bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Intrathecal morphine sulfate (ITM); Bupivacaine hydrochloride; ropivacaine hydrochloride
Intervention description: Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion; Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion; Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
Intervention MeSH terms: Morphine; Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: post c section pain; pain control after baby; nerve block for post delivery pain

Summary:

      the purpose of this study is to compare opioid consumption in morphine equivalents between
      the groups that received postoperative analgesia with intrathecal morphine versus US guided
      QL blocks versus US guided QL catheters
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective C section via Pfannenstiel incision

          -  Living singleton pregnancy

          -  Gestation week at least 37 weeks

          -  American Society of Anesthesiologists (ASA) status 1, 2 and 3

          -  Primary and secondary C sections

        Exclusion Criteria:

          -  Chronic pain

          -  Opioid tolerant patients

          -  Allergy to drugs used in the study.

          -  Cognitive dysfunction

          -  BMI > 40

          -  Coagulation disorder

          -  Local infection

          -  Inability to tolerate oral medication

          -  Previous intra-abdominal surgery

          -  Patients who will receive a combined spinal epidural for their C section

          -  Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.-
             local wound infiltration by surgeon)

          -  Patients who received sedation or general anesthesia during their C section
             (midazolam, ketamine, fentanyl, propofol, hydromorphone)
The Role of Estrogen in Luteinizing Hormone Surge and Ovulation
Condition: Ovulation Disorder; Ovarian Cysts
MeSH terms: Ovarian Cysts
Intervention: Letrozole
Intervention description: Letrozole administered daily through the time of ovulation.
Intervention MeSH terms: Letrozole
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to establish that sustained estrogen levels are the driving force
      for the LH surge, and are thereby necessary for ovulation to occur. We predict that by
      reducing levels of circulating estrogen, letrozole, an aromatase inhibitor, will inhibit
      ovulation from occurring.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient having regular menstrual cycles between 26-30 days

          -  Ages 18-40

          -  Patient must not be sexually active during the study period, or if so must be using a
             reliable form of non-hormonal birth control including tubal ligation or vasectomy,
             non-hormonal intrauterine contraceptive device (IUD), or condoms with spermicide.

          -  Willing to participate in study and available for all monitoring visits.

          -  IRB consent

        Exclusion Criteria:

          -  Patient must NOT have used hormonal contraception three months or less prior to study.

          -  Irregular menstrual cycles (<26 days or >30 days within the last 6 months.

          -  Untreated thyroid dysfunction or hyperprolactinemia

          -  Pregnancy (current or within 3 months) or breastfeeding

          -  Allergy or contraindication to letrozole
Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell
Intervention: temsirolimus; temsirolimus
Intervention description: 175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit; 75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma; temsirolimus

Summary:

      This study will compare the effectiveness and safety of two different doses of temsirolimus
      (Torisel).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have confirmed mantle cell lymphoma diagnosis.

          -  Have measurable disease.

          -  Have received at least 2 prior treatment, which may include stem cell transplant.

          -  Have adequate organ and bone marrow function.

          -  There are other criteria--please discuss with your doctor.

        Exclusion Criteria:

          -  Had any prior treatment with temsirolimus or mTOR inhibitor.

          -  Had allogeneic stem cell transplant within last 6 months and on immunosuppressive
             therapy.

          -  Has active or untreated brain or central nervous system metastases.

          -  There are other criteria--please discuss with your doctor.
Propofol Versus Sevoflurane Recovery After Gynecological Surgery
Condition: Surgery; Anesthesia
Intervention: Sevoflurane; Propofol
Intervention description: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube; Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Intervention MeSH terms: Propofol; Sevoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 90.0
Sex: Female
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Outpatient; Surgery; Anesthesia

Summary:

      80% of 25 million American who undergo surgery describe moderate to severe pain. The use of
      multimodal analgesic techniques can attenuate patient's postoperative pain and several
      different medication have been found to be effective. Pain can significantly affect patient's
      quality of recovery after surgery. Volatile anesthetics can increase sensitivity to pain at
      the low concentrations present on emergence from anesthesia. Propofol may have analgesic
      effect at sedative doses. The effects of propofol,when used for anesthesia maintenance, on
      postoperative pain have demonstrated controversial results with some investigators showing a
      potential benefit whereas others have not shown any benefit. Propofol for maintenance of
      anesthesia has been advocated as an strategy for high risk patients even though it has shown
      controversial results on reduction of Post operative nausea and vomiting. A comparison of
      propofol vs.volatile anesthetic in regards to the time required by patients to meet discharge
      criteria has also shown conflicting results.The QOR 40 is a validated instrument that has
      been specifically developed to evaluate patients recovery after anesthesia and surgery.

      The purpose of this study is to compare the effects of maintenance of anesthesia with two
      agents (Propofol and Sevoflurane) on quality of recovery after ambulatory surgery

      Significance: the results of this study can lead to the discovery of an anesthesia technique
      that is associated with a better recovery for patients after ambulatory surgery.

      Research question is: do patients anesthetized with propofol have a better quality of
      recovery after ambulatory anesthesia than patients anesthetized with Sevoflurane? The
      hypothesis: patients anesthetized with propofol will have better quality of recovery than
      patients anesthetized with Sevoflurane after ambulatory surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women

          -  Age 18-64

          -  Patients undergoing ambulatory surgery

          -  ASA PS I, II

        Exclusion Criteria:

          -  Chronic opioid use

          -  Pregnant patient

        Drop Out : patient or surgeon request
Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren Hydrochlorothiazide; Ramipril
Intervention description: Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks; Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Intervention MeSH terms: Hydrochlorothiazide; Ramipril
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 386.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension, Obese, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, ramipril, stage 2

Summary:

      Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril
      in Obese patients (BMI ≥ 30) with Stage 2 Hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are eligible and able to participate in the study, and who give written
             informed consent before any assessment is performed.

          -  Male or female outpatients, 18 years of age and older.

          -  Patients with Stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and < 200
             mmHg at Study Visit 5 (randomization).

          -  Patients must have a BMI ≥ 30 kg/m2 but ≤ 45 kg/m2.

        Exclusion Criteria:

          -  Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg) at
             any visit.

          -  Use of other investigational drugs within 30 days of enrollment, or 5 half-lives,
             which ever is longer.

          -  Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in
             a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days
             of Visit 1.

          -  History of hypersensitivity to any of the study drugs or to drugs belonging to the
             same therapeutic class (ACE inhibitors or renin inhibitors) as the study drugs.

          -  History or evidence of a secondary form of hypertension.

          -  Refractory hypertension, defined as, unresponsive to triple drug therapy at the
             maximum dose of each drug, one of which must be a diuretic, and not at blood pressure
             goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances
             represent two drugs.

          -  Patients on 4 or more antihypertensive medications.

          -  Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening.

        Other protocol-defined inclusion/exclusion criteria may apply.
Is Levocetirizine Less Sedating Than Cetirizine?
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Cetirizine; Levocetirizine; Placebo
Intervention description: Cetirizine 10 mg tab daily x 7 days; 5 mg tab daily x 7 days; Placebo tablet daily x 7 days
Intervention MeSH terms: Cetirizine; Levocetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No
Keywords: Allergic Rhinitis

Summary:

      The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine
      (xyzal), and placebo differ in the degree of sedation they produce and their relief of
      allergy symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients 18 years of age or older

          -  patients with perennial allergic rhinitis sensitized (positive RAST within the last 3
             years or wheal greater than or equal to 3 mm within the last 3 years) to either:

               -  dust mite

               -  cat (if they own an indoor cat)

               -  dog (if they own an indoor dog)

          -  will allow for sensitization to tree, grass, or weed pollen, cockroach, or mold

          -  history of reported sedation/somnolence when taking cetirizine

          -  patient must have taken cetirizine for at least 1 week prior to discontinuing it

          -  patients must have either tolerated levocetirizine in the past or have never tried
             levocetirizine.

        Exclusion Criteria:

          -  chronic urticaria requiring ongoing antihistamine or steroid treatment

          -  atopic dermatitis requiring ongoing antihistamine or steroid treatment

          -  URI or sinus infection during the 2 weeks preceding the beginning of the study

          -  vasomotor (non-allergic) or irritant rhinitis

          -  afrin use

          -  elderly or over 77 years of age (could affect creatinine clearance) or chronic renal
             insufficiency

          -  patients who have not tolerated levocetirizine in the past due to sedation.

          -  taking other prescription or over the counter antihistamines and unwilling to stop
             them during the study

          -  the presence of a sleep disorder such as sleep apnea or narcolepsy

          -  the use of as needed sleeping aid medication

          -  the presence of other chronic medical conditions which in the opinion of the
             investigator would prevent the subject from being able to participate effectively
Adipokines in Obese Adolescents With Insulin Resistance
Condition: Obesity
MeSH terms: Insulin Resistance
Intervention: Metformin; Placebo
Intervention description: Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.; Tablet of 500 mg oral placebo every 12 hours for 3 months.
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 9 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Metformin; Obesity; Insulin resistance; Interleukin six; Adiponectin; High sensitivity C reactive protein.; Tumour Necrosis Factor alpha

Summary:

      The purpose of this study is to compare serum concentrations of inflammatory cytokines,
      interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour
      necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese
      adolescents with insulin resistance (IR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obesity defined as Body Mass Index (BMI) ≥ percentile 95

          -  Tanner stage ≥ 2

          -  Insulin resistance defined as Basal insulin > 15 µU/mL or Homeostasis Model Assessment
             index (HOMA) > 4.5

          -  Patients' parents signed written consents when they and their adolescent children
             agreed to enroll

        Exclusion Criteria:

          -  Glucose intolerance

          -  Diabetes mellitus (type 1 or 2)

          -  Anemia (Hb < 10 g/dL)

          -  Plasma creatinine > 1.4 mg/dL

          -  Abnormal hepatic function

          -  Any associated Disease (Pulmonary, Infection, Autoimmune Disease)

          -  History of lactic acidosis
Study of Medication Patch to Treat Children Ages 6-12 With ADHD
Condition: ADHD; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate Transdermal System; Placebo
Intervention description: Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses); Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; Attention Deficit Hyperactivity Disorder; Daytrana; MTS Patch; Methylphenidate Transdermal System

Summary:

      The purpose of this study is to investigate the effectiveness of a medication skin patch
      called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a
      placebo patch. We want to find out how well it treats ADHD during the early morning hours
      before a child leaves for school or summertime routines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients 6 to 12 years of age.

          -  Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested
             in clinical evaluation and confirmed by structured interview.

          -  Participation in structured morning routine (e.g. school, camp, or other organized
             activities).

        Exclusion Criteria:

          -  Mental retardation (IQ <75).

          -  Subjects with a medical condition, or treatment that will either jeopardize subject
             safety or affect the scientific merit of the study.

          -  Subjects with moderate to severe dermatological atopy.

          -  Subjects with known structural cardiac abnormalities.

          -  Organic brain disorders.

          -  Seizure Disorder.

          -  Subjects with Tourette's syndrome, or a history of psychosis or bipolar disorder.

          -  Subjects with current comorbid psychopathology that in the investigator's opinion will
             warrant immediate treatment or will interfere with the safe execution of the protocol
             (i.e. Anxiety or Major Depressive Disorder rated as moderate on CGI).

          -  Subjects with a history of intolerable adverse effects or non-response to
             methylphenidate.

          -  Pregnant or nursing females.
Management of Mandibular ORN: PENTO as Medical Treatment
Condition: Osteoradionecrosis
MeSH terms: Osteoradionecrosis
Intervention: Pentoxifylline and Tocopherol
Intervention description: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).
Intervention MeSH terms: Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol; Pentoxifylline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Mandibular osteoradionecrosis; Tocopherol; pentoxifylline; vitamine E; wounds and injuries; antioxidants; free radical scavengers; radiation-protective agents; vasodilatadors agents; osteonecrosis; mandible; extraoral fistula; exposed bone; necrotic bone; head and neck radiotherapy

Summary:

      Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic
      and irreversible complication after head and neck radiotherapy with no medical treatment to
      limit or reduce symptoms.

      Different clinical trials have shown a significant scientific evidence that the treatment
      with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the
      tissue fibrosis. This study proposes to use this drugs to determine if there is healing of
      mandibular osteoradionecrosis and/or a symptomatic improvement as well.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over 18 years and under 90 years old.

          -  Patients who have received radiotherapy after being diagnosed with head and neck
             cancer and currently are diagnosticated of mandibular osteoradionecrosis (any clinical
             stage)

          -  Follow-up for at least a year after the radiation treatment is completed.

          -  Absence of tumor at the time of recruitment.

          -  Patients with the capacity to give informed consent

        Exclusion Criteria:

          -  Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol
             (vitamin E).

          -  Patients taking oral anticoagulants (acenocoumarol, warfarin).

          -  Known hemorrhagic/coagulation disorder.

          -  Vitamin K deficiency due to any cause.

          -  Use of estrogens oral contraceptives.

          -  Serious bleeding or extensive retinal hemorrhage.

          -  Ischaemic heart diseases, including recent Myocardial Infarction.

          -  Serious cardiac arrhythmia.

          -  Severe LIVER DISEASE.

          -  Severe renal failure (creatinine clearance <30 mL/min).

          -  Hypotension.

          -  Female patients who are pregnant or lactating

          -  Any other situation or condition that, in the opinion of the INVESTIGATOR, may
             interfere with optimal PARTICIPATION in the study.