bioihbjkbjnl/mcl2 huggingface dataset:
Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ADT; OPC-34712
Intervention description: Once daily dosing during the duration of the study.; OPC-34712, Oral Tablets, 0.25 - 3 mg
Intervention MeSH terms: Antidepressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1036.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the long-term safety, tolerability and efficacy of
      oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive
      Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18 and 65 years of age, with a diagnosis of a single
             or recurrent, non-psychotic episode of major depressive disorder, as defined by
             DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview
             (M.I.N.I.) which is equal to or greater than 8 weeks in duration.

          -  Subjects must currently be taking allowable antidepressant therapy at an adequate dose
             for a minimum of six weeks by the end of the screening period (ie at the time of the
             Baseline visit).

          -  Subjects must report a history for the current depressive episode of an inadequate
             response to at least one and no more than four adequate antidepressant treatments.

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving study drug.

          -  Subjects who report an inadequate response to more than three adequate trials of
             antidepressant treatments during current depressive episode at a therapeutic dose for
             an adequate duration.

          -  Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic
             or other cognitive disorder Schizophrenia, schizoaffective disorder, or other
             psychotic disorder Bipolar I or II disorder, eating disorder (including anorexia
             nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic
             stress disorder.

          -  Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of
             borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality
             disorder.
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
Condition: Endometrial Cancer; Papillary Serous; Clear Cell Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Vaginal Cuff Brachytherapy
Intervention description: Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Endometrial cancer; Gynecologic Cancer; Vaginal Cuff Brachytherapy; Vaginal radiation

Summary:

      The purpose of this study is to determine the progression-free survival of patients with
      surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with
      high-intermediate risk factors treated by vaginal cuff brachytherapy followed by
      chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have undergone specified complete surgical staging.

          -  Patients must be surgically staged endometrial cancer patients at high-risk for
             recurrence.

          -  Patients must have adequate bone marrow, renal and hepatic function.

        Exclusion Criteria:

          -  Patients with recurrent disease.

          -  Patients with GOG performance status of 3 or 4.
Study to Evaluate Multiple Doses in Patients With Nasal Polyposis
Condition: Nasal Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Nasal Polyps
Intervention: AK001 low dose; AK001 high dose; Placebo
Intervention description: 25 mg AK001 will be administered as multiple doses; 250 mg AK001 will be administered as multiple doses; Placebo will be administered as multiple doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses.
      Pharmacodynamic activity will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in
             each nostril according to the polyp grading scale

          -  History of sinusitis symptoms

          -  SNOT-22 ≥30

          -  No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or
             urinalysis findings

        Exclusion Criteria:

          -  Use of systemic corticosteroids within 6 weeks of screening

          -  Chronic use of antibiotic therapy within 3 months prior to Screening

          -  Nasal surgery (including polypectomy) within 6 months prior to Screening

          -  Use of investigational drugs or participation in another clinical trial within 30 days
             prior to Screening or 5 half-lives, whichever is longer
Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade
Condition: Immunoglobulin A Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Intervention: CCX168
Intervention description: CCX168 30 mg, twice daily (b.i.d.) orally for 84 days (12 weeks). The CCX168 dose was taken in the morning, optimally within one hour after breakfast, and in the evening, optimally within one hour after dinner.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary safety objective of this study is to evaluate the safety and tolerability of
      CCX168 in subjects with IgAN on background supportive therapy with a maximally tolerated dose
      of RAAS blockade. The primary efficacy objective is to evaluate the efficacy of CCX168 based
      on an improvement in proteinuria.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of Immunoglobulin A nephropathy

          -  estimated glomerular filtration rate >60 mL/min/1.73 m2

          -  Proteinuria (first morning urinary protein:creatinine ratio >1g/g creatinine)

        Key Exclusion Criteria:

          -  Severe renal disease

          -  Pregnant or nursing

          -  Proteinuria >8g/g creatinine or >8g/day

          -  Systemic manifestations of Henoch-Schonlein purpura within 2 years prior

          -  Patients with Immunoglobulin A nephropathy deemed secondary to underlying disease

          -  Biopsy reported severe crescentic Immunoglobulin A nephropathy

          -  History of treatment with glucocorticoids, cyclophosphamide, azathioprine,
             mycophenolate mofetil, or any biologic immunomodulatory agent with 24 weeks prior

          -  History of clinically significant cardiac conditions

          -  History of cancer within 5 years prior

          -  Any infection requiring antibiotic treatment that has not cleared prior to study start
Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MGCD265
Intervention description: MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mirati; MGCD265; MET; NSCLC

Summary:

      MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and
      other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced,
      unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic
      changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing
      for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have
      previously received treatment with chemotherapy. The number of patients to be enrolled will
      depend on how many enrolled patients experience tumor size reduction. MGCD265 will be
      administered orally, twice daily. The study is designed to evaluate whether the number of
      patients experiencing tumor size reduction is substantially higher than would be expected
      with other available treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of non-small cell lung cancer

          -  Metastatic or locally advanced disease

          -  Prior platinum chemotherapy or immunotherapy

          -  Test result showing genetic change in MET tumor gene

          -  At least one tumor that can be measured on a radiographic scan

        Exclusion Criteria:

          -  Prior treatment with inhibitor of MET or HGF

          -  Prior positive test for EGFR mutation or ALK gene rearrangement

          -  Uncontrolled tumor in the brain
Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Recombinant human erythropoietin alfa (drug); Placebo
Intervention description: 200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days; Normal saline to match active drug (rHuEpo)
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Platelet function tests; Erythropoietin; Myocardial infarction

Summary:

      The purpose of this study is to see if a naturally-occurring hormone called erythropoietin
      changes the action of platelets in the blood. Patients with heart attacks are treated with
      medicines to reduce the clotting action of platelets. This study is trying to determine
      whether erythropoietin alters the clotting action of platelets in patients receiving
      anti-platelet medicines. It is important to understand the effects of erythropoietin on
      platelets since preliminary studies in animals suggest that erythropoietin may protect the
      heart from damage during a heart attack.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21-75 years

          -  Clinical evidence of acute myocardial infarction (MI) with total or sub-total
             occlusion on angiogram

          -  Status post percutaneous revascularization procedure for acute MI with TIMI 3 flow

          -  Ongoing clinically-indicated treatment with aspirin, thienopyridines

        Exclusion Criteria:

          -  Hemodynamic instability/shock or severe congestive heart failure

          -  Time from onset of chest pain to revascularization procedure > 16 hours

          -  Use of intravenous thrombolytic agents for treatment of MI

          -  Known need for additional revascularization procedures
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: SP-304 0.3 mg; SP-304 1.0 mg; SP-304 3.0 mg; SP-304 9.0 mg; Placebo
Intervention description: SP-304 0.3 mg; SP-304 1.0 mg; SP-304 3.0 mg; SP-304 9.0 mg; Placebo
Intervention MeSH terms: Plecanatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic Idiopathic Constipation; Constipation; Irritable Bowel Syndrome

Summary:

      This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose
      ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD)
      effects of SP-304 in patients with chronic idiopathic constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is able to understand and willing to sign the Informed Consent Form (ICF) and
             capable of providing written authorization for use and disclosure of protected health
             information per requirements of 45 CFR 164.508 (Health Insurance Portability and
             Accountability Act [HIPAA]).

          -  Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of
             age (inclusive) at the time of first dose.

          -  Subject has a body mass index (BMI) between 18 and 35 kg/m2.

          -  Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for
             the past 3 months with symptom onset > 6 months prior to diagnosis.

        Exclusion Criteria:

          -  Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery
             stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the
             absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs
             during the 3 months prior to the Screening visit and during the 14 day pre-treatment
             period.

          -  Subjects who meet the Rome III criteria for IBS.

          -  Subject has failed to complete the pre-treatment bowel movement diary accurately and
             completely during the pre-treatment period prior to Day 1 dosing.
A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy
Condition: Small Fiber Neuropathy
MeSH terms: Small Fiber Neuropathy
Intervention: VX-150; Placebo
Intervention description: Participants received VX-150 1250 milligrams (mg) once daily (qd) orally for 6 weeks.; Participants received placebo matched to VX-150 for 6 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter
      study evaluating the efficacy of VX-150 for the treatment of pain caused by small fiber
      neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight >50 kg

          -  Diagnosis of small fiber neuropathy, as per European Federation Neurological Societies
             (EFNS)/American Academy of Neurology (AAN) guidelines, with pain for at least 3 months
             prior to screening

          -  Reduction below the 5th percentile of sex and age-adjusted normal values in epidermal
             nerve fiber density on punch skin biopsy at the distal site of the leg performed at
             screening

          -  Normal nerve conduction studies (NCS), including presence of sural response.

          -  Average NRS score between ≥4 and ≤9 reported in the daily diary on Days -7 through -1

        Exclusion Criteria:

          -  History in the past 10 years of malignancy except for squamous cell skin cancer, basal
             cell skin cancer, and Stage 0 cervical carcinoma in situ

          -  History of connective tissue disorders, sarcoidosis, Sjögren's syndrome, amyloidosis,
             Fabry's disease, celiac disease, lyme disease, autoimmune disorders

          -  A known or clinically suspected infection with human immunodeficiency virus or
             hepatitis B or C viruses

          -  Current clinically significant liver or kidney dysfunction

          -  Current uncontrolled thyroid dysfunction

          -  A diagnosis of diabetes, HbA1C ≥8% at screening

          -  History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)

          -  Concomitant severe pain conditions which may impair self-assessment of pain due to
             small fiber neuropathy

        Other protocol defined Inclusion/Exclusion criteria may apply.
Oral LAT8881 in Neuropathic Pain
Condition: Neuropathic Pain; Diabetic Peripheral Neuropathy (DPN); Post Herpetic Neuralgia (PHN)
MeSH terms: Neuralgia; Peripheral Nervous System Diseases; Neuralgia, Postherpetic
Intervention: LAT8881; Placebo
Intervention description: LAT8881 oral capsule; Placebo oral capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is the first study with LAT8881 in subjects with neuropathic pain. As such, it has been designed to evaluate, in a well-defined patient group, the concept that LAT8881 is safe and effective in this indication.
Subjects enrolled into this study have been diagnosed with Post Herpetic Neuralgia (PHN) or Diabetic Peripheral Neuropathy (DPN), both conditions being well accepted examples of neuropathic pain. Because the pain is chronic, without a period effect, and treatment is symptomatic rather than curative, a crossover study is considered appropriate. Studies with other agents have successfully demonstrated analgesic effects in PHN and DPN with a crossover study design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to
      investigate the efficacy and safety of oral LAT8881 in neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of post herpetic neuralgia, with pain persisting for at least 3
             months after the onset of herpes zoster rash OR

          2. Clinical diagnosis of distal painful polyneuropathy due to Type I or Type II diabetes
             mellitus with:

               1. symmetrical, bilateral pain in the lower extremities for at least 3 months and

               2. diabetes under control for at least 3 months prior to randomisation, as indicated
                  by a glycated haemoglobin level (HbA1c) of ≤ 11% (97 mmol/mol) and on a stable
                  dose of insulin or oral diabetic medication for 3 months prior to screening, and

               3. no change in diabetic medication planned for the duration of the study

          3. Positive sensory symptoms (mechanical or thermal) associated with neuropathic pain,
             confirmed by:

               1. painDETECT questionnaire (PD-Q) and

               2. Clinical assessment, showing signs of neuropathic pain in either a dermatomal
                  (PHN) or distal symmetrical distribution (DPN)

        8. An average daily pain score on the numeric pain rating scale (NPRS) of at least 4 and no
        more than 8 in the last five diary entries before randomisation

        Exclusion Criteria:

          1. Presence of moderate to severe pain from other causes that may confound assessment or
             self-evaluation of NP.

          2. Subjects with both DPN and PHN
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Condition: Anemia; Dialysis Dependent Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Vadadustat; Placebo
Intervention description: Daily oral dose; Daily oral dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Anemia; kidney; dialysis dependent chronic kidney disease; CKD; DD; renal; vadadustat; AKB-6548; hypoxia-inducible factor; Akebia (AKB); hypoxia-inducible factor (HIF); HIF; prolyl-hydroxylase inhibitor (PHI); PHI; Japan; Japanese

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess
      the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally
      administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent
      Chronic Kidney Disease (DD-CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female Japanese participants ≥20 years of age

          -  Receiving chronic maintenance hemodialysis for end-stage kidney disease

          -  Hemoglobin (Hb) <10.0 grams per deciliter (g/dL)

        Exclusion Criteria:

          -  Anemia due to a cause other than chronic kidney disease (CKD) or presence of active
             bleeding or recent blood loss

          -  Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic
             malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia

          -  Red blood cell transfusion within 4 weeks prior to or during screening

          -  Anticipated to recover adequate kidney function to no longer require hemodialysis
             during study participation