bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Trans-Nasal Afferent Loop Decompression on Post-Pancreaticoduodenectomy Pancreatic Fistula
Condition: Pancreatic Fistula; Pancreaticoduodenectomy; Complication of Surgical Procedure
MeSH terms: Pancreatic Fistula; Fistula
Study type: Interventional

Summary: 
      Postoperative pancreatic fistula (POPF) is a major complication and an important cause of
      mortality after pancreaticoduodenectomy (PD). Trans-nasal afferent loop decompression
      technique (TNALD) may reduce the rate of POPF based on our previous retrospective study. The
      aim of this open-label randomized controlled trial is to determine whether TNALD is a
      protective factor against the development of POPF after PD.
    

Detailed description: 
      In our previous retrospective study, decompression of the afferent jejunal and pancreatic and
      biliary anastomoses with a special nasogastric tube and postoperative continuous closed
      negative pressure suction was shown to be associated with a reduction in overall POPF rate
      from 39% to 27% after PD. However, TNALD has the potential theoretical risk of increased
      morbidity including pulmonary complications and delayed gastric emptying.

      The objective of this prospective randomized study is to evaluate the impact of trans-nasal
      afferent loop decompression on the incidence of complications after PD, especially POPF rate
      according to International Study Group of Pancreatic Surgery (ISGPS) 2016 updates. We
      hypothesize that the TNALD may prevent the development of POPF after PD. This study
      randomizes patients to TNALD versus no TNALD group. Subgroup analysis of the outcomes in
      different POPF risk groups is also planned.
    

Intervention name(s): Trans-Nasal Afferent Loop Decompression; Without Trans-Nasal Afferent Loop Decompression
Intervention type(s): Procedure; Procedure
Intervention description(s): A 14Fr silicon tube with multiple side holes within the range of 15 cm from the tip will be placed into the afferent jejunal limb with its end close to the pancreaticojejunostomy (<3 cm) during the surgery. Continuous closed negative-pressure suction will be applied to that tube for 72 hours and after that the nasogastric tube will be removed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.; No decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lubiprostone and Mucus Secretion in Patients With Chronic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators hypothesize that the symptoms of chronic constipation in some patients are
      developed due to diminished production and secretion of the alimentary tract mucus resulting
      in poor lubrication.

      Therefore, the investigators assume that administration of lubiprostone may restore this
      lubrication impairment by stimulation of mucus production and secretion within the
      gastrointestinal tract.
    

Detailed description: 
      Specific Aim 1. To test the effect of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on
      gastric mucus production in 20 asymptomatic volunteers and 20 patients with chronic
      constipation in basal conditions (primary outcome).

      Specific Aim 2. To explore the effect of Lubiprostone, 24 mcg twice a day (BID) for 1 week,
      on gastric mucus production in 20 asymptomatic volunteers and 20 patients with chronic
      constipation during stimulation of gastric secretion with pentagastrin, mimicking the
      meal-stimulated conditions (primary outcome).

      Specific Aim 3. To address the influence of Lubiprostone, 24 mcg twice a day (BID) for 1
      week, on gastric mucin production, the major component of mucus, in 20 asymptomatic
      volunteers and 20 patients with chronic constipation in basal conditions (primary outcome).

      Specific Aim 4. To test the influence of Lubiprostone, 24 mcg twice a day (BID) for 1 week,
      on gastric mucin production, the major component of mucus, in 20 asymptomatic volunteers and
      20 patients with chronic constipation during stimulation of gastric secretion with
      pentagastrin, mimicking the meal-stimulated conditions (primary outcome).

      Specific Aim 5. To explore the impact of Lubiprostone, 24 mcg twice a day (BID) for 1 week,
      on viscoelasticity of gastric mucus in 20 asymptomatic volunteers and 20 patients with
      chronic constipation in basal conditions (secondary outcome).

      Specific Aim 6. To address the impact of Lubiprostone, 24 mcg twice a day (BID) for 1 week,
      on viscoelasticity of gastric mucus in 20 asymptomatic volunteers and 20 patients with
      chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the
      meal-stimulated conditions (secondary outcome).
    

Intervention name(s): lubiprostone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 24mcg twice a day (BID) 1 week; Placebo pills twice a day for one week.
Other intervention name(s): Amitiza
Intervention MeSH terms: Lubiprostone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Constipation
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Condition: Hematological Malignancy
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of
      multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in
      pediatric patients. The PK data will be utilized to establish a pediatric population PK model
      of isavuconazole, the active moiety of isavuconazonium sulfate.
    


Intervention name(s): isavuconazonium sulfate - intravenous; isavuconazonium sulfate - oral
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion; Oral
Other intervention name(s): Cresemba®; Cresemba®
Intervention MeSH terms: Isavuconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: invasive fungal disease; Cresemba®; Hematological malignancy; isavuconazonium sulfate; ASP9766; isavuconazole; pediatric population
The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries Upon Outcomes of Chronic Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The objective of this study is to determine whether enhanced micronutrient intake in the form
      of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in
      chronic periodontitis patients prior to standard non-surgical treatment.
    

Detailed description: 
      The objective of this study is to determine whether enhanced micronutrient intake in the form
      of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in
      chronic periodontitis patients prior to non-surgical treatment. In addition, the effects of
      supplementation prior to and following standard non-surgical management will be assessed,
      relative to a placebo supplemented group.

      The investigators hypothesize that 3-months of nutritional support using this FVB will result
      in additional reductions in marginal gingival inflammation (bleeding) and additional
      reductions in probing pocket depth (mean & cumulative), over and above any placebo-related or
      behavioral effect. In addition, the investigators hypothesize that 3-months of nutritional
      support prior to a standard non-surgical therapy in conjunction with a continuation of the
      nutritional support for 3 months will result in further additional reductions in marginal
      gingival inflammation and probing pocket depth, over and above any placebo-related or
      behavioral effect following standard non-surgical therapy.
    

Intervention name(s): Juice plus+; Placebo non active capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects in active group will be supplemented with Juice plus+ capsules (3 in the morning and 3 in the evening, for 3 months); Subjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: longitudinal, randomised, block stratified (for smoking), double-blind, 2-arm interventional study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Periodontitis; Dietary supplementation
Day Case Laparoscopic Sacrocolpopexy, a New Management
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      Facing the stakes of hospital beds, this study assessed day case variant technic of
      laparoscopic sacrocolpopexy with or without robotic assistant.
    

Detailed description: 
      Pelvic organ prolapse (POP) is an increasingly common functional disorder which affects
      approximately 40% of female population. Of these 12% are symptomatic and suffer of physical
      and emotional distress. 11% will undergo a surgical procedure. Since its introduction by Lane
      in 1982, Sacrocolpopexy (SCP) became the surgical "gold standard" for correcting vaginal
      vault .

      With minimal invasive approach, SCP had an mean hospitalization time of 3 to 7 days .

      With rising health care cost and its inherent economic burden, safe and viable options to
      reduce cost must be sought.

      Day case surgery has developed rapidly in the USA since the 1970s, and has spread to Europe,
      especially in Great Britain. But the High Authority of Health in France found a delay in its
      development.

      In view of the evolution of surgical and anesthetic techniques, and the low complication rate
      of SCP, it seemed natural to imagine that this intervention could be done in an ambulatory
      setting.
    

Intervention name(s): Cohort
Intervention type(s): Procedure
Intervention description(s): Patients undergoing ambulatory laparoscopic sacrocolpopexy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study cohort is selected from the investigators institution. All consecutive patients
        undergoing ambulatory laparoscopic sacrocolpopexy performed by two experimented urologist
        surgeons at the investigators university hospital, with an ambulatory department, was
        enrolled.
      
Keywords: Sacrocolpopexy; Day case surgery; Laparoscopic
A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a
      monomethyl fumerate (MMF) molecule.
    

Detailed description: 
      This study record was previously posted/updated by Alkermes, Inc. As of 29 Oct 2019, the
      sponsorship of the trial was transferred to Biogen along with responsibility for subsequent
      updates to the record.
    

Intervention name(s): Study Drug; Active Control; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): ALKS 8700 capsules; TECFIDERA® capsules; Placebo capsules
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alkermes; ALKS 8700
Mix Vaccine for Metastatic Sarcoma Patients
Condition: Metastatic Sarcoma; Reaction - Mixed Vaccine
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of mix vaccine to small metastases of
      sarcoma.
    

Detailed description: 
      By enrolling patients with small metastases of sarcoma adapted to enrolled criteria, this
      study will document for the first time the safety and the short and long term efficacy of mix
      vaccine.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Mix vaccine
Intervention type(s): Biological
Intervention description(s): Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
Other intervention name(s): Active immunotherapy for cancer
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL)
Condition: T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Immunoblastic Lymphadenopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by
      complete response rate at the end of treatment. Approximately 80 patients aged between 60 and
      80 years will be included, to have 70 evaluable patients. The treatment consists of two
      phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment
      duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be
      administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is
      taken for 14 days. Patients will be followed for at least 18 months after inclusion of the
      last patient.
    


Intervention name(s): Lenalidomide
Intervention type(s): Drug
Intervention description(s): Lenalidomide
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T-cell lymphoma; CHOp; lenalidomide
Pharyngeal Airway Dimensions With Twinblock Versus Myobrace Appliances in Developing Skeletal Class II Patients
Condition: Malocclusion, Angle Class II, Division 1
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the pharyngeal airway changes after treatment
      with Myobrace and after treatment with Twinblock in developing skeletal Class II patients.

      The main question it aims to answer is: Is the efficacy of the twin-block Vs Myobrace
      appliances in the improvement of pharyngeal airway dimensions in adolescents having skeletal
      Class II malocclusion with retrognathic mandible utilizing sagittal pharyngeal airway area
      measurements.
    


Intervention name(s): Myobrace Functional Appliance; Twin Block
Intervention type(s): Device; Device
Intervention description(s): An Appliance for treating growing Class II patients with mandibular deficiency; An Appliance for treating growing Class II patients with mandibular deficiency
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Airway; Myobrace; Twinblock
Concerta (Methylphenidate) -To-Generic Switch Study
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The primary purpose of this study is to identify whether, after adjustment for confounders
      via stratification on a propensity score and adjustment for calendar year, the combined
      endpoint consisting of #1 to #4 (1. switching back to Concerta, 2. changing the use of
      immediate release [IR] methylphenidate, 3. beginning a new attention deficit hyperactivity
      disorder [ADHD] medication, or 4. stopping both Concerta and the long acting [LA]
      methylphenidate {authorized generic [AG] methylphenidate or equivalent generic [EG]
      methylphenidate} that was begun on the index date), differs between participants who switch
      from branded Concerta to the EG formulations versus participants who switch from branded
      Concerta to the AG formulation.
    

Detailed description: 
      This is a retrospective cohort study based on a health claims database, the Truven Commercial
      Claims and Encounters (CCAE) database. Participants will enter the cohort when, after using
      Concerta continuously for at least 60 days after October 3, 2012, they receive a dispensing
      of the AG or EG formulation within 15 days of the end of the days of Concerta supplied. The
      date of that dispensing of the AG or EG formulation is the participants index date. This
      study will track various events, example, back-switches, and methylphenidate dose changes
      over time (the 60 days before the switch from Concerta to an AG or EG generic compared to the
      60 days after that switch).
    

Intervention name(s): Concerta; Concerta AG formulation; Concerta EG formulation
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This is an observational study. Participants who have been on Concerta for at least 60 days will be observed.; This is an observational study. Participants who have been on Concerta for at least 60 days and switch to authorized generic will be observed.; This is an observational study. Participants who have been on Concerta for at least 60 days and switch to equivalent generic will be observed.
Other intervention name(s): Methylphenidate; Methylphenidate; Methylphenidate
Intervention MeSH terms: Methylphenidate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in the Truven Commercial Claims and Encounters (CCAE) database who enroll in
        the study will have a confirmed diagnosis of ADHD and continuously used Concerta brand of
        methylphenidate for at least 60 days and receive a dispensing of the AG or EG formulation
        within 15 days of the end of the days of Concerta supplied.
      
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate
Does Cold Provocation Increase Brown Adipose Tissue Volume?
Condition: Brown Adipose Tissue, Human
Study type: Interventional

Summary: 
      About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of
      ability to avoid feeling cold, for 6 weeks. Basal metabolic rate and magnetic resonance (for
      determination of brown adipose tissue volume) imaging are performed before and after the
      study.
    


Intervention name(s): cold arm; warm arm
Intervention type(s): Procedure; Procedure
Intervention description(s): 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering; To the best of ability avoid feeling cold during 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: brown adipose tissue, human
Emergency Classification According to Fingertip Circulation
Condition: Dyspnea
MeSH terms: Dyspnea
Study type: Interventional

Summary: 
      Dyspnea is one of the most common reasons for admission to the emergency department[1].
      Oxygen saturation has great importance in determining the triage status of patients admitted
      to the hospital with dyspnea and planning the emergency treatment [2].

      Peripheral perfusion index (PI), which shows tissue oxygenation is a noninvasive way of
      demonstrating tissue perfusion in critically ill patients. Studies have shown that PI is an
      accurate, fast and reliable pulse oximetry-based indicator of tissue perfusion [3-5]. PI
      shows the perfusion status of the tissue in the applied area for an instant and a certain
      time interval. The PI value ranges from 0.02% (very weak) to 20% (strong) [6].

      Triage scales are used to distinguish emergency and non-emergency patients. The emergency
      triage system is used to quickly determine the care priorities of patients during admission
      to the emergency department[7,8].

      It is important to make the triage classification for dyspnea in emergency services quickly
      and accurately to start the treatment protocols as early as. In this study, the investigators
      aimed to determine the relationship between perfusion index and the emergency triage
      classification in patients admitted to the emergency department with dyspnea.
    

Detailed description: 
      Purpose: To determine the effect of PI measurement on the emergency triage classification in
      patients with dyspnea.

      Methods: Adult patients who presented with dyspnea and whose perfusion index values were
      measured with Masimo Radical-7 device at the time of admission, at the first hour and the
      second hour of admission were included in the study. The PI and oxygen saturation measured by
      finger probes were compared and the superiority of their effects on the emergency triage
      classification was compared.
    

Intervention name(s): Masimo Radical-7
Intervention type(s): Device
Intervention description(s): perfusion index measuring device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Dyspnea; Emergency; Perfusion index; Triage