bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Cost Effectiveness of ISTDP: A Quasi Experimental Study
Condition: Anxiety; Somatoform Disorders; Personality Disorders; Depression; Psychotic Disorders
MeSH terms: Depression; Psychotic Disorders; Personality Disorders; Somatoform Disorders
Study type: Observational

Summary: 
      Objective: To evaluate whether or not cases treated with Intensive Short-term Dynamic
      Psychotherapy (ISTDP) facilitate healthcare cost reduction, whether any observed reduction is
      greater than that of a control group and whether any such gains would be maintained in follow
      up.

      Design: A quasi-experimental design was employed in which pre and post healthcare cost and
      usage data were extracted for all ISTDP treated cases from 1999 to 2008 and compared to
      parallel measures of a control group of cases referred but never treated.
    

Detailed description: 
      Importance: Psychiatric and psychological disorders result in excess health care service use
      and costs. Brief psychotherapy methods may be effective across a broad range of mental
      disorders and could therefore result in healthcare cost reduction.

      Objective: To evaluate whether or not cases treated with Intensive Short-term Dynamic
      Psychotherapy (ISTDP) facilitate healthcare cost reduction, whether any observed reduction is
      greater than that of a control group and whether any such gains would be maintained in follow
      up.

      Design: A quasi-experimental design was employed in which pre and post healthcare cost and
      usage data were extracted for all ISTDP treated cases from 1999 to 2008 and compared to
      parallel measures of a control group of cases referred but never treated.

      Setting: Treatments were provided at an urban University based psychotherapy service.

      Participants: All cases from the province of Nova Scotia treated within the research time
      frame were included. 890 patients were included with a very broad range of psychiatric
      disorders including anxiety, mood, somatoform, personality and psychotic disorders. 192
      referred but never see cases served as non randomized controls.

      Intervention(s): ISTDP is an emotionally focused form of brief psychotherapy which has
      supportive, cognitive, experiential and primarily psychodynamic elements. In this setting the
      average length of treatment was 7.3 sessions and cost an estimated $500 dollars per treatment
      course.
    

Intervention name(s): ISTDP
Intervention type(s): Behavioral
Intervention description(s): An emotion focused brief psychotherapy format.
Other intervention name(s): Intensive Short-term Dynamic Psychotherapy
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All Major DSM IV categories included including mood, anxiety, personality, somatoform,
        dissociative, eating and psychotic disorders
      
Keywords: somatoform disorder; psychotherapy; depression; anxiety; personality disorder
Perimenopausal Estrogen Replacement Therapy Study
Condition: Perimenopause; Menopause; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Study Background and Objectives: In the U.S. the majority of heart disease deaths are in
      women, not men. Much of the gender disparity in CVD rates relate to the burden of CV risk in
      women after the menopause. Depression has been associated with an increased risk for CVD
      morbidity and mortality. Even histories of recurrent depression in euthymic individuals are
      associated with elevated CV risk. Understanding the depression-CVD link may have particular
      relevance for women since women experience depression at a rate twice that of men.
      Substantial convergent evidence indicates that ovarian failure (estrogen deprivation) is one
      likely mechanism contributing to both CVD and depression in women. The perimenopause, a time
      associated with a two-fold increase in rates of depression, may provide an ideal opportunity
      for studying the pathophysiology of CV risk and depression in women.

      The primary objective of this study is to examine the prophylactic role of estradiol in the
      development of depressive symptoms and the progression of cardiovascular risk in
      perimenopausal women with or without histories of depression. The investigators predict that
      women susceptible to depression will be particularly vulnerable to the acceleration of CVD in
      the context of the perimenopause and, consequently, will show differentially greater benefit
      of estradiol treatment during the menopause transition for both indices of CV risk (e.g.
      inflammation, endothelial function, stress reactivity), as well as depressive symptoms.
    


Intervention name(s): Estradiol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered.; Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months.
Other intervention name(s): Climara and Prometrium.
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Perimenopause; Menopause; Depression; Cardiovascular health
A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects
Condition: Overactive Bladder; Pharmacokinetics
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to
      exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and
      tolerability of warfarin alone and combined with YM178.
    


Intervention name(s): warfarin; YM178
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Coumadin; mirabegron
Intervention MeSH terms: Warfarin; Mirabegron
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: YM178; Mirabegron; DDI; Phase I; Warfarin; Pharmacokinetics
Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma, Kaposi; Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes
      necessary for their growth.

      PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating
      patients with HIV-related Kaposi's sarcoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine clinical response in patients with HIV-related Kaposi's sarcoma treated with
           imatinib mesylate.

      Secondary

        -  Determine the inhibition of platelet-derived growth factor receptors, as determined by
           immunohistochemistry, in patients treated with this drug.

        -  Determine cytokine profiles before and after treatment with this drug in these patients.

        -  Determine the pharmacokinetic profile of this drug and antiretrovirals in these
           patients.

        -  Determine mechanisms of primary and secondary resistance to this drug in these patients.

      OUTLINE: This is an open-label, multicenter study.

      Patients receive oral imatinib mesylate once daily. Treatment continues for up to 1 year in
      the absence of disease progression or unacceptable toxicity.

      Patients are followed at 30 days.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
    

Intervention name(s): imatinib mesylate
Intervention type(s): Drug
Intervention description(s): 400 mg orally once a day for up to 6 months.
Other intervention name(s): Gleevec
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AIDS-related Kaposi sarcoma; recurrent Kaposi sarcoma
Tau Screening Study in Subjects With Early Symptomatic AD
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol is designed to serve as a pre-screening study for subjects who are potentially
      eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for
      inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.
    


Intervention name(s): Flortaucipir F18; Brain PET Scan
Intervention type(s): Drug; Procedure
Intervention description(s): 370 megabecquerel (MBq) IV single-dose; positron emission tomography (PET) scan of the brain
Other intervention name(s): 18F-AV-1451; [F-18]T807; LY3191748
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
rTMS Bimodal Treatment For Tinnitus: A Pilot Study
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Repetitive Transcranial Magnetic Stimulation (rTMS) is a novel brain stimulation technique
      that uses pulsating magnetic fields to stimulate underlying neurons in the cerebral cortex.
      The investigators propose an open-label pilot study investigating the effectiveness of rTMS
      in the treatment of tinnitus stimulation of the left dorsolateral prefrontal cortex (DLPFC),
      an area known to be important for mood and attention, along with stimulation of the left
      temporoparietal cortex (TPC). This is a feasibility pilot study.
    

Detailed description: 
      Converging data implicate structures of the brain that are important for mood and attention
      as playing a role in the maintenance of tinnitus; suggesting an alternative rTMS treatment
      approach that targets these structures. A growing number of studies demonstrate involvement
      of the prefrontal cortex in the generation and maintenance of tinnitus. rTMS stimulation in
      the dorsolateral prefrontal cortex in association with stimulation in the temporoparietal
      cortex has been shown to increase the durability of the TPC stimulation. The independent
      effect of rTMS stimulation to the DLPFC is not known. Studies in depression suggest that
      increasing the intensity and duration of stimulation has beneficial treatment effects.
      However, the field is new and more work is needed to assess the effectiveness of this
      treatment, predictors and correlates of response, and safety.

      Recent exciting work in schizophrenia used a bimodal (DLPFC and TPC) treatment approach in
      pharmacologically non-responsive patients. The study used high-frequency stimulation to the
      left DLPFC and low-frequency stimulation to the left TPC. Bimodal rTMS stimulation of left
      DLPFC and left TPC induced clinical improvement in pharmacologically non-responsive
      schizophrenia patients and may have improved their short-term verbal memories.57
    

Intervention name(s): Bimodal rTMS
Intervention type(s): Device
Intervention description(s): High frequency (10 Hz) at 110% of the motor threshold TMS delivered over the left dorsolateral prefrontal cortex, subsequently, a low frequency TMS (1 Hz) at 110% motor threshold will be delivered over 31 minutes over the TPJ area, according to the protocol below.
DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000
TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000
Other intervention name(s): The rTMS system is a Magpro R 30 stimulator.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tinnitus; bimodal stimulation; rTMS; Repetitive Transcranial Magnetic Stimulation
Maternal and Fetal Compatibility in Assisted Reproductive Technology (ART)-Oocyte Donor Influences Live Birth Rate
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Has the maternal KIR haplotype an impact in pregnancy, miscarriage and live birth rates per
      embryo transfer in donor oocytes -ART by paternal and oocyte donor HLA-C?
    

Detailed description: 
      The combination of maternal KIR haplotype and parental, donors HLA-C, could predict which
      couple can benefit for the selection of single embryo transfer (SET)/double embryo transfer
      (DET), or donor selection by HLA-C in ART, in order to increase the live birth rate
      (LBR)/cycle since HLA-C1/C1 donors are predicted to be safer and C2/C2 males or oocyte donors
      may be mor "dangerous" as identified by epidemiological studies
    

Intervention name(s): KIR HLAC determinations
Intervention type(s): Genetic
Intervention description(s): We will take blood samples for KIR HLA-C determinations.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing an assisted reproductive treatment
      
Biospecimen description: 
      Genomic DNA will be obtained and will be studied in Professor Moffet laboratory in Cambridge
      (department of Pathologí, University of Cambridge) KIR typing including copi number and HLA-C
      loci will be performed as previously described (Hiby 2010, Jiang 2012). KIR haplotype regions
      will be defined by the presence of the following KIR genes: Cen-A/2DL3; Tel-A/3DL1 and 2DS4;
      Cen-B/2DL2 and 2DS2; Tel-B/2DS1 and 3DS1. The HLA-C ligands for KIRs will be divided into 2
      groups: HLA-C1 and HLA-C2.
    
Keywords: KIR HLA-C; ART
Clinical Study to Investigate the Efficacy and Safety of SJP002 Ophthalmic Solution in Patients With Dry Eye Syndrome.
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to
      placebo in patients with Dry Eye Syndrome.
    


Intervention name(s): SJP002 BID; SJP002 QID; SJP002 Placebo 1; SJP002 Placebo 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 drop b.i.d for 12 weeks; 1 drop q.i.d for 12 weeks; 1 drop q.i.d for 12 weeks; 1 drop q.i.d for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
Condition: Bariatric Surgery Candidate; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine
      (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing
      total IV and oral morphine equivalents required after laparoscopic bariatric surgery.
      Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the
      course of three days. Having a long acting local anesthetic should provide better pain
      control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the
      use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery.
      This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can
      potentially improve patient post-operative pain control, decrease narcotic use, decrease
      hospital length of stay and readmission rates and improve patient satisfaction after
      bariatric surgery.
    


Intervention name(s): Exparel 266 MG Per 20 ML Injection; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).; 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Other intervention name(s): EXPAREL; Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthetics, Local; Liposomal Bupivacaine; Bupivacaine; Postoperative Complications; Roux-en-Y Gastric Bypass; Sleeve Gastrectomy; Laparoscopic Bariatric Surgery
A Clinical Trial to Evaluate Investigational Silicone Hydrogel Contact Lenses Worn Continuously for One Week
Condition: Visual Disorder
MeSH terms: Vision Disorders
Study type: Interventional

Summary: 
      This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group
      clinical trial design. All subjects will participate in a 2-week daily disposable contact
      lens adaptation period prior to being randomized into one of the four extended wear lenses.
      The study has a total of 9 scheduled study visits and a total duration of ~197 days. The
      lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.
    


Intervention name(s): Investigational Lens 1; Investigational Lens 2; Investigational Lens 3; etafilcon A (Reusable); etafilcon A (1-Day)
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.; One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.; One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.; One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear.; 2-week contact lens adaptation period wearing prior to randomization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
Condition: Anogenital Human Papilloma Virus Infection; Condyloma Acuminata
MeSH terms: Papillomavirus Infections; Papilloma
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus
      [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to
      26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence
      of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501
      reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection,
      condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal,
      or perineal cancer compared with placebo.
    


Intervention name(s): V501; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant; Formulated with AAHS adjuvant
Other intervention name(s): GARDASIL™; Quadrivalent HPV (Type 6, 11, 16 and 18) L1 Virus-Like Particle vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Heated Glass Ionomer Cement in Primary Molars
Condition: Dental Caries; Glass-Ionomer Cement; Primary Teeth
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Objective: The aim of this study was to assess the influence of heated in the clinical
      success of proximal high viscosity glass ionomer cement (GIC) restorations in primary molars.

      Material & Method: This randomized, split mouth, multicenter study was performed in four
      different centers including 88 patients aged between 5-7 years old. Selection criteria
      included clinically and/or radiographically detected proximal caries extending into the
      dentin tissue. A total of 250 primary molars were restored with a bulk fill GIC (Equia Forte,
      GC, Europe) and randomly allocated to one of the following groups: 1) non-heated (n = 125)
      and 2) heated (n = 125). LED light (GC- D-Light DUO, Tokyo Japan) was used at standard mode
      1200 mW/cm2, at 50-60 ºC, for 60 sec for heat application. All restorations were clinically
      evaluated using modified USPHS criteria at the baseline, 6 months and 12 months. Chi-square
      test, Fisher's Exact Chi-square test, Continuity (Yates) correction, Fisher Freeman Halton
      test and Mc Nemar test were used to compare qualitative data with descriptive statistical
      methods (frequency). Kaplan Meier and Life Tables were used for survival analysis. P value <
      0.05 was considered statistically significant.
    


Intervention name(s): Glass -Ionomer Cement with /without Led Light Cure
Intervention type(s): Other
Intervention description(s): Teeth were restored as same protocole with non-Heated Group. LED light (GC- D-Light DUO) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Control
Masking: None (Open Label)
Primary purpose: Treatment
Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections
Condition: First Trimester Abortion
MeSH terms: Reproductive Tract Infections; Abortion, Spontaneous
Study type: Observational

Summary: 
      The study group included 910 women who attended Fayoum university hospital gynecology
      outpatient clinic for postabortive evaluation. The control group included 940 women attended
      outpatient clinic for any other procedure or complaint
    

Detailed description: 
      The study group included 910 women who attended Fayoum university hospital gynecology
      outpatient clinic for postabortive evaluation. The control group included 940 women attended
      outpatient clinic for any other procedure or complaint all patients were screened by serum
      samples to detect IgM / IgG to Chlamydia trachomatis (DRG Chlamydia Trachomatis IgM / IgG
      Enzyme immunoassay) and by high vaginal and Endocrvical swabs for bacterial, protozoal and
      chlamydial infection- examined by PCR- (from +ve samples to chlamydial IgM / IgG).
    

Intervention name(s): vaginal swab
Intervention type(s): Procedure
Intervention description(s): high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR
Other intervention name(s): high vaginal swab
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  The Study group included Women with recent unexplained early miscarriage (pregnancy
             duration 12 weeks or less and miscarriage within 4 weeks)

          -  The control group included Women with any other gynecological complaint or in need of
             family planning