play skills in young children with Autism
      Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an
      enhancer of response to PRT. Participants will be randomly assigned to either an intranasal
      OXT group or a placebo group. Neither the research team nor the participants will know or
      choose which group the participant is assigned to. Children in both groups will participate
      in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels
      of activity in and functional connectivity among certain PRT-response brain regions will
      benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of
      PRT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Fit the age requirement: age 5-9

          2. Have been diagnosed previously with an ASD and meet criteria for ASD when
             characterized by research team

          3. Be in good medical health

          4. Be cooperative with testing

          5. Speak English in the family

          6. Successfully complete an fMRI scan

          7. Full-scale intelligence quotient (IQ)>70

        Exclusion Criteria:

          1. Any metal or electromagnetic implants, including:

               1. Cardiac pacemaker

               2. Defibrillator

               3. Artificial heart valve

               4. Aneurysm clip

               5. Cochlear implants

               6. Shrapnel

               7. Neurostimulators

               8. History of metal fragments in eyes or skin

          2. Significant hearing loss or other severe sensory impairment

          3. A fragile health status.

          4. Current use of prescription psychotropic medications that may affect cognitive
             processes under study.

          5. A history of significant head trauma or serious brain or psychiatric illness
An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: SEP-363856
Intervention description: One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      An extension study of safety and tolerability of SEP-363856 in adult subjects with
      schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

        Subject must give written informed consent and privacy authorization prior to participation
        in the study and able to comply with the protocol, in the opinion of the investigator.

          -  Subject has completed Study SEP361 201 through Week 4

          -  Subject has not taken any medication other than the study drug for the purpose of
             controlling schizophrenia symptoms during Study SEP361 201.

          -  Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361
             201; females who are post-menopausal (defined as at least 12 months of spontaneous
             amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will
             be exempted from the pregnancy test.

          -  Male subjects with female partner(s) of childbearing potential must agree to avoid
             fathering a child and use acceptable methods of birth control from screening until at
             least 30 days after the last study drug administration

        Exclusion Criteria:

          -  Subject answers "yes" to "suicidal ideation" Item 4 (active suicidal ideation with
             some intent to act, without specific plan) or Item 5 (active suicidal ideation with
             specific plan and intent) on the C-SSRS assessment at Visit 7 of Study SEP361 201.
             Subjects who answer "yes" to this question must be referred to the Investigator for
             follow up evaluation.

          -  Subject has a clinically significant abnormality including physical examination, vital
             signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in
             consultation with the medical monitor considers to be inappropriate to allow
             participation in the study.

          -  Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of
             Study SEP361 201.

          -  Subject is pregnant or lactating.

          -  Subject is at high risk of non-compliance in the Investigator's opinion.

          -  Subject is in the opinion of the Investigator, unsuitable in any other way to
             participate in this study.
Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD2475/101 40 mg; Doxycycline 100 mg; Placebo
Intervention description: Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.; Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks; Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 662.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: acne vulgaris; inflammatory lesions

Summary:

      The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for
      16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry
      Forward, Intent To Treat) in inflammatory lesion counts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects 12 years of age or older

          -  acne vulgaris with facial involvement

          -  A score of 3 (Moderate) or 4 (Severe) on the Investigator's Global Assessment Scale
             (inflammatory)

          -  25 to 75 inflammatory lesions (papules and pustules) on the face (including the nose)

        Exclusion Criteria:

          -  More than two acne nodules/cysts on the face

          -  Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne, etc.),
             or severe acne requiring systemic retinoid treatment

          -  Underlying diseases or other dermatologic conditions that require the use of
             interfering topical or systemic therapy such as, but not limited to, atopic
             dermatitis, perioral dermatitis or rosacea

          -  Beard or facial hair which might interfere with study assessments

          -  planning excessive exposure to sun or ultraviolet light during the study (i.e. natural
             or artificial sunlight, including tanning booths and sun lamp)

          -  Use of oral contraceptives solely for control of acne

          -  Liver function test alanine transaminase (ALT) and/or aspartate transaminase (AST) 2.5
             times above upper limit of normal

          -  Renal function test serum creatinine at 150 umol/L (17 mg/L) or higher

          -  Presence of oral or genital candidiasis or history of multiple episodes of oral or
             genital candidiasis

          -  Females who intend to conceive a child within 5 months following Baseline visit

          -  Males who intend to conceive a child with partner during the study period

          -  Requiring concomitant use of methoxyflurane
A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Upadacitinib; Placebo
Intervention description: Tablet; Oral; Tablet; Oral
Intervention MeSH terms: Upadacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hidradenitis suppurativa (HS); Upadacitinib

Summary:

      Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in
      the axilla (underarm), inguinal (groin) and anogenital (anal and genital) regions. This study
      will evaluate how well upadacitinib compared to placebo (no medicine) works to treat
      hidradenitis suppurativa in adult participants with moderate to severe disease. The study
      will assess change in disease signs and symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.

          -  Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline, presence of HS
             lesions in at least 2 distinct anatomical areas, and draining fistula count of ≤ 20 at
             Baseline.

          -  History of inadequate response or an intolerance to adequate trial of oral antibiotics
             for treatment of HS.

          -  Required to use a daily antiseptic wash on HS lesions.

        Exclusion Criteria:

        -History of active skin disease (other than HS) that could interfere with assessment of HS,
        including skin infections requiring systemic treatment within 4 weeks of the Baseline
        visit.