bioihbjkbjnl/mcl2 huggingface dataset:
Anastrozole Administration in Elderly Hypogonadal Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: anastrozole
Intervention description: 1 mg QD
Intervention MeSH terms: Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: Male
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Aging

Summary:

      The purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to
      reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex
      hormones).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men ages 60 and older

          -  Serum testosterone between 150-300 ng/dL

          -  Symptoms suggestive of androgen deficiency
Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica
Condition: Sciatica
MeSH terms: Sciatica
Intervention: Prednisone; Placebo
Intervention description: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.; Placebo capsules will look the same as the study medication but will not contain active medicine.
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Back Pain; Leg Pain

Summary:

      Sciatica is a condition that causes a sharp, burning pain in the back, buttock, and leg. The
      condition is caused by injury to or compression of the sciatic nerve, which is located in the
      back of the leg. This study will determine the effectiveness of the steroid prednisone in
      decreasing pain and improving function in people with sciatica.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Seeks care at a Kaiser Permanente clinic spine care specialist at the San Jose,
             Redwood City, or Roseville site

          -  Complains of low back pain and functionally incapacitating leg pain extending below
             the knee with a nerve root distribution

          -  Score of at least 20 on the modified Oswestry Disability Index

          -  Appears, in the opinion of the study physician, to be very likely to have a herniated
             lumbar disc

          -  MRI study confirms a herniated disc consistent with the signs and symptoms

        Exclusion Criteria:

          -  Onset of sciatica symptoms occurred more than 3 months before study entry

          -  Cauda equina syndrome

          -  Active cancer

          -  Acute spinal fracture

          -  Currently taking oral steroids

          -  Diabetes mellitus and taking insulin or glycohemoglobin greater than 10%

          -  Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater
             than 110 mm Hg

          -  Pregnant or breastfeeding

          -  Active peptic ulcer disease

          -  History of intolerance to steroid therapy

          -  Bleeding diathesis or anticoagulant therapy

          -  Ongoing litigation or workers compensation claim for low back pain or sciatica

          -  Underwent previous lumbar surgery

          -  Received epidural steroid injection (ESI) within the 12 months before study entry

          -  Unable to read or speak English

          -  Progressive or severe motor loss
Clonidine Versus Adenosine to Treat Neuropathic Pain
Condition: Pain
MeSH terms: Neuralgia
Intervention: clonidine; adenosine; placebo; placebo
Intervention description: Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain.; Adenosine-a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.; inactive substance; inactive substance
Intervention MeSH terms: Adenosine; Clonidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Healthy volunteers: No
Keywords: pain; chronic pain; clonidine; adenosine; complex regional pain syndrome; CRPS; a2-adrenergic agonists; alpha2-adrenergic agonists

Summary:

      The purpose of this study is to determine the effects of clonidine and adenosine on nerve
      pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with complex regional pain syndrome (CRPS), type I involving a lower
             extremity

        Exclusion Criteria:

          -  Pregnancy

          -  Allergy to clonidine

          -  Currently taking clonidine or other direct a2-adrenergic agonists, or taking
             cholinesterase inhibitors

          -  Patients with any serious or unstable medical problems (heart, lung, liver, kidney, or
             nervous system disease)
Developing and Testing a Comprehensive MS Spasticity Management Program
Condition: Multiple Sclerosis; Spasticity
MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis
Intervention: Spasticity: Take Control; Usual care
Intervention description: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures; 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple sclerosis; spasticity; stretching; exercise; rehabilitation

Summary:

      This is a study to determine the impact of education and specific lower extremity stretches
      for MS-related spasticity. The study will evaluate the acceptance and efficacy of education
      and stretching using a randomized controlled pilot trial.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of definite MS

          -  At least 18 years old

          -  Able to walk 25 feet independently with common assistive devices if needed

          -  Presence of spasticity by self-report interfering with usual daily activities

          -  Have an email account and be familiar with using it

          -  Willing to track daily exercise for 4 weeks

          -  Fluent in English

        Exclusion Criteria:

        Other medical or behavioral conditions that would limit participation or completion of the
        study.
Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: CNP520; Placebo
Intervention description: Matching placebo to CNP520 was supplied in capsules.
Intervention MeSH terms: Umibecestat
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 60 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alzheimer's Disease,; Amyloid Beta,; cerebrospinal fluid,; beta secretase

Summary:

      The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for
      Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in
      subsequent efficacy studies.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy status

          -  Body weight: ≥45kg

          -  BMI: 18-34 kg/m2

        Key Exclusion Criteria:

          -  History or presence of any clinically significant disease of any major system organ
             class.

          -  Heavy smoker status

          -  History /presence of clinically significant neurological or psychiatric disorders

          -  Any medical condition that might lead to or is associated with any cognitive deficit

          -  History or presence of severely impaired renal function
Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab; Gemcitabine
Intervention description: Trastuzumab; Gemcitabine
Intervention MeSH terms: Gemcitabine; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as
      well as the additive activity observed for gemcitabine administered in combination with
      trastuzumab, the clinical activity of the combination of gemcitabine administered with
      trastuzumab represents an exciting and ideal combination to further evaluate in Her 2
      over-expressing metastatic breast cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Her-2 positive metastatic breast cancer confirmed by biopsy

          -  Measurable disease

          -  Able to perform activities of daily living without considerable

          -  No previous chemotherapy with gemcitabine

          -  No more than one prior chemotherapy regimen for metastatic breast cancer

          -  Adequate bone marrow, liver and renal function

          -  Normal heart function

          -  Give written informed consent prior to entering this study.

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Received previous treatment with gemcitabine

          -  History of brain metastases

          -  Serious underlying medical conditions

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.
An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
Condition: Liver Neoplasms; Unresectable Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Intervention: Sunitinib (SU011248)
Intervention description: Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver neoplasms, sunitinib, Phase 2

Summary:

      The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and
      then further 25 patients up to a total of 63 eligible patients. If the study gives good
      results it can be expanded to a total of 160 patients. SU011248 will be administered orally
      daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg [milligrams] with
      provision for dose reduction based on tolerability. All patients will receive repeated cycles
      of SU011248 until disease progression, occurrence of unacceptable toxicity, or other
      withdrawal criteria are met. After discontinuation of treatment, patients will be followed up
      in order to collect information on further antineoplastic therapy and survival
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of hepatocellular carcinoma

          -  Patients must present with disease not amenable to curative surgery (i.e. either
             hepatectomy, or liver transplant).

          -  Evidence of measurable disease by radiographic technique

          -  Adequate organ function.

        Exclusion Criteria:

          -  Prior treatment with any systemic treatment for liver cancer

          -  Presence of clinically relevant ascites

          -  Severe hemorrhage <4 weeks of starting study treatment.

          -  Diagnosis of second malignancy within last 3 years

          -  History of or known brain metastases, spinal cord compression, or carcinomatous
             meningitis

          -  Known human immunodeficiency virus (HIV)

          -  Serious acute or chronic illness

          -  Current treatment on another clinical trial

          -  Pregnant or breastfeeding
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
Condition: Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Intervention: BGS649; Placebo
Intervention description: Capsules were taken weekly for a maximum of 24 weeks; Capsules were taken weekly for a maximum of 24 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 271.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hypogonadotropic; hypogonadism; testosterone

Summary:

      The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese
      subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24
      weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a
      6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male subject aged 18 to 65 years inclusive

          -  BMI > 30 kg/m2 and < 50 kg/m2

          -  Serum total testosterone concentration below the normal range

          -  LH levels below the upper limit of normal

          -  Oestradiol levels within or above the normal range of approved assay

          -  At least two symptoms of androgen deficiency present for at least 2 months prior to
             the first Screening Visit, with at least one of these being a sexual dysfunction

        Exclusion Criteria:

          -  Evidence of clinically significant endocrinopathy at screening that may interfere with
             the study assessments

          -  Other types of hypogonadotropic hypogonadism or primary hypogonadism

          -  Any other pituitary or hypothalamic disease
A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: IGF-1; Placebo/saline
Intervention description: IGF-1 is an FDA-approved (IND exemption #113450), commercially available compound that crosses the blood-brain barrier and has beneficial effects on synaptic development by promoting neuronal cell survival, synaptic maturation, and synaptic plasticity.; Placebo
Intervention MeSH terms: Mecasermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Autism Spectrum Disorder; IGF-1

Summary:

      The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of
      autism. We will use a double-blind, placebo-controlled crossover trial design in five
      children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments
      in socialization, language, and repetitive behaviors. We expect to provide evidence for the
      safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic
      Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on
      secondary outcomes of social impairment, language delay, and repetitive behavior, as well as
      on functional outcomes of global severity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet DSM-5 criteria for Autism Spectrum Disorder confirmed by the Autism Diagnostic
             Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule- Generic
             (ADOS-G)

          -  Children between the ages of 5-12 years of age

          -  Language delay (lack of fluent phrase speech) reflected by use of ADOS Module 1 or 2

          -  Must be on stable medication regimens for at least three months prior to enrollment,
             assuming the concomitant medication is safe for use with IGF-1

        Exclusion Criteria:

          -  Closed epiphyses

          -  Active or suspected neoplasia

          -  Intracranial hypertension

          -  Hepatic insufficiency

          -  Renal insufficiency

          -  Cardiomegaly/valvulopathy

          -  History of allergy to IGF-1

          -  Patients with comorbid conditions deemed too medically compromised to tolerate the
             risk of experimental treatment with IGF-1
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
Condition: Asthma
MeSH terms: Asthma
Intervention: AZD5069; Placebo
Intervention description: AZD5069 oral capsules self-administered twice daily.; Placebo oral capsules self-administered twice daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1147.0
Sex: All
Minimum age: 18 Years
Maximum age: 150 Years
Healthy volunteers: No
Keywords: Uncontrolled Asthma,; Exacerbation,; Safety

Summary:

      The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of
      AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS)
      and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged 18 years and above. Females of childbearing potential must use a
             highly effective contraceptive method plus a condom by their male partner.

          -  Diagnosis of asthma for at least 12 months (GINA 2011)

          -  Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and
             LABA, and with a history of exacerbations during the last year

          -  Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment

          -  Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)

        Exclusion Criteria:

          -  Any clinically significant disease or disorder (including any chronic lower
             respiratory disease other than asthma) that may put the patient at risk or influence
             study results

          -  Patients with recurrent, latent, or chronic infections

          -  Active tuberculosis or latent tuberculosis without completion of an appropriate course
             of treatment or prophylactic treatment

          -  Significant lower respiratory tract infection not resolved within 30 days prior to
             enrolment

          -  Current smoker or smoking history of more than 20 pack years
Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification
Condition: Cataract; Phacoemulsification Cataract Surgery
MeSH terms: Cataract
Intervention: PRO-155; Nevanac
Intervention description: Pre-medication (before surgery) and maintenance treatment.; Pre-medication (before surgery) and maintenance treatment.
Intervention MeSH terms: Nepafenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bromfenac; nepafenac; cataract; phacoemulsification cataract surgery

Summary:

      The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution
      PRO-155 in patients post phacoemulsification.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients older than 18 years who require cataract surgery

          -  Both genders

          -  Provide informed consent

          -  Normal Laboratory results

        Exclusion Criteria:

          -  Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery

          -  Patients with any trans-surgical complication

          -  Patients with a cataract >NC4, C4 or P4 classified with the system LOCS

          -  Patients with any active corneal pathology

          -  Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior
             surgery or NSAIDs 7 days before the surgery (except low-dose aspirin)

          -  Patients with IOP <5 or >21 mmHg

          -  Patients that have ocular pain, cellularity or flare at the moment of selection

          -  Patients with ocular exfoliation, trauma or any inflammatory disease

          -  Patients with diabetic retinopathy that need treatment or uncontrolled diabetes
             mellitus

          -  Patients who are planning cataract surgery of the contralateral eye 14 days after
             surgery of the study eye

          -  Patients with history of hypersensitivity or contraindication for any drug used in the
             study

          -  Patients under anticoagulant treatment

          -  Contact lens users

          -  Pregnant patients, at risk of pregnancy or breastfeeding

          -  Patients without birth control treatment

          -  Patients with any active toxicomania (alcoholism, cigarette, cannabis or others)

          -  Patients who had participated in any clinical trial in the last 90 days

          -  Legal or mentally disabled patients who could not give informed consent

          -  Patients who cannot comply with all study requirements