bioihbjkbjnl/mcl2 huggingface dataset:
TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors
Condition: HIV Infections; HIV-1
MeSH terms: HIV Infections
Intervention: TMC278; efavirenz
Intervention description: 25 mg tablet once daily for 96 weeks; 600 mg tablet once daily for 96 weeks
Intervention MeSH terms: Efavirenz; Rilpivirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 680.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Antiretroviral; HIV-1; AIDS; TMC278-C215; TMC278-TiDP6-C215; Treatment Naive

Summary:

      The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278
      given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily,
      when combined with a background regimen containing 2 nucleoside/nucleotide reverse
      transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1
      infected patients who have not yet taken any anti-HIV drugs. The following evaluations will
      be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution,
      relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource
      utilization and treatment adherence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with documented HIV-1 infection

          -  Patient has never been treated with a therapeutic HIV vaccine or an ARV drug prior to
             screening

          -  Patient's HIV-1 plasma viral load at screening is > 5,000 HIV-1 RNA copies/mL (assayed
             by RNA PCR standard specimen procedure)

          -  Patient's virus is sensitive to the 2 nucleoside/nucleotide reverse transcriptase
             inhibitors chosen for treatment

          -  Patient agrees not to start ART before the baseline visit

          -  Patient is HLA-B*5701 negative in case abacavir is included in the patient's treatment
             regimen.

        Exclusion Criteria:

          -  Previous use of ANY ARV drug for ANY length of time

          -  Any documented evidence of NNRTI resistance associated mutations in patient's HIV

          -  Category C AIDS defining illness, except, Stable Kaposi Sarcoma Wasting syndrome if
             not progressive

          -  Pneumocystis carinii pneumonia (PCP) that is considered not cured

          -  Active TB

          -  Allergy or hypersensitivity to study or background ARTs

          -  Specific grade 3 or 4 toxicity

          -  Kidney impairment: calculated creatinine clearance <50 ml/min
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: IPX066 95 mg; IPX066 145 mg; IPX066 195 mg; IPX066 245 mg
Intervention description: 23.75 - 95 mg CD-LD capsules; 36.25 - 145 mg CD-LD capsules; 48.75 - 195 mg CD-LD capsules; 61.25 - 245 mg CD-LD capsules
Intervention MeSH terms: Carbidopa, levodopa drug combination; Carbidopa; Levodopa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 617.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: motor Symptoms; efficacy; IPX066; Parkinson's Disease

Summary:

      The purpose of this study is to determine the long term safety and clinical utility of IPX066
      in subjects with Parkinson's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Each subject must meet the following inclusion criteria in order to be enrolled in the
             study:

               1. Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.

               2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still
                  valid and the subject remains eligible for LD therapy.

        Exclusion Criteria:

          -  Each subject must be free of the following exclusion criteria in order to be enrolled
             in the study:

               1. Received an investigational medication other than those from an IPX066 trial
                  within 4 weeks prior to the planned start of treatment.

               2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep
                  brain stimulation) during study participation.

               3. Received within 4 weeks prior to Baseline Visit or planning to take during study
                  participation: nonselective monoamine oxidase (MAO) inhibitors (with the
                  exception of rasagiline).

               4. In the opinion of the Investigator, should not participate in the study.
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma (ESCC)
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Intervention: Cisplatin; Oxaliplatin; Fluorouracil (5-FU); Capecitabine; Paclitaxel; Tislelizumab; Placebo
Intervention description: Administered IV; Administered IV; Administered IV; Administered orally; Administered IV; Administered IV; Placebo to match Tislelizumab
Intervention MeSH terms: Paclitaxel; Capecitabine; Fluorouracil; Oxaliplatin; Tislelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 649.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first
      line treatment in combination with chemotherapy in participants with advanced
      unresectable/metastatic esophageal squamous cell carcinoma (ESCC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Pathologically (histologically) confirmed diagnosis of ESCC

          2. Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced
             recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition),
             if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a
             treatment-free interval of at least 6 months is required.

        Key Exclusion Criteria:

          1. Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation

          2. Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC

          3. Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed
             cell death protein ligand-1 (PD-L1) or PD-L2

          4. Participants with evidence of fistula (either esophageal/bronchial or
             esophageal/aorta)

          5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent
             drainage or medical intervention (clinically significant recurrence requiring an
             additional intervention within 2 weeks of intervention)

          6. Evidence of complete esophageal obstruction not amenable to treatment

          7. Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional
             Risk Index (NRI) < 83.5 per investigator's choice

          8. Locally advanced esophageal carcinoma that is resectable or potentially curable with
             radiation therapy per local investigator.

          9. Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV)
             carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus
             (HCV)

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Intervention: Insulin Glargine; Insulin Aspart
Intervention description: Use of human insulin glargine for slow decrease of blood sugar level over 24 hours.; Use of human insulin aspart for rapid lowering of the blood glucose level over 24 hours.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Acute Lymphocytic Leukemia; Leukemia; Lymphoma; Burkitts Lymphoma; Lymphoblastic Leukemia; Blood Sugar; Hyperglycemia; Insulin Aspart; Insulin Glargine; Hyper-CVAD

Summary:

      The goal of this clinical research study is to learn if intense management and control of
      blood sugar levels during treatment for acute lymphocytic leukemia, Burkitts lymphoma, or
      lymphoblastic lymphoma will result in decreased risk of relapse, fewer complications, and/or
      longer survival.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >/= 15 years.

          2. Previously untreated ALL, Burkitt's lymphoma, or lymphoblastic leukemia receiving
             induction chemotherapy with hyper-CVAD or variants of the hyper-CVAD regimen.

          3. Random serum glucose >/= 180 mg/dL detected during the first 2 cycles of chemotherapy
             and confirmed with a second measurement.

        Exclusion Criteria:

          1. History of Type I diabetes mellitus.

          2. Pregnancy or breast feeding.

          3. Allergy to insulin or insulin products.

          4. On-going treatment of steroid-induced hyperglycemia by an endocrinologist and/or
             general internist.
Bimatoprost for the Treatment of Eyebrow Hypotrichosis
Condition: Eyebrow Hypotrichosis
MeSH terms: Hypotrichosis
Intervention: bimatoprost solution; Vehicle to bimatoprost solution
Intervention description: Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.; Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of bimatoprost solution compared with
      vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).
    

Eligibility criteria:

        Inclusion Criteria:

        -Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).

        Exclusion Criteria:

          -  Patients with disease, infection, or abnormality of the eyebrow area

          -  Patients with permanent eyebrow loss due to over-grooming
Effects of Two Doses of a Common Cold Treatment on Alertness
Condition: Common Cold
MeSH terms: Common Cold
Intervention: paracetamol + caffeine; paracetamol
Intervention description: paracetamol with caffeine; paracetamol
Intervention MeSH terms: Acetaminophen; Caffeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: alertness

Summary:

      This study will investigate any improvement in alertness and performance based on cognitive
      function and mood assessment in subjects suffering the common cold, when taking a novel
      paracetamol and caffeine combination verses paracetamol alone.
    

Eligibility criteria:

        -  Participants with symptoms of cold < 96 hours, rating of at least '2' on malaise at
             least 4 other symptoms of cold.

          -  No history of clinically significant perennial rhinitis, no recent antibiotic,
             antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive
             medication in the 14 days prior to screening, no pregnancy, breastfeeding or
             participation in this trial, or another trial in the 30 days prior to screening.
The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-493/ABT-530
Intervention description: Tablet; ABT-493 coformulated with ABT-530
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Genotype 4; Hepatitis C; Chronic Hepatitis C; Hepatitis C Genotype 6; Hepatitis C Genotype 5

Summary:

      The purpose of this study is to evaluate the effect of response to treatment by evaluating
      the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12
      weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in
      participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or
             6 infection.

          2. Chronic HCV infection.

          3. HCV treatment-naïve or treatment experienced (interferon [IFN] or pegylated interferon
             [pegIFN] with or without ribavirin [RBV]; sofosbuvir [SOF] plus RBV with or without
             pegIFN).

          4. Non-cirrhotic participants.

        Exclusion Criteria:

          1. History of severe, life-threatening or other significant sensitivity to any excipient
             of the study drugs.

          2. Female who is pregnant, planning to become pregnant during the study, or
             breastfeeding; or male whose partner is pregnant or planning to become pregnant during
             the study.

          3. Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol in the opinion of the
             investigator.

          4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or
             anti-human immunodeficiency virus antibody (HIV Ab).

          5. Co-infection with more than one HCV genotype.
Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
Condition: Pain; Inflammation; Cataract
MeSH terms: Cataract; Inflammation
Intervention: Bromfenac Ophthalmic Solution; Placebo
Intervention description: Sterile ophthalmic solution; Sterile ophthalmic solution
Intervention MeSH terms: Bromfenac; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 440.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cataract surgery

Summary:

      This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age who are scheduled for unilateral cataract
             surgery

        Exclusion Criteria:

          -  Have known hypersensitivity to bromfenac or to any component of the investigational
             product
A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Intervention: Valganciclovir CMV Prophylaxis; Valganciclovir (Pre-emptive CMV Therapy); Ganciclovir
Intervention description: 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.; If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function. If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.; If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
Intervention MeSH terms: Valganciclovir; Ganciclovir; Ganciclovir triphosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 299.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily)
      prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active
      CMV infection, in CMV positive renal transplant recipients. The influence of the two
      prevention concepts on the occurrence of direct and indirect effects of active CMV infections
      will be compared. The anticipated time on study treatment is 3 months-1 year, and the target
      sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  primary or secondary renal allograft within preceding 14 days;

          -  IgG seropositive for CMV;

          -  receiving immunosuppressive therapy.

        Exclusion Criteria:

          -  active CMV infection;

          -  current/history of malignancy;

          -  acute steroid resistant rejection episode since transplantation.
Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers
Condition: Healthy
Intervention: NPC-01; IKH-01
Intervention description: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol; IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Norinyl; Mestranol; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 14.0
Sex: Female
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: NPC-01; IKH-01; Pharmacodynamics; Norethisterone; Ethinyl Estradiol; Estradiol; Progesterone; FSH; LH

Summary:

      The purpose of this study is to compare the serum levels of estradiol, progesterone, FSH and
      LH in NPC-01 or IKH-01 one treatment cycle with those in before and after administration
      cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female aged between 20 to 35 years

          -  BMI:18.0-26.0

        Exclusion Criteria:

          -  Females who are pregnant

          -  Drug use affecting sex hormone secretion
A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Condition: Partial Seizures With or Without Secondary Generalization; Epilepsy
MeSH terms: Neoplasm Metastasis; Epilepsy; Seizures
Intervention: Placebo; Brivaracetam
Intervention description: Pharmaceutical form: Film-coated tablets
Route of administration: Oral use; Pharmaceutical form: Film-coated tablets
Concentration: 25 mg tablets and 50 mg tablets
Route of administration: Oral use
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 449.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Epilepsy; Partial seizures with or without secondary generalization; Brivaracetam; Briviact

Summary:

      The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to
      placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial
      seizures with or without secondary generalization despite current treatment with 1 or 2
      concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in
      subjects >= 16 years to 80 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive

          -  Female subjects with childbearing potential are eligible if they use a medically
             accepted contraceptive method

          -  Subjects having at least 8 partial seizures (according to the 1981 ILAE
             classification) during the 8-Week Baseline Period with at least 2 partial seizures
             during each 4-week interval of the Baseline Period

          -  Subjects having at least 2 partial seizures whether or not secondary generalization
             per month during the 3 months preceding Visit 1

          -  Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug
             [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a
             concomitant AED

        Exclusion Criteria:

          -  Subject has history or presence of status epilepticus during the year preceding Visit
             1 or during Baseline

          -  Subject is currently treated with levetiracetam

          -  Subject has taken levetiracetam within 90 days prior to Visit 1