bioihbjkbjnl/mcl2 huggingface dataset:
Stanford Accelerated Recovery Trial (START)
Condition: Pain; Breast Cancer; Lung Cancer
Intervention: Gabapentin; Lorazepam (active control); Placebo (inactive)
Intervention description: 1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.; 0.5 mg Lorazepam (active control) given pre-operatively in a single dose.; 2 capsules of inactive placebo given 3-times a day post-operatively for the 72-hour post-surgical period.
Intervention MeSH terms: Gabapentin; Lorazepam
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 422.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The goal of this study is to determine whether administering Gabapentin prior to surgery
      affects duration of pain and opioid use post-surgery. The investigators aim to compare
      gabapentin to placebo in a prospective, randomized clinical trial in which patients will be
      followed post-surgery until pain resolves and opioid use ceases.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Age 18 to 75

          -  Undergoing a scheduled surgery

          -  English speaking

          -  Ability and willingness to complete questionnaires or use Palm Pilot

        EXCLUSION CRITERIA

          -  Known kidney disease

          -  Currently receiving gabapentin or (pregabalin) lyrica already

          -  Cognitive impairment

          -  Previous history of excessive sedation or adverse reaction to gabapentin (not it was
             tried but ineffective for nerve pain)

          -  Coexisting chronic pain > 4/10 disorder in area other than surgical target

          -  Plan to move out of state

          -  Condition that would in judgment of team member make patient likely to be lost to
             follow-up

          -  Elevated suicidality

          -  Known pregnancy

          -  Current symptoms of ataxia, dizziness, or sedation

          -  Narrow angle glaucoma

          -  Severe respiratory insufficiency (ie, severe emphysema or chronic obstructive
             pulmonary disease)

          -  History of gastric bypass surgery and obstructive sleep apnea requiring continuous
             positive airway pressure (CPAP)
Endometrial Injury for Assisted Reproduction
Condition: Infertility
MeSH terms: Infertility
Intervention: Endometrial injury; Control group
Intervention description: Evaluate the position and size of the uterus by transabdominal ultrasonography, with the bladder comfortably full.
Identify the cervix with a disposable speculum. Open one sealed opaque envelope for allocation.
Endometrial injury:
Slide the Pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France) gently through the cervix up to the uterine fundus. Transbadominal ultrasound might be used to confirm position.
Draw back the piston to the end of the biopsy cannula until it locks creating a negative pressure.
Sweep the uterine fundus slowly several times up to the internal orifice of the cervix, using regular to-and-fro movements while rotating the sampler to include the whole uterine cavity in the specimen, for 30 seconds or until participant ask for stopping.; The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: Female
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: No
Keywords: Reproductive Techniques; Embryo Implantation; Endometrium; Ultrasonography

Summary:

      The objective of this study is to evaluate the effect of endometrial injury performed prior
      ovulation induction for assisted reproductive techniques main outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who will start assisted reproductive techniques with planned fresh embryo
             transfer.

          -  Age between 18 and 38 years.

          -  Written informed consent.

        Exclusion Criteria:

          -  None
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Ferrous Sulfate tablets; Ferric Carboxymaltose (FCM)
Intervention description: 325 mg/TID x 8 weeks; A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Anemia; Chronic Kidney Disease; Iron

Summary:

      This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron
      (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with
      non-dialysis dependent chronic kidney disease (NDD-CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females > or = 12 years of age

          -  NDD-CKD subjects

          -  Baseline hemoglobin < or = 11g/dl

          -  Stable erythropoietin (EPO) status

        Exclusion Criteria:

          -  Known hypersensitivity to ferrous sulfate or IV iron

          -  Unstable EPO status

          -  Anemia not related to CKD

          -  Chronic, serious infection

          -  Recent IV iron

          -  Recent blood transfusion

          -  Recent blood loss

          -  Need for surgery

          -  Received investigational drug within 30 days

          -  Female subjects who are pregnant or lactating
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mirikizumab; Placebo
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Mirikizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1281.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Interleukin-23 (IL-23) antibody; IL-23p19

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in
      participants with moderately to severely active ulcerative colitis (UC) who have had an
      inadequate response to, loss of response, or intolerant to conventional or biologic therapy
      for UC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of UC for at least 3 months prior to baseline.

          -  Confirmed diagnosis of moderately or severely active UC, as assessed by the modified
             Mayo score (MMS).

          -  Demonstrated an inadequate response to, a loss of response to, or an intolerance to
             conventional or to biologic therapy for UC.

          -  If female, must meet the contraception requirements.

        Exclusion Criteria:

          -  Participants with a current diagnosis of Crohn's disease or inflammatory bowel
             disease-unclassified (indeterminate colitis).

          -  Participants with a previous colectomy.

          -  Participants with current evidence of toxic megacolon.

          -  Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19
             antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Baricitinib; Placebo
Intervention description: Administered orally.; Administered orally.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE

Summary:

      The reason for this long term study is to see how safe and effective the study drug known as
      baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the
      final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the final treatment study visit of an originating study, such as study
             JAHZ (NCT03616912) or Study JAIA (NCT03616964).
A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema
Condition: Macular Edema; Diabetic Mellitus; Retinal Disease
MeSH terms: Macular Edema; Retinal Diseases; Edema
Intervention: pegaptanib sodium; sham injection
Intervention description: Intravitreal injection of 0.3 mg every 6 weeks; sham injection every 6 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 243.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: diabetic macular edema; Macugen; sham-controlled study

Summary:

      The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham
      injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular
      edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type I, or Type II diabetic subjects

          -  Subjects must have macular edema that involves the center field of the macula 3.
             Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the
             study eye must be a letter score between 68 and 35 inclusive

        Exclusion Criteria:

          -  Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline
             eyes in which PRP is needed now or is likely to be needed within the next 9 months

          -  HbA1C level >12% or recent signs of uncontrolled diabetes

          -  Atrophy/scarring/fibrosis involving the center of the macula, including evidence of
             laser treated atrophy
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
Condition: Relapsing Multiple Scelrosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ofatumumab subcutaneous injection; Teriflunomide-matching placebo capsules; Teriflunomide capsule; Matching placebo of ofatumumab subcutaneous injections
Intervention description: Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter; Placebo capsule, matching in appearance to teriflunomide, taken orally once daily; Teriflunomide 14 mg oral capsule taken once daily; Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
Intervention MeSH terms: Teriflunomide; Ofatumumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 955.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing multiple sclerosis; Ofatumumab; adult; OMB157; multiple sclerosis; T1 lesions; T2 lesions; relapse; GD-enhancing MRI; McDonald criteria; RRMS; SPMS

Summary:

      To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4
      weeks versus teriflunomide administered orally once daily in patients with relapsing multiple
      sclerosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged 18 to 55 years at Screening

          -  Diagnosis of multiple sclerosis (MS)

          -  Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with
             disease activity

          -  Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during
             the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior
             to randomization

          -  Disability status at Screening with an Expanded Disability Status Scale (EDSS) score
             of 0 to 5.5

          -  Neurologically stable within 1 month prior to randomization

        Exclusion Criteria:

          -  Patients with primary progressive MS or SPMS without disease activity

          -  Disease duration of more than 10 years in patients with an EDSS score of 2 or less

          -  Patients with an active chronic disease of the immune system other than MS

          -  Patients at risk of developing or having reactivation of hepatitis

          -  Patients with active systemic infections or with neurological findings consistent with
             PML
BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Bevacizumab; Standard adjuvant chemotherapy
Intervention description: Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.; All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2591.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of
      patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy
      with 1 year of bevacizumab.

      The secondary objectives of this trial are to:

        -  compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free
           Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to
           treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination
           with 1 year of bevacizumab

        -  evaluate the safety and tolerability of bevacizumab

      An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or
      serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab
      to standard adjuvant systemic treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  operable primary invasive breast cancer;

          -  completed definitive loco-regional surgery;

          -  primary tumor centrally confirmed as triple negative.

        Exclusion Criteria:

          -  locally advanced breast cancers;

          -  previous breast cancer history;

          -  clinically significant cardiovascular disease.
Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
Condition: Postmenopausal Symptoms
Intervention: Brisdelle (paroxetine mesylate); Placebo capsules
Intervention description: Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84; Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
Intervention MeSH terms: Paroxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 614.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Menopause; Vasomotor Symptoms; Hot Flashes Perimenopause; Climacteric Symptoms; Mesafem; Low-Dose Mesylate salt of Paroxetine (LDMP)

Summary:

      The purpose of this study is to assess the safety & efficacy of Brisdelle (paroxetine
      mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with
      menopause.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female, ≥ 40 years of age at screening (inclusive)

          2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60
             moderate to severe hot flashes per week for at least 30 days prior to the screening
             visit

          3. Spontaneous amenorrhea for at least 12 consecutive months or

          4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause or

          5. Bilateral salpingo-oophorectomy ≥ 6 weeks with or without hysterectomy

        Exclusion Criteria:

          1. Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or
             Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS

          2. History of self injurious behavior

          3. History of clinical diagnosis of depression or treatment for depression

          4. History of clinical diagnosis of borderline personality disorder

          5. Use of an investigational study medication within 30 days prior to screening or during
             the study

          6. Concurrent participation in another clinical trial or previous participation in this
             trial

          7. Family of investigational-site staff
Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections
Condition: Postoperative Wound Infection
MeSH terms: Infections; Wound Infection; Surgical Wound Infection
Intervention: chlorhexidine-alcohol; Povidone-Iodine
Intervention description: Preoperative skin preparation with scrub and paint technique; preoperative skin preparation with scrub and paint technique
Intervention MeSH terms: Chlorhexidine; Povidone-Iodine; Povidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 849.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prevention; Antiseptic Preoperative Scrub; Postoperative Wound Infection

Summary:

      Most cases of infection of clean-contaminated wounds (wounds without gross spillage of
      organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore,
      it is conceivable that application of an optimal antiseptic agent can reduce the rate of
      surgical wound infections. This trial is to compare the impact of disinfecting the skin with
      Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection
      of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse
      effects on the skin from either antiseptic agent and the cost-savings associated with the use
      of Chloraprep vs Betadine.
    

Eligibility criteria:

        Inclusion Criteria: Adult patients who are scheduled for a clean-contaminated surgical
        procedure of the alimentary or respiratory tract will be eligible for participation. A
        clean-contaminated wound is one that is entered under controlled conditions without unusual
        contamination.

        -

        Exclusion Criteria: Patients will be excluded form the study if: (1) they are unable or
        unwilling to give informed consent; (2) the patient is less than 18 years of age; (3) there
        is evidence of pre-existing infection at or adjacent to the operative site; (4) a break in
        sterile technique occurs; (5) the patient has a history of allergy to chlorhexidine,
        alcohol or iodophors.

        -
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence
Intervention: Retzius sparing radical prostatectomy; Vattikuti Urology Institute radical prostatectomy; da Vinci Surgical System
Intervention description: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique; Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique; The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 120.0
Sex: Male
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: prostate cancer; Urinary continence; robotic assisted radical prostatectomy; Vattikuti Urology Institute (VIP) radical prostatectomy; Retzius sparing radical prostatectomy

Summary:

      To assess and compare the short-term post-operative continence recovery rate in two cohorts
      of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo
      RARP with Vattikuti Institute technique or Retzius sparing technique.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical
             prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as
             the primary treatment modality

          -  Be able to read and speak English and be able to provide written informed consent

        Exclusion Criteria:

          -  patients with high risk prostate cancer,defined as a biopsy Gleason score ≥8 and/or a
             pre-operative prostate specific antigen value ≥20 ng/ml.

          -  evidence of clinical nodal involvement (cN1) or metastatic disease (M1)

          -  patients participating in a competing study

          -  patients with pre-operative urinary incontinence.