bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Safety of Minocycline in Patients With Gum Disease
Condition: Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Intervention: Minocycline HCl microspheres
Intervention description: At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm.
Intervention MeSH terms: Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: chronic periodontitis, antibiotic resistance

Summary:

      This study will look at the safety of using the study medicine for a long time. It will see
      if the germs get used to the medicine, making it not work as well, if it's used by people
      with gum disease for a long time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  generally healthy

          -  over 25 years of age

          -  moderate-to-severe chronic periodontitis

          -  documented informed consent

          -  willing to comply with contraceptive requirements

          -  free from any significant oral soft tissue pathology

        Exclusion Criteria:

          -  willing to adhere to prohibitions and restrictions of the study

          -  oral health inappropriate for study inclusion

          -  females self-reporting pregnancy or lactation, or having a positive urine pregnancy
             result

          -  reporting any of the following conditions:

               -  allergy to a tetracycline-class drug

               -  systemic medical conditions requiring antibiotic prophylaxis prior to invasive
                  dental procedures

               -  active systemic infectious disease such as hepatitis, human immunodeficiency
                  virus (HIV) or tuberculosis

               -  diagnosed with clinically significant or unstable organic disease, or compromised
                  healing potential, heart murmurs, histories of rheumatic fever, valvular disease
                  or prosthetic joint replacement

          -  participation in a dental clinical trial or use of an investigational drug within 30
             days of enrollment

          -  employees of the Investigator or study center, with direct involvement in the proposed
             study or other studies, as well as family members of the employees or the Investigator

          -  anyone who the investigator determines should not be included in the study for any
             reason that could compromise safety or the analysis of study results
Melatonin in Smoke-induced Vascular Injury
Condition: Smoking; Vascular System Injuries
MeSH terms: Vascular System Injuries; Wounds and Injuries
Intervention: non-smoker oral placebo; non-smoker oral melatonin; smoker oral placebo; smoker oral melatonin
Intervention description: Participants oral placebo last 2 weeks.; Participants oral melatonin 3 mg/day last 2 weeks.; Participants oral placebo last 2 weeks.; Participants oral melatonin 3 mg/day last 2 weeks.
Intervention MeSH terms: Melatonin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 25 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking; melatonin; vascular injury

Summary:

      The main purpose of this study was to evaluate the effects of melatonin in the regulation of
      the vascular injury in smokers through population-based, randomized, double-blind,
      placebo-controlled trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy smokers：must above 10 cigarettes per day, at least 1 year

          -  Healthy non-smokers

        Exclusion Criteria:

          -  Cardiovascular disease

          -  Systolic blood pressure above 140 mm Hg

          -  Diastolic blood pressure above 90 mmHg

          -  Psychiatric disorders

          -  Cancer

          -  Pregnant

          -  Lactating

          -  Taking antipsychotic drugs orally during the 2 weeks of the trial
Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins
Condition: Candidemia
MeSH terms: Candidemia
Intervention: micafungin; Micafungin; Caspofungin
Intervention description: 100 mg qd by slow IV infusion for 24 h; 200 mg qd by slow IV infusion for 24 h; 70 mg LD followed by 50 mg qd by slow IV infusion for 24 h
Intervention MeSH terms: Caspofungin; Micafungin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: candidemia; echinocandin; micafungin; caspofungin

Summary:

      The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is:

      To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin
      (MFG) against Candida isolates from the subject and against Candida glabrata with varying
      degrees of caspofungin susceptibilities.

      This investigation will provide clinicians information supporting the use of caspofungin and
      micafungin in situations where Candida strains may be a cause of infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with presumptive candidemia

        Exclusion Criteria:

          -  Patients with severe neutropenia (<500)

          -  Patients with APACHE II scores > 20

          -  Patients with severe liver disease
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Triferic AVNU
Intervention description: Ferric Pyrophosphate Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the delivery of Triferic AVNU intravenously
      using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood
      lines.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant must be 18 years of age inclusive, at the time of signing the informed
             consent.

          2. Receiving chronic hemodialysis for 3-4 hours each session 3x/week.

          3. Medically stable according to the investigator opinion

          4. Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the informed consent form (ICF) and in this
             protocol.

        Exclusion Criteria:

          1. Hemodynamically unstable during hemodialysis

          2. Evidence of active bleeding from the GI tract.
Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease
Condition: Major Depressive Disorder; Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease; Depressive Disorder; Depressive Disorder, Major
Intervention: Duloxetine hydrochloride
Intervention description: Duloxetine 30 milligram (mg) once daily (QD) orally (PO) for 1 week, then duloxetine 60 mg QD PO for 11 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label
      fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are outpatients, male or female, 30 through 75 years of age

          -  Meet diagnostic criteria for major depression episode and a clinical diagnosis of
             idiopathic Parkinson's disease

          -  Have a clinician-rated 17-item Hamilton Depression Rating Scale (HAMD17) total score
             greater than or equal to 15, a Beck Depression Inventory (BDI) total score greater
             than or equal to 13 and a Clinical Global Impression of Severity (CGI-S) score greater
             than or equal to 3 at both Visit 1 and Visit 2

          -  Have satisfactory cognitive function

          -  Have been held on stable dosage of antiparkinsonian medications for at least 4 weeks
             immediately prior to Visit 1

        Exclusion Criteria:

          -  Any current primary psychiatric diagnosis other than Major depressive episode, and any
             personality disorder that could interfere with the compliance with the study protocol

          -  Atypical or secondary parkinsonism due to drugs or diseases with features of
             Parkinson's disease

          -  Motor conditions for which it is to be expected to change the antiparkinsonian
             treatment during the course of the study

          -  Clinically significant laboratory abnormalities or serious, unstable medical illness

          -  Lack of response of current episode to two or more adequate courses of antidepressant
             therapy
The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft; Platelet Rich Plasma
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PRP; BPTB; VAS; Anterior Knee Pain

Summary:

      The purpose of this research study is to investigate whether or not platelet rich plasma
      (PRP) may help to improve tendon healing and decrease post operative pain in patients
      undergoing anterior cruciate ligament (ACL) reconstructive surgery using their own patellar
      tendons as autografts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary ACL Reconstruction

          -  Outerbridge </= 2

          -  Minimum follow up of two years

          -  No ligamentous secondary injury

          -  Willingness to participate in study

        Exclusion Criteria:

          -  Any previous knee injury

          -  prior history of anterior knee pain

          -  Outerbridge classification 3 or greater

          -  Revision ACL

          -  Diabetic or smoker

          -  Workers compensation patient

          -  pregnant or nursing women

          -  Any patient with limited English Proficiency
The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin; Solifenacin plus Tamsulosin
Intervention description: Solifenacin (5mg, qd, oral); Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Overactive bladder; Solifenacin succinate; Tamsulosin

Summary:

      The aim of the study is to investigate if the combination therapy consisting of
      anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive
      Bladder (OAB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female aged 20 ≤ and < 70 years

          -  History of OAB symptoms for ≥ 3 months

          -  International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in
             total score and 2 in Q 3 index from OABSS questionnaire

          -  An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3
             to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per
             24 hours as documented in a 3-day micturition diary

        Exclusion Criteria:

          -  Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine

          -  Any condition that would contraindicate their usage of anticholinergics or alpha
             blockers

          -  History of lower urinary tract surgery (e.g. incontinence surgery or
             electrostimulation)

          -  History of stress urinary incontinence or urinary retention

          -  History of interstitial cystitis, bladder outlet obstruction or other significant
             genitourinary disorder

          -  Pregnant or nursing women

          -  Current urinary tract infection

          -  Neurological bladder dysfunction

          -  Treatment with drugs that may interfere with CYP3A4 metabolic function

          -  Significant hepatic or renal disease

          -  Any other condition which, in the opinion of the investigator, makes the patient
             unsuitable for inclusion
Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine; Fesoterodine
Intervention description: Fesoterodine fumarate, sustained release (SR) tablet, 4 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier); Fesoterodine fumarate, sustained release (SR) tablet, 8 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier)
Intervention MeSH terms: Fesoterodine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: overactive bladder idiopathic; elderly fesoterodine SOFIA Portugal extension study

Summary:

      This is an open-label extension study intended for subjects who have previously completed
      study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the
      investigator as being suitable for the extended use of Fesoterodine. Data from this study
      will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older
      subjects from Portugal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have previously completed fesoterodine study A0221045 [in Portugal]

          -  Subjects must be recommended for inclusion by the investigator

        Exclusion Criteria:

          -  Conditions or states excluding use of fesoterodine e.g. contraindication to
             fesoterodine

          -  Predominant stress incontinence as determined by the investigator
Renal and Hormonal Effects of Pioglitazone
Condition: Diabetes; Hypertension
MeSH terms: Hypertension
Intervention: Pioglitazone; Metformin
Intervention description: placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance; placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance
Intervention MeSH terms: Metformin; Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: diabetes; blood pressure; pioglitazone; sodium; insulin resistance, renal function, sodium, pioglitazone

Summary:

      This study examines the effects of pioglitazone on renal sodium handling in subjects prone to
      insulin resistance, i.e. diabetic and/or hypertensive subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type II Diabetes

          -  Hypertension

        Exclusion Criteria:

          -  Cardiac or renal diseases

          -  Anaemia

          -  Drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement
             therapy.
Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism
Condition: Subclinical Hypothyroidism
MeSH terms: Hypothyroidism
Intervention: Levothyroxine; Placebo
Intervention description: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.; Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators propose the following hypothesis: discontinuation of levothyroxine (LT4)
      for veterans with subclinical hypothyroidism (SCH) will be feasible, acceptable, and safe and
      will not negatively affect their Quality of Life (QoL). The investigators aim to evaluate the
      feasibility of LT4 discontinuation among veterans with SCH and determine the changes in QoL
      measures, lipids, and adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veterans

          -  diagnosis of SCH

        Exclusion Criteria:

          -  thyroid-stimulating hormone (TSH) > 10 milli-international units per liter (mlU/L) (at
             any point)

          -  Levothyroxine (LT4) dose more than 75 mcg daily

          -  use of antithyroid medications, amiodarone, tyrosine kinase inhibitors or lithium

          -  history of thyroidectomy or radioactive iodine therapy

          -  LT4 suppressive therapy for thyroid cancer, goiter, or inflammation

          -  pregnancy or plans for pregnancy in the next 6 months

          -  an unstable medical condition that would jeopardize safety or interfere with study
             participation

          -  severe hypothyroidism-related symptoms

          -  strong family history of hypothyroidism

          -  severe dyslipidemia

          -  hospitalization for major illness within the previous 4 weeks

          -  acute coronary artery syndrome, acute myocarditis, or pancarditis with the previous 12
             months

          -  grade IV New York Heart Association heart failure

          -  receiving services from hospice

          -  lack of decision-making capacity

          -  terminal medical condition for which life expectancy would be less than 6 months

          -  not willing to stop LT4

          -  self-reported non-adherence to LT4 therapy

          -  abnormal TSH at time of screening for participation (assessed during Baseline Visit)
Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Escitalopram
Intervention description: Patients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: depression; major depressive disorder; escitalopram; Lexapro; pediatric

Summary:

      This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in
      children 7 to 11 years of age with major depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients 7 to 11 years of age, inclusive

          -  Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of
             Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL
             (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with
             a minimum duration of 6 weeks

          -  Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about
             his or her condition, provides informed consent, and agrees to accompany the patient
             to all study visits. (Preferably the same parent, guardian, or LAR will accompany the
             patient to all study visits)

          -  Patient's family is sufficiently organized and stable to guarantee adequate safety
             monitoring

        Exclusion Criteria:

          -  Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that
             was the primary focus of treatment

          -  Patients with a diagnosis of conduct disorder will not be allowed to participate in
             this study

          -  Current diagnosis of mental retardation, dementia, or amnestic or other cognitive
             disorders based on DSM-IV-TR criteria

          -  History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or
             other drugs of the same class

          -  Imminent risk of injuring self or others or causing significant damage to property, as
             judged by the PI

          -  Suicide risk as determined by meeting any of the following criteria:

               -  Any suicide attempt

               -  Significant risk, as judged by the PI, based on the psychiatric interview or
                  information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS)