bioihbjkbjnl/mcl2 huggingface dataset:
Extended Resection After Positive Intraoperative Pathology in Gastric Cancer Surgery
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      Of 737 consecutive patients undergoing (sub)total gastrectomy for gastric or GEJ
      adenocarcinoma, 679 cases with curative intent surgery between 05/1996 and 03/2019 were
      included. Patients were categorized into: i) R0 without further resection (direct R0), ii) R0
      after positive IOC and extension of resection (converted R0) and iii) R1.
    

Detailed description: 
      This retrospective cohort study was performed at our tertiary referral center at the
      University Hospital of Cologne, Germany. Since 1st May 1996 medical charts of patients who
      undergo surgery for gastric or GEJ adenocarcinomas are collected in a department internal
      database for research analyses (Chairman since 05/2016 CJ Bruns, from 5/1996-4/2016 AH
      Hölscher).

      In this study, patients undergoing curative surgery between 1st May 1996 and 31st March 2019
      with (sub)total gastrectomy for gastric or GEJ adenocarcinoma were included. Palliative
      resections and resections with transthoracic esophagectomy and gastric pull-up were excluded.

      Demographics, perioperative treatment, survival and clinicopathologic data were obtained.
      Medical records were reviewed and complications were categorized according to Clavien-Dindo
      classification.

      Depending on IOCs, extended resection and final pathology report a treatment flow-chart was
      created (Figure 1): Patients were grouped on a) IOC received (yes/no), b) IOC positive
      (yes/no), c) extended resection (yes/no), d) second IOC (IOC2; yes/no), e) IOC2 positive
      (yes/no) and final pathology results (R0/R1). The decision to perform IOC and to carry out
      extended resection in case of positive IOC was at the discretion of the treating surgeon.
      Patients were then categorized into 3 subgroups according to final R status: R0 after
      extended resection (i.e. converted R0), R0 without extended resection (i.e. direct R0) and
      R1.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        This retrospective cohort study was performed at our tertiary referral center at the
        University Hospital of Cologne, Germany. Since 1st May 1996 medical charts of patients who
        undergo surgery for gastric or GEJ adenocarcinomas are collected in a department internal
        database for research analyses (Chairman since 05/2016 CJ Bruns, from 5/1996-4/2016 AH
        Hölscher).

        In this study, patients undergoing curative surgery between 1st May 1996 and 31st March
        2019 with (sub)total gastrectomy for gastric or GEJ adenocarcinoma were included.
      
Keywords: excision margin; prognosis; gastric cancer; resection
Immediate Effects of Two Semi-occluded Vocal Tract Exercises
Condition: Voice
Study type: Observational

Summary: 
      This study aims to observe the physiological effects of two different Semi-occluded vocal
      tract (SOVT) exercises in the larynx when they are executed by individuals with constant
      vocal effort and without vocal pathology.
    

Detailed description: 
      SOVT is a voice education or rehabilitation method that involves different postures which
      partially occlude or elongate the vocal tract. It causes a change in the vibration pattern of
      the vocal folds. SOVT postures have been postulated to produce changes in contact quotient
      (CQ), measured with electroglottograph (EGG). This study aims to observe the physiological
      effects of two different SOVT exercises in larynx when they are executed by people with
      constant vocal effort and without vocal pathology. In order to do so, EGG will be performed
      before and after 43 volunteers execute two SOVT exercises (tongue trill and resonance tubes).
      The following parameter will be captured: CQ. A t-paired test will be performed to compare
      pre and post-test information. Furthermore, a generalized estimating equation will be fit to
      find the effects of each exercise in the subjects.

      This protocol was modified due to different administrative issues related to the use of the
      stroboscopy (one of the assesment tools previosly considered), so that stroboscopy was
      removed from the protocol.
    

Intervention name(s): Resonance tube; Tongue trill
Intervention type(s): Other; Other
Intervention description(s): Participants will phonate into a tube (10cm length 4mm inner diameter) during 5 minutes. They will produce series of the vowel /u/ into the tube. They will be asked to maintain the same pitch and loudness as they did in the baseline samples. They will be perceptually controlled by experimenters. When performing the exercise, the participants will be instructed to phonate with ease voice and to sense vibrations in the anterior face and the mouth.; Participants will produce series of a similar /r/ Spanish sound during 5 minutes. They will be asked to maintain the same pitch and loudness as they did in the baseline samples. They will be perceptually controlled by experimenters. When performing the exercise, the participants will be instructed to phonate with ease voice and to sense vibrations in the anterior face and the mouth.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy university teachers despite constant vocal effort, without past voice training or
        therapy.
      
Keywords: Semi-occluded vocal tract; resonance tubes; tongue trill; voice therapy
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind,
      parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I
      or Bipolar II disorder having a major depressive episode.
    


Intervention name(s): Lumateperone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Lumateperone 42 mg (ITI-007 60 mg tosylate); Placebo
Other intervention name(s): ITI-007
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Evaluation of Giomer and Resin-based Fissure Sealants
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

Summary: 
      The objective of this research was to evaluate the clinical success of giomer and resin-based
      sealants applied in the first permanent molars (FPMs) affected by MIH.
    

Detailed description: 
      One-hundred FPMs with MIH which were indicated for non-invasive fissure sealant were selected
      in 39 children (between 6-12 years). Using a split mouth design, the FPMs were randomized
      into two groups; Group 1: resin sealant (Conceal F); Group 2: giomer sealant (BeautiSealant)
      and dental isolation device was used during the procedure (Mr. Thursty). Clinical evaluation
      was performed by two blinded examiners using the United States Public Health Service (USPHS)
      criteria to assess anatomical form, marginal adaptation, surface texture, marginal
      discoloration, retention and secondary caries at 1, 3, 6 and 12 months. Statistical analysis
      was performed using SPSS 20.0 software (IBM Corp., Chicago, IL, USA) and the level of
      significance was set at p<0.05. The association between independent variable (groups) and
      dependent variable (USPHS scores) was evaluated with Fisher's exact test. The crosstabulation
      of the categorical data regarding the groups were analyzed with chi-square test or Fisher's
      exact test. The Log-rank test and Kaplan-Meier analysis were used to calculate and compare
      the cumulative survival rates of the sealants.
    

Intervention name(s): Resin-based sealant; Giomer sealants
Intervention type(s): Device; Device
Intervention description(s): Etching with 37% phosphoric acid for 30 s (i-GEL N, i-dental, Lithuania), rinsing for 30 s with air-water spray and drying with oil-free air for 15 s, resin sealant (Conceal F, SDI, Australia) application into the occlusal and buccal/palatal pits and fissures with direct placement syringe system and light curing with 460-500 nm wavelength halogen light unit (Hilux Dental Curing Light Unit 250, Benlioğlu Dental Inc, Turkey) for 20s on each surface.; Self-etch primer (BeautiSealant Primer, Shofu, Japan) application to the occlusal and buccal/palatal pits and fissures with fine microbrush and waiting for 5 s, homogenizing the bond layer with gentle air stream for 5 s, giomer sealant application (BeautiSealant Paste, Shofu, Japan) with direct placement syringe system and light curing with 460-500 nm wavelength halogen light unit (Hilux Dental Curing Light Unit 250, Benlioğlu Dental Inc, Turkey) for 20 s on each surface.
Other intervention name(s): Conceal F; BeautiSealant
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two intervention groups and split-mouth design
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: molar incisor hypomineralization; giomer fissure sealants; resin sealants; adhesion
Effect of Vitamin D3 and Omega-3FA on Estradiol
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The effect of vitamin D3 and omega-3 Fatty acids on estradiol levels.
    

Detailed description: 
      The data about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum levels
      of estradiol (E2) are scarce and conflicting and nothing is published in the literature about
      the effect of the combination of VD3 and omega-3FA on the E2 levels.

      This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other
      on serum E2 levels in premenopausal females with vitamin D deficiency (VDD).

      This randomized, placebo-controlled clinical trial was designed to test effects of 50,000 IU
      VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on the
      mid-follicular serum levels of E2 and 25-hydroxy vitamin D (25OHD). This study was conducted
      during winter in 86 healthy premenopausal Jordanian females with VDD with a mean age of (32.8
      ± 8.9) years. Fasting serum levels for 25OHD, E2, PTH (parathyroid hormon), calcium,
      phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of
      the trial.
    

Intervention name(s): VD3; Omega3-FA; VD3 and Omega-3FA; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 50,000 IU VD3 / week for 8 weeks; 300 mg of omega3-FA once daily for 8 weeks; 50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks; No intervention was given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vitamin D3; Vitamin D deficiency; estradiol; omega-3 fatty acids; menopausal
Safety, Tolerability and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With NAFLD
Condition: Liver Transplant; Complications; NAFLD
MeSH terms: Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the
      safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant
      recipients with NAFLD.
    

Detailed description: 
      This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the
      safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant
      recipients with NAFLD.

      The study will be conducted over a period of up to 33 weeks and will include 5 weeks
      screening, a 24 week treatment period and 4 week follow-up period. The primary end point of
      the study is to assess the safety of Saroglitazar Magnesium 4 mg in liver transplant
      recipients with NAFLD over 24 weeks of treatment.
    

Intervention name(s): Saroglitazar
Intervention type(s): Drug
Intervention description(s): Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Other intervention name(s): Not any
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peroxisome proliferator-activated receptors; NAFLD; NASH; Post Transplant Metabolic Syndrome
Effectiveness Trial for Project SafeCare for Child Neglect
Condition: Child Neglect
Study type: Interventional

Summary: 
      The study is a field trial comparing the SafeCare family preservation model to a comparable
      usual care model for parents in child welfare. The study also compares two levels of service
      quality control.
    

Detailed description: 
      The study is a cluster-randomized field trial of the SafeCare(SC) home-based family
      preservation model for families in the child welfare system. The trial is conducted in
      collaboration with the state child welfare agency and their contracted in-home service
      system. The service system is regionalized and provides in home services to families referred
      by child welfare. Regions of the state are assigned by the study to either the SC model or to
      services as usual. Provider teams, nested within regions, are assigned to either a monitored
      or unmonitored model implementation quality control condition. The aims of the project are to
      test client level child welfare reentry outcomes between SC and standard conditions, across
      the two implementation and quality control conditions.
    

Intervention name(s): SafeCare; In vivo coached quality control; Services As Usual; Uncoached
Intervention type(s): Behavioral; Other; Behavioral; Other
Intervention description(s): Behavioral home based family preservation. Weekly visits X six months.; Live observation of practice with expert coaching, feedback and fidelity monitoring; Home based services not using the SafeCare model; No in vivo coached quality control or fidelity monitoring
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: child abuse
The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters
Condition: Ventricular Septal Defect; Closure; Interventricular Septum; Autonomic Nervous System Imbalance
MeSH terms: Heart Septal Defects; Heart Septal Defects, Ventricular
Study type: Observational

Summary: 
      In this study; we evaluated the heart rate variability parameters of pediatric patients whose
      VSDs were closed with the transcatheter method before and after, and compared with the
      control group.
    

Detailed description: 
      Heart rate variability (HRV) is a sign of cardiac autonomic nervous system. Evaluation of HRV
      in pediatric ventricular septal defect (VSD) cases before and after transcatheter closure
      will enlighten us in terms of cardiac autonomic control.

      Methods: 19 VSD cases treated with transcatheter closure method and 18 healthy children were
      enrolled in the study. 24 hours Holter rhythm monitorization was applied to all patients
      before closure of VSD and to the control group. In the patient group, Holter rhythm
      monitorization was repeated in the third months. HRV parameters were obtained from Cardio
      Scan Premier 12® program. Frequency domain (Total power, VLF, LF, HF, LF/HF ratio) and time
      domain analysis (SDNN, SDANN, SDNNi, pNN50, rMSSD) were applied.
    

Intervention name(s): 24 hours ambulatory Holter monitoring
Intervention type(s): Diagnostic Test
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patient group consists of pediatric patients who underwent transcatheter VSD closure in
        our institute.

        The control group consists of children who admitted to our institute with the complaint of
        palpitations and had a normal Holter record.
      
Keywords: ventricular septal defect; heart rate variability; percutaneous VSD closure
Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of
      Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to
      provide necessary safety and immunogenicity data for the lyophilized formulation of V710
      prior to its subsequent evaluation in patients at risk for developing serious S. aureus
      infections.
    


Intervention name(s): Comparator: V710; Comparator: placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.; Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: study in healthy subjects
Maxolon to Improve Breastmilk Supply in Diabetic Women: a Randomised Controlled Trial
Condition: Breastfeeding
Study type: Interventional
Phase: Phase 3

Summary: 
      Early use of oral maxalon can hasten and improve the establishment of breastfeeding in
      diabetic mothers after preterm and term deliveries.

      Maxolon promotes breastfeeding by working on the central nervous system which increases the
      milk producing hormone, prolactin which in turn helps to increase the milk supply for
      breastfeeding. Successful early breastfeeding establishment is important for continued
      breastfeeding.
    

Detailed description: 
      The study aims to determine the breastfeeding initiation and duration rate of a cohort of
      pregnant women with gestational diabetes(diet-controlled) and insulin dependent and
      pre-existing diabetes, assess the impact of a post natally administered galactogogue,
      metoclopramide on the milk volume production and timing of lactogenesis II in diabetic women
      on diet control and insulin and determine the prolactin response to lactation among diabetic
      women on diet control and insulin.
    

Intervention name(s): Metoclopramide (Maxolon); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metoclopramide 10 mg 3 times a day for 7 days, 2 times a day from day 8 to day 10, once a day for day 11 and 12; Placebo 10 mg 3 times a day for 7 days, 2 times a day from day 8 to 10, once a day from day 11 to 12
Other intervention name(s): Maxalon
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Beginning of breastfeeding
Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
Condition: Myasthenia Gravis, Generalized
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 3

Summary: 
      The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to
      confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized
      Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of
      0.3 mg/kg zilucoplan or placebo for 12 weeks.
    


Intervention name(s): zilucoplan (RA101495); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily subcutaneous (SC) injection; Daily subcutaneous (SC) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this study is to assess the safety and tolerability of AZD1446 following
      single and multiple ascending doses of an orally administered solution of AZD1446 in healthy
      young and elderly Japanese subjects.
    


Intervention name(s): AZD1446; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel.; Oral solution Dose single and followed by 7-day multiple dosing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: safety; tolerability; AZD1446; AD; Japanese
Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi
      antibody response following secondary vaccination with the Novartis Vaccines Institute for
      Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either
      the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01_04TP study (NCT01193907) and
      the immunogenicity and the kinetics of the anti-Vi antibody response following primary
      vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.
    


Intervention name(s): NVGH Vi-CRM197
Intervention type(s): Biological
Intervention description(s): Vi-CRM197 glycoconjugated vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Typhoid fever; Glycoconjugate vaccine; Vi polysaccharide; Immunogenicity