bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
Condition: Post-Menopausal Osteopenia
MeSH terms: Bone Diseases, Metabolic
Intervention: Placebo; ibandronate [Bonviva/Boniva]
Intervention description: po monthly for 1 year; 150mg po monthly for 1 year
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 160.0
Sex: Female
Minimum age: 45 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly
      compared with placebo in post-menopausal women with osteopenia. Patients will be randomized
      to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study
      treatment is 1-2 years, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women 45-60 years of age;

          -  post-menopausal;

          -  ambulatory.

        Exclusion Criteria:

          -  vertebral fracture (except traumatic fracture such as in a motor vehicle accident);

          -  low-trauma osteoporotic fracture in any other bone;

          -  breast cancer diagnosed within last 20 years;

          -  other malignancy diagnosed within last 10 years, except successfully resected basal
             cell cancer;

          -  treatment with any bisphosphonate within last 2 years;

          -  treatment with other drugs affecting bone metabolism within last 6 months.
Post-operative Analgesia in Elective, Soft-tissue Hand Surgery
Condition: Carpal Tunnel; Ganglion Cyst; Trigger Finger; De Quervain Disease
MeSH terms: Ganglion Cysts; Trigger Finger Disorder; De Quervain Disease
Intervention: Acetaminophen/Ibuprofen; Acetaminophen/Hydrocodone
Intervention description: Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free; Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adult; soft-tissue hand surgery

Summary:

      The purpose of this research study is to find out which combination of pain medications
      following surgery work the best and result in the fewest side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 18

          -  Male or Female (non-pregnant)

          -  Elective, soft tissue hand surgery indicated based on diagnosis made by either
             clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination
             of the two (carpal tunnel release, trigger finger release, first dorsal compartment
             release, ganglion cyst excision, second extensor compartment release)

          -  Subjects are capable of giving informed consent

        Exclusion Criteria:

          -  Allergy to study medication

          -  Any pre-existing pain condition requiring analgesia

          -  Fibromyalgia

          -  Recent upper gastrointestinal bleeding

          -  Coagulopathy (primary or medication-related)

          -  Renal impairment

          -  Liver disease

          -  Pregnancy

          -  Patients who consent to the study but require unexpected admission, including those
             requiring admission resulting from operative complications, will be excluded before
             randomization
Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: Pioglitazone then Placebo; Placebo then Pioglitazone
Intervention description: Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo.; Subjects will take the placebo for the first 12 weeks of the study. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take the pioglitazone 30mg tablet daily for 3 months.
Intervention MeSH terms: Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cardiovascular risk; biological markers

Summary:

      SPECIFIC AIMS

        1. To determine whether pioglitazone will reduce levels of asymmetric
           dimethylarginine(ADMA) in patients with diabetes.

        2. To determine whether nitric oxide(NOx) products are increased with pioglitazone
           treatment.

        3. To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 40--75 years-of-age, non-pregnant

          -  Informed consent

          -  History of type 2 Diabetes Mellitus

          -  Stable weight for the last 3 months (no change greater than +5% of body weight)

          -  ADMA > 0.50 µM/L (mean of non-diabetic reference group) (Devangelio 2007)

          -  On stable medical therapy for at least 3 months

          -  A working telephone

        Exclusion Criteria:

          -  Any history of known coronary heart disease, including a history of congestive heart
             failure, myocardial infarction, coronary re-vascularization, or stroke

          -  Pregnancy

          -  Chronic kidney disease, serum creatinine >2.0mg/dl, chronic liver disease, or
             uncontrolled hypertension (>160/100).

          -  Current participation in a formal weight loss program or planning to start such a
             program during the next 3 months

          -  Collagen vascular disease, infection, or other inflammatory condition

          -  Electrocardiogram (EKG) evidence of ischemia or infarction

          -  Macular edema (swelling of the back of the eye), recent excessive weight gain (over 5%
             of weight in 30 days), elevated liver function tests > 2.5 X the upper limit, or
             history of osteoporosis
Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery
Condition: Intrauterine Device Expulsion
Intervention: Copper IUD placement at time Cesarean Delivery (Copper T 380A)
Intervention description: Placement of Paragard IUD at time of Cesarean Delivery
Intervention MeSH terms: Copper
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Postpartum IUD; Cesarean Delivery; 6 months postpartum; satisfaction

Summary:

      The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices
      (IUDs) placed at time of Cesarean Delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  singleton gestation

          -  greater than 35 weeks gestation

          -  speaks English or Spanish

          -  desires IUD for contraception

          -  undergoing a cesarean delivery

        Exclusion Criteria:

          -  evidence of chorioamnionitis

          -  history of chlamydia within this pregnancy
Diurnal Variation of Plasminogen Activator Inhibitor-1
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome
Intervention: Eplerenone (Morning); Eplerenone (Night-time)
Intervention description: Eplerenone - 50mg, by mouth, daily, in the morning x 2 weeks followed by 4 weeks at 100mg.
100mg, by mouth, daily, in the morning x 4 weeks then patients cross over to 100mg, by mouth, daily, in the evening x another 4 weeks.; Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg
Intervention MeSH terms: Eplerenone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Metabolic syndrome; Aldosterone inhibitor; Diurnal drug regimen; PAI-1 levels

Summary:

      To determine if nighttime administration of an aldosterone antagonist would effectively lower
      peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning
      administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age18-65

          -  Metabolic Syndrome (3 or more of the following):

               1. Blood pressure 130/85 or greater

               2. Central obesity (Waist - Male > 40", Female > 35")

               3. Fasting glucose ≥ 110 mg/dl

               4. Low HDL (Male < 40 mg/dl, Female < 50 mg/dl)

               5. Elevated Triglycerides (> 150 mg/dl)

        Exclusion Criteria:

          -  Cigarette Use

          -  Renal insufficiency

          -  Coronary Artery Disease

          -  Diabetes

          -  Blindness

          -  Cerebrovascular Disease

          -  Secondary hypertension (renal artery stenosis, pheo, etc.)

          -  RAAS disease (Primary Aldosteronism, etc.)

          -  Other chronic illness (cancer, autoimmune or liver disease)

          -  Pregnancy

          -  Anemia (Hgb < 12 mg/dl)

          -  Evening or Night Shift work

          -  Transmeridian travel in previous 6 months

          -  History of sleep disorders

          -  Hypokalemia (serum potassium < 3.5 milliequivalent (mEq/L)

          -  Hyperkalemia (serum potassium > 5.5 mEq/L

          -  Reported hypersensitivity to HCTZ or eplerenone
Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
Condition: Anesthesia, Local
Intervention: Ropivacaine 0.75%; Ropivacaine 0.75% + 300 mcg Buprenorphine; Ropivacaine 0.75% + 75 mcg clonidine; Ropivacaine 0.75% + 8 mg dexamethasone
Intervention description: Only ropivacaine 0.75% is administered for this arm of the interscalene block; Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block; Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block; Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
Intervention MeSH terms: Dexamethasone; Clonidine; Buprenorphine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Brachial Plexus Block; Clonidine; Dexamethasone; Buprenorphine

Summary:

      This is a prospective randomized controlled triple-masked study looking at the duration of
      nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and
      clonidine) plus ropivacaine versus plain ropivacaine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have or are:

               1. Orthopedics service patients having shoulder surgery

               2. ASA(American Society of Anesthesiologists) class I, II, or III.

               3. Patients at least 18 years old but less than 71 years old.

               4. Patients giving informed consent.

               5. Non-Emergency Surgery

                  Exclusion Criteria:

          -  Patients who have or are:

               1. An inability to cooperate during the block placement.

               2. Neuropathy of the planned extremity to block

               3. Diabetes

               4. Documented Kidney Disease

               5. Documented Liver Disease

               6. A lack of or inability to give informed consent.

               7. Currently incarcerated.

               8. Pregnant
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
Condition: Pseudobulbar Affect (PBA); Stroke; Dementia; Traumatic Brain Injury (TBI)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Intervention: Nuedexta (DM 20 mg/Q 10 mg)
Intervention description: Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 367.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of the study are to evaluate the safety, tolerability, and effectiveness of
      NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of
      Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and
      traumatic brain injury (TBI)over a 12 week period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Center for Neurologic Study-Lability Scale (CNS-LS)score of 13 or greater

          -  Clinical diagnosis of Pseudobulbar Affect (PBA)

          -  Documentation of Neurologic disease or brain injury

        Exclusion Criteria:

          -  Unstable neurologic disease

          -  Severe dementia

          -  Stroke within 3 months

          -  Penetrating TBI

          -  Contraindications to Nuedexta

          -  Severe Depressive Disorder
Postoperative Pain Control in Septum and Sinus Surgery
Condition: Post-operative Pain; Sinus Surgery
MeSH terms: Pain, Postoperative
Intervention: Acetaminophen 325 mg Oral Tablet; Acetaminophen 650 mg Oral Tablet; OxyCODONE 5 mg Oral Tablet; Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet
Intervention description: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain; Acetaminophen 650 mg scheduled every 6 hours round the clock for pain; Oxycodone 5 mg every 4 hours as needed for breakthrough pain; Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Oxycodone; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open, randomized into one of two arms study. Study arm 1: Standard of care arm of Acetaminophen (Tylenol) 325 mg every 6 hours as needed plus acetaminophen/hydrocodone 7.5 mg/325mg every 4 hours for breakthrough pain. Study arm 2: Acetaminophen 650 mg. every 6 hours round the clock plus 5 mg oxycodone every 4 hours as needed for breakthrough pain.
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post-operative pain; Sinus pain; Sinus surgery; Septum Pain; deviated septum

Summary:

      This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will
      lead to less opiate use in the first week post-operative (after surgery) in sinus/septum
      surgery patients. Participants will be randomized like a flip of a coin to either the
      standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates
      (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of
      acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum
             surgery

          -  18 years of age or older

          -  Male or female

          -  No known allergies to or contraindications to the use of acetaminophen, hydrocodone,
             or oxycodone

          -  Patients discharged to home after surgery

        Exclusion Criteria:

          -  Undergoing revision sinus, septum, or sinus/septum surgery

          -  Younger than 18 years old

          -  Allergy or contraindication to acetaminophen, hydrocodone, or oxycodone

          -  Patients admitted to the hospital postoperatively for airway monitoring
Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI
Condition: Delirium on Emergence
MeSH terms: Delirium; Emergence Delirium
Intervention: Propofol; Propofol; Sevoflurane; Isoflurane
Intervention description: Propofol infusion with nasal oxygen; Propofol infusion with an LMA; Sevoflurane with an LMA; Isoflurane with an LMA
Intervention MeSH terms: Propofol; Sevoflurane; Isoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: children; sevoflurane; isoflurane; propofol; anesthesia; MRI; delirium

Summary:

      Children who receive general anesthesia may become agitated (emergence delirium) in the
      recovery period. This occurs more often after inhalational anesthetics, particularly
      sevoflurane and desflurane than after propofol. However, agitation after anesthesia in
      children may be difficult to distinguish from pain; accordingly studies are ideally designed
      during MRI to obviate the contribution of pain during emergence. Airway complications have
      been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs.
      Whether the airway complications were due to the LMA or the isoflurane was unclear.
      Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane
      compared with IV propofol and 2. airway complications after LMA or nasal prongs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 2-12yrs,

          -  ASA Class I-II,

          -  Fasting,

          -  Unmedicated,

          -  Elective MRI scan

        Exclusion Criteria:

          -  Cognitive impairment,

          -  On psychotropic medications,

          -  Taking multiple (>2) antiepileptic medications,

          -  Requiring endotracheal intubation for GA
Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
Condition: Heart Transplant Surgery; Lung Transplant Surgery
MeSH terms: Heart Failure
Intervention: iNO; iEPO
Intervention description: Subject will receive inhaled Nitric Oxide in this intervention; Subject will receive inhaled Epoprostrenol in this intervention
Intervention MeSH terms: Nitric Oxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 519.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart and Lung transplantation surgery; Pulmonary vasodilation therapy

Summary:

      1. to conduct a clinical investigation to determine if inhaled epoprostenol (Veletri®, iEPO)
      and inhaled nitric oxide (iNO) will have similar impact on outcomes in adult patients
      undergoing durable LVAD placement, heart transplantation, or lung transplantation 2. to
      conduct a cost-capture analysis on the expense each drug incurs per patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heart transplantation

          -  LVAD placement

          -  Lung Transplantation

        Exclusion Criteria:

          -  Combined Organ Transplantation

          -  Age < 18 years old

          -  Pregnancy

          -  Known allergy to prostaglandin (rare)

          -  Refusal of blood products due to personal or religious preference

          -  Subject is enrolled in another study protocol, which does not allow randomization of
             PVD therapy

          -  Heart transplant or durable LVAD recipients with adult congenital heart disease (CHD)

             o Caveat: Does NOT meet exclusion criteria if the scheduled heart transplant or LVAD
             implantation is due to heart failure from a previous heart transplantation related to
             CHD, performed more than 90 days previous to the date of trial enrollment

          -  Heart transplant recipients diagnosed with Arrythmogenic Right Ventricular
             Cardiomyopathy

          -  Heart transplant recipients diagnosed with Acute Cardiac Allograft Rejection after a
             previous heart transplantation.

          -  Heart transplant or durable LVAD recipients with preoperative RVAD for right heart
             failure

          -  Patient is scheduled to undergo lung transplantation but has undergone heart
             transplantation in the previous 90 days

          -  Patient is scheduled to undergo durable LVAD implantation but has undergone heart
             transplantation in the previous 90 days

          -  Patient is scheduled to undergo heart transplantation but has undergone lung
             transplantation in the previous 90 days

          -  Patients with preoperative Venovenous ECMO as a bridge to lung transplantation

          -  Heart transplant or durable LVAD recipients with preoperative RVAD for right heart
             failure