bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Levomilnacipran in Geriatric Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: levomilnacipran; Placebo
Intervention description: antidepressant; an inactive drug
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: depressed; older adults; antidepressants; depression; MDD

Summary:

      The purpose of this study is to examine the effects of levomilnacipran (FETZIMA) compared to
      placebo for the treatment of depression in older adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  60 years of age or older

          -  The presence of a major depressive disorder diagnosed according to the Diagnostic and
             Statistical Manual and Mental Disorders, 5th edition (DSM-V) criteria

          -  A 24-item Hamilton Rating Scale for Depression (HAMD) score of 16 or higher at
             baseline

          -  Mini-Mental State Exam (MMSE) score > 24.

        Exclusion Criteria:

        Subjects will be excluded if they had 1) any current and/or lifetime history of other
        psychiatric disorders (except unipolar depression with or without comorbid generalized
        anxiety disorder), or 2) recent unstable medical or neurological disorders; 3) any
        disabilities preventing participation in the study or in the MRI; 4) diagnosis of dementia;
        5) acute suicidality; 6) subjects with known allergic reactions to milnacipran,
        uncontrolled narrow angle glaucoma, seizures, poorly-controlled hypertension or ischemic
        changes on ECG, serotonin syndrome, or the recently used monoamine oxidase inhibitors
        (MAOIs) within last 4 weeks; 7) ineligible for MRI (e.g., metal in the body or
        claustrophobia)
Ideal Steroids for Asthma Treatment in the PICU
Condition: Asthma Childhood
MeSH terms: Asthma
Intervention: Dexamethasone
Intervention description: Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single Arm Treatment Group with a Prospective, Comparative Cohort Receiving Standard Care
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Determine if differences in (1) pediatric intensive care unit length of stay, (2) continuous
      nebulized albuterol duration, and (3) a composite outcome of advanced asthma therapy
      incidence including use of non-invasive ventilation (NIV), terbutaline, inhaled helium and
      mechanical ventilation between cohorts of children admitted with status asthmaticus to the
      PICU treated with either IV dexamethasone (DM) or methylprednisolone (MP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria are children 5 to 17 years of age with primary admission diagnoses
             of acute asthma exacerbation or status asthmaticus admitted to the PICU

        Exclusion Criteria:

          -  children with existing tracheostomy, cystic fibrosis, and pulmonary hypertension
Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria
Condition: Cystinuria
MeSH terms: Cystinuria
Intervention: Tiopronin 1g per day; Tiopronin 2g per day; Tiopronin 3g per day
Intervention description: 500mg PO BID x 7 days; 1g PO BID x 7 days; 1.5g PO BID x 7 days
Intervention MeSH terms: Penicillamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: cystinuria; D-penicillamine (Cuprimine®); tiopronin (Thiola®)

Summary:

      The purpose of this study is to evaluate the effect of escalating doses of cystine biding
      thiol drugs, including tiopronin and d-penicillamine, on the urinary cystine capacity, which
      is a measure of the amount of cystine in the urine, in patients with cystinuria. The overall
      goal will be to help guide therapy and ultimately minimize unnecessary side effects caused by
      larger doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a patient with a confirmed diagnosis of cystinuria.

          -  Be already taking a CBTD (either D-penicillamine (Cuprimine®) or tiopronin (Thiola®)
             as part of your medication regimen.

          -  Be between 18 and 80 years of age

          -  Be enrolled in the Cystinuria Registry.

        Exclusion Criteria:

          -  You are not a patient with cystinuria

          -  You are not already taking a cystine binding thiol drug

          -  You have renal colic (if you are passing a stone)

          -  You are scheduled to undergo a urologic procedure

          -  You are unwilling or unable to provide informed consent in order to be able to
             participate.
An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin
Condition: Type 2 Diabetes
Intervention: dapagliflozin; Placebo
Intervention description: SGLT-2 inhibitor for the treatment of type 2 diabetes
Intervention MeSH terms: Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a single center, prospective, randomized, placebo -controlled, parallel design and
      double blind study to evaluate oxidative stress, inflammation and hypertension markers and
      mediators before and after treatment with dapagliflozin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 20-80 years inclusive.

          -  Type 2 diabetes

          -  BMI ≥30 kg/m2

          -  Subjects on statins, ACE inhibitors, ARBs, thiazolidinediones and -antioxidants will
             be allowed as long as they are on stable doses of these -compounds and the dosage in
             not changed during the course of study. -Patients will be evenly distributed between
             the 2 groups based on statins, -ARBs, TZDs and ACE inhibitors use.

          -  HbA1c ≤ 8.0%

        Exclusion Criteria:

          -  Use of GLP-1 agonists or DPP-IV or SGLT-2 inhibitors therapy in the last 3 -months.

          -  Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and
             -hypertriglyceridemia.

          -  Coronary event or procedure (myocardial infarction, unstable angina, coronary -artery
             bypass, surgery or coronary angioplasty) in the previous 3 months.

          -  Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver
             -function defined as:

          -  aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or -alanine
             aminotransferase (ALT) >3x ULN

          -  Total bilirubin >2.0 mg/dL (34.2 µmol/L)

          -  Positive serologic evidence of current infectious liver disease including Hepatitis B
             viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody

          -  (liver function tests more than 3 times the upper limit of normal)

          -  Renal impairment (serum eGFR <60 ml/min)

          -  Any other life-threatening, non-cardiac disease

          -  Uncontrolled hypertension (BP > 160/100 mm of Hg)

          -  Congestive Heart Failure class III or IV.

          -  Use of an investigational agent or therapeutic regimen within 30 days of study

          -  Participation in any other concurrent clinical trial

          -  pregnant or breastfeeding patients

          -  Volume depleted patients. Patients at risk for volume depletion due to co-existing
             conditions or concomitant medications, such as loop diuretics
The Efficacy of Intravenous Acetaminophen During Perioperative Neurosurgery Period
Condition: Craniotomy; Brain Surgery
Intervention: Acetaminophen; Placebo
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: craniotomy; brain surgery; acetaminophen; Tylenol

Summary:

      This is a prospective randomized double blinded trial study involving 128 patients undergoing
      any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed
      envelope technique. The anesthesiologist and nurses who will be administering the placebo or
      intravenous acetaminophen will be blinded to the group in which patients are assigned.

      The following general perioperative data will be recorded: patient information/preoperative
      data, procedural information, postoperative information, and overall satisfaction of pain
      management at 24 hours after surgery.

      Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require
      no opioids in the first 24 hour postoperative period. With the use of intravenous
      acetaminophen, it is hypothesized that the number of patients that do not require opioids in
      the first 24 hours after surgery will double.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject are able to provide informed consent prior to participation in the study

          -  Subjects must be scheduled to undergo elective open craniotomy procedure of > 2 hour
             duration

          -  Subjects must be >18 years old but less than 90 years old

          -  Subjects must have an American Society of Anesthesiologists (ASA) class I-IV

          -  Subjects must have the ability to communicate meaningfully with the investigator staff
             and read/understand the study procedures and the use of pain scales

        Exclusion Criteria:

          -  Subjects used opioids or tramadol daily for >7 days before study medication
             administration

          -  Subjects had been treated with any of the following within 14 days of surgery:
             chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's
             wort, or valerian

          -  Subjects who have a chronic pain condition, significant medical disease or laboratory
             abnormality that in the investigator's judgment could compromise the subject's welfare

          -  Subjects with known hypersensitivity to opioids, acetaminophen or the inactive
             ingredients

          -  Subjects with known or suspected history of alcohol or drug abuse or dependence in the
             previous 2 years prior to the proposed surgery
Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries
Condition: Postoperative Pain; Carpal Tunnel Release; Distal Radius Fracture
MeSH terms: Carpal Tunnel Syndrome; Pain, Postoperative; Fractures, Bone; Radius Fractures; Wrist Fractures
Intervention: Acetaminophen; Ketorolac Tromethamine; Saline
Intervention MeSH terms: Acetaminophen; Ketorolac; Ketorolac Tromethamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: carpal tunnel syndrome; opioid analgesics; postoperative pain; IV tylenol; IV toradol

Summary:

      The purpose of this study is to determine the efficacy of intra-operative administration of
      IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and
      distal radius fracture patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  carpal tunnel release surgery candidates,

          -  distal radius fracture surgery candidates

        Exclusion Criteria:

          -  under 18 years of age,

          -  pregnant women,

          -  prisoners
Nicotine Gum Recovery After Colorectal Surgery
Condition: Post-operative Ileus
MeSH terms: Ileus
Intervention: Nicotine gum; Regular chewing gum
Intervention description: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first; Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: ILEUS

Summary:

      The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative
      period influences surgical outcome in patients undergoing colorectal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to freely give written informed consent to participate in the study and have
             signed the Informed Consent Form;

          -  Due to undergo small and/or large partial bowel resection via laparotomy or
             laparoscopy;

        Exclusion Criteria:

          -  Prior intestinal surgery

          -  Mentally incompetent or unable or unwilling to provide informed consent or comply with
             study procedures

          -  American Society of Anesthesiologists (ASA) Class IV or V;

          -  History of abdominal carcinomatosis;

          -  History of radiation enteritis;

          -  Children < 18 or adults > 85 years of age

          -  Pregnant women

          -  Current cigarette, cigar smokers and chewers of tobacco. ex smokers who quit less than
             3 months ago.

          -  Patients requiring postoperative ventilation, pressor requirement or ICU stay

          -  Patients with prior cardiovascular disorders
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
Condition: Contraception; Postpartum Depression; Lactation
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Depot medroxyprogesterone acetate; Depot medroxyprogesterone acetate
Intervention description: Postpartum administration of DMPA (prior to hospital discharge); Delayed administration of DMPA (4-6 weeks postpartum)
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Postpartum contraception; Contraceptive continuation; Breastfeeding; Postpartum depression; Progestins

Summary:

      The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after
      delivery to find out whether the timing of postpartum administration of DMPA (prior to
      hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of
      breastfeeding among women who plan to breastfeed their infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years old and > 24 0/7 weeks pregnant at time of enrollment

          -  Planning to deliver at Magee-Womens Hospital and to breastfeed

          -  Plans to use DMPA for postpartum contraception for at least 6 months

          -  Willing and able to provide informed consent in English and to comply with study
             protocol

        Exclusion Criteria:

          -  Intolerance of irregular vaginal bleeding

          -  Severe coagulation disorder

          -  Severe liver disease (LFTs >2x upper limits of normal at time of randomization)

          -  Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with
             breast lesions; active varicella; active, untreated tuberculosis; antineoplastic,
             thyrotoxic, or immunosuppressive medications; concern that the infant may have
             galactosemia

          -  History of breast cancer, reduction or augmentation surgery

          -  History of severe clinical depression

          -  Multiple gestation
Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension
Condition: Prolonged Second Stage of Labor
Intervention: intravenous nitroglycerin
Intervention description: Infusion at started at time of hysterotomy and stopped at neonate delivery
Intervention MeSH terms: Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second
      stage arrest of descent to prevent or uterine extension at the hysterectomy site.
    

Eligibility criteria:

        Inclusion Criteria: women 37weeks or greater gestation diagnosed with second stage arrest
        of descent undergoing cesarean delivery -

        Exclusion Criteria: elective, active phase arrest cesarean delivery, successful operative
        vaginal delivery

        -
Maintain Respiratory Muscle Function and Reduce Pneumonia Risk in Cancer Patients
Condition: Cancer
MeSH terms: Pneumonia
Intervention: 1,25 (OH)2 D3; Inspiratory isometric resistance training; Oral Placebo; Sham Inspiratory Isometric Resistance Training; Threshold Inspiratory Muscle Trainer (IMT)
Intervention description: 0.25 micrograms, taken daily for eight weeks, orally; A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax).; Placebo will be created to mimic the appearance of the study drug; A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax.; A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.
Intervention MeSH terms: Calcitriol; Dihydroxycholecalciferols
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pneumonia

Summary:

      This research is intended to begin to explore the impact of inspiratory muscle resistance
      exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients
      (subjects).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of cancer

          -  Renal and hepatic function (creatinine </= 2 x the institutional upper limit of
             normal; bilirubin </= 2 x the institutional upper limit of normal)

          -  No contraindication to receive either of the planned interventions of inspiratory
             resistance training or 1,25(OH)2D3 in the opinion of the healthcare provider

          -  No difficulties with swallowing oral medications in the opinion of the enrolling
             physician

        Exclusion Criteria:

          -  Patient is taking calcium or Vitamin D supplements and is unwilling to stop for 8
             weeks

          -  Severe chronic obstructive pulmonary disease (oxygen dependent or patient self-reports
             unable to walk one block without difficulty)

          -  Calcium or phosphorus level above the institutional upper limit of normal
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Condition: Trauma; Fractures, Closed; Children, Only; Deep Sedation; Ketamine
MeSH terms: Fractures, Bone; Fractures, Closed
Intervention: Intravenous Ketamine; Intranasal Ketamine
Intervention description: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.; Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: procedural sedation; ketamine; pediatric; fracture; intranasal; intravenous; emergency department

Summary:

      This a randomized clinical trial involving children with non-operative fractures presenting
      the emergency department randomized either to intranasal or intravenous ketamine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 1-18 years of age.

          -  American Society of Anesthesiologists (ASA) I or II

          -  Non-operative fracture requiring reduction

          -  Body weight less than or equal to 25 kg as measured by standard weighing scale

        Exclusion Criteria:

          -  ASA classification III or above

          -  Age less than 1 year

          -  History of hypertension, known coronary artery disease or Kawasaki disease, congestive
             heart failure, acute glaucoma or globe injury, increased intracranial pressure or
             intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric
             disorder

          -  Prior allergy to ketamine

          -  Unavailable parent or guardian to provide consent

          -  Non-English speaking