bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
Condition: Pain
MeSH terms: Chronic Pain
Intervention: morphine sulfate extended release capsules
Intervention description: 30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1570.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: pain; opioid; abuse; moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time

Summary:

      The purpose of this study is to provide information in a broad, "real world" population of
      chronic pain patients assessing both pain control with AVINZA as well as the potential risk
      for misuse and abuse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is an adult (greater than or equal to 21 years old

          -  Patient has chronic (greater than or equal to 3 months) moderate-severe pain who, at
             the discretion of the Investigator, requires an around-the-clock opioid for optimal
             analgesia. Patients may be opioid naïve (not currently on an opioid) or opioid
             tolerant. Opioid naïve patients with a pain score of greater than or equal to 4 on an
             11-point NRS (numerical rating scale. OR Opioid tolerant patients experiencing
             suboptimal response (i.e. pain score of greater than or equal to 4) or unacceptable
             side effects to sustained release opioids or short-acting opioids.

          -  Patient is able to read and understand English and comply with protocol requirements.

        Exclusion Criteria:

        A patient who meets ANY of the following exclusion criteria will not be enrolled:

          -  Hypersensitivity to morphine, morphine salts, or any components of AVINZA

          -  Respiratory depression (slowed breathing)

          -  Acute or severe bronchial asthma or severe chronic obstructive pulmonary disease
             (COPD)

          -  Currently has or is suspected of having paralytic ileus

          -  Requires a daily dose of AVINZA greater than 1600mg/day

          -  Patient is abusing alcohol

          -  Pregnancy or breast feeding

          -  Currently taking AVINZA

          -  Patient unwilling to sign the Treatment Agreement

          -  Life expectancy is less than 2 months

          -  Migraine as the primary pain score

          -  Patient resides in a hospital or nursing home

          -  Patient has had more than 2 surgeries for low back pain

          -  Patient is anticipated to require major surgery or steroid injections for chronic pain
             over the next 12 weeks
The INDORSE Study: Inhibition of Dipeptidyl Peptidase IV: Outcomes on Renal Sodium Excretion
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Sitaglitpin; Placebo
Intervention description: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days; Oral tablet (no medicinal ingredients) administered once daily for 28 days
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes, DPP-4 inhibitors, renal sodium excretion

Summary:

      Background: Dedicated renal hemodynamic and renal function studies are lacking for DPP-4
      inhibitors in patients with Type 2 diabetes; accordingly little is known regarding the
      mechanisms mediating the renal effects of DPP-4 inhibitors in humans.

      Objectives: To evaluate the effect of DPP-4 inhibition acutely (single dose) and following
      short-term therapy (28 days) on renal sodium handling and renal hemodynamics and function in
      patients with type 2 diabetes and systolic hypertension.

      Design: double-blind, randomized, placebo-controlled trial, Phase IV.

      Patient population: 32 patients with Type 2 diabetes, HbA1c (6.5%-9%), with systolic blood
      pressure ranging from 120-160 mmHg.

      Intervention: subjects will be randomized (1:1) to either sitagliptin (100 mg daily) or to
      placebo (1 tablet daily) for 28 days.

      Endpoints: Fractional excretion of sodium, renal function, and renal hemodynamics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals of 18-70 years of age,

          -  with Type 2 Diabetes,

          -  with an HbA1c (6.5%-9%),

          -  and with a systolic blood pressure (120-160 mmHg).

        Exclusion Criteria:

          -  Individuals with:

               1. Type 1 Diabetes,

               2. eGFR <50mL/min/1.73m,

               3. pregnancy or breast feeding,

               4. significant cardiac, pulmonary or liver disease,

               5. prior history of pancreatitis, medullary thyroid cancer, multiple endocrine
                  neoplasia syndromes,

               6. SBP >161 mmHg, 7) DBP >100 mmHg,

               7. alcohol or substance abuse,

               8. states of secondary hypertension.
Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Hypersensitivity
Intervention: Experimental: PreOp, NutriciaNordica AB; Placebo Comparator: Water
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Insulin sensitivity; Beta cell function; Carbohydrate preload; Elective hip replacement; Double-blind randomized control study

Summary:

      The purpose of this study is to determine whether preload of carbohydrate or water before
      elective hip replacement improve insulin sensitivity and or beta cell function in human.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective hip replacement

        Exclusion Criteria:

          -  Known diabetes mellitus

          -  Kidney failure (creatinine clearance <40 ml/min

          -  Liver failure (aspartate and alanine aminotransferases x 2 above reference)

          -  Hb <110 g/l

          -  Ongoing severe bacterial or viral infection

          -  Malignancies

          -  Psychiatric disease
Januvia (Sitagliptin) in Healing Chronic Diabetic Foot Ulcers
Condition: Type II Diabetes
MeSH terms: Diabetic Foot; Foot Ulcer; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Placebo
Intervention description: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator; Sugar pill manufactured to mimick Sitagliptin 100mg pill.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to compare the rate of healing as well as percent of
      wounds healed in Type II diabetic patients with chronic foot ulcerations receiving
      sitagliptin versus placebo.

      The hypothesis for this study is that subjects receiving daily doses of sitagliptin in
      combination with their regular antihyperglycemic medications will result in increased healing
      rates as well as a greater number of healed wounds as compared to subjects receiving placebo
      and their regular antihyperglycemic medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age >18

          -  Type II Diabetes with glycated hemoglobin (hemoglobin A1C) of < 11

          -  Currently on an oral hyperglycemic medication other than sitagliptin

          -  A chronic wound defined as the lack of wound healing progress of <15% per week or 50%
             over a month period

          -  Ankle brachial index of > 0.80

          -  Wound located on the foot or ankle (Wagner Grade 1,2)

          -  Able to comply with the requirements of the research trial

        Exclusion Criteria:

          -  Current use of dipeptidyl-peptidase four (DPP-4) inhibitor or glucagon like peptide
             one (GLP-1)agonist

          -  End stage renal disease

          -  Currently enrolled in another research trial that involves treatment of the wound

          -  Active infection of the wound

          -  Wound that probes to bone with osteomyelitis (Wagner Grade 3)
Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
Condition: Allergic Asthma
MeSH terms: Asthma
Intervention: omalizumab at a dose of 0.016mg/kg/IU/mL; Placebo
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma, adults, anti-immunoglobulin E ( IgE), omalizumab, airway inflammation, airway remodeling, allergy

Summary:

      This study aims to investigate the effect of omalizumab on the number of tissue eosinophils
      and other markers of airway inflammation and remodeling, including thickness of the lamina
      reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway
      inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists.
      This study will also investigate the correlation between systemic and pulmonary inflammation,
      and the correlation between clinical outcomes and changes within the tissue, to assist in the
      future identification of patients with tissue eosinophilia and their response to treatment,
      without the need for invasive bronchoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18-75 years of age with moderate to severe persistent allergic asthma
             receiving a high dose inhaled corticosteroid (≥800µg per day BDP or equivalent) and a
             regular long acting beta-agonist for at least 3 months prior to screening

          -  With a body weight between 20 and 150kg and a serum total IgE level of 30 to 700 IU/mL

          -  With ≥2% eosinophilia in induced sputum at screening

          -  With post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥60% predicted

          -  With a positive skin prick test (diameter of wheal ≥ 3 mm) or RAST test to at least
             one perennial aero-allergen (eg. dust mite, cat/dog dander, cockroaches), documented
             within the past 2 years or demonstrated at Visit 1, to which the patient will be
             exposed on a regular basis (most days) for the duration of the study.

        Exclusion Criteria:

          -  Patients who've had an asthma exacerbation during the 4 weeks prior to randomization

          -  Current smokers, stopped smoking within the last 12 months or have a smoking history
             of >10 pack years

          -  History of severe allergy to food or drugs

          -  Previous treatment with omalizumab

          -  Any patient considered to be unsuitable to bronchoscopy, according to the judgment of
             the investigator

        Other protocol-defined inclusion/exclusion criteria applied.
A Study for Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Insulin lispro low mixture; Insulin glargine; Insulin lispro
Intervention description: Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.; Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks; Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 426.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily
      injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections)
      on lowering the blood sugar level
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Receiving oral antihyperglycemic medications (including metformin) without insulin
             injection in the last 90 days

          -  Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%

          -  Willing to receive insulin injection while continuing to take the prestudy oral
             antihyperglycemic medications

          -  Able to perform self monitoring of blood glucose

        Exclusion Criteria:

          -  Are taking any other glucose-lowering agents other than metformin, sulfonylurea or
             Thiazolidinedione (Pioglitazone)

          -  Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in
             the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks

          -  Have a body mass index greater than 35 kg/m2

          -  History or presence of kidney disease

          -  Have cardiac disease (Class III or IV)
Improving Sleep Quality in Heart Failure
Condition: Sleep Disturbance; Heart Failure
MeSH terms: Dyssomnias; Parasomnias; Heart Failure
Intervention: Zolpidem Tartrate; Placebo oral capsule
Intervention description: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights; Placebo capsule one per night taken for 7 nights
Intervention MeSH terms: Zolpidem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-site, randomized, parallel, placebo controlled, double blind study
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 21 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      Poor sleep quality is common in patients with heart failure. The limited available evidence
      intimates that improving sleep quality in patients with heart failure may improve morbidity
      and quality of life in this patient population. However, there is a paucity of evidence
      assessing the use of effective pharmacologic therapies in heart failure. The
      nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable
      benefits over traditional benzodiazepines as a soporific medication. The investigators
      hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21-79 years old

          -  HFrEF, EF ≤ 45% (by echocardiography)

          -  NYHA functional class I to III

          -  Able to give written consent

          -  On goal-directed medical therapy for HF, with stable dosing of HF medications for 2
             weeks prior to enrollment

          -  No hospitalizations for HF within the past month

          -  Positive response to experiencing any of the following sleep-related symptoms at least
             once a week:

          -  Difficulty falling asleep

          -  Waking up during the night and having difficulty getting back to sleep

          -  Waking up too early in the morning and being unable to get back to sleep.

        Exclusion Criteria:

          -  Use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks

          -  Current treatment with other sedating medications such as opioids

          -  On therapy for pharmacological therapy for depression

          -  History of alcohol/drug dependence

          -  History of liver disease, HIV, or severe COPD

          -  On Thorazine

          -  Current use of ketoconazole

          -  Current use of tricyclic antidepressants

          -  Current use of macrolide antibiotics

          -  Current use of anticonvulsant medications

          -  Pregnancy. A urine pregnancy test will be performed to exclude pregnancy in potential
             subjects.
Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Tetracaine; Bupivacaine
Intervention description: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.; Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
Intervention MeSH terms: Bupivacaine; Tetracaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: labor pain; combined spinal epidural labor analgesia; CSE analgesia; labor analgesia

Summary:

      The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for
      CSE labor analgesia volume will last a significantly longer period of time that that of
      spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects
      meeting criteria when analgesia is requested will be randomized to receive a combined
      spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or
      bupivacaine 2 mg with fentanyl and epinephrine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  early labor (>=2cm but =<6cm cervical dilation)

          -  at least 12 years of age

          -  have an assigned ASA physical status 1 or 2

          -  singleton pregnancy

        Exclusion Criteria:

          -  contraindications to neuraxial anesthesia

          -  with allergies to drugs used in the study

          -  have an assigned ASA status 3 or 4

          -  advanced labor (> 6cm cervical dilation)

          -  less than 12 years of age

          -  Patients with the potential for distorted epidural anatomy, such as Harrington rods or
             prior back surgery, will also be excluded.
Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting
Condition: Behavior; Anxiety
Intervention: Placebo then intranasal oxytocin; Intranasal oxytocin then placebo
Intervention description: Participant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session.; Participant received a single dose of 40 IU intranasal oxytocin at the first psychotherapy session, and received a similar dose of intranasal placebo spray at the second session.
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: psychotherapy

Summary:

      Subjects-currently in outpatient mental health care--will participate in 2 psychotherapy
      sessions, one with oxytocin spray and one with placebo spray. Sessions will be videotaped,
      and cortisol and heart rate will be measured. We hypothesize that oxytocin will have positive
      benefits on nonverbal behavior in the therapy session, as well as have positive effects on
      subjective anxiety, cortisol and heart rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  in current mental health treatment

          -  male 18-65

        Exclusion Criteria:

          -  diagnosis of schizophrenia or psychosis

          -  diagnosis of autism or Aspergers disorder

          -  active substance use disorder

          -  at moderate or high risk of self-harm
Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Intervention: Indomethacin; Placebo
Intervention description: Topical indomethacin; Placebo patch
Intervention MeSH terms: Indomethacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle
      sprain in adult patients, compared to a placebo patch
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours
             before screening visit

          -  Participant with self-assessed pain intensity score after movement (5 steps) at the
             site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating.

          -  Participant with a peri-malleolar edema (sub-malleolar perimeter difference of >=20mm
             between injured and uninjured ankle)

        Exclusion Criteria:

          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely
             related compounds) or any of their stated ingredients.

          -  Participant who had medication that could interfere with the subject's perception of
             pain since experiencing ankle sprain.

          -  Pregnancy , Breast Feeding and Substance Abuse