bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Intranasal Oxytocin on Cigarette Smoking
Condition: Nicotine Dependence; Tobacco Smoking
MeSH terms: Tobacco Use Disorder
Intervention: Oxytocin; Placebo
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and neural
      processes that encode, interpret, and respond to socially and emotionally relevant stimuli)
      have been implicated in tobacco smoking and relapse, however this potential target for
      medication development has not been systematically examined. Evidence from animal and human
      laboratories indicate that administration of intranasal oxytocin enhances socioemotional
      processing and may be efficacious for the treatment of drug addiction, including nicotine
      dependence. In order to evaluate the potential efficacy of intranasal oxytocin for smoking
      cessation, this laboratory-based proposal will examine whether intranasal oxytocin attenuates
      smoking lapse, nicotine withdrawal, and socioemotional processing disruptions in regular
      smokers following overnight abstinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-40

          -  Smoke >= 10 cig/day for the past year

          -  English fluency

        Exclusion Criteria:

          -  Current DSM-5 substance use disorder, excluding nicotine dependence (to minimize
             alcohol or drug withdrawal symptoms during the study sessions)

          -  Any medical condition that would increase risk for study participation (such as sinus
             infection or other condition blocking access to the olfactory epithelium)

          -  Women who are pregnant or nursing

          -  Current use of psychiatric medication

          -  Breath Carbon Monoxide (CO) levels < 10ppm measured during study intake (to exclude
             individuals who overreport smoking in order to participate in the study)

          -  Planning to quit or reduce smoking in the next 30 days

          -  Current regular use of other nicotine products
Effectiveness Study of Different Local Anesthetic Mixtures
Condition: Pain
Intervention: 1% Lidocaine with Epinephrine (1:100,000); 0.25% Bupivacaine with Epinephrine (1:200,000); 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000); 1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)
Intervention description: 0.2ml Intradermal injection once.; 0.2ml Intradermal injection once.; 0.2ml Intradermal injection once.; 0.2ml Intradermal injection once.
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Purpose and Background The purpose of this research study is to investigate the benefits of
      mixing lidocaine and bupivacaine for numbing the skin. Lidocaine and bupivacaine are two
      commonly used medications to numb the skin for minor procedures. Lidocaine has a faster
      onset. Bupivacaine has a longer duration. They are often combined with epinephrine to
      increase the length of action. These medications are used to control pain at the time of the
      operation and to decrease discomfort immediately afterward. Participating in the study
      involves injection of local anesthetic containing lidocaine, bupivacaine, and lidocaine and
      bupivacain with epinephrine at 4 sites on the forearm. Your participation will potentially
      improve the administration of these medications in persons undergoing a variety of
      procedures. You will be one of approximately 25 healthy volunteer subjects in this research
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 18-60

        Exclusion Criteria:

          -  Pregnancy

          -  allergy to local anesthetics

          -  history of heart disease or diabetes
Litramine in Weight Maintenance
Condition: Weight Maintenance; Overweight; Obese
MeSH terms: Overweight; Body Weight
Intervention: Litramine; Placebo
Intervention description: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal); Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Weight maintenance; Overweight; Obese; Weight management

Summary:

      The effect of Litramine on weight loss has previously been studied during a 12-week
      intervention period with promising results. The present study looks into the effect of weight
      maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented weight loss, achieved over the last 3 to 6 months either from participation
             in weight loss clinical trials or weight loss regimens, of at least 3% at the point of
             screening

          -  BMI 25-35 before initial weight loss

          -  Documented compliance (according to the investigator's judgement) to previous weight
             loss clinical trials/ regimens

        Exclusion Criteria:

          -  Known sensitivity to the ingredients of the device (citric acid, acacia or Fabaceae
             family)

          -  BMI < 18.5

          -  Presence of other factor(s) that, in the investigator's judgement, should preclude
             subject participation
The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
Condition: Hepatic Encephalopathy; Cirrhosis
MeSH terms: Hepatic Encephalopathy; Brain Diseases; Fibrosis
Intervention: Rifaximin; Lactulose
Intervention description: Rifaximin will be administered per the dose and schedule specified in the arms.; Laculose will be administered per the schedule specified in the respective arm.
Intervention MeSH terms: Rifaximin; Lactulose
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver Failure; Hepatic Insufficiency; Liver Diseases; Brain Diseases; Rifaximin; Cirrhosis

Summary:

      The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays
      the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a
      previous episode of HE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating females greater than or equal to (≥) 18 years old.

          -  In remission from demonstrated overt HE (Conn score 0 or 1).

          -  Have had one or more episodes of overt HE associated with cirrhosis within 6 months
             prior to screening visit (Day -7 to -1).

          -  Participant has a close family member or other personal contact who is familiar with
             the participant's HE and can provide continuing oversight to the participant and is
             willing to perform as caregiver for the participant during the conduct of the trial.

        Exclusion Criteria:

          -  Participant has been diagnosed with human immunodeficiency virus (HIV) as determined
             by medical history.

          -  History of tuberculosis infection.

          -  Participant has been diagnosed with chronic respiratory insufficiency.

          -  Participant has been diagnosed with a current infection for which they are currently
             taking oral or parenteral antibiotics.

          -  Renal insufficiency requiring routine dialysis.

          -  Participant has an active spontaneous bacterial peritonitis(SBP) infection.

          -  Intestinal obstruction or inflammatory bowel disease.

          -  Participant has active malignancy within the last 5 years prior to screening visit,
             except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that
             has been surgically excised.

          -  Current gastrointestinal (GI) bleeding or has a history of a GI hemorrhage of
             sufficient severity to require hospitalization and a transfusion of ≥2 units of blood
             within 3 months prior to screening visit.

          -  Participant is anemic, as defined by a hemoglobin of less than (<) 8 grams/deciliter
             (g/dL).

          -  Scheduled to receive a liver transplant within 1 month of screening.
Treatment of Binge Eating in Obese Patients in Primary Care
Condition: Obesity; Binge Eating
MeSH terms: Bulimia; Binge-Eating Disorder
Intervention: Sibutramine; Placebo; Self-help CBT + Sibutramine; Self-help CBT + Placebo
Intervention description: 15 mg daily; Daily; Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily; Cognitive behavioral treatment manual for binge eating Placebo daily
Intervention MeSH terms: Sibutramine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Binge eating; Sibutramine; Self-help; Primary care

Summary:

      This study will test the effectiveness of two empirically-supported but distinct treatments
      for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure
      self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy
      for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered
      alone and in combination in a primary care setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese (BMI >= 30)

        Exclusion Criteria:

          -  Medication regimen that represents medical contraindication to sibutramine

          -  Serious unstable or uncontrolled medical conditions that represent contraindication to
             sibutramine

          -  Pregnancy
Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: FDC of tiotropium + olodaterol; Placebo; Tiotropium; Olodaterol
Intervention description: Fixed Dose Combination of tiotropium + olodaterol
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 221.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled
      study.

      Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of
      either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the
      free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat®
      inhaler. The purpose is to show non-inferiority between the FDC and the free combination of
      tiotropium and olodaterol in patients with COPD.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patients.

          -  Patients 40 years of age or older.

          -  Patients with a smoking history > 10 pack years.

          -  Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one
             second) >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced
             Vital Capacity) <70% at screening.

          -  Symptomatic patients with CAT (COPD Assessment Test TM) score >= 10 at screening.

          -  Further inclusion criteria apply.

        Exclusion criteria:

          -  COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks
             prior to screening.

          -  Patients with a current diagnosis of asthma.

          -  Further exclusion criteria apply.
Subject Satisfaction With AbobutulinumtoxinA Treatment
Condition: Glabellar Frown Lines
Intervention: AbobotulinumtoxinA
Intervention description: AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to Severe Glabellar Lines at Maximum Frown

          -  Understands study requirements and signs an informed consent

        Exclusion Criteria:

          -  Known allergy to any component of study product

          -  Pregnant or breast feeding or intending to get pregnant during the study

          -  Botulinum toxin treatment in the face within 9 months
The Anesthetic Efficacy of 3% Mepivacaine Plus 2% Lidocaine With 1:100,000 Epinephrine for Lower Jaw Dental Injections
Condition: Pain
Intervention: mepivacaine + lidocaine followed by lidocaine +lidocaine; lidocaine + lidocaine followed by mepivacaine + lidocaine
Intervention description: 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine; 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine
Intervention MeSH terms: Lidocaine; Mepivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mepivacaine; lidocaine; inferior alveolar nerve block; pulpal anesthesia; mepivacaine/lidocaine; lidocaine/lidocaine

Summary:

      The inferior alveolar nerve block (shot) is the most frequently used injection technique for
      achieving local anesthesia (numbness) for the teeth in the lower jaw. However, this injection
      does not always result in successful pulpal (tooth) anesthesia (patient felt pain). No study
      has combined mepivacaine and lidocaine anesthetics (numbing solutions) for this type of
      injection (shot). The investigators propose to compare an injection of mepivacaine followed
      by lidocaine to an injection of lidocaine followed by lidocaine to determine if there is a
      difference in effectiveness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between the ages of 18 and 65 years

          -  good health (ASA classification I or II)

          -  able to provide informed consent

        Exclusion Criteria:

          -  allergy to lidocaine or mepivacaine

          -  history of significant medical problem (ASA classification III or greater)

          -  depression

          -  have taken CNS depressants (including alcohol or any analgesic medications) within the
             last 48 hours

          -  lactating or pregnant

          -  inability to give informed consent
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Morphine; Methadone
Intervention description: Morphine wean protocol as described in arm description; Methadone wean protocol as described in arm description
Intervention MeSH terms: Morphine; Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 0 Hours
Maximum age: 12 Hours
Healthy volunteers: No

Summary:

      This study investigates the use of methadone versus morphine wean for the treatment of
      neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who
      require pharmacotherapy for NAS will receive a methadone wean, and half will receive a
      morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be
      studied.
    

Eligibility criteria:

        Inclusion criteria:

          -  Born at University of New Mexico Hospital

          -  Greater than 34 weeks gestation

          -  Primary in-utero drug exposure was opioids other than buprenorphine

          -  Maternal or infant urine drug screen positive for methadone and/or opioids on
             admission

        Exclusion criteria:

          -  Born prior to 34 weeks

          -  Neonatal intensive care unit admission

          -  Serious medical comorbidities

          -  Primary substance exposure in-utero was buprenorphine, or was not opioids
Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)
Condition: Chronic Lung Disease
MeSH terms: Lung Diseases
Intervention: Lyophilized Palivizumab; Liquid Palivizumab
Intervention description: Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.; Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.
Intervention MeSH terms: Palivizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 417.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to measure the rate of anti-palivizumab antibodies (also
      referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid
      or lyophilized formulation of palivizumab. This study will compare the number and percentage
      of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized
      formulation of palivizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically stable child with chronic lung disease of prematurity who is ≤24 months of
             age at randomization OR child with premature birth (gestational age ≤35 weeks or less)
             and who is 6 months of age or younger at randomization

          -  Written informed consent obtained from the patient's parent(s) or legal guardian(s)

          -  The child must be able to complete the follow-up visit 4-6 months after the last dose
             of study drug

        Exclusion Criteria:

          -  Hospitalization at the time of randomization (unless discharge is anticipated within 3
             weeks)

          -  Be receiving mechanical ventilation at the time of study entry (including CPAP)

          -  Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal
             defect] and children with complicated CHD who are currently anatomically and
             hemodynamically normal can be enrolled).

          -  Mother with HIV infection (unless the child has been proven to be not infected)

          -  Life expectancy <6 months

          -  Known allergy to Ig products

          -  Acute respiratory or other acute infection or illness

          -  Previous reaction to IGIV, blood products, or other foreign proteins

          -  Receipt of lyophilized palivizumab, RSV-IG IV, or other RSV-specific monoclonal
             antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG)
             within 3 months prior to randomization

          -  Any previous receipt of MEDI-524

          -  Participation in other investigational drug product studies
Plaque Psoriasis Study in Pediatric Subjects
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: calcitriol ointment; placebo comparator
Intervention MeSH terms: Calcitriol
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: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to
      8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice
      daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 2 to 12 years of age

          -  Clinical diagnosis of stable mild to moderate plaque psoriasis

        Exclusion Criteria:

          -  Other forms of psoriasis

          -  Hypercalcemia

          -  Past history of kidney stones

          -  Vitamin D deficiency

          -  Other concomitant dermatological disease
Preventing Propofol-associated Injection Pain
Condition: Pain
Intervention: Saline; Lidocaine / propofol admixture; lidocaine pretreatment
Intervention description: 3.3 mL normal saline; lidocaine 50 mg plus propofol 50 mg intravenous (iv); lidocaine 50 mg iv under tourniquet-control
Intervention MeSH terms: Lidocaine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: propofol; lidocaine; injection pain

Summary:

      Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics
      have been shown to attenuate this response in some patients. This randomized, double-blind,
      placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be
      superior to lidocaine administered directly into the vein, under tourniquet control, prior to
      injection of propofol. Both groups are expected to be superior to placebo.
    

Eligibility criteria:

        Inclusion criteria:

          -  weight >40kg, <100kg

          -  ambulatory surgery

        Exclusion criteria:

          -  allergy to propofol or lidocaine

          -  taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)