bioihbjkbjnl/mcl2 huggingface dataset:
Serratus Anterior Plane Block in Patients Undergoing Mastectomy
Condition: Pain, Post-operative
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine 0.35%
Intervention description: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized interventional prospective model to investigate effect of block placement in two treatment arms. Opioid consumption in the first 24 hours after the operation will be main outcome variable.
Masking: Single (Participant)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, interventional prospective study. Patients (n=66) undergoing
      mastectomies with or without tissue expander will be randomized to receive a supra-serratus
      or sub-serratus regional plane block prior to surgery. The main effect to be measured is
      total opioid consumption 24 hours after the operation. Secondary endpoints include measuring
      a change between pre-and post-operative pain scores, patient satisfaction of pain control
      during first 24 hours after the operation, presence of postoperative nausea and vomiting,
      duration of sleep on first postoperative night, and block performance time and length of
      stay, between the two treatment arms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients 18 years or older

          2. Individuals undergoing either a mastectomy or mastectomy with tissue expander for
             which the anesthetic plan includes a serratus anterior plane block.

        Exclusion Criteria:

          1. Any known sensory deficit of the anterolateral chest wall.

          2. Any local disorder of the skin or otherwise where blockade is to be performed which
             would prevent safe performance of the block

          3. Pregnancy

          4. American Society of Anesthesiology classification greater than 3

          5. Allergy to amide local anesthetic medications

          6. Chronic pain conditions

          7. Preoperative opioid use greater than 20 oral morphine equivalents per day

          8. Any coagulation abnormality which would be a contraindication for block placement

          9. Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum
             creatinine greater than 1.4 mg/dL

         10. Body mass index >50

         11. Incarceration

         12. Inability to understand study procedures including inability to understand the English
             language

         13. Inability to provide adequate informed consent

         14. Refusal to participate in the study
Oral Versus Intravenous Tranexamic Acid
Condition: Blood Loss; Blood Transfusion
MeSH terms: Hemorrhage
Intervention: Tranexamic Acid
Intervention description: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The goal of this randomized clinical control trial is to determine whether oral TXA dosing in
      THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients
      undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are:

      Does oral TXA dosing in THA/TKA result in more blood loss compared to IV TXA dosing?

      Does oral TXA dosing in THA/TKA result in more transfusions compared to IV TXA dosing?

      Participants will be randomly assigned to either get the Oral TXA (1950mg) or the IV TXA (1g)
      on their day of surgery. Researchers will compare these groups to see if any differences
      emerged. 200 THA patients (100 Oral, 100 IV), 200 TKA patients (100 oral, 100 IV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing total hip arthroplasty (THA) through a posterior approach

          -  Patients undergoing total knee arthroplasty (TKA)

          -  Patients between 18-80 years of age

        Exclusion Criteria:

          -  Patients with >80 years of age

          -  Patients with a BMI over 40

          -  Patients undergoing general anesthesia

          -  Patients with a history of major ipsilateral joint surgery

          -  Patients on pre-operative anticoagulation or anti-platelet drugs (other than aspirin)

          -  Patients with a history of bleeding disorders

          -  Patients with platelets less than 100/nl

          -  Patients with new-onset/active atrial fibrillation

          -  Patients with a history of myocardial infarction in the past year

          -  Patients with a history of a stroke in the past year
Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: Vancomycin; Fidaxomicin
Intervention description: Vancomycin 125mg by mouth every 6 hours for 10 days; Fidaxomicin 200mg by mouth every 12 hours for 10 days
Intervention MeSH terms: Vancomycin; Fidaxomicin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open-label
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare number of vegetative cells and spores in stool over
      time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C.
      difficile infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age and above

          -  First diagnosis of C. difficile infection

          -  Treatment for C. difficile infection less than 24 hours

          -  Female subjects must be nonpregnant, nonlactating, and either postmenopausal for at
             least 1 year, surgically sterile (i.e., documented tubal ligation or hysterectomy) for
             at least 90 days, abstinent, or agree to use 1 of the following forms of contraception
             from the time of signing the Informed Consent form (ICF) until 30 days after leaving
             the study site: a nonhormonal intrauterine device (IUD) with spermicide, female condom
             with spermicide, contraceptive sponge with spermicide, diaphragm with spermicide,
             cervical cap with spermicide, a male sexual partner who agrees to use a male condom
             with spermicide, or a sterile sexual partner.

        Exclusion Criteria:

          -  History of hypersensitivity to fidaxomicin or vancomycin

          -  Pregnant or breast-feeding

          -  Active treatment with other therapies with activity against C. difficile

          -  Receiving any peristaltic agents

          -  Medical history including ulcerative colitis or Chron's disease

          -  Ordered to be nothing by mouth or cannot swallow the study medication

          -  Participation in another clinical research study utilizing pharmacological treatment
             within 1 month or five half-lives of the medication whichever is longer

          -  Any other reason felt by the investigator to potentially affect the outcomes of the
             study
Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Metformin XR; Metformin IR; Placebo matching with Metformin XR; Placebo matching with Metformin IR
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1736.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2
      diabetes is non-inferior to Metformin IR monotherapy
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women, aged ≥18 years old at time of enrollment

          -  Treatment naive subjects with type 2 diabetes mellitus with inadequate glycemic (HbA1c
             ≥7.0% and ≤9.2% obtained at screening visit) control on diet and exercise alone

          -  Women must have a negative serum or urine test within 24 hours prior to start of
             investigational product

        Exclusion Criteria:

          -  History of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma

          -  Symptoms of poorly controlled diabetes, including but not limited to marked polyuria
             and polydipsia with >10% weight loss during last 3 months

          -  Serum creatinine ≥1.50 mg/dL (133 μmol/L) for male subjects; serum creatinine ≥1.40
             mg/dL (124 μmol/L for female subjects)
Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm
Condition: Atrial Fibrillation; Pulmonary Embolism; Deep Vein Thrombosis
MeSH terms: Pulmonary Embolism; Atrial Fibrillation; Thrombosis; Embolism; Venous Thrombosis
Intervention: Warfarin Dose based on pharmacogenetics
Intervention description: Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm
Intervention MeSH terms: Warfarin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: mechanical valve

Summary:

      This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in
      diagnosed patients requiring warfarin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed patients with atrial fibrillation, deep venous thrombosis, or pulmonary
             embolism requiring warfarin therapy

        Exclusion Criteria:

          -  Patients with atrial fibrillation, deep venous thrombosis, or pullmonary embolism
             requiring warfarin therapy who do not consent to participate
Resveratrol for Pain Due to Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Placebo; Resveratrol
Intervention description: 40mg of starch; 40mg of resveratrol (powder)
Intervention MeSH terms: Resveratrol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: Female
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: resveratrol

Summary:

      This study aims to verify whether the use of 40 mg of resveratrol per day associated with
      monophasic contraceptive pill (levonorgestrel 0.15mg/ethinyl estradiol 0.03mg) reduces pelvic
      pain at the end of 2 months of treatment, compared to the use of the pill with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Endometriosis diagnosed by laparoscopy

        Exclusion Criteria:

          -  Known allergy to resveratrol

          -  Use of gonadotropin or danazol in the last month
A Pilot Study Assessing EmSam in Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: EmSam
Intervention description: Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch
Intervention MeSH terms: Selegiline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar; depression

Summary:

      This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a
      selegiline transdermal system (STS), in bipolar depression.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages 18 - 65

          2. DSM-IV Bipolar Disorder (I, II, NOS), Depressed Phase

          3. DSM-IV Bipolar Disorder (I,II, NOS), Mixed state with adequate mood stabilization (ie,
             resolution of manic or hypomanic symptoms for 8 weeks with a minimum of 4 weeks on a
             stable dose of mood-stabilizing medication that will be continued through all phases
             of the study).

          4. Prior failure of or inability to tolerate at least one other antidepressant treatment

          5. Physically healthy

          6. Agrees to participate in the study

          7. HAM-D 24 > 10

        Exclusion Criteria:

          1. Bipolar Disorder (I, II, NOS), Mixed State without adequate mood stabilization

          2. Prior significant adverse reaction to EmSam

          3. Unstable medical disorder

          4. History of epilepsy (febrile seizure o.k.)

          5. Current use of any medication that might interact with EnSam.

          6. Use within 2 weeks of other antidepressant medication (6 weeks for fluoxetine)

          7. Inability to adhere to a tyramine-free diet

          8. Recent (past 6 months) suicide attempt

          9. Serious suicidal ideation

         10. Pregnant

         11. Breast feeding

         12. Fecund, sexually active females, without adequate contraception

         13. Prior failure to respond to 2 or more adequate oral MAOI trials (2/3 PDR maximum dose,
             minimum 4 weeks)

         14. Non-nicotine substance abuse/dependence within the past 6 months (1 year for
             amphetamines/cocaine)
A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Intervention: tolterodine
Intervention description: tablet, 4 mg, daily, 1 month
Intervention MeSH terms: Tolterodine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: Female
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nocturia; urinary incontinence; overactive bladder; tolterodine; sleep; sleep disorder; menopause; midlife women; psychological tests

Summary:

      This study is being done to compare frequency of urination during the night when women take
      tolterodine tablets vs. when they take placebo tablets.

      We will also measure whether between these two treatment conditions there are any differences
      in women's sleep, mood and performance on cognitive tests.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Post-menopausal women, age 45 to 65 years old.

          2. No menses for at least 6 months before the study start.

          3. Have at least 14 episodes of nocturia per week.

          4. Have at least 4 hot flashes daily.

          5. Overall good health, as evidenced by a letter from the primary care provider.

          6. Agree not to use exogenous hormones including soy isoflavones or soybean-based shakes,
             or nutritional supplements that potentially reduce hot flashes.

          7. Have discontinued all hormone treatments, systemic, topical, or vaginal, at least 60
             days before admission and throughout participation in the study.

        Exclusion Criteria:

          1. Use of anti-cholinergic, hypnotic or sedating drugs

          2. Presence of urinary retention, gastric retention, chronic severe constipation,or
             narrow-angled glaucoma.

          3. A urinary tract infection within a month of study start.

          4. Undiagnosed abnormal vaginal bleeding.

          5. Benign or malignant liver disease.

          6. History or presence of chronic alcoholism or medication addiction within the past 5
             yrs.

          7. An acute systemic infection within seven days before the study start.

          8. Concurrent participation in another clinical trial and/or receiving an experimental
             medication/device in the last 30 days before admission to the study.

          9. History of shift work within the past 6 months.

             -
Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone
Condition: Heart Failure; Ventricular Dysfunction, Left
MeSH terms: Heart Failure; Ventricular Dysfunction; Ventricular Dysfunction, Left
Intervention: Captopril; Enalapril; Lisinopril; Ramipril; Trandolapril; Bisoprolol; Carvedilol; Metoprolol succinate; Candesartan; Valsartan; Eplerenone; Spironolactone; Diuretics; HF treatment according to Swedish guidelines; Blood samples; The Kansas City Cardiomyopathy Questionnaire (KCCQ)
Intervention MeSH terms: Metoprolol; Valsartan; Carvedilol; Candesartan; Ramipril; Enalapril; Lisinopril; Eplerenone; Bisoprolol; Captopril; Trandolapril; Spironolactone; Diuretics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Failure; Ventricular Dysfunction; NTproBNP

Summary:

      The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms
      and signs is more effective than treatment guided by clinical symptoms and signs alone in
      patients with HF and left ventricular systolic dysfunction
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female/male, over 18 years with previously verified HF with left ventricular systolic
             dysfunction.

          -  New York Heart Association(NYHA) class II-IV,

          -  NTproBNP males>800 ng/L, females >1000 ng/L

        Exclusion Criteria:

          -  Planned CV hospitalisation, stroke or acute myocardial infarction (MI) last 3 months,

          -  Mitral/aortic stenosis,

          -  Patients already receiving optimal HF treatment,

          -  Severe reduction of kidney function
Remifentanil Intravenous Patient Controlled Analgesia (IVPCA) for Ablation of Idiopathic Ventricular Tachycardia
Condition: Tachycardia, Ventricular
MeSH terms: Tachycardia; Tachycardia, Ventricular
Intervention: Remifentanil
Intervention description: Patients with established PVC's , sedated with remifentanil IVPCA per study protocol
Intervention MeSH terms: Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: idiopathic ventricular tachycardia

Summary:

      Determine effects of remifentanil conscious sedation in patients undergoing
      Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia
      and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo EP studies for the ablation of idiopathic ventricular
             tachycardia and/or persistent frequent PVCs of non-ischemic origin

          -  Patients between 18 and 65

          -  ASA 1-3

        Exclusion Criteria:

          -  ASA 4 and 5

          -  Age 18 and 65
Effect of Nuvigil on Fatigue
Condition: Menopause
MeSH terms: Fatigue
Intervention: Armodafinil
Intervention description: Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio. No primary outcomes were studied in the discontinuation phase.
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: fatigue; menopausal symptoms; hot flashes; Vasomotor symptoms; perimenopause; related Quality of life

Summary:

      The purpose of this study is to determine if armodafinil improves quality of life and is an
      effective treatment of fatigue in symptomatic perimenopausal and postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

        Women

          -  Ages 40-65

          -  Peri- and postmenopausal

          -  Suffering from fatigue

          -  Experiencing hot flashes(Not required for perimenopausal women)

        Exclusion Criteria:

          -  Current episode of major depression

          -  Moderate-to-severe insomnia

          -  Night shift workers

          -  Previous diagnosis of manic depressive disorder, psychotic disorder, or psychotic
             symptoms

          -  Suicidal ideation

          -  Alcohol/drug abuse

          -  Concern about potential misuse of study medication

          -  Use of prescribed medications to treat insomnia or other sleep disturbance symptoms

          -  Pregnant or breastfeeding

          -  Use of systemic menopausal hormonal therapy or birth control

          -  Use of centrally active medications, such as antidepressants, anxiolytics, and
             hypnotics agents

          -  Use of clopidogrel

          -  Use of atomoxetine

          -  Cardiovascular contraindications of use of armodafinil