bioihbjkbjnl/mcl2 huggingface dataset:
Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)
Condition: Pregnancy
Intervention: misoprostol/placebo
Intervention description: buccal or vaginal routes of administration/ placebo to compare methods for efficacy and safety during induction.
Intervention MeSH terms: Misoprostol
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 300.0
Sex: Female
Minimum age: 14 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: induction of labor; safety; pharmacokinetic; misoprostol

Summary:

      The primary objective of this study is to compare the efficacy and safety of vaginal and
      buccal misoprostol for women undergoing labor induction at greater than or equal to 37+ 0
      completed weeks gestation. Thus, the investigators have both efficacy and a safety primary
      outcomes.

      The secondary objective of this study is to assess the pharmacokinetic(PK) parameters with
      these two routes of administration in a sub-cohort of this trial. The long term objective of
      this line of research is to inform providers' clinical decision making for the large number
      of women having labor induction. By providing robust PK and pharmacodynamic (PD) evaluation,
      clinical outcomes data for these two routes of administration, clinicians will be informed
      for evidence-based decisions about the preferred route of administration of misoprostol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A medical indication for induction of labor at a gestational age between 37 +0 and 38
             +6 weeks OR an elective or medical indication for induction of labor at a gestational
             age greater than or equal to 39 + 0 completed weeks

          -  Participant age of greater than or equal to14 years old

          -  Singleton pregnancy

          -  Modified Bishop score of less than or equal to 6

          -  Vertex fetal presentation by examination or ultrasound

          -  Any membrane status

        Exclusion Criteria:

          -  Elective inductions between 37 +0 and 38 +6 completed weeks are specifically excluded

          -  Known intrauterine fetal demise

          -  Any uterine scar including prior cesarean section and myomectomy

          -  Known major fetal congenital malformations that may impact neonatal health

          -  Other evidence of fetal compromise (such as Category 2 or 3 tracing) before the
             induction begins

          -  Prior induction/cervical ripening methods utilized during this pregnancy

          -  Allergy to misoprostol

          -  Known untreated cervical infection (e.g. Gonorrhea, Chlamydia)

          -  Planned cesarean section due to maternal or fetal condition

          -  Any other contraindication to labor induction or misoprostol therapy
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
Condition: Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children
MeSH terms: Muscle Spasticity
Intervention: Botulinum toxin type A
Intervention description: Subjects randomised to receive Dysport 2 U/kg, 8 U/kg or 16 U/kg administered intramuscularly in the study limb.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 212.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport
      used in the treatment of upper limb spasticity (altered skeletal muscle performance) in
      children with cerebral palsy (CP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Upper limb spasticity due to cerebral palsy

          -  Body weight 10 kg or over

          -  MAS score of 2 or more in affected elbow or wrist flexors

        Exclusion Criteria:

          -  Fixed myocontracture

          -  Previous phenol or alcohol injection within 1 year

          -  Severe athetoid or dystonic movements

          -  Previous or planned surgery for spasticity in elbow or wrist flexors

          -  Neuromuscular disorders

          -  Previous Rhizotomy within 6 months

          -  Intrathecal baclofen within 30 days
A Study Of Galcanezumab In Participants With Episodic Cluster Headache
Condition: Episodic Cluster Headache
MeSH terms: Cluster Headache; Headache
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as Galcanezumab in participants with episodic cluster headaches.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of cluster headache as defined by International Headache Society
             (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines with
             a history of episodic cluster headache with at least two cluster periods lasting from
             7 days to 1 year (when untreated) and separated by pain-free remission periods of >=1
             month.

          -  Participants are able to distinguish cluster headache attacks from other headaches.

        Exclusion Criteria:

          -  Current enrollment in or discontinuation within the last 30 days from, a clinical
             trial involving any investigational drug or device.

          -  Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP)
             antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).

          -  Are taking indomethacin and/or are suspected of having another distinct trigeminal
             autonomic cephalalgia.

          -  A history of migraine variants that could implicate or could be confused with
             ischemia.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins.

          -  A history or presence of other medical illness that indicates a medical problem that
             would preclude study participation.

          -  Evidence of significant active or unstable psychiatric disease, in the opinion of the
             investigator.

          -  Women who are pregnant or nursing.
Midodrine for the Treatment of Refractory Hypotension
Condition: Hypotension; Critical Illness
MeSH terms: Hypotension; Critical Illness
Intervention: Midodrine; Placebo
Intervention description: Patients will be randomized to blinded to 20 mg of midodrine; Patients will be randomized to blinded placebo control
Intervention MeSH terms: Midodrine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Midodrine; Hypotension; Intensive care unit; IV vasopressors; ICU discharge

Summary:

      We hypothesize that midodrine treatment of refractory hypotension in patients otherwise ready
      for discharge from the ICU shortens duration of receiving IV vasopressors and SICU length of
      stay without increasing MGH length of stay or putting the patient at risk of being readmitted
      to an ICU.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Admitted to the SICU

          -  Requiring IV vasopressors at a rate of less than 100 mcg/min of phenylephrine, or 8
             mcg/min of norepinephrine, or 60 mcg/min of metaraminol; and unable to wean for more
             than 24 hours while still maintaining desired blood pressure goal

        Exclusion Criteria:

          -  Inadequate tissue oxygenation

          -  Liver failure

          -  Renal failure

          -  Hypovolemic shock or hypotension due to adrenal insufficiency

          -  Pregnancy

          -  Severe organic heart disease

          -  Urinary retention

          -  Pheochromocytoma

          -  Thyrotoxicosis

          -  Midodrine as pre-admission medication

          -  Any known allergies to midodrine

          -  Enrollment in another clinical trial
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; Upadacitinib; Placebo Upadacitinib; Placebo Methotrexate
Intervention description: Capsule; Oral; Tablet; Oral; Tablet; Oral; Capsule; Oral
Intervention MeSH terms: Methotrexate; Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 648.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Musculoskeletal Disease; Arthritis; Joint Disease; Anti-inflammatory agents; Antirheumatic agents; Upadacitinib; ABT-494

Summary:

      The study objective of Period 1 of this study is to compare the safety and efficacy (signs
      and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone
      versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis
      (RA) with an inadequate response to MTX.

      The study objective of Period 2 is to evaluate the long term safety, tolerability, and
      efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA for >= 3 months.

          -  Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable
             dose for >= 4 weeks prior to first dose of study drug.

          -  Must have discontinued all conventional synthetic disease-modifying anti-rheumatic
             drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.

          -  Meets the following minimum disease activity criteria: >= 6 swollen joints (based on
             66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and
             Baseline Visits.

        Exclusion Criteria:

          -  Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
             tofacitinib, baricitinib, and filgotinib).

          -  Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).

          -  Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of
             secondary Sjogren's Syndrome is permitted.
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Condition: Uremic Pruritus
MeSH terms: Pruritus
Intervention: CR845 0.5 mcg/kg
Intervention description: IV CR845 0.5 mcg/kg administered three times/week
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Hemodialysis; Pruritus; Uremic Pruritus; Dialysis; CR845; Chronic Itch; CKD; CKD-associated pruritus; CKD-aP; ESRD (end stage renal disease); difelikefalin; Itch; Itching; KALM; Chronic Kidney Disease; Kidney failure, chronic; Kidney dysfunction; Generalized pruritus

Summary:

      This is a multicenter, open-label study to evaluate the safety and effectiveness of
      intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The
      study includes an up to 12-week Treatment Period.
    

Eligibility criteria:

        Key Inclusion Criteria:

        To be eligible for inclusion into the study, a patient must meet the following criteria:

          -  Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for
             at least 3 months prior to the start of screening;

          -  Has at least 2 single-pool Kt/V measurements ≥1.2, or at least 2 urea reduction ratio
             measurements ≥65%, or 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio
             measurement ≥65% on different dialysis days during the 3 months period prior to
             screening;

          -  Prior to Treatment:

               -  Has completed at least 3 Worst Itching Intensity NRS questionnaires from the
                  start of the Run-in Period up to and including the pre-dose assessment on Day 1;

        Key Exclusion Criteria:

        A patient will be excluded from the study if any of the following criteria are met:

          -  Known noncompliance with dialysis treatment that in the opinion of the investigator
             would impede completion or validity of the study;

          -  Scheduled to receive a kidney transplant during the study;

          -  New or change of treatment received for itch including antihistamines and
             corticosteroids (oral, IV, or topical) within 14 days prior to screening;

          -  New or change of prescription for opioids, gabapentin, or pregabalin within 14 days
             prior to screening;

          -  Received another investigational drug within 30 days or five half-lives (whichever is
             longer) prior to the start of dosing or is planning to participate in another
             interventional clinical study while enrolled in this study;

          -  Has pruritus only during the dialysis session (by patient report);

          -  Is receiving ongoing ultraviolet B treatment and/or anticipates receiving such
             treatment during the study;

          -  Participated in a previous clinical study with CR845.
A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: AMG334 (70 mg) Pre-Filled Syringe (PFS); Placebo Pre-Filled Syringe (PFS)
Intervention description: Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection; Subcutaneous injection of matching placebo
Intervention MeSH terms: Erenumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; attack; headache; episodic; aura; AMG 334; CGRP receptor agonist; erenumab; adult

Summary:

      The purpose of this study is to determine if AMG 334 is effective in treating migraines in
      patients who have failed other preventive migraine treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented history of migraine in the 12 months prior to screen

          -  4-14 days per month of migraine symptoms

          -  >=80% diary compliance during the Baseline period

          -  Failure of previous migraine prophylactic treatments

        Exclusion Criteria:

          -  >50 years old at migraine onset

          -  Pregnant or nursing

          -  History of cluster or hemiplegic headache

          -  Evidence of seizure or psychiatric disorder

          -  Score of over 19 on Beck Depression Inventory-2

          -  Active chronic pain syndrome

          -  Cardiac or hepatic disease
Pacritinib Versus Best Available Therapy to Treat Myelofibrosis
Condition: Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Intervention: Pacritinib; Best Available Therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis; Primary Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia; Bone Marrow Disease; Hematologic Disease; Splenomegaly; Pacritinib; MPN-SAF; MPN-SAF TSS; Anemia; Myeloproliferative Neoplasm; Spleen volume; Thrombocytopenia; SB1518

Summary:

      Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib
      compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)

          -  Palpable splenomegaly ≥ 5 cm on physical examination

          -  Total Symptom Score >13 on the MPN-SAF TSS 2.0, not including the inactivity question

          -  Patients who are platelet or red blood cell transfusion-dependent are eligible

          -  Adequate white blood cell counts (with low blast counts), liver function, and renal
             function

          -  No spleen radiation therapy for 6-12 months

          -  Last therapy for myelofibrosis was 2-4 weeks ago, including any erythropoietic or
             thrombopoietic agent

          -  Not pregnant, not lactating, and agree to use effective birth control

        Exclusion Criteria:

          -  Prior treatment with a JAK2 inhibitor

          -  History of (or plans to undergo) spleen removal surgery or allogeneic stem cell
             transplant

          -  Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel
             disease, chronic diarrhea, or constipation

          -  Cardiovascular disease, including recent history or currently clinically symptomatic
             and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or
             other QTc risk factors, myocardial infarction

          -  Other malignancy within last 3 years other than certain limited skin, cervical,
             prostate, breast, or bladder cancers

          -  Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A,
             B, or C), psychiatric disorder, or social situation that would prevent good care on
             this study

          -  Life expectancy < 6 months
Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation
Condition: Cancer of the Cervix
MeSH terms: Vaginal Neoplasms; Uterine Cervical Neoplasms
Intervention: Granisetron; Ondansetron; Questionnaires; Study Drug Diary
Intervention description: 34.3 mg of granisetron formulated in a transdermal patch replaced every 7 days. At cycle 1, participants receive granisetron by vein prior to IV cisplatin and prior to administration of transdermal patch.; 8 mg of ondansetron by mouth three times a day starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.; Completion of 3 questionnaires at study visits taking about 5 minutes each time.; Study drug diary to record times that study drugs taken, and to record any nausea or vomiting experienced.
Intervention MeSH terms: Ondansetron; Granisetron
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer of the Cervix; Anti-emetic therapy; Granisetron; Transdermal patch; Ondansetron; Zofran; Questionnaires; Surveys; Study Drug Diary; Nausea and Vomiting

Summary:

      The goal of this clinical research study is to compare granisetron (when given through a
      patch) to ondansetron (when taken by mouth) for reducing nausea and vomiting in women with
      cervical, endometrial, or vaginal cancer having chemoradiation.

      Granisetron and ondansetron are designed to help reduce nausea and vomiting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women with cervical, endometrial or vaginal cancer dispositioned to receive primary or
             postoperative adjuvant pelvic radiation therapy with concurrent cisplatin
             administration.

          2. Women must be at least 18 years of age.

          3. Women must be able to read English or Spanish at a sixth grade level.

          4. Women with childbearing potential must have a negative pregnancy test within 1 week of
             starting chemoradiation therapy.

        Exclusion Criteria:

          1. Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy
             and/or radiation therapy for recurrent disease.

          2. Women with cervical, endometrial, or vaginal cancer who are receiving extended field
             radiation therapy.

          3. Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy
             and/or radiation therapy in a palliative setting.

          4. Women with cervical, endometrial, or vaginal cancer who have already received their
             first dose of chemotherapy or radiation for more than 7 days prior to starting
             chemotherapy.
Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
Condition: Osteoarthritis; Cancer Pain; Recurrent Low Back Pain
MeSH terms: Low Back Pain; Cancer Pain
Intervention: Investigational medical product (IMP) administered in parent study
Intervention description: IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 0 Years
Maximum age: 2 Months
Healthy volunteers: No
Keywords: Exposure in utero in tanezumab program

Summary:

      A4091065 is a multicenter, prospective, cohort study with enhance physical an
      neurodevelopmental surveillance to characterize the outcomes related to the development of
      infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or
      comparator via maternal exposure or in utero in any tanezumb study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is an infant born to a mother who was exposed to study drug on a tanezumab
             clinical study.

          -  The infant's mother (who was the tanezumab clinical study participant) must review,
             agree and sign an informed consent document explaining the details of the perinatal
             and post natal follow up. Where local regulations mandate, the male parent would also
             review and sign the informed consent.

          -  Parents or legal guardian must be willing and able to comply with scheduled visits and
             study procedures.

        Exclusion Criteria:

          -  There are no exclusion criteria for participating in this study.