bioihbjkbjnl/mcl2 huggingface dataset:
Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
Condition: Headache; Pregnancy Related; Occipital Nerve Block
MeSH terms: Headache
Intervention: Occipital Nerve Block
Intervention description: This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.
Intervention MeSH terms: Acetaminophen; Caffeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled Trail
Masking: None (Open Label)
Enrollment: 62.0
Sex: Female
Minimum age: 16 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: headache; Pregnancy; Acute treatment; Emergency department; Occipital nerve block

Summary:

      This is an open label randomized controlled trial evaluating response to bupivacaine
      occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients
      seeking care of headache.
    

Eligibility criteria:

        Inclusion criteria:

          1. Women presenting to Maternal Evaluation Unit at UAB hospital

          2. Confirmed live intrauterine pregnancy (previous ultrasound, bedside ultrasound, fetal
             monitoring)

          3. Complaint of headache

          4. Minimal pain level of 4 on VRS

        Exclusion criteria:

          1. Systolic BP >= 140 or diastolic BP>=90 with 1+ protein on urine dip

          2. Systolic BP >=160 or diastolic BP>=105

          3. Focal neurological symptoms

          4. Altered level of consciousness defined as not being oriented to person, place,
             situation, and/or year

          5. Complaint of seizure

          6. Known under lying brain abnormality

          7. Fever

          8. Use of >3 grams of acetaminophen in past 24hrs

          9. ONB in the past 3 months

         10. Reported allergy to study medications (Bupivacaine, acetaminophen, or caffeine)
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Scopolamine and naltrexone; placebo arm
Intervention description: participants will receive scopolamine and naltrexone in buccal drops; participants will receive placebo medications
Intervention MeSH terms: Scopolamine; Naltrexone; Butylscopolammonium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, randomized, controlled parallel design
Masking: Double (Participant, Care Provider)
Masking description: The participants and physician are both blinded to medication vs. control medication
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this clinical trial is to determine the safety and efficacy of scopolamine
      utilized in conjunction with naltrexone for the treatment of major depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female, aged 18-65

          -  in good health other than major depression for 8 weeks or more

          -  negative pregnancy test

          -  able to comply with instructions

          -  able to provide informed consent

        Exclusion Criteria:

          -  pregnant or lactating

          -  danger to self or others

          -  severe kidney or liver disease

          -  schizophrenia

          -  allergy to scopolamine or naltrexone

          -  glaucoma

          -  Monoamine oxidase (MAO) inhibitor use
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
Condition: HIV/AIDS; Substance Use Disorders; Adherence, Medication
MeSH terms: Substance-Related Disorders
Intervention: Digital pill; Truvada
Intervention description: Digital pills over encapsulating Truvada; Truvada prescribed with digital pills for PrEP
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Single group pilot demonstration project
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PrEP; Substance Use Disorder; Digital Pills; Medication Adherence

Summary:

      This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with
      substance use to monitor PrEP adherence. The investigators will enroll N=15 HIV uninfected
      MSM with self reported substance use who are on PrEP or initiating PrEP to use digital pills
      over encapsulating TDF/FTC for 3 months. The investigators will assess the feasibility of
      using digital pills in this study population as well as understand the acceptability of
      digital pills for adherence measurement using semi-structured individual interviews.
      Additionally, the investigators will measure adherence over time, as well as episodes of
      suboptimal PrEP adherence.
    

Eligibility criteria:

        Inclusion Criteria:

          1. MSM (cisgender male)

          2. Self-reported use of non-alcohol substances of abuse in past 6 months

          3. Currently taking PrEP

          4. Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and
             syphilis)

          5. Age 18 or older

        Exclusion Criteria:

          1. Does not speak English

          2. HIV positive

          3. Identifies as transgender

          4. Estimated creatinine clearance <60ml/min

          5. Active hepatitis B treatment

          6. Does not own a smartphone

          7. Taking proton pump inhibitors

          8. History of Crohn's disease or ulcerative colitis

          9. History of bowel surgery, gastric bypass, bowel stricture

         10. History of GI malignancy or radiation to abdomen

         11. Unable/unwilling to ingest digital pill
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Condition: Hyperlipidemia; Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Niacin; Colestipol; Ezetimibe
Intervention MeSH terms: Niacin; Ezetimibe; Colestipol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: ezetimibe; niacin; colestipol; hyperlipidemia; adjunct therapy; zetia

Summary:

      To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA
      Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or
      niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol
      Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density
      lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures
      examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis.
      High-density lipoproteins (HDL) elevations are monitored between the three groups to
      determine efficacy as a secondary outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veterans eligible for treatment at the Tuscaloosa VA Medical Center

          -  50 years of age

          -  Male or female

          -  Any race or ethnic group

          -  Signed informed consent

          -  Hyperlipidemia despite current maximum tolerated dose of an HMG CoA Reductase
             inhibitor (statin) for > 6 weeks

          -  Currently not meeting NCEP ATPIII treatment goals for LDL cholesterol

        Exclusion Criteria:

          -  Known hypersensitivity or intolerance to ezetimibe, niacin, or colestipol

          -  Previous failed adequate trial of adjunctive ezetimibe, niacin, or colestipol

          -  Consumes more than 8oz. grapefruit juice daily

          -  Significant medical condition that would impact safety evaluations (i.e. significantly
             elevated LFT, hepatitis, severe dermatitis, uncontrolled diabetes, severe GI disease,
             fibromyalgia, renal failure, recent CVA or MI, pancreatitis, etc.)

          -  Receiving medications that would be contraindicated to use in combination with
             ezetimibe, niacin, or colestipol
Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin detemir; insulin aspart; insulin detemir; insulin aspart
Intervention description: Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart; Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir; Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin aspart; Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin detemir
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe. The aim of the trial is to compare two methods of
      injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin
      detemir associated with insulin aspart given twice daily in either separate or mixed
      injections and to investigate if there is any clinical impact in choosing one regimen over
      another.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parents' Informed Consent (IC) obtained before any trial-related activities

          -  Obtained child's assent (when possible)

          -  Type 1 diabetes

          -  Treatment with insulin detemir and insulin aspart either in extemporaneous mixed or
             separate injections

          -  HbA1c (glycosylated haemoglobin A1c) lesser than or equal to 8.6%

        Exclusion Criteria:

          -  History of alcoholism, drug abuse, or psychiatric disease or personality disorders
             likely to invalidate voluntary consent or to prevent good compliance with the trial
             protocol

          -  Mental incapacity, unwillingness or language barrier precluding adequate understanding
             or co-operation

          -  Anticipated change or new use in concomitant medication known to interfere with
             glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)

          -  Any other condition that the Investigator (trial physician) feels would interfere with
             trial participation or evaluation of results
Examining Tolerance to CNS Stimulants in ADHD
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate
Intervention description: Children will receive a double-blind assessment to determine their optimal starting dose of Concerta. Doses will be adjusted over the course of the school year and inceased if tolerance to the medication is detected.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 267.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Tolerance to stimulant medication

Summary:

      Although stimulant medication is a well-established treatment for ADHD, it is often necessary
      for doctors to increase the dose over time to maintain the benefits of the medication. While
      medication can be very effective for improving symptoms of ADHD during the first year of use,
      it has not been found to significantly improve the long term course of children with ADHD.
      For example, in large research studies, groups of children who take medication for ten years
      do not have consistently better academic grades than groups of children who never used
      medication (individual results will vary from child to child).

      In order to help children with ADHD achieve the best possible outcomes, it is important for
      doctors to study why this happens. One possible reason is development of tolerance to the
      medication. Tolerance means that a drug's effects decrease when it is taken consistently over
      time, so that an increased dose is needed to continue showing effects. Some doctors believe
      that children who take stimulant medication for ADHD develop tolerance to it which would
      explain why benefits may not persist over time, but no research studies have been done to
      measure whether this occurs. This study aims to see if children show a tolerance effect to
      stimulant medication and whether that tolerance can be prevented by taking short breaks from
      the medication called medication holidays.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of attention-deficit/hyperactivity disorder

          -  Full Scale IQ above 80

        Exclusion Criteria:

          -  Psychotropic medications for conditions other than ADHD

          -  Active medical or psychiatric conditions that could be worsened by stimulants

          -  Diagnosis of Autism or Asperger's Disorder

          -  Documented intolerance fo methylphenidate or failed trial of OROS MPH
Patient Education in Adherence on Acne (PEAce)
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Standard of care + supplementary education; Standard of care + additional visits; Standard of care
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The
      main objective of this study is to evaluate the effect of a supplementary patient education
      intervention (in addition to the standard-of-care patient education) on treatment adherence
      and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary
      care clinics.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects age of 12 years or older,

          2. With facial acne vulgaris that can be managed in primary care

        Exclusion Criteria:

          1. Female subjects who are pregnant, nursing or planning a pregnancy during the study,

          2. Subjects have a very severe variant of acne such as fulminating acne with systemic
             symptoms (acne fulminans)
Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
Condition: Deep Partial Thickness Burn; Full Thickness Burns
MeSH terms: Burns
Intervention: Mepitel One
Intervention description: Dressing
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Split thickness skin grafts; Mepitel One; Bridal Veil and staples; Pain

Summary:

      This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5
      centres in the US with deep-partial of full thickness burns in need of skin grafts will be
      enrolled.The subjects will be equally randomised to either treatment with Mepitel One or
      bridal veil together with staples.

      The primary objective is to compare pain at the time of dressing change for the use of
      Mepitel One versus bridal veil together with staples on deep partial or full thickness burns
      requiring skin grafts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion Criteria

               1. Subjects presenting with 1% - 25% Total Body Surface Area (TBSA) deep partial or
                  full-thickness burns requiring skin graft

               2. At least 1%-10% TBSA is available for grafting that can be considered for study
                  site selection (must have intact, healthy peri-wound area around entire portion
                  of this burned site)

               3. Both genders with age ≥18 years but < 70 years

               4. Signed informed consent

        Exclusion Criteria:

          1. Subjects with chronic wounds

          2. Subjects who are on mechanical ventilation

          3. Subjects with dermatologic skin conditions or necrotizing disorders

          4. Diagnosed underlying disease(s) (HIV/AIDS, cancer and severe anaemia)judged by the
             investigator to be a potential interference in the treatment

          5. Subjects treated with systemic glucocorticosteroids, except subjects taking occasional
             doses or doses less than 10 mg prednisolon/day or equivalent

          6. Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days

          7. Known allergy/hypersensitivity to any of the components of the investigational
             products

          8. Subjects with physical and/or mental conditions that are not expected to comply with
             the investigation

          9. Participation in other clinical investigation(s) within 1 month prior to start of the
             investigation

         10. Previously randomised to this investigation

         11. Pregnancy
Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
Condition: Nocturnal Vasomotor Symptoms
Intervention: SCE-B; Placebo
Intervention description: 0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo; Matching placebo for 0.3 mg and 0.625 mg tablets
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP); Estrogens, conjugated synthetic A; Estrogens, conjugated synthetic B
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 157.0
Sex: Female
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nocturnal vasomotor symptoms in postmenopausal women

Summary:

      This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor
      symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening
      period and approximately 5 scheduled clinic visits. Participants will receive one of two
      strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical
      and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a
      pap smear. Participants will be asked to wear a monitoring device for a portion of the study
      and be asked to complete a daily dairy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Naturally or surgically menopausal

          -  Minimum 7 daily or 50 weekly moderate-to-severe hot flashes

        Exclusion Criteria:

          -  Any contraindication to hormone therapy
Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: tiotropium; Placebo
Intervention description: Oral inhalation once daily of 18mcg tiotropium via handihaler; Oral inhalation once daily of placebo matching tiotropium via handihaler
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 457.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the
      efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler
      once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol
      (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.
    

Eligibility criteria:

        Inclusion criteria:

        All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
        according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline
        criteria:

        post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC)
        ratio < 70% (visit 1).

        Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of
        predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history
        of >=10 pack years.

        Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.

        Exclusion criteria:

        Subjects who have been treated with maintenance medications for chronic respiratory disease
        within six months prior to screening.

        Subjects with significant diseases other than COPD. Subjects on chronic systemic
        corticosteroids.

        Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in
        the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3
        Subjects with a recent (past 6 months) myocardial infarction, any unstable or life
        threatening cardiac arrhythmia requiring intervention or change in drug therapy during the
        last year; or who have been hospitalized for cardiac failure during the past year.