bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Nicotine Dependence and Acute Depression
Condition: Major Depressive Disorder; Nicotine Dependence
MeSH terms: Tobacco Use Disorder; Depressive Disorder; Depressive Disorder, Major
Intervention: bupropion and smoking cessation behavioral intervention
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and feasibility of concurrent treatment of
      nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV
      criteria for both nicotine dependence and acute major depression will be given
      pharmacological treatment for both disorders at the same time, along with a brief behavioral
      intervention for smoking cessation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at least 18 at the beginning of the study

          -  Smoking at least 10 cigarettes a day (1/2 pack)

          -  Meets DSM-IV criteria for major depressive episode

        Exclusion Criteria:

          -  Currently pregnant

          -  Currently breastfeeding

          -  Currently diagnosed with a seizure disorder, liver disease, kidney disease, congestive
             heart failure or diabetes mellitis

          -  History of a seizure, seizure disorder, significant head trauma or central nervous
             system tumor

          -  Family history of seizures

          -  Currently using intravenous drugs

          -  Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on
             a daily basis

          -  Currently using any over-the-counter stimulants and anorectics (diet pills)

          -  Currently on fluoxetine (Prozac), bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL)
             or any other antidepressants, monoamine oxidase inhibitors, antipsychotics,
             benzodiazepines, theophylline, systemic steroids or levodopa

          -  Currently on NRT or bupropion (Zyban)

          -  Current or past diagnosis of anorexia nervosa

          -  Previous allergic response to fluoxetine, bupropion, or NRT

          -  Previous failed quit attempt using NRT and bupropion in combination

          -  Current suicidal ideation

          -  Current or past psychosis, mania/hypomania, or any other Axis I or Axis II psychiatric
             diagnosis other than major depression and nicotine dependence
An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache
Condition: Pain
MeSH terms: Headache
Intervention: aspirin and ketamine; Nurtec (Rimegepant)
Intervention description: Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin; Drug: 75 mg of ODT
Intervention MeSH terms: Aspirin; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Emergency Medicine; Pain; Pain Management; Acute Headache

Summary:

      Headaches affect over 50% of patients annually, with close to 4% of ED visits for headache.
      Most headaches managed in the ED are benign, with 90% of these headaches classified as
      tension, migraine, or cluster. At present, the satisfaction with ED treatment of headache is
      low, and despite the multitude of available medications, the evidence- based treatment
      options are often quite limited. There are over twenty different types of medications
      available to the ED clinicians for managing headache, many with different routes of
      administration (parenteral, intranasal, subcutaneous, and oral). Many of these medications
      are provided in so-called "headache cocktail", which varies based on the physician,
      institution, and patient preferences.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 and older

          -  Acute Headache

          -  Initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating
             scale.

          -  Awake, alert, and oriented to person, place, and time

        Exclusion Criteria:

          -  altered mental status,

          -  allergy to aspirin, ketamine and rimegepant,

          -  pregnancy and breastfeeding

          -  unstable vital signs (systolic blood pressure <90 or>180 mm Hg, pulse rate <50 or >150
             beats/ min, and respiration rate <10 or >30 breaths/min)

          -  inability to provide consent

          -  consumption of Aspirin or NSAID's within 6 hours of arrival to the ED or acetaminophen
             within 4 hours of arrival

          -  active PUD

          -  history of GI Hemorrhage

          -  history of renal and hepatic insufficiency

          -  past medical history of alcohol or drug abuse

          -  schizophrenia

          -  clinical findings concerning for acute intracranial process, acute infections process
A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients
Condition: Antiplatelet Aggregation
Intervention: Blood Collection
Intervention description: 4 weeks
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to look at the biomarkers of inflammation and platelet activation
      in patients with drug eluting stents implanted approximately 12 months ago on aspirin and
      statin, for a 4-week period after the routine discontinuation of clopidogrel
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with one or more drug-eluting stents of any type who are coming to the end of
             their 12 months of clopidogrel (75 mg daily) treatment

          -  Subjects receiving low dose ASA

          -  Subjects receiving a statin

          -  Current medication regimen (including ASA and statins) must have been stable for three
             (3) months. i.e. no initiation of new prescription medication or change in dosage of
             any previously initiated medication within three (3) months of entering this study

          -  Subjects with no clinical history of diabetes mellitis

          -  Men and women, ages 18 years or older
Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30; biphasic human insulin 30; metformin
Intervention description: The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner; The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 IU/kg body weight and to be divided in the ratio of 2/3:1/3 between pre-breakfast and pre-dinner; Metformin dose must remain the same as that used prior to the trial.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood
      sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to
      biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive
      subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes diagnosed for at least 6 months

          -  Insulin-naive (less than or equal to 1 week of daily use of insulin therapy)

          -  Treatment with metformin as monotherapy or in combination therapy with other OAD(s)
             for at least 3 months prior to this trial

          -  Currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks

          -  Currently at least one of other OAD(s) reaching at least one-half of the recommended
             maximum dose for at least 2 weeks

          -  Glycosylated haemoglobin (HbA1c) between 7.5-11.0%

          -  Body Mass Index (BMI) between 18.5 - 35.0 kg/m^2

          -  Be able and willing to perform continuous glucose monitoring system (CGMS ) and
             self-monitored blood glucose (SMBG)

        Exclusion Criteria:

          -  Known or suspected allergy to trial product(s) or related products

          -  Any contraindication of metformin

          -  Receipt of investigational drug within the last 3 months prior to this trial

          -  Any history of chronic insulin therapy (more than 1 week of daily use)

          -  Systemically treated with thiazolidinediones (TZDs) for more than one month within 6
             months prior to this trial

          -  Pregnancy, nursing mother, or unwillingness to use adequate contraception
Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Intervention: 4% lidocaine topical anesthetic cream; Placebo cream
Intervention description: A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture; A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture
Intervention MeSH terms: Lidocaine; Anesthetics, Local; Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 114.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pediatric patients; pain; anxiety; topical anesthetic; randomized control trial

Summary:

      The purpose of this study is to evaluate the amount of anxiety and pain felt by children
      during procedures that require a needle stick after using a topical anesthetic or placebo
      cream.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children ages 5-18 years of age

          -  treated as an inpatient or outpatient at Lehigh Valley Hospital within the past 24
             hours

          -  venipuncture order, and that order is their initial venipuncture order (required
             within 30 mins)

        Exclusion Criteria:

          -  known allergy to EMLA, LMX4 or any of their ingredients

          -  known sensitivities to local anesthetics of the amide type, lidocaine or prilocaine

          -  G6PD deficiency

          -  methemoglobinemia or concomitant administration of methemoglobin-inducing agent

          -  brain injured or disoriented (Glasgow Coma Scale <15)

          -  cognitively impaired (Mini Mental Status Exam <28)

          -  active skin conditions at venipuncture site including frequent rashes, eczema or
             unexplained bruising
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
Condition: Urinary Incontinence; Urgency Urinary
MeSH terms: Urinary Incontinence; Enuresis; Inflammation
Intervention: Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine
Intervention description: Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.
Intervention MeSH terms: Solifenacin Succinate; Tolterodine Tartrate; Fesoterodine; Oxybutynin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Urinary Incontinence; Urgency Urinary; Anticholinergic Treatment; Urinary Microbiome

Summary:

      Urinary incontinence (UI) is a very common condition affecting women of all ages. The
      objective of this pilot study is to better understand the urinary microbiome and associated
      inflammatory markers in blood and urine in women with urgency UI. The study will assess how
      inflammation may affect response to standard of care anticholinergic medication treatment for
      urgency urinary incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal (Age ≥ 50) women with Urgency Urinary Incontinence (UUI)

          -  English speaking

          -  Willing to take anticholinergics for at least 6 weeks

          -  Willing to complete UDI-6 and voiding diary at baseline and 6 weeks

          -  Willing to give urine and blood for study at baseline and 6 weeks

        Exclusion Criteria:

          -  Have taken anticholinergic medication within the last month

          -  Have taken antibiotics within the last month

          -  Urinary Tract Infection (UTI) in the last three months

          -  Neurological disease (eg. Parkinson's disease, Multiple Sclerosis, etc.)

          -  Immunological deficiencies

          -  History of sexually transmitted disease (STD)

          -  Lack of consent

          -  Not ambulatory (e.g. uses a wheelchair)
A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: bendamustine; chlorambucil; rituximab [MabThera/Rituxan]
Intervention description: 90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6; 10mg/m2 po days 1-7 every 4 weeks, for up to 12 cycles; 375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride; Chlorambucil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label, parallel group study will assess the effect on response rate and
      the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic
      lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A)
      MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as
      first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera
      plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive
      up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is
      6-12 months, and target sample size is 600-700 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >/=18 years of age

          -  chronic lymphocytic leukemia

          -  active CLL with progressive Binet stage B or C

          -  ineligible for treatment with fludarabine

          -  for second line patients, only pretreatment with rituximab and/or chlorambucil is
             allowed

          -  EOCG performance status >/=2

        Exclusion Criteria:

          -  patients who have relapsed within <12 months of first dose of prior rituximab or
             chlorambucil first-line therapy

          -  previous or planned stem cell transplantation

          -  radioimmunotherapy within 6 months prior to starting study treatment

          -  transformation to aggressive B-cell malignancy

          -  any other concurrent anti-cancer therapy, or glucocorticoid >/=20mg daily prednisolone
             or equivalent