bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Oxytocin in Obese Adults
Condition: Obesity
Intervention: oxytocin nasal spray; Placebo
Intervention description: oxytocin intranasal spray; Placebo nasal spray
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: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: weight loss; body mass index; oxytocin; magnetic resonance imaging

Summary:

      This is a randomized, double blind, placebo-controlled study of the effects of intranasal
      oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of
      intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study
      visits include screening to determine eligibility, a 2-part baseline visit, and visits every
      2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose
      of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine
      assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-45 years old;

          -  BMI greater than or equal to 30 kg/m2

        Exclusion Criteria:

          -  Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose
             and weight are stable for at least 3 months);

          -  history of medication changes within 4 weeks of enrollment;

          -  active substance use;

          -  history of cardiovascular disease, gastrointestinal disorders, bariatric surgery,
             epilepsy, untreated thyroid disease;

          -  hematocrit >2% below normal;

          -  fasting glucose > 125 mg/dL or hemoglobin A1c ≥ 7% ;

          -  ALT or AST >2.5 times upper limit of normal;

          -  Cr >1.5 mg/dL; hyponatremia;

          -  pregnancy or breastfeeding;

          -  unwilling to use medically acceptable form of contraception (females only)

          -  follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo,
             Atkins, raw diet, macrobiotic diet)

          -  current smoking or tobacco use
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
Condition: 15q Duplication Syndrome; CDKL5 Deficiency Disease
MeSH terms: Deficiency Diseases; Syndrome
Intervention: Soticlestat
Intervention description: TAK-935 tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 2 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Drug Therapy; 15q Duplication Syndrome (Dup15q); CDKL5 Deficiency Disorder (CDD); Brain Diseases; Epilepsy; Central Nervous System Diseases; Autism; Cholesterol 24S-hydroxylase inhibitor; Anti-epilepsy drug; Anticonvulsants

Summary:

      The purpose of this study is to investigate the effect of soticlestat on the frequency of
      motor seizures for participants with Dup15q or CDD during the Maintenance Period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of Dup 15q or CDKL5 deficiency disorder.

          2. Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose.

        Exclusion Criteria:

          1. Two or more episodes of convulsive status epilepticus per 3 months requiring
             hospitalization and intubation.

          2. Currently receiving a study drug or participated in a clinical study involving another
             investigational product in the previous month.
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: BT-11 880 mg; Placebo
Intervention description: Oral once daily tablet; Oral once daily tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. Approximately 100 sites will participate from Europe and the USA. A total of 150 subjects with moderate to severe CD (CDAI Score 220-450 and a Simplified Endoscopic Index of Severity of Crohn's Disease (SES-CD) SCORED ≥ 6 (≥ 4 for isolated ileitis) will be randomized in a 1:1 ratio to receive BT-11 1,000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (yes/no) and corticosteroid use at baseline (yes/no). The study consists of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter
      induction study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;

          2. Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD
             scored ≥ 6 ( ≥ 4 for isolated ileitis) (centrally read);

        Key exclusion criteria:

          1. Ulcerative colitis;

          2. Known current bacterial or parasitic pathogenic enteric infection; live virus
             vaccination within 12 weeks of screening.
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
Condition: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Intervention: Concizumab; Eptacog alfa
Intervention description: A loading dose of 0.5 mg/kg will be given as the first dose, followed by 0.15 mg/kg (with potential stepwise dose escalation to 0.25 mg/kg) administered daily s.c. (subcutaneously, under the skin). Treatment duration is 24 weeks in the main trial, and up to 52 weeks in the extension phase; A single dose of 90 μg/kg eptacog alfa one week after dosing with concizumab. On-demand treatment during bleeding episodes in both treatment arms
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to
      assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once
      daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.
    

Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial
        related activities are any procedures that are carried out as part of the trial, including
        activities to determine the suitability for the trial - Male haemophilia A or B patients
        with inhibitors aged 18 years or older at the time of signing informed consent - Patients
        currently in need of treatment with bypassing agents Exclusion Criteria: - Known or
        suspected hypersensitivity to trial product(s) or related products - Known inherited or
        acquired bleeding disorder other than haemophilia - Ongoing or planned immune tolerance
        induction therapy or prophylaxis with FVIII or FIX
PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Condition: Carcinoma, Basal Cell
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: cemiplimab
Intervention description: Regimen as per protocol
Intervention MeSH terms: Cemiplimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to estimate the objective response rate (ORR) for metastatic Basal
      Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when
      treated with cemiplimab as a monotherapy
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Confirmed diagnosis of invasive BCC

          -  Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI
             therapy

          -  At least 1 measurable lesion

          -  ≥18 years of age

          -  Hepatic function, renal function, bone marrow function in defined lab-value-ranges

          -  Anticipated life expectancy >12 weeks

          -  Consent to provide archived tumor biopsy material (all patients)

          -  Group 2: consent to undergo research biopsies

          -  Group 2: must not be a candidate for radiation therapy or surgery

          -  Comply with study procedures and site visits

          -  Sign Subject Information Sheet and Informed Consent Form

        Key Exclusion Criteria:

          -  Ongoing or recent significant autoimmune disease

          -  Prior treatment with specific pathway-blockers (PD-1/PD-L1)

          -  Prior treatment with immune-modulating agents within 28 days before cemiplimab

          -  Untreated brain metastasis that may be considered active

          -  Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to
             treatment with cemiplimab

          -  Active infections requiring therapy, including HIV, hepatitis

          -  Pneumonitis within the last 5 years

          -  Cancer treatment other than radiation therapy, including investigational or standard
             of care, within 30 days prior to treatment with cemiplimab

          -  Documented allergic reactions or similar to antibody treatments

          -  Concurrent malignancies other than BCC, other than those with negligible risk of
             metastases or death

          -  Any acute or chronic psychiatric problems

          -  Having received a solid organ transplantation

          -  Inability to undergo contrast radiological assessments

          -  Breastfeeding, pregnant, women of childbearing potential not using contraception

        Note: Other protocol-defined inclusion/exclusion criteria apply
Phase II Study of Azacitidine and Sargramostim as Maintenance Treatment for Poor-Risk AML or MDS
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes
Intervention: Azacitidine; Sargramostim
Intervention description: Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.; Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles.
Intervention MeSH terms: Azacitidine; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: maintenance treatment; stem cell transplant; cytarabine-based chemotherapy

Summary:

      To determine the impact of maintenance therapy in patients with MDS/AML in remission.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age > 6 months

          2. Initial diagnosis of poor -risk AML or MDS (defined in section 3.2), treated with
             either stem cell transplant or cytarabine-based consolidation chemotherapy, within the
             past 60-185 days

          3. ECOG performance status 0-2

          4. No morphologic evidence of leukemia or active MDS as determined by JHH
             Hematopathologist independent review of a bone marrow aspirate and biopsy done
             following the completion of therapy and within 14 days prior to enrollment

          5. Peripheral blood count recovery: Neutrophil count ≥ 1000 /µL, platelet count ≥ 50x 109
             /µL without platelet transfusions, and adequate hematocrit independent of red cell
             transfusions .

          6. No evidence of extramedullary leukemia, such as CNS or soft tissue involvement

          7. Adequate end organ function as measured by the following: AST and ALT < 4 x normal,
             total serum bilirubin < 2 x upper limit normal (unless due to hemolysis, Gilbert's
             syndrome, or ineffective erythropoiesis), creatinine < 2 x upper limit of normal

          8. Ability to give informed consent

          9. In agreement to use an effective barrier method of birth control to avoid pregnancy
             during the study and for a minimum of 30 days after study treatment, for all male and
             female patients who are fertile

        Exclusion Criteria:

          1. Patients with untreated or uncontrolled infections

          2. Patients with untreated or uncontrolled grade 3 or 4 GVHD

          3. Pregnancy and lactation

          4. Concurrent use of any other investigational agents.

          5. Known HIV-positive patients.

          6. Known hypersensitivity to 5AC or GM-CSF
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Condition: Fistulizing Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Filgotinib; Placebo to match filgotinib
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of filgotinib as compared to
      placebo in establishing combined fistula response at Week 24. Participants will have the
      option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if
      they meet eligibility requirements.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on
             the date of screening visit

          -  Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months

          -  Has draining perianal fistulae as a complication of CD, confirmed by magnetic
             resonance imaging (MRI) at screening

          -  Previously demonstrated an inadequate clinical response, loss of response to, or
             intolerance of at least 1 of the following agents (depending on current country
             treatment recommendations/guidelines):

               -  Antibiotics AND/OR

               -  Immunomodulators AND/OR

               -  Tumor necrosis factor α (TNFα) Antagonist

          -  Is willing and able to undergo MRI per protocol requirements

          -  Is willing and able to undergo flexible sigmoidoscopy per protocol requirements

        Key Exclusion Criteria:

          -  Presence of current rectovaginal anovaginal or enterovesicular fistulae

          -  Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis,
             fulminant colitis, or toxic mega-colon

          -  History of total proctocolectomy, total colectomy, presence of ileostomy or colostomy,
             or likely requirement for surgery during the study

          -  Use of any prohibited concomitant medications as described in the study protocol

          -  Active tuberculosis (TB) or history of latent TB that has not been treated

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ublituximab; Umbralisib
Intervention description: Ublituximab IV infusion; Umbralisib tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to provide the opportunity to the participants who progressed
      on treatment arm previously in the study UTX-TGR-304 (NCT02612311) to receive ublituximab
      (TG-1101) treatment in combination with umbralisib (TGR-1202).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior treatment in clinical trial UTX-TGR-304

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

        Exclusion Criteria:

          -  Participants refractory to ublituximab + TGR-1202

          -  Transformation of chronic lymphocytic leukemia (CLL) to aggressive Non-Hodgkin's
             Lymphoma (NHL) (Richter's transformation)
RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
Condition: Male Infertility, Azoospermia
MeSH terms: Infertility; Infertility, Male; Azoospermia
Intervention: 13-cis retinoic acid
Intervention description: Accutane is used for the treatment of severe acne
Intervention MeSH terms: Tretinoin; Isotretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: 20 mg 13-cis retinoic acid twice daily (BID) with meals for 32 weeks
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Infertility

Summary:

      Men with infertility and normal hormone levels have few options for fertility treatment.
      Previous research suggests that men with infertility may have low levels of the active form
      of Vitamin A, called retinoic acid, in their testes. In a pilot study of 20 men with low
      numbers of sperm (<10 million motile sperm), roughly half the men showed improvement in sperm
      production. Thus, we want to see if retinoic acid administration to men with azoospermia (no
      sperm present) can initiate sperm production.
    

Eligibility criteria:

        Inclusion Criteria: Infertile men with azoospermia on at least two semen analyses separated
        by at least one week, and no pregnancy with partner with normal cycles and normal
        hysterosalpingogram despite >1 year of unprotected intercourse.

        -

        Exclusion Criteria: hypogonadotropic hypogonadism (that might respond to gonadotropin
        injections); use of anabolic steroids,illicit drugs, or consumption of more than 4
        alcoholic beverages daily; current therapy with retinoic acid (eg Accutane) or vitamin A-
        of use of isotretinoin within eight weeks of start of dosing;phenytoin, or medication
        containing tetracycline; personal history of serious psychiatric disorders, score of
        greater than 15 on the PHQ9 (mood) questionnaire; elevated serum serum triglycerides or
        other abnormal serum chemistry values; history of inflammatory bowel disease or bone
        disease; not living within catchment area; participation in another clinical trial

        -
Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Brazikumab IV Infusion; Brazikumab SC Injection; Placebo
Intervention description: Brazikumab IV infusion as per protocol specified dosing schedule.; Brazikumab IV infusion as per protocol specified dosing schedule.; Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: MEDI2070; inflammatory bowel disease; moderate to severe Crohn's Disease; IL-23

Summary:

      A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants
      with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor
      necrosis factor-alpha (anti-TNFα) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior
             to screening

          -  Men or women age 18 - 80 years at the time of screening

          -  Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI)
             and endoscopic demonstration of inflammation

          -  Stable dose of medications for Crohn's disease therapy

          -  Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis
             Factor-Alpha Therapy (anti-TNF α) agent

          -  Effective contraception from screening, and for 36 weeks after the last dose of
             investigational product

          -  No known history of active tuberculosis (TB) & negative assessment for TB/latent TB

        Exclusion Criteria:

          -  Severe underlying immunosuppression

          -  Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing
             strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel
             perforation

          -  Significant infections at screening; Infected abscess, positive for Clostridium
             difficile, recent infectious hospitalization

          -  Recent treatment with approved or investigational biologic therapy for Crohn's disease

          -  Recent or planned live attenuated vaccine

          -  History of cancer, except for basal cell carcinoma or carcinoma in situ (CIS) of the
             cervix with apparent cure ≥ 12 months before screening

          -  Pregnancy/breast feeding

          -  Drug abuse