bioihbjkbjnl/mcl2 huggingface dataset:
Tenaculum Pain Control Study
Condition: Cervical Pain; Pelvic Pain
MeSH terms: Pelvic Pain; Neck Pain
Intervention: Intracervical Lidocaine Injection; Topical Lidocaine Gel
Intervention description: Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle; Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 74.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tenaculum; Pain; Lidocaine

Summary:

      The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine
      injection versus topical lidocaine gel on the pain experienced by patients undergoing
      tenaculum application to the cervix during office gynecologic procedures. This study will
      also evaluate how satisfied women are with the method of pain control used.

      The researchers hypothesize that:

        1. There is less pain perceived by patients undergoing placement of a tenaculum on the
           cervix when a lidocaine injection is used compared to a topical lidocaine gel.

        2. Patients are more satisfied with pain control during the overall experience of
           undergoing tenaculum placement on the cervix when a lidocaine injection is used compared
           to a topical lidocaine gel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy women

          -  Age 18 and over

          -  Indication for endometrial biopsy or IUD placement

        Exclusion Criteria:

          -  Allergy to lidocaine or other local anesthetic

          -  Pregnancy, known or suspected

          -  Patients who are premedicated with misoprostol

          -  Patients with a chronic pain condition for which the patient takes daily pain
             medication
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lamotrigine + Aripiprazole; Lamotrigine + Placebo
Intervention description: Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks
Lamotrigine 100-200 mg/day
Aripiprazole 10-30 mg/day; Tablets, Oral, once daily, Phase 2 - up to 52 weeks
Lamotrigine 100-200 mg/day
placebo 0 mg/day
Intervention MeSH terms: Lamotrigine; Anticonvulsants; Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bipolar I Disorder with a recent manic or mixed episode

Summary:

      Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance
      Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder,
             recently experiencing a manic or mixed episode with a history of one or more manic or
             mixed episodes of sufficient severity to require treatment with a mood stabilizer or
             antipsychotic

        Exclusion Criteria:

          -  First manic episode

          -  Current manic or mixed episode with > 2 years duration

          -  Treated with aripiprazole within the past 3 months

          -  Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine
Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder, Major
Intervention: Lamotrigine; Ketamine; Riluzole
Intervention description: anticonvulsant medication; subanesthetic dose of NMDAR antagonist; glutamate release inhibitor
Intervention MeSH terms: Lamotrigine; Ketamine; Riluzole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study is examining the safety and effectiveness of two medications, ketamine and
      riluzole, in treating patients with treatment resistant major depressive disorder. This study
      will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing
      the potential side effects associated with ketamine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients, 21- 70 years of age

          2. Subjects have a history of at least one previous episode of depression prior to the
             current episode (recurrent major depressive disorder) or have chronic major depressive
             disorder (at least two years' duration)

          3. Subjects have not responded to an adequate trial of one antidepressant in the current
             episode

        Exclusion Criteria:

          1. Female subjects who are either pregnant or nursing

          2. Serious, unstable illnesses

          3. Any previous use or treatment with ketamine, or riluzole

          4. Past intolerance to lamotrigine, including drug rash
A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: Bimatoprost 0.03%
Intervention description: Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Intervention MeSH terms: Bimatoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure
      (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open-angle glaucoma or ocular hypertension

          -  No use of Lumigan® in the past 3 months

        Exclusion Criteria:

          -  Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery
             within the past 3 months
SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Intervention: Sodium Oxybate; placebo (fresh potable water)
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic fatigue syndrome

Summary:

      The investigators wish to investigate whether enhancement of SWS, which is seen after a drug
      called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function,
      specifically sleepiness and mental performance. This is a safe and well-tolerated drug that
      is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.

      The investigators will study 12 patients diagnosed with CFS using international diagnostic
      guidelines. The investigators will record overnight sleep with EEG (brainwave) measurement on
      the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will be
      taken nightly, and the investigators will measure next-day sleepiness, mental performance and
      fatigue, and compare drug and placebo nights.
    

Eligibility criteria:

        Inclusion criteria

          -  Meeting criteria for CFS according to both the revised CDC (Fukuda 5) and Canadian
             diagnostic systems.

          -  Aged 25-65.

          -  Good grasp of the English language.

        Exclusion criteria

          -  Taking any of the following medication: opioids, tramadol, phenytoin, valproate,
             ethosuximide, benzodiazepines, zolpidem, zopiclone, zaleplon, antidepressant except
             <30mg amitriptyline, or any other medications likely to interact with sodium oxybate
             or with sleep in the opinion of the investigators.

          -  Current major psychiatric disorder.

          -  Unusual sleep schedule; (bedtime routines that fall outside 9 p.m. to 10 a.m.; usual
             time in bed > 12 hours).

          -  Pregnancy, lactation or being female and not using reliable contraception.

          -  Relevant abnormal clinical findings at screening visit.

          -  Taken alcohol in the 24 hours before each study visit or drugs of abuse in the week
             before each study visit
A Study to Look at Day to Day Changes in Lung Function in COPD Subjects Taking Albuterol/Salbutamol and Ipratropium
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Albuterol/salbutamol; Ipratropium
Intervention description: Albuterol/salbutamol (daily); Ipratropium (daily)
Intervention MeSH terms: Albuterol; Ipratropium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the daily variation in bronchodilator response to an
      inhaled short acting beta2-agonist (albuterol/salbutamol) and an inhaled short acting
      anticholinergic (ipratropium) individually and when used in combination in subjects with
      COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must give their signed and dated written informed consent to participate.

          -  Subjects 40 years of age or older at Visit 1.

          -  Male or female subjects .

          -  An established clinical history of COPD.

          -  Current or former cigarette smokers with a history of cigarette smoking of >=10
             pack-years at Visit 1.

          -  A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a post-albuterol/salbutamol
             FEV1 of >=30 and <= 70% of predicted normal values at Visit 1 calculated using NHANES
             III reference equations .

        Exclusion Criteria:

          -  A current diagnosis of asthma

          -  Women who are pregnant of lactating or are planning on becoming pregnant during the
             study.

          -  Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.

          -  Participation in pulmonary rehabilitation
Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation
Condition: Abortion
MeSH terms: Dilatation, Pathologic
Intervention: Digoxin; Placebo
Intervention description: Trans-abdominal injection; Trans-abdominal injection
Intervention MeSH terms: Digoxin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 178.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a research study to measure the effect of digoxin injection on Dilation and
      Evacuation (D&E) procedure duration. Digoxin is the most commonly used feticidal agent among
      family planning subspecialists, and is commonly used for a variety of reasons including
      provider preference, patient preference, and concerns over legal status of later D&E
      procedures. There have been several studies on digoxin administration, adverse effects, and
      impact on the D&E procedure, but doctors want to clarify how digoxin effects D&E procedure
      time, if at all.
    

Eligibility criteria:

        Inclusion Criteria:

          -  20 weeks 0 days-24 weeks 0 days gestation

          -  English or Spanish speaking

          -  18 years or older

        Exclusion Criteria:

          -  Under 18

          -  Contraindications to digoxin
Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients
Condition: Anaesthesia
Intervention: The placement according to the manufacturer's instructions; Cuff inner pressure was held below 44 mmHg
Intervention description: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®(LMU)) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience; cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: elderly; laryngeal masks; postoperative complications

Summary:

      Laryngeal Mask is widely used for air-way management during anaesthesia. Pharyngolaryngeal
      morbidity linked to laryngeal mask use is related to correct choice of mask size, placement
      technique, placement of the laryngeal mask in the correct position on the larynx, cuff volume
      and cuff pressure. It has been stated that keeping laryngeal mask cuff pressure below 45 mmHg
      (60 centimeter of water(cmH2O) ) can prevent pharyngolaryngeal morbidity related to laryngeal
      mask (throat pain, dysphonia, dysphagia) and shown that using a manometer after Laryngeal
      Mask Unique placement to limit pressure within the cuff can reduce this morbidity by nearly
      70%. Studies commenting on pharyngolaryngeal morbidity generally do not choose a certain age
      group and cover stages including very young and middle-aged groups. In the literature only
      one similar study on the geriatric age group was found.

      The aim of this study is to compare the postoperative pharyngolaryngeal morbidity in a group
      with cuff pressure held to 44 mmHg (60 cmH2O with a manometer and a group with Laryngeal Mask
      cuff inflated without reference to pressure in the geriatric age group with indications for
      Laryngeal Mask Unique placement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Above the age of 65

          -  ASA I-III

          -  Undergoing elective surgery

        Exclusion Criteria:

          -  Patients with recent history of upper respiratory infection

          -  Obese patients with body-mass index above 35 kg/m2

          -  Symptomatic hiatus hernia

          -  Severe gastroesophageal reflux

          -  Dementia
Burden of Obstructive Sleep Apnea in Stroke (BOSAST)
Condition: Stroke; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Stroke
Intervention: CPAP; CPAP at sub-therapeutic pressure
Intervention description: CPAP at therapeutic pressure during nighttime; CPAP delivered at sub-therapeutic pressure at nighttime
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: stroke; obstructive sleep apnea; fatigue; quality of life

Summary:

      There are two purposes of this study. The first purpose is to define the frequency of
      obstructive sleep apnea in stroke survivors as well as its association with fatigue and
      quality of life. The second purpose is to determine if continuous positive airways pressure
      (CPAP) treatment can have a beneficial effect on these patients' fatigue and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  stroke survivor in stroke rehabilitation unit

          -  age 45-85

          -  able to consent

          -  no prior treatment with CPAP

        Exclusion Criteria:

          -  complex apnea

          -  known inflammatory disease

          -  neurological disease precluding patient's ability to consent and cooperate
A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS
Condition: Non-ST or ST Elevation Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Ticagrelor; Clopidogrel
Intervention description: 90mg tablets. loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. Duration of treatment: 6 weeks.; 75mg capsule. loading dose of 600mg clopidogrel capsules (eight 75mg capsules) taken orally, follow by 75mg of clopidogrel capsules orally od. Duration of treatment: 6 weeks.
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect

Summary:

      The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect
      of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Provision of informed consent prior to any study specific procedures

          -  2. Female or male aged at least 18 years

          -  3. Females of child-bearing potential must have a negative urine pregnancy test at
             enrolment and be willing to use reliable contraception

          -  4. Index event of non-ST or ST segment elevation ACS.

        Exclusion Criteria:

          -  1.Contraindication or other reason that clopidogrel or ticagrelor should not be
             administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease,
             history of previous intracranial bleed, GI bleed within the past 6 months, major
             surgery within 30 days)

          -  2. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30
             days prior to randomisation or cannot be stopped

          -  3. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to
             randomisation

          -  4. Requires dialysis

          -  5. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins
             (PGI2) therapy that cannot be stopped
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Intervention: Havrix™
Intervention description: 2 doses at 12 months interval
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 29 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HAVRIX™; Hepatitis A

Summary:

      The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150,
      162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a
      2 dose vaccination schedule of hepatitis A vaccine.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      11 to 20.

      No additional subjects will be recruited during this long-term follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who had received at least one dose of the study vaccine in the primary study

          -  Written informed consent will have been obtained from the subjects before the blood
             sampling visit of each year.
Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
Condition: Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage; Headache
Intervention: Gabapentin; Placebo
Intervention description: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.; Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: aSAH; SAH

Summary:

      The purpose of this study is to see how much gabapentin will reduce headaches associated with
      subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication
      prescribed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older

          2. Have aneurysmal subarachnoid hemorrhage (aSAH) diagnosed by CT scan of the brain
             and/or angiogram evidence of intracranial aneurysm (CTA or digital subtraction
             angiogram or MRA)

          3. Have symptomatic headache

          4. Able to swallow and verbalize pain score

          5. No known allergy to gabapentin or fentanyl

          6. Numeric pain score ≥ 5

          7. Ability to provide written personal consent

        Exclusion Criteria:

          1. Gabapentin use prior to SAH admission

          2. Renal failure with creatinine clearance less than 30 mL/min

          3. Unable to receive standard of care pain medications

          4. Pregnant or breastfeeding patients

          5. History of severe depression defined by the Diagnostic and Statistical Manual of
             Mental Disorders, 4th Edition, Text Revision (DSM IV)