bioihbjkbjnl/mcl2 huggingface dataset:
IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation
Condition: Pain
MeSH terms: Cancer Pain
Intervention: IncobotulinumtoxinA
Intervention description: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions.
Intervention MeSH terms: incobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer pain, radiation therapy, surgery, incobotulinum toxin

Summary:

      The purpose of this research study is to investigate the safety and effectiveness of
      botulinum toxin A (Xeomin) ® injections in patients who suffer from focal pain in areas of
      radiation and/or surgery as a result of cancer treatment. Our hypothesis is that injection of
      incobotulinum toxin A into an area of local pain, at or around the area of a
      post-surgical/post radiation scar, relieves the focal cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18- 80 years, both sexes, all races and ethnic groups.

          -  Diagnosis of post- surgical/post - radiation cancer pain.

          -  Focal pain duration longer than 3 months

          -  Pain of moderate to severe intensity ( mean VAS over the previous week >4 )

          -  Subjects who are able to read, speak, and understand English.

        Exclusion Criteria:

          -  Existing significant acute medical condition (i.e. cardiovascular, endocrine,
             hematologic, neoplastic, infectious, or autoimmune disorders).

          -  Pregnancy or planned pregnancy (determined by urine pregnancy test). Women of
             childbearing age should use a reliable mode of contraception during the study period
             (abstinence, etc).

          -  Active breast feeding.

          -  Enrollment in any clinical trial (currently or within the past 3 months) in which
             treatments are imposed by a protocol.

          -  Any subject for whom botulinum toxin treatment would be contraindicated; known allergy
             or sensitivity to medication.

          -  Subjects who are younger than 18 years of age.

          -  Neuromuscular-junction disorders.

          -  Axis I diagnosis determined by a neurologist or psychiatrist.

          -  Use of anesthetic medications within two weeks or corticosteroid injections within 4
             weeks of enrollment.

          -  Received botulinum toxin injections in the past 4 months.

          -  Patients taking high doses of aminoglycosides or other drugs affecting the function of
             neuromuscular junction ( anticholinergic, muscle relaxants)

          -  Patients who have unstable pain in/at sites other than areas of planned injection
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; ZPL389 3mg; ZPL389 10mg; ZPL389 30mg; ZPL389 50mg
Intervention description: once daily from baseline until week 16; ZPL389 3 mg oral powder; once daily from baseline to week 16; ZPL389 10 mg oral powder; once daily from baseline to week 16; ZPL389 30 mg oral powder; once daily from baseline to week 16; ZPL389 50 mg oral powder; once daily from baseline to week 16
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atopic dermatitis; AD; eczema; atopic eczema; itch, pruritus; histamine 4 receptor; antagonist; H4R; ZPL389; ZPL389A2203; dermatitis

Summary:

      This was a randomized, double-blind, placebo-controlled, parallel-group study to assess
      safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a
      total study duration up to 24 weeks
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must give a written, signed and dated informed consent

          -  Chronic atopic dermatitis present for at least 1 year before Baseline

          -  Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.

          -  Documented recent history (within 6 months before the screening visit) of inadequate
             response to treatment with topical medications or for whom topical treatments are
             otherwise medically inadvisable

          -  Candidate for systemic treatment

        Exclusion Criteria:

          -  Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis
             disease activity

          -  Use of other investigational drugs within 5 half-lives of enrollment, or within 30
             days or until the expected pharmacodynamic effect has returned to baseline, whichever
             is longer.

          -  History of hypersensitivity to any of the study drug constituents or to drugs of
             similar chemical classes.

          -  Participation in prior ZPL389 studies
Efficacy of ArTiMist™ in Children
Condition: Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: Quinine; Artemether
Intervention description: 20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy; Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy
Intervention MeSH terms: Artemether; Quinine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Healthy volunteers: No
Keywords: Plasmodium infections; Remittent fever; Artemether; Artemisinins; quinine; Malaria; Protozoan Infections; Anti-Infective Agents; Antiprotozoal Agents; Schistosomicides; Pharmacologic Actions; Malaria, Falciparum; Antimalarials; Antiparasitic Agents; Parasitic Diseases; sublingual

Summary:

      The purpose of this study is to compare the efficacy of Artemether Sublingual Spray
      (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum
      malaria, or children with uncomplicated malaria with gastrointestinal complications.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient's parent or attendant relative has provided informed consent and the
             patient has assented (where relevant) to participation in the trial

          2. The patient is a child that weighs between 5 and 15 kg (kilogram)

          3. The patient has falciparum malaria as evidenced by

               1. Thick or thin blood smears of > 500 P falciparum per mcl (microlitre)(patients
                  with mixed infections may be included provided >500 P Falciparum /mcl) and /or

               2. Positive RDT (rapid diagnostic test)for malaria

          4. The patient has either

               1. severe or complicated malaria as determined by the Investigator based on the WHO
                  criteria for severity, or

               2. the patient has uncomplicated malaria but is unable to tolerate oral medication
                  as a result of gastrointestinal complications such as vomiting or diarrhoea.

        Exclusion Criteria:

          1. Attending relative or parent does not provide informed consent for participation, or
             the child if capable does not assent to participation in the trial.

          2. Ability to tolerate oral therapy

          3. Patient has received any treatment with an artemisinin or quinine in the last 24 hours

          4. Patient has evidence of significant co-infections (this does not include mixed
             Plasmodium infections).

          5. Patient is allergic or intolerant to artemisinins.
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
Condition: Stasis Dermatitis
MeSH terms: Dermatitis
Intervention: crisaborole ointment; vehicle ointment
Intervention description: crisaborole ointment; vehicle ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Stasis Dermatitis; venous hypertension; venous insufficiency

Summary:

      This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of
      concept study that will include participants with stasis dermatitis without active skin
      ulceration, who will receive crisaborole ointment 2% or vehicle twice daily for 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are ≥45 years of age and in generally stable health

          -  Participants who are in generally stable health and have a known diagnosis of Stasis
             Dermatitis or newly diagnosed Stasis Dermatitis

          -  Participants whose mental and physical status allows them to be able to mostly perform
             their activities of daily living with minimal assistance

        Exclusion Criteria:

          -  Participants with clinically significant active or potentially recurrent dermatitis
             conditions and known genetic dermatological conditions that are not Stasis Dermatitis
             or overlap with Stasis Dermatitis

          -  Participants with active venous stasis ulceration on either lower extremity.

          -  Participants with current infection or suspected infection of any Stasis Dermatitis
             lesions

          -  Women of child bearing potential (WOCBP) are not eligible for this study
Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: LCP-AtorFen; atorvastatin; fenofibrate
Intervention description: 40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia; dyslipidemia and mixed dyslipidemia; dyslipidemia and mixed dyslipidemia
Intervention MeSH terms: Atorvastatin; Fenofibrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LCP-AtorFen; Non-HDL cholesterol; Triglycerides; HDL cholesterol; LDL cholesterol; Atorvastatin; Fenofibrate

Summary:

      The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a
      combination of atorvastatin and fenofibrate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. A diagnosis of dyslipidemia (non-HDL-C >130 mg/dL and Triglycerides > or equal to 150
             mg/dL and < or equal to 500 mg/dL).

          2. Subject may be currently on a statin or other lipid-lowering therapy but must be
             willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks
             if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant,
             ezetimibe, or >1000 mg of fish oil per day.

          3. Other inclusion criteria might apply

        Exclusion Criteria:

          1. TGs > 500 mg/dL.

          2. History of coronary heart disease (CHD), transient ischemic attacks, stroke or
             revascularization procedure in the six months prior.

          3. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.

          4. Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes
             mellitus requiring insulin therapy.

          5. Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial
             dysbetalipoproteinemia.

          6. History of pancreatitis.

          7. Known allergy or sensitivity to statins or fibrates.

          8. Poorly controlled hypertension.

          9. Other exclusion criteria might apply.
99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer
Condition: Breast Cancer; Doxorubicin Induced Cardiomyopathy
MeSH terms: Breast Neoplasms; Cardiomyopathies; Cardiotoxicity
Intervention: 99mTc-rhAnnexin V-128
Intervention description: Kit for the preparation of 99mTc-rhAnnexin V-128
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a single center, proof-of-concept (PoC), Phase II study. Patients with
      histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and
      scheduled to receive doxorubicin-based (neo)adjuvant therapy to be followed by paclitaxel or
      docetaxel as per clinical practice. The planned doxorubicin-based chemotherapy treatment
      consisted of doxorubicin 60 mg/m2 in combination with cyclophosphamide 600 mg/m2 (AC)
      intravenous (IV) every 2 or 3 weeks for 4 cycles. Patients were scheduled for CMRI and
      99mTc-rhAnnexin V-128 imaging (planar and SPECT / CT) at the following visits:

        1. Screening/baseline, i.e. 2 weeks prior to initiating AC treatment (Visit 1)

        2. After the 2nd and before the 3rd cycle of AC treatment (Visit 2)

        3. After the 4th cycle of AC treatment and within 2 weeks (Visit 3)

        4. At 12 weeks after the 4th cycle of AC treatment (Visit 4). The imaging procedures were
           conducted and analyzed. Bloodwork for cardiotoxicity biomarkers (troponin, N terminal
           pro B-type natriuretic peptide [NT-proBNP]) was performed at each visit.
    

Eligibility criteria:

        Inclusion criteria:

          1. Females >= 18 years of age with histologically confirmed early stage (Stage I, II or
             III) HER-2 negative breast cancer and planned for (neo)adjuvant doxorubicin-based
             chemotherapy (AC every 2 or 3 weeks x 4 cycles)

          2. Eastern Cooperative Oncology Group Status (ECOG) ≤ 2

          3. Able and willing to comply with the study procedures

        Exclusion criteria:

          1. Pregnancy or lactation

          2. Moderate or severe valvular stenosis or regurgitation

          3. History of atrial fibrillation or flutter

          4. History of any disease or relevant physical or psychiatric condition which may
             interfere with the study objectives at the investigator judgment

          5. Know hypersensitivity to the investigational product (IP) or any of its components

          6. Prosthetic valve or pacemaker

          7. Claustrophobia or inability to lie still in a supine position

          8. Contraindication(s) to the CMRI procedure

          9. Participation in another clinical trial within 4 weeks before study inclusion, except
             for patients who have participated or who are currently participating in a study
             without any study drug administration

         10. Unwillingness to provide consent
Open-label Extension Study Of RN624
Condition: Osteoarthritis; OA Knee Pain; Arthritis
MeSH terms: Osteoarthritis
Intervention: RN624 (PF-04383119)
Intervention description: 50 mcg/kg
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 287.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Monoclonal antibody

Summary:

      Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have
      previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624
      on an open-label basis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Enrolled in Study RN624-CL006

        Exclusion Criteria:

          -  The occurrence of any adverse event or condition during the controlled studies that,
             in the opinion of the Investigator, should exclude the subject from participating in
             the open-label extension

          -  Pregnant or lactating female subjects or subjects who do not agree to use an
             appropriate form of birth control throughout the study and for 3 months after
             completing the study
A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Gefapixant; Sugar Pill
Intervention description: BID; 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: 171.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of a single dose level of gefapixant
      (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA)
      of the knee compared with placebo after 4 weeks of treatment.

      The study will also assess the safety and tolerability, changes in physical function,
      stiffness, treatment response and health outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women

          -  Women of child bearing potential must not be pregnant during the study and must use
             two forms of birth control

          -  Men and their female partners must use two forms of birth control

          -  Clinical and radiographic evidence of chronic knee osteoarthritis

          -  An average NPRS score of >=5 and <=9 over a 4-7 day washout period of their previous
             osteoarthritis medications

          -  Ambulatory

          -  Have provided written informed consent
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
Condition: Chronic Genotype 4 HCV; Chronic Genotype 5 HCV
Intervention: LDV/SOF
Intervention description: LDV/SOF (90/400 mg) FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV GT 4; HCV GT 5

Summary:

      This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir
      (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis
      C virus (HCV) infection as measured by the proportion of subjects with sustained virologic
      response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after
      discontinuation of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic genotype 4 or 5 HCV Infection

          -  Individuals may be treatment naive or treatment experienced

          -  Presence or absence of cirrhosis, a liver biopsy may be required

          -  Healthy according to medical history and physical examination with the exception of
             HCV diagnosis

          -  Agree to use two forms of highly effective contraception for the duration of the study

        Exclusion Criteria:

          -  History or current evidence of any condition, therapy, laboratory abnormality or other
             circumstance that might confound the results of the study, or interfere with the
             individual's participation for the full duration of the study or not be in the best
             interest of the individual in the opinion of the investigator

          -  Prior exposure to approved or experimental HCV specific direct acting antiviral(s)
             (DAA) other than NS3/4A protease inhibitors

          -  History of any other clinically significant chronic liver disease

          -  Evidence of or history of decompensated liver disease

          -  HIV or chronic hepatitis B (HBV) infection

          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
             skin cancers)

          -  Chronic use of immunosuppressive agents or immunomodulatory agents
PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: PT001 MDI; Tiotropium Bromide; PT001 Placebo MDI
Intervention description: Administered as two puffs BID for 14 days; Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
Intervention MeSH terms: Bromides; Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The overall objective of this study is to determine an optimal dose and dosing regimen of
      PT001 MDI for further evaluation in later stage studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent

          -  40 - 80 years of age

          -  Clinical history of COPD with airflow limitation that is not fully reversible

          -  Females of non-child bearing potential or females of child bearing potential with
             negative pregnancy test; and acceptable contraceptive methods

          -  Current/former smokers with at least a 10 pack-year history of cigarette smoking

          -  A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70

          -  A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of
             predicted normal values

          -  Able to change COPD treatment as required by protocol

        Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Primary diagnosis of asthma

          -  Alpha-1 antitrypsin deficiency as the cause of COPD

          -  Active pulmonary diseases

          -  Prior lung volume reduction surgery

          -  Abnormal chest X-ray (or CT scan) not due to the presence of COPD

          -  Hospitalized due to poorly controlled COPD within 3 months of Screening

          -  Clinically significant medical conditions that preclude participation in the study
             (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma,
             symptomatic prostatic hypertrophy)

          -  Cancer that has not been in complete remission for at least 5 years

          -  Treatment with investigational study drug or participation in another clinical trial
             or study within the last 30 days or 5 half lives

        Other inclusion/exclusion criteria as defined in the protocol