bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Epoetin beta
Intervention description: Epoetin beta 30,000 or 60,000 IU per week SC injection
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase IV, prospective, multi-center, open-label study to assess the effectiveness
      and safety profile of epoetin beta (Recormon®) for treatment of symptomatic anemia in adult
      participants associated with low/intermediate-1-risk MDS. After screening, eligible
      participants will be treated with epoetin beta as recommended in the approved label and
      international guidelines for the use of epoetin in MDS participants and the dosage will be
      adjusted on the basis of erythroid response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants with low or intermediate-1 risk MDS

          -  No previous treatment with hematopoietic growth factors within 3 months prior to
             screening

          -  Symptomatic anemia (hemoglobin <10 g/dL) as determined by investigator

          -  Serum erythropoietin <500 milliunits/milliliter (mU/mL) within 14 days prior to the
             first dose of study treatment

          -  Require no red blood cell transfusion or dependent on <4 units within 8 weeks prior to
             screening

          -  Clinically stable for at least 1 month prior to entry into the study

          -  For female participants of childbearing potential and male participants with partners
             of childbearing potential, agreement (by participants and/or partner) to use highly
             effective form(s) of contraception

        Exclusion Criteria:

          -  Contraindications and/or known hypersensitivity to the active substance and/or any of
             the excipients of epoetin beta treatment

          -  Poorly controlled hypertension as assessed by the investigator

          -  History of Acute Myeloid Leukemia (AML) or high risk for AML

          -  Administration of another investigational drug within 1 month before screening or
             planned during the study period

          -  Previously documented evidence of Pure Red Cell Aplasia (PRCA)
Evaluation Exparel Delivered in Knee Replacement
Condition: Arthritis
MeSH terms: Arthritis
Intervention: Exparel; Saline
Intervention description: Exparel is infiltrated into posterior compartment for pain control; Saline is infiltrated into posterior compartment for control
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Pain control after knee replacement requires analgesia to both the top (anterior) and bottom
      (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion.
      The investigators want to to examine if giving Exparel into the posterior portion will give
      better pain relief.

      Hypothesis: There is no difference in, the use of analgesics or the length and quality of
      analgesia and no decrease in the time to be able to accomplish simple to complex knee
      movements using Exparel infiltration when compared to controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18-75 years inclusive and American Society of Anesthesiologist physical
             status 1-3

          -  Patients undergoing knee replacement (total knee arthroplasty)

          -  Subjects must be physically and mentally able to participate in the study and complete
             all study assessments.

          -  Subjects must be able to give fully informed consent to participate in this study
             after demonstrating a good understanding of the risks and benefits of the proposed
             components of infiltration into the posterior capsule of the knee.

        Exclusion Criteria:

          -  History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics

          -  Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator,
             might preclude the potential successful performance of a appropriate Exparel
             infiltration into the posterior capsule of the knee.

          -  Any subject who in the opinion of the Investigator, might be harmed or be a poor
             candidate for participation in the study.

          -  Any subject, who in the opinion of the Investigator, is on chronic pain medicine
             (opioids), including large doses of non-steroidal anti-inflammatory drugs s.

          -  Subjects who have received any investigational drug within 30 days prior to study drug
             administration, or planned administration of another investigational product or
             procedure during their participation in this study.

          -  History of pre-existing neurological disorders/neuropathy

          -  Morbid Obesity
Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Intervention: TKA surgery with the rotating platform mobile-bearing knee design; TKA surgery with the all-polyethylene tibia knee design
Intervention description: Depuy Sigma RP rotating platform design; Depuy Sigma fixed-bearing design with all-polyethylene tibia
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 400.0
Sex: All
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: knee arthritis; total knee arthroplasty; total knee replacement; mobile bearing design; all-polyethylene tibia

Summary:

      This study will be designed to compare prospectively, in a randomized fashion, the clinical,
      functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing
      posterior cruciate substituting design with a modular posterior cruciate substituting
      rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will
      afford the investigators information in the following areas:

        1. Does a RP design offer improvement in range of motion over a AP design?

        2. Does a RP design have improved wear characteristics over a nonmodular AP design?

        3. Is there a clear clinical advantage to the RP design that justifies its increased cost?

      Answering these questions will allow surgeons to use RP designs appropriately in different
      demand populations.

      This study was designed to address the questions of whether an RP design offers improvement
      in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of
      Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short
      Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators'
      primary hypothesis was that there would be no difference in these outcome measures at a
      minimum two year followup. A secondary hypothesis based on the anticipated long-term followup
      of this group was that there would be no difference in implant survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  generally accepted clinical and radiographic criteria for primary total knee
             arthroplasty

        Exclusion Criteria:

          -  substantial angular deformity or bony deformity requiring structural grafting or
             modular augmentation were excluded at the discretion of the principle investigator

          -  patients whose mental function precluded them from responding to our standard
             questionnaires
A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum
Intervention: ZULRESSO®
Intervention description: Intravenous infusion of ZULRESSO®.
Intervention MeSH terms: Pregnanolone; Brexanolone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study was to evaluate whether the safe-use conditions for
      administration of brexanolone (ZULRESSO®) can be implemented in a home setting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ambulatory female ≥18 years of age.

          2. Participant has a current diagnosis of postpartum depression (PPD), as confirmed by
             the investigator.

          3. Participant agrees not to be the primary caregiver of any dependents during the
             infusion and must be accompanied by another adult (other than the home healthcare
             provider) during interactions with their child(ren).

          4. Participant has no history of sleep apnea or any clinically significant respiratory
             conditions.

          5. Participant agrees to refrain from the use of central nervous system depressants, such
             as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion.

          6. Participant is suitable for administration of ZULRESSO® in a home setting, as per the
             judgement of the investigator.

          7. Participant's home is suitable and has necessary provisions for administration of
             ZULRESSO® and meets the following criteria:

               -  safe environment for the home infusion provider staff.

               -  access to a working telephone.

               -  electricity and grounded electrical outlets.

               -  running water.

               -  access to back-up emergency services (911 service or ambulance availability).

               -  sanitary environment.

          8. Participant agrees to stay at home until the end-of-study visit has been completed,
             except for a medical emergency.

          9. Participant must have a negative pregnancy test at screening and on Day 1 prior to the
             start of the ZULRESSO® infusion.

        Exclusion Criteria:

          1. Participant has end stage renal failure.

          2. Participant has known allergy to progesterone or allopregnanolone or any excipients in
             the brexanolone injection.

          3. Participant is currently at risk of suicide, as judged by the investigator, or has
             attempted suicide associated with the current episode of PPD.
Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease
Condition: Schizophrenia; Schizoaffective Disorder; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Treatment as usual (TAU), Paliperidone ER
Intervention description: Treatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: antipsychotic; paliperidone ER; liver disease; Schizophrenia; Schizoaffective Disorder; Invega

Summary:

      The purpose of this study is to evaluate the tolerability and safety of paliperidone ER
      (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the
      treatment of patients with schizophrenia or schizoaffective disorder and liver disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or
             agree to practice an effective method of birth control if they are sexually active
             before entry and throughout the study, and must also have a negative urine pregnancy
             test at Screening

          -  Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis
             of schizophrenia or schizoaffective disorder

          -  Must have identified current, stable liver disease (e.g., viral hepatitis, alcoholic
             cirrhosis)

          -  Child-Pugh class A or B (total score < 10)

        Exclusion Criteria:

          -  Not able to swallow the study medication whole with the aid of water

          -  Not currently meeting criteria for any other Axis I diagnosis, including a DSM-IV
             diagnosis of Bipolar Disorder

          -  Not using alcohol in the previous 2 weeks or meeting the DSM-IV criteria for substance
             abuse or dependence or alcohol abuse or dependence in the 6 months before study entry

          -  Not experiencing severe liver disease or an acute exacerbation of the underlying liver
             disease (Child-Pugh total score >=10)

          -  No evidence of severe hepatic decompensation within the previous 3 months, such as:
             ascites not controlled with diuretics, peritonitis, portal hypertension or gross
             hepatic encephalopathy (eg, somnolence, stupor, coma)
A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
Condition: Schizophrenia; Bipolar 1 Disorder; Major Depressive Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Abilify MyCite - Digital Medicine System; Aripiprazole or other oral antipsychotics
Intervention description: The Abilify MyCite system is a drug-device combination product comprised of aripiprazole (an atypical antipsychotic) tablets embedded with a sensor that communicates with a patch (wearable sensor) and a medical software application with collected information (ingestion, mood, activity, rest) tracked and summarized for participants, healthcare providers, and potential caregivers. Abilify MyCite is intended to track drug ingestion and is indicated for the treatment of adults with schizophrenia (SCH), bipolar 1 disorder (BP1) (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with major depressive disorder (MDD).; For the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD.
Intervention MeSH terms: Aripiprazole; Antipsychotic Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 63 Years
Healthy volunteers: No
Keywords: Digital Medicine System

Summary:

      The primary objective of this pragmatic clinical trial (Main Study) was to assess the
      difference between all-cause hospitalizations in participants using Abilify MyCite versus
      virtual matched controls. In addition, secondary and exploratory objectives were to assess
      medication adherence, healthcare utilization and costs, and patient-reported outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants are actively enrolled in an Anthem-affiliated commercial, Medicaid, or
             Medicare health plan with medical and pharmacy benefits.

          -  Participants must have a smartphone with data plan.

          -  Participants currently prescribed aripiprazole, or appropriate for aripiprazole
             treatment.

          -  Participants must have a current diagnosis of SCH, BP1, or MDD.

        Exclusion Criteria:

          -  Any participant who participated in another clinical trial within 30 days of
             enrollment into the current study.

          -  Females who are breast-feeding and/or who are pregnant at the time of study
             enrollment, or who plan to become pregnant during the study.

          -  Participants who are currently being treated with a long-acting injectable
             antipsychotic.
Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Condition: Bacterial Infections; Eye Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Eye Infections
Intervention: AzaSite (azithromycin ophthalmic solution); Vigamox (moxifloxacin hydrochloride ophthalmic solution)
Intervention description: One drop ophthalmic solution at Visit 2; One drop ophthalmic solution at Visit 2
Intervention MeSH terms: Moxifloxacin; Azithromycin; Pharmaceutical Solutions; Ophthalmic Solutions; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the drug concentrations of AzaSite compared to
      Vigamox in tears of healthy volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both
             eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.

          -  Have normal lid anatomy.

        Exclusion Criteria:

          -  Have an abnormal biomicroscopy or ophthalmoscopy exam.

          -  Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms
             (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in
             the past thirty days.

          -  Have used artificial tears in the past thirty days.

          -  Have a diagnosis of on-going ocular infection or lid margin inflammation.

          -  Have ever had penetrating ocular surface or intraocular surgery.

          -  Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any
             of the ingredients in AzaSite.

          -  Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to
             any of the ingredients in Vigamox.

          -  Have had corneal or lid abnormalities.

          -  Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.

          -  Have any ocular pathology with the exception of cataracts.

          -  Have a serious systemic disease or uncontrolled medical condition.

          -  Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.

          -  Have a history of liver or kidney disease resulting in persisting dysfunction.
Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Intervention: Dexamethasone
Intervention description: Dexamethasone 10 mg intravenous administration
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 291.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: postoperative nausea and vomiting; postoperative pain

Summary:

      This study was conducted to determine the efficacy of an additional preemptive, single,
      low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting
      (PONV), pain level, and the safety in terms of wound complications in patients managed with
      our antiemetic protocol based on Ramosetron following TKA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary osteoarthritis, knee

          -  Scheduled for elective total knee arthroplasty

          -  Signed written informed consent

        Exclusion Criteria:

          -  Refusing participate

          -  Contraindication to regional anesthesia

          -  Severe impairment of bowel motility

          -  administration of other antiemetic drug within 24hours before surgery

          -  systemic steroid within 24hours before surgery

          -  history of cardiovascular & respiratory disease

          -  renal & hepatic failure
Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis
Condition: Deep Vein Thrombosis; Postthrombotic Syndrome
MeSH terms: Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
Intervention: Rivaroxaban; Diosmin; compression stockings
Intervention description: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month; 600 mg q.d. for 12 month; above knee stocking for 12 month
Intervention MeSH terms: Rivaroxaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized open-labeled clinical trial with a masked outcomes assessor
Masking: Single (Outcomes Assessor)
Masking description: Outcomes assessor does not involve in randomisation and treatment process, has no information about the patient's belonging to one of the study groups
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: deep vein thrombosis; postthrombotic syndrome; anticoagulation; treatment; prevention

Summary:

      The randomized clinical study aimed to assess the efficacy and safety of standard
      anticoagulation with rivaroxaban in combination with diosmin compared to the isolated use of
      standard rivaroxaban for prolonged therapy of acute femoro-popliteal deep vein thrombosis
      reflected the speed of deep vein recanalization and incidence of post-thrombotic syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age over 18 years

          -  The first episode of femoro-popliteal deep vein thrombosis (DVT)

          -  Verification of DVT by duplex ultrasound

          -  Informed consent signed

        Exclusion Criteria:

          -  Suspicion of pulmonary embolism (PE)

          -  Verified PE

          -  Bilateral DVT

          -  Contraindications for rivaroxaban (in accordance with the official instructions)

          -  Contraindications for diosmin (in accordance with the official instructions)

          -  Active cancer

          -  Verified severe thrombophilia (antiphospholipid antibodies, deficiency of proteins C,
             S, antithrombin 3)

          -  Use of other anticoagulants for more than 7 days from the DVT verification

          -  Impossibility of using compression stocking after 3 days from DVT verification

          -  Performed surgical intervention on the superficial or deep veins of the lower
             extremities (thrombolysis, thrombectomy, vein ligation, implantation of the inferior
             cava filter)

          -  Continuous use of other drugs that affect the hemostasis system (except for
             acetylsalicylic acid in a dose of not more than 100 mg).

          -  Low compliance