bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Intervention: NAFT-600 ( naftin 2 % gel ); Placebo
Intervention description: Topical; applied once daily for two weeks; Topical; applied once daily for two weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 855.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: fungal infection; athlete foot

Summary:

      The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once
      daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with
      tinea pedis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of
             child-bearing potential must have a negative urine pregnancy test.

          -  Presence of interdigital only or both interdigital and moccasin types of tinea pedis
             on one or both feet characterized by clinical evidence of a tinea infection (at least
             moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in
             the affected area(s)).

        Exclusion Criteria:

          -  Subjects with life-threatening condition (ex. autoimmune deficiency syndrome,
             cancer,unstable angina or myocardial infarction) within the last 6 months.

          -  Subjects with abnormal findings - physical or laboratory - that are considered by the
             investigator to be clinically important and indicative of conditions that might
             complicate interpretation of study results.

          -  Subjects with a known hypersensitivity to study drugs or their components.

          -  Subjects who have a recent history or who are currently known to abuse alcohol or
             drugs.

          -  Uncontrolled diabetes mellitus.

          -  Hemodialysis or chronic ambulatory peritoneal dialysis therapy.

          -  Current diagnosis of immunocompromising conditions.

          -  Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact
             dermatitis.

          -  Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous
             candidiasis or bacterial skin infection.

          -  Extremely severe tinea pedis (incapacitating).

          -  Female subject who is pregnant or lactating, who is not using or does not agree to use
             an acceptable form of contraception during the study, or who intends to become
             pregnant during the study
A Study to Evaluate GSK1325760A - a Long-Term Extension Study
Condition: Pulmonary Arterial Hypertension; Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Hypertension
Intervention: GSK1325760A
Intervention description: 2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW.
Intervention MeSH terms: Ambrisentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; Ambrisentan

Summary:

      The primary objective of this study is to evaluate the safety of long-term administration of
      GSK1325760A in patients with PAH.

      The secondary objectives of this study are to evaluate long-term administration of
      GSK1325760A on:

        -  Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO
           Functional Classification and time to clinical worsening of PAH

        -  Change in the Borg Dyspnea Index (assessed immediately following the six-minute walk
           test [6MWT])

        -  Change in plasma brain natriuretic peptide (BNP) levels

        -  Cardiopulmonary hemodynamics parameters (as measured by echocardiography)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who complete the 24-week administration of the Phase II/III study (Study
             No.AMB107816)

          -  Subjects who are assessed that the long-term extension administration of GSK1325760A
             is appropriate in the judgement of the investigator or subinvestigator

          -  Subjects who request the long-term extension administration of GSK1325760A, and agree
             to newly sign the informed consent form

        Exclusion Criteria:

          -  Subjects who have been withdrawn from the Phase II/III study.

          -  Female subjects who wish to become pregnant.

          -  Treatment with other PAH medication is needed.

          -  A worsening of 2 or more levels of the WHO Functional Classification (see Appendix
             2.1) comparing with the baseline of Phase II/III study (Study No.AMB107816).

          -  Worsening of right ventricular failure (e.g. as indicated by increased jugular venous
             pressure, new/worsened hepatomegaly, ascites, or peripheral edema) during Phase II/III
             study (Study No.AMB107816).

          -  Rapidly progressing cardiac, hepatic or renal failure during Phase II/III study (Study
             No.AMB107816).

          -  Participation to the long-term extension study is considered as inappropriate in the
             judgment of the investigator or subinvestigator.
Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors
Condition: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders; Hemorrhage
Intervention: vatreptacog alfa (activated); eptacog alfa (activated)
Intervention description: 1-3 doses per bleeding episode; 1-3 doses per bleeding episode
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The purpose of this trial is to confirm the efficacy and
      safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors
             to coagulation factors VIII or IX

          -  Minimum of five bleeds requiring haemostatic drug treatment within the previous 12
             months at trial entry

        Exclusion Criteria:

          -  Previous participation in this trial defined as withdrawal after administration of
             trial product

          -  Patient has received an investigational medicinal product within 30 days prior to this
             trial

          -  Congenital or acquired coagulation disorders other than haemophilia A or B

          -  Any clinical signs or known history of arterial thrombotic events or of deep venous
             thrombosis or pulmonary embolism (as defined by available medical records)

          -  Platelet count of less than 50,000 platelets/mcL (at the screening visit)

          -  ALAT (alanine-transaminase) of more than 3 times the upper normal limit (according to
             laboratory reference ranges)

          -  Factor VIII/IX Immune Tolerance Induction regimen planned to occur during the trial

          -  Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during
             the trial

          -  HIV (Human Immunodeficiency Virus) positive with current CD4+ count of less than
             200/mcL (defined by medical records)
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Silodosin; Placebo
Intervention description: 8 mg daily for 12 weeks; 1 capsule daily for 12 weeks
Intervention MeSH terms: Silodosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 461.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Benign prostatic hyperplasia, BPH, alpha blocker

Summary:

      A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is
      safe and effective. The study lasts approximately 20 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males in good general health and at least 50 years of age, with symptoms of moderate
             to severe benign prostatic hyperplasia.

        Exclusion Criteria:

          -  Medical conditions that would confound the efficacy evaluation.

          -  Medical conditions in which it would be unsafe to use an alpha-blocker.

          -  The use of concomitant drugs that would confound the efficacy evaluation.

          -  The use of concomitant drugs that would be unsafe with this alpha-blocker.
Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Vaniprevir; peg-IFN; ribavirin
Intervention description: Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 24 weeks; Open-label peg-IFN alfa-2b at 1.5 μg/kg once per week, administered subcutaneously (SC) for 24 weeks; Capsules containing 200 mg RBV, orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 weeks
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir
      (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and
      ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC) genotype (GT) 1 who
      have not responded to previous treatment. The primary efficacy objective is to estimate
      efficacy of vaniprevir, peg-IFN and RBV for 24 weeks as assessed by the percentage of
      participants achieving undetectable Hepatitis C Virus ribonucleic acid (HCV RNA) 24 weeks
      after completion of all study therapy (Sustained Viral Response 24 [SVR24]).
    

Eligibility criteria:

        Inclusion criteria:

          -  Japanese participant diagnosed with compensated CHC GT 1

          -  Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other
             signs or symptoms of advanced liver disease

          -  Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN)
             with or without use of ribavirin, but failed to respond to the prior treatment
             (partial responder or null responder)

          -  No evidence of cirrhosis

        Exclusion criteria:

          -  Co-infection with human immunodeficiency virus (HIV)

          -  Positive hepatitis B surface antigen or other evidence of active hepatitis B infection

          -  Any other condition that is contraindicated or for which caution is required for
             treatment with peg-IFN or RBV

          -  Any condition or pre-study laboratory abnormality, or history of any illness, that, in
             the opinion of the investigator, might confound the results of the study or pose
             additional risk in administering the study drugs, peg-IFN and RBV, to the participant
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: PEP005 (ingenol mebutate) Gel; Vehicle gel
Intervention description: two day treatment; two day treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peplin; Actinic keratosis; PEP005

Summary:

      The purpose of this study is to determine whether topical application of PEP005 is effective
      for the treatment of actinic keratoses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be male or female and at least 18 years of age.

          -  Female patients must be of:

          -  Non-childbearing potential;

          -  Childbearing potential, provided negative serum and urine pregnancy test and using
             effective contraception.

          -  4 to 8 AK lesions on non-head locations.

        Exclusion Criteria:

          -  Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected
             treatment area.

          -  Treatment with immunomodulators, or interferon/ interferon inducers or systemic
             medications that suppress the immune system within 4 weeks.

          -  Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and
             2 cm of treatment area
Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
Condition: Helicobacter Pylori Infection
Intervention: BreathID® Hp System; BreathID® Hp Lab System; Stool Test
Intervention description: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea; Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea; Each subject was asked to perform a stool test in parallel to the breath test.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
Masking: None (Open Label)
Masking description: The investigator and treating physician will remain blinded to the breath test results until the end of the study. There is only one arm.
Enrollment: 54.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath
      Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be older than 3 and younger than 18 years of age

          -  Present with a clinical indication compatible with H. pylori based on the judgement of
             the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic
             ulcer, dyspepsia, etc., or following treatment for H.pylori)

          -  Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed
             Consent/Assent Form

          -  Naïve to H. pylori treatment in the past 6 weeks

        Exclusion Criteria:

          -  Participation in other interventional trials

          -  PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test

          -  Pregnant or breastfeeding female

          -  Allergy to test substrates

          -  Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within
             four (4) weeks prior to breath test

          -  Exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the
             breath test.

          -  Exposure to any 13C-enriched substance 24 hours prior to the breath test.

          -  Children 12 years and older - to be excluded after a written notification from the
             sponsor is received at the site that the limit of 1/3 of the sample size was achieved
             for this group

          -  Subjects outside US - to be excluded after a written notification from the sponsor is
             received at the site that the limit of 1/3 of the sample size was achieved for this
             group
Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage
Intervention: turoctocog alfa; turoctocog alfa
Intervention description: The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.; Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: Male
Healthy volunteers: No

Summary:

      This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy
      of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe
      haemophilia A (FVIII≤1%).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients

          -  Age from 0 years

          -  With the diagnosis of severe congenital haemophilia A (FVIII≤1%)

          -  History of exposure days (ED) to any FVIII products fulfilling the criteria of
             previously treated patients:

          -  Patients of 12 years or above: 100 exposures days (ED) or more

          -  Patients below 12 years: 50 exposure days (ED) or more

        Exclusion Criteria:

          -  Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory

          -  Known history of FVIII inhibitors
Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion
Condition: Other Abnormal Granulation Tissue Nos
Intervention: Silver Nitrate; Kenalog (Triamcinolone); Washcloth Abrasion
Intervention description: Silver nitrate to be applied 3 times weekly for a period of 3 weeks.; Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.; Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
Intervention MeSH terms: Silver Nitrate; Triamcinolone; Triamcinolone Acetonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Granulation tissue, or excess tissue, forms around gastrostomy tube sites and is a common
      problem seen in the pediatric surgery population. There is no standard treatment that has
      been identified in clinical practice to treat granulation tissue effectively. Clinicians
      prescribe treatments of varying nature to help treat this condition. By conducting this
      study, the investigators hope to identify if there is any difference in the treatment groups
      and if there is any superiority for one treatment over the other. The three arms in the study
      are Silver Nitrate treatment, treatment with Kenalog, and Washcloth abrasion. Treatments will
      continue over a period of three weeks, and the progress will be followed using surveys and
      photographs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient falling within age group with granulation tissue around G tube site

        Exclusion Criteria:

          -  Patients falling outside of age group range
To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
Condition: Macular Edema (ME)
MeSH terms: Macular Edema; Edema
Intervention: Sham control; Ranibizumab
Intervention description: The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.; Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vision Impairment

Summary:

      To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult
      patients with visual impairment due to macular edema (ME).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of active ME secondary to any causes (for adult patients: except diabetic
             macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion
             (RVO));

          -  BCVA must be between ≥ 24 and ≤ 83 letters;

          -  Visual loss should be mainly due to the presence of any eligible types of ME.

        Exclusion Criteria:

          -  Women of child-bearing potential,

          -  Active malignancies;

          -  History of stroke less than 6 months prior to screening;

          -  Uncontrolled systemic inflammation or infection, related directly to the underlying
             causal disease of ME;

          -  Active diabetic retinopathy, active ocular/periocular infectious disease or active
             severe intra-ocular inflammation;

          -  Any type of advanced, severe or unstable ocular disease or its reatment;

          -  ME with a high likelihood of spontaneous resolution.

        Other protocol-defined inclusion/exclusion criteria may apply.
Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Ziprasidone
Intervention description: Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Open label extension study of Ziprasidone, evaluation of safety of long term use of
      ziprasidone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final
             visit) or ZIP-NY-98035 and with QTc <= 500 msec.

        Exclusion Criteria:

          -  All other patients who do not fit the inclusion criteria as stated above.