bioihbjkbjnl/mcl2 huggingface dataset:
Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia
Condition: Oropharyngeal Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      The purpose of this trial is to design, implement and evaluate the effect of a nutritional
      intervention in patients with Oropharyngeal Dysphagia on body composition and oral intake of
      energy and protein.
    

Detailed description: 
      Oropharyngeal Dysphagia causes complications that compromise the efficacy and security of
      deglutition. An inefficacy deglutition increases the risk of malnutrition and/or dehydration.
      On the other hand, unsafe deglutition requires more time to complete the oral preparation of
      the bolus, which can leave residues in the mouth that can then lead to penetration of small
      food particles into the respiratory tract. These tracheobronchial aspirations cause
      aspiration pneumonia in 50% of cases, with 50% of mortality rate.

      Despite the enormous impact of Oropharyngeal Dysphagia in functional capacity and quality of
      life, this problem is underestimated and underdiagnosed as a major cause of nutritional and
      pulmonary complications that generate more material and human resources. There are few
      studies evaluating the effect of a nutritional intervention on recovery in swallowing ability
      or improvement of nutritional status.

      The purpose of this trial is to design a nutritional intervention with modified texture foods
      to increase viscosity (measured accurately) according to the patient's requirements, also
      assess if the intervention has a positive effect on the swallowing ability, calorie and
      protein oral intake and nutritional status.
    

Intervention name(s): Modified consistency and volume diet
Intervention type(s): Dietary Supplement
Intervention description(s): Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Nutritional Intervention in Oropharyngeal Dysphagia
Strongest Families (Formerly Family Help Program): Pediatric Disruptive Behaviour Disorder
Condition: Pediatric Disruptive Behaviour Disorder
MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the
      effectiveness of the Strongest Families distance intervention compared to usual or standard
      care that is typically provided to children with mild to moderate Disruptive Behaviour
      symptomology. This is a single-centre trial based at the IWK Health Centre. The primary
      outcome is change in diagnosis.
    

Detailed description: 
      The purpose of the Strongest Families (formerly Family Help Program): is to deliver, primary
      care mental health services to children and their families in the comfort and privacy of
      their own home. Approximately 60 children (3-7 years of age)suffering from mild to moderate
      (but clinically significant) symptoms of pediatric behavior disorder will be randomized.

      The intervention is delivered from a distance, using educational materials (manuals,
      video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach"
      who is supervised by a licensed health care professional. The telephone coach delivers
      consistent care based on written protocols, with on-going evaluation by a professional team.

      Fifty percent of the eligible participants will receive Family Help Program telephone-based
      treatment and 50% will be referred back to their family physician to receive standard care as
      determined by that physician. Those receiving standard care will be evaluated for outcome
      results and then compared to the Strongest Families treated participants. It is anticipated
      that Strongest Families treatment will be proven to be as or more effective than standard
      care.
    

Intervention name(s): Strongest Families (formerly Family Help Program): Behaviour Disorder Program
Intervention type(s): Behavioral
Intervention description(s): Evidence-based psychological and behavioural Distance Intervention
Other intervention name(s): Strongest Families (formerly Family Help Program):
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers
Condition: Homocystinuria
MeSH terms: Homocystinuria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, double-blind (Sponsor-open), placebo-controlled, randomized,
      dose-escalation, inpatient study using a multiple-ascending dose (MAD) design to assess the
      safety, tolerability, and PD of SYNB1353 in HVs.
    

Detailed description: 
      This study is evaluating the safety, tolerability and PD of SYNB1353 in up to 8 cohorts of
      HVs. In each cohort, HVs will be randomly assigned to investigational medicinal product
      (IMP), according to a MAD design, to receive either SYNB1353 or placebo (6 active:2 placebo
      per cohort). A methionine loading study will be performed on Day -1 and Day 7. At each IMP
      dose level, a dose of methionine will be evaluated. The methionine dose may increase if
      necessary to evaluate the PD of SYNB1353.
    

Intervention name(s): SYNB1353
Intervention type(s): Drug
Intervention description(s): SYNB1353 IMP is formulated as a nonsterile solution intended for oral administration. SYNB1353 is subsequently lyophilized to form the bulk drug product. The lyophilized product is sieved into powder form and filled into high-density polyethylene (HDPE) bottles. Placebo will be manufactured using an inactive powder that is color matched to the SYNB1353 drug product. L-Methionine will be supplied as dry powder and will be suspended in a diluent prior to use.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose-escalation decisions will be made once at least 6 subjects in a cohort have received IMP and have had at least 24 hours of post-dose observation. Dose escalation will be up to approximately 3-fold per cohort.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HCU; Amino acid metabolism; Inborn error of metabolism
Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer
Condition: Stomach Neoplasms; Neoplasms Metastasis; ERBB2 Gene Amplification
MeSH terms: Neoplasms; Neoplasm Metastasis; Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with inoperable, locally advanced or recurrent and/or HER2-positive metastatic
      gastric or gastro-esophageal junction cancer, with no prior treatment for metastatic disease
      are to be recruited in the study. In the current study, the efficacy and safety of
      Trastuzumab in combination with Capecitabine/Docetaxel will be evaluated in Chinese patients
      with HER2 positive advanced or recurrent gastric cancer.60 patients could provide adequate
      precision rather than controlling type I&II error. Assuming the target PFS is 6.7m, 60
      patients will give 90% CI of (5.5, 8.4). Considering the 5% drop out rate, 65 patients will
      be enrolled.
    

Detailed description: 
      This is a phase II, multi-center, open label, single arm, interventional study. Patients with
      HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not
      received prior treatment for metastatic disease will be treated with trastuzumab(8 mg/kg
      loading dose followed by 6 mg/kg every 3 weeks ),Capecitabine(2000mg/m2d, d1-14,every 3
      weeks) and Docetaxel (60mg/m2 every 3 weeks for 6 cycles).All patients will continue to
      receive trastuzumab and Capecitabine until either disease progression, occurrence of
      unacceptable toxicity or withdrawal from the study for another reason.Primary endpoints is
      PFS and secondary endpoints are ORR, OS and Safety.Recruitment period:24 months;PFS follow-up
      period: 80% PFS events;OS follow-up period: 18 months or 80% OS events, whichever occurs
      first.
    

Intervention name(s): Trastuzumab; Docetaxel; Capecitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Trastuzumab (Herceptin) will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks (q3w), until disease progress or intolerable toxicity.; Docetaxel 60mg/m2 (on day 1) every 3 weeks for 6 cycles.; Capecitabine (Xeloda) 2000mg/m2d, d1-14, every 3 weeks until disease progress or intolerable toxicity.
Other intervention name(s): Herceptin; Taxotere; Xeloda
Intervention MeSH terms: Docetaxel; Capecitabine; Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic gastric or gastro-esophageal junction cancer; Trastuzumab; HER2-positive; Capecitabine; Docetaxel; First-line therapy
A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.
Condition: Pulmonary Disease, Chronic Obstructive; Lung Diseases; Lung Diseases, Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung
      disease (COPD)
    


Intervention name(s): PF-00610355; PF - 00610355; PF- 00610355; Placebo; Salmeterol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral, inhaled, dry powder, 600ug, OD; oral, inhaled, dry powder, 300ug, OD; oral, inhaled, dry powder, 100ug, OD; oral, inhaled, dry powder, placebo, OD; salmeterol, 50ug, BID
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD Respiratory Long acting beta agonist
Learning Curve for Laparoscopic Distal Pancreatectomy
Condition: Pancreatic Lesions Located at Body or Tail.
Study type: Interventional

Summary: 
      Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions has
      recently becoming the treatment of choice in experienced centres. No data have been published
      about learning curve so far. The purpose of this study was to identify the learning curve
      period for performing LDP.
    

Detailed description: 
      Between March 2009 and August 2010 all patients with lesion of body or tail of pancreas were
      assessed for eligibility for LDP. Exclusion criteria were: major vessels contact in cancer
      patients, severe organ dysfunction, BMI > 35, and refusing laparoscopic approach. All
      laparoscopic procedures were carried out by the same surgical team with large experience in
      open pancreatic surgery. All patients were treated according to an early recovery after
      surgery protocol. Primary endpoint was conversion rate. Secondary endpoints were operation
      time, operative blood loss, postoperative morbidity, and length of stay.
    

Intervention name(s): Laparoscopy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic distal pancreatectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distal pancreatectomy, laparoscopy, learning curve
Relationship Between Serum 1,25-dihydroxy Vitamin D and Markers of Bone Metabolism in Renal Dysfunction Patients
Condition: Chronic Kidney Disease-Mineral and Bone Disorder
MeSH terms: Bone Diseases; Chronic Kidney Disease-Mineral and Bone Disorder; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Observational [Patient Registry]

Summary: 
      This cross-sectional study was conducted, including those subjects tested for 1,25(OH)2D
      during Jan 2015-Dec 2021. Estimated glomerular filtration rate (eGFR) was calculated and
      subjects were classified into chronic kidney disease (CKD) stages. Associations between
      biochemical marker, calcium, phosphorus, magnesium, alkaline phosphatase, 1,25(OH)2D and CKD
      stages was determined.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Laboratory data of patients tested for 1,25(OH)2D from January 2015 to December 2021 was
        retrieved from laboratory integrated systems (ILMS), and only the initial results for
        1,25(OH)2D were included.
      
Keywords: renal dysfunction; bone metabolism marker; 1,25(OH)2 vitamin D
A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity
Condition: Spasticity, Post-Stroke
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      Botulinum toxin A (GSK1358820) is a sterile, purified type A botulinum neurotoxin complex. In
      Japan, 240 units of botulinum toxin A are approved as a maximum dose per administration for
      upper limb spasticity. This study is planned to evaluate the effectiveness and safety of 400
      units of botulinum toxin A which can help to increase the maximum dose per administration to
      400 units from 240 units as the treatment with 240 units is considered insufficient in
      subjects with post-stroke upper limb spasticity. Approximately 120 subjects will be
      randomized to receive either 400 or 240 units of botulinum toxin A in double blind phase
      followed by open-label phase in which 400 units of the study treatment will be injected in
      both the groups. The study period will be up to 52 weeks, consisting of a screening phase up
      to 4 weeks, minimum 12-week double blind phase (Part 1), maximum 36- week open-label phase
      (12 weeks per cycle with 3 treatment phases: Part 2, Part 3 and Part 4).
    


Intervention name(s): Botulinum toxin A (GSK1358820); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK1358820 is sterile, purified type A botulinum neurotoxin complex. GSK1358820 injection will contain botulinum toxin A (100 units), sodium chloride (0.9 milligrams [mg]), and human serum albumin (0.5 mg). It will be available with doses of 400 units and 240 units.; Placebo injection will contain sodium chloride (0.9 mg).
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will receive either 400 units of botulinum toxin A injection or 240 units of botulinum toxin A injection plus placebo in double blind phase. Eligible subjects for open-label treatment period will receive 400 units of botulinum toxin A injection.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Botulinum toxin A; Safety; post-stroke upper limb spasticity; Efficacy; GSK1358820; double blind
Vacuum vs Manual Drainage During Unilateral Thoracentesis
Condition: Pleural Effusion; Pleural Diseases; Thoracic Diseases
MeSH terms: Pleural Effusion; Thoracic Diseases; Pleural Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine if there are any differences in terms of safety,
      pain, or drainage speed between thoracenteses via manual drainage vs vacuum suction.
    

Detailed description: 
      Patients with pleural effusions routinely undergo thoracentesis in which a catheter is placed
      into the pleural space to remove the fluid both for diagnostic and therapeutic reasons. In
      this setting, large amounts (often liters) of fluid are removed to palliate the patient's
      symptoms of breathlessness.

      Thoracentesis is the most commonly performed and least invasive method to remove pleural
      fluid. These frequently performed using a catheter drainage system where a small, flexible
      temporary catheter is inserted over a needle into the pleural cavity. After insertion of
      catheter into the pleural space, the operator has two drainage system options: 1. Manual
      drainage via syringe-pump that connects to drainage bag or 2. Drainage into a vacuum bottle.
      Both are routinely performed in almost every hospital in the United States.

      Pleural pressure (Ppl) is determined by the elastic recoil properties of the lung and chest
      wall. Normal pleural pressure is estimated to be -3 to -5 cm H20 at functional residual
      capacity. During drainage of pleural fluid, negative pressure is applied either via syringe
      during manual drainage or via vacuum using vacuum drainage bottle. Hypothetically more
      negative pressure can translate to increased perception of pain or visceral pleural injury.

      Two techniques (manual vs vacuum drainage) are used based on the operator preference and both
      are standard of care. To our knowledge there is no head to head comparison of these two
      available systems of drainages during thoracentesis of pleural effusions. Knowing if one is
      superior to the other will aid future clinicians.
    

Intervention name(s): Vacuum Bottle Drainage
Intervention type(s): Device
Intervention description(s): Patients undergo drainage via vacuum bottles
Other intervention name(s): Evacuated Cylinder
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomly assigned immediately before performing the procedure to either of the two investigational arms: manual drainage or vacuum bottle drainage.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pleural Effusion; Pleural Drainage; Thoracentesis
Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
Condition: Meningitis; Meningococcemia; Neisseria Meningitidis
MeSH terms: Diphtheria; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to simulate meningococcal challenge by vaccination with a fractional
      combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in
      children who were vaccinated with one dose of TetraMenD at least 18 months earlier.

      Primary Objective:

      To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants
      who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine
      to those responses in participants who received the same reduced dose of Menomune® but had
      not previously received any meningococcal vaccine.
    

Detailed description: 
      This was a two stage, controlled, open-label trial. Stage I of the trial simulated
      meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve
      participants from Stage I, who had also received a reduced dose of Menomune® vaccine in Stage
      I and were administered a full dose of Menactra® vaccine 6 months later.
    

Intervention name(s): A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®); A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Intervention type(s): Biological; Biological
Intervention description(s): 0.05 mL, Subcutaneous; 0.05 mL, Subcutaneous
Other intervention name(s): Menomune®; Menomune®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Menactra®; Menomune®; Meningitis; Meningococcemia; Neisseria meningitidis
Cortiment® MMX Pharmacokinetic Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Budesonide is a well-known and well-characterised locally acting glucocorticosteroid with
      comparable efficacy to that of conventional glucocorticosteroids, but with fewer systemic
      side effects due to its low bioavailability following oral administration.

      There are no benefits for subjects participating in this pharmacokinetic (PK) profile and
      safety study. This is an open-label study to investigate the PK profile and safety of single
      oral dose of budesonide prolonged release tablets (9 mg, Cortiment® MMX [multi-matrix
      system]) in healthy subjects in Indian population.

      Two study visits are planned: One out-patient visit (screening) and one residential session
      consisting of three consecutive nights (admission to the clinical investigation unit at least
      12 hours before dosing and discharge approximately 60 hours after dosing). End-of-study
      assessments will be performed before discharge from the clinical investigation unit in the
      single dosing period. Subjects should be in the fasted state for at least 10 hours pre-dose.

      Number of subjects planned in total in the study are 24 men and women, with a minimum
      requirement of 7 women. The safety assessments comprise of adverse events (AEs), vital signs,
      electrocardiogram (ECG) and clinical laboratory variables. Adverse events will be collected
      throughout the study.
    


Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention description(s): Budesonide 9 mg prolonged release tablet
Other intervention name(s): Cortiment® MMX
Intervention MeSH terms: Budesonide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Budesonide; Healthy; Pharmacokinetic