bioihbjkbjnl/mcl2 huggingface dataset:
Omentectomy and Metabolic Syndrome
Condition: Metabolic Syndrome; Morbid Obesity
MeSH terms: Metabolic Syndrome; Obesity, Morbid; Syndrome
Study type: Interventional

Summary: 
      The aim of the present study was to evaluate the additional effect of sudden visceral fat
      reduction by omentectomy on Metabolic Syndrome, acute phase reactants and inflammatory
      mediators in patients with morbid obesity undergoing Laparoscopic Roux-en-Y Gastric Bypass.
    

Detailed description: 
      Although weight loss controls Metabolic Syndrome and reduces the level of inflammatory
      markers in patients with Morbid Obesity, patients may enjoy the benefit achieving metabolic
      control before significant weight loss occurs.
    

Intervention name(s): Laparoscopic Roux-en-Y Gastric Bypass; Omentectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic Roux-en-Y Gastric Bypass was performed according to the following standards: Gastric pouch was constructed using the lesser curvature of the stomach. A 45mm stapler was initially fired horizontally 2 to 3 cm below the gastroesophageal junction and then 2 o 3 additional fires towards the angle of His and against a 32 French intragastric tube completed the vertical transection. Lengths of the biliopancreatic and alimentary limbs were approximately 50, and 150 cm respectively. An antecolic and antegastric gastrojejunostomy, 1.0 to 1.5 cm in size was hand sewn and the jejuno-jejunostomy was completed in a latero-lateral fashion using one fire of 45 mm lineal stapler with hand sewn closure of the common enterotomy.; After laparoscopic gastric bypass, the greater omentum was divided in the middle from the free edge to the colonic margin using ultrasonic energy. Attachments between the omentum and the transverse colon were dissected. The omentum was detached from the stomach transecting the vessels between the right gastroepiploic vessels and the greater curvature of the stomach. Once the omentum was freed from the stomach, the duodenum and the lower pole of the spleen, it was extracted from the abdominal cavity in a sterile plastic bag.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Omentectomy; metabolic syndrome; acute phase reactants
Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study evaluates the acute and longer term effects of a tomato pomace extract on platelet
      aggregation in health subjects.
    

Detailed description: 
      Evidence from human intervention trials and mechanistic studies suggests that tomato and
      tomato based products are associated with a reduction in CVD risk. The mechanism by which
      this protective effect occurs is not clearly understood but research has focused on its
      potential to modulate platelet function. This single-blind, randomized, parallel design human
      intervention trial will recruit 99 participants to consume an orange flavoured beverage
      containing different doses of a tomato pomace extract (1.0 and 2.5 g) or placebo control over
      a 5-day period. The study aims is to investigate the effects of consuming different doses of
      the tomato pomace extract on platelet aggregation. Safety and tolerability of the tomato
      pomace extracts was tested prior starting this study by undertaking a single ascending dose
      study.
    

Intervention name(s): Placebo control; Low dose pomace extract; High dose pomace extract
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The placebo control is water containing a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions; Immediately prior to ingestion, 'drinks' containing 1 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.; Immediately prior to ingestion, 'drinks' containing 2.5 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Platelet Aggregation
Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate
      with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.
    


Intervention name(s): Etanercept; Methotrexate; Etanercept; Methotrexate; Placebo; Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous (SC), 50 mg, once weekly for 88 weeks; Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).; Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.; Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).; Subcutaneous (SC), once weekly from week 36 to week 88.; Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Active Rheumatoid Arthritis
Dysphagia and VFMI in Cardiac Patients
Condition: Cardiac Disease
MeSH terms: Deglutition Disorders; Heart Diseases
Study type: Observational

Summary: 
      The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility
      impairment (VFMI) in individuals undergoing cardiothoracic surgical procedures. It also seeks
      to determine the impact of postoperative swallowing impairment on health-related outcomes.
    

Detailed description: 
      Swallowing impairment and VFMI are common, yet often overlooked, complications of cardiac
      surgical procedures. The true incidence of both dysphagia and VFMI in this patient population
      is unclear due to a lack of rigorous study using instrumental assessment techniques and
      validated outcomes in all patents undergoing cardiac surgery. We therefore aimed to determine
      the incidence of dysphagia and VFMI in this patient population and to characterize impairment
      profiles related to swallowing safety and efficiency. We also aimed to assess the relative
      impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay,
      pneumonia, sepsis, reintubation, and discharge status.
    

Intervention name(s): Fiberoptic Endoscopic Evaluation of Swallowing
Intervention type(s): Procedure
Intervention description(s): This procedure involves a flexible laryngoscope that contains a light source and video camera on the end through the open passages of your nose and to the back of the throat in order to visualize the swallowing mechanism.
Other intervention name(s): FEES
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        230 individuals undergoing cardiothoracic surgery will be enrolled in this study.
      
Keywords: Dysphagia; Extubation; Cardiac Intensive Care Unit (CICU); Forced Expiratory Volume in One second (FEV1); Peak Expiratory Flow (PEF)
Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The development of selexipag for intravenous administration will be useful to avoid treatment
      interruptions in patients with pulmonary arterial hypertension (PAH) already treated with
      selexipag administered orally as tablets (Uptravi®). The target population for intravenous
      selexipag includes those PAH patients who are hospitalized and are unable to swallow tablets
      of Uptravi.

      The primary objective of this study is to assess whether it is safe for patients with PAH to
      temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein
      (intravenous selexipag), and then switching back to the initial oral dose of selexipag.
    

Detailed description: 
      After screening (Visit 1), each subject will participate in the following consecutive
      treatment periods: Period 1(treatment with oral selexipag at Visit 2/Day 1), Period 2
      (treatment with intravenous selexipag at Visit 2/ Day 2 and Day 3), Period 3 (treatment with
      oral selexipag starting in the evening of Visit 2/Day 3 and ending 7 to 11 days later at
      Visit 3). Then a safety follow-up period is planned up to end of study visit (EOS), which
      occurs between Day 33 and Day 40.
    

Intervention name(s): i.v. selexipag; oral selexipag (Uptravi)
Intervention type(s): Drug; Drug
Intervention description(s): Selexipag for intravenous administration, twice daily as an infusion over 87 min. The dose is individualized for each subject to correspond to his/her current oral dose of Uptravi®.; Uptravi is used as an auxiliary medicinal product, as part of the PAH standard treatment and administered according to the local prescribing information
Other intervention name(s): ACT-293987; ACT-293987
Intervention MeSH terms: Selexipag
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: switch; intravenous; selexipag
Assessing the PK of Met DR, Met IR, and Met XR in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compared the pharmacokinetics (PK) and assessed the safety of delayed-release
      metformin (Met DR, EFB0027) at two dosage levels, immediate-release metformin (Met IR,
      ETB0015), and extended-release metformin (Met XR, ETB0014) in healthy subjects.
    


Intervention name(s): Met DR; Met XR; Met IR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): metformin delayed-release tablets; metformin extended-release tablets; metformin immediate-release tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
Condition: Readiness to Discharge
Study type: Interventional
Phase: Phase 4

Summary: 
      There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some
      patients receive an epidural analgesia, a femoral nerve block and pills for pain. More
      recently, some surgeons have replaced femoral nerve blockade with peri-articular injections.
      These patients receive a peri-articular injection (injection of pain medication around the
      knee), pills for pain and a pain patch on the skin. The purpose of this research project is
      to find out if one of these ways to treat pain is better than the other. The investigators
      will look at this question in many ways, but the main way is how long it takes for you to be
      judged ready for discharge from the hospital.
    


Intervention name(s): Peri-Articular Injection; Epidural Pathway (PCEA+FNB)
Intervention type(s): Procedure; Procedure
Intervention description(s): Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN); Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Effectiveness of App-based Relaxation for Patients With Chronic Neck Pain
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of the pragmatic randomized study is to evaluate whether additional relaxation
      technique is more effective in the reduction of chronic neck pain compared to usual care
      alone.
    

Detailed description: 
      Objective: To evaluate whether additional relaxation technique is more effective in the
      reduction of chronic neck pain compared to usual care alone.

      Study design: Open single-centered randomized two-armed pragmatic trial.

      Participants: 220 patients aged 18-65 years with chronic (>12 weeks) neck pain and a mean
      pain score ≥ 4 on a Numeric Rating scale (NRS) in the last week before randomization who will
      be randomly allocated to two groups (relaxation, usual care alone as waiting list)

      Intervention: Participants apply either a daily 15-minute relaxation exercise guided by a
      smartphone application ("app"). or apply no additional intervention. The exercise should be
      applied daily, (minimally, five days per week) for 6 months. The app contains audios to guide
      autogenic training, muscle relaxation training and guided imagery. On a daily basis,
      participants can select one of the three exercises which they want to apply.

      Main outcome measure: The primary outcome is the mean pain intensity after 3 months measured
      by the daily pain intensity on the NRS.
    

Intervention name(s): relaxation exercise; ususal care
Intervention type(s): Behavioral; Other
Intervention description(s): relaxation exercise
Other intervention name(s): meditation; waiting list
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: chronic neck pain; relaxation technique; comparative effectiveness research
Search Cytomegalovirus in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant
Condition: CMV; Healthy Volunteers
Study type: Interventional

Summary: 
      Fecal microbiota transplantation (FMT) is recommended in the treatment of recurrent
      Clostridium difficile infection (CDI). The principle is to administer a fecal suspension of a
      healthy subject (donor) in the digestive tract of a patient with an CDI (receiver). Donors
      are being clinical and laboratory screening to reduce the likelihood of pathogens
      transmission (infectious and other). Cytomegalovirus (CMV) is part of the examinations
      requested by the Agence national de sécurité du médicament et des produits de santé in the
      context of clinical research. A sero-matching between donor and recipient CMV is requested.
      This recommendation eliminates many potential donors to a recipient. To date, the frequency
      detection level of CMV in stool in healthy volunteers with documented positive CMV serology
      is not known. In addition, CMV transmission risk via the stool is not established. This study
      aims to determine the detection frequency of CMV in healthy volunteers stool samples selected
      as potential donors for a FMT and having a positive CMV serology documented
    


Intervention name(s): Blood and stool samples
Intervention type(s): Other
Intervention description(s): Blood sample at Day 1 and blood and stool sample at the next visit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cytomegalovirus; Stool sample; Healthy Volunteers; Fecal microbiota transplant
Safety and Feasibility of imILT Locally Advanced Pancreatic Cancer (LAPC)
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      10 Patients with Locally Advanced Pancreatic Cancer, no further responsive to neoadjuvant
      treatments but with a Stage-III disease will be submitted to imILT (Immunostimulating
      Interstitial Laser Thermotherapy). Safety and feasibility of imILT on LAPC will be evaluated
      as primary objective. Secondary objectives will be QoL after imILT, study of the immune
      reaction after imILT, oncological analysis of patients suffering from LAPC submitted to
      imILT.
    


Intervention name(s): immunostimulating Interstitial Laser Thermotherapy; Laser
Intervention type(s): Procedure; Device
Intervention description(s): Through a laparotomy a laser device will be inserted into the locally advanced pancreatic cancer.
Other intervention name(s): imILT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sleep, HIV Disease Progression, and Function in HIV Infected Children and Adolescents
Condition: Sleep; HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This study is a first step in approaching the gap existing between understanding sleep
      abnormalities, alterations in sleep-regulating cytokines and HIV-1 disease regulating
      cytokines, and abnormal higher cortical function.
    

Detailed description: 
      BACKGROUND:

      In the growing number of HIV infected youth and young adults, it is important to study the
      effects of HAART treatment on sleep patterns and related neurocognitive and psychosocial
      function.

      DESIGN NARRATIVE (including primary and secondary outcomes):

      Using validated sleep questionnaires and actigraphy measurements, overnight polysomnography
      (PSG, sleep study) will assess the degree of abnormal sleeping patterns and daytime
      sleepiness in HIV infected children and HIV uninfected children (control group).

      The following peripheral blood levels will be measured over a 24-hour period, at multiple
      time points, in all participants: TNF-alphaRI and IL-6 (sleep-regulating cytokines);
      IFN-gamma and IL-12 (cytotoxic or TH1 cytokines); and IL-10 and IL-1RA (inflammatory or TH2
      cytokines). This will help to determine the association between alterations in
      sleep-regulating cytokines and HIV disease progression (CD4+ T-cell count, HIV-1 RNA level).

      Neurocognitive and neuropsychological tests will be performed on all participants to
      determine if there is an association between lack of normal sleeping habits, alterations in
      sleep-regulating cytokines and HIV-1 disease progression cytokines, and
      neurocognitive/neuropsychological performance.

      Computer analysis of electroencephalography (EEG) will be performed during wakefulness and
      all stages of sleep to determine if greater disease severity, sleepiness, sleep disruption,
      and neurocognitive impairment is associated with increased amounts of slow activity.
      Improvement in these related factors will be associated with normalizations of these
      parameters. For some of these quantitative measures, the findings may be more significant for
      particular brain regions; for example, frontal regions in the case of attention problems.
    

Intervention name(s): Wrist Actigraphy
Intervention type(s): Device
Intervention description(s): Wrist actigraph will record participants' sleeping patterns.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV-infected children with and without asthma.
      
Biospecimen description: 
      Blood
A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when
      administered alone without routine infant vaccines to healthy infants in their first year of
      life according to different two and three dose immunization schedules, which are suitable to
      be adopted by various national programs. This study will also investigate antibody
      persistence post primary series and administration of a subsequent booster dose of rMenB+OMV
      NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of
      two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of
      age.

      This study will also evaluate the safety and immunogenicity of the concomitant administration
      of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and
      12-month schedule.
    


Intervention name(s): rMenB + OMV NZ vaccine; rMenB + OMV NZ vaccine; rMenB + OMV NZ vaccine; rMenB + OMV NZ vaccine; Meningococcal C oligosaccharide conjugated vaccine; Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.; rMenB + OMV NZ vaccine; rMenB + OMV NZ vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age); 2 doses (3.5, 5 months of age) plus booster (11 months of age); 2 doses (6, 8 months of age) plus booster (11 months of age); 2 doses 2 months apart; Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine; Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.; Schedule 3, 5, 12 rMenB + OMV vaccine; Schedule 13,15 rMenB + OMV vaccine
Other intervention name(s): rMenB for Group I; rMenB for Group II; rMenB for Group III; rMenB for Group IV; rMenB for Group V; rMenB for Group VI
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal disease; Vaccines; intercalated administration