bioihbjkbjnl/mcl2 huggingface dataset:
Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer
Condition: Carcinoma, Non Small Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Docetaxel; Suramin; Docetaxel
Intervention description: IV over 60 minutes, 75 mg/m2; IV over 30 minutes; IV over 60 minutes. 56 mg/m2
Intervention MeSH terms: Suramin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carcinoma, non small cell lung; Second line; Third line

Summary:

      The overall purpose of the study is to determine whether or not the inclusion of suramin to
      standard treatment with docetaxel improves progression-free survival for patients with
      advanced non-small cell lung cancer in the second and third line settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically proven diagnosis of non-small cell lung cancer

          -  Documented disease progression after first-line chemotherapy for non-small cell lung
             cancer

          -  Stable and treated CNS metastasis is allowed

          -  Radiation must be completed at least 2 weeks prior to starting protocol treatment

          -  Major surgery must be completed at least 4 weeks prior to starting protocol treatment

          -  ECOG performance status 0-2

          -  Sexually active patients must use adequate contraception

          -  Adequate bone marrow function

          -  Adequate renal function

          -  Adequate liver function

        Exclusion Criteria:

          -  Severe hypersensitivity reaction to docetaxel

          -  Pre-existing grade 3 or 4 neuropathy

          -  Women who are pregnant or breastfeeding

          -  Uncontrolled intercurrent illness

          -  Receipt of 3 or more prior chemotherapy regimens
Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Grazoprevir/Elbasvir FDC; Sofosbuvir
Intervention description: FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.; Sofosbuvir 400mg tablet taken q.d. by mouth.
Intervention MeSH terms: Sofosbuvir; Grazoprevir; Elbasvir-grazoprevir drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in
      treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The
      objective is to determine the proportion of participants achieving sustained virologic
      response 12 weeks after ending study treatment (SVR12).
    

Eligibility criteria:

        Inclusion Criteria:

          -  has HCV RNA ≥10,000 IU/mL in peripheral blood at the time of screening

          -  has documented chronic HCV GT1 or GT3 infection

          -  has either negative or positive history of liver cirrhosis based on liver biopsy,
             Fibroscan, or FibroSure ® (Fibrotest®)

          -  is treatment naïve to all anti-HCV treatment

        Exclusion Criteria:

          -  has evidence of decompensated liver disease

          -  is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or
             human immunodeficiency virus

          -  has a history of malignancy ≤5 years prior to signing informed consent, or is under
             evaluation for other active or suspected malignancy

          -  has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of
             hepatocellular carcinoma (HCC) or is under evaluation for HCC

          -  has clinically-relevant drug or alcohol abuse within 12 months of screening

          -  has any of the following conditions: organ transplants other than cornea and hair,
             poor venous access that precludes routine peripheral blood sampling, history of
             gastric surgery or malabsorption disorders, or any medical condition requiring, or
             likely to require, chronic systemic administration of corticosteroids during the
             course of the trial

          -  has a history of chronic hepatitis not caused by HCV
Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer; Stage 3 Cancer; Stage 4 Cancer
MeSH terms: Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms
Intervention: Bevacizumab; Carboplatin; Paclitaxel
Intervention description: cycle 2 (6 cycles re-evaluated and follow up); cycle #1 and continuous through entire regimen; treated every 3 weeks; cycle #1 and continuous through entire regimen; treated every 3 weeks
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: No
Keywords: ovarian cancer; fallopian tube cancer; peritoneal cancer

Summary:

      The primary objective is to determine whether the addition of bevacizumab to a regimen of
      carboplatin plus paclitaxel significantly improves Progression Free Survival (PFS) for
      patient with Stage III suboptimally cytoreduced or Stage IV ovarian, primary peritoneal or
      fallopian tube carcinomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of primary peritoneal carcinoma, fallopian tube epithelial ovarian
             carcinoma,

          -  stage III suboptimal surgery or biopsy,

          -  stage IV disease

          -  no prior chemotherapy

        Exclusion Criteria:

          -  unstable heart conditions

          -  high blood pressure

          -  vascular disorders

          -  bleeding problems
BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: risankizumab; placebo for risankizumab
Intervention description: Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection; Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 182.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: BI 655066; ABBV-066; risankizumab

Summary:

      This is a randomized double blind, double dummy, placebo controlled, parallel design study
      that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for
             at least 6 months before the first administration of study drug. Duration of diagnosis
             may be reported by the patient.

          -  Have stable moderate to severe chronic plaque psoriasis with or without psoriatic
             arthritis at both Screening and Baseline (Randomisation):

               1. Have an involved body surface area (BSA) ≥10% and

               2. Have a Psoriasis Area and Severity Index (PASI) score ≥12 and

               3. Have a Static Physician Global Assessment (sPGA) score of ≥3.

        Exclusion Criteria:

          -  Patients with

               1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)

               2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta
                  blockers, calcium channel blockers, or lithium)

               3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis
                  that might confound trial evaluations according to investigator's judgment

          -  Previous exposure to BI 655066
Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Spesolimab (low dose); Placebo; Spesolimab (high dose)
Intervention description: 12 weeks treatment; 12 weeks treatment; 12 weeks treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in
      patients with PPP following multiple intravenous administrations compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, 18 to 65 years of age at screening.

          -  Palmoplantar Pustulosis

          -  Further inclusion criteria apply

        Exclusion Criteria:

          -  Presence or known history of anti- Tumor necrosis factor (TNF)-induced Palmoplantar
             Pustulosis (PPP)-like disease.

          -  Active or latent tuberculosis

          -  Further exclusion criteria apply
An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine
Condition: Chronic Hepatitis C Infection; Chronic Hepatitis C
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267; ABT-333; Ribavirin (RBV)
Intervention description: Tablet; ABT-450 coformulated with ritonavir and ABT-267; Tablet; Tablet
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HCV Genotype 1; Hepatitis Genotype 1; Interferon Free; methadone; HCV; Buprenorphine; Hepatitis C; Viekira Pak; paritaprevir; Viekira; ombitasvir; dasabuvir

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267
      (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and
      ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus
      (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be practicing specific forms of birth control on study treatment, or be
             postmenopausal for more than 2 years or surgically sterile.

          -  Chronic HCV infection prior to study enrollment.

          -  Screening laboratory result indicating HCV genotype 1-infection.

          -  Subject must be treatment naive or previous pegylated interferon/ribavirin treatment
             experienced.

          -  Subjects must be on a stable opioid replacement therapy of methadone or buprenorphine
             ± naloxone for at least 6 months prior to screening.

        Exclusion Criteria:

          -  Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human
             Immunodeficiency virus antibody (HIV Ab) at screening.

          -  Prior therapy with direct acting antiviral agents for the treatment of HCV, including
             telaprevir and boceprevir.

          -  Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose
             partners are pregnant or planning to become pregnant within 7 months (or per local RBV
             label) after their last dose of study drug.

          -  Any current or past clinical evidence of cirrhosis such as ascites or esophageal
             varices, or prior biopsy showing cirrhosis, e.g., a Metavir Score of >3 or Ishak score
             of > 4.
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Fluoxetine
Intervention description: Total dose How to take:
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-6 40 mg BID Week 7-12 40mg BID
Intervention MeSH terms: Fluoxetine
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: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; Pulmonary Hypertension

Summary:

      This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for
      three months among patients with pulmonary arterial hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent prior to any study-mandated procedure

          2. PAH of the following subtypes: idiopathic PAH WHO functional class II-III

          3. Catheterization within one week showing mPAP >=25, wedge or LV end diastolic pressure
             ≤15, and PVR > 4 wood units, and baseline fick cardiac output results available

          4. Age 16-75

          5. Able to complete a six minute walk distance

          6. Women of childbearing potential*: negative serum pre-treatment pregnancy test +
             consistently and correctly uses a reliable method of contraception** Oral approved PAH
             therapy for >3 months with no change in dose for > 1 month

        Exclusion Criteria:

          1. PAH with connective tissue disease, congenital heart disease, portal hypertension,
             glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia,
             hemoglobinopathy, myeloproliferative disorders.

          2. Moderate to severe obstructive or restrictive lung disease: forced expiratory volume
             in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 60% of predicted value
             after bronchodilator administration. -or- total lung capacity (TLC) < 60% of
             predicted.

          3. Systemic systolic blood pressure <100 mmHg Breastfeeding

          4. Significant liver, renal or other medical disease preventing completion of the study
             procedures or with life expectancy <12 months, or any other acute or chronic physical
             impairment (other than dyspnea), limiting the ability to comply with study
             requirements
A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Naproxen Sodium (Aleve, BAY117031); Acetaminophen ER; Celecoxib; Placebo
Intervention description: 660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A); 3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B); 200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C); Over-encapsulation capsule, 4 days, oral (Treatment D)
Intervention MeSH terms: Acetaminophen; Celecoxib; Naproxen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder that
      frequently affects several joints such as knee, hip, spine and hands.This placebo-controlled
      clinical trial assessed the effects of naproxen sodium, acetaminophen and celecoxib on
      stiffness in subjects with osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 40 and 80 years

          -  Body Mass Index (BMI) between 18 and <40 kg/m^2

          -  Unilateral or bilateral osteoarthritis of the knee

          -  Diagnostic quality radiography of the target knee performed no more than 1 year prior
             to baseline showing evidence of osteoarthritis (OA) with Kellgren and Lawrence grade
             of II or III

          -  Joint Stiffness Severity score ≥3.0 on a 0-10 numerical rating scale (NRS) at
             screening

        Exclusion Criteria:

          -  History of underlying inflammatory arthropathy, rheumatoid arthritis or fibromyalgia

          -  History of or scheduled for target knee replacement surgery

          -  Recent injury in target knee (past 4 months)
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Intervention: AZD2423; AZD2423; Placebo
Intervention description: 20 mg tablet; 150 mg tablet; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Analgesic effect

Summary:

      A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days
      treatment in patients with painful diabetic polyneuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed informed consent form

          -  Males and female of non-child bearing potential patients aged 18 to 80 years

          -  Patients with neuropathic pain due to painful diabetic polyneuropathy.

        Exclusion Criteria:

          -  Other pain that may confound assessment of neuropathic pain

          -  History of treatment failure with more than three adequate trials of medication for
             neuropathic pain

          -  Central neuropathic pain conditions (caused by Central Nervous System injury/disease,
             eg. Stroke)
Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension
Condition: Hypertension; Ankle Edema
MeSH terms: Hypertension
Intervention: Aliskiren/amlodipine; Amlodipine; Placebo to Aliskiren/amlodipine; Placebo to Amlodipine
Intervention description: Aliskiren/amlodipine 150/5 mg/day; Amlodipine 5 mg/day.; Placebo to Aliskiren/amlodipine 150/10 mg/day; Placebo to Amlodipine 5 mg/day
Intervention MeSH terms: Amlodipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pedal edema; hypertension; aliskiren; amlodipine

Summary:

      The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can
      attenuate ankle edema formation in hypertensive patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients (male or female) with hypertension aged between 18-75 yrs.

          -  Patients not treated with amlodipine or no amlodipine in previous 1 year.

          -  Post-menopausal females

        Exclusion Criteria:

          -  Patients unable to switch from prior hypertensive medication.

          -  Severe hypertension.

          -  Pregnant or nursing females.

          -  Patients with Type 1 or Type 2 diabetes mellitus

          -  History of immunodeficiency diseases, including a positive Human immunodeficiency
             virus (HIV) (Enzyme-linked immunosorbent assay [ELISA] and Western blot) test result.

          -  A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

        Other protocol-defined inclusion/exclusion criteria are applied
Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors
Condition: Stomach Neoplasms; Esophageal Neoplasms
MeSH terms: Neoplasms; Stomach Neoplasms; Esophageal Neoplasms
Intervention: 5-fluorouracil; Oxaliplatin; Leucovorin
Intervention MeSH terms: Leucovorin; Tetrahydrofolates; Formyltetrahydrofolates; Fluorouracil; Oxaliplatin; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase II; Gastric cancer; Gastroesophageal cancer; Metastatic; FOLFOX; Thymidylate synthase; Pharmacogenomic

Summary:

      This study is for patients who have stomach cancer or cancer of the lower part of the
      esophagus that has spread to other organs. There are many different chemotherapy treatments
      for this type of cancer. At the present time, there is no general agreement on the way to
      choose the most beneficial therapy for an individual patient. Patients with different genetic
      backgrounds may respond differently to the same chemotherapy treatments. In this study the
      investigators will use a certain genetic difference in an important gene (thymidylate
      synthase or TS gene) to see whether treating patients who have a particular type of that gene
      will respond better to a standard chemotherapy regimen. The investigators are hoping that by
      treating patients according to their genes, that they may respond to treatment of their
      cancer better and it will help the investigators choose cancer treatments better in the
      future.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed adenocarcinoma of the
             stomach or gastroesophageal junction.

          -  Patients must have measurable disease.

          -  No prior therapy for metastatic disease. Prior neo-adjuvant or adjuvant therapy is
             permitted if the disease free interval has been longer than 6 months.

          -  Age ≥18 years.

          -  Life expectancy of greater than 3 months.

          -  ECOG (Eastern Cooperative Oncology Group) performance status greater than 2 (Karnofsky
             greater than 60%).

          -  Patients must have normal organ and marrow function.

          -  Not pregnant. Not breast feeding.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Patients may not be receiving any other chemotherapy agents.

          -  Patients with known active brain metastases. Patients with treated brain metastases
             are permitted if stable off steroids for at least 30 days.

          -  History of allergic reactions to 5-FU or oxaliplatin.

          -  Uncontrolled intercurrent illness.

          -  Patients with immune deficiency.