bioihbjkbjnl/mcl2 huggingface dataset:
Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET
Condition: Gastroenteropancreatic Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Intervention: Lanreotide Autogel 120 mg; Temozolomide (TMZ)
Intervention description: Lanreotide Autogel 120 mg subcutaneous (s.c) - injection, every 28 days (+/-2 days).; Temozolomide capsule (variable dose). 150 mg/m2 per day for 5 days in the first month. 200 mg/m2 per day for 5 days in months 2, 3, 4, 5 and 6.
Intervention MeSH terms: Temozolomide; Lanreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the efficacy and tolerability of the combination of
      Lanreotide Autogel 120 mg and Temozolomide in patients with progressive
      gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All
      progressive tumours classified according to Response Evaluation Criteria In Solid Tumours
      (RECIST, 1.1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study related procedures

          -  Inoperable, Gastro-Entero-Pancreatic-Neuroendocrine Tumour G1 or G2 (Proliferation
             Index, Ki67-Index: 0 to ≤20%) confirmed by pathological/histological assessment

          -  Progressive disease within 12 months before inclusion (RECIST 1.1: increase of >20%
             tumour load; by Computer Tomography (CT) or Magnetic Resonance Imaging (MRI)

          -  Measurable disease according to RECIST 1.1.

          -  Metastatic disease confirmed by CT/MRI.

          -  Functioning or non-functioning NET (G1, G2).

          -  Positive Octreo-Scan (≥ Grade 2 Krenning scale) or positive DOTA
             (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid)-TATE (Tyr3-Thre8-Octreotide
             or DOTA-Tyr3-octreotate)/TOC (Tyr3-octreotide) -PET (Positron-Emission-Tomography) -CT
             within 12 months prior to screening

        Exclusion Criteria:

          -  Has the diagnosis of Insulinoma

          -  Has a diagnosis of a multiple endocrine neoplasia (MEN)
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: MEDI8968 600 mg IV, 300 mg SC; Placebo
Intervention description: MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.; Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 464.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD); MEDI8968

Summary:

      The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or
      severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult
      subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic
      Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the
      underlying disease condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 45 through 75 years

          -  Predicted (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II,
             III, and IV) at Screening

          -  History of previous acute exacerbations of chronic obstructive pulmonary disease
             (AECOPD) 12 months prior to Screening

          -  Clinically stable and free from an AECOPD for 8 weeks prior to Day 1

          -  Current smoker or ex-smoker with a tobacco history of more than or equal to (>=) 10
             pack-years.

        Exclusion Criteria:

          -  Past or present disease or disorder,

          -  Significant or unstable ischemic heart disease etc

          -  Known history of allergy or reaction to any component of the investigational
             manufacturing product (IMP)

          -  Past or current malignancy within the past 5 years

          -  Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of
             malignancy or tuberculosis (TB).

          -  Use of immunosuppressive medication receipt of any biologic agent.
Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Directly Observed Therapy
Intervention description: Use of a patient nominated peer supporter who will observe the morning dose of ARVs
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Directly Observed Therapy; DOT

Summary:

      Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These
      drug regimens must be closely followed in order to be successful. Having a support person
      watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her
      regimen. This study will see if patient-chosen treatment supporters help patients take HIV
      medicines correctly and improve their health.

      Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly
      higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm
      as compared to the self-administered arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infected

          -  Viral load greater than 1000 copies/ml

          -  CD4 count of 200 cells/mm3 or less, or World Health Organization Stage 4 disease

          -  Living in the area of the study site

          -  Had a known address for more than 3 months

          -  Willing to nominate a treatment supervisor (a close family member, sexual partner,
             friend, or community volunteer) to observe daily ingestion of tablets

          -  Willing to disclose HIV status to a treatment supervisor and ready to commit to
             long-term antiretroviral therapy

          -  Acceptable methods of contraception

        Exclusion Criteria:

          -  Pregnant
A Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy
Condition: Moderate to Severe Pain Due to Diabetic Polyneuropathy
MeSH terms: Polyneuropathies; Diabetic Neuropathies
Intervention: Oxycodone Naloxone; Placebo tablets
Intervention description: Oxycodone Naloxone tablets; Placebo Oxycodone Naloxone tablets
Intervention MeSH terms: Oxycodone; Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of
      pregabalin compared to pregabalin alone.
    

Eligibility criteria:

        Inclusion criteria:

          -  Moderate to severe pain due diabetic polyneuropathy

          -  Opioid-naive subjects

        Exclusion criteria:

          -  Females who are pregnant or lactating

          -  Subjects with evidence of significant structural abnormalities of the gastrointestinal
             tract

          -  Subjects with evidence of impaired liver/kidney function upon entry into the study
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
Condition: Breast Cancer; Head and Neck Squamous Cell Carcinoma; Colorectal Cancer; Prostate Cancer; Ovarian Cancer; Urothelial Carcinoma; Non-small Cell Lung Cancer
MeSH terms: Carcinoma; Squamous Cell Carcinoma of Head and Neck
Intervention: ONM-100
Intervention description: A polymer micelle covalently conjugated to indocyanine green.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of
      ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients
      with solid tumors undergoing routine surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled
             to undergo surgical resection

          -  Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or
             breast cancer

          -  Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer,
             prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.

          -  Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers

        Exclusion Criteria:

          -  Histologically diagnosed by an excisional biopsy procedure

          -  Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging
             would not be feasible

          -  Life expectancy <12 weeks

          -  Hepatic impairment (Child-Pugh score >5) or significant liver disease including active
             hepatitis or cirrhosis
AZD2066 Neuropathic Pain - Mechanical Hypersensitivity
Condition: Neuropathic Pain; Mechanical Hypersensitivity
MeSH terms: Neuralgia; Hypersensitivity
Intervention: AZD2066; Placebo
Intervention description: Capsule, once daily; Capsule, once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pain, Mechanical Hypersensitivity; Allodynia; Efficacy; analgesia; Neuropathic

Summary:

      The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to
      placebo can relieve the pain arising from the nervous system when the patients are touched by
      something that should not cause pain or have severe pain when they are touched by something
      that should only cause a little pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures.

          -  Male or non-fertile females

          -  Painful symptoms due to neuropathic pain for a period of 3 months to 5 years,
             associated with mechanical allodynia and/or punctate hyperalgesia.

        Exclusion Criteria:

          -  Other pain that may confound assessment of neuropathic pain.

          -  Diagnosis of any severe neurological disease.

          -  History of significant psychiatric disease/condition and/or history of psychotic
             disorders among first degree relatives.
A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma
Condition: Osteosarcoma; Malignant Fibrous Histiocytoma (MFH) of Bone
MeSH terms: Osteosarcoma; Histiocytoma; Histiocytoma, Benign Fibrous; Histiocytoma, Malignant Fibrous
Intervention: Bevacizumab; Cisplatin; Doxorubicin; Methotrexate; Ifosfamide; etoposide; Surgery; Radiotherapy
Intervention description: Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV).; Given IV.; Given IV.; Given IV.; Given IV.; Given IV.; Participants undergo definitive surgery and assessment of histologic response at week 10.; Radiation therapy delivered for positive margins or intralesional resections.
Intervention MeSH terms: Bevacizumab; Doxorubicin; Methotrexate; Etoposide; Ifosfamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This study adopts a novel strategy for first-line treatment of osteosarcoma by combining
      chemotherapy with anti-angiogenic therapy using bevacizumab (Avastin®), a humanized
      monoclonal antibody against vascular endothelial growth factor (VEGF). Chemotherapy for
      localized disease comprises a 3-drug regimen (cisplatin, doxorubicin, and high-dose
      methotrexate). Chemotherapy for metastatic or unresectable disease comprises a
      cisplatin-based regimen that includes high-dose methotrexate, doxorubicin, ifosfamide, and
      etoposide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have newly diagnosed high-grade, biopsy proven, osteosarcoma or malignant
             fibrous histiocytoma (MFH) of bone with no history of prior chemotherapy or radiation;

          -  Participant is able to perform tasks and daily activities as defined in the study
             guidelines

          -  Patient meets established guidelines for adequate function of the kidney, liver, heart
             and bone marrow

          -  Participants meets other requirements defined in the eligibility portion of the study

        Exclusion Criteria:

          -  recent major surgical procedure or injury

          -  Known bleeding diathesis, platelet disorder or coagulopathy

          -  Thrombosis

          -  Cardiac disease or hypertension

          -  Significant proteinuria

          -  Central nervous system disease

          -  Gastrointestinal perforation/abdominal fistula

          -  Osteosarcoma or MFH of bone as second malignancy
Phase II Study of HMPL-004 in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: HMPL-004 low dose; Placebo; HMPL-004 high dose
Intervention description: HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).; Matching dose of Placebo; HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with
      active mild to moderate ulcerative colitis (UC), compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have active confirmed mild to moderate ulcerative colitis

        Exclusion Criteria:

          -  Diagnosed with Crohn's Disease or
A Phase I / II Trial of Nintedanib in Asian Hepatocellular Carcinoma Patients
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Sorafenib; BIBF 1120
Intervention description: 400 mg twice daily; Twice daily
Intervention MeSH terms: Sorafenib; Nintedanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver
      cancer patients
    

Eligibility criteria:

        Inclusion criteria:

          1. Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically
             diagnosed, which is not amenable to curative surgery or loco-regional therapy

          2. Age 18 years or older

          3. Eastern Cooperative Group performance score of 2 or less

          4. Child-Pugh score of 7 or less

          5. Written informed consent in accordance with International Conference on Harmonisation
             (ICH) and Good Clinical Practice (GCP) and local legislation

        Exclusion criteria:

          1. Prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase
             II)

          2. More than one line of prior systemic therapy for metastatic/unresectable
             hepatocellular carcinoma (for phase I)

          3. Uncontrolled or refractory ascites to adequate medical therapy

          4. Bilirubin greater than 1.5 times upper limit of normal

          5. Aspartate amino transferase or alanine amino transferase greater than 5 times upper
             limit of normal

          6. Absolute neutrophil count less than 1500/microliter

          7. Platelet count less than 75000/microliter

          8. Hemoglobin less than 9 g/dL

          9. Serum creatinine greater than 1.5 times upper limit of normal
Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Palifermin; Palifermin placebo
Intervention description: Keratinocyte growth factor administered via injection; Keratinocyte growth factor placebo administered via injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Experienced

Summary:

      Palifermin is a modified version of a naturally occurring human growth factor that is
      currently approved by the FDA to treat blood cancers. The purpose of this study is to
      determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected
      adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infected

          -  Receiving potent ART, defined as a combination of three or more antiretroviral drugs
             for at least 6 months prior to study entry

          -  CD4 count of 200 cells/mm3 or less within 30 days prior to study entry

          -  Documented CD4 count obtained at study screening

          -  Documented current, persistent viral load less than or equal to 200 copies/ml for at
             least 6 months prior to study entry

          -  Willing to use acceptable forms of contraception for the duration of the study

        Exclusion Criteria:

          -  Active pancreatitis

          -  Androgens, Immunomodulators (e.g., growth factors, systemic corticosteroids, HIV
             vaccines, immune globulin, interleukins, interferons), or investigational ART within
             30 days prior to study entry

          -  Systemic cancer chemotherapy within 30 days prior to study entry, or history of
             radiation therapy to the neck and chest regions at any time.

          -  Allergy or sensitivity to any component of palifermin

          -  Prior treatment with palifermin or other keratinocyte growth factors

          -  Current drug or alcohol use that, in the opinion of the investigator, may interfere
             with study participation

          -  Serious illness or recent surgery that requires systemic treatment or hospitalization.
             Participants who have completed therapy or are clinically stable on therapy for at
             least 30 days prior to study entry are not excluded.

          -  Active cancer

          -  HIV-1 RNA levels >200 copies/mL within 6 months prior to study entry

          -  Pregnant or breastfeeding
Use of Celecoxib in Patients With Intraductal Papillary Mucinous Neoplasms (IPMNs)
Condition: Pancreas Neoplasms
MeSH terms: Neoplasms; Pancreatic Neoplasms
Intervention: COX-2 Inhibitor 6-8 weeks prior to surgery; COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP
Intervention description: 400 mg BID 6-8 weeks prior to surgery; 400 mg BID for 6 months prior to follow-up EUS or ERCP
Intervention MeSH terms: Celecoxib; Cyclooxygenase 2 Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: celecoxib for pancreas lesions

Summary:

      The purpose of the study is to find out whether the drug celecoxib has beneficial effects on
      people with pre-cancerous lesions of the pancreas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of IPMN

          -  ECOG Performance status of 0, 1, or 2

          -  Adequate liver function, bilirubin < 1.5 times ULN, ALT or AST < 2.5 times ULN

          -  Adequate renal function: creatinine < 1.8

          -  Must be at least 18

        Exclusion Criteria:

          -  Use of COX-2 selective inhibitors within the last month

          -  More than occasional use of NSAIDS in last month (occasional use defined as up to
             twice weekly dosing)

          -  CA19-9 levels 1.5 times the ULN

          -  Active pancreatitis

          -  Taking sulphonylureas, fluconazole or lithium concomitantly
Ketamine In Thoracic Surgery (KITS) Trial
Condition: Lung Cancer
Intervention: Ketamine; 0.9% saline
Intervention description: Interventional; placebo
Intervention MeSH terms: Ketamine
Phase: Phase 2
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
Healthy volunteers: No
Keywords: Lobectomy; VATS

Summary:

      The primary aim of the study is to demonstrate a reduction in circulating interleukin 6
      levels at 4 and 24 hours after completion of lobectomy (either VATS or open). The null
      hypothesis (H0) is thus that there is no difference in circulating interleukin 6 levels when
      patients are given either ketamine or placebo (0.9% saline in equivalent volume). The
      alternative (two tailed) hypothesis (HA) if the null is disproved is that ketamine leads to
      significantly different levels of interleukin 6 at 4 and 24 hours after completion of
      surgery. We plan to randomize 40 patients to receive either ketamine or placebo, in a block
      of 4 randomization design stratified by whether surgery is performed by VATS or open
      lobectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients presenting for lobectomy either VATS or open.

        Exclusion Criteria:

          -  Patients with myocardial infarction in the previous six months,

          -  Patients with a history of psychotic disorder,

          -  Patients with a history of chronic pain syndrome,

          -  Patients with documented previous allergy to ketamine.