bioihbjkbjnl/mcl2 huggingface dataset:
Examining the Impact of Tampon Use on the Vaginal Microbiota
Condition: Vaginal Microbiota
Intervention: Tampon A; Tampon B
Intervention description: 24 Tampax Pearl Regular Tampons for use during a single menstrual period.; 24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for one of the first two menstrual cycles during the study. Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the other of the first two menstrual cycle during the study. Subjects used tampons A and B in a randomly assigned order. Subjects then used tampons of their choosing for the third menstrual cycle of the study.
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tampon; menstruation; menstrual period

Summary:

      The vaginal microbiota is the community of bacteria in the vagina. The composition of the
      vaginal microbiota (which bacteria are present and how many of each are present) is known to
      affect vaginal health and contribute to the development of bacterial vaginosis (the largest
      cause of vaginal discharge and malodor, and the most common vaginal disorder). It is also
      known that the composition of the vaginal microbiota changes across a menstrual cycle with
      the largest changes happening during a woman's period. However, it is not know how tampon use
      affects vaginal microbiota composition. This study is being done to learn what effect tampon
      use has on vaginal microbiota composition during a woman's period and between periods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  regular menstrual cycles lasting 21-35 days

          -  menses lasting for at least 4 days

          -  current tampon user

          -  good self-reported general health

          -  good self-reported vaginal health

        Exclusion Criteria:

          -  currently pregnant

          -  planning to become pregnant in 4 months following enrollment

          -  difficulty using tampons

          -  current toxic shock syndrome

          -  history of toxic shock syndrome

          -  current sexually transmitted infection

          -  current urinary tract infection

          -  currently using antibiotics

          -  antibiotic use in 4 weeks prior to enrollment

          -  current antifungal use

          -  antifungal use in 4 weeks prior to enrollment

          -  autoimmune condition
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
Condition: Back Pain Without Radiation; Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Ketorolac; Ibuprofen; Diclofenac; Educational Intervention
Intervention description: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed; Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed; Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed; Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information
Intervention MeSH terms: Ibuprofen; Diclofenac; Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: ketorolac; diclofenac; ibuprofen; low back pain; back pain

Summary:

      Purpose: This is a randomized clinical trial comparing the effects of three different
      medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac

      Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or
      diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris
      Disability Questionnaire (RMQ)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women age 18-64.

          -  Present to ED primary for management of Low Back Pain (LBP)

          -  Functionally impairing back pain: A baseline score of greater than 5 on the
             Roland-Morris Disability Questionnaire

          -  Musculoskeletal etiology of low back.

          -  Non-radicular pain.

          -  Pain duration <2 weeks (336 hours).

          -  Non-traumatic LBP

          -  Participant is to be discharged home.

        Exclusion Criteria:

          -  Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.

          -  Not available for follow-up

          -  Pregnant

          -  Chronic pain syndrome

          -  Allergic to or intolerant of investigational medications

          -  Contra-indications to investigational medications
The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life
Condition: Dementia
MeSH terms: Dementia; Mixed Dementias
Intervention: Galantamine; Nimodipine; Placebo
Intervention description: Galantamine 8 mg/day for one month, followed by 4 weeks of galantamine 16 mg/day. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day.; Nimodipine 30 mg 3 times a day (tid).; Matching placebo three times a day (tid).
Intervention MeSH terms: Nimodipine; Galantamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Dementia; Mixed Dementia; Galantamine; Reminyl ER; Nimodipine

Summary:

      The purpose of this study is to evaluate the combination of galantamine with nimodipine in
      patients with mixed dementia on cognition and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients should fulfill DSM-IV criteria for dementia (APA, 1994)

          -  Patients should fulfill criteria for AD with cerebrovascular disease according to
             NINDS-AIREN criteria (Román et al., 1993)

          -  The severity of dementia should be mild to moderate, as defined by MMSE score between
             10 and 26 (inclusive)

          -  Patients (and their legally acceptable representatives) must have signed an informed
             consent document indicating that they understand the purpose of and procedures
             required for the study and are willing to participate in the study.

        Exclusion Criteria:

          -  History of neurodegenerative disorders such as Parkinson's disease, Pick's disease or
             Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease. Patients who have
             mild extrapyramidal signs, for which no treatment is required, are not excluded from
             the trial

          -  History of liver or renal insufficiency

          -  significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological,
             psychiatric, or metabolic disturbances in the past 6 months

          -  Patients who have previously received M1 agonists or cholinesterase inhibitors
             (tacrine, donepezil, metrifonate, rivastigmine) for treatment of Alzheimer's disease,
             no matter if approved or experimental can be included in this trial provided there was
             at least a washout period of 60 days prior to the screening assessments

          -  History of drug or alcohol abuse within the last year or prior prolonged history

          -  History of severe drug allergy or hypersensitivity

          -  including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or
             similar agents, or bromide

          -  Subjects who have previously been enrolled in other galantamine trials.
Cranial Blocks for Postoperative Anesthesia
Condition: Craniotomy Surgery
Intervention: Liposomal bupivacaine; Bupivacaine Injection; Saline
Intervention description: Used as cranial block for craniotomy surgery; Used as cranial block for craniotomy surgery; Used as cranial block for craniotomy surgery
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to one of three groups: saline, bupivacaine, liposomal bupivacaine
Masking: Double (Participant, Care Provider)
Masking description: On the morning of the procedure, participants will be assigned sequentially to the lowest unassigned randomization number. The surgeon performing the procedure and operating room staff will not be blinded to the intervention, since they will see whether the patient is receiving liposomal bupivacaine, bupivacaine or saline. However, all providers obtaining post-operative data from the patients will be blinded as to which treatment the patient received, in addition to the patient themselves.
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: craniotomy

Summary:

      This study compares the standard of care to the standard of care plus the administration of
      bupivacaine or liposomal bupivacaine in patients receiving craniotomies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years of age

          -  Need for elective supratentorial craniotomy

          -  Preoperative GCS > 13

        Exclusion Criteria:

          -  Preoperative GCS ≤ 13

          -  Child (<18 years of age)

          -  Inability to understand or use the visual analog scale (VAS)

          -  Proven or suspected allergy to local anesthetics

          -  Craniotomy incision extending beyond the field of the block

          -  Patients chronically (more than 2 wk) treated with narcotic medications

          -  Previous scalp incision

          -  Bilateral craniotomies

          -  Allergies to local anesthetics

          -  GCS verbal score < 4 after extubation

          -  Patients whose surgeries extend past 6 hours (will be placed on standard of care and
             removed from study)

          -  Patients currently on ergot-type oxytoxic drugs, MAOIs, or certain antidepressants

          -  Lactating Mothers
Bronchodilator Responsiveness in Obliterative Bronchiolitis
Condition: Obliterative Bronchiolitis
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
Intervention: albuterol plus tiotropium
Intervention description: Four separate doses of 100 μg of albuterol and 18 μg of tiotropium bromide. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber and tiotropium by a dry-powder device.
Intervention MeSH terms: Albuterol; Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Healthy volunteers: No
Keywords: Obliterative bronchiolitis; Bronchodilator responsiveness; Partial forced expiratory flow; Lung volumes

Summary:

      This study has been designed to provide a substantial evidence of acute bronchodilator
      responsiveness to two sequentially inhaled drugs, a beta2-agonist (i.e., albuterol) and an
      anticholinergic (i.e., tiotropium bromide), in a group of patients who developed obliterative
      bronchiolitis after hematopoietic stem cell transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obliterative bronchiolitis (OB) following allogeneic HSCT

          -  FEV1 to slow inspiratory vital capacity (VC) ratio (FEV1/VC)<5th percentile

          -  FEV1 <75% predicted or absolute FEV1 fall >10% of pre-HSCT value

          -  evidence of OB by computed tomography scanning

          -  negative microbiological yields in bronchoalveolar lavage fluid

          -  chronic graft-versus-host disease score >0

          -  negative history for bronchial asthma, chronic obstructive pulmonary disease or other
             significant respiratory disease.

        Exclusion Criteria:

          -  inability to perform lung function maneuvers

          -  pre-existent chronic lung disease other than OB
Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery
Condition: Spine Surgery
Intervention: sugammadex; Neostigmine
Intervention description: once at the end of the surgery; once at the end of the surgery
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will receive (per a randomization schedule) either sugammadex, or neostigmine/glycopyrrolate to reverse neuromuscular blockade at the end of the surgery. The reversal agent will be prepared in a blinded fashion.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The surgeon, anesthesiologist, operating room staff, patients, personnel in the postanesthesia care unit (PACU) as well as the investigators collecting the postoperative data will be blinded to the group allocation.
Enrollment: 40.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: spine surgery; neuromuscular blockade; sugammadex; elderly; reversal; neostigmine; recovery

Summary:

      Spine surgery is one of the most common operative procedures in the United States. It is
      performed in the prone position (a patient laying on belly). Muscle relaxants are given for
      neuromuscular blockade often referred as paralysis for surgical exposure which is maintained
      until the patient is returned to the supine position (a patient laying on back) at the end of
      surgery. At the end of the surgery the paralysis is reversed with a drug (neostigmine). A new
      drug (sugammadex) has the ability to rapidly reverse the paralysis but it is not well
      investigated in elderly. This study will investigate speed of recovery and complications of
      the two reversal drugs in elderly patients (age ≥ 65 years) undergoing posterior spine
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Posterior spinal surgery

          2. Age ≥ 65 years

          3. American Society of Anesthesiologists (ASA) grade I-III

        Exclusion Criteria:

          1. Inability to obtain written informed consent

          2. Allergy to rocuronium or anesthetic agents used in the protocol

          3. Known or suspected neuromuscular disorders

          4. Significant renal disease with a serum creatinine ≥ 2 mg/dl

          5. Significant liver disease

          6. A family history of malignant hyperthermia
Study Comparing the Efficacy of Two Ibuprofen Formulations
Condition: Pain
Intervention: placebo; ibuprofen Formulation 1; ibuprofen Formulation 2
Intervention description: 2 placebo gels capsules delivered as a single dose.; 2 marketed ibuprofen gels; 2 marketed ibuprofen gels
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 211.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dental pain analgesia

Summary:

      This is a study of healthy volunteers to compare how quickly different ibuprofen products
      relieve dental pain.
    

Eligibility criteria:

        Inclusion criteria :

          -  Outpatients with post-operative pain following surgical extraction of third molars,

          -  examined by the attending dentist or physician and medically cleared to participate in
             the study,

          -  in general good health and have no contraindications to the study or rescue
             medication.

        Exclusions criteria:

          -  any serious medical condition,

          -  acute localized dental infection at the time of surgery ,

          -  females who are pregnant, lactating, of child-bearing potential, or post-menopausal
             for less than 2 years and not using a medically approved method of contraception.
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Condition: Insomnia; Sleep Initiation and Maintenance Disorders; Alzheimer Disease
MeSH terms: Alzheimer Disease; Sleep Initiation and Maintenance Disorders
Intervention: modafinil
Intervention description: 100-400 mg daily for 4 weeks
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Mild Cognitive Impairment (MCI); Sleep; Fatigue; Memory

Summary:

      Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration
      for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work
      sleep disorder. Each of these problems is characterized by difficulty sleeping at night and
      excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this
      sleepiness. The idea behind this treatment is that sleepiness that leads to napping during
      the day prevents a patient from being tired or sleepy enough to get good sleep at night. This
      study is designed to determine if the medication can "reset" participants' sleep/wake rhythm
      to a more normal rhythm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment

          -  Subjective complaint of sleep disruption, unsatisfactory sleep, early morning
             awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made
             by either the potential participant or by the caregiver.

        Exclusion Criteria:

          -  Participation in any other clinical drug trial

          -  Liver failure

          -  Believed by the investigator to be unwilling or unable to follow the protocol

          -  Active liver or coronary disease
Subclinical Cardiovascular Disease in Psoriatic Disease
Condition: Cardiovascular Diseases; Myocardial Infarction; Atherosclerotic Cardiovascular Disease; Thrombotic Vascular Disease
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Vascular Diseases; Atherosclerosis; Infarction
Intervention: Aspirin and/or Atorvastatin
Intervention description: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.
Intervention MeSH terms: Aspirin; Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cardiovascular disease; CVD

Summary:

      This study will look at how chronic inflammation seen in psoriatic disease translates into
      the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk.
      The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic
      disease and measures of vascular function. 2) Evaluate the association between moderate to
      severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional
      medications used in cardiovascular disease (CVD) prevention such as aspirin and statins
      affect vascular function and thrombotic risk in those with moderate to severe psoriatic
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a history of moderate to severe psoriatic disease

          -  Group 2: Healthy subjects without known psoriatic disease or cardiovascular disease

        Exclusion Criteria:

          -  Unable to speak Spanish or English

          -  Active smoking (within the past year)

          -  Autoimmune, rheumatologic or inflammatory disease which are not psoriasis or psoriatic
             arthritis

          -  Known active cancer receiving treatment

          -  Pregnancy

          -  Anemia (hemoglobin < 9 mg/dl) or thrombocytopenia (Platelet count <75), or
             thrombocytosis (Platelet count >600)

          -  A history of severe bleeding or bleeding disorders

          -  Current medication use which interact with either aspirin or atorvastatin

          -  Chronic kidney disease (CrCl < 30ml/min)

          -  Congestive heart failure

          -  Currently taking aspirin or a statin.

          -  NSAID use within the past 48 hours
Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery
Condition: Foot and Ankle Procedures
Intervention: Dexamethasone; Saline
Intervention description: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc; 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Pain management; Postoperative opioid requirements; Perioperative outcomes; Dexamethasone; Anesthetic adjuvant; Analgesic adjuvant

Summary:

      The purpose of this research study to evaluate the effects of dexamethasone as an addition to
      peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on
      length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain
      scores, and patient satisfaction after foot and ankle procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  60 patients (30 per group) undergoing foot and ankle procedures

          -  Willingness and ability to sign an informed consent document

          -  No allergies to anesthetic or analgesic medications

          -  American Society of Anesthesiologists (ASA)physical status Class I - III

          -  Aged 18-90 years,either sex

        Exclusion Criteria:

          -  Refusal to participate in the study

          -  Age<18 or> 90 years -

          -  Contraindications to regional blockage including but not limited to:

          -  Patient refusal to regional blockade

          -  Infection at the site of needle insertion

          -  Systemic infection

          -  Bleeding diathesis or coagulopathy