bioihbjkbjnl/mcl2 huggingface dataset:
Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy
Condition: Digestive System Surgical Procedure; Pancreaticoduodenectomy
Study type: Interventional

Summary: 
      The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current
      practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity,
      delayed gastric emptying and finally an increased length of hospital stay.

      The absence of NG decompression could be the corner stone of the concept of the enhanced
      recovery program after PD.
    

Detailed description: 
      The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current
      practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity,
      delayed gastric emptying and finally an increased length of hospital stay. In the era of the
      enhance recovery after major abdominal surgery, the place of the NG tube remains unproven
      after PD even if NG tube is clearly abandoned in liver, stomach and colonic surgery.
      Nowadays, only few retrospective series had reported the feasibility of the absence of
      nasogastric tube after PD, but not with a randomized control trial. The absence of NG
      decompression could be the corner stone of the concept of the enhanced recovery program after
      PD.

      The objective of this prospective randomized monocentric study is to evaluate the impact of
      the absence of NG decompression after PD.

      The aim of the study is to decrease postoperative morbidity after PD including pulmonary and
      delayed gastric emptying complication. The impact of the absence of systematic NG
      decompression could be interesting in terms of public health with a decreased of length of
      hospital stay. Furthermore, this is the first randomized study comparing NG tube
      decompression after PD to absence of NG tube after PD which would bring relevant elements to
      improve the recovery after PD.
    

Intervention name(s): no nasogastric tube; nasogastric tube
Intervention type(s): Device; Device
Other intervention name(s): no double lumen nasogastric tube; double lumen nasogastric tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: nasogastric decompression
Vitamin D3 Supplementation in Pediatric IBD: Weely vs Daily Dosing Regimens
Condition: Inflammatory Bowel Disease (IBD)
MeSH terms: Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      The purpose of this prospecitve randomized controlled trial is to compare effectiveness and
      patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with
      Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or
      deficient. The primary aim of this pilot study is to evaluate the effectiveness of once
      weekly verses daily D-3 dosing regimens based on the most current IBD supplementation
      guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference
      in adherence between dosing regimns.
    


Intervention name(s): Vitamin D-3
Intervention type(s): Dietary Supplement
Intervention description(s): Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a routine clinic visit or lab draw that included a 25(OH)D level as part of clinical practice/standard care. Once consent and assent are obtained, the children who are 25-hydroxyvitamin D [259OH)D] insufficient or deficient will be randomly assigned to a daily or weekly dosing regimen using block randomization to ensure equal group size.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be
        recruited at the time of a rountine clinic visit or lab draw that includes a 25(OH)D level
        as part of a clinical practice/standard of care.
A Study of Milvexian Using an IV Microtracer With Additional Formulation and Food Effect Comparison in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the absolute oral bioavailability (amount of drug
      entering the bloodstream) of spray-dried dispersion (SDD) milvexian capsules in the fed and
      fasted states, and to bridge the exposures seen using only the oral solution.
    


Intervention name(s): BMS-986177 Oral Solution; [14C]BMS-986177 Solution for Infusion; BMS-986177 Spray-dried Dispersion Capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): Milvexian, JNJ-70033093
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; BMS-986177; 14C-Microtracer; Milvexian
Seroquel for Frequent, Heavy Drinkers
Condition: Alcoholism
MeSH terms: Alcoholism; Alcoholic Intoxication
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effects of quetiapine in reducing percent heavy
      drinking days and increasing percent abstinent days in alcohol dependent patients who are
      frequent heavy drinkers.
    

Detailed description: 
      This trial is a phase 2, randomized, double-blind, placebo-controlled, parallel group trial
      intended to assess the efficacy of quetiapine compared to placebo in alcoholics who are
      frequent heavy drinkers.
    

Intervention name(s): Seroquel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg/day; 400 mg/day
Other intervention name(s): quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of PKU Explore
Condition: Phenylketonuria; Inborn Errors of Metabolism
MeSH terms: Phenylketonurias; Metabolism, Inborn Errors
Study type: Interventional

Summary: 
      To evaluate the acceptability, tolerance and effect on metabolic control of PKU Explore, a
      renovated Phe free protein substitute for the dietary management of PKU in children from 6
      months to 5 years.
    

Detailed description: 
      This is a prospective, acceptability study to evaluate the gastrointestinal tolerance,
      palatability and adherence of PKU explore in a four-week period for 15 participants aged
      between 6 months and 5 years for the dietary management of PKU.

      The outcome of this assessment will be used in a submission to the regulatory authorities,
      Advisory Committee on Borderline Substances (ACBS), for PKU Start to become reimbursable on
      prescription in the UK.

      The participant's dietitian will advise on an appropriate amount of PKU Explore based on
      individual requirements. Parents/carers will be asked to substitute their usual Phe-free
      protein substitute with PKU Explore for one (1) month. The sponsor will supply PKU Explore
      free of charge.

      Parents/guardians will be asked to record information about the following:

      Daily PKU Explore intake Stools Vomiting and Spit-up Feed / Fluid Intake Compliance
      Phenylalanine Levels (from their routine blood spot testing)

      Final Evaluation about the presentation of the product, ease of preparation and use.
    

Intervention name(s): PKU Explore
Intervention type(s): Dietary Supplement
Intervention description(s): PKU Explore is an unflavoured, powdered, phenylalanine-free, protein substitute, containing essential and non-essential amino acids, carbohydrate, sugar, vitamins, minerals, trace elements and the long chain polyunsaturated fatty acids (LCPs); arachidonic acid (AA) and docosahexaenoic acid (DHA).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phenylketonuria; PKU; Metabolism; Metabolic; Control; Acceptability
Study to Investigate Dose Proportionality of the Fixed Dose Combination of COREG CR and Lisinopril.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, single-dose, non-randomized, five-period crossover study in
      healthy volunteers. The duration of the study will last up to eleven weeks from screening to
      follow-up. PK samples will be taken.
    


Intervention name(s): COREG CR and lisinopril (FDC)
Intervention type(s): Drug
Intervention MeSH terms: Lisinopril
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COREG CR,; lisinopril,; hypertension,; dose proportionality,; fixed dose combination (FDC)
Effect of Brivaracetam in Photosensitive Epileptic Subjects
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive
      epileptic subjects
    


Intervention name(s): Brivaracetam
Intervention type(s): Drug
Intervention MeSH terms: Brivaracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: POC; photosensitive; epileptic; brivaracetam; PPR; AED
Use of the Perinatal Database and Biologic Tissue Bank at The Perinatology Research Branch (PRB)
Condition: Pregnancy; Premature Birth; Prenatal Care; Preterm Delivery; Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of this application is to request permission to use a bank of biological
      specimens and clinical information collected by the investigators prior to their joining the
      intramural program. The samples have been gathered under the sponsorship and approval of the
      Human Investigations Committees at Yale University, Wayne State University and Pennsylvania
      Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad
      de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a
      bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of
      delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic
      examinations of the fetus, including echocardiography, stored on videotapes. Clinical
      information with patient identifiers is available for these samples and sonographic
      examinations.
    

Detailed description: 
      The purpose of this application is to request permission to use a bank of biological
      specimens and clinical information collected by the investigators prior to their joining the
      intramural program. The samples have been gathered under the sponsorship and approval of the
      Human Investigations Committees at Yale University, Wayne State University and Pennsylvania
      Hospital in the United States, the Sotero del Rio Hospital, the Hospital of the Universidad
      de Chile and the Universidad Catolica de Chile , in Chile. The investigators have generated a
      bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of
      delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic
      examinations of the fetus, including echocardiography, stored on videotapes. Clinical
      information with patient identifiers is available for these samples and sonographic
      examinations.
    

Observational model: Cohort
Time perspective: Retrospective
Keywords: Pregnancy; Preterm Birth; Preterm Birth Prevention; Prematurity; Pregnancy Complications
Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants
Condition: SARS-CoV2 Infection; COVID-19; SARS-CoV-2 Acute Respiratory Disease; SARS (Disease)
MeSH terms: COVID-19; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial consists of three parts, Part A, Part B, and Part C, and will evaluate the safety
      and immunogenicity of a third booster injection of the multivalent vaccine BNT162b2 (B.1.1.7
      + B.1.617.2), and the safety and immunogenicity of a third booster injection of the
      monovalent vaccine BNT162b2 (B.1.617.2) or BNT162b2 (B.1.1.7), in participants who have
      received two doses of the parent vaccine BNT162b2 at 30 µg, at least 6 months after the
      second dose of BNT162b2. It will also evaluate the safety and immunogenicity of a three-dose
      regimen of BNT162b2 (B.1.1.7 + B.1.617.2) in participants who have not received prior
      Coronavirus Disease 2019 (COVID-19) vaccination. In addition, the safety and immunogenicity
      of BNT162b2 (B.1.1.529.1) or BNT162b2 given as a third or fourth vaccine dose to RNA COVID-19
      vaccine-experienced participants with history of SARS-CoV-2 infection will be evaluated and
      contrasted with the natural immune response reached after infection with the SARS-CoV-2
      Omicron variant.
    

Detailed description: 
      Trial participants in Part A will be assigned to one of 6 cohorts (Cohort 1-6). Trial
      participants in Part B will be assigned to one of 3 cohorts (Cohort 1, 4, and 6). Trial
      participants in Part C will be randomized in a 2:2:1 ratio into 3 cohorts (Cohort 7-9).
    

Intervention name(s): BNT162b2; BNT162b2 (B.1.1.7 + B.1.617.2); BNT162b2 (B.1.1.7); BNT162b2 (B.1.617.2); BNT162b2 (B.1.1.529.1); Observational
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Other
Intervention description(s): Intramuscular (IM); Intramuscular (IM); Intramuscular (IM); Intramuscular (IM); Intramuscular (IM); No vaccination within 3 months after Visit 1.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A+ Treatment/Feasibility of Adapted ESDM-informed Caregiver Coaching Delivered Remotely for Children With ASD and ADHD
Condition: Autism Spectrum Disorder; Adhd
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study will evaluate the feasibility of adapted ESDM-informed caregiver coaching in
      children with comorbid ASD and ADHD, who are between 36 and <132 months of age. There will be
      no study provided medication treatment in this study. Children will either be on ADHD
      medication prescribed by their own personal provider or will not be taking any ADHD
      medication (this will be documented by the study). The provided behavioral treatment will be
      eight ~60-minute sessions in ESDM-informed caregiver coaching delivered remotely through
      telehealth, for 8 consecutive weeks. The behavioral treatment is provided to children through
      Early Start Denver Model (ESDM)-informed caregiver coaching strategies, implemented within
      the child's typical daily routine by the caregiver.
    

Detailed description: 
      The overarching goal of A+ Treatment is to evaluate feasibility and gather pilot data of
      remotely-delivered ESDM informed caregiver coaching for children with ASD and ADHD which may
      inform future combination clinical trials (pharmacotherapy and behavioral intervention).
      Using an implementation science approach, the investigators will characterize the
      acceptability, appropriateness, feasibility and fidelity of remote behavioral intervention.
      Approximately 30-35 participants who are between 36 months and <132 months of age with
      comorbid ASD and ADHD will take part in this study, which includes parent coaching sessions
      completed remotely. Total participation is expected to require a maximum of 20 weeks,
      including optional remote follow-up at 16 weeks. The A+ Treatment diagnostic and screening
      visits will generally occur between 1 and 6 weeks prior to baseline. The provided behavioral
      treatment will be eight ~60-minute weekly sessions of ESDM-informed caregiver coaching
      delivered remotely through telehealth, for 8 consecutive weeks. Endpoint assessments will be
      completed after the final coaching visit. No medication will be provided by the study team.
      The final assessment will be obtained at 16 weeks after baseline.
    

Intervention name(s): P-ESDM informed caregiver coaching
Intervention type(s): Behavioral
Intervention description(s): Caregiver coaching informed by P-ESDM done remotely (via telehealth)
Intervention model: Single Group Assignment
Intervention model description: Feasibility trial
Masking: None (Open Label)
Primary purpose: Treatment
Automated Harness Tightener for Child Safety Seat
Condition: Child Passenger Safety
Study type: Interventional

Summary: 
      The overall objective of this study is to evaluate the efficacy of a tensioning progress
      indicator light to achieve proper harness tensioning in child safety seats.
    

Detailed description: 
      The primary objective of the study is to determine whether a prototype convertible child
      safety seat with visual indication of successful tensioning technology reduces the amount of
      harness slack compared with a standard safety seat. The secondary objective of the study is
      to assess caregivers' perceptions of the quality, design, and ease of use of the prototype
      child safety seat tensioning progress indicator lights. Participants will be
      parents/caregivers aged 18 to 75 years of children between 6 and 24 months of age.
      Approximately 130 caregiver-child dyads will be enrolled. Participants will be asked to
      harness their child into two versions of a convertible child safety seat, twice in each car
      seat. The intervention seat will be equipped with the technology that gives visual indication
      of successful harness tensioning. Participants will be observed, assessed, and asked a series
      of survey questions after each harnessing period.
    

Intervention name(s): Prototype child safety seat with tension indicator lights; Control child safety seat
Intervention type(s): Device; Device
Intervention description(s): The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.; The control child safety seat is a convertible rear-facing seat without tension indicator lights.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a 2-treatment, 4-period, 4-sequence crossover design. Each enrolled dyad will experience the prototype seat two times and the control seat two times for a total of four harnessing periods. The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants.
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D for Schizophrenia
Condition: Clozapine Resistant Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Background: Despite improvements in medications, treatment delivery and rehabilitation,
      schizophrenia outcomes remain suboptimal. There are a proportion of 30-40%
      treatment-resistant schizophrenia patients. Multiple lines of evidence suggest that vitamin D
      is a neuro-active steroid that acts on brain development, leading to alterations in brain
      neurochemistry and adult brain function. Early deficiencies have been linked with
      neuropsychiatric disorders, such as schizophrenia, and adult deficiencies have been
      associated with adverse brain outcomes, including Parkinson's disease, Alzheimer's disease,
      depression and cognitive decline. Ecological studies support a potential role for vitamin D
      in schizophrenia. These data include studies that have explored the association between
      schizophrenia and winter/spring birth and also the apparent increased incidence and
      prevalence of schizophrenia at higher latitudes. Objective: To evaluate the effect of
      vitamin-D supplementation on the mental state of clozapine-treated chronic schizophrenia
      patients, and the relation of disease severity to serum vitamin D levels. Methods: the
      investigators will use a prospective, interventional, longitudinal, double blinded,
      placebo-controlled, randomized design. The investigators will recruit 50 clozapine-treated
      chronic schizophrenia patients, with low level of serum vitamin-D, that will be randomly
      assigned (1:1 ratio) to receive either weekly oral drops of vitamin D (Cholecalciferol) or
      oral drops of placebo for 8 weeks follow-up. Repeated assessments will include: clinical
      severity scales (PANSS, CGI), side effects (SAS, BARS, clozapine side effects), cognitive
      (MoCA), metabolic parameters and laboratory data. Patients who were assigned to placebo will
      be supplemented with vitamin D after the 8 weeks period, and then will be assessed again with
      the same protocol of vitamin D treated patients. All participants will be assessed again
      after 24 weeks after vitamin D initiation. Analysis: the investigators will use on-way ANOVA
      with repeated measures for comparison of vitamin D and control groups. The investigators will
      apply intention to treat and LOCF.
    


Intervention name(s): Vitamin D3; placebo
Intervention type(s): Drug; Drug
Intervention description(s): once weekly oral drops preparation at a daily dose of 2000 IU X 7 = 14,000 IU per week (about 60 drops each week).
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clozapine; Schizophrenia; Vitamin-D; Treatment-resistant