bioihbjkbjnl/mcl2 huggingface dataset:
Pain Outcomes Following Intralesional Corticosteroid Injections
Condition: Keloid; Alopecia Areata; Acne; Hypertrophic Scar; Epidermal Inclusion Cyst; Frontal Fibrosing Alopecia; Lichen Plano-Pilaris; Keratoacanthoma; Plaque Psoriasis; Lichen Simplex Chronicus; Prurigo Nodularis; Nummular Eczema; Granuloma Annulare; Morphea; Lichen Planus
MeSH terms: Epidermal Cyst; Granuloma; Alopecia; Alopecia Areata; Lichen Planus; Prurigo; Granuloma Annulare; Neurodermatitis; Keratoacanthoma; Cicatrix, Hypertrophic
Intervention: Corticosteroid with lidocaine; Corticosteroid with normal saline
Intervention description: Intralesional corticosteroid injection; Intralesional corticosteroid injection
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: corticosteroid; local anesthetic

Summary:

      Corticosteroid therapy, including intralesional and topical applications, has many
      indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However,
      these injections can be quite painful, which leads many patients to discontinue treatment.

      Often, the injection involves a mixture of local anesthetic and corticosteroids despite a
      lack of evidence that the use of lidocaine improves pain. Due to the acidic pH, the lidocaine
      component of the injection can actually cause a significant burning sensation during the
      procedure. Lidocaine does not have anti-inflammatory properties and does not treat the
      underlying pathology. By including another medication, lidocaine also adds cost and risk to
      the procedure.

      The purpose of this study is to see if removing lidocaine from intralesional injections
      decreases the pain of injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >12 years old presenting with an indication for intralesional steroid injection

        Exclusion Criteria:

          -  Unconsentable

          -  Not a candidate for corticosteroid injection

          -  Contraindication to lidocaine
A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Risperidone long-acting injection (LAI); Oral Antipsychotic
Intervention description: Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion.; Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg.
Intervention MeSH terms: Risperidone; Antipsychotic Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizoaffective disorder; Schizophreniform disorder; Risperidone; Risperdal Consta

Summary:

      The purpose of this study is to evaluate the effectiveness, safety and tolerability of
      risperidone long-acting injection (LAI) versus oral antipsychotics in participants with
      recent onset psychosis (abnormal thinking and/or hallucinations).
    

Eligibility criteria:

        Inclusion Criteria:

          -  In-patients or out-patients

          -  Primary Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
             diagnosis of schizophrenia, schizophreniform disorder or schizoaffective disorder for
             no longer than 3 years after diagnosis and treatment of a psychotic illness

          -  Positive and Negative Syndrome Scale (PANSS) score of 60-120 at Visit 1 and 2

          -  Currently on monotherapy atypical antipsychotic treatment below local label guidelines
             or treatment naive

          -  Able to complete self-assessments in either English or French

        Exclusion Criteria:

          -  Current primary Axis-1 diagnosis other than schizophrenia, schizophreniform disorder
             or schizoaffective disorder, according to DSM-IV

          -  Current drug or alcohol dependence

          -  Treatment with a depot antipsychotic within 3 months of study start

          -  Confirmed or suspected history of lack of tolerability, hypersensitivity or allergy to
             risperidone

          -  Risperidone non-responders (based on evidence of adequate trial of treatment)
The OBstetric Lidocaine Patch (OBLido) Trial
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Transdermal Lidocaine Patch; Transdermal Hydrocolloid Placebo Patch
Intervention description: Transdermal Lidocaine Patch; hydrocolloid placebo patches
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, single blind, randomized controlled trial
Masking: Single (Participant)
Enrollment: 66.0
Sex: Female
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: lidocaine; patch

Summary:

      This study will be a single-center, single blind, randomized controlled trial. The study will
      be conducted at UnityPoint-Health Meriter Hospital under investigators from the University of
      Wisconsin-Madison. Obstetric patients with prepregnancy obesity undergoing a Cesarean
      delivery at UnityPoint-Health Meriter will be eligible.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Maternal age greater than or equal to 18

          -  Prepregnancy body mass index greater than or equal to 30 kg/m2 or ≥35 kg/m2 at
             delivery if no prepregnancy/ early pregnancy weight available

          -  Singleton or multifetal pregnancy

          -  Able to receive neuraxial analgesia

          -  Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery with adequate
             time to consider and consent to the study

          -  Gestational age greater or equal to 32 weeks

        Exclusion Criteria:

          -  Known hypersensitivity to lidocaine or colloid patch (defined as a history of a
             reaction or allergy to lidocaine (injectable, intravenous, or transdermal) or
             hydrocolloid patch reported by patient or documented in the medical record) or patient
             report

          -  Contraindication to regional analgesia

          -  Positive urine drug screen at admission to the hospital, if ordered for clinical
             purposes.

          -  Current opioid use or opioid use disorder per patient report or documented in the
             medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery)

          -  Chronic opioid use or opioid use disorder, either patient reported or documented in
             the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery), defined
             as opioid use on most days for >3 months

          -  Planned Cesarean hysterectomy (excluded due to anticipated blood loss and alternative
             pain control measures, possible prolonged intubation)

          -  Planned vertical midline incision

          -  Presence of renal dysfunction precluding the use of NSAIDs

          -  Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy

          -  Coagulopathy

          -  Planned discharge from the hospital less than 24 hours postpartum
The Effect of Glucomannan Soluble Fiber on Glucose Homeostasis in Patients With Roux En Y (RNY) Gastric Bypass Surgery
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: glucomannan
Intervention description: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant. It will be given during the Intervention Phase in conjunction with the MMTT and then for 5 days at home with meals.
Intervention MeSH terms: (1-6)-alpha-glucomannan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      One of the emerging complications of RNY gastric bypass surgery is mild to severe refractory/
      recurrent postprandial hypoglycemia. This complication can lead to a significant reduction in
      quality of life to severe disability. Unfortunately at this time there are no treatment
      guidelines or proven therapeutic options for the treatment of this complication. One of the
      proposed treatment options is the use of fiber supplements to help modify the absorption of
      glucose, slow the food bolus transit time more toward normal and restore the postprandial
      (after meal) glucose homeostasis. The investigators are proposing a pilot project for the use
      of Glucomannan soluble fiber as a treatment option for postprandial hypoglycemia in this
      cohort. This project will help the investigators to identify if Glucomannan soluble fiber can
      be used as an effective dietary supplement to eliminate or reduce this condition
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age: >18 year

          2. Have undergone RNY Gastric Bypass >1 year.

          3. Have symptoms of hypoglycemia (altered mental status or level of consciousness, with
             or without seizure, palpitations, tremor, anxiety/arousal, sweating, hunger,
             paresthesias, behavioral changes, fatigue, confusion), documented hypoglycemia (blood
             glucose<70 mg/dl), hypoglycemic unawareness (recurrent hypoglycemia without symptoms).

        Exclusion Criteria:

          1. Patient with Diabetes Type 1 or Type 2. Information identified during history taking
             or subject undergoing treatment of active diabetes.

          2. Patient on medications or treatment (insulin, metformin, glyburide, diazoxide,
             octreotide, calcium channel blockers), which can cause hypoglycemia.

          3. Patients with disorders, which can cause hypoglycemia, like untreated hypothyroidism,
             adrenal insufficiency, and growth hormone deficiency.

          4. Complications of RNY i.e. Ulcers and hernia.

          5. Current use of glucocorticoids or medications known to affect blood glucose levels.

          6. Any patient that is unable to comply with dietary recommendations, technical iPro,
             glucometer actions or any part of the research protocol
Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment
Condition: CHRONIC SPONTANEOUS URTICARIA
MeSH terms: Urticaria; Chronic Urticaria
Intervention: OMALIZUMAB
Intervention description: sub cutaneous injections of 300 mg every 4 weeks until Week 8.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CHRONIC SPONTANEOUS URTICARIA; OMALIZUMAB; URTICARIA CONTROL TEST; IGE025

Summary:

      Evaluate the proportion of patients with an urticaria control test [UCT] score of greater
      than or equal to 12 at Week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged between 18 and 75 years.

          -  Diagnosis of CSU for ≥ 6 months and an inadequate response to nsH1 antihistamines at
             the time of the request, as defined by the following:

          -  The presence of itch and hives for > 6 consecutive weeks at any time prior to
             enrollment, despite current use of H1 antihistamine therapy during this time period.

          -  Weekly UAS7 score (range 0 to 42) 16 and UCT score (range 0 to 16) < 8 prior to
             enrollment (Day 1)

          -  Current use of an H1 antihistamine for CSU on the day of the initial visit and Day

          -  Informed consent

        Exclusion Criteria:

          -  Treatment with an investigational agent within 30 days before enrollment.

          -  Routine (daily or every other day during 5 or more consecutive days) doses of the
             following medications within 30 days prior to Day -7: systemic or cutaneous (topical)
             corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate,
             cyclosporine, or cyclophosphamide.

          -  Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7

          -  Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7.

          -  Any H2 antihistamine use within 7 days prior to Day -7.

          -  Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days
             prior to Day 7.

          -  Concomitant use of cyclosporine or any other immunosuppressive agent.

          -  Hypersensitivity to omalizumab or any component of the formulation.

          -  History of anaphylactic shock.
A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Losartan 50 mg / HCTZ 12.5 mg
Intervention description: Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks
Intervention MeSH terms: Losartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hypertension

Summary:

      This study is being conducted to evaluate the safety and antihypertensive efficacy of
      MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to
      moderate essential hypertension.
    

Eligibility criteria:

        Inclusion criteria:

          -  Participant will have reached the legal age by the time of entrance into the run-in
             period.

          -  Participant has no active medical problem, other than essential hypertension,

        which might of itself or by this treatment significantly affect the Participant's blood
        pressure.

        - Participants diagnosed with mild to moderate essential hypertension or

        hypertension accompanying with established cardiovascular (CV) and renal diseases who are
        receiving antihypertensive regimen (exclude diuretic), yet not attaining to treatment
        goal*.

        * Note: For essential hypertension, the goal is to reduce the blood pressure to less than
        140/90. For hypertension with established CV and renal diseases, the BP goal is < 130/80.
        (According to 2007 European Society of Hypertension (ESH) - European Society of Cardiology
        (ESC) guideline)

          -  Participant is either receiving antihypertensive therapy or no treatment.

          -  Participants with stable diabetes mellitus may enter the study.

        Exclusion criteria:

          -  Pregnant or lactating females.

          -  Secondary hypertension of any etiology (such as unilateral or bilateral renal

        disease, renal artery stenosis, coarctation of the aorta, pheochromocytoma).

          -  History of malignant hypertension.

          -  Sitting systolic blood pressure >210 mmHg at Visit 1 (Day 0).

          -  Participants with unresolved cerebrovascular accident or transient ischemic attack in
             the acute stage at visit 1.

          -  A clinically confirmed myocardial infarction within the recent 3 months.

          -  Angina pectoris.

          -  Clinically important cardiac arrhythmia.

          -  History of unexplained syncope within the prior 2 years, or a known syncopal

        disorder.

        - Presence of hemodynamically significant obstructive valvular disease of

        cardiomyopathy.

          -  Percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 3
             months of visit 1.

          -  Participant with a single functioning kidney.
Study of the Effectiveness of Administration of Meperidine on the Length of Active Phase of Labor in Women
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Meperidine; Saline
Intervention description: 0.5 ml meperidine injection intravenously injected in randomly selected patients; 0.5 ml saline solution injection intravenously injected in randomly selected patients
Intervention MeSH terms: Meperidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized parallel double blind plasebo controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Both drug provider and patient do not know which drug or placebo was given
Enrollment: 250.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: labor,; meperidine,; active phase,; duration of labor

Summary:

      This study aims to evaluate the effect of meperidine on the length of active phase of labor
      in nulliparous or multiparous women, who will be randomized into two (control and study)
      groups. Our hypothesis is that the use of meperidine during active labor has no effect on the
      duration of labor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  gestational age between 38 and 42 weeks

          -  live fetus

          -  cephalic presentation

          -  in active phase of labour

        Exclusion Criteria:

          -  placenta previa, placental abruption

          -  caesarean section or any uterine scarring

          -  multiple gestation

          -  fetal macrosomia (≥4000 g)

          -  meperidine allergy

          -  use any kind of labour induction or augmentation before on admission for delivery in
             our hospital
Hybrid Blood Pressure Monitor Validation
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Blood Pressure Measurement
Intervention description: All patients have their blood pressure measured simultaneously by two observers using parallel connected mercury sphygmomanometers and by a supervisor using the tested device, NISSEI DM 3000. Six sets of measurements are performed.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Blood pressure measuring devices; Essential Hypertension; Automated blood pressure measurement

Summary:

      Assessment of the accuracy of a Blood Pressure Measuring Device with a digital
      display-column, NISSEI DM 3000, according to an adaptation of the "European Society of
      Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure
      Measuring Devices in Adults".
    

Eligibility criteria:

        Inclusion Criteria:

          -  Above 25 years of age

          -  Sinus rhythm

          -  Informed consent

        Exclusion Criteria:

          -  Sustained arrhythmia

          -  Pregnancy

          -  Poor quality Korotkoff sounds

          -  Unavailable cuff size

          -  Completed blood pressure range (according to protocol)
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Condition: Trauma; Fractures, Closed; Children, Only; Deep Sedation; Ketamine
MeSH terms: Fractures, Bone; Fractures, Closed
Intervention: Intravenous Ketamine; Intranasal Ketamine
Intervention description: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.; Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: procedural sedation; ketamine; pediatric; fracture; intranasal; intravenous; emergency department

Summary:

      This a randomized clinical trial involving children with non-operative fractures presenting
      the emergency department randomized either to intranasal or intravenous ketamine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 1-18 years of age.

          -  American Society of Anesthesiologists (ASA) I or II

          -  Non-operative fracture requiring reduction

          -  Body weight less than or equal to 25 kg as measured by standard weighing scale

        Exclusion Criteria:

          -  ASA classification III or above

          -  Age less than 1 year

          -  History of hypertension, known coronary artery disease or Kawasaki disease, congestive
             heart failure, acute glaucoma or globe injury, increased intracranial pressure or
             intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric
             disorder

          -  Prior allergy to ketamine

          -  Unavailable parent or guardian to provide consent

          -  Non-English speaking