bioihbjkbjnl/mcl2 huggingface dataset:
Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Eplerenone; Spironolactone
Intervention description: 26 Subjects will take Eplerenone, one 50mg capsule by mouth once daily for 12 months.; 26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months.
Intervention MeSH terms: Eplerenone; Spironolactone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: Male
Minimum age: 7 Years
Healthy volunteers: No

Summary:

      The study is to demonstrate non-inferiority of spironolactone vs. eplerenone in preserving
      cardiac and pulmonary function in patients with preserved LV ejection fraction. Males with
      Duchenne muscular dystrophy (DMD) confirmed clinically and by mutation analysis will be
      enrolled. Subjects will be randomized to either eplerenone or spironolactone. Subjects will
      use a drug diary to record daily compliance of taking the study medication as well as any
      concerns they may have during the study period. Subjects will undergo cardiac magnetic
      resonance imaging (CMR) and pulmonary function tests (PFT) at baseline and then again at 12
      months post enrollment. Subjects will also complete a quality of life questionnaire at
      baseline and 12 months. Degree of elbow contracture will be measured using a goniometer at
      baseline and 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Boys age ≥7 years with DMD confirmed clinically and by mutation analysis able to
             undergo cardiac magnetic resonance (CMR) without sedation

          -  LV EF ≥45% (+/-5%) by clinically-acquired echocardiography, nuclear scan or cardiac
             MRI done within 2 weeks of enrollment

        Exclusion Criteria:

          -  Non-MR compatible implants

          -  Severe claustrophobia

          -  Gadolinium contrast allergy

          -  Kidney disease

          -  Prior use of or allergy to aldosterone antagonist

          -  Use of other investigational therapy.
Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
Condition: Low Back Pain; Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Intervention: NKTR-181 BID tablets
Intervention description: NKTR-181 tablets 100-600 mg twice daily (BID)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 638.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this 52-week open label study is to determine the long-term safety of a new
      opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or
      chronic non-cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-nursing female aged 18 to 75 years old

          -  Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at
             least three months

          -  Not experiencing adequate pain relief or have failed previous treatment with
             non-opioid analgesics

          -  Opioid analgesia is necessary

          -  Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate
             equivalents (MSE) per day of opioid analgesics for at least 7 days prior to entry

          -  Females of child bearing potential must be using a highly effective form of birth
             control. All subjects must agree to use double-barrier contraception during
             participation in this study and for at least 2 months after the last dose of the study
             drug.

          -  Willing and able to provide informed consent

        Exclusion Criteria:

          -  History of hypersensitivity, intolerance, or allergy to opioids

          -  Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during
             the study period

          -  Untreated moderate to severe sleep apnea

          -  Chronic migraines as the primary pain condition

          -  Cancer related pain
A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA)
Condition: Infant, Small for Gestational Age
Intervention: Recombinant human growth hormone (r-hGH)
Intervention description: Recombinant human GH were administered subcutaneously (s.c) at the daily dose of 0.067 mg/kg of body weight to Group A1.
Intervention MeSH terms: Hormones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Infant, small for gestational age; Growth hormone; Saizen

Summary:

      This open, multicentric, randomized, controlled study is planned to evaluate the correlation
      between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in
      SGA children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  SGA at birth (defined as a length at birth equal or below the tenth percentile
             according to the Italian reference table of Bertini and Fabris)

          -  Age of 24 Months

          -  Caucasic

          -  Born at term (i.e. after the 37th completed week of gestation)

          -  Height equal or below (Group A) or up (Group B) the third percentile at the age of 24
             months according to the Tanner reference table

          -  Sufficient GH secretion (more than 10 nanogram (ng)/milliliter (ml)) at least to one
             of the tests commonly used at that age (glucagon, Levo-dopa, arginine, clonidine,
             Growth Hormone Releasing Hormone (GHRH), GH integrated secretion)

          -  Normal level of Thyroid-stimulating hormone (THS), Free Triiodothyronine (FT3), Free
             Thyroxine (FT4), Insulin-like growth factor 1(IGF-1), insulin and haemoglobin A1c
             (HbA1c)

          -  Normal level of Immunoglobulin A (IgA)

          -  Children parents willing to comply with the protocol for the whole duration of the
             study

          -  A written Informed Consent before the baseline visit must be obtained from the
             parent(s) / legal guardian(s)

        Exclusion Criteria:

          -  Congenital malformations (including Silver-Russel syndrome)

          -  Known abnormal karyotype, especially in girls

          -  Twins

          -  Severe psychomotor retardation

          -  Previous or ongoing treatment with anabolic steroids or r-hGH

          -  Treatments interfering with the immune system (including bacterial lysate)

          -  Severe chronic illnesses

          -  Autoimmune diseases
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
Condition: Meniscus Tear, Tibial; Pain, Postoperative; Postoperative Complications; Ketorolac Adverse Reaction; Opioid Use
MeSH terms: Pain, Postoperative; Postoperative Complications; Tibial Meniscus Injuries
Intervention: Ketorolac; Oxycodone-Acetaminophen
Intervention description: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.; Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.
Intervention MeSH terms: Acetaminophen; Ketorolac; Acetaminophen, hydrocodone drug combination; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ketorolac; meniscus tear; analgesics; pain

Summary:

      The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase
      in recent years, partly due to a younger, more active population, and improved technology and
      technique. However, pain management in the post-operative period is critical to the ability
      to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have
      been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents
      are associated with several side effects, including nausea/vomiting, constipation, and
      somnolence. In addition, opioid agents have a significant potential for abuse in comparison
      to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives
      to limit narcotic usage, surgeons must explore alternate pain modalities in the acute
      postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with
      analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the
      beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative
      period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this
      agent following arthroscopic meniscus surgery have not been extensively described.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 18 and 89 years of age

          -  Patients undergoing primary arthroscopic meniscus surgery

        Exclusion Criteria:

          -  Patients age less than 18 or greater than 89 years

          -  Illiterate or non-English speaking patients

          -  Patients with contraindications to ketorolac

          -  History of drug or alcohol abuse

          -  Chronic use of analgesic or psychotropic drugs
Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.
Condition: Wilson's Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: NPC-02
Intervention description: zinc acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      The purpose of this long-term study is to determine whether Zinc Acetate is effective and
      safe in the treatment of Wilson's disease among Japanese.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Wilson's disease(adult, infant, pregnant woman)

        Exclusion Criteria:

          -  Acute hepatitis

          -  Malignant tumor
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Condition: Musculoskeletal Complications; Pain; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: naproxen; placebo
Intervention description: Oral naproxen twice daily for 5-8 days.; Oral placebo twice daily for 5-8 days.
Intervention MeSH terms: Naproxen
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 510.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: pain; musculoskeletal complications; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not
      yet known whether naproxen is more effective than a placebo in preventing bone pain caused by
      pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.

      PURPOSE: This randomized phase III trial is studying naproxen to see how well it works
      compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with
      non-hematologic cancer undergoing chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a non-hematologic (non-myeloid) malignancy

          -  Scheduled to receive chemotherapy; chemotherapy may be given for adjuvant,
             neoadjuvant, curative, or palliative intent

          -  Scheduled to receive the first dose of pegfilgrastim (Neulasta®) to ameliorate
             chemotherapy-induced neutropenia

          -  Creatinine ≤ 1.5 times upper limit of normal

          -  Able to understand English

          -  More than 6 months since prior surgery on the heart

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Clinical evidence of active gastrointestinal bleeding, prior gastrointestinal
             bleeding, or gastric or duodenal ulcers

          -  Allergy to naproxen

          -  Prior development of the triad of asthma, rhinitis, and nasal polyps after taking
             acetylsalicylic acid (aspirin) or other NSAIDs

          -  Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen,
             or any product containing naproxen (e.g., Naprosyn, EC-Naprosyn, Anaprox, Anaprox-DS,
             Naprosyn suspension, or Aleve), on a regular basis

          -  Concurrent steroids on a regular basis

          -  Concurrent prescription or non-prescription medications for preexisting chronic pain;
             concurrent cardioprotective doses (≤ 325 mg/day) of aspirin allowed

          -  Concurrent therapeutic doses of warfarin
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: CSF-1; Vehicle
Intervention description: One drop bilaterally twice daily for approximately 2 weeks.; One drop bilaterally twice daily for approximately 2 weeks.
Intervention MeSH terms: Pilocarpine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 45 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study
      evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have presbyopia.

        Exclusion Criteria:

        Subjects must not:

          -  Have any contraindications to the study medications or diagnoses that would confound
             the study.
Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: neuromuscular electrical stimulation (NMES); Sham electrical stimulation
Intervention description: NMES was applied by means of a commercially available four channel electrostimulator which generated a symmetrical biphasic pulsed current. Each session lasted 30 minutes and was performed 5 days/week for 5 weeks.; Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 60 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to elucidate whether combination of usual pulmonary
      rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise
      capacity in patients affected by chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of COPD

          -  Must be able to walk

        Exclusion Criteria:

          -  Previous or current diagnosis of chronic respiratory failure

          -  A history of diseases other than COPD, in particular neurological disease

          -  Need for treatment with systemic steroids during the rehabilitation period
Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
Condition: Pain; Osteoarthritis, Hip; Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Intervention: OROS hydromorphone HCl; Placebo
Intervention description: 4 to 32 mg taken orally once daily for 16 weeks; placebo tablet once daily for 16 weeks
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 288.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Strong pain killer; Strong opioid; Low starting dose; Fewer side effects; Physical functioning; Pain control; Quality of life; Sleep quality

Summary:

      This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a
      once-daily formulation of a strong opioid against placebo in patients, who are suffering from
      pain due to osteoarthritis of the hip or the knee and who previously did not receive any
      strong opioids.The clinical trial tests the effect of the treatment on symptoms of pain,
      stiffness and physical function. The effect of the treatment on parameters on health related
      quality of life as well as quality of sleep will be measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented Osteoarthritis of the hip or knee

          -  Chronic pain for more than 3 months treated with daily analgesic for the last month

          -  Moderate to severe OA pain of the target joint, which cannot be adequately treated
             with non-steroidal anti-inflamatory drugs or paracetamol

          -  Moderate to severe pain by means of a mean weekly score of >= 5 in the Brief Pain
             Invetory item 5 'pain on average'

        Exclusion Criteria:

          -  Regular treatment with an opioid in the 4 weeks before screening visit (infrequent use
             of tramadol, codeine, tilidine, or dihydrocodeine for no more than 10 days in the 4
             weeks before the screening visit is acceptable, however, treatment must be stopped at
             screening visit)

          -  Diagnosis of major depression

          -  Treatment for epilepsy

          -  Corticosteroid injection within the last 3 months

          -  Major surgery in the 3 months before the start of the study

          -  Women who are pregnant or breast-feeding
Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
Condition: NTM Lung Infection Due to MAC
MeSH terms: Infections
Intervention: LAI 590 mg; Multi-drug regimen
Intervention description: LAI 590 mg QD: administered by inhaling drug product that had been aerosolized in an investigational eFlow nebulizer over approximately 14 minutes; Multidrug antimycobacterial regimen from study INS-212
Intervention MeSH terms: Amikacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ALIS; ARIKAYCE

Summary:

      This is an open-label safety extension study to assess the safety and tolerability of once
      daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen
      in participants with nontuberculous mycobacterial (NTM) lung infections due to Mycobacterium
      avium complex (MAC) who were refractory to therapy and failed to convert in Study INS-212
      (NCT02344004).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. had successfully completed the Month 6 and End of Treatment visits in Study INS-212

          2. had not achieved the INS-212 protocol definition of culture conversion by Month 6 in
             Study INS-212 OR had experienced a relapse or recurrence by Month 6 in Study INS-212.

        Key Exclusion Criteria:

        1. achieved culture conversion without relapse or recurrence in the Study INS-212 study by
        Month 6
A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Inhaled Insulin (Exubera); Standard of Care
Intervention description: Addition of inhaled insulin to pre-existing oral diabetes therapy.; Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Intervention MeSH terms: Insulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 354.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Type 2 diabetes melllitus

Summary:

      To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes
      who are not well controlled on 2 or more oral anti-diabetic agents
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes mellitus type 2

          -  Failing two or more oral anti-diabetic agents

        Exclusion Criteria:

          -  Asthma, COPD

          -  Smoking
A Phase III Study of NK105 in Patients With Breast Cancer
Condition: Breast Cancer Nos Metastatic Recurrent
MeSH terms: Breast Neoplasms
Intervention: NK105; Paclitaxel
Intervention description: IV, Weekly; IV, Weekly
Intervention MeSH terms: Paclitaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 436.0
Sex: Female
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: NK105, Paclitaxel, Breast cancer, Micelle

Summary:

      To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to
      paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent
      breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent of the patient signed by herself.

          -  Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.

          -  Aged 20 to 74 at the time of informed consent.

        Exclusion Criteria:

          -  Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent
             breast cancer.