bioihbjkbjnl/mcl2 huggingface dataset:
Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Escitalopram placebo; Gaboxadol placebo; Escitalopram 20 mg; Gaboxadol 5 mg; Gaboxadol 10 mg
Intervention description: Once daily before bedtime for 8 weeks; Once daily before bedtime for 8 weeks; Once daily before bedtime for 8 weeks; Once daily before bedtime for 8 weeks; Once daily before bedtime for 8 weeks
Intervention MeSH terms: Gaboxadol; Dexetimide; Citalopram; Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 490.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses
      of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of
      treatment in patients with Major Depressive Disorder
    

Eligibility criteria:

        Inclusion Criteria:

        Clinical Diagnosis of MDD according to DSM-IV-TR criteria:

          -  With reported duration of the current major depressive episode of at least 3 months

          -  With MADRS total score of at least 30

        Exclusion Criteria:

        The patient has 1 or more of the following:

          -  Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR

          -  Current or past history of: manic or hypomanic episode, schizophrenia, or any other
             psychotic disorder, including major depression with psychotic features, mental
             retardation, organic mental disorders, or mental disorders due to a general medical
             condition as defined in the DSM-IV-TR

          -  Any substance disorder (except nicotine and caffeine) within the previous 6 months as
             defined in the DSM-IV-TR

          -  Presence or history of a clinically significant neurological disorder (including
             epilepsy)

          -  Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis,
             Huntington disease, etc)

          -  Any Axis II disorder that might compromise the study

          -  Previous use of hallucinogenic drug

        The patient has a significant risk of suicide according to the investigator's opinion, or
        has a score >=5 on item 10 (suicidal thoughts) of the MADRS, or has made a suicide attempt
        in the previous 12 months.
FLX475 in Combination With Ipilimumab in Advanced Melanoma
Condition: Advanced Melanoma
MeSH terms: Melanoma
Intervention: FLX475; Ipilimumab
Intervention description: Tablet; IV infusion
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoplasms; Ipilimumab; Antineoplastic Agents; Immunological

Summary:

      This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of
      FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated
      with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1
      (anti-PD-L1) agent.

      The study will be conducted starting with a safety run-in portion in which 6 eligible
      subjects will be enrolled and treated for at least one 3-week cycle to determine if the
      safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately
      20-subject study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IV or unresectable Stage III advanced melanoma

          -  Prior treatment with at least 2 months of anti-PD-(L)1 agent

          -  Measurable disease at baseline

          -  Tumor available for biopsy

        Exclusion Criteria:

          -  History of allergy or severe hypersensitivity to biologic agents

          -  History of Grade 3-4 immune-related adverse events leading to discontinuation of prior
             immunotherapy

          -  Prior treatment with ipilimumab or other (cytotoxic T-lymphocyte-associated antigen 4)
             CTLA-4 antagonists
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Guselkumab Dose 1; Guselkumab Dose 2; Golimumab Dose 1; Golimumab Dose 2; Placebo
Intervention description: Guselkumab Dose 1 will be administered as IV infusion.; Guselkumab Dose 2 will be administered as SC injection.; Golimumab Dose 1 will be administered as SC injection.; Golimumab Dose 2 will be administered as SC injection.; Placebo will be administered.
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the clinical efficacy and safety of combination
      therapy with guselkumab and golimumab in participants with moderately to severely active
      ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before
             screening

          -  Moderately to severely active UC as defined by Mayo score

          -  History of inadequate response to or failure to tolerate conventional therapy

          -  Has screening laboratory test results within the study protocol defined parameters

          -  A woman of childbearing potential must have a negative highly sensitive serum (beta
             human chorionic gonadotropin) pregnancy test result at screening and a negative urine
             pregnancy test result at Week 0

        Exclusion Criteria:

          -  Has severe extensive colitis as defined in the study protocol

          -  Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon

          -  Has a history of latent or active granulomatous infection, including histoplasmosis or
             coccidioidomycosis, before screening

          -  Has any known malignancy or has a history of malignancy (with the exception of basal
             cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in
             situ that has been treated with no evidence of recurrence; or squamous cell carcinoma
             of the skin that has been treated with no evidence of recurrence within 5 years before
             screening)

          -  Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or
             their excipients
Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)
Condition: Retinopathy of Prematurity
MeSH terms: Retinopathy of Prematurity
Intervention: Caffeine citrate; Ibuprofen; Ketorolac
Intervention description: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose); Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days; Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
Intervention MeSH terms: Ibuprofen; Ketorolac; Caffeine; Caffeine citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Maximum age: 28 Weeks
Healthy volunteers: No

Summary:

      Phase 2, open-label, randomized, multi-center studies in infants and premature infants are
      necessary to determine treatment and preventative strategies for ROP. This study was designed
      to: a) target infants at the highest risk of ROP in a large number of centers with variable
      rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus
      systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study
      is designed to determine whether the novel treatment regimens are safe and potentially
      effective for ROP prevention and to obtain requisite data for the development of a Phase III
      efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as
      standard of care for ELGANs, no placebo group is included.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonates at high risk for ROP as outlined by the American Academy of Pediatrics,
             Section on Ophthalmology; American Association for Pediatric Ophthalmology and
             Strabismus; and American Academy of Ophthalmology (129) will be enrolled. Inclusion
             criteria are:

               1. all infants with a birth weight of less than 1250 grams;

               2. all infants with a gestational age of 28 weeks or less; and

               3. all infants who required oxygen therapy and ventilator support within the first 2
                  days of life.

        Exclusion Criteria:

          -  Exclusion criteria are:

               1. major congenital malformations and or chromosomal anomalies including
                  duct-dependent cardiac anomalies;

               2. maternal antenatal NSAID exposure <72 hours before birth;

               3. renal failure or oliguria defined as a urine flow rate <0.5 mL/kg/hour in the 8
                  hours prior to randomization. Anuria is acceptable if infant is less than 24
                  hours of life;

               4. platelet count <75,000.mm3;

               5. clinical bleeding such as oozing from puncture sites; and

               6. participation in other clinical drug trials while subject participates in this
                  study and for 7 days after last dose of study drug.
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: RhACE2 APN01; Physiological saline solution
Intervention description: Patients will be treated with APN01 intravenously twice daily (BID).; Patients will be treated with placebo intravenously twice daily (BID).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Recombinant human angotensin-converting enzyme 2 (rhACE2) as a treatment for patients with
      COVID-19 to block viral entry and decrease viral replication.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Hospitalized male or female

          2. Diagnosed to be COVID-19 POSITIV

          3. Signed Inform Consent Form

        Exclusion Criteria:

          1. Any patient whose clinical condition is deteriorating rapidly

          2. Known history of positive Hepatitis B surface antigen, Hepatitis C antibody or HIV
             antibody

          3. History of sensitivity to any of the study medications, or components thereof or a
             history of drug or other allergy that, in the opinion of the investigator or Medical
             Monitor, contraindicates their participation

          4. Pregnant females as determined by positive serum or urine hCG test prior to dosing

          5. Lung transplantation

          6. Pre-existing renal failure, i.e. requiring renal replacement therapy with hemodialysis
             or peritoneal dialysis

          7. There are other uncontrolled co-morbidities that increase the risks associated with
             the study drug administration, that are assessed by the medical expert team as
             unsuitable

          8. Patient in clinical trials for COVID-19 within 30 days before ICF

          9. Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell
             transplants)
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Erlotinib (Tarceva)
Intervention description: Erlotinib
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate Tarceva in a selected population of patients with untreated advanced
      non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis
      based on clinical criteria. It is anticipated that selection will enrich for tumor
      characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater
      than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for
      patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at
      some point in the future and may prolong the time to chemotherapy related progression.

      Patients will remain on study until disease progresses, a decline in performance status, if
      patient cannot tolerate the side effects or develops symptoms requiring conventional
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Performance status 0-1.

          -  Weight Loss < 10% in preceding 3 months

          -  Age 18 years and older.

          -  Adjuvant chemotherapy allowed if > 6 months from protocol entry

          -  Adequate Organ Function

          -  Liver enzymes < 2X normal, bilirubin = normal

          -  Oxygen saturation> 89% on room air unless chronically oxygen dependent (not cancer
             related)

          -  Creatinine <2.0 mg

        Exclusion Criteria:

          -  Not pregnant or lactating.

          -  No Clinical Brain Metastases

          -  No prior chemotherapy for systemic disease

          -  Imminent need for chemotherapy for impending organ dysfunction is not allowed
Sleep Apnea Treatment After Stroke (SATS)
Condition: Obstructive Sleep Apnea; Stroke
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Stroke
Intervention: continuous positive airway pressure or CPAP; sham CPAP
Intervention description: RemStar Pro (Respironics, Inc.) The CPAP is applied through a nasal mask during the hours of sleep. Positive air pressure holds the naso-oro-pharyngeal airway open during sleep.; sham CPAP
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: obstructive sleep apnea; stroke; OSA; CPAP; continuous positive airway pressure

Summary:

      The purpose of this study is to determine if treating stroke patients who have obstructive
      sleep apnea with continuous positive airway pressure will improve symptoms caused by the
      stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ischemic stroke within 7 days of planned polysomnography/sleep screening study

          -  Modified Rankin Scale score >1

          -  If of child-bearing potential, has a negative urine or serum pregnancy test

        Exclusion Criteria:

          -  Decompensated heart failure

          -  Cardiac or respiratory arrest within the past 3 months

          -  Myocardial infarction within the past 3 months

          -  Severe pneumonia

          -  Hypertension refractory to treatment

          -  Any other unstable medical condition which is thought to interfere with participation

          -  Known preexisting OSA already on CPAP or previously failed CPAP or used CPAP

          -  Previous pneumothorax

          -  Bullous emphysema

          -  Chronic obstructive pulmonary disease (COPD), obesity-hypoventilation, or another
             condition warranting the use of nasal bilevel positive airway pressure instead of CPAP

          -  Acute sinus or ear infection
Rituximab for the Primary Treatment of Denovo Extensive Chronic Graft Versus Host Disease (GVHD)
Condition: Chronic Graft-versus-host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: Rituximab
Intervention description: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months.
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic Graft versus Host Disease; allogeneic stem cell transplant

Summary:

      Rituximab is an attractive agent to bring to the upfront treatment of chronic
      graft-versus-host disease (cGVHD) due to its favorable toxicity profile, its proven efficacy
      in the treatment of steroid-refractory cGVHD, and its ability to serve as a steroid sparing
      agent in other autoimmune diseases. The investigators hope to demonstrate that Rituximab has
      significant activity in cGVHD when utilized early in the course of the process. In addition,
      the investigators hope to show that the early use of Rituximab may allow for the earlier
      discontinuation of immunosuppression while obviating the need for long courses of systemic
      corticosteroids, which should translate into reduced treatment-related morbidity and
      mortality associated with cGVHD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First episode of extensive chronic GvHD, without residual or concurrent acute GvHD.

          -  Age 18 - 75

          -  Any primary diagnosis requiring treatment by allogeneic HSCT

          -  Recipient of an allogeneic stem cell transplant (bone marrow, peripheral blood stem
             cell, or cord blood) from a related or unrelated donor, minimum 80 days ago

          -  Conditioning regimen: Myeloablative or non-myeloablative

          -  Patient gives written informed consent

        Exclusion Criteria:

          -  Creatinine > 2.0 mg/dl

          -  Uncontrolled, active infection

          -  Recurrent or progressive malignancy

          -  Anticipated life expectancy of less than 1 year

          -  Pregnant or breast feeding

          -  Contraindications to administration of the study intervention or known inability of
             the patient to tolerate the study intervention

          -  Patients with perceived fixed, irreversible defects (pulmonary involvement,
             contractures, etc.) which would not be expected to improve with the study intervention

          -  Residual or concurrent acute GVHD
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
Condition: Bone Metastases in Men With Hormone-Refractory Prostate Cancer; Bone Metastases in Subjects With Advanced Breast Cancer; Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasm Metastasis; Neoplasms, Second Primary; Neoplasms; Bone Neoplasms; Bone Marrow Diseases
Intervention: AMG 162 180 mg (SC) q 12 weeks; IV Bisphosphonate q 4 weeks; AMG 162- 180 mg q 4 weeks
Intervention description: A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses.; IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase. If enrolled to the extension phase, subject will be assigned to the AMG 162 180mg (SC) every 4 weeks for 26 doses.; A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses.
Intervention MeSH terms: Diphosphonates; Denosumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bone Metastases; AMG 162; Bisphosphonates; Solid Tumor Carcinomas; Advanced

Summary:

      The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary
      N-telopeptide in advanced cancer subjects with bone metastases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years of age with histologically confirmed solid tumor carcinomas
             (except lung) or multiple myeloma

          -  Radiographic evidence of 1 or more bone lesions or lytic lesion in myeloma

          -  Currently receiving IV bisphosphonates

          -  Urinary N-Telopeptide (uNTx) greater than 50 nM BCE/mM creatinine

          -  Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2

        Exclusion Criteria:

          -  More than 2 prior skeletal related events (SRE)

          -  Known brain metastases

          -  Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw

          -  Active dental or jaw conditions which requires oral surgery

          -  Non-healed dental/oral surgery

          -  Prior administration of AMG 162

          -  Evidence of impending fracture in weight bearing bones

          -  Pregnancy or breastfeeding. Subjects must be surgically sterile, postmenopausal, or
             must agree to use effective contraception during the study.