bioihbjkbjnl/mcl2 huggingface dataset:
A Study for Leukemia Patients With Life-Threatening Infections
Condition: Leukemia
MeSH terms: Infections; Leukemia
Intervention: White Blood Cell Transfusion
Intervention description: 4 Transfusions, each taking approximately 1 hour:
Patients <50 years of age receive 4 standard transfusions before they are randomized to receive further radiated or non radiated transfusions.
Patients >50 years of age are randomized to receive either radiated or non radiated transfusions.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: White Blood Cell Transfusion; Radiated Cells; Unradiated Cells; Leukocyte Transfusions; Life-threatening Infections

Summary:

      The goal of this clinical research study is to compare the effectiveness of a white blood
      cell transfusion with radiated cells to a white blood cell transfusion with cells that have
      not been radiated. The safety of this procedure will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of hematologic malignancy admitted to the Leukemia service.

          2. Severe neutropenia defined as Absolute neutrophil count (ANC) less than or equal to
             1000.

          3. Persistent fever and/or signs of life threatening infection despite 48 hours on
             antibiotics.

          4. Sign a written informed consent form.

          5. Greater than 18 years of age.

        Exclusion Criteria:

        1) None
BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Intervention: Riociguat (BAY63-2521)
Intervention description: BAY63-2521: 1mg tid -2.5 mg tid oral until end of study
Intervention MeSH terms: Riociguat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 396.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pulmonary arterial hypertension; PH; Stimulator

Summary:

      Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934)
      will be asked to participate in this long term extension study with BAY63-2521.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed 12 weeks of treatment in the double blind trial PATENT 1

        Exclusion Criteria:

          -  Patients who have an ongoing serious adverse event from PATENT 1 that is assessed as
             related to BAY63-2521 are not allowed to participate in the extension trial.
Efficacy and Safety of Acupuncture for Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Intervention: acupuncture; mosapride citrate
Intervention description: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks.; 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Intervention MeSH terms: Mosapride; Citric Acid; Sodium Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 684.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acupuncture; Functional constipation

Summary:

      A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25
      has the same effect as lactulose in unaided self-defecation frequency of a week and has
      better effect in symptoms improvement (in press). The object is to evaluate whether
      acupuncture is effective for functional constipation. As an explanatory research, it took one
      single point as its intervention and sham acupuncture as its control group (patients were
      blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized
      controlled trial to further evaluate whether acupuncture is more effective than routine
      treatment. Acupuncture prescriptions used in this trial are individually prescribed according
      to syndrome differentiation, which can improve clinical effect. .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who has been diagnosed with functional constipation according to Rome Ⅲ
             criteria

          -  Patients who are aged 18-75 years old

          -  Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in
             other trials

          -  Sign the informed consent out of one's own will

        Exclusion Criteria:

          -  Secondary constipation

          -  Patients with consciousness impairment, psychotic patients or patients unable to
             express clearly

          -  Patients with malignant tumor in progressive stage, severe wasting disease and liable
             to be infected and bleed

          -  Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive
             disease or hematological diseases

          -  Women in pregnancy and lactation period
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Condition: Geographic Atrophy
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Lampalizumab; Sham Comparator
Intervention description: 10 mg dose of lampalizumab administered intravitreally.; A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 975.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled
      study evaluating the efficacy and safety of lampalizumab administered by intravitreal
      injections in participants with geographic atrophy (GA) secondary to age-related macular
      degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants aged greater than or equal to (>/=) 50 years

          -  Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular
             Degeneration (AMD) with no evidence of prior or active choroidal neovascularization
             (CNV) in both eyes

        Exclusion Criteria:

        Ocular Exclusion Criteria (Study Eye):

          -  History of vitrectomy surgery, submacular surgery, or other surgical intervention for
             AMD

          -  Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein
             occlusion, and proliferative diabetic retinopathy

          -  Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection,
             anti-angiogenic drugs, anti-complement agents, or device implantation)

        Ocular Exclusion Criteria (Both Eyes):

          -  GA in either eye due to causes other than AMD

          -  Previous treatment with eculizumab, lampalizumab, and/or fenretinide
Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Condition: Benign Prostatic Hypertrophy
MeSH terms: Prostatic Hyperplasia; Hypertrophy
Intervention: Cetrorelix 78+78; Cetrorelix 78 + Placebo; Placebo
Intervention description: Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg); Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28; Placebo on Week 0, Week 2, Week 26 and Week 28
Intervention MeSH terms: Cetrorelix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 420.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is
      characterized by an enlargement of the prostate occurring in human male over the age of 50
      which increases in prevalence with age, and among those aged 50 to 80, about 40% report
      moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve
      patients' quality of life which primarily depends on the severity of the symptoms of BPH.
      Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.

      For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection
      in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to
      52) are eligible to receive the active drug during the open-label part of the study (Week 52
      to 90).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Benign Prostatic Hyperplasia, based on medical history

          -  Voiding symptoms

        Exclusion Criteria:

          -  Urgent need for prostate surgery or prior surgical treatment of the prostate or
             bladder

          -  Major organ dysfunction

          -  Eczema (atopic dermatitis) treated during the last 6 months

          -  Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or
             botulinum toxin type a (Botox) within the last 6 months prior randomization or with α
             blockers or saw palmetto within the last 6 weeks prior to randomization

          -  Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus
             or documented neurologic disorder, urethral stricture disease or history of pelvic
             radiation therapy

          -  History of acute obstructive, infectious, or neurological disorders of the
             genitourinary tract within the last 3 months
Paradoxical Stimulation of Hepatic Glucose Production With Dapagliflozin
Condition: Type II; Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: Three 5-hour measurements (after dapagliflozin 10mg administration) of endogenous glucose production (EGP) will be performed on separate days.; Three 5-hour measurements (after placebo administration) of endogenous glucose production (EGP) will be performed on separate days.
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To determine the role of plasma glucagon and insulin in the rise of endogenous glucose
      production (EGP) following the SGLT2 inhibition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  T2DM according to ADA criteria-HbA1C < 8.0%

          -  BMI = 25-35 kg/m2

          -  Subjects must be in good general health as determined by physical exam, medical
             history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis

          -  Body weight has been stable (± 3 lbs) over the preceding three months

          -  Do not participate in an excessively heavy exercise program

          -  Taking stable dose (more than 3 months) of monotherapy or combination therapy with
             metformin and/or a sulfonylurea

        Exclusion Criteria:

          -  Subjects taking drugs known to affect glucose metabolism (other than metformin and
             sulfonylurea) will be excluded

          -  Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine
             >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be
             excluded
Effect of Indacaterol on Inspiratory Capacity (IC)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Intervention: Indacaterol; Tiotropium; Placebo
Intervention description: Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI); Tiotropium 18µg o.d. delivered via a proprietary inhalation device.; Placebo to indacaterol o.d. delivered via SDDPI
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 173.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; indacaterol; QAB149; inspiratory capacity

Summary:

      This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on
      inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as
      comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In
      particular, spirometric timepoints are included to elucidate the peak-IC in a period of
      approximately 4 hour post inhalation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD
             Guidelines, 2008) and including:

               -  Smoking history of at least 10 pack years

               -  Post-bronchodilator FEV1 <80% and ≥50% of the predicted normal value (Visit 2).

               -  Post-bronchodilator FEV1/forced vital capacity (FVC) <70% (Visit 2).

        Exclusion Criteria:

          -  Patients who received any corticosteroid (including inhaled) for 3 months prior to
             screening

        Other protocol-defined inclusion/exclusion criteria may apply
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
Condition: Non-valvular Atrial Fibrillation
MeSH terms: Renal Insufficiency; Atrial Fibrillation
Intervention: DU-176b 15mg; DU-176b 30mg; DU-176b 60mg
Intervention description: oral DU-176b 15mg once daily; oral DU-176b 30mg once daily; oral DU-176b 60mg once daily
Intervention MeSH terms: Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: anticoagulant; DU-176b; edoxaban; factor Xa; oral; atrial fibrillation; severe renal impairment

Summary:

      To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial
      fibrillation patients with severe renal impairment, compared with DU-176b administered to
      non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal
      impairment (Normal/MiRI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.

        Exclusion Criteria:

          -  Patients who are on hemodialysis or patients who may start hemodialysis before the
             follow-up assessment

          -  Patients who are at a significantly high risk for bleeding

          -  Patients who are receiving treatment with any anticoagulant drugs excluding warfarin,
             rivaroxaban, and dabigatran

          -  Patients who have evidence of hepatic function test abnormalities
Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses
Condition: Abscesses
MeSH terms: Abscess
Intervention: bactrim; placebo
Intervention description: bactrim DS (800/160) 2 pills PO BID x 7 days; placebo 2 pills po BID x 7 days
Intervention MeSH terms: Trimethoprim, Sulfamethoxazole Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 212.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: abcess; MRSA; cellulitis; antibiotics; uncomplicated abscesses

Summary:

      Patients will be enrolled in a multi-center study to prospectively evaluate outcome after
      treatment for an uncomplicated skin abscess. All patients will receive incision and drainage
      and wound cultures. Patients will then be randomized to 1) placebo two tablets PO BID X 7
      days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the
      emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary
      outcome is treatment failure rates at 7 days after incision and drainage. Patients who are
      clinically worsening or not improving after 48 hours will then be treated with additional
      antibiotics or admission if needed. Data will be analyzed both by initial randomization and
      intention to treat.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria include all patients age 16 and older who present to the emergency
             department with a skin abscess that requires incision and drainage.

        Exclusion Criteria:

          -  Exclusion criteria include patients with diabetes, HIV, cancer or other
             immunocompromised patients.

          -  Additionally, any patients who received antibiotics within one week of presentation or
             were hospitalized in previous month will be excluded to minimize potential confounding
             variables.

          -  Pregnant and breastfeeding patients will also be excluded due to possible safety
             concerns with antibiotic treatment.

          -  Patients with abscesses on face, perirectal, or perianal regions, abscesses with known
             tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in
             an operating room are excluded.

          -  Patients with fever or evidence of systemic infection

          -  Finally, patients with sulfa allergy will be excluded.
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines
Condition: Lateral Canthus Rhytides; Crow's Feet Lines
Intervention: onabotulinumtoxinA; normal saline
Intervention description: 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1; Injected into bilateral Crow's Feet Line areas on Day 1
Intervention MeSH terms: 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: 446.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of botulinum toxin Type A compared to
      placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe Crow's Feet Lines

          -  Have adequate vision without the use of eyeglasses to assess facial wrinkles in a
             mirror (contact lenses OK)

        Exclusion Criteria:

          -  Current or previous botulinum toxin treatment of any serotype

          -  Facial laser or light treatment, microdermabrasion or superficial peels within 3
             months

          -  Oral retinoid therapy within 1 year

          -  Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye
             lift, or eyebrow surgery)

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge
Condition: Analgesia After ED Discharge for Extremity Injuries
MeSH terms: Acute Pain
Intervention: Hydrocodone (first trial); Codeine (first trial); Oxycodone (for second trial); Codeine (for second trial); Oxycodone (third trial); Hydrocodone (third trial)
Intervention description: Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain; Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain; Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain; Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain; Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain; Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
Intervention MeSH terms: Acetaminophen; Oxycodone; Hydrocodone; Codeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 720.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Pain Management; Emergency Medicine; Extremity Injuries

Summary:

      There will be 3 randomized, double-blinded clinical trials to help determine which of
      commonly prescribed oral opioid combination is most effective in managing acute extremity
      pain after discharge from the adult emergency department. The first trial compares
      hydrocodone 5mg / acetaminophen 500mg to codeine 30mg/acetaminophen 300mg. The second trial
      compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg. The third
      trial compares oxycodone 5mg/acetaminophen 325 mg to hydrocodone 5mg/acetaminophen 325 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patient has complaint of acute extremity pain (less than 7 days duration)

          -  clinician plans to discharge on oral pain medication

        Exclusion Criteria:

          -  patients on methadone

          -  chronic pain condition such as sickle cell anemia or fibromyalgia

          -  history of adverse reaction to one of the study medications

          -  taken prescribed opioids in the past 24 hrs

          -  have a medical condition that might alter the metabolism of one of the study
             medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease)

          -  Take a medication that might interact with one of the study medications