bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: IPX203
Intervention description: IPX203 extended release capsules
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 419.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: motor fluctuations; IPX203

Summary:

      The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203
      in the treatment of participants with advanced Parkinson's disease (PD) who have motor
      fluctuations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed Study IPX203-B16-02

          -  Able to provide written informed consent prior to the conduct of any study-specific
             procedures.

          -  Female participants of childbearing potential must have a negative urine pregnancy
             test at the baseline visit (Visit 1).

          -  Agrees to use a medically acceptable method of contraception throughout the study and
             for 6 weeks after completing the study.

        Exclusion Criteria:

          -  Intends to use any doses of Rytary® or Duopa™ during this study.

          -  Plans to use an investigational treatment other than IPX203 during the course of this
             study.

          -  Neurosurgical ablation treatment for PD is planned or anticipated during the study
             period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is
             permitted during this study.

          -  Participants who, in the opinion of the clinical investigator, should not participate
             in the study.
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: 20 mg VEC-162; 50 mg VEC-162; 100 mg VEC-162; Placebo
Intervention description: 20 mg VEC-162; 50 mg VEC-162; 100 mg VEC-162; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 411.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the safety and efficacy of VEC-162 compared to
      placebo to improve sleep parameters in a model of insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects with no medical, psychiatric or current sleep disorders.

          -  Subject must sign a written consent form.

        Exclusion Criteria:

          -  Recent history of night shift work or jet lag.

          -  Prior experience sleeping in a sleep lab environment.

          -  History of sleep disorders.
Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Empagliflozin; Placebo; Placebo; Empagliflozin; Placebo
Intervention description: Placebo tablet matching Empagliflozin low dose; Empagliflozin low dose; Placebo tablet matching Empagliflozin high dose; Placebo tablet matching Empagliflozin low dose; Empagliflozin high dose tablet once daily; Placebo tablet matching Empagliflozin high dose
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 60.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of empagliflozin administered orally once daily in postprandial
      glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as
      mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic
      control on no antidiabetic treatment.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of type 2 diabetes mellitus prior to informed consent

          -  Male and female patients on diet and exercise regimen for 12 weeks prior to informed
             consent who are:

               -  drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to
                  informed consent or,

               -  pre-treated with one oral antidiabetic drug (except sulfonylurea and
                  thiazolidinedione); the present antidiabetic therapy has to be unchanged for at
                  least 12 weeks prior to the informed consent. (Sulfonylurea is permitted as
                  pre-treatment drug only if the dose is equal or less than a half of daily maximum
                  approval dose.)

          -  Glycosylated haemoglobin (HbA1c) at Visit 1 (screening)

               -  for patients without antidiabetic therapy : HbA1c >=7.0 to =<10.0%

               -  for patients with one oral antidiabetic drug : HbA1c >=7.0 to =<9.5%

        Exclusion criteria:

          -  Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)

          -  Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60
             mL/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal
             disease (MDRD) formula)

          -  Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks
             prior to informed consent

          -  Indication of liver disease, defined by serum levels of either alanine transaminase
             (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper
             limit of normal (ULN)
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Levomilnacipran ER; Placebo
Intervention description: Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks; Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 442.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Depression; Major Depressive Disorder

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive
      disorder
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-80 years old

          -  Currently meet the DSM-IV-TR criteria for Major Depressive Disorder

          -  The patient's current depressive episode must be at least 4 weeks in duration

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women
             with childbearing potential who are not practicing a reliable method of birth control.

          -  Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic
             episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive
             disorder.

          -  Patients who are considered a suicide risk
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection
Condition: Chronic Hepatitis B Virus, Pediatric
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Entecavir; Placebo
Intervention description: Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response; Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response
Intervention MeSH terms: Entecavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric
      patients with chronic hepatitis B virus infection
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Males and females, aged 2 to <18 years

          -  Hepatitis B surface antigen-positive

          -  Detectable hepatitis B e (HBe) antigen, and no detectable anti-HBe antibodies

          -  Alanine aminotransferase (ALT) 1.5 to <10 times the upper limit of normal at screening
             and within 8 to 24 weeks prior to screening

          -  Evidence of the presence of hepatitis B virus DNA at least 4 weeks before screening
             and >100,000 copies/mL at screening

        Key Exclusion Criteria

          -  Any prior therapy with entecavir

          -  At least 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent

          -  Therapy with interferon alpha, thymosin alpha, or nucleototide antiviral agents within
             24 weeks of screening

          -  Coinfection with HIV, hepatitis C virus, or hepatitis D virus

          -  Decompensated liver disease

          -  Liver transplant recipients

          -  Other forms of acute and chronic conditions which may cause increased ALT levels

          -  Children who were breastfed while their mothers received lamivudine or whose mothers
             received lamivudine during pregnancy
A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Pegylated-interferon alfa-2a; Ribavirin
Intervention description: Pegylated-interferon alfa-2a was administered subcutaneously once weekly.; Participants received ribavirin with food, as the bioavailability of ribavirin is increased when taken with food. Ribavirin was administered as split doses, that is, 2 doses were given 12 hours apart, 1 in the morning and 1 in the evening. Participants received either 1000 or 1200 mg ribavirin per day according to body weight: 400 mg (2 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing < 75 kg or 600 mg (3 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing ≥ 75 kg.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or
      in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have
      participated in a previous Roche or Roche partner protocol where access to treatment or
      re-treatment was promised or deemed appropriate following completion of the original protocol
      ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS
      monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus,
      800-1200 mg daily, as continuation of treatment after the wash-out period defined in their
      donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48
      weeks in genotype G1 with a treatment-free follow up period of 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age.

          -  Chronic hepatitis C (CHC) patients with compensated liver disease (Child-Pugh A) who
             have participated in a donor protocol where access to treatment or re-treatment with
             PEGASYS monotherapy or in combination with Copegus was promised or deemed appropriate
             after completion of the donor protocol.

        Exclusion Criteria:

          -  Evidence of decompensated liver disease (Child B or C cirrhosis).
New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day
Condition: Asthma
Intervention: Symbicort; Symbicort; Budesonide
Intervention description: Breath actuated metered dose inhaler; Actuation counter pressured metered dose inhaler; Actuation counter pressured metered dose inhaler
Intervention MeSH terms: Budesonide; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 214.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the
      Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 12 years and above

          -  Clinical diagnosis of asthma according to the American Thoracic Society definition at
             least 6 months

          -  Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal

          -  Patients with reversible airway obstruction

          -  Documented daily use of inhaled corticosteroids for ≥ 3 months

        Exclusion Criteria:

          -  History of life-threatening asthma, defined for this protocol as an asthma episode
             that required intubation and/or was associated with hypercapnea, respiratory arrest or
             hypoxic seizures during the 2 years prior to Visit 2

          -  Hospitalized during previous 6 months for asthma

          -  Required emergency treatment more than once during previous 6 months for an
             asthma-related condition

          -  Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment

          -  Respiratory infection affecting the asthma within 30 days
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Placebo; SAGE-547 60 μg/kg/h; SAGE-547 90 μg/kg/h
Intervention description: Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.; Intravenous infusion of SAGE-547.; Intravenous infusion of SAGE-547.
Intervention MeSH terms: Pregnanolone; Brexanolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 138.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Severe Postpartum Depression; SAGE-547

Summary:

      The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up
      to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in
      participants with severe postpartum depression (PPD) compared to placebo injection as
      assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total
      score.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants must have ceased lactating at screening; or if still lactating or
             actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to
             their infant(s) from just prior to receiving study drug through nine days (Day 12)
             after the end of the infusion

          -  Participants had a major depressive episode that began no earlier than the third
             trimester and no later than the first 4 weeks following delivery, as diagnosed by
             Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)

          -  Participant had a HAM-D total score of ≥26 at screening and Day 1 (prior to dosing)

          -  Participant was ≤6 months postpartum at screening

          -  Participant was amenable to IV therapy

        Key Exclusion Criteria:

          -  Active psychosis

          -  Attempted suicide associated with index case of postpartum depression

          -  Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.

        Note: Other protocol-defined inclusion/exclusion criteria applied.
Standardization of Surgery on the Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Standard pancreatoduodenectomy; Extended pancreatoduodenectomy
Intervention description: Standard pancreatoduodenectomy; Extended pancreatoduodenectomy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 244.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Pancreatic cancer; Pancreaticoduodenectomy; Extended lymphadenectomy

Summary:

      This study was designed to test the hypothesis that more extensive nodal and soft-tissue
      clearance in patients with adenocarcinoma of the head of the pancreas would improve survival
      without an increase in morbidity and mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age : 20- 85 years old

          -  No evidence of metastasis and to be possible to resect radically

          -  No history of previous radiation therapy or chemotherapy

          -  Pathological diagnosis: adenocarcinoma of pancreas

          -  Patients who agree and sign the informed consent

          -  More than 70 in Karnofsky performance scale

        Exclusion Criteria:

          -  Past medical history of treatment for other malignant disease

          -  Recurred pancreatic cancer patients

          -  Patients with R1/R2 resection

          -  Patients who underwent neoadjuvant chemotherapy
Train New Examiners Via Modified Gingival Margin Plaque
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Fluoride; Triclosan/Fluoride
Intervention description: Brush twice daily; Brush twice daily
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to train new examiners while testing two commercial products
      using our standard one-day brushing study regimen by measuring gingival margin plaque index.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers 18-65 years of age

          -  Good general health

          -  Must sign informed consent form

          -  Must discontinue oral hygiene for 24-hrs.after initial appointment.

          -  Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.

          -  No history of allergy to personal care consumer products, or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study.

        Exclusion Criteria:

          -  Subjects unable or unwilling to sign the informed consent form.

          -  Medical condition which requires pre-medication prior to dental visits/procedures

          -  Moderate or advanced periodontal disease or heavy dental tartar (calculus).

          -  2 or more decayed untreated dental sites at screening.

          -  Other disease of the hard or soft oral tissues.

          -  Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

          -  Use of medications that can affect salivary flow

          -  Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

          -  Pregnant or nursing women.

          -  Participation in any other clinical study within 1 week prior to enrollment into this
             study.

          -  Use of tobacco products

          -  Subjects who must receive dental treatment during the study dates.

          -  Current use of Antibiotics for any purpose.

          -  Presence of an orthodontic appliance.

          -  History of allergy to common dentifrice ingredients.

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)