bioihbjkbjnl/mcl2 huggingface dataset:
Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Condition: Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia
Intervention: Neugranin; Pegfilgrastim; Chemotherapy
Intervention description: Neugranin will be administered per dose and schedule specified in the arm description.; Pegfilgrastim will be administered per dose and schedule specified in the arm description.; The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 in combination
Intervention MeSH terms: Docetaxel; Doxorubicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 381.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Determination of the effect of neugranin on the duration and severity of severe neutropenia
      in participants receiving doxorubicin in combination with docetaxel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast cancer participants scheduled to receive the AT regimen (doxorubicin/
             docetaxel)

        Exclusion Criteria:

          -  Participants may have received no more than 1 prior chemotherapy regimen (including
             adjuvant therapy if given within the last 12 months)
Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
Condition: Opioid-induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: Naldemedine; Placebo
Intervention description: Naldemedine 0.2 mg tablet taken orally once a day; Placebo tablet taken orally once a day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 547.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Opioid-induced Constipation

Summary:

      The purpose of this study is to evaluate the efficacy and safety of naldemedine in the
      treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who
      are not using laxatives.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects aged 18 to 80 years inclusive at the time of informed consent

          2. Subjects must have non-malignant chronic pain treated with opioids and must have
             opioid-induced constipation (OIC)

          3. Subjects must be treated with a stable opioid regimen at a total daily dose on average
             of ≥ 30 mg equivalents of oral morphine sulfate

          4. Subjects must not be currently using laxatives or must be willing to discontinue
             laxative use at Screening and must be willing to use only the rescue laxatives
             provided throughout the study duration

          5. Subjects must meet opioid-induced constipation criteria based on the Bowel Movement
             and Constipation Assessment (BMCA) Diary

        Exclusion Criteria:

          1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract

          2. Evidence of active medical diseases affecting bowel transit

          3. History or presence of pelvic disorders that may be a cause of constipation

          4. Surgery (except for minor procedures) within 60 days of Screening

          5. History of chronic constipation prior to starting analgesic medication or any
             potential non-opioid cause of bowel dysfunction that may be a major contributor to the
             constipation (e.g., mechanical GI obstruction)

          6. Subjects who have never taken laxatives for the treatment of OIC

          7. History of active treatment for cancer within the last 2 years (except for basal cell
             or squamous cell carcinoma of the skin that have been successfully resected) or
             tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of
             breast cancer

          8. Current use of any prohibited medication including opioid antagonists, partial
             agonists or mixed agonists/antagonists
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: SMC021 Oral Calcitonin; SMC021 Placebo
Intervention description: 0.8mg SMC021 (Oral Calcitoinin) twice daily; Placebo orally, twice daily
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1176.0
Sex: All
Minimum age: 51 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability

Summary:

      The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon
      calcitonin in the treatment of patients with osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medical history and symptoms of knee osteoarthritis

        Exclusion Criteria:

          -  Any other disease or medication affecting the bone or cartilage.

          -  Any clinical signs or laboratory evidence diseases, which in the Investigator's
             opinion would preclude the participant from adhering to the Protocol or completing the
             trial.

        Other protocol defined inclusion/exclusion criteria may apply
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Intervention: Ciprofloxacin (BAYQ3939) dry powder for inhalation; Ciprofloxacin (BAYQ3939) dry powder for inhalation; Placebo; Placebo
Intervention description: Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.; Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.; Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off; Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 521.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ciprofloxacin; Dry Powder for Inhalation; Exacerbation; Bronchiectasis

Summary:

      The purpose of this study is to evaluate if the time to first pulmonary exacerbation of
      bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days
      every other 28 days or for 14 days every other 14 days over 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a proven and documented diagnosis of non CF idiopathic or post
             infectious bronchiectasis

          -  Stable pulmonary status and stable regimen of standard treatment at least for the past
             4 weeks

        Exclusion Criteria:

          -  Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted

          -  Active allergic bronchopulmonary aspergillosis

          -  Active and actively treated non tuberculosis mycobacterial (NTM) infection or
             tuberculosis

          -  Primary diagnosis of Chronic obstructive pulmonary disease (COPD)
Effect of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Knee Replacement
Condition: PAIN
Intervention: Pregabalin; Pregabalin; Placebo
Intervention description: Group 1 (n=16, multi-dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
Group 2 (n=16, single dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
Group 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2.; Group 2 (n=16, single dose pregabalin): patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.; Group 3 (n=16, placebo): patients receive matching placebo at the same 3 time points as Groups 1 and 2.
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 55 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pregabalin; CSF; Neurotransmitter

Summary:

      This study involves research. Pregabalin is a Food and Drug Administration (FDA) medication
      approved in the United States for the treatment of nerve pain related to diabetes and
      post-herpetic neuralgia "shingles", and for seizures in adults. The purpose of this research
      is to study the effect of oral Pregabalin on spinal neurotransmitters in subjects undergoing
      Total Knee Replacement Surgery (TKA). TKA is associated with considerable postoperative pain
      which if unrelieved may result in prolonged hospital stay, inability to participate in
      rehabilitation programs, poor outcomes, and greater use of health-care resources. This study
      examines the effect of pregabalin administered for TKA on pain-related neurotransmitter
      concentrations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of osteoarthritis

          -  Subjects who can understand and communicate in English

        Exclusion Criteria:

          -  Younger than 55 years or older than 75 years.

          -  American Society of Anesthesiologists physical status IV

          -  Prior use of pregabalin or gabapentin will not be an exclusionary criterion; however
             patients will have been withdrawn from these medications at least 14 days before
             surgery

          -  Patients who are currently enrolled in another investigational study.
Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: Interferon γ-1b
Intervention description: The study drug dose is planned to be escalated on a weekly basis over the first 4 weeks of treatment (from 10 µg/m² to 25, 50, and 100 µg/m²). The dose may be reduced, interrupted, or held based on tolerability. By Week 13, all participants are to be on a stable tolerated dose of study drug in order to continue study participation; the dose may not be further increased after Week 13, however, it may be reduced on a case-by-case basis to manage drug-related adverse events (AEs).
Intervention MeSH terms: Interferons; Interferon-gamma
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 10 Years
Maximum age: 26 Years
Healthy volunteers: No
Keywords: Interferon gamma

Summary:

      The purpose of this phase 3 multi-center, open-label extension study is to evaluate the
      long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and child assent, if applicable.

          -  Completed 26 weeks of blinded treatment in Study HZNP-ACT-301 (NCT02415127).

          -  If female, the subject is not pregnant or lactating or intending to become pregnant
             during the study, or within 30 days after the last dose of study drug. Female subjects
             of child-bearing potential must have a negative urine pregnancy test result at
             Baseline/Day 1 (Week 26 of Study HZNP-ACT-301 [NCT02415127]), and agree to use a
             reliable method of contraception throughout the study and for 30 days after the last
             dose of study drug.

        Exclusion Criteria:

          -  Subjects will be ineligible if, in the opinion of the Investigator, they are unlikely
             to comply with the study protocol or have a concomitant disease or condition that
             could interfere with the conduct of the study or potentially put the subject at
             unacceptable risk.

        NOTE: Additional inclusion/exclusion criteria may apply.
Rhodiola Rosea Therapy of Major Depressive Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Herbal extract; Sertraline; Lactose monohydrate
Intervention description: 340-1,360 mg daily; 50-200 mg daily; 1-4 capsules daily
Intervention MeSH terms: Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Depression; Antidepressant Therapy; Herbal Treatment; Rhodiola rosea; Alternative Therapy

Summary:

      Prior research has shown that Rhodiola rosea may be an effective, short-term, anti-depressant
      therapy. This study will examine the anti-depressant effect of Rhodiola rosea vs. a
      conventional, anti-depressant drug in the treatment of major depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women (all races and ethnicity) ≥ 18 years old

          -  DSM IV Axis I diagnosis of mild to moderate Major Depressive Disorder

          -  Baseline CGI/S rating of 3 ('mild') or 4 ('moderate')

          -  Baseline Hamilton Depression Rating score ≥ 10

          -  Not receiving other antidepressant therapy

          -  Able to provide signed informed consent

        Exclusion Criteria:

          -  Patients < 18 years old

          -  Current primary DSM IV Axis I diagnosis other than Major Depressive Disorder

          -  CGI/S rating of 5 ('marked'), 6 ('severe') or 7 ('very severe')

          -  Actively suicidal or requiring hospitalization

          -  Uncontrolled medical condition

          -  Pregnant or nursing women

          -  Women of child-bearing potential not using a medically acceptable form of
             contraception

          -  Concurrent use of herbal remedies or mineral supplements [Note: Use of mineral
             supplements prescribed for medical purposes (e.g., osteoporosis) will not be excluded]

          -  Current use of chemotherapy or other medication (e.g., interferon) known to produce
             fatigue or mood changes

          -  Known sensitivity to R. rosea or sertraline

          -  History of non-response to sertraline in the current depressive episode
An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Telmisartan80mg+Amlodipine5mg; amlodipine 5mg; Telmisartan80mg+Amlodipine 5mg
Intervention description: combination therapy; monotherapy; combination therapy
Intervention MeSH terms: Amlodipine; Telmisartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 324.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this trial is to demonstrate that the fixed-dose combination of
      telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing
      seated trough diastolic blood pressure (DBP) at 8 weeks.
    

Eligibility criteria:

        Inclusion criteria:

          1. diagnosis of essential hypertension

          2. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy

          3. provision of written informed consent

        Exclusion criteria:

        1. clinical conditions which, in the opinion of the investigator, would not allow safe
        completion of the protocol and safe administration of telmisartan and amlodipine for the
        planned duration of this trial (e.g. populations where labeling of either product
        recommends against its utilization)
Safety Study of the VEGA UV-A System to Treat Ectasia
Condition: Ectasia
MeSH terms: Dilatation, Pathologic
Intervention: VEGA UV-A Illumination System; Riboflavin
Intervention description: Only subjects assigned to the treatment group will receive treatment with the UV Light; Both treatment and sham groups will receive riboflavin
Intervention MeSH terms: Riboflavin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety, tolerability, and effectiveness of
      corneal collagen cross-linking (CXL) when used to treat ectasia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 Years of age or older

          -  Diagnosis of Ectasia

          -  Presence of central or inferior steepening

          -  Topography consistent with ectasia

          -  BSCVA 20/20 or worse

          -  If contact lens wearer; removal of contact lenses for required period of time

          -  Signed informed consent

          -  Willingness and ability to comply with schedule for follow-up visits

        Exclusion Criteria:

          -  Previous ocular condition that may predispose the eye for future complications or
             prevent the possibility of improved vision

          -  History of chemical injury or delayed epithelial healing

          -  A known sensitivity to study medications

          -  Nystagmus or any other condition that would prevent a steady gaze during the treatment
             or other diagnostic tests

          -  A condition that would interfere with or prolong epithelial healing

          -  Presence or history of any other condition or finding that makes the patient
             unsuitable for treatment
A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab Pegol
Intervention description: Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 857.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; CDP870; Certolizumab Pegol; Cimzia

Summary:

      An open ended study in which patients who completed the double-blind study CDP870-027
      [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of
      Rheumatoid Arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients must have either failed to achieve American College of Rheumatology 20 % Response
        Criteria (ACR20) at Weeks 12 and 14 in C87027 [NCT00152386], or must have completed the
        entire Week 52 assessment of C87027 [NCT00152386] trial.

        Exclusion Criteria:

          -  A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or
             Ankylosing Spondylitis)

          -  A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia)
             that in the Investigator's opinion is symptomatic enough to interfere with evaluation
             of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis

          -  Any concomitant biological therapy

          -  Any experimental therapy, within or outside a clinical trial
Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: recombinant human chorionic gonadotropin
Intervention description: Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions.
Intervention MeSH terms: Chorionic Gonadotropin
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: polycystic ovary syndrome; androgens; ovary; LH

Summary:

      The mechanism for increased androgen production in women with polycystic ovary syndrome
      (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by
      increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators
      hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen
      synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal
      women. To test this hypothesis, the investigators propose to conduct a dose-response study in
      which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH
      surrogate, will be assessed in PCOS and normal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal CBC (Hemoglobin must be at least 11mg/dl)

          -  Normal renal and liver function tests

          -  Normal vital signs including normal blood pressure

        Exclusion Criteria:

          -  No oral contraceptives

          -  No insulin lowering drugs

          -  No anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)

          -  No medications that will influence androgen metabolism or clearance

          -  No medications that will inhibit the cytochrome P450 enzyme system (cimetidine,
             ketoconozole, etc)

          -  No use of clomiphene citrate within 3 months prior to study