bioihbjkbjnl/mcl2 huggingface dataset:
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions
Condition: Adult Intracranial Neoplasm; Vascular: Intracranial
MeSH terms: Brain Neoplasms
Intervention: Fluorescein Sodium
Intervention description: All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and
      the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older.

          -  Diagnosed by preoperative imaging modalities to have a brain tumor or vascular lesions
             (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical
             intervention.

          -  The patient is determined by a board certified Neurosurgeon (above mentioned
             neurosurgeons) to benefit from the application of Fluorescein Sodium intraoperatively

          -  Patient or legally authorized representative provides written informed consent to
             enroll in this study.

        Exclusion Criteria:

          -  Known allergic reaction to Fluorescein Sodium.

          -  Children.

          -  Prisoners.

          -  Students.

          -  Infection of the central nervous system or other sites.

          -  Hemodynamic instability or significant impairments in circulation.

          -  Concomitant treatment with other investigational drugs.

          -  Any uncontrolled condition unrelated to the neurosurgical disease.

          -  History of psychiatric, additive, or any other disorder that compromises the ability
             to provide informed consent or comply with study protocols.

          -  Participation on other clinical trials during the last thirty days.

          -  Pregnant patients.

          -  Patients unable to discontinue medications that affect Fluorescein metabolism.
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
Condition: Bradycardia
MeSH terms: Bradycardia
Intervention: Closed Loop Stimulation (CLS); Standard Rate Adaptive (R) Technology; Non-rate adaptive (DDD) pacing
Intervention description: Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the Closed Loop Stimulation (DDD-CLS or VVI-CLS) pacing mode for the long-term follow-up portion of this study.; Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the standard are adaptive pacing mode (DDDR or VVIR) for the long-term follow-up portion of this study.; Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the non-rate adaptive pacing mode (DDD or VVI) for the long-term follow-up portion of this study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1491.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bradycardia; Sinus Node Dysfunction; Chronotropic incompetence; Pacemaker; Rate adaptive

Summary:

      This is a randomized, prospective, single-blinded, multi-center study involving approximately
      1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness
      of Closed Loop Stimulation (CLS) rate adaption technology over both standard rate responsive
      technology (R) and non-rate responsive mode (DDD) during activities of daily living (ADL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Implanted within the last 45 days or being considered for implant with a BIOTRONIK
             pacemaker utilizing CLS rate adaptation technology (currently the Cylos family of
             pacemakers).

          -  Ability to give written informed consent

          -  Geographically stable and able to return for regular follow-ups for 12 months after
             ADL testing

          -  At least 18 years old

        Exclusion Criteria:

          -  Patients physically limited and unable to perform all or parts of the ADL testing

          -  Currently enrolled in any other clinical study

          -  Patients with medical reasons that preclude regular participation in the follow-ups
Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy
Condition: Pain; Quality of Life
Intervention: Meperidine; Fentanyl
Intervention description: Injection meperidine 1 mg/kg with diazepam 0.1 mg/kg.to intravenous 5 minutes before inserting the applicator and then when the patients had pain score greater or equal to 4. All patients received supplement oxygen cannula 3 LPM continuously monitored for saturation, pulse and monitored every 5 minutes for blood pressure.; Injection meperidine 1 mg/kg to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4. All patients received supplement oxygen cannula 3 LPM continuously monitored for saturation, pulse and monitored every 5 minutes for blood pressure.
Intervention MeSH terms: Fentanyl; Meperidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 40.0
Sex: Female
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Meperidine; Fentanyl; Pain management; brachytherapy

Summary:

      Purpose: To compare the pain level and quality of life of the two sedation regimens
      consisting of diazepam in combination with meperidine or fentanyl.

      Materials and methods: A total of 40 patients (160 sessions of brachytherapy), unselected
      brachytherapy out patients at Chulabhorn Hospital, Thailand were enrolled with informed
      consent and randomized to receive meperidine or fentanyl. Data of perceived pain (according
      to standard 10-cm visual analog scales [VAS]), and perceived Quality of life (EQ-5D) were
      collected. Patients and all brachytherapy staffs directly involved with the procedure were
      blinded about the drug used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 20 years old or older,

          -  Diagnosed with cervical cancer

          -  On course of external Radiation therapy

          -  Treated with brachytherapy 4 times.

        Exclusion Criteria:

          -  Pregnant

          -  Previously underwent intracavitary brachytherapy

          -  Illiterate
Pain Control With Total Knee Replacement
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Gabapentin
Intervention description: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 25 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this project is to study the effects of gabapentin on pain control in the
      perioperative and post-operative period of total knee arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • Age > 25 years old

               -  Primary osteoarthritis of the knee

               -  Must be undergoing unilateral total knee arthroplasty

               -  Anesthesia assesment score I, II, or III

        Exclusion Criteria:

          -  Severe joint malalignment (defined as varus/valgus angle > 20 deg)

               -  Use of gabapentin pre-operatively

               -  History of chronic pain (currently under treatment)

               -  History of substance abuse

               -  Impaired kidney function (defined as creatinine > 1.5)

               -  Epilepsy (currently on medication for treatment)

               -  Known allergy to Gabapentin

               -  Known history of depression or suicidal thoughts and behaviors

               -  Anyone who is not a candidate for general anesthesia or any other portion of the
                  investigator's standard of care.
Valproate in Late Life Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Valproate
Intervention description: Enrolled individuals received adjunctive, open-label valproate semisodium, initially started as valproate semisodium delayed -release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended- release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50-100 µg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Intervention MeSH terms: Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Schizophrenia; Anticonvulsants; Valproic Acid; Valproate

Summary:

      The purpose of this research study is to analyze the effectiveness and tolerability of a
      medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who
      have schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a diagnosis of schizophrenia as confirmed by the MINI

          -  Must be on antipsychotic medication

          -  Must be age 50 year or older

          -  Must be capable of providing written informed consent for study participation. In
             situations where individuals have guardians of person, guardian and subject must both
             provide written consent; and

          -  Must live in the Northeast Ohio area.

        Exclusion Criteria:

          -  A primary psychiatric DSM Axis I diagnosis other than schizophrenia

          -  Actively abusing substances; or

          -  Medically unstable.
Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children
Condition: Infection Prevention
MeSH terms: Infections
Intervention: Antibiotic-impregnated Catheters (M/R); Non-impregnated Catheters (C/S)
Intervention description: Patients randomized to this arm will have the antibiotic-impregnated catheters inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.; Patients randomized to this arm will have the central venous catheter inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
Intervention MeSH terms: Anti-Bacterial Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 326.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary purpose of the study is to determine if a therapeutic difference exists between
      central venous catheters impregnated with minocycline and rifampin and conventional catheters
      not impregnated with antibiotics when used in children at high risk for bloodstream
      infections (CABSI) after cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 18 years

          -  Cardiovascular surgery patient with a case complexity warranting CVC placement longer
             than 3 days

          -  Study devices of appropriate size for patient use without modification

          -  Informed consent obtained prior to patient entering the operating room

        Exclusion Criteria:

          -  Age ≥ 18 years

          -  Drug allergy to minocycline, other tetracyclines, or rifampin

          -  Ventricular assist device (VAD) therapy

          -  Extracorporeal membrane oxygenation (ECMO) therapy

          -  Patients undergoing cardiac transplant

          -  Any active infection or being treated for bacteremia at the time of randomization
RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)
Condition: Parkinson's Disease; Essential Tremor; Dystonia
MeSH terms: Parkinson Disease; Tremor; Dystonia; Dystonic Disorders; Essential Tremor
Intervention: Activa RC
Intervention description: Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No
Keywords: Parkinson's disease; Essential Tremor; Dystonia (where indication is approved); Deep brain stimulation; Activa RC

Summary:

      The purpose of this study is to assess the recharge feature of the Activa RC System in
      patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD),
      Essential Tremor (ET), or dystonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is enrolled in the Implantable Systems Performance Registry (ISPR) and will
             receive one Activa RC as their first implantable neurostimulator or as a replacement
             implantable neurostimulator for DBS.

          -  Patient must meet the indications in the Activa RC labeling.

          -  Patient (or patient's legally authorized representative) signs and dates the
             appropriate RECHARGE Informed Consent Form and/or Informed Assent Form and
             Authorization to Use and Disclose Health Information (HIPAA, US only).

          -  Patient has a diagnosis of Parkinson's Disease, Essential Tremor, or dystonia that
             meets the approved indication for Activa RC in the applicable geography.

          -  Patient with dystonia is 7 years of age or older (EU only).

          -  Patient with either PD or ET is 18 years of age or older.

          -  Patient (or caregiver) is able to use the patient programmer and correctly interpret
             the icons.

          -  Patient (or caregiver) is able and willing to regularly monitor the status of the
             rechargeable battery and respond appropriately.

          -  Patient (or caregiver) is able to locate the INS, position the recharge antenna for
             sufficient coupling, put on the recharge holster/belt, and monitor progress during the
             recharge session.

          -  Patient (or caregiver) is able to perform recharging activities for sufficient
             duration and frequency to maintain therapy and to perform recharging activities on an
             ongoing basis.

          -  Patient is willing and able to comply with protocol requirements.

        Exclusion Criteria:

          -  Patient has a contraindication identified in the Activa RC labeling.

          -  Patient who is currently enrolled in or plans to enroll in any concurrent drug and/or
             device study that may confound the results of the RECHARGE study.

          -  Patient has or will be implanted with a non-Medtronic Deep Brain Stimulation system
             component.
Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: zoledronic acid
Intervention description: Zoledronic acid concentrate (4 mg/5 milliliters [ml]) was diluted in 100 mL sterile 0.9% calcium-free sodium chloride or 5% dextrose injection, administered IV, either 4 or 12 weeks for 96 weeks.
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple myeloma; zoledronic acid; skeletal complications; bone

Summary:

      This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in
      preventing skeletal complications in multiple myeloma participants who have been on an
      intravenous (IV) bisphosphonate for about one to two years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of multiple myeloma

          -  Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been
             initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due
             to multiple myeloma

          -  Stable renal function

        Exclusion Criteria:

          -  Known sensitivity to bisphosphonates

          -  Receiving investigational drugs considered not safe for co-administration or have a
             significant effect on bone turnover

          -  Current active dental problems

          -  Had bone marrow transplant or blood stem cell transplant within 2 months before study
             entry or planned transplant within 2 months following enrollment

        Other protocol-defined inclusion/exclusion criteria may apply.
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Intervention: Havrix™
Intervention description: 2 doses at 6 months interval
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 29 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Havrix™; Hepatitis A

Summary:

      The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at
      11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a
      2 dose vaccination schedule of hepatitis A vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who had received at least one dose of the study vaccine in the primary study

          -  Written informed consent will have been obtained from the subjects before the blood
             sampling visit of each year.
The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Blood sampling; Blood sampling
Intervention description: Subjects who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study will be enrolled in this retrospective cohort study wherein single blood sampling will be performed for pharmacogenetic markers analysis.; Subjects who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study will be enrolled in this retrospective cohort study wherein single blood sampling will be performed for pharmacogenetic markers analysis.
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 324.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Biomarkers; Genetic markers

Summary:

      This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease -
      pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study
      of the REGARD trial.

      The aim of this trial is to provide additional data on the factors influencing interferon
      (IFN) beta response.

      This is a Phase 4 trial involving subjects who previously participated in the REGARD trial.
      To address the trial objectives, a single visit follow-up trial will be performed during
      which a blood sample will be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Was randomized in the REGARD 24735 study

          -  Is willing and able to comply with the protocol

          -  Has given written informed consent before performing any trial-related activities

        Exclusion Criteria:

          -  Is unwilling or unable to participate in the study

          -  Is already included in the initial REGARD 24735 PGx sub-study
Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Ibandronate (SB743830HD)
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 365.0
Sex: Female
Healthy volunteers: No
Keywords: risedronate; Ibandronate; preference; Osteoporosis

Summary:

      This is a randomized open label, multi-centre study for Korean women with postmenopausal
      osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or
      the once-weekly dosing of risedronate.

      Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly
      regimen.

      Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with
      risedronate 35 mg or vice versa.

      After taking the first interventional medicine for 3 months or 12 weeks completely, a subject
      changes the treatment arm. There is no washout period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with postmenopausal osteoporosis diagnosed by DXA scanning, defined by T-score
             of -2.5 SD at spine or femur.

          -  Patients who have never received bisphosphonates therapy (bisphosphonates naive)

        Exclusion Criteria:

          -  Inability to stand or sit in the upright position for at least 60 minutes;

          -  Hypersensitivity to any component of risedronate and ibandronate;

          -  Administration of any investigational drug within 30 days preceding the first dose of
             the study drug;

          -  Patient has been on hormone (estrogen) replacement therapy or other osteoporosis
             medication (e.g. SERMS and calcitonin) within the previous 3 months.

          -  Patient has been on systemic corticosteroids therapy for more than 1 month within the
             past year.

          -  Other bone disease except osteoporosis

          -  Current medical history of uncontrolled major upper GI disease