bioihbjkbjnl/mcl2 huggingface dataset:
Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if adding the study drug, ziprasidone, to an
      antidepressant medication helps improve symptoms of Major Depressive Disorder (MDD). We are
      studying the drug's effectiveness in treating depression, as well as its safety when it is
      added to another drug.

      Hypothesis A: There will be a difference in the percentage of responders in the two treatment
      conditions during phase 2; response rates will be higher for the ziprasidone group.
    

Detailed description: 
      The proposed study involves three phases. The first phase is an 8-week, open-label trial of
      an SSRI for MDD. Patients who do not experience sufficient symptom improvement following this
      open-label trial will be enrolled in a 6-week, double-blind, placebo controlled trial of
      ziprasidone augmentation (second phase). Ziprasidone and placebo-remitters will then enter a
      12-month, double-blind extension phase (third phase). We estimate that approximately 400
      patients will enter phase 1 of the study so that a minimum of 180 subjects will enter
      double-blind treatment (phase 2) over 5 years. Each treatment arm during phase 2 will have 90
      subjects.

      Hypothesis B1: During phase 2, there will be a difference between the two groups in the
      percentage of responders (50% or greater reduction in symptom severity) with regards to
      anxious symptoms of MDD as measured by the 14-item Hamilton Anxiety Rating Scale (HAM-A);
      response rates will be higher for the ziprasidone group.

      Hypothesis B2: During phase 2, there will be a difference between the two groups in the
      percentage of responders (50% or greater reduction in symptom severity) with regards to
      painful symptoms of MDD, as measured by the overall visual analogue pain (VAS-pain) scale
      scores; response rates will be higher for the ziprasidone group.

      Hypothesis C: The time to relapse during phase 3 will be shorter among adjunctive placebo-
      than ziprasidone-remitters.
    

Intervention name(s): Ziprasidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.; 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.
Other intervention name(s): Geodon
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Major Depression; Depression; Geodon; Ziprasidone; SSRI Augmentation; Treatment Resistant Depression
Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study seeks to determine whether clinical outcome following initial treatment of severe
      pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin.
      The study will also provide an estimate of the proportion of Kenyan children with severe
      pneumonia who fail treatment with a single antibiotic.
    

Detailed description: 
      Case management for the treatment of childhood acute respiratory infections has been widely
      promoted in many developing countries for over 20 years. Despite this, pneumonia continues to
      claim over 1.5 million lives of children under five annually. The use of affordable,
      easily-administered, safe, effective treatments can potentially reduce the burden of
      childhood pneumonia. The WHO recommends the use of a single antibiotic for the treatment of
      severe pneumonia. Whereas in Asia, evidence from large randomized clinical trials has changed
      policy recommendations for treatment of severe pneumonia from parenteral penicillin to oral
      amoxicillin, there is little evidence to inform a similar move in African children where
      pneumonia is associated with poorer outcomes. In this study the investigators will
      investigate effectiveness of oral amoxicillin versus the current standard treatment, benzyl
      penicillin in severe childhood pneumonia using a randomized controlled non-inferiority design
      preceded by a pilot pre-intervention phase. The investigators will also collect observational
      data HIV-exposed / infected children with severe pneumonia. 594 children aged 2 - 59 months
      admitted with clinical signs of severe pneumonia to up to 7 hospitals in Kenya will be
      randomly assigned to receive either oral amoxicillin or injectable benzyl penicillin. They
      will then be followed up for the primary outcome of pre-defined treatment failure at 48
      hours. The results of this trial will provide valuable data on the effectiveness of oral
      amoxicillin in the treatment of severe pneumonia in a population of Kenyan children and
      determine the practicability of conducting large pragmatic trials on pneumonia in Africa
      similar to those done in Asia.
    

Intervention name(s): Amoxicillin; Benzyl penicillin
Intervention type(s): Drug; Drug
Intervention description(s): Oral 45mg/kg 12 hourly; Intravenous 50,000IU/kg 6 hourly
Intervention MeSH terms: Amoxicillin; Penicillins; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Severe pneumonia
Measurement of Total Retinal Blood Flow During Flicker Stimulation in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      Neurovascular coupling or functional hyperemia is defined as an essential physiologic
      mechanism in the brain, which is necessary for the local adaption of blood flow to altered
      metabolic demands of the tissue. It has been shown that also in the eye, blood flow is
      considerably coupled to retinal neural activity. The current concept of functional hyperemia
      is that visual stimulation, as flicker light, effectuates increasing neural activity in the
      retina, which elevates the metabolic needs of the retinal tissue for oxygen and glucose and
      consequently induces dilatation and augmented blood flow in the retinal vasculature. In
      several studies, stimulation with flicker light has been shown to induce an increase of blood
      flow in major retinal arteries and veins as well as an increase of optic nerve head blood
      flow. Up until now, flicker induced changes in blood flow were measured solely in the major
      retinal arteries and veins with systems such as the commercially available dynamic vessel
      analyzer (DVA) by Imedos and with laser Doppler velocimetry (LDV).

      In the present study, the investigators propose to measure the response of total retinal
      blood flow to diffuse luminance flicker stimulation with bi-directional Fourier Domain
      Doppler Optical Coherence Tomography (FDOCT) as well as with Laser Speckle Flowgraphy (LSFG)
      in healthy subjects by assessing vessel diameter, blood velocity and blood flow of all
      retinal vessels. For comparative reasons, the investigators will furthermore assess the blood
      flow of major retinal arteries and veins with the dynamic vessel analyzer (DVA) and laser
      Doppler velocimetry (LDV).
    


Intervention name(s): FDOCT; LDV; DVA; LSFG
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Measurement of retinal blood velocities; Measurement of retinal blood velocities; Measurement of retinal vessel diameters; Imaging of retinal blood flow
Other intervention name(s): Fourier Domain Color Doppler Optical Coherence Tomography; Laser Doppler Velocimetry; Dynamic Vessel Analyzer; Laser Speckle Flowgraphy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: flicker induced changes; total volumetric retinal blood flow
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy of pantoprazole for the treatment of infants with symptomatic
      Gastroesophageal Reflux Disease (GERD).
    


Intervention name(s): pantoprazole; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GERD; Infants; Gastroesophageal Reflux
The Effect of Vildagliptin Based Treatment Versus Sulfonylurea on Glycemic Variability, Oxidative Stress, GLP-1, and Endothelial Function in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of vildagliptin based treatment versus sulfonylurea based treatment on glycemic
      variability, oxidative stress, and endothelial function in patients with type 2 diabetes.
    

Detailed description: 
      Recently, improved understanding of the incretin effect on the pathophysiology of type 2
      diabetes has led to development of new agent for hypoglycemic therapy. Vildagliptin is a
      potent and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor that augments the active
      glucagon-like peptide(GLP)-1 concentration, increases insulin secretion and improves glucose
      tolerance. Vildagliptin has a similar glucose lowering effect, but lower hypoglycemic events,
      as compared to glimepiride. Vildagliptin could improve not only the mean glycemic control but
      also 24 hour glycemic fluctuation by restoring the physiologic pattern of insulin and
      glucagon secretion. Furthermore, decreased postprandial glycemic excursion might reduce the
      oxidative stress markers and improve endothelial dysfunction. Those effects might be
      amplified in Asian patients because of prominent early phase insulin secretory defects
      accompanied with relatively less degree of insulin resistance. In addition, GLP-1 and GLP-1
      analogues exert direct beneficial effects on endothelium-dependent vasodilatation. Therefore
      DPP-4 inhibitors may directly improve endothelial dysfunction.

      Based on this assumption, this research will focus on the effect of vildagliptin on glycemic
      variability, oxidative stress markers and endothelial cell function compared to long acting
      sulfonylurea glimepiride in type 2 diabetic patients with inadequate glycemic control on
      metformin.
    

Intervention name(s): Add Vildagliptin; Add Glimepiride
Intervention type(s): Drug; Drug
Intervention description(s): Adding Vildagliptin 50 mg bid to patients with type 2 diabetes mellitus being treated with metformin 500-1000mg bid per day who had hemoglobin A1c of 7.0-10.0%; Adding Glimepiride 2mg to patients with type 2 diabetes mellitus being treated with metformin 500-1000mg bid per day who had hemoglobin A1c of 7.0-10.0%
Intervention MeSH terms: Glimepiride; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glucose variability; Oxidative stress; Endothelial cell function
Serum FGF-23 and Vitamin D Deficiency
Condition: Osteomalacia
MeSH terms: Osteomalacia
Study type: Observational

Summary: 
      We aimed to determine the effect of vitamin D replacement therapy on serum FGF-23
      concentrations in vitamin D deficient women and to compare the FGF-23 concentrations of
      vitamin D deficient patients with healthy subjects and patients with genetically-determined
      hypophosphatemic rickets.
    

Detailed description: 
      Study group was composed of vitamin D deficient females (n =18, mean age 29.1±9.9 yrs),
      vitamin D sufficient healthy females (control group; n = 19, mean age 28.5±5.2 yrs) and
      patients with genetically-determined hypophosphatemic rickets (n=13, mean age 26.5±15.1 yrs).
      Groups were compared for serum FGF-23, 1,25 dihydroxy vitamin D3, calcium, phosphate, bone
      turnover markers, intact parathyroid hormone and urinary excretion of calcium and phosphate.
      Vitamin D deficient group was re-evaluated after a standard treatment regimen.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Group 1: Eighteen premenopausal female patients with a diagnosis of vitamin D deficient
        osteomalacia were included in this group. Vitamin D deficiency was diagnosed according to
        the serum 25 hydroxy vitamin D3 (25OHD) concentrations (< 30 ng/mL). Reasons for vitamin D
        deficiency were verified as insufficient exposure to sunlight, frequent parturition and
        prolonged lactation. All of these patients received a standard treatment regimen; oral
        Vitamin D3 150 000 IU once for all and subsequently 880 IU D3 and 1000 mg calcium carbonate
        for six weeks. This group was also evaluated after replacement therapy at sixth week.

        Group 2: Nineteen healthy premenopausal women who had normal levels of serum 25OHD Vitamin
        (>30 ng/mL) composed the control group.

        Group 3: Thirteen hypophosphatemic rickets (3 autosomal dominant and 10 X-linked; 9 female
        and 4 male) were included in this group.
      
Keywords: fibroblast growth factor 23; Osteomalacia; vitamin D
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Condition: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

        -  To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for
           all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one
           month after a three-dose primary series.

      Secondary Objectives:

        -  To describe in each group the immunogenicity parameters one month after the three-dose
           primary series.

        -  To describe safety profile after each vaccination in both groups.
    


Intervention name(s): DTaP-IPV-HB-PRP~T; DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular (right and left thighs, respectively)
Other intervention name(s): PENTAXIM™; ENGERIX B® PEDIATRICO
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Whooping cough; Hepatitis B; Poliomyelitis; Haemophilus influenzae type b
The Impact of Cigarette Smoking on Periodontal Therapy
Condition: Periodontitis; Cigarette Smoking
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      Periodontitis patients, 40 cigarette smokers and 40 non-smokers (defined by cotinine measures
      in serum), were recruited to this double arm prospective cohort study. Data were collected 3
      months following non-surgical and surgical periodontal treatment, and following 12 months
      with supportive periodontal therapy. Data collected were clinical attachment level, probing
      depth, bleeding on probing,oral bacteria, serum, blood (PAXgeneBlood), and gingival
      crevicular fluid.
    

Detailed description: 
      The overall aim of this work was to study clinical outcomes of active and supportive
      periodontal therapy in smokers and non-smokers with chronic periodontitis at patient, tooth,
      and site level. Moreover, to compare the periopathogenic microflora and inflammatory markers
      in gingival crevicular fluid and in blood in smokers and non-smokers following therapy.

      Eighty patients, 40 smokers and 40 non-smokers, with moderate to severe chronic periodontitis
      were included in this prospective cohort study and treated non-surgically and surgically, and
      then followed-up in a supportive periodontal therapy program for 12 months. Smoking status
      was validated measuring serum cotinine levels at pre-treatment and 12 months following
      supportive periodontal therapy.

      Clinical measurements included full mouth recordings of clinical attachment level, probing
      depth, bleeding on probing, and plaque index at pre-treatment and following active and
      supportive periodontal therapy. At the same timepoints, subgingival plaque samples of 20
      subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA
      hybridization. Blood samples (PAXgeneBlood), serum, gingval crevicular fluid were also
      collected at the three timepoints.
    

Intervention name(s): Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA).
Intervention type(s): Procedure
Intervention description(s): Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers
Other intervention name(s): Periodontal surgery: periodontal flap and gingivectomy with postoperative rinse with 0.2% chlorhexidine gluconate (Corsodyl, GlaxoSmithKline, London, UK).
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Obesity and Goal-directed Intraoperative Fluid Therapy
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the study is to compare non-obese patients (BMI≤ 30 kg/m2)versus obese
      patients (BMI> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy
      during laparoscopic surgery.

      Specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation
      (PsqO2)is increased in obese patients when fluid management is optimized by means of
      esophageal Doppler monitoring compared to obese patients undergoing standard fluid
      management.

      Furthermore the investigators will test the hypothesis that PsqO2 is decreased in obese
      patients undergoing conventional fluid therapy compared to non-obese patients when fluid
      management is optimized. Thus the investigators assume that PsqO2 is similar in obese and
      non-obese patients when fluid management is optimized in both groups.
    

Detailed description: 
      Hemodynamic stability and normovolemia are critical determinants of tissue perfusion and
      oxygenation. Adequate tissue oxygenation is essential to maintain normal physiologic
      functions and to reduce complications, such as wound infections.

      Fat tissue is relatively hypoperfused and, therefore, poorly oxygenated. Subcutaneous tissue
      oxygenation in the obese is thus critically low and even supplemental oxygen only slightly
      increases subcutaneous oxygenation.It is likely that poor subcutaneous oxygenation in the
      obese surgical patients results in part from inadequate intraoperative fluid replacement.

      It remains unknown how to hydrate obese surgical patients best. The most physiologic approach
      for perioperative fluid replacement is now thought to be goal-directed management, using
      stroke volume as the treatment parameter.
    

Intervention name(s): Goal directed fluid therapy
Intervention type(s): Other
Intervention description(s): Fluid will be administered to reach maximal stroke volume during the intraoperative period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obesity; Esophageal Doppler monitoring; tissue oxygen tension
Geodon (Ziprasidone) for Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder; Post-Traumatic Stress Disorder; PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      Atypical antipsychotics have shown promise in the treatment of depression and anxiety, which
      are prominent symptoms of PTSD. The profile of the atypical antipsychotic, ziprasidone
      (Geodon), suggests possible anxiolytic and antidepressant properties. This research will
      assess the potential effectiveness of Geodon in civilian men and women who suffer from severe
      PTSD. Response to ziprasidone or placebo will be measured by Clinician Administered PTSD
      Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).
    

Detailed description: 
      PTSD is a common disorder with 10% lifetime prevalence among Americans. The major causes of
      PTSD are sexual assault, accidents, disasters Despite this public health burden, only two
      drugs, sertraline (Zoloft) and paroxetine (Paxil), are approved by the FDA for the treatment
      of PTSD. New options for the treatment of PTSD are much needed. Approximately half of
      patients with PTSD respond to Zoloft and Paxil. Many patients experience psychotic symptoms
      with PTSD, which may not respond to treatment to Zoloft and Paxil.

      Though classified as an anxiety disorder in the DSM-IV, PTSD is accompanied by psychotic
      symptoms in almost half of patients (Butler et al 1996; Hamner et al 1999, Lindley et al
      2000). Also, PTSD has an extensive comorbidity with major depressive disorder (Davis et al
      2000). While Geodon is approved by the FDA in the United States for the treatment of
      psychosis, it has not been evaluated for the treatment of PTSD . A clinical trial of Geodon
      in PTSD will help delineate the potential antidepressant spectrum of efficacy of Geodon as
      well as its anxiolytic profile.
    

Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Posttraumatic Stress Disorder; Post-traumatic Stress Disorder; PTSD; Geodon; Ziprasidone