bioihbjkbjnl/mcl2 huggingface dataset:
Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain
Condition: Bruxism; Temporomandibular Joint Disorders; Obstructive Sleep Apnea Syndrome
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Bruxism; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Facial Pain
Study type: Observational

Summary: 
      This study evaluated the influence of the sleep bruxism (SB), awake bruxism (AB) and
      obstructive sleep apnea syndrome (OSAS) on the signs and symptoms of temporomandibular
      disorders (TMD).
    

Detailed description: 
      Obstructive sleep apnea (OSA) is characterized by partial or total obstruction of the upper
      airways. Bruxism is defined as a repetitive activity of the mandibular musculature
      characterized by the tightening or grinding of the teeth and/or by the retrusion or
      propulsion of the mandible, and according to their manifestation circadian is defined as
      sleep bruxism (SB) or wake bruxism (AB). This prospective clinical study will be performed
      with adults (20 to 60 years) and elderly (> 60 years) (WHO-World Health Organization) who
      will be undergone polysomnography (PSG) at a private medical outpatients clinic from January
      to December 2019 to evaluate the influence of SB, AB, and OSA on signs and symptoms of TMD.
      The individuals will be assessed clinically and diagnosed for TMD using the "Diagnostic
      Criteria for Temporomandibular Disorders", for SB and OSA using PSG, and AB using the
      smartphone application. Specific statistical tests will be determined after preliminary
      analysis of the data (α= 0.05).
    

Intervention name(s): Evaluation of TMD and pain sensitivity; Evaluation of SB; Evaluation of AB
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Extra and intraoral clinical examination will be performed and the Diagnostic Criteria for Temporomandibular Disorders (DC / TMD) questionnaire will be applied. Measurements shall be bilateral in the masseter, anterior temporal and tenar muscles and the arithmetic mean between three measurements will be considered the value for each side for pain sensitivity analysis with an dynamometer.; The presence or absence of SB will be diagnosed by Polysomnography; A smartphone will be used, which was developed for a momentary evaluation that allows a report of the exact moment of AB and its possible associated symptoms.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All adults (aged 20 to 60 years) and elderly (aged > 60 years) who had undergone PSG at the
        Pelotas Sleep Institute (ISP), a private medical outpatients clinic, from January to
        December 2019, will be invited to participate in the study. Written consent was given by
        all participants who agreed to participate in the study.
      
Keywords: sleep bruxism; polisomnography; sleep wake disorders
A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer
Condition: Adenocarcinoma; Pancreatic Neoplasms; Neoplasm, Glandular; Neoplasms; Neoplasms Pancreatic; Digestive System Neoplasm; Endocrine Gland Neoplasms; Digestive System Disease; Pancreatic Diseases; Endocrine System Diseases
MeSH terms: Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Gastrointestinal Neoplasms; Neoplasms, Glandular and Epithelial; Endocrine Gland Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Pancreatic Diseases; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the clinical activity of gemcitabine,
      nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic
      pancreatic cancer.
    

Detailed description: 
      This was a two-part, single-institution, open-label, dose-escalation, phase 1/2 study to
      evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and
      irinotecan in patients with metastatic pancreatic cancer.

      Part 1 of the study was a Phase 1 3 + 3 dose escalation study designed to evaluate the
      maximally tolerated dose (MTD) and safety of increasing doses of nab-paclitaxel in
      combination with gemcitabine, capecitabine, cisplatin, and irinotecan. There were two cohorts
      of dose escalations. The two cohorts differed based on the treatment cycle length (28 days
      for Cohort 1 and 21 days for Cohort 2). Dose escalation started with Cohort 1. Enrollment for
      Cohort 2 dose level 1 began once dose level 2 of Cohort 1 was shown to be safe and did not
      exceed MTD.

      Part 2 was a Phase 2 expansion cohort study for the evaluation of efficacy once the MTD had
      been determined.
    

Intervention name(s): Nab-paclitaxel; Gemcitabine; Capecitabine; Cisplatin; Irinotecan; Nab-paclitaxel; Gemcitabine; Capecitabine; Cisplatin; Irinotecan
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): IV over 30 minutes; Days 1 and 15; IV over 30 minutes; Days 1 and 15; PO twice daily (BID); Days 1-7, 15-21; IV over 60 minutes; Days 1 and 15; IV over 30 minutes; Days 1 and 15; IV over 30 minutes; Days 4 and 11; IV over 30 minutes; Days 4 and 11; PO BID; Days 1- 14; IV over 60 minutes; Days 4 and 11; IV over 30 minutes; Days 4 and 11
Other intervention name(s): Abraxane; Gemzar; Xeloda; Platinol; Camptosar; Abraxane; Gemzar; Xeloda; Platinol; Camptosar
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Cisplatin; Gemcitabine; Capecitabine; Irinotecan
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CTPVB for Hepatectomy
Condition: Pain Management; Paravertebral Block; Hepatectomy
Study type: Interventional

Summary: 
      Moderate to severe postoperative pain often influence patients quality of recovery after
      hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after
      hepatectomy in many medical center, but the analgesic effect can be limited and undesirable
      side effects may bring about negative effects on patients recovery. Regional block has been
      proved to improve patients postoperative recovery in many kinds of surgeries.

      The investigators therefore designed a prospective, randomized, subject and assessor blinded,
      parallel-group, placebo controlled study to test the hypothesis that continuous right
      thoracic paravertebral block increase patients quality of recovery score on the 7th
      postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia
      (PCA) with morphine.
    


Intervention name(s): Continuous Paravertebral block with ropivacaine; Continuous Paravertebral "block" with saline; Patient-controlled analgesia with morphine
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Inject 25 ml 0.5% ropivacaine in the T8 paravertebral space followed with catheter insertion and continuous 0.2% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h).; Inject 25 ml 0.9% saline in the T8 paravertebral space followed with catheter insertion and continuous 0.9% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h).; Morphine given as intravenous patient-controlled analgesia bolus: 2mg, lock time: 5min, 1h limitation: 8mg
Intervention MeSH terms: Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller
Condition: Cardiac Surgery; Mechanically Ventilated Patients
Study type: Interventional

Summary: 
      The study compares automated settings (Intellivent) with protocolized settings of the
      ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory
      and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated
      settings are feasible and safe.

      The study design is a randomized controled study. 30 patients will be ventilated with
      automated mode and 30 patients with protocolized settings after cardiac surgery.

      The hypothesis is that the automated mode allows a safer ventilation with better maintain of
      the patient in predefined optimal zone of ventilation.
    

Detailed description: 
      Aim: feasibility and safety study = evaluation of the possibility for a fully automated
      ventilator to safely manage the ventilation and oxygenation after cardiac surgery

      Hypothesis:

      Intellivent will maintain the patient with " optimal ventilation " better than during usual
      management with a minimal number of interventions

      Monocentric: IUCPQ, Hôpital Laval, Québec Randomized controlled safety study, unblinded
      Patients after elective cardiac surgery Two arms Intellivent (fully automatic ventilation)
      Protocolized ventilation 4 hours study 60 patients planned to be included Primary outcome:
      number of episodes in the " not acceptable " zone of ventilation and duration

      Secondary outcome:

      Number of episodes in the " acceptable " zone of ventilation and duration Number of manual
      settings and duration of interventions Comparison of arterial blood gases Time to wean the
      FiO2 the PEEP Time to begin the assisted ventilation Duration of mechanical ventilation
    

Intervention name(s): Hamilton ventilator (G5 modify to S1) Automated settings; Hamilton ventilator (G5) protocolized settings
Intervention type(s): Device; Other
Intervention description(s): Automated settings (respiratory rate [RR], FiO2, Insp and exp pressures) Ventilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...); Mechanical ventilation settings performed by the respiratory therapists according to the local protocols
Other intervention name(s): Intellivent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiac surgery; mechanical ventilation; automation; weaning
Effects of Preservation Rhinoplasty Nasal Valve Angle and Area
Condition: Nasal Obstruction, Bilateral
MeSH terms: Nasal Obstruction
Study type: Interventional

Summary: 
      The study planned to compare the internal nasal valve angle measurements of patients who
      underwent preservation rhinoplasty before and after surgery.
    

Detailed description: 
      Nasal congestion is one of the most common complaints in Otorhinolaryngology medicine. One of
      the most common causes of this is the collapse or blockage of the Internal Nasal Valve (INV).
      The internal nasal valve is the narrowest part of the airway and creates the greatest
      resistance to airflow. Its most important function is to regulate the inspiratory airflow. It
      is determined by the angle formed between the caudal part of the upper lateral cartilage and
      the nasal septal cartilage. This angle normally varies between 9-15 degrees. The tip of the
      inferior turbinate and the tissues surrounding the piriform aperture may affect this area.
      When this angle is less than 9 degrees, the valve collapses in inspiration. The internal
      nasal valve region should be evaluated in every patient complaining of nasal congestion. the
      investigators planned to radiologically examine the improvement in the internal nasal valve
      angle of the patients we operated on.
    

Intervention name(s): Preservation Rhinoplasty Nasal Valve Angle and Area
Intervention type(s): Procedure
Intervention description(s): The same group of patients who underwent Preservation Rhinoplasty will be followed and the nasal valve angles before and after surgery will be compared.
Other intervention name(s): Preservation Rhinoplasty
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Carbohydrate on Amino Acid Absorption From Dietary Protein (ICADP)
Condition: Muscle Protein Synthesis; Amino Acid
Study type: Interventional

Summary: 
      10 young males will be recruited to participate in a randomized double blinded crossover
      study to investigate the influence of concomitant intake of two different types of
      carbohydrate with protein hydrolysate on the absorption kinetics of protein-derived amino
      acids and the impact on myofibrillar protein synthesis. During the trial days the subjects
      will perform a bout of whole body resistance exercise and ingest a supplement of meat
      hydrolysate labeled with D5-phenylalanine together with randomized and double blinded type of
      carbohydrate consisting of either glucose or cluster dextrin.

      The primary outcome is the time to obtain peak concentration of D5-phenylalanine after intake
      of meat hydrolysate with either glucose or cluster dextrin.

      Hypotheses:

      I) The cluster dextrin will increase the absorption of the amino acids from the meat
      hydrolysate, and thereby result in a faster rise and a higher peak in plasma amino acid
      concentration in the postprandial period.

      II) The meat hydrolysate will increase the protein synthesis rate to a higher extent when
      combined with cluster dextrin than with glucose.
    


Intervention name(s): Meat Hydrolysate; Cluster Dextrin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 25 grams of meat hydrolysate to maximally stimulate protein synthesis.; 75 grams of Cluster Dextrin; 75 grams of Glucose
Other intervention name(s): CAS no.: 9050-36-6; Glico Nutrition Co., Ltd.; Glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Carbohydrate; Cluster Dextrin; Exercise training; Protein supplement
Phase I Clinical Trial in Healthy Male Volunteers
Condition: Inflammatory Bowel Diseases
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers
      To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose.
    

Detailed description: 
      Eligible subjects will randomly recieve 1200 mg tablets (600 mg tablet X 2) or 1200 mg
      capsules (200 mg capsule X 6) of HMPL-011 under fed and fed circumstance in part 1. In part
      2, eight subjects will be enrolled and given 800 mg tablets (400 mg/tablet X 2) every 8 hours
      daily for 6 days (morning dose only on Day 6).
    

Intervention name(s): HMPL-011 tablets; HMPL-011 capsules
Intervention type(s): Drug; Drug
Intervention description(s): Eligible subjects will recieve 1200 mg HMPL-011 tablets under fed and diet circumstance.; Eligible subjects will recieve 1200 mg HMPL-011 capsules under fed and diet circumstance.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Exposure of Children With Asthma to Household Environmental Tobacco Smoke
Condition: Asthma; Lung Diseases
MeSH terms: Asthma; Lung Diseases
Study type: Observational

Summary: 
      To examine whether or not primary school-aged children with asthma from low-income households
      have lower household environmental tobacco smoke (ETS) exposure than matched control
      children.
    

Detailed description: 
      BACKGROUND:

      Children with asthma are particularly vulnerable to environmental tobacco smoke (ETS).
      However, despite this special vulnerability to ETS, children with asthma are at least as
      likely to live in smoking households, as are healthy children. Controversy exists, however,
      about whether or not the smoking members of households with children with asthma use specific
      strategies to reduce the harmful effects of their smoking on their children more than the
      smoking members of households of healthy children.

      DESIGN NARRATIVE:

      The case-control study examines whether or not primary school-aged children with asthma from
      low-income households have lower household ETS exposure than matched control children.
      Household ETS exposure will be measured by both objective monitoring, specifically passive
      nicotine dosimeters and child cotinine assays (the primary hypothesis), and maternal-report
      (the secondary hypothesis). Ninety children with physician diagnosed asthma and smoking
      mothers will be matched by age, gender, race/ethnicity, and other relevant variables to 90
      healthy children. All children will be recruited from Metro Denver clinics providing services
      to low-income, underserved populations. The sample will contain equal numbers of African
      Americans, Hispanics, and Whites. Recruitment will target low-income populations due to their
      increased prevalence of, and associated morbidity from both asthma and tobacco smoking.
      Specific household smoking behaviors, as reported by mothers, will be examined for
      association with household nicotine and child cotinine levels. Finally, a set of carefully
      chosen measures will be examined in tertiary, exploratory analyses to help understand,
      clarify, and contextualize the observed results.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD)
Condition: Chronic Granulomatous Disease
MeSH terms: Granuloma; Granulomatous Disease, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find a dose for a twice daily regimen for posaconazole (PSZ)
      as prophylactic treatment in children with CGD, based on the PSZ trough level.
    

Detailed description: 
      At this moment itraconazole is the drug of first choice in the prophylaxis of fungal
      infections in children with CGD. Breakthrough fungal infections while on itra-conazole
      prophylaxis are described in literature indicating the need for a drug with a broader
      antifungal spectrum. PSZ might provide in this need. PSZ may also have a clinical safety and
      tolerability advantage over other antifungal agents. Because PSZ is metabolized through phase
      II glucuronidation it is less common to be subject to drug interactions. PSZ is known to be a
      CYP3A4 inhibitor, but does not inhibit other CYP enzymes, therefore it may exhibit fewer drug
      interactions as compared with other azole antifungal agents.

      Treatment of children is still off-label use. No data have been published to date on the
      exposure of PSZ in children under the age of 8 or in children with CGD. There is an urgent
      need to study the use of PSZ in these young children. Furthermore, the current regimen for
      antifungal prophylaxis requires a three times daily administration of PSZ. For this specific
      purpose less complex dosing schedules are warranted thus defining the need to examine a twice
      daily schedule.

      As the tolerability and pharmacokinetics are unknown in patients under the age of 8 years and
      only limited data are available for age groups 8 to 16 years, we propose a feasibility study
      of a twice daily regimen of PSZ prophylaxis in CGD patients. With this information available
      we can suggest a dosage for future prophylaxis in this patient group.
    

Intervention name(s): posaconazole (PSZ)
Intervention type(s): Drug
Intervention description(s): Intake of PSZ oral suspension 40mg/ml twice daily with food. Starting dose is based on bodyweight. The dosage will be adjusted if the exposure is not adequate based on PSZ trough level on Day 10 and 20.
Other intervention name(s): Noxafil
Intervention MeSH terms: Posaconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prophylaxis; CGD; pharmacokinetics
Iron Supplementation and Side Effects
Condition: Iron Deficiency Anemia; Iron Overload
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies; Iron Overload
Study type: Interventional

Summary: 
      The objective of this study is to examine patient-reported gastrointestinal side effects, as
      well as iron status indicators, inflammatory markers and oxidative stress following
      administration of ferrous sulfate and iron-enriched Aspergillus oryzae supplementation.
    

Detailed description: 
      Iron deficiency anemia (IDA) afflicts more than 2 billion people globally, making it the most
      prevalent nutrient disorder, today. Inadequate dietary intake of iron results in consequences
      like cognitive decline, fatigue, abnormal growth and adverse pregnancy outcomes. These
      ramifications have associated burdens on economical progression due to decreased market
      productivity. Inorganic iron supplements like ferrous sulfate (FeSO4) are most commonly used
      to treat IDA, however known associated side effects occur, decreasing compliancy in
      individuals. Moreover, inorganic iron salts present a large bolus of iron to the intestinal
      lumen, resulting in non-transferrin bound iron which leads to systemic inflammation and
      further exacerbation of chronic diseases. Organic iron compounds have strong potential to be
      utilized for supplementation, however only under circumstances in which contain high
      absorbance. Seventeen subjects were randomized in a three-armed, double-blinded crossover
      design to examine the differences among three treatments (FeSO4, ASP-s and placebo). Outcomes
      will be to assess acute inflammatory proteins, oxidative stress, iron status indicators,
      non-transferrin bound iron and gastrointestinal-related side effects.
    

Intervention name(s): Ferrous sulfate; Aspiron; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 65 mg Fe as ferrous sulfate; 65 mg Fe as iron-enriched koji culture, called AspironTM; Contains maltodextrin.
Other intervention name(s): Aspergillus oryzae; Starch pill
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three armed, cross-over, double blinded design. Fifteen subjects will be randomized to treatment FeSO4, ASP or placebo for two week per treatment. Following each treatment, will be a two week washout period whereby subjects will not consume a supplement. Baseline and final blood draws of each treatment will be collected, in addition to serum collection at 0h, 1h, 2h, 3h, 4h following one dose to determine NTBI concentration curve.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: ferrous sulfate; non-transferrin bound iron; oral iron supplement; oral iron supplement side effects