bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: BIIB019 (Daclizumab High Yield Process); Placebo
Intervention description: SC injection; Placebo SC injection
Intervention MeSH terms: Daclizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 517.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: MS; Multiple Sclerosis

Summary:

      The primary objective of the study was to assess the safety and immunogenicity of extended
      treatment with DAC HYP. This evaluation included the following major components:

        -  An assessment of safety and immunogenicity of extended treatment with DAC HYP when
           administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in
           Study 201.

        -  An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.

        -  An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP
           after a 6-month washout period.

        -  An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects
           who previously received placebo during Study 201.

      The secondary objective is to assess the durability of the effect of DAC HYP on multiple
      sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans
      and clinical MS relapses.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant
             with the 205MS201 protocol in the opinion of the Investigator.

        Key Exclusion Criteria:

          -  Subjects with any significant change in their medical status from 205MS201 that would
             preclude administration of DAC HYP, as determined by the Investigator

          -  Any subject who has permanently discontinued study treatment in Study 205MS201 except
             subjects who were unblinded during evaluation of an adverse event (AE) and found to be
             on placebo

          -  Planned ongoing treatment with any approved or experimental treatment for MS except
             for the protocol-allowed use of concomitant interferon-beta

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
Condition: Age-Related Maculopathy
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: RN6G; Placebo
Intervention description: Intravenous, 11 doses, 30 minute infusion, dose ranging from 2.5 mg/kg up to a maximum of 15 mg/kg; Intravenous, 11 doses, 30 minute infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Phase 2; Advanced Dry Age-Related Macular Degeneration; Geographic Atrophy; RN6G

Summary:

      The purpose of this study is to determine the efficacy, safety and tolerability of multiple
      doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular
      Degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women between the ages of 60 and 90 years.

          -  Diagnosis of a geographic atrophy (GA) secondary to dry Age-Related Macular
             Degeneration.

          -  Best Corrected Visual Acuity (BCVA) of 20/80 or better in the study eye

        Exclusion Criteria:

          -  Evidence of ocular disease other than geographic atrophy (GA) secondary to dry
             Age-Related Macular Degeneration in the study eye.

          -  History or diagnosis of exudative (wet) Age-Related Macular Degeneration, with
             subretinal or choroidal neovascular lesions in the study eye.

          -  Presence of disease or condition that might compromise the cardiovascular,
             hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or
             gastrointestinal system
Intrathecal Hydromorphone for Pain Control After Cesarean Section
Condition: Pain; Cesarean Section
Intervention: Intrathecal morphine; Intrathecal hydromorphone
Intervention description: 0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.; 50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.
Intervention MeSH terms: Morphine; Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Intrathecal hydromorphone; Intrathecal morphine; Primary cesarean section; Analgesia

Summary:

      The use of intrathecal opioids for analgesia in the setting of cesarean section has become
      standard obstetric anesthesia practice. Currently, two opioids are commonly used. These
      opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of
      analgesia and act to reduce the stress response to surgery.

      Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after
      cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use
      of this medication is associated with side effects such as pruritus and nausea and vomiting.

      Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for
      cesarean delivery when morphine was unavailable. As groups began to use hydromorphone,
      retrospective data became available that demonstrated its safety and efficacy for use during
      cesarean section.

      In order to fully elucidate the analgesic and side effect properties of hydromorphone for
      cesarean delivery, a prospective randomized, double blind study comparing morphine and
      hydromorphone is necessary. The investigators need to understand whether hydromorphone is as
      effective as morphine for analgesia after cesarean section, and whether it is associated with
      fewer or more side effects. The results of the study will allow providers to make educated
      decisions to better care for their patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective primary cesarean section

          -  Females age 18-40

        Exclusion Criteria:

          -  Emergency cesarean section

          -  Anesthetic other than spinal

          -  History of chronic pain or pre-op opioid use

          -  Allergy to morphine or hydromorphone

          -  BMI>40
Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Condition: Respiratory Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Intervention: High Dose Vitamin D; Standard Dose Vitamin D; Placebo; Usual Care
Intervention description: Vitamin D3 100,000 IU monthly; Vitamin D 12,000 IU monthly; Placebo monthly; Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Vitamin D Deficiency; Respiratory Infection; Nursing Home Residents; Geriatrics; Immunosenescence; Prevention

Summary:

      This study will test the role of high dose vitamin D supplementation in prevention of acute
      respiratory infection in older nursing home residents. The investigators hypothesize that
      residents on high dose vitamin D supplementation will have a lower incidence of acute
      respiratory infection that those on standard dose vitamin D supplementation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 60+ years

          -  Resides in nursing home

        Exclusion Criteria:

          -  Terminal illness (expected survival <6 months)

          -  Anticipated discharge within 12 months

          -  Unable to take whole or crushed tablets

          -  Active cancer, except squamous/basal cell carcinoma

          -  Severe malnutrition (body mass index <18 kg/m2)

          -  Current immunosuppressive medications (including corticosteroids)

          -  Renal failure (estimated glomerular filtration rate < 15 mL/min/1.73m2)

          -  Currently taking >1,000 IU/d vitamin D supplementation

          -  History (or strong family history) of kidney stones

          -  History of sarcoidosis or other granulomatous disorders associated with hypercalcemia

          -  Elevated baseline hypercalcemia (albumin-adjusted serum calcium >10.5 mg/dL)

          -  Baseline serum 25OHD level ≥ 100 nmol/L

          -  Inability to provide informed consent and no available healthcare legally authorized
             representative

          -  Inability of participant or legally authorized representative to speak/understand
             English
A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Condition: Hyperphosphatemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: HS219; Placebo
Intervention description: Chewing for 30 min three time a day far after meal; Chewing for 30 min three times a day far after meal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: hyperphosphatemia; hemodialysis; chitosan

Summary:

      This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum,
      when given three times a day for 3 weeks to the hemodialysis (HD) patients with
      hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium
      carbonate or sevelamer hydrogen chloride.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent given

          -  Able to comply with the study procedures and medication

          -  On a stable HD regimen (at least 3 x per week) for ≥ 3 months

          -  Subject receiving calcium carbonate or sevelamer hydrochloride as a phosphate binder
             at screening, must have been on a stable regimen (dose and medication) for at least 1
             month

          -  A mean serum inorganic phosphorous in the previous 3 tests : > 5.5 mg/dL and < 9.0
             mg/dL

          -  Removal rate of blood urea nitrogen (BUN) ≥ 60%

          -  Rate of salivary flow by Saxon test ≥ 1 g/2 min

        Exclusion Criteria:

          -  Blood purification therapy other than HD

          -  Current clinically significant intestinal motility disorder

          -  Possible parathyroid intervention during the study period

          -  History of malignancy and severe cardiovascular disorders such as heart disease,
             angina, congested heart failure, valve stenosis, atrial fibrillation and arrhythmia

          -  History of allergy against active ingredient

          -  Receipt of any investigational drug within 30 days of informed consent
Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease
Condition: Chronic Graft Versus Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: Immunosuppressive Therapy; Immunosuppressive Therapy; Survey Administration
Intervention description: Discontinued IST; Continued IST; Ancillary studies
Intervention MeSH terms: Immunosuppressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Healthy volunteers: No

Summary:

      This randomized trial studies how well discontinuation or continuation of immunosuppressive
      therapy works in treating participants with chronic graft versus host disease. Continuation
      of immunosuppressive treatment may prevent graft-versus-host disease worsening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior first allogeneic stem cell transplant, with any graft source, donor type, and
             GVHD prophylaxis

          -  Patients who are on one systemic immunosuppressive agent for chronic GVHD with a plan
             to withdraw all systemic IST; hydrocortisone or prednisone continued for treatment of
             adrenal insufficiency is not considered a systemic IST

          -  No evidence of malignancy at the time of enrollment

          -  Agree to be evaluated at the transplant center or by local provider every 3 months for
             12 months after randomization

          -  Agreement to be contacted by phone or e-mail for health status evaluation for up to 3
             years

          -  Signed, informed consent

        Exclusion Criteria:

          -  Inability to comply with study procedures

          -  Pregancy
A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
Condition: Depression; Depressive Disorder; Depression, Postpartum; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Postpartum; PPD
MeSH terms: Depression, Postpartum; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Mental Disorders; Mood Disorders; Behavioral Symptoms
Intervention: Ganaxolone; Placebo
Intervention description: Ganaxolone IV; Placebo IV
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Postpartum Care; Postpartum Depression

Summary:

      This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of
      Ganaxolone in Women with Postpartum Depression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant experienced a Major Depressive Episode, which started between the start of
             the third trimester and 4 weeks following delivery. The Major Depressive Episode must
             be diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0
             interview

          -  Participant gave birth in the last 6 months

          -  Participant has a Hamilton Depression Rating Scale 17-item version (HAMD17) score of ≥
             26 at screening

          -  Participant must agree to stop breastfeeding from start of study treatment or must
             agree to temporarily cease giving breast milk to her infant(s)

        Exclusion Criteria:

          -  Current or past history of any psychotic illness, including Major Depressive Episode
             with psychotic features

          -  History of suicide attempt within the past 3 years

          -  Active suicidal ideation

          -  History of bipolar I disorder

          -  History of seizure disorder
Phase II HDM-SPIRE Safety and Efficacy Study
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Intervention: HDM-SPIRE; Placebo
Intervention description: 1 dose every 4 weeks; 1 dose every 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 715.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cat allergy; Rhinoconjunctivitis

Summary:

      The purpose of this study is to compare the treatment effect of three treatment regimens of
      HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue
      medication usage, Quality of Life and Sleep Quality
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged 18-65 years.

          -  Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.

          -  Mean TRSS ≥10

          -  Positive skin prick test to Der p and Der f.

          -  Dep p and Der f specific IgE ≥0.7 kU/L

        Exclusion Criteria:

          -  Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3
             (www.ginasthma.org)or higher treatment

          -  FEV1 <80% of predicted.

          -  Clinically significant confounding symptoms of allergy to seasonal allergens during
             the final evaluation period.

          -  Significant symptoms of another clinically relevant illness that is likely to affect
             scoring of rhinoconjunctivitis symptoms.

          -  Clinically relevant abnormalities detected on physical examination.

          -  History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery
Condition: Gynecologic Cancer; Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: Bupivicaine; Placebo
Intervention description: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis; The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain control; Gynecologic Oncology; Surgery

Summary:

      This study is a single-center, randomized, placebo-controlled, double-blind clinical trial.
      The purpose of this study is to evaluate the impact of pre-operative transverses abdominis
      plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for
      gynecologic cancers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing robotic-assisted surgery under the care of the Division of
             Gynecologic Oncology at UWHC.

          -  Patients must be ≥18 years old.

          -  Patients must be English speaking.

          -  Patients must have the ability to understand visual and verbal pain scales.

          -  ASA physical status 1-3.

        Exclusion Criteria:

          -  Known allergy to local anesthetics.

          -  Immunocompromised.

          -  Known history of opioid dependence, as available within the medical record and
             standard of care pre-operative work-up.

          -  Known history of chronic pain disorders.

          -  Pregnancy or lactation.

          -  Patient is a prisoner or incarcerated.

          -  Significant liver disease that would inhibit prescription of opioids.
The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients
Condition: Cancer-related Cognitive Difficulties
Intervention: Ibuprofen; Home-Based Exercise; Placebo
Intervention description: 200 mg BID and 8 hours apart; A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period; 200mg BID and 8 hours apart
Intervention MeSH terms: Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Cognitive difficulties

Summary:

      This research seeks to determine if a combination of low-dose ibuprofen along with a
      structured home-based walking and progressive resistance exercise program, EXCAP, will be
      effective in reducing cognitive difficulties among cancer patients receiving chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must report cognitive difficulties of 3 or higher on a 0-10 scale

          -  Must provide informed consent

          -  Be able to read English

          -  Have a primary diagnosis of cancer

          -  Be able to swallow medication

          -  Women of child-bearing potential must not be pregnant or become pregnant during the 6
             week study

          -  Agree not to take NSAIDs during the 6 week intervention period

          -  Be scheduled to receive at least 2 additional cycles of oral or IV chemotherapy over
             the 42-day study period.

          -  Must have the approval of their treating physician to begin the exercise program and
             receive the ibuprofen

          -  Must be over 18 years of age

        Exclusion Criteria:

          -  Currently taking a consistent dosage of a NSAID at least 3 days a week for the last 3
             months that is over 400mg daily

          -  Have an allergy to ibuprofen

          -  Be identified as in active or maintenance stage of exercise behavior as assessed by
             the single-item exercise stages of change short form

          -  have physical limitations that contraindicate participation in sub-maximal
             physiological fitness testing or a low to moderate home-based walking and progressive
             resistance program

          -  have a history of peptic ulcer disease within the last 12 months

          -  Diagnosed with a neurodegenerative disease

          -  Had a myocardial infraction within the past 6 months

          -  Patients with a neutropenic episode during the first cycle of chemotherapy or at high
             risk for a neutropenic episode during future chemotherapy cycles at the treating
             physicians discretion

          -  Have confirmed metastatic disease to the central nervous system

          -  Have been hospitalized for a major psychiatric illness within the last 5 years