bioihbjkbjnl/mcl2 huggingface dataset:
Targeting Cognition in Bipolar Disorder With Pramipexole
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Converging evidence suggests that patients with bipolar disorder suffer from deficits in
      neurocognitive functioning that persist, despite remission of acute affective symptoms. These
      impairments contribute directly to functional disability, highlighting the need for
      interventions above and beyond standard treatments in order to achieve a full inter-episode
      recovery. The current study aims to investigate the safety and efficacy of a dopamine agonist
      (pramipexole), on these persistent cognitive abnormalities in euthymic bipolar patients using
      a placebo-controlled, adjunctive, 12-week trial design.
    

Detailed description: 
      All eligible participants will undergo study visits at screening, baseline (week 0), week 1,
      week 2, week 3, week 4, week 6, week 8, and week 12, (end of study).

      Randomization will be conducted via a computer generated program and all study staff will be
      blinded unless un-blinding is required for safety reasons. Subjects will be randomized on a
      1:1 ratio with stratification for concomitant antipsychotic status and depression at baseline
      (HRSD <8 vs > 8). Study drug will be blinded and matched to placebo. Adapting from our
      previous work in BD and according to package labeling, the dosage titration schedule will be
      slow and flexible. Dosing will be initiated at 0.25 mg QHS on night one, followed by 0.25 mg
      BID day two onward, and increased every week to a target of 4.5 mg/day. As compared with our
      previous maximum 1.5 mg/day (Burdick et al. 2012), we opted to allow up to 4.5 mg/day (the
      maximum approved dosage in Parkinson's disease) to ensure adequate target engagement. We are
      familiar with this dose range, as 4.5 mg/day was allowed in our study in BD depression
      (Goldberg et al. 2004). Dosing will be flexible based on side effects; however, if 1.5 mg/day
      cannot be tolerated, the subject will be discontinued. Titration will occur up to week 6 and
      then efforts will be made to maintain the same dose until the completion of the trial (week
      12).
    

Intervention name(s): Pramipexole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Up to 4.5mg, PO, (by mouth) per day of the 12-week study.; placebo match study drug
Other intervention name(s): Mirapex
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Cognition
Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone
      relative to placebo in the treatment of generalized anxiety disorder (GAD)
    


Intervention name(s): Placebo; Vilazodone; Vilazodone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,; Vilazodone, 20mg, oral administration once per day.; Vilazodone, 40mg, oral administration once per day.
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder; GAD
Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women
Condition: Breast Cancer; Healthy, no Evidence of Disease
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Eating a
      diet high in isoflavones, compounds found in soy foods, may keep cancer from forming.

      PURPOSE: This randomized phase III trial is studying the effects of dietary soy on estrogens
      in breast fluid, blood, and urine samples from healthy women.
    

Detailed description: 
      OBJECTIVES:

        -  Examine the effects of two daily servings of soy on estrogen levels in nipple aspirate
           fluid (NAF) and serum.

        -  Investigate cytologic patterns of epithelial breast cells obtained from NAF as a measure
           of proliferation in relation to soy intake.

        -  Explore the effect of two daily servings of soy on cytochrome alterations of estrogen
           metabolism as expressed in the formation of urinary 2-, 16α-, and 4-hydroxy estrogen
           metabolites.

        -  Compare estrogen levels in NAF and serum measured at the same time during the luteal
           phase.

      OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 intervention
      arms.

        -  Arm I: Participants partake in a high soy diet consisting of 2 daily soy servings
           (approximately 50mg isoflavones). The choice of soy foods will include ½ cup of tofu, ¾
           cup of soy milk, or ¼ cup of soy nuts. Replacement of currently consumed foods with soy
           foods will be encouraged.

        -  Arm II: Participants will be asked to keep their soy intake below 3 servings per week.
           The participants will also receive general nutrition counseling.

      In both arms, intervention continues for 6 months. After 6 months, participants undergo a
      1-month washout period and then cross-over to the other intervention arm.

      Nipple aspirate fluid, urine, and blood samples are collected periodically to measure
      laboratory endpoints.
    

Intervention name(s): soy isoflavones
Intervention type(s): Dietary Supplement
Intervention description(s): High or low dose of soy isoflavones in the diet.
Allocation: Randomized
Primary purpose: Prevention
Keywords: breast cancer; healthy, no evidence of disease
Taste Reward Processing in Pediatric Obesity
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Observational

Summary: 
      The study aims to provide a better understanding of the neural influence of eating behavior
      in the development of childhood obesity. Children ages 4-8 will be recruited to examine fMRI
      brain response to pictures that signal delivery of a chocolate milkshake and to the taste
      itself. The brain response will be compared to body mass index percentile scores for each
      child to help us determine whether brain differences present in adolescents and adults with
      obesity are present in young children.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children ages 4-8
      
Keywords: Picture food type; Taste type
Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele
Condition: Rectocele
MeSH terms: Rectocele
Study type: Interventional

Summary: 
      We assumed that the technique of plication of the rectovaginal septum and rectal wall may
      factor in providing better and more sustained repair that confers more satisfactory
      improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR
      with vertical plication of the rectovaginal septum as compared to the horizontal plication
      with regards to improvement in ODS, recurrence of rectocele, postoperative complications and
      dyspareunia.
    


Intervention name(s): Vertical plication; Horizontal plication
Intervention type(s): Procedure; Procedure
Intervention description(s): Vertical plication of the rectovaginal septum was done; Horizontal plication of the rectovaginal septum was done
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Randomized Controlled Trial on the Effect of Retrograde Partial Bladder Fill on Time to Discharge and Overall Medical Staff Satisfaction
Condition: Retrograde Bladder Fill
Study type: Interventional

Summary: 
      This study is a randomized controlled trial on the effect of retrograde partial bladder fill
      on time to discharge in patients who have had urological surgery for BPH, and whether it
      affects overall medical staff satisfaction.
    


Intervention name(s): retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter
Intervention type(s): Procedure
Intervention description(s): 0.9% NS 250cc was introduced before foley catheter removed for discharge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Analysis of Cerebral Correlates of Pedophilia With Neuroimaging Techniques
Condition: Pedophilia
MeSH terms: Pedophilia
Study type: Interventional

Summary: 
      The main objective is to identify cerebral correlated of pedophilia using neuroimaging
      techniques.
    


Intervention name(s): Pedophiles patients; Healthy subjects; PET/MRI
Intervention type(s): Behavioral; Behavioral; Device
Intervention description(s): cerebral MRI and/or cerebral PET imaging; cerebral MRI and/or cerebral PET imaging
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Brain, pedophilia, neuroimaging
Vasopressin and V2 Receptor in Meniere's Disease
Condition: Meniere Disease
MeSH terms: Meniere Disease
Study type: Interventional

Summary: 
      Summary: Some of sicknesses are well known to be provoked by inadequate adaptation to
      physical and/or psychogenic stress in their daily life. Meniere's disease is also a common
      inner ear disease accompanied with vertigo, hearing loss and tinnitus especially in civilized
      people under stressed life style. Its oto-pathology was firstly revealed in 1938 to be inner
      ear endolymphatic hydrops through the temporal bone study. To elucidate the neuroscientific
      relationship between "stress" and "inner ear", we examined plasma vasopressin (the
      anti-diuretic "stress" hormone) and its receptor, V2R in the endolymphatic sac (the "inner
      ear" endo-organ for endolymph absorption) in Meniere's patients.
    

Detailed description: 
      Methods: Between 1998 and 2006, we enrolled and assigned 105 intractable Meniere's patients
      to examine plasma vasopressin during remission of vertigo attacks (controls: 30 patients with
      chronic otitis media). Using the real-time PCR method, we examined V2R mRNA expression in the
      endolymphatic sac in 12 patients (controls: 6 patients with acoustic neurinoma). By means of
      cell culture and cyclic AMP assay, we also examined cyclic AMP activity in the endolymphatic
      sac in 3 patients (controls: 3 patients with acoustic neurinoma).
    

Intervention name(s): vasopressin, V2 receptor and cyclic AMP
Intervention type(s): Genetic
Intervention description(s): plasma vasopressin, V2 receptor, cyclic AMP
Other intervention name(s): plasma vasopressin; V2 receptor; cyclic AMP
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Meniere's disease; stress; vasopressin; endolymphatic sac; V2 receptor; cyclic AMP; Plasma vasopressin level and V2R mRNA expression level in the endolymphatic sac both were significantly higher in patients with Meniere's disease.; In Meniere's disease, there were significant negative co-relationships between vasopressin and V2R.; The cyclic AMP activity was basically up-regulated in the endolymphatic sac in Meniere's disease..; The cyclic AMP sensitivity for vasopressin was significantly elevated in the endolymphatic sac in Meniere's disease.
B195: Effect of Diet-Induced Energy Deficit and Body Fat Reduction on Inflammatory Markers in Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Aim: To dissociate the effects on plasma concentrations of the inflammatory marker c-reactive
      protein of a negative energy balance and a reduction in body fat stores. Secondly to compare
      CRP with fibrinogen and interleukin-6 (IL-6).
    

Detailed description: 
      Background:

      Previous epidemiological studies have associated elevated levels of acute phase proteins,
      mainly C-reactive protein, with cardiovascular diseases (CVD) and cardiac death. Levels of
      several cy-tokines and acute phase proteins as CRP, haptoglobin and fibrinogen have been
      found associated with elevated body fat and the risk of diseases associated to the metabolic
      syndrome.

      Method:

      Thirty-six otherwise healthy obese subjects (BMI: 34.23.2 kg/m2, age: 43.410.5 y)
      participated in a 20-week controlled dietary intervention divided into 4 periods. Weight
      reduction was induced by an 8-week low caloric diet (LCD) (3.4 MJ/d) followed by a 4-week
      weight stable maintenance program (M1). Subsequently, they underwent another 4-week LCD (4.2
      MJ/d) followed by a final 4-week weight stable maintenance diet (M2). Blood samples and
      anthropometrical measures were assessed at baseline and after each of the four periods (8,
      12, 16 and 20 weeks).
    

Intervention name(s): energy restriction and maintenance
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Weight loss; obesity; energy restriction
Vitamin E Supplementation in Burned Patients
Condition: Burn
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E
      short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn
      injury and, in the process, decrease the secondary consequences of burn injury, including
      lung injury and impaired wound healing. This may improve the quality of life of the burn
      patient by preventing pathophysiology that may result from oxidative stress and may reduce
      hospital stay. Our research will lay the foundation for the future development of effective,
      safe, and economic therapeutic interventions to treat burn injury-associated metabolic
      abnormalities. Also, it will provide the basis for the development of supplemental
      regulations and pharmacotherapy to treat burn patients with vitamin E. The risks are very
      reasonable in relation to the anticipated benefits to our subjects because a) vitamin E is a
      simple vitamin that is abundant and approved for clinical use, and b) the subjects will be
      monitored consistently for the minimal increased tendency to bleed.
    

Detailed description: 
      Please see above.
    

Intervention name(s): Vitamin E
Intervention type(s): Drug
Intervention description(s): 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
Other intervention name(s): dl-Alpha Tocopheryl; Alpha Tocopherol; Aqueous Vitamin E Oral Drops
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alpha-Tocopherol; Inflammation; Oxidative Stress; Malondialdehyde; Isoprostanes; Lung Dysfunction; Wound Healing
Intranasal Oxytocin Effects in Alcohol Withdrawal and Dependence; Follow-up Study
Condition: Alcoholism; Substance-Related Disorders
MeSH terms: Alcoholism; Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is an assessment of the long-term effect of oxytocin nasal spray on alcohol
      withdrawal and dependence in adults admitted for detoxification of alcohol after 60 days and
      1 year. It is a follow-up study of a placebo-controlled randomized controlled study where
      subjects used oxytocin nasal spray during acute withdrawal and the following 4 weeks in an
      outpatient setting. Half of the participants have received oxytocin nasal spray, the other
      half placebo nasal spray (NCT02903251). (added March 2019: 24 patients were available for
      1-year follow-up)
    


Intervention name(s): intranasal oxytocin spray; intranasal spray without oxytocin
Intervention type(s): Drug; Other
Intervention description(s): 6 insufflations (24 IU of oxytocin total) given twice daily, day 1-3. 2 insufflations (8 IU of oxytocin total) as needed, max thrice daily, day 3-30 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual.; 6 insufflations (24 IU of placebo total) given twice daily, day 1-3. 2 insufflations (8 IU of placebo total) as needed, max thrice daily, day 3-30 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual.
Other intervention name(s): Syntocinon; placebo
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oxytocin; Administration, Intranasal; Ethanol; Follow-up Studies
Neuropathic Pain After Breast Surgery
Condition: Chronic Neuropathic Pain, Postoperative; Chronic Pain, Postoperative; Chronic Chemotherapy-induced Neuropathic Pain; Chronic Chemotherapy-induced Pain; Chronic Chemotherapy-induced Peripheral Neuropathy
MeSH terms: Neuralgia; Peripheral Nervous System Diseases; Chronic Pain; Pain, Postoperative
Study type: Observational

Summary: 
      To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging
      from molecular pathways to societal impacts.
    

Detailed description: 
      Pain and loss of function are intimately associated with the reaction of the nervous system
      to neural damage. A lesion to the somatosensory nervous system caused by mechanical trauma,
      metabolic disease, neurotoxic chemicals, infection or tumor invasion may give rise to
      neuropathic pain. Neuropathic pain affects around 8% of the population and may negatively
      impact the individual's quality of life; moreover, the condition leads to significant costs
      to the healthcare system and society. Not all subjects with such a lesion develop neuropathic
      pain, and those who do develop neuropathic pain have varying degrees of symptom severity,
      impact and outcomes and may respond unpredictably to treatment.

      The interaction between genetics and environmental and clinical factors in a susceptible
      individual most likely contribute to the variation in pain prevalence and severity. A better
      understanding of the exact nature of these risk factors and their interactions will
      ultimately improve the patients' health, both in terms of recognizing patients at risk and
      identifying new treatment modalities.

      Genetic, neurophysiological and psychological factors all influence the risk of developing
      persistent pain. It is therefore possible to describe a genetic, neurophysiological and
      psychological profile, in particular in patients experiencing neuropathic pain after surgery
      and/or neurotoxic chemotherapy.
    

Intervention name(s): Surgery for breast cancer
Intervention type(s): Procedure
Intervention description(s): Breast cancer resection performed via lumpectomy or mastectomy with or without sentinal node biopsy and axillary lymph node dissection.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for breast cancer resection at the Department of Breast Surgery, Aarhus
        University Hospital, Aarhus, and the Breast Surgery Clinic, Viborg Regional Hospital,
        Viborg, Denmark.
      
Biospecimen description: 
      Blood
NEO6860, a TRPV1 Antagonist, First in Human Study
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a double blind, placebo controlled, ascending single and multiple oral dose
      study conducted in two parts, aimed at determining the safety and tolerability of single and
      multiple oral doses of NEO6860 in healthy subjects.

      Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and
      gender.

      The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked pain
      methods.

      Part A will comprise an ascending single dose, with 6 dose levels. Part B will comprise an
      ascending multiple dose, with 2 dose levels.
    

Detailed description: 
      This study is a double blind, placebo controlled, ascending single and multiple oral dose
      study conducted in two parts, aimed at determining the safety and tolerability of single and
      multiple oral doses of NEO6860 in healthy subjects.

      Key secondary objectives are: assessment of the pharmacokinetic profile, effect of food and
      gender.

      The analgesic effect of NEO6860 will be investigated using experimental capsaicin-evoked pain
      methods. Measurement of capsaicin evoked pain, and secondary hyperalgesia will be performed
      at baseline and at estimated Tmax and 8 hours post dosing.

      Part A will comprise an ascending single dose, sequential group study in male subjects,
      incorporating a two-period crossover group to investigate the effect of food and a single
      group of female subjects to investigate gender effect.

      56 subjects will be studied in 7 groups (Groups A1 to A7), each group consisting of 8
      subjects (6 subjects will receive NEO6860 and 2 will receive placebo). Six dose levels will
      be explored: 50, 100, 200, 400, 800 and 1 600mg.

      Part B will comprise an ascending multiple dose, sequential group study. 16 subjects will be
      studied in 2 groups (Groups B1 to B2), each group consisting of 8 subjects (6 subjects will
      receive NEO6860 and 2 will receive placebo) receiving 5 days of therapy with a dose schedule
      to be determined during Part A.
    

Intervention name(s): NEO6860; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NEO6860 is an NCE acting as a TRPV1 antagonist; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment