bioihbjkbjnl/mcl2 huggingface dataset:
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Intervention: LAT8881; Placebo
Intervention description: Two 30 mg capsules of LAT8881; Two capsules of placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a randomised, placebo controlled, double blind, crossover proof of concept study to
      investigate the efficacy and safety of oral LAT8881 in acute migraine, with or without aura.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females aged 18 to 75 years at the time of consent

          2. Diagnosis of episodic migraine headache at least 12 months ago with or without aura as
             defined in International Classification of Headache-3

          3. Onset of migraine headache before age 50

          4. Medical history of 2 - 8 migraine headache attacks per month for the previous 12
             months; ≥ 75% of attacks progress to moderate or severe pain within 2 hours (ie,
             rapidly-escalating)

          5. Minimum 48 hours on average between migraine headache attacks

          6. Acute headache medication on ≤ 14 days/month in the 3 months prior to screening

          7. Willing and able to comply with all study procedures including completion of a
             headache diary and a migraine diary on the day of a migraine headache

        Exclusion Criteria:

          1. Unable to distinguish migraine from other primary headache conditions

          2. Average of 15 or more headache (migraine or nonmigraine) days per month or history of
             more than 25% of headaches occurring at time of wakening (wake up headaches)

          3. History of aura lasting more than 60 minutes

          4. History of vomiting within 2 hours of onset of a migraine headache in more than 25% of
             migraine headaches

          5. Medication overuse headache, defined as:

               1. use of opioids, triptans or ergot alkaloids or any combination of these
                  medications for treatment of headaches 10 or more days per month during the 90
                  days prior to screening OR

               2. Non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics for treatment
                  of headaches on more than 14 days per month during the 90 days prior to screening

          6. Recent (3 years) history of frequent or chronic hemiplegic/ basilar migraine, tension
             headache, retinal migraine, ophthalmoplegic migraine as per ICHD classification, or
             treatment resistant atypical migraine

          7. Hospital admission for status intractable migraine or medication overuse headache
             within 6 months of screening
A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Ruxolitinib; Capecitabine; Placebo
Intervention description: 5 mg tablets to be administered by mouth
Ruxolitinib 15 mg BID (starting dose); Capecitabine 2000 mg/m^2 daily given as 1000 mg/m^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle; 5 mg matching placebo tablets to be administered by mouth
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer

Summary:

      This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the
      overall survival of women with advanced or metastatic HER2-negative breast cancer who
      received treatment with capecitabine in combination with ruxolitinib versus those who
      received treatment with capecitabine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast

          -  Locally advanced (Stage 3B) or metastatic (Stage 4) disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

          -  Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant
             therapy) for advanced or metastatic disease

          -  Participants with hormone-receptor positive tumors must have failed available lines of
             hormonal therapy unless hormone therapy was not tolerated or not clinically
             appropriate

          -  ≥ 2 weeks elapsed from the completion of previous treatment regimen and must have
             recovered or be at a new stable baseline from any related toxicities

          -  Radiographically measurable or evaluable disease

          -  An mGPS of 1 or 2 as defined below:

               -  Criteria:

                    1. modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥
                       35 g/L

                    2. mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L

        Exclusion Criteria:

          -  Received prior treatment with capecitabine or fluoropyrimidine for advanced or
             metastatic disease

          -  Received more than 2 prior regimens for advanced or metastatic disease (not including
             hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)

          -  Unknown hormone-receptor status

          -  Ongoing radiation therapy or radiation therapy administered within 2 weeks of
             enrollment

          -  Concurrent anticancer therapy

          -  Inadequate renal, hepatic or bone marrow function

          -  Another current or previous malignancy within 2 years of study entry unless approved
             by the sponsor
Phase II Study of Curcumin vs Placebo for Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Placebo; Curcumin
Intervention description: daily placebo for 6 weeks; 500 mg BID
Intervention MeSH terms: Curcumin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Chemotherapy; Radiotherapy; NF-kB; DNA Binding; Curcumin; IL-6; TNF; sTNFR2; IL-1-ra; Fatigue; Cytokine

Summary:

      The main purpose of the investigation is to determine if curcumin reduces NF-kB DNA binding
      and ultimately its downstream mediator IL-6 in patients receiving XRT for their breast cancer
      after having completed chemotherapy. Patients who have received prior chemotherapy will be
      eligible, because we have found that this enriched population is at particular risk for
      exhibiting increased NF-kB DNA binding and IL-6 following XRT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female breast cancer patients over the age of 18 will be recruited for this study.
             Patients enrolled in the study will meet standard criteria for whole breast XRT.

        Exclusion Criteria:

          -  Subjects will be excluded for a number of medical conditions that are
             contraindications to XRT and/or might confound the relationship among fatigue, and
             inflammation, including pregnancy, major psychiatric disorders, autoimmune or
             inflammatory disorders, chronic infectious diseases (e.g. HIV, hepatitis B or C),
             neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal
             disease (as determined by medical history, physical examination and laboratory
             testing). Subjects with a history of a major psychiatric disorder including
             Schizophrenia or Bipolar Disorder or a diagnosis of Substance Abuse or Dependence
             within the past 1 year (as determined by standardized psychiatric interview) will be
             excluded. Subjects taking drugs known to affect the immune system (e.g.
             glucocorticoids, methotrexate) will also be excluded. Subjects using supplements or
             other natural products with one week of starting medications, excluding vitamins and
             calcium supplementation or at the discretion of the attending physician, will be
             excluded. Patients who have evidence of infection as determined by history, physical
             exam or laboratory testing (complete blood count and urinalysis) at baseline will be
             excluded. In addition, patients who develop evidence of infection (as determined by
             history, physical exam or laboratory testing) during the study will be discontinued
             from the study.
A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Comparator: Placebo; MK0974; MK0974; MK0974; MK0974; MK0974; MK0974; MK0974; Rizatriptan
Intervention description: Placebo to match assigned treatment arm; one orally-administered dose; MK0974 25 mg; one orally-administered dose; MK0974 50 mg; one orally-administered dose; MK0974 100 mg; one orally-administered dose; MK0974 200 mg; one orally-administered dose; MK0974 300 mg; one orally-administered dose; MK0974 400 mg; one orally-administered dose; MK0974 600 mg; one orally-administered dose; Rizatriptan 10 mg; one orally-administered dose
Intervention MeSH terms: Rizatriptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 420.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the efficacy and safety of an MK 0974 for
      migraine headache and to identify an appropriate dose range for further study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has at least 1 year history of migraine (with or without aura)

          -  Females of childbearing years must use acceptable contraception throughout trial

          -  Patient is in general good health based on screening assessment

        Exclusion Criteria:

          -  Patient is pregnant/breast-feeding (or is a female expecting to conceive during the
             study period)

          -  Patient has heart disease, uncontrolled hypertension (high blood pressure),
             uncontrolled diabetes or other significant disease

          -  Patient has major depression, other pain syndromes that might interfere with study
             assessments, psychiatric conditions, dementia, or significant neurological disorders
             (other then migraine)

          -  Patient has a history of gastric or small intestinal surgery or has a disease that
             causes malabsorption

          -  Patient has a history of cancer within the last 5 years
PsA Treatment With hOKT3γ1 (Ala-Ala)
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: hOKT3gamma1(Ala-Ala); Placebo
Intervention description: Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle; Intravenous dose of placebo given over 5 days of each 28 day cycle
Intervention MeSH terms: Muromonab-CD3
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Arthritis; Psoriasis; Psoriatic; PsA

Summary:

      hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ
      rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe
      and effective in psoriatic arthritis patients who are unable to control their arthritis with
      methotrexate or azathioprine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of psoriatic arthritis. Participants do not need to have concurrent
             psoriasis to participate in the study;

          -  Active inflammation in 3 or more joints;

          -  Currently receiving ongoing therapy with methotrexate or azathioprine; and

          -  Willing to use acceptable forms of contraception.

        Exclusion Criteria:

          -  Active infection with HIV, hepatitis C virus, or hepatitis B virus;

          -  Uncompensated heart failure or a recent myocardial infarction (heart attack) within
             the 6 months prior to study entry;

          -  Certain other serious illnesses or cancers;

          -  Participation in another clinical trial within the 6 weeks prior to study entry; or

          -  Pregnant or breastfeeding.
Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: LIK066
Intervention description: LIK066 50 mg tablets taken orally once daily before breakfast for 7 days.
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: renal function; sodium-glucose co-transporter; pharmacokinetics; decreased renal function; decreased kidney function; kidney disease; urinary glucose excretion; UGE

Summary:

      The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose
      excretion in urine in patients with varying degrees of decreased kidney function and in
      subjects with normal kidney function. Blood samples were collected to measure the
      concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is
      meant to study how LIK066 is absorbed, distributed and eliminated, in other words what the
      body does to the drug. The results of this study may be used to help determine whether LIK066
      can be used to treat people with reduced kidney function and the proper dosing regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed.

          -  Male and female subjects age 18-78 years, inclusive, with controlled health condition
             as determined by past medical history, physical examination, electrocardiogram and
             laboratory test at screening.

          -  patients with Type 2 diabetes, HbA1c <10% at screening.

          -  Body mass index (BMI) ≤ 50 kg/m^2 at screening.

        Exclusion Criteria:

          -  Patients with Type 1 diabetes

          -  Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline
             phosphatase >3 X ULN; serum bilirubin > 1.5 X ULN.

          -  Patients undergoing any method of dialysis

          -  clinically significant GI disorder related to malabsorption or that may affect drug or
             glucose absorption.

          -  subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6
             months of screening visit.
Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Condition: Primary Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Milnacipran
Intervention description: maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Fibromyalgia; Pediatric Fibromyalgia; Adolescent Fibromyalgia; milnacipran; Savella; loss of therapeutic response; Forest Research Institute; Pain; Fatigue; Serotonin Norepinephrine Reuptake Inhibitors

Summary:

      The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in
      pediatric patients aged 13 to 17 years with primary fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have completed or discontinued prematurely from lead-in study,
             MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran

        Exclusion Criteria:

          -  Can not tolerate a minimum daily dose of 50mg milnacipran

          -  Significant risk of suicidality

          -  Pregnant or breastfeeding
A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BMS-986036; Placebo (Matching with BMS-986036)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 219.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults
      with type-2 diabetes.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Diagnosed with type-2 diabetes mellitus with HbA1c ≥6.5% to less than 10.0%

          -  Body mass index 30.0 to 50.0

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Inability to self-administer subcutaneous injections

          -  Inability to be venipunctured

          -  Evidence of organ dysfunction beyond what is consistent with the target population

          -  History of allergy to PEGylated compounds or Fibroblast growth factor 21 (FGF21)
             related compounds
Pharmacokinetic Study to Determine Time to Steady-state
Condition: Male Hypogonadism; Primary Hypogonadism; Secondary Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone undecanoate
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
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to confirm how long (i.e., how many days) it takes to reach
      steady-state when testosterone undecanoate is administered twice daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, age 18-75

          -  Morning serum testosterone (T) <300 ng/dL on two occasions

          -  Naive to androgen-replacement therapy or willing to wash-out from current T therapy

        Exclusion Criteria:

          -  Significant intercurrent disease

          -  Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history
             of prostate cancer.

          -  Serum transaminases >2 times upper limit of normal

          -  Serum bilirubin >2.0 mg/dL

          -  Hematocrit <35% or >50%

          -  BMI >36

          -  Untreated, obstructive sleep apnea.
A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
Condition: Neuralgia, Postherpetic
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: AGN-214868; AGN-214868 Placebo (Vehicle)
Intervention description: AGN-214868 given as injections into the area of pain on Day 1.; AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia
      (PHN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postherpetic neuralgia with pain present for at least 9 months

        Exclusion Criteria:

          -  Active herpes zoster skin rash

          -  Anticipated treatment for postherpetic neuralgia during the first 3 months of the
             study, including oral and topical medications, acupuncture, spinal cord stimulation,
             transcutaneous nerve stimulation (TNS), or trigger point injection

          -  Anticipated treatment with pain medication for the treatment of postherpetic neuralgia
             during the first 3 months of the study

          -  Use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated
             use during the first 3 months of the study

          -  Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated
             use during the study