bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Aripiprazole in the Treatment of CD in Adolescents
Condition: Conduct Disorder
MeSH terms: Conduct Disorder
Intervention: Aripiprazole
Intervention description: The initial dose depending on the weight of the patient will be as follows: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. Thereafter the dose was individualized based on response and tolerance. Maximum dose was 20 mg.
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open label trial
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Aripiprazole

Summary:

      The proposed study will be a 6-week open label study evaluating aripiprazole in the treatment
      of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct
      disorder. The initial dose depending on the weight of the patient will be as follows: < 25 kg
      = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003,
      Bristol-Myers Squibb). For the first two weeks of the study, the dose will be flexible based
      on response and tolerance and thereafter will remain fixed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct
             disorder.

        Exclusion Criteria:

          -  Clinically significant laboratory and/or ECG abnormalities

          -  Pre-existing health conditions that would compromise patient safety

          -  Mental retardation

          -  Previous use of aripiprazole

          -  Active psychosis
Prevention of Recurrence in Depression With Drugs and CT
Condition: Depression
MeSH terms: Recurrence; Depression; Depressive Disorder
Intervention: Cognitive Therapy; Medications
Intervention description: CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.; Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 452.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant
      medication (ADM) enhances treatment for depression. This study will also test whether the
      addition of CT to ADM will prevent recurrences of depression after therapy is over.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent or chronic major depressive disorder

        Exclusion Criteria:

          -  Current diagnosis of psychotic affective disorder

          -  History of nonaffective psychotic disorder

          -  Substance dependence last three months requiring detox

          -  Schizotypal, antisocial, or borderline personality disorder
Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy
Condition: Post-surgical Dental Pain
MeSH terms: Toothache
Intervention: Paracetamol 1000 mg; Paracetamol 650 mg; Placebo
Intervention description: Paracetamol 1000mg; Paracetamol 650 mg; Placebo
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: dental pain; paracetamol; Post-surgical dental pain

Summary:

      GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol
      1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic
      efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The
      duration of the entire study will be approximately 18 weeks. Each subject will have to come
      to the clinic for three visits (Screening, Treatment and Follow up visits).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18 to 45 years with moderate-to-severe dental pain as assessed by verbal
             rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a
             visual analogue (VAS) following the surgical removal of up to two mandibular third
             molars. If only one mandibular third molar is removed, it must be a full bony
             impaction. If two mandibular third molars are removed, both may be partial bony
             impactions OR there may be a combination of one full bony impaction with the second
             tooth being erupted, soft tissue impaction, or partial bony impaction. Ipsilateral
             maxillary third molars may be removed at the surgeon's discretion, regardless of
             impaction level.

        Exclusion Criteria:

          -  Pregnant and lactating females

          -  Allergy/intolerance to study materials or nitrous oxide or local anaesthetic used
             during surgery

          -  Current or recurrent liver, kidney or cardiac disease, stomach ulcers,
             gastrointestinal bleeding, gastroesophageal reflux disease, bronchospasm, rhinitis,
             urticaria or asthma
Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines
Condition: Glabellar Rhytides
Intervention: botulinum toxin Type A
Intervention description: 20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in
      Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated
      with facial laser resurfacing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  moderate or severe frown lines

          -  facial laser treatment between 4 to 8 weeks prior to Day 1

        Exclusion Criteria:

          -  previous use of botulinum toxin for any indication

          -  diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis

          -  microdermabrasion or superficial peels, permanent make-up to the brow and forehead
             area within the last 3 months

          -  facial cosmetic procedures within the last 6 Months

          -  treatment to forehead, brow, nose or midface areas with any filler within the last 12
             months

          -  use of a new topical skin care product within 1 month of the screening

          -  any prior forehead or periorbital surgery or brow lift

          -  deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin
             elasticity

          -  any facial skin infection or unhealed skin lesion

          -  pregnant or breast-feeding
Trospium Chloride XR in Obese Female Patients With Overactive Bladder
Condition: Obesity; Overactive Bladder; Incontinence
MeSH terms: Urinary Bladder, Overactive
Intervention: Trospium Chloride, Extended Release (XR); placebo
Intervention description: Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.; Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.
Intervention MeSH terms: Trospium chloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 127.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study evaluated the effectiveness of trospium chloride extended release (XR) in obese
      female patients with overactive bladder (OAB). Patients received either placebo and trospium
      chloride XR or placebo only. The study assessed the change from baseline in urinary
      frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The
      study was 14 weeks in duration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence

          -  Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine
             patches, etc., for 6 months prior to the screening visit).

          -  Obese

        Exclusion Criteria:

          -  Chronic kidney failure

          -  Abdominal bypass surgery for obesity

          -  Moderate or severe memory impairment

          -  Uncontrolled narrow angle glaucoma

          -  Uncontrolled systemic disease

          -  Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine),
             Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia
Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Intervention: nebivolol; Placebo
Intervention description: Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily
Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration; Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration
Intervention MeSH terms: Losartan; Lisinopril; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 491.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: nebivolol; Bystolic ™; lisinopril; losartan; Hypertension

Summary:

      This study will assess blood pressure reduction with nebivolol or placebo in patients taking
      lisinopril or losartan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ambulatory outpatients 18-85 years old at screening

          -  Have a history of hypertension

          -  Qualifying laboratory results

        Exclusion Criteria:

          -  Severe hypertension, including chronic kidney disease

          -  Documented congestive heart failure

          -  Have clinically significant respiratory, liver, or heart disease

          -  History of stroke, heart attack, or heart surgery in the last 6 months

          -  Have a history of hypersensitivity to nebivolol or other beta blockers.
The Effects of Pentoxifylline on PAI-1 in an Obese Population
Condition: Obesity
Intervention: Pentoxifylline; Placebo
Intervention description: 400mg PO TID x 8 weeks; PO TID x 8 weeks
Intervention MeSH terms: Pentoxifylline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Plasma PAI-1 level at 0, 4, 8 weeks; Plasma hsCRP level at 0, 4, 8 weeks; Plasma TNF-a level at 0, 4, 8 weeks

Summary:

      PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to
      play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with
      antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal
      models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human
      subjects.
    

Eligibility criteria:

        Inclusions: 1. A Body Mass Index of ≥ 30.0 2. Age 21 or older 3. Few or no medical problems
        4. PAI-1 level ≥ 10 ng/dl

        Exclusions: 1. Cigarette use 2. Present use of angiotensin converting enzyme (ACE)
        Inhibitors 3. Recent cerebral and/or retinal hemorrhage 4. Intolerance to pentoxifylline or
        methylxanthines such as caffeine, theophylline, and theobromine 5. Presently on warfarin
        therapy 6. Pregnancy or breast-feeding 7. Recent surgery 8. Recent diagnosis/treatment for
        peptic ulcer
Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Intervention: Tamsulosin; Solifenacin
Intervention description: Alpha blocker used to in the treatment of urinary difficulties related to enlarged prostate or symptomatic benign prostatic hypertrophy. All men will receive Tamsulosin (Flomax®) 0.4 mg, 1 tab, per morning with Solifenacin (Vesicare®).; Antispasmodic/anticholinergic used to treat overactive bladder. All men will receive Solifenacin (Vesicare®) 5 mg, 1 tab, per morning with Tamsulosin.
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      A single center, pilot trial using tamsulosin and solifenacin in 10 men with symptomatic
      lower urinary tract symptoms (LUTS). Subjects will be evaluated at baseline, 1, 2, and 3
      months for urinary NGF, urine creatinine, NGF/CR ratio and patient reported outcomes through
      questionnaires.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men > 45 years old with symptomatic LUTS (clinical benign prostatic hypertrophy/BPH)

          -  International Prostate Symptom Score (IPSS) > 8

          -  PSA < 10 ng/ml (negative biopsies within 6 months for any age-specific PSA elevation
             suspicious for prostate carcinoma)

          -  Post void residual urine < 150 mls

          -  Urinary Flow rate > 15 mL/sec

        Exclusion Criteria:

          -  Neurogenic bladder

          -  Urinary tract infection, Urinary stone(s), Urinary tract tumor

          -  Radiation therapy for urologic malignancy or prostate surgery; radiation to pelvic,
             colon, rectum, prostate, bladder, uterus or ovaries

          -  Alpha blocker therapy or anticholinergic therapy within 3 months of entry or 5 alpha
             reductase therapy within 18 months.

          -  History of cataracts with planned surgery
Parietex Progrip Study
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Intervention: Parietex Progrip; Low weight polypropylene mesh
Intervention description: Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.; Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 603.0
Sex: Male
Minimum age: 31 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Uncomplicated primary inguinal hernias

Summary:

      The objective of the study is to evaluate pain and disabling complications inducing social
      consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair
      with lightweight polypropylene mesh.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All male patients at participating centers with a primary, uncomplicated inguinal
             hernia.

          -  Collar of the defect ≤ 4 cm

          -  Signed informed consent

        Exclusion Criteria:

          -  30 years ≥ Age ≥ 75 years

          -  Emergency procedure

          -  Inclusion in other trials

          -  Bilateral inguinal hernia

          -  Recurrence
Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Generic alendronate
Intervention description: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.
Intervention MeSH terms: Alendronate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Osteoporosis; Bisphosphonates; Alendronate; Bone mineral density; Bone markers

Summary:

      Osteoporosis is a common disease defined as a decrease in bone mass and strength which
      increases risk of fragility fractures. This disorder may affecting health in many adults
      which causing disability, morbidity, and mortality. Current first-line medical therapy is
      bisphosphonates which alendronate is one of the most widely used. However, expenditure on
      medicines is one of the major problem of inadequate access to treatment.

      The investigators hypothesized that generic alendronate will have the same clinical efficacy
      as the brand formulation. Therefore, the result of this study is extremely crucial. If
      adequate efficacy of generic alendronate could be established and if it affords the same
      safety profile as those of brand alendronate, the use of generic alendronate could then be
      recommended.
    

Eligibility criteria:

        Inclusion Criteria: patients who are postmenopausal women or men who aged older than 50
        years and meet the indications for osteoporosis treatment according to the Thai
        Osteoporosis Foundation's 2010 treatment guidelines.

          -  History of spinal or hip fractures with low energy trauma.

          -  BMD by Dual energy X-ray absorptiometry (DXA) scan with T-score ≤ -2.5 at the femoral
             neck, total hip, or L1-L4 spine.

          -  BMD by DXA scan with T-score between -1 and -2.5 at the femoral neck, total hip, or
             L1-L4 spine and a 10-year hip fracture probability ≥ 3% or a 10-year major
             osteoporosis-related fracture probability ≥ 20% based on Fracture risk assessment tool
             (FRAX)

        Exclusion Criteria:

          -  Patients who have contraindications to use bisphosphonates e.g. gastroesophageal
             reflux disease or drug allergy to bisphosphonates

          -  Patients with an abnormality of serum calcium levels (more than 10.2 mg/dl or less
             than 8.7 mg/dl)

          -  Patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m2

          -  Patients with metabolic bone diseases such as Paget's disease, hyperparathyroidism,
             etc.

          -  Patients who were received anti-osteoporotic drugs during the past 1 year.

          -  Patients who currently taking steroids, hormone replacement therapy, or selective
             estrogen receptor modulators (SERMs) within 1 year.
Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: clobetasol propionate spray; clobetasol propionate ointment
Intervention description: Apply twice daily; Apply twice daily
Intervention MeSH terms: Clobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate
      Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in
      Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one
      of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate
      ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20%
             of the body surface area. For the purposes of study treatment, most areas will be
             treated with the exception of face, scalp, groin, axillae and other intertriginous
             areas

          -  Overall disease severity is at least 3 (moderate)

        Exclusion Criteria:

          -  Subjects who have surface area involvement too large that would require more than 50
             grams per week of clobetasol propionate spray or more than 50 grams per week of
             clobetasol propionate ointment

          -  Subjects whose psoriasis involves only the scalp, face or groin

          -  Subjects with non-plaque psoriasis or other related diseases not classified as plaque
             psoriasis