bioihbjkbjnl/mcl2 huggingface dataset:
Age of Red Blood Cells in Premature Infants Study (ARIPI)
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      To determine if the age of blood transfused to new borns in the NICU setting has an impact on
      their outcome.
    


Intervention name(s): Transfusion
Intervention type(s): Biological
Intervention description(s): PRBC blood transfusions.
Other intervention name(s): non applicable
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transfusion
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets
      administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as
      immunosuppression for the prevention of organ rejection in newly transplanted adult kidney
      transplant recipients. Patients will be treated for a 12 month study period followed by a 12
      month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically
      similar to Prograf Capsules in the prevention of acute rejection.
    

Detailed description: 
      This is a two-armed parallel group, prospective, randomized, double-blind,
      double-dummy,multicenter Phase 3 clinical study to establish the efficacy and safety of
      LCP-Tacro Tablets (tacrolimus, LifeCycle Pharma A/S, Hørsholm, Denmark) once daily for the
      prevention of allograft rejection in de novo adult male and female recipients of a primary or
      secondary kidney transplant evaluated by a combined efficacy endpoint comprised of acute
      rejection, graft loss and patient loss. The trial is designed to determine if the test drug,
      LCP-Tacro, is not inferior to an unacceptable extent to the reference compound, Prograf.
      Recipients of a kidney transplant who sign an informed consent form and fulfill all other
      inclusion and exclusion criteria will be randomly assigned to once-daily therapy with
      LCP-Tacro Tablets or to twice-daily therapy with Prograf Capsules (tacrolimus, Astellas
      Pharma US, Inc., Deerfield, IL), each concomitantly administered with mycophenolate mofetil
      (MMF) and corticosteroids. All patients will also receive interleukin-2 (IL-2) receptor
      antagonist (e.g.,Simulect®, basiliximab; Novartis Pharmaceuticals, East Hanover, NJ).
      Following screening,transplantation, and randomization, study visits will be conducted over a
      12-month treatment period; with additional visits during a 12 month extension period on
      treatment and a follow-up safety assessment by visit or telephone interview 30 days after
      withdrawal from study drug.
    

Intervention name(s): Prograf (tacrolimus); LCP-Tacro
Intervention type(s): Drug; Drug
Intervention description(s): Administered per current product labeling; Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
Other intervention name(s): tacrolimus; Tacrolimus modifed-release
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tacrolimus; Acute Rejection; Kidney
Validation of Patient Reported Outcome Measures for Use in Vulvodynia
Condition: Vulvodynia
MeSH terms: Vulvodynia
Study type: Observational

Summary: 
      The overall aim of this project is to demonstrate content validity and usability of the
      modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function
      Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with
      Vulvodynia
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects referred by clinicians
Utility of Disconnection Technique for One Lung Ventilation
Condition: Pneumothorax
MeSH terms: Pneumothorax
Study type: Interventional

Summary: 
      Lung isolation technique is useful for lung or heart surgeries for better visualization.
      Double lumen endobronchial tube and bronchial blocker are available for lung isolation.
      Adding disconnection technique before lung isolation is helpful to accelerate the lung
      deflation. However, the utility of disconnection technique has never been evaluated in
      comparison of double lumen tube and bronchial blocker. Therefore, the utility of
      disconnection technique in two different lung isolation technique, double lumen tube and
      bronchial blocker will be evaluated
    


Intervention name(s): disconnection technique
Intervention type(s): Other
Intervention description(s): Before lung isolation, the ventilator stays switched-off until the carbon dioxide on the capnogram reached to zero. Then, inflate the balloon either on the double lumen tube or on the bronchial blocker.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
In-office Bleaching With a 2-day Interval Between Sessions: Tooth Sensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Observational

Summary: 
      The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2
      days after the first bleaching session without increasing the bleaching-induced tooth
      sensitivity
    

Detailed description: 
      The in-office bleaching uses 35% hydrogen peroxide gel which is applied in 2 to 3 sessions
      usually with one week interval between sessions, without a scientific and plausible reason
      for this recommendation (. The aim of this study was to evaluate the tooth sensitivity (TS)
      risk using a shorter interval between clinical sessions. Methods: In this randomized,
      single-blind study, 40 young patients with color C2 or darker were selected and randomly
      divided in two groups. In the 7-day group, two bleaching sessions with a 35% hydrogen
      peroxide gel (Whiteness HP Blue Calcium - FGM) were performed with a one-week interval and in
      the 2-day group, the same protocol was performed but with a 2-day interval. TS was recorded
      on a 0-10 visual analog scale up to 48 h after bleaching. The color evaluation was performed
      at baseline and 30 days after bleaching with a value-oriented shade guide and a
      spectrophotometer. The absolute risk of TS (%) was evaluated by Fisher´s exact. The TS
      intensity was evaluated by two-way repeated measured ANOVA and color changes (ΔSGU and ΔE)
      were evaluated by Student´s t-test (alpha = 5%).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants included in this clinical trial were at least 18 years old and had good
        general and oral health. Participants were recruited by means of visual communication
        through posters in the university and in stores at Umuarama city. A total of 116
        participants were examined in a dental chair to check if they met the inclusion and
        exclusion criteria.
      
Keywords: Randomized Controlled Clinical Trial; Tooth Bleaching
Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases
Condition: Colorectal Liver Metastases
MeSH terms: Neoplasm Metastasis; Liver Neoplasms
Study type: Observational

Summary: 
      Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative
      outcome after resection of colorectal liver metastases.
    

Detailed description: 
      Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor
      (VEGF) increasingly added to other drugs in the treatment of colorectal cancer. Bev is
      typically used in combination with other chemotherapeutic agents such as oxaliplatin,
      irinotecan, leucovorin and 5-fluorouracil (5-FU) for treatment of patients with CRLM. The
      objective of this study was to assess the impact of neoadjuvant bevacizumab on clinical
      outcome after hepatectomy of colorectal liver metastases (CRLM).

      Patients, who underwent liver resection due to colorectal liver metastases after neoadjuvant
      chemotherapy, operated between 2005 and 2007 will be evaluated retrospectively. The patients
      will be distributed in two groups, either with or without bevacicumab. Outcome parameters are
      mortality, complications, hospital stay and ICU stay. To increase the power of the study the
      total number of patients will be increased by adding patients from other centers. Results
      will be adjusted for the propensity of developing complications.
    

Intervention name(s): bevacizumab
Intervention type(s): Drug
Intervention description(s): Neoadjuvant chemotherapy with bevacizumab
Intervention MeSH terms: Bevacizumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, who underwent liver resection due to CRLM between 2005 and 2007, were
        retrospectively assessed for eligibility. Patients with chemotherapy containing Bev prior
        to surgery are identified consequtively. This group of patient with preoperative Bev is
        matched to patients without Bev. Consecutive patients with neoadjuvant application of
        Bevacizumab will be matched to patients without Bevacizumab. Results are statistically
        adjusted according to potential confounders.
      
Keywords: neoadjuvant chemotherapy; bevacizumab
The Impact of the SCN9A Gene Polymorphism on Postoperative Pain
Condition: Pain, Postoperative; Pregnancy
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The purpose of this study to determine the association between postoperative pain after
      cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene.
    

Detailed description: 
      SCN9A gene encodes an alpha subunit of the voltage-gated sodium channel (Nav1.7) and
      polymorphisms of this gene are associated with severe pain disorders. The impact of the
      polymorphisms in SCN9A on postoperative pain and opioid consumption after cesarean section is
      unclear.
    

Intervention name(s): cesarean section; Opioid Tramadol
Intervention type(s): Procedure; Drug
Intervention description(s): Women in 36 to 40 weeks of pregnancy undergoing cesarean section by Pfannenstiel technique; Tramadol will be administered via patient controlled analgesia (PCA) pump in the postoperative period
Other intervention name(s): Tramadol (contramal)
Intervention MeSH terms: Tramadol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The women in 36 to 40 weeks of pregnancy undergoing cesarean section will be included
      
Biospecimen description: 
      Two ml blood will be collected from the peripheral venous before the operation and all blood
      samples will be stored at -80℃. Genomic DNA will be extracted from the blood samples and
      polymorphism in SCN9A gene will be identified by PCR
    
Keywords: NAV1.7 Voltage-Gated Sodium Channel; pain, postoperative; cesarean section
Effects of Mindfulness Training on Emotion Regulation and Impulsivity
Condition: Mindfulness Skills; Interpersonal Effectiveness Skills
MeSH terms: Impulsive Behavior
Study type: Interventional

Summary: 
      Mindfulness training has proven to be a reliable treatment for patients with Borderline
      Personality Disorder (BPD).The present randomized-controlled study examines the effects of
      mindfulness training on emotion regulation and impulsitivy. In addition, fMRI data was
      collected pre and post intervention. 70 patients with BPD diagnosis were randomized to either
      mindfulness or interpersonal effectiveness skills training. Assessments were conucted
      pre-and-post-intervention.
    


Intervention name(s): Mindfulness skills training; Interpersonal Effectiveness skills training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness skills were taught over a 10-week period. Mindfulness skills were delivered in a weekly group-format. Participants were instructed to follow mindfulness practice at home. The treatment was focused on enhancing the patient capacity to defuse from cognitive and emotional content.; Interpersonal effectiveness skills were taught over a 10-week period. Skills were delivered in a weekly group-format. The treatment was focused on improving interpersonal effectiveness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mindfulness; emotion regulation; impulsivity
Egg Oral Immunotherapy
Condition: Egg Hypersensitivity
MeSH terms: Hypersensitivity; Egg Hypersensitivity
Study type: Observational

Summary: 
      For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management
      includes identification of the causative food and avoidance. Egg allergy is among the most
      common causes of IgE-mediated food allergy in children, affecting approximately 1.6% of
      children (its prevalence is higher in children with atopic dermatitis or other food
      allergies). Given the prevalence of egg and the difficulty to avoid it in the diet, we aim to
      investigate the safety and efficacy of baked egg oral immunotherapy.
    

Detailed description: 
      The primary objective is to study the efficacy of baked egg oral immunotherapy. The secondary
      objectives are to determine the safety of allergen-specific immunotherapy for egg allergy
      through ingestion of baked egg products and whether it will ultimately lead to a desensitized
      state for native egg. We will also examine if quality of life is improved by expansion of
      diets.

      Subjects aged six to 17 years with a history of egg protein allergy will be recruited from
      The Children's Hospital of Philadelphia (CHOP) Allergy practice (main campus and satellite
      locations).

      Prior to and after the desensitization to baked egg, we will conduct double blind
      placebo-controlled food challenges to native egg protein. During the desensitization phase,
      we will give increasing doses of baked egg (meringue cookie or equivalent) on a weekly basis,
      as tolerated.

      The primary endpoint of the study includes the percentage of subjects who can successfully
      complete the food challenge to native egg once they have completed the desensitization
      protocol to baked egg. Secondary outcome measures include egg-specific IgE, quality of life
      before and after desensitization, and egg skin prick test size.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        outpatient Allergy patients followed at The Children's Hospital of Philadelphia
      
Biospecimen description: 
      Immunocap testing (bloodwork) will be performed prior to and upon completion of the
      desensitization protocol. This testing is considered standard of care in the management of
      food allergies.
    
Keywords: Egg hypersensitivity; egg allergy; egg protein allergy
A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of romosozumab on parameters of bone
      quality of the forearm using peripheral quantitative computed tomography (pQCT) following
      multiple subcutaneous dose administrations of romosozumab in postmenopausal women with low
      bone mass.
    


Intervention name(s): Romosozumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 785; EVENITY™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amgen; Postmenopausal; Bone Density
Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The objective of this study is to provide evidence supporting the efficacy of fermented milk
      containing Lactobacillus casei strain Shirota in alleviating hard or lumpy stools. A
      randomized, controlled trial has been designed on constipated adults with a high prevalence
      of hard stools in Vietnam.
    


Intervention name(s): Lactobacillus casei strain Shirota fermented milk
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will take one bottle (65 ml) of Yakult® drink daily, containing at least 6.5 x 10^9 CFU of Lactobacillus casei strain Shirota, for a period of 4 weeks. Subsequently, there will be a two-week follow-up period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
FluAlert: Influenza Vaccine Alerts for Providers in the Electronic Health Record
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      Childhood influenza coverage rates are far below rates for the other childhood vaccinations.
      Increasing influenza vaccine coverage rates is important not only for the health of the
      child, but for that of the child's household and community. Yet,influenza vaccine delivery
      rates at pediatric clinics are low, even when the vaccine is available. The proposed project
      will take advantage of existing health information technology to tailor, implement and
      evaluate influenza vaccine alerts in the electronic health record (EHR) for pediatric
      providers to help improve health care decision making.
    


Intervention name(s): Provider Alert
Intervention type(s): Other
Intervention description(s): Provider influenza vaccine alert
Other intervention name(s): alert for provider in electronic health record
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: influenza, vaccine, clinical decision support
The Effect of Staining Beverage on Color Alteration During In-office Tooth Bleaching
Condition: Tooth Discoloration
MeSH terms: Tooth Discoloration
Study type: Interventional

Summary: 
      This double-blind randomized controlled clinical trial aimed to investigate the effect of
      staining beverage on color alteration of in-office tooth bleaching procedures.
    

Detailed description: 
      Sixty-three eligible participants (25 males and 38 females, mean age 26.5 years) with at
      least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly
      allocated into 3 groups (n = 21), according to the different staining beverage used in this
      clinical trial: Coffee for group C, Tea for group T, and distilled water for group W. All
      participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence
      Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). The
      participants will be instructed to use only the provided beverage rinses for 30 seconds, four
      times daily. Colour parameters (CIE L*, a*, b*) will be measured with a spectrophotometer
      (Vita Easyshade Advance 4.0) at baseline (T1), after the first bleaching session (T2), after
      the second bleaching session (T3), 1 week after the completion of in-office bleaching (T4),
      and 3 weeks after the completion of in-office bleaching (T5). The colour differences (ΔE) and
      whiteness index (W) will also be calculated. The data will be statistically analysed through
      repeated ANOVA and Tukey's test (α = 0.05).
    

Intervention name(s): making staining beverage rinse during in-office tooth bleaching
Intervention type(s): Behavioral
Intervention description(s): the subjects in experimental group should make staining beverage(coffee or tea) rinse for 30 second, four times daily.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: factorial assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tooth bleaching; staining beverage
Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix
Condition: Ovarian Cysts
MeSH terms: Ovarian Cysts
Study type: Interventional
Phase: Phase 3

Summary: 
      Laparoscopy has become the gold standard for the surgical treatment of benign ovarian cysts
      and is usually performed by stripping the ovarian cyst wall, followed by bleeding control of
      the ovarian wound ground using bipolar coagulation. However, the hemostasis with bipolar
      coagulation could result in the damage of ovarian reserve and decrease the response of the
      ovaries to hormonal stimulation for assisted reproductive technologies. The possible
      mechanism may contribute to thermal destruction of ovarian follicles by excessive use of
      bipolar coagulation for hemostasis purposes.

      To avoid additional ovarian tissue damage by conventional bipolar coagulation being
      potentially important ovarian reproductive function, hemostasis using various topical
      hemostatic agents has introduced to control post-cystectomy ovarian wound bleeding. Among
      them, FloSeal (Baxter Healthcare Corporation, Deerfield, IL, USA) is a hemostatic matrix
      sealant composed of a gelatin-based matrix and thrombin solution. On coming into contact with
      blood after application at a bleeding site, the gelatin particles swell and tamponade
      bleeding. The bulk of the gelatin matrix-thrombin composite has the effect of slowing blood
      flow and providing exposure to a high thrombin concentration, thus hastening clot formation.
      Therefore, it may more suitable for use in post-cystectomy ovarian wound bleeding, where
      there is superficially pervasive focus of bleeding.

      Ovarian reserve is defined as the functional potential of the ovary, which reflects the
      number and quality of antral follicles left in the ovary, and is correlated with the response
      to ovarian stimulation using exogenous gonadotropin. Serum anti-Müllerian hormone (AMH) has
      been accepted as the most reliable and easily measurable marker for postoperative assessment
      of ovarian reserve.

      The investigators conducted a multicenter, large-scale, randomized controlled trial to
      investigate whether hemostasis by Floseal was superior to that by bipolar coagulation in
      preserving ovarian reserve by assessing serial AMH levels in patients undergoing laparoscopic
      ovarian cystectomy for benign ovarian cysts.
    


Intervention name(s): Floseal; Bipolar coagulation
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment