bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
Condition: Non-Small-Cell Lung Carcinoma NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: MEDI4736 (Durvalumab); MEDI4736 (Durvalumab)+Tremelimumab; Paclitaxel + Carboplatin; Gemcitabine + Cisplatin; Gemcitabine + Carboplatin; Pemetrexed + Cisplatin; Pemetrexed + Carboplatin; Tremelimumab
Intervention description: Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agents
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Gemcitabine; Pemetrexed; Durvalumab; Tremelimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1118.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: NSCLC, PD-L1, MEDI4736, Tremelimumab, PFS, OS

Summary:

      This is a randomized, open-label, multi-center, global, Phase III study to determine the
      efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy
      versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal
      growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced
      or metastatic NSCLC
    

Eligibility criteria:

        Inclusion Criteria:

        For inclusion in the study, patients should fulfill the following criteria:

          -  Aged at least 18 years

          -  Documented evidence of Stage IV NSCLC

          -  No sensitizing EGFR mutation or ALK rearrangement

          -  No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC

          -  World Health Organization (WHO) Performance Status of 0 or 1

        Exclusion Criteria:

        Patients should not enter the study if any of the following exclusion criteria are
        fulfilled:

          1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant

          2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable
             (not requiring steroids)

          3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other
             anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1
             (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies,
             excluding therapeutic anticancer vaccines

          4. Active or prior documented autoimmune or inflammatory disorders (including
             inflammatory bowel disease [eg, colitis or Crohn's disease]
Pregabalin Trial In HIV Neuropathic Pain
Condition: HIV-1 Infection; Neuropathic Pain
MeSH terms: Neuralgia
Intervention: pregabalin (Lyrica)
Intervention description: 150 mg-600 mg/day (twice daily)
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: peripheral neuropathic pain; pregabalin; safety

Summary:

      This study examines the safety of pregabalin over a 6 month period in patients with
      neuropathic pain associated with HIV infection as an extension of another trial that tests
      the efficacy of pregabalin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who participated in the preceding A0081244 double-blind trial and completed
             at least through Visit 9 of that trial.

        Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on
        investigator's clinical judgment.

        Subjects who had acceptable tolerability of study drug in A0081244.

        Exclusion Criteria:

          -  Clinically significant or unstable conditions that, in the opinion of the
             investigator, would compromise participation in the study. This includes, for example,
             medical conditions such as, but not limited to: hepatic, renal, respiratory,
             hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or
             rheumatologic disease, active infections, symptomatic peripheral vascular disease,
             psychiatric illness, and untreated endocrine disorders.

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the subject
             inappropriate for entry into this study.

          -  Active Acquired Immune Deficiency Syndrome (AIDS)- defining Opportunistic Infection
             (OI) that requires hospitalization.
A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: TVP-1012 1mg
Intervention description: TVP-1012 1mg Tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in
      Japanese participants with early Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has completed the preceding study.

          -  The participant has shown no safety issues during the study treatment in the preceding
             study, in the opinion of the investigator or subinvestigator.

        Exclusion Criteria:

          -  The participant has undergone blood collection of >= 400 mL within 90 days prior to
             the start of treatment in this study.

          -  The participant is required to take any of the excluded medications or treatments.

          -  The participant is required surgery or hospitalization for surgery during the study
             period.
Phase III Cat-PAD Follow-on Study
Condition: Cat Allergy
Intervention: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]; Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]; Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 430.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in
      cat allergic subjects for up to five years after the start of administration of treatment.
      The study is an optional follow-up study to a phase III double-blind, placebo controlled,
      Cat-PAD study; no further investigational product is administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  previously completed clinical study CP007 [NCT01620762]

        Exclusion Criteria:

          -  started allergen therapy since completing CP007

          -  Institutionalised due to a legal or regulatory order
Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Metformin XR; Dapagliflozin; Placebo matching with Dapagliflozin; Placebo matching with Saxagliptin
Intervention description: Tablets, Oral, 5mg , Once daily, 24 weeks; Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks; Tablets, Oral, 10mg , Once daily, 24 weeks; Tablets, Oral, 0mg, Once daily, 24 weeks; Tablets, Oral, 0mg, Once daily, 24 weeks
Intervention MeSH terms: Metformin; Dapagliflozin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS
      -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin
      (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of
      this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%

          -  Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening

          -  Body mass index (BMI) ≤ 45.0kg/m2

        Exclusion Criteria:

          -  Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine
             (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females

          -  Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic
             Blood Pressure (DBP) ≥ 100mmHg

          -  Hepatic disease

          -  Cardiovascular disease within 3 months
Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome
Condition: Marfan Syndrome
MeSH terms: Marfan Syndrome; Arachnodactyly; Syndrome
Intervention: Atenolol; Losartan
Intervention description: Atenolol 50mg PO QD; Losartan 100mg PO QD
Intervention MeSH terms: Losartan; Atenolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: Marfan syndrome; Losartan; Atenolol; Diastolic Function; Aortic Stiffness

Summary:

      Marfan syndrome is an inherited connective tissue disorder with morbidity and mortality from
      aortic dilation and dissection. The degree of aortic dilation and response to beta-blockade
      (standard of care) vary in adults with Marfan syndrome. However, aortic stiffness is often
      present, and can be a predictor of aortic dilation and cardiovascular complications. In
      addition, adults with Marfan syndrome develop left ventricular diastolic dysfunction, which
      can progress to heart failure. Aortic stiffness and diastolic dysfunction are important and
      logical therapeutic targets in adults with Marfan syndrome.

      TGF-beta mediates disease pathogenesis in Marfan syndrome and contributes to aortic
      stiffness. The angiotensin receptor blocker, losartan, inhibits TGF-beta activity and
      reverses aortic wall pathology in a Marfan mouse model. Losartan also decreases aortic
      stiffness and improves diastolic function in hypertension, renal disease and hypertrophic
      cardiomyopathy.

      This trial is a randomized, double-blind trial of 50 adults with Marfan syndrome, treated
      with 6 months of atenolol vs. losartan. Arterial tonometry for aortic stiffness and
      echocardiography for diastolic function will be performed at the beginning and end of
      treatment. A blood draw for serum markers of extracellular matrix turnover and inflammation
      will also be performed at 0 and 6 months. We plan to determine whether losartan decreases
      aortic stiffness and left ventricular diastolic dysfunction significantly more than atenolol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 25 years

          -  Clinical Marfan Syndrome

        Exclusion Criteria:

          -  Previous aortic or cardiac surgery

          -  Pregnancy

          -  Renal Insufficiency

          -  Medication intolerance
Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Formoterol (OT)
Intervention description: 9 μg/dose, Inhaled, twice daily for 52 weeks
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; COPD; Japanese; Phase 3; Safety; OT; Oxis

Summary:

      This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one
      inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be
      the group to refer to when safety results of formoterol arm will be evaluated. 240 patients
      with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120
      patients on standard COPD therapy).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients, men or women ≥ 40 years

          -  A clinical diagnosis of COPD according to guidelines, and current COPD symptoms.

          -  Post-bronchodilator FEV1 < 80% of predicted normal value and FEV1/FVC < 70%,
             post-bronchodilator

        Exclusion Criteria:

          -  A history and/or current clinical diagnosis of asthma and atopic diseases such as
             Allergic rhinitis

          -  Patients who have experienced COPD exacerbation requiring at least one of the
             following treatment, hospitalisation and/or a course of systemic steroid within 4
             weeks prior to the study start.

          -  Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart
             failure, uncontrolled hypertension as defined by the investigator, or any other
             relevant cardiovascular disorder as judged by the investigator
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
Condition: Non Small Cell Lung Carcinoma NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Durvalumab +Tremelimumab; Paclitaxel + carboplatin; Gemcitabine + cisplatin; Gemcitabine + carboplatin; Pemetrexed + cisplatin; Pemetrexed + carboplatin
Intervention description: Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agent; Chemotherapy Agent
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Gemcitabine; Pemetrexed; Durvalumab; Tremelimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 953.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: NSCLC; PDL1; TMB; MEDI4736; Durvalumab; Tremelimumab; OS

Summary:

      This is a randomized, open-label, multi-center, global, Phase III study to determine the
      efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based
      SoC chemotherapy in the first-line treatment of patients with epidermal growth factor
      receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

        For inclusion in the study, patients should fulfill the following criteria:

          -  Aged at least 18 years

          -  Documented evidence of Stage IV NSCLC

          -  No activating EGFR mutation or ALK rearrangement

          -  No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC

          -  World Health Organization (WHO) Performance Status of 0 or 1

          -  No Prior exposure to Immune Mediated Therapy (IMT), including, but not limited to,
             other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, excluding therapeutic
             anticancer vaccines

        Exclusion Criteria:

        Patients should not enter the study if any of the following exclusion criteria are
        fulfilled:

          -  Mixed small cell lung cancer and NSCLC histology, sarcomatoid variant

          -  Brain metastases or spinal cord compression unless the patient is stable
             (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for
             at least 14 days prior to start of study treatment.

          -  Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's
             disease, ulcerative colitis)
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
Condition: Opioid-induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: Naldemedine; Placebo
Intervention description: Naldemedine 0.2 mg tablet taken orally once a day; Placebo tablet taken orally once a day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 553.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Opioid-induced Constipation

Summary:

      The purpose of this study is to evaluate the efficacy and safety of naldemedine in the
      treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who
      are not using laxatives.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18 to 80 years inclusive at the time of informed consent

          -  Subjects must have non-malignant chronic pain treated with opioids and must have
             opioid-induced constipation (OIC)

          -  Subjects must be treated with a stable opioid regimen at a total daily dose on average
             of ≥ 30 mg equivalents of oral morphine sulfate

          -  Subjects must not be currently using laxatives or must be willing to discontinue
             laxative use at Screening and must be willing to use only the rescue laxatives
             provided throughout the study duration

          -  Subjects must meet opioid-induced constipation criteria based on the Bowel Movement
             and Constipation Assessment (BMCA) Diary

        Exclusion Criteria:

          -  Evidence of significant structural abnormalities of the gastrointestinal (GI) tract

          -  Evidence of active medical diseases affecting bowel transit

          -  History or presence of pelvic disorders that may be a cause of constipation

          -  Surgery (except for minor procedures) within 60 days of Screening

          -  History of chronic constipation prior to starting analgesic medication or any
             potential non-opioid cause of bowel dysfunction that may be a major contributor to the
             constipation (e.g., mechanical GI obstruction)

          -  Subjects who have never taken laxatives for the treatment of OIC

          -  History of active treatment for cancer within the last 2 years (except for basal cell
             or squamous cell carcinoma of the skin that have been successfully resected) or
             tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of
             breast cancer

          -  Current use of any prohibited medication including opioid antagonists, partial
             agonists, or mixed agonists/antagonists
Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: AbobotulinumtoxinA; Placebo
Intervention description: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA; Treatment of glabellar facial lines with placebo
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An interventional phase 3 study to evaluate efficacy and safety of a new dilution and
      injection volume of AbobotulinumtoxinA treatment for glabellar lines
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe glabellar lines at maximum frown

          -  Understands the study requirements and signs an informed consent form

        Exclusion Criteria:

          -  Botulinum toxin treatment in the face within 6 months prior to study treatment