bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Oral testosterone undecanoate (TU) (300 mg T equivalents/dose); Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose); Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food); Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)
Intervention description: Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.; Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.; Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods.; Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner.
Masking: None (Open Label)
Enrollment: 29.0
Sex: Male
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: testosterone; male hypogonadism; low testosterone

Summary:

      The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester
      formulations can be used effectively to treat men with low testosterone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, ages 18-68

          -  Serum total T less than or equal to 275 ng/dL

        Exclusion Criteria:

          -  Significant intercurrent disease of any type, in particular, liver, kidney or heart
             disease, uncontrolled diabetes mellitus or psychiatric illness.

          -  Abnormal prostate digital rectal examination, elevated prostate-specific antigen
             (PSA), American Urological Association (AUA) symptom score of >15, and/or history of
             prostate cancer.

          -  Hematocrit of <35 or >50%

          -  Body mass index (BMI) >36

          -  Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2.0 mg/dL
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: 4 mg CLS-TA; Sham; IVT aflibercept
Intervention description: 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension); suprachoroidal sham procedure; 2 mg intravitreal injection of aflibercept
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RVO; ME; Central Subfield Thickness; OCT; optical coherence tomography; cystoid macular edema; subretinal fluid; Eylea; aflibercept; anti-VEGF

Summary:

      A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to
      evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA,
      triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT)
      injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein
      occlusion (RVO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of macular edema following RVO

          -  History of ME ≤ 12 months

          -  20-70 letters inclusive BCVA using ETDRS

        Exclusion Criteria:

          -  has had an IVT injection of anti-VEGF for RVO in the study eye

          -  has had a corticosteroid injection in the past 3 months in the study eye

          -  any uncontrolled ophthalmic condition in the study eye other than RVO
Study of OPA-15406 Ointment in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: OPA-15406; Placebo
Intervention description: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.; Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 15 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in
      patients with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

        Exclusion Criteria:

          -  Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a
             sudden intensification of atopic dermatitis.

          -  Subjects who have an active viral skin infection.

          -  Subjects with a current or history of malignancy.
PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: PF-04856884; Axitinib (AG-013736); Axitinib (AG-013736)
Intervention description: 15 mg/kg/week intravenously [IV] until toxicity or disease progression; 5 mg PO BID; 5 mg PO BID
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CVX-060; PF-04856884; AG-013736; axitinib; mRCC; metastatic renal cell cancer; second line; anti-angiogenic; Ang-2

Summary:

      To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736)
      in patients that have received one prior systemic regimen for metastatic renal cell carcinoma
      (mRCC) vs. axitinib alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or female patients with histologically or cytologically confirmed renal
             cell cancer (RCC) with a component of clear cell subtype and evidence of metastasis

          -  Evidence of unidimensionally measurable disease

          -  Prior therapy: Part I: Having received 1 to 3 prior systemic regimens for treatment of
             mRCC

          -  Part II: Evidence of disease progression following 1 prior regimen administered as 1st
             line therapy for mRCC. The prior regimen must have contained one of the following:
             VEGFR2 tyrosine kinase inhibitor (TKI) or other anti VEGF [Vascular Endothelial Growth
             Factor] compounds, such as bevacizumab

          -  adequate bone marrow, liver and renal function

        Exclusion Criteria:

        Part I:

          -  Intolerant to prior AG 013736 therapy or prior treatment with compounds which contain
             the core platform antibody as PF 04856884

        Part II:

          -  Prior AG 013736 therapy, more than one systemic first-line regimen for the treatment
             of mRCC and prior treatment with compounds which contain the core platform antibody as
             PF 04856884

          -  major surgery <4 weeks or radiation therapy <2 weeks prior to start of therapy

          -  clinically significant gastrointestinal abnormalities

          -  current use or anticipated need for drugs that are known potent CYP3A4 inhibitors and
             drugs that are known CYP3A4 or CYP1A2 inducers

          -  history of bleeding diathesis or coagulopathy

          -  Grade 3 or greater hemorrhage from any cause <4 weeks prior to screening;

          -  hemoptysis >½ teaspoon of blood per day within 2 weeks prior to screening.
Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Carboplatin/Paclitaxel; Trastuzumab
Intervention description: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.; Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
Intervention MeSH terms: Paclitaxel; Carboplatin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Healthy volunteers: No
Keywords: Uterine serous papillary carcinoma; Type II endometrial cancer; HER2/neu; Paclitaxel, Carboplatin, Trastuzumab

Summary:

      The primary objective of this study is to estimate whether the addition of trastuzumab to
      paclitaxel and carboplatin chemotherapy improves progression free survival when compared to
      paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients
      overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence
      in situ hybridization (FISH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have advanced (stage III-IV) or recurrent histologically confirmed USPC
             with measurable disease.

          -  Patients must harbor a tumor HER2/neu+ based upon IHC staining score of 3+ or 2+ with
             confirmed gene amplification by FISH

        Exclusion Criteria:

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancers, significant history of cardiac disease, uncontrolled
             hypertension, unstable medical issue, brain leptomeningeal, prior therapy with
             trastuzumab, uncontrolled seizure disorder, seropositive for HIV, active hepatitis,
             hemorrhagic diathesis or requiring supplemental oxygen.
Pilot Study of Pyridostigmine Upon Immune Activation in HIV-1 Patients Who Have an Inadequate Immune Response
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Pyridostigmine tablets
Intervention description: Patients will take 30mg tid PO for 12 weeks
Intervention MeSH terms: Pyridostigmine Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIDS; Immunological non-responders; Neuroimmune modulation; Pyridostigmine; Treatment Experienced

Summary:

      The purpose of this study is to determine whether the addition of Pyridostigmine to Highly
      Active Antiretroviral Therapy (HAART) increases the number of CD4+ T-cells in discordant
      patients in which viral load diminishes, but T-cell levels remain low after the initiation of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected subjects 18 years of age or older

          -  Receiving HAART for at least two years

          -  At least a viral load determination per year since HAART initiation, all undetectable

          -  Patient's status is Immunological Non Responder (InR), that is, his or her viral load
             is reduced, but CD4+ cell count has not raised accordingly

          -  Current viral load: undetectable

          -  Patient agrees and signs informed consent

        Exclusion Criteria:

          -  Concomitant active infectious or neoplastic disease

          -  History of new AIDS-defining events during HAART

          -  Pregnancy or breast-feeding

          -  Patients who have been subjects of an investigational agent, chemotherapy or
             radiotherapy within the previous 28 days

          -  Subjects requiring treatment for Tuberculosis

          -  Subjects unable to follow, or comply with the protocol interventions

          -  Subjects receiving immunosuppressive treatment, including corticosteroids
A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Condition: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MeSH terms: Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Intervention: Rozanolixizumab
Intervention description: Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Intervention MeSH terms: Rozanolixizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic inflammatory demyelinating polyradiculoneuropathy; CIDP; UCB7665; rozanolixizumab

Summary:

      The purpose of the study is to assess long-term safety and tolerability of weekly doses of
      rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy
      (CIDP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject who has completed one of the previous rozanolixizumab study(ies) that allow
             access to the present study (e.g. study CIDP01)

          -  Female subjects of childbearing potential must agree to use a highly effective method
             of birth control, during the study and for a period of 3 months after their final dose
             of investigational medicinal product (IMP)

          -  Male subjects with a partner of childbearing potential must be willing to use a condom
             when sexually active during the study and for 3 months after the final administration
             of IMP

        Exclusion Criteria:

          -  Subject has any medical (acute or chronic illness) or psychiatric condition that, in
             the opinion of the investigator, could harm the subject or would compromise the
             subject's ability to participate in this study

          -  Subject has a clinically relevant active infection (eg, sepsis, pneumonia, abscess)

          -  Subject has a known hypersensitivity to any components of rozanolixizumab

          -  Subject intends to have a live vaccination during the course of the study or within 7
             weeks following the final dose of rozanolixizumab

          -  Subject has an ongoing serious adverse event (SAE) or a medical condition in the
             parent study that the investigator considers to put the subject at a significantly
             increased risk of participating in CIDP04

          -  Subject has any planned elective surgery due to occur during the study dosing period
             which in the opinion of the investigator could interfere with study procedures
A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: Lipitor; Placebo
Intervention description: 40mg caplets per day for six weeks; 1 placebo caplet per day for six weeks.
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Polycystic Ovary Syndrome

Summary:

      The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the
      treatment of PCOS with elevated LDL cholesterol.
    

Eligibility criteria:

        Inclusion Criteria: Women with PCOS

          -  8 or fewer menstrual periods per year

          -  elevated serum total testosterone

          -  elevated LDL cholesterol

        Exclusion Criteria:

          -  current pregnancy or breastfeeding

          -  current use of oral contraceptives, progestins

          -  insulin sensitizing medications

          -  thyroid disease, hyperprolactinemia, active liver disease, type 1 or type 2 diabetes
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine nasal spray; Placebo
Intervention description: Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries; placebo nasal spray 1, 2 3, and 4 puffs
Intervention MeSH terms: Rotigotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Rotigotine; Rotigotine nasal spray; Efficacy, safety and tolerability; Parkinson's disease

Summary:

      The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM
      952) in a single dose application scheme.

      Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be
      checked. Subjects will then be hospitalized for one night. In the morning of the next day,
      subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then
      receive a single dose of trial medication. Safety assessments after application include
      adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and
      laboratory checks. Efficacy will be assessed by application of motor examination scores.

      The first subject is planned to be enrolled in February 2006. The last subject is planned to
      be enrolled in May 2006. Last subject out is expected for August 2006.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects with idiopathic Parkinson's disease for at least 3 years in
             duration

          -  At least 30 years of age

        Exclusion Criteria:

          -  Patients with atypical Parkinson's or clinically relevant concomitant diseases or
             medical conditions
To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: tetomilast (OPC-6535); tetomilast (OPC-6535); tetomilast (OPC-6535); placebo
Intervention description: oral administration of 12.5mg OPC-6535, once daily for 24months; oral administration of 25mg OPC-6535, once daily for 24months; oral administration of 50 mg OPC-6535, once daily for 24months; oral administration of placebo, once daily for 24months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 771.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; emphysema

Summary:

      To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of
      trough FEV1 over time as the primary endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 40 to 75 years, inclusive, at the time informed consent is obtained

          -  Ability to provide own written informed consent

          -  Agree to use an appropriate method of contraception until 3 months after the last dose
             of the investigational medicinal product (IMP)

          -  A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by
             chest CT scan at screening

          -  Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of
             less than 70% at screening

          -  Cigarette smoking history of at least 20 pack years at screening

        Exclusion Criteria:

          -  Subjects with obstructive disorders due to bronchial asthma

          -  Subjects receiving long-term oxygen therapy

          -  Subjects with active tuberculosis or obvious bronchiectasis

          -  Complication of malignant tumor

          -  Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders

          -  Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to
             the start of washout period (within 12 weeks prior to start of treatment period)