bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer
Condition: Alzheimer Dementia (AD)
MeSH terms: Dementia; Alzheimer Disease
Intervention: Memantine (once daily); Memantine (twice daily)
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared
      with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range
      5-18.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a knowledgeable and reliable caregiver who will accompany the patient
             to all clinical visits during the study.

          -  The patient has a diagnosis of probable AD consistent with the National Institute of
             Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and
             Related Disorders Association (NINCDS-ADRDA) criteria.

          -  The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening
             visit

          -  The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior
             to screening

        Exclusion Criteria:

          -  The patient has one or more of the following conditions: Evidence and/or history of
             any clinically significant neurodegenerative disease or other serious neurological
             disorders other than Alzheimer's disease including, but not limited to, Lewy body
             dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major
             cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary
             cerebral neoplasm.

          -  The patient has a modified Hachinski ischemia score greater than 4 at the screening
             visit.

          -  The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™
             criteria), established as the primary diagnosis, other than AD

          -  The patient is currently receiving treatment with an unstable dose of acetyl
             cholinesterase inhibitor

        Other protocol defined inclusion and exclusion criteria may apply
Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Intervention: cyclosporine 0.05% ophthalmic emulsion; carboxymethylcellulose-based lubricant eye drops
Intervention description: Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.; Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
Intervention MeSH terms: Cyclosporine; Carboxymethylcellulose Sodium; Ophthalmic Solutions; Lubricant Eye Drops; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion
      (Restasis®) in patients with dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of dry eye in both eyes

          -  Willing to use eye drops for dry eye symptoms

        Exclusion Criteria:

          -  Anticipate wearing contact lenses during the study

          -  Laser-assisted in situ keratomileusis (LASIK) surgery within the past 12 months

          -  Any ocular and/or lid surgeries within the past 6 months

          -  Cataract surgery in either eye

          -  Current or anticipated use of temporary punctal plugs during the study
Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
Condition: Osteoporosis Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: alendronate sodium (+) cholecalciferol; Comparator: Alendronate sodium (Fosamax); Comparator: Calcium
Intervention description: Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks; Alendronate sodium; tablet, once weekly, for 16 weeks; 500 mg oral tablet calcium once daily, for 16 weeks
Intervention MeSH terms: Cholecalciferol; Vitamin D; Alendronate; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 343.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To demonstrate the efficacy/safety of Fosamax Plus D
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during
             the study

          -  Patient has been diagnosed with osteoporosis

          -  Patient has been postmenopausal for more than 6 months

          -  Patient has no contraindication to taking oral bisphosphonates

          -  Patient is eligible for dual energy x-ray absorptiometry in spine or hip

        Exclusion Criteria:

          -  Patients with esophageal dysfunction

          -  Patients who can not sit or stand at least 30 minutes

          -  Patients who had a malignant disease or active systemic disease 5 years prior to
             participating in this trial

          -  Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving
             therapies which affect bone metabolism or calcium metabolism

          -  Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption,
             esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months
Comparison of Levobupivacaine and Ropivacaine for Femoral Neural Block
Condition: Pain; Arthroplasty, Replacement, Knee
Intervention: Levobupivacaine; Ropivacaine
Intervention description: Femoral bolus 150μM followed by femoral infusion 400μM; Bolus and infusion
Intervention MeSH terms: Ropivacaine; Levobupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: local anesthetic; levobupivacaine; ropivacaine; femoral perineural block

Summary:

      The anaesthetic management of patients undergoing total knee replacement is still not
      standardised. Epidural analgesia is common, but is associated with bilateral lower limb motor
      block and limited mobilisation. Spinal anaesthesia with intrathecal morphine provides good
      pain relief, but only for 12 to 16 hours, and is often associated with nausea and vomiting.
      Combined single injection femoral / sciatic blocks give good pain relief, but for a variable
      length of time (between 12 and 24 hours).

      In contrast, continuous femoral perineural infusion of local anaesthetic provides very good
      pain relief for several days. Pain relief is maintained by a constant infusion of local
      anaesthetic using an elastomeric ball. The investigators overriding aim is to develop a local
      anaesthetic regimen which offers complete pain relief for at least 48 hours, yet allows full
      mobilisation within 24 hours Given that ropivacaine may offer a more advantageous
      pharmacological profile (less lipid solubility) compared to levobupivacaine, the
      investigators feel it is pertinent to investigate the capacity of ropivacaine to prevent pain
      relief after surgery. Thus, the investigators aim in this study is to compare the median
      effective dose of levobupivacaine with the of ropivacaine for preventive pain relief after
      total knee replacement. Further, calculation of the equipotent median effective dose's of
      each local anaesthetic allied to objective measurement of quadriceps motor block using an
      electromyogram will allow us to determine the sensory - motor split of each local
      anaesthetic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients >18 years of age and non pregnant presenting for elective knee
             replacement

        Exclusion Criteria:

          -  Signs of cardiac failure (3rd heart sound, lung crepitations)

          -  Type I and type II diabetes

          -  Abnormal cardiac arrhythmias

          -  Hypovolaemia

          -  Presence of seizures,

          -  Dementia,

          -  Depression

          -  Encephalopathy,

          -  Terminal illness with a life expectancy < 3 months

          -  Age < 18 years

          -  Pregnant

          -  Coagulopathy
Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: ropivacaine; adrenaline; ketorolac; morphine; fentanyl; bupivacaine
Intervention description: intraoperative and 1. postoperative day; intraoperative LIA (IV and IA) and continuous EDA; intraoperative and 1. postoperative day; intraoperative; continuous postoperatively; continuous postoperatively
Intervention MeSH terms: Ketorolac; Epinephrine; Racepinephrine; Fentanyl; Morphine; Bupivacaine; Ropivacaine; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: osteoarthritis; knee arthroplasty; local infiltration analgesia; TKA; epidural analgesia; operation; surgery

Summary:

      Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain,
      causing patient discomfort, mobilisation and hospital discharge.

      The aim of this study is to:

        1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee
           arthroplasty.

        2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural
           analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients at least 18 years of age

          -  scheduled for elective total knee arthroplasty

          -  ASA I-III

          -  signed written informed consent

        Exclusion Criteria:

          -  age < 18

          -  ASA > III

          -  moderate or severe cardiac disease, bronchial asthma

          -  allergy against ropivacaine, ketorolac or morphine

          -  analgetic abuse

          -  pregnancy or nursing women

          -  severe psychiatric disease

          -  moderate to severe dementia
Methadone in Pediatric Anesthesia
Condition: Anesthesia
Intervention: Methadone 0.1mg/kg; Methadone 0.2mg/kg; Methadone 0.3mg/kg; Control
Intervention description: Subjects will receive methadone as their intraoperative opioid.; Subjects will receive methadone as their intraoperative opioid.; Subjects will receive methadone as their intraoperative opioid.; Subjects will not receive methadone as their intraoperative opioid.
Intervention MeSH terms: Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Pediatric patients undergoing surgery

Summary:

      This study will determine the pharmacokinetics of intravenous (IV) methadone in children
      undergoing surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 5-18

          -  Undergoing General anesthesia and surgery with anticipated postoperative inpatient
             stay of greater than or equal to 3 days

          -  Signed, written, informed consent from legal guardians and assent from patient

        Exclusion Criteria:

          -  History of or known liver or kidney disease
A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Ibandronate
Intervention description: Participants will receive ibandronate 150 mg QM orally for 6 months.
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 716.0
Sex: Female
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This 2 arm study will assess the impact of bone marker feedback (BMF), using serum
      carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on
      adherence to once monthly ibandronate (150 milligrams [mg] per oral [po]) in women with
      post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants
      will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The
      anticipated time on study treatment is 3-12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ambulatory, post-menopausal women with osteoporosis;

          -  eligible for bisphosphonate treatment;

          -  naïve to bisphosphonate therapy, or lapsed users (last bisphosphonate intake greater
             than or equal to [>=] 6 months ago).

        Exclusion Criteria:

          -  inability to stand or sit upright for at least 60 minutes;

          -  inability to swallow a tablet whole;

          -  hypersensitivity to bisphosphonates;

          -  treatment with drugs, or presence of active disease, known to influence bone
             metabolism;

          -  history of upper gastrointestinal disease.
Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.
Condition: Cervical Cancer; Uterine Cancer
MeSH terms: Endometrial Neoplasms; Uterine Neoplasms
Intervention: 18F fluciclovine; 18F fluciclovine PET
Intervention description: Each subject will receive one IV dose of 18F fluciclovine for PET scanning; Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      18F Fluciclovine is a recently FDA- approved radiopharmaceutical for prostate cancer
      biochemical recurrence, which is only minimally eliminated by the kidneys and therefore the
      image interpretation is not affected by nonspecific urine activity in the ureters and
      bladder, which is advantageous for pelvic imaging. Recent literature suggests that
      Fluciclovine PET has diagnostic potential for a variety of solid tumors, thus, allowing new
      opportunities for noninvasive probing of glutamine metabolism and clinical use in patient
      management. Current literature indicates that amino acid transporters including that of
      glutamine are upregulated in endometrial and cervical cancer so that Fluciclovine PET may
      have clinical potentials. The hypothesis is that Fluciclovine PET provides better imaging
      properties and greater diagnostic confidence and accuracy than FDG PET does in pelvic
      malignancies.

      Given the lack of current clinical data, a pilot study providing a direct comparison of
      Fluciclovine PET with FDG PET is warranted. The investigators seek to conduct a pilot study
      with 10 subjects to evaluate the clinical utility of Fluciclovine PET for staging of cervical
      cancer and endometrial cancer. This research will compare the diagnostic performance of the
      research Fluciclovine PET/MRI with the standard-of-care FDG PET/CT as an exploratory
      endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  18 years and older

          -  Biopsy-proved cervical cancer or endometrial cancer within three months of study
             enrollment

          -  Standard-of-care (SOC) FDG PET/CT exam performed within 30 days of study enrollment

        Exclusion Criteria:

          -  Female < 18 years old

          -  No history of cervical cancer or endometrial cancer

          -  Primary biopsy > 3 months of study enrollment

          -  Systemic therapy or radiation therapy initiated

          -  SOC FDG PET/CT exam performed > 30 days of study enrollment

          -  Therapeutic procedures (chemotherapy, radiation therapy) have been initiated

          -  Pregnancy or lactation

          -  Claustrophobia or inability to tolerate the imaging procedure on the PET/MR scanner

          -  Individual is not willing to give informed consent
Superficial Cervical Plexus Block for Shoulder Pain After Lung Surgery
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: Superficial Cervical Plexus Block; Bupivacaine
Intervention description: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a "fan" technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.; Single dose of 37.5 mg of bupivacaine subcutaneously
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Superficial Cervical Plexus Block; Thoracic Surgery; Thoracotomy; Video-Assisted Thoracoscopic Surgery

Summary:

      The investigators want to know whether injecting numbing medication on the side of the neck
      (also called superficial cervical plexus block) can prevent or reduce shoulder pain that
      patients commonly experience after lung surgery. The investigators will perform the injection
      at the end of your surgery while the subjects are still under general anesthesia and before
      they wake up. The investigators will use a local anesthetic (bupivacaine or Marcaine®) that
      is routinely used for skin infiltration of the surgical wounds.

      This study is randomized and single-blind. This means that subjects will be assigned by
      chance (like flipping a coin) to receive either an injection with active medication
      (bupivacaine), or no injection at all.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subjects who clinically consented to elective thoracotomy or video-assisted
             thoracoscopic surgery (VATS) under general anesthesia and epidural analgesia

          -  ages between 18 and 75 years

        Exclusion Criteria:

          -  inability to perform thoracic epidural

          -  violation of protocol (e.g., administration of medication that does not comply with
             the study protocol)

          -  subject has change of mind

          -  surgery has to be repeated

        Non-inclusion Criteria:

          -  subject refusal

          -  non-English speaking

          -  previous chronic or neuropathic pain

          -  previous chronic use of opioids

          -  history of psychiatric disorder

          -  allergy to local anesthetic

          -  previous ipsilateral thoracotomy or VATS

          -  prior history of shoulder pain
Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Drug: Budesonide/formoterol (Symbicort Turbuhaler; Drug: ipratropium (AtroventTM); theophylline SR
Intervention description: budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily); ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily); theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
Intervention MeSH terms: Budesonide; Theophylline; Formoterol Fumarate; Ipratropium; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 581.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Severe chronic obstructive pulmonary disease (COPD) patients

Summary:

      Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD)
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent

          -  Men or women patients ≥ 40 years of age

          -  Diagnosis of COPD with symptoms for more than 2 years and there is a history of at
             least one COPD exacerbation requiring a course of oral steroids and/or antibiotics
             within 1-12 months before Visit 2

          -  Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value,
             pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital
             Capacity (FVC) < 70%, pre-bronchodilator

          -  Total symptom score of 2 or more per day for at least half of run-in period
             (breathing, cough and sputum scores from the diary card) and complete morning
             recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the
             run-in period

        Exclusion Criteria:

          -  A history of asthma and seasonal allergic rhinitis before 40 years of age

          -  Patients who have experienced exacerbation of COPD requiring hospitalisation and /or
             emergency room treatment and/or a course of oral steroids and/or intravenous
             corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during
             run-in period

          -  Patients with relevant cardiovascular disorder judged by the investigator

          -  Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by
             the investigator

          -  Women who are pregnant, breast-feeding or of child-bearing potential judged by the
             investigator