bioihbjkbjnl/mcl2 huggingface dataset:
Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
Condition: Cancer; Melanoma
MeSH terms: Melanoma
Intervention: Sorafenib (Nexavar, BAY43-9006); Placebo; Dacarbazine
Intervention description: Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21; Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21; Dacarbazine, 1000 mg/m^2 intravenous on Study Day 1
Intervention MeSH terms: Sorafenib; Dacarbazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double blind, placebo controlled, multicenter, phase II study to
      compare the anti-tumor activity as measured by progression-free survival (PFS) and the
      tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination
      with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not
      received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be
      randomized to receive DTIC + Sorafenib or DTIC + Placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have a life expectancy of at least 12 weeks

          -  Patients with histologically or cytologically confirmed unresectable (Stage III) or
             metastatic (Stage IV) melanoma

          -  Patients who have an ECOG PS of 0, or 1

          -  Measurable disease defined as at least one lesion that can be accurately and serially
             measured per the modified RECIST criteria

        Exclusion Criteria:

          -  Primary ocular or mucosal melanoma

          -  Previous or concurrent cancer that is distinct in primary site or histology from the
             cancer being evaluated in this study except cervical carcinoma in situ, treated basal
             cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis
             [Carcinoma in situ: "flat tumor"] & T1 [Tumor invades subepithelial connective
             tissue]) or any cancer curatively treated < 3 years prior to study entry

          -  History of cardiac disease

          -  Known history of human immunodeficiency virus (HIV) infection
Dapagliflozin (DAPA) Effects in HFpEF
Condition: Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure
Intervention: Dapagliflozin; Placebo
Intervention description: 10 mg orally once a day; Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
Intervention MeSH terms: Dapagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether treatment with Dapagliflozin (DAPA) for 6
      months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart
      failure/preserved ejection fraction (HFpEF) and improve cardiac metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to any study specific procedures.

          -  Male or female.

          -  Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation.

          -  EF ≥ 50% + BMI ≥ 30 kg/m^2

          -  Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥ 25 mmHg)
             ascertained at Visit 1. Patients that have consented to study procedures but do not
             meet this invasive criterion will be considered as screen failures and will not be
             randomized .

        Exclusion Criteria:

          -  Type I diabetes.

          -  Type II diabetes with poor control (HgbA1C ≥ 10%).

          -  Recent hospitalization (< 30 days) or revascularization (< 90 days).

          -  Primary cardiomyopathy (such as amyloid).

          -  Constrictive pericarditis.

          -  Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the
             investigator.

          -  Severe anemia (hemoglobin < 9gm/dl.

          -  Significant left-sided valvular heart disease (> mild stenosis, > moderate
             regurgitation),

          -  Severe kidney disease (estimated glomerular filtration rate (GFR) < 30) or liver
             disease,
Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
Condition: Colorectal Cancer; Metastatic Cancer
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Intervention: Panitumumab
Intervention description: Panitumumab 6 mg/kg every once 2 weeks weeks administered by intravenous (IV) infusion.
Intervention MeSH terms: Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: EGFr; Clinical Trial; Panitumumab; ABX-EGF; Immunex; Metastatic Cancer; Vectibix; Abgenix; Amgen

Summary:

      The purpose of this study is to determine that panitumumab will have clinically meaningful
      anti-tumor activity in patients with metastatic colorectal cancer who have developed
      progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and
      oxaliplatin chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by
             tissue biopsy)

          -  Metastatic colorectal carcinoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

          -  Documented evidence of disease progression during, or following treatment, with
             fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal
             cancer

          -  Radiographic documentation of disease progression during or within 6 months following
             the most recent chemotherapy regimen is required

          -  Bidimensionally measurable disease

          -  Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry

          -  At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal
             cancer

          -  Adequate hematologic, renal and hepatic function

        Exclusion Criteria:

          -  Symptomatic brain metastases requiring treatment

          -  Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence
             of interstitial pneumonitis or pulmonary fibrosis

          -  Use of systemic chemotherapy or radiotherapy within 30 days before enrollment

          -  Prior epidermal growth factor receptor targeting agents

          -  Prior anti-tumor therapies including prior experimental agents or approved anti-tumor
             small molecules and biologics of short (less than 1 week) serum half-life within 30
             days before enrollment, or prior experimental or approved proteins with longer serum
             half-life (e.g., AvastinTM) within 6 weeks before enrollment
Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair
Condition: Infertility; Asherman's Syndrome
MeSH terms: Infertility; Gynatresia
Intervention: Intrauterine infusion of platelet rich plasma
Intervention description: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: During Study Period #1: Subjects were randomized to receive either PRP or standard care. A total of 13 subjects were randomized.
The study design was then altered to remove randomization (10/4/2018). All patients in Study Period #2 received PRP. An additional 14 subjects were enrolled in Study Period #2.
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Maximum age: 43 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: endometrium; thin uterine lining; uterine scarring

Summary:

      Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial
      lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to
      standard therapies, present a significant clinical challenge. The aim of this trial is to
      assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial
      lining thickness in patients with thin lining or Asherman's Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persistent thin lining < 6mm on >1 cycle in previous IVF or FET cycle OR
             moderate-to-severe Asherman's syndrome

        Exclusion Criteria:

          -  Age <18 years old or >43 years old,

          -  Pregnancy,

          -  Diagnosis of cancer,

          -  Hb <11 g/dL, platelets <150,000/mm3,

          -  Anticoagulation,

          -  NSAIDs in the 10 days before procedure

          -  Any significant comorbidity or psychiatric disorder that would compromise patient
             safety or compliance, interfere with consent, study participation, follow up, or
             interpretation of study results.

          -  Incision in the uterus: myomectomy; cesarean section
Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Intervention: Lacosamide; Placebo
Intervention description: Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg; Matching placebo tablet administered twice daily
Intervention MeSH terms: Lacosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fibromyalgia Syndrome; Lacosamide; Vimpat; Harkoseride

Summary:

      This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to
      placebo in reducing the signs and symptoms of fibromyalgia syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, 18 to 65 years old

          -  Fulfills all 3 points of American College of Rheumatology (ACR) definition for
             diagnosis of fibromyalgia

          -  At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7
             days prior to Baseline)

          -  Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50

          -  Completed an adequate washout period for excluded medications prior to beginning the
             Baseline Diary Phase

        Exclusion Criteria:

          -  Symptomatic regional or structural rheumatic disease

          -  Diagnosed neuropathic pain syndrome

          -  Receiving treatment with neurostimulating devices

          -  Significant psychopathology

          -  History of chronic alcohol or drug abuse within 6 months prior to Screening

          -  Been hospitalized for psychiatric or behavioral reasons within 6 months prior to
             Screening

          -  Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias

          -  Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or
             tricyclic antidepressants (TCAs)

          -  Other medical conditions that could compromise the subject's ability to participate in
             the study
A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer
Condition: Prostatic Neoplasms; Metastases, Neoplasm
MeSH terms: Prostatic Neoplasms; Neoplasms; Neoplasm Metastasis
Intervention: ZD4054 10 mg; ZD4054 15 mg; ZD4054 22.5 mg
Intervention description: 1 x 10 mg oral tablets once daily; 1 x 10 mg + 2 x 2.5 mg oral tablets once daily; 2 x 10 mg + 2 x 2.5 mg oral tablets once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Enrollment: 22.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; Metastatic prostate cancer; bone metastases

Summary:

      The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in
      men with prostate cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 18 years & older

          -  Confirmed diagnosis of prostate cancer with bone metastases

        Exclusion Criteria:

          -  No more than 2 prior chemotherapy regimens

          -  No radiation, chemotherapy or bisphosphonates in the past 4 weeks
Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab Pegol; Placebo
Intervention description: Active Substance: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 200 mg/mL
Route of Administration: Subcutaneous use; Active Substance: isotonic sodium chloride solution
Pharmaceutical Form: Solution for injection
Concentration: 1 mL
Route of Administration: Subcutaneous use
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Crohn's Disease; CDP870; Certolizumab pegol

Summary:

      This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in
      patients with Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  Patients who are diagnosed with Crohn's disease (according to the Crohn's disease
             diagnostic criteria developed by the research group on intractable inflammatory bowel
             disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting
             date of the observation period

          -  Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450
             inclusive during the observation period

          -  C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the
             start of the observation period

        Exclusion Criteria:

          -  Stoma patient

          -  Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF
             alpha antibody

          -  Patients who participated in a clinical study with CDP870

          -  Pregnant or lactating patients, patients of childbearing potential, or patients who
             will attempt pregnancy during the study period

          -  Patients who are judged inappropriate for enrollment by the principal investigator or
             subinvestigators

        Exclusion Criteria:
Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: CINRYZE with rHuPH20
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Crossover; C1 esterase inhibitor; Prevention; C1 inhibitor; Hereditary Angioedema; Subcutaneous; Recombinant human hyaluronidase

Summary:

      The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of
      two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by
      subcutaneous (SC) injection to prevent angioedema attacks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be ≥12 years of age.

          -  Have a confirmed diagnosis of Hereditary Angioedema.

        Exclusion Criteria:

          -  Receipt of any C1 inhibitor (C1 INH) therapy or any blood products for treatment or
             prevention of an angioedema attack within 7 days before the first dose of study drug.

          -  Be receiving prophylactic intravenous CINRYZE that exceeds 1000 units every 3 or 4
             days (maximum weekly dose 2000 units).

          -  Have received any androgen therapy (e.g., danazol, oxandrolone, stanozolol,
             testosterone) within 7 days prior to the first dose of study drug.

          -  If female, have started taking or changed the dose of any hormonal contraceptive
             regimen or hormone replacement therapy (i.e., estrogen/progestin containing products)
             within 3 months prior to the first dose of study drug.

          -  History of allergic reaction to C1 INH products, including CINRYZE or other blood
             products.

          -  History of abnormal blood clotting.

          -  Have a known allergy to hyaluronidase or any other ingredient in the study
             formulation.
Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine; Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1; Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine; Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1; Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine; MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine
Intervention description: Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3.; Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3.; Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3.; Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3.; Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.; Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.
Intervention MeSH terms: Vaccines; MF59 oil emulsion
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 601.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: avian flu; seasonal influenza vaccine; influenza vaccine; prepandemic vaccine; virus strain with the potential to cause pandemic; tetravalent vaccine; Prophylaxis of influenza

Summary:

      Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years
      and above (as part of a tetravalent vaccine)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects (aged 18 years and above) who have signed an informed consent form

        Exclusion Criteria:

          -  Any acute or chronic illness

          -  Receipt of seasonal influenza vaccine for the current season 2007/2008

          -  Known or suspected impairment/alteration of immune function

          -  Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination
             within 3 weeks following the last study vaccination

          -  Any serious disease

          -  Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral
             protein,neomycin or kanamycin or any other component of the study vaccine

          -  Receipt of blood, blood products or immunoglobulins 3 months prior to vaccination
Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg
Condition: Pancreatic Tumours; Midgut Neuroendocrine Tumours
MeSH terms: Neoplasms; Neuroendocrine Tumors; Pancreatic Neoplasms
Intervention: Lanreotide autogel 120 mg
Intervention MeSH terms: Lanreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered
      every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable
      pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the
      standard dose of lanreotide Autogel® 120 mg every 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced,
             unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone
             related syndromes, with a proliferation index (Ki67) ≤20%.

          -  Positive somatostatin receptors type 2

          -  Progression as assessed by an independent central reviewer according to RECIST v1.0
             while receiving first line treatment with lanreotide Autogel® at a standard dose of
             120 mg every 28 days for at least 24 weeks

        Exclusion Criteria:

          -  Grade 3 or rapidly progressive (within 12 weeks) NET

          -  Any NET other than pancreatic and midgut

          -  Previous treatment with any antitumour agent for NET other than lanreotide Autogel®
             120 mg every 28 days. Exception made of prior treatment with Octreotide at standard
             dose stopped for other reason than disease progression.

          -  Symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis
             with no cholecystectomy since then.