bioihbjkbjnl/mcl2 huggingface dataset:
Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients
Condition: Constipation
MeSH terms: Constipation
Intervention: MOVANTIK™ (naloxegol); Sugar Pill
Intervention MeSH terms: Naloxegol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Constipation is a known complication of the postoperative period after spinal surgery, where
      prescription pain medicines called opioids are traditionally used in high doses for the
      treatment of surgery-related pain. The goal of this study is to determine the effectiveness
      of Movantik (naloxegol)-a FDA-approved drug used to treat constipation that is caused by
      opioids-in preventing constipation in patients undergoing spinal fusion surgery at MGH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients between the ages of 18 and 75 years undergoing non-urgent,
             elective spinal fusion at Massachusetts General Hospital who are admitted to the
             neurosurgery floor from the operating room

        Exclusion Criteria:

          -  Patients who are taken to the operating room from another inpatient floor or service
             (already hospitalized prior to surgery)

          -  Patients with evidence of bowel obstruction

          -  Patients unable to take oral medications by mouth or by enteric feeding tube
             (gastrostomy or jejunostomy)

          -  Patients with a documented or potential allergy or adverse reaction to Movantik
             (naloxegol) from outpatient use

          -  Patients currently taking Movantik (naloxegol) in the outpatient setting

          -  Patients with a preoperative diagnosis of irritable bowel syndrome (IBS) obtained via
             Rome III questionnaire on screening

          -  Patients with disruptions to the blood-brain barrier (eg, multiple sclerosis, recent
             brain injury, Alzheimer's disease, and uncontrolled epilepsy)

          -  Patients with a history of cancer.

          -  Patients concomitantly using strong CYP3A4 inhibitors (eg, clarithromycin,
             ketoconazole), strong CYP3A4 inducers and other opioid antagonists.

          -  Patients with severe hepatic impairment.

          -  Patients with a previous history of or risk of bowel perforation.

          -  Patients with a post-op regional anesthetic technique employed like a continuous
             epidural or spinal.

          -  Patients for which local anesthetics will be placed in the wound.
Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Ipack; Bupivacaine; Peri Articular Infiltration
Intervention description: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.; 20 cc of bupivacaine(o.25%) injection; Adductor Canal Catheter and Peri Articular Infiltration
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Total knee arthroplasty; Peri articular infiltration; Pack block; Adductor canal catheter

Summary:

      Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced
      osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed
      as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by
      2030.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA (American Society of Anesthesiology) class I-IV

          -  age 18-75.

        Exclusion Criteria:

          -  ASA class V

          -  morbid obesity

          -  patient refusal

          -  patients with chronic pain or on pain medication

          -  allergy to LA

          -  patients receiving any additional regional techniques

          -  coagulopathy

          -  patients receiving systemic anticoagulation

          -  local infection and procedures anticipated to last more than 5 hours.
Nutrition, Physical Performance & Fitness in Indian School Children
Condition: Physical Fitness; Nutritional Status
Intervention: Nutritional supplement; Placebo
Intervention description: Fortified nutritional powder; Un-fortified nutritional powder
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: physical performance; micronutrients; physical fitness; healthy children

Summary:

      The purpose of this study is to evaluate the effect of nutritional supplement on physical
      performance measures of apparently healthy school going children in India.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Boys and girls between ages 7-10.5 years

          -  Z score of height for age and weight for age of 0 to < -3

          -  Good general health at screening

          -  Understands and is willing, able and likely to comply with all study procedures and
             restrictions

          -  Written informed consent from the parents/ guardians and writtent assent by the study
             participant

        Exclusion Criteria:

          -  Severe anemia (Hb<8 g% )

          -  Cardiovascular disease on clinical examination or history

          -  Any underlying respiratory disease with impairment of lung function

          -  Physical disability Children consuming nutritional supplements (tonics, syrups,
             tablets or chews) and/ or health food drinks on a regular basis

          -  Recent history [3mo] of serious infections, injuries and/ or surgeries

          -  Participation in any nutritional study in the last 1 year

          -  Indication that they are likely to move within the period of study intervention

          -  Any known food allergies like peanut allergy, gluten allergy

          -  Family members of an employee of the Sponsor or the study site.
Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Intervention: Nifedipine; Indomethacin
Intervention MeSH terms: Indomethacin; Nifedipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: pregnancy; preterm labor; tocolysis

Summary:

      Tocolytic agents are used for the treatment of preterm labor. It is unclear whether
      combination treatments of two tocolytic agents are more effective in stopping preterm labor
      compared to one. Therefore, the investigators propose a comparative effective trial of
      nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor
    

Eligibility criteria:

        Inclusion Criteria:

          -  We will include pregnant women between 22 0/7 to 31 6/7 weeks gestation who present
             with regular uterine contractions defined as at least one contraction every 10 minutes
             for 30 minutes with at least one of the following:

          -  cervical change of at least 1 cm or

          -  cervical dilation of 2 cm at the time of initial exam or

          -  positive fetal fibronectin and transvaginal cervical length <2.5 cm

        Exclusion Criteria:

          -  We will exclude pregnant women with any contraindication to tocolysis:

          -  clinical chorioamnionitis (defined as a temperature of >100.4 F and any of the
             following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent
             vaginal discharge)

          -  non reassuring fetal heart tones

          -  suspected placental abruption

          -  preterm premature rupture of membranes

          -  prior tocolytic treatment during the past 48 hours

          -  known adverse effect to indomethacin or nifedipine

          -  already receiving nifedipine for chronic hypertension
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG
Condition: Obesity
MeSH terms: Emergencies
Intervention: Levonorgestrel-based emergency contraception 1.5 mg; Levonorgestrel-based emergency contraception 3.0mg
Intervention description: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC; Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Body weight; Emergency contraception; Levonogestrel; Ulipristal acetate

Summary:

      Obese women are significantly more likely than their normal BMI counterparts to experience
      failure of orally-dosed emergency contraceptives. The PI's preliminary data provides evidence
      for testing a dose escalation strategy in an effort to provide improved efficacy from
      orally-dosed emergency contraceptives in obese women. The overall project will be focused on
      both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but
      this protocol registration is for the LNG aspect of the study procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally health women

          -  Aged 18-35 years old

          -  Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a
             progesterone level of 3ng/ml or greater.

          -  Subjects must have a BMI of >30 kg/m2 and weigh at least 80 kg or more.

        Exclusion Criteria:

          -  Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian
             Syndrome

          -  Impaired liver or renal function

          -  Actively seeking or involved in a weight loss program (must be weight stable)
             pregnancy, breastfeeding, or seeking pregnancy

          -  Recent (within last 8 weeks) use of hormonal contraception

          -  Current use of drugs that interfere with metabolism of sex steroids

          -  Smokers.
Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Salmeterol 50 mcg BID; Fluticasone Propionate/Salmeterol 250/50 mcg BID; DISKUS inhaler
Intervention description: Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.; Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.; Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 186.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoporosis; Bone Mineral Density; Osteopenia; Chronic Obstructive Pulmonary Disease; COPD

Summary:

      This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits
      will include lung function tests and scans of your bones. The purpose of this study is to
      determine the effect of the steroid component of an inhaled product on bone mineral density
      in patients with Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion criteria:

          -  Established clinical history of COPD.

          -  Baseline FEV1 <70% predicted normal, and FEV1/FVC ratio of less than 70%.

          -  Smoking history of at least 10 pack-years, where both current and former smokers will
             be eligible.

          -  Must have at least one native, evaluable hip.

        Exclusion criteria:

          -  History of or evidence for metabolic bone diseases other than osteoporosis or
             osteopenia.
Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
Condition: Carcinoma, Non-Small-Cell Lung; ErbB Receptors
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Afatinib
Intervention description: afatinib starting at 30 mg daily dose
Intervention MeSH terms: Afatinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end
      of trial. The end of trial is one year after the last patient has entered the study.
    

Eligibility criteria:

        Inclusion criteria:

          -  Pathologically or cytologically confirmed NSCLC Stage IV Cancer (includes
             cytologically proven pleural effusion or pericardial effusion) or recurrent disease.
             Staging is based on American Joint Committee on Cancer (AJCC) Staging for NSCLC 7th
             edition (R12-4710)

          -  Evidence of common EGFR mutation (Del 19 and/or L858R)

          -  Age >= 70 years

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (R01-0787)

          -  Further inclusion criteria apply.

        Exclusion criteria:

          -  Prior participation in an afatinib clinical study, even if not assigned to afatinib
             treatment

          -  Prior systemic therapy for metastatic or recurrent NSCLC.

          -  Concurrent investigational therapy or investigational therapy within 4 weeks of start
             of afatinib therapy

          -  Radiotherapy within 4 weeks prior to start of study treatment, except as follows:

               -  Palliative radiation to target organs other than chest may be allowed up to 2
                  weeks prior to study treatment, or

               -  Single dose palliative treatment for symptomatic metastasis outside above
                  allowance to be discussed with sponsor prior to enrolling.

               -  Major surgery within 4 weeks before starting study treatment or scheduled for
                  surgery during the projected course of the study

               -  Systemic chemotherapy, biological therapy, immunotherapy or investigational
                  agents within 5 half-life of the drug or within four weeks prior to the start of
                  afatinib treatment (if the half-life of the drug is unknown).

          -  Men, capable of fathering a child, who are unwilling to use adequate contraception
             prior to study entry, for the duration of study participation, and for at least 28
             days after treatment has ended.

          -  Further exclusion criteria apply.
Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA
Condition: Anterior Cruciate Ligament Reconstruction
MeSH terms: Hemarthrosis
Intervention: Tranexamic Acid
Intervention description: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
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: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of the proposed study is to evaluate the effects of administering intravenous
      tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction
      with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and
      post operative pain.
    

Eligibility criteria:

        Inclusion Criteria:

        -PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT

        Exclusion Criteria:

          -  Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects,
             dementia, etc.)

          -  Younger than 18 years of age

          -  Any patient considered a vulnerable subject

          -  Have bleeding or clotting disorder

          -  Preoperative anticoagulation therapy

          -  Abnormal coagulation profile

          -  Renal disorder or insufficiency

          -  Sickle cell disease
Comparison of PIEB vs CEI for Labor Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Programmed Intermittent Epidural Bolus; Continuous Epidural Infusion; Ropivacaine; Fentanyl
Intervention MeSH terms: Fentanyl; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: epidural analgesia

Summary:

      The aim of this prospective, doubled-blinded randomized study is to compare two modes of
      epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus
      continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing,
      for providing labor epidural analgesia. The primary outcome will be the volume of local
      anesthetic received through PCEA. Secondary outcomes will measure time to first PCEA bolus,
      labor pain scores, degree of motor blockade, mode of delivery, PCEA attempts and ratio of
      successful to unsuccessful attempts, frequency of hypotension, duration of first and second
      stages of labor and level of patient satisfaction. The investigator plans to enroll 120
      nulliparous participants at 2-5 com cervical dilation, with 60 patients to each arm. The
      subject will be assigned to receive either delivery of epidural medication ropivacaine 0.1%
      with fentanyl 2mcg/mL with PIEB + PCEA dosing method or CEI + PCEA. Continuous data will be
      analyzed using the Kruskal-Wallis test or t-test as appropriate. Categorical data will be
      analyzed using Chi-square test or Fisher's exact test as appropriate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiology (ASA) class 2 and 3 women

          -  Nulliparous

          -  Age > 18 yrs

          -  gestational age > 36 weeks

          -  singleton pregnancies

          -  vertex pregnancies

          -  spontaneous labor or scheduled induction of labor

          -  cervical dilatation 2-5 cm at time of epidural placement

          -  Pain score > 5

        Exclusion Criteria:

          -  BMI > 50 kg/m2

          -  history of past or current intravenous drug or chronic opioid abuse

          -  chronic analgesic use

          -  allergy or contraindication to any study medications

          -  any maternal or fetal condition requiring planned assisted stage 2 delivery
Post-Operative Therapy for Nausea or Vomiting
Condition: Vomiting; Nausea
MeSH terms: Nausea; Vomiting
Intervention: Acupressure; Ondansetron
Intervention description: Specifically trained personnel will apply pressure on the wrists bilaterally at the P6 point for up to 3 minutes. The P6 point is located three fingerbreadths from the wrist crease on the volar surface of the arm between the palmaris longus and flexor carpi radialis.
In the event of failure in the acupressure group, further treatments will be identical to the control group. Since Ondansetron is the standard Post Anesthetic Care Unit treatment, it will be first line rescue therapy except in the case that the patient has received 8mg in the past 6 hours. If needed, further antiemetic pharmacologic treatments may include, but are not limited to, phenergan, metoclopramide, haloperidol, diphenhydramine or propofol at the clinical discretion of the patient's anesthesiology care team.; Ondansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery.
Intervention MeSH terms: Ondansetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PONV; Nausea; Vomiting; Acupressure

Summary:

      This is a single site, prospective, randomized controlled study designed to evaluate the
      impact of acupressure when used as an initial treatment before rescue medications in the
      treatment of post-operative nausea and/or vomiting at UCD.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients scheduled for elective surgery requiring general anesthesia

        Exclusion Criteria:

          -  Age less than 18 years

          -  Adults unable to give primary consent

          -  Pregnancy

          -  Prisoners

          -  Unable to access pericardial 6 acupressure point bilaterally post procedure

          -  Allergy to Ondansetron