bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Glutamine on Systemic Inflammation During Human Experimental Endotoxemia
Condition: Sepsis; Systemic Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Glutamine levels decrease during severe sepsis; this may be associated with increased
      mortality. The investigators tested the effects of glutamine supplementation on systemic
      inflammation in a human sepsis model.

      The investigators found that glutamine levels drops significantly during experimentally
      induced systemic inflammation. However, glutamine did not affect the degree of inflammation.
    

Detailed description: 
      Glutamine levels have been shown to decrease substantially with severe sepsis and this has
      been connected with increased mortality. Therefore, in the present study, we infused either
      saline or Alanine-glutamine during an endotoxin challenge and measured parameters related to
      an immune response, i.e. plasma cytokines and Heat Shock Protein (HSP)-70.

      Materials and Methods This was a double blind, randomised, placebo-controlled crossover trial
      in eight healthy young men. The study was performed in random order on two separate days,
      with a four-week washout period between days. Subjects received an infusion of
      Alanine-glutamine ( Dipeptiven) at a rate of 0.025 g / (kg BW * h) for 10 hrs or saline.
      After two hours of infusion subjects received an intravenous bolus of E. coli endotoxin (0.3
      ng/kg). Blood samples were collected hourly for the following eight hours. HSP-70 protein
      content in isolated Blood Mononuclear Cells (BMNCs) was measured by western blotting.

      Results and Discussion Plasma glutamine was significantly increased during infusion with
      alanine-glutamine infusion. En-dotoxin caused a reduction in plasma-glutamine during saline
      infusion as well as during Alanine-glutamine infusion. A significant effect of endotoxin was
      found on leukocyte subpopulations, tumor necrosis factor-a, interleukin-6, the expression of
      HSP-70 in BMNCs, temperature, and heart rate. However, no differences were detected between
      treatments with regard to the effect of endotoxin on any of these parameters.

      Conclusion Endotoxemia reduces plasma glutamine independently of parenteral infusion of
      alanine-glutamine. Glutamine does not alter the response of leukocytes, leukocyte
      subpopulations, IL-6, or TNF-α, or the expression of HSP-70 in BMNCs to endotoxemia.
    

Intervention name(s): alanine-glutamine infusion
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: glutamine inflammation HSP70 sepsis
Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of the study was to evaluate the performance of the meter system in the hands of
      subjects and healthcare professionals (HCPs). It also evaluated the product user guides in
      the hands of untrained subjects.
    

Detailed description: 
      The study evaluated the performance of the blood glucose meter system (BGMS) compared to a
      laboratory glucose method. Subjects and healthcare professionals tested subject capillary
      blood and healthcare professionals tested subject venous blood. Two meter configurations were
      evaluated. The study evaluated the acceptability of product labeling in enabling subjects to
      perform blood glucose testing with the new meter system and for using meter features.
      Subjects and healthcare professionals provided feedback about the BGMS and its features.
    

Intervention name(s): Apollo Blood Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).
Other intervention name(s): CONTOUR® USB
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Analgesic Potentials of Preoperative Pregabalin,Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the effect of giving preoperative adjuvant drug as pregabalin or
      magnesium sulphate or a combination of both drugs to decrease postoperative morphine
      consumption and pain intensity in the first 24 hours in postoperative period . quarter of
      patients receive single dose oral pregabalin 300mg 1 hour preoperatively ,other quarter
      receive single intravenous Magnesium sulphate 50mg per Kg over 200ml saline over 20 minutes
      preoperatively , other quarter receive combination of both drugs , the last quarter receive
      placebo drugs . All patients receive 0.1mg per Kg intravenous morphine sulphate
      intraoperatively
    

Detailed description: 
      Magnesium (Mg) acts on N-methyl-D-aspartate (NMDA) receptor as a non-competitive antagonist
      with antinociceptive effects.

      Gabapentin is an alkylated analogue of gammaaminobutyric acid (GABA) developed primarily as
      an anticonvulsant drug. It was described as an analgesic drug for the treatment of
      neuropathic pain in the 1990s. Although it is named Gabapentin,it does not bind at the GABA A
      or GABA B receptor. It binds with high affinity for the α2δ subunit of the presynaptic
      voltage-gated calcium channels, which reduce calcium-dependent release of pro-nociceptive
      neurotransmitters in the pain pathways. Pregabalin is a structural analogue of GABA was
      introduced after Gabapentin. If we used these drugs in combination to opioids preoperatively
      as preventive analgesia may decrease postoperative opioid consumption and pain intensity.
    

Intervention name(s): Pregabalin & Placebo; Magnesium sulphate & Placebo; Pregabalin & Magnesium sulphate; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Magnesium Sulfate; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Cognitive Complaints in Obstructive Sleep Apnea
Condition: Cognition Disorders; Sleep Apnea Syndromes, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Cognition Disorders
Study type: Observational

Summary: 
      The study assesses cognitive complaints in newly diagnosed patients with obstructive sleep
      apnea with no medical-comorbity affecting cognition. Cognitive complaints will be compared to
      healthy controls matched on age, sex and educational level. Factors related to cognitive
      complaints will also be assessed, including anxiety and depressive symptoms, complaints of
      fatigue and sleepiness, quality of life, psychological coping strategies and objective
      measures of cognition. Patients starting treatment for sleep apnea (continuous positive
      airway pressure or mandibular repositioning device) will be reassessed on all measures after
      6 months of treatment to study the impact of treatment as usual on cognitive complaints and
      its related factors.
    


Intervention name(s): questionnaires and neuropsychological assessments
Intervention type(s): Behavioral
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients newly diagnosed with obstructive sleep apnea according to the clinical guidelines
        of the adult OSA taskforce of the American Academy of Sleep Medicine (apnea/hypopnea-index
        (AHI) of ≥15 or AHI of ≥5 with significant daytime symptoms)
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy
      adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be
      randomized equally to receive either a single intramuscular dose of multivalent pneumococcal
      conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month
      later with a dose of PPSV23 (control group).
    


Intervention name(s): Multivalent; Prevnar 13; PPSV23; Saline
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine; Pneumococcal polysaccharide vaccine; Placebo
Other intervention name(s): Pneumovax 23
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post
      tips hepatic encephalopathy'
    

Detailed description: 
      The outcome is the prevention of post tips hepatic encephalopathy
    

Intervention name(s): Albumin
Intervention type(s): Drug
Intervention description(s): albumin 20% 1 g/Kg body weight for the first two days after TIPS followed by 0,5 g/Kg body weight at day 4 and then 0,5 g/Kg body weight once a week for three weeks.
Other intervention name(s): human albumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: TIPS; albumin; hepatic encephalopathy; hyponatremia; hypovolemia; cirrhosis
Drug Interaction Study Between Eltrombopag and Lopinavir/Ritonavir in Healthy Adult Subjects.
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, single sequence, crossover study to be conducted in healthy
      adult subjects. There will be a screening visit, three treatment periods, and a follow-up
      visit. In Period 1, subjects will receive a single dose of eltrombopag on Day 1, and PK
      sampling will occur for 72 hours. In Period 2, subjects will receive LPV/RTV for 14 days with
      PK sampling for 12 hours. In Period 3, subjects will receive a single dose of eltrombopag
      with LPV/RTV on Day 1 only with PK sampling for 72 hours. Subjects will return for a
      follow-up visit within 10 to 14 days of the last dose of study drugs.
    


Intervention name(s): Eltrombopag; Lopinavir/Ritonavir; Eltrombopag and Lopinavir/Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Eltrombopag 100 mg single oral dose; Lopinavir/Ritonavir 400/100 mg oral dose given twice a day for 14 days; Elrombopag 100 mg single oral dose and Lopinavir/Ritonavir 400/100 mg oral dose given in the AM and PM
Intervention MeSH terms: Ritonavir; Lopinavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug interaction, SB-497115 (eltrombopag), Kaletra (Lopinavir, Ritonavir),thrombocytopenia, pharmacokinetics
Effects of Intensive cART During Acute/Early HIV Infection
Condition: Acute HIV Infection
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial will investigate the efficacy and safety of intensified antiretroviral treatment
      that includes raltegravir and maraviroc during the early stages of HIV infection. With the
      proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to
      investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART
      backbone to further decrease the viral load in acutely infected treated HIV infected
      individuals.
    

Detailed description: 
      The trial is a prospective, randomized, double-blinded, placebo-controlled study with
      follow-up to 5 years. Thirty-two individuals presenting with newly diagnosed acute or early
      HIV-1 infection as described in the inclusion criteria will be enrolled, with sixteen
      randomized to each arm. Individuals will be randomized to one of two arms: the "Intensive"
      arm with standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400mg /ritonavir
      100mg BID) + Raltegravir + Maraviroc or the "placebo" arm with standard HAART+ Placebo for 48
      weeks. Another group of individuals diagnosed with acute or early HIV-1 who elect to forego
      early treatment will be followed as non-randomized, untreated controls. At week 48, all
      patients will be informed of study results. If results are positive in the intensive
      treatment group, the placebo group will be offered to roll-over to the intense treatment arm
      and followed as an open-label cohort out to five years. Participants may stop treatment at
      any time and withdraw from the study. If they choose to do so, they will be followed
      according to the standards employed for all HIV-1 patients at the Maple Leaf clinic. At the
      five year point, the decision to terminate treatment will be made based on the existing state
      of the HIV-1 literature at the time.
    

Intervention name(s): raltegravir; maraviroc; emtricitabine 200mg /tenofovir 300mg; lopinavir 400 mg/ritonavir 100mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART; Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART; emtricitabine 200mg /tenofovir 300mg QD; lopinavir 400 mg/ritonavir 100mg BID
Other intervention name(s): Isentress; MK-0518; Celsentri; Selzentry; Truvada; Kaletra; Aluvia
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Emtricitabine; Raltegravir Potassium; Maraviroc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Mother-Sung Lullabies on Infant Pain and Maternal Anxiety
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Childhood pain can cause long-term and psychologically harmful effects. Music can reduce pain
      and anxiety. This study aimed to investigate the effects of the mother-sung lullaby during
      vaccine administration on vaccine-induced pain in babies and anxiety in mothers.
    

Detailed description: 
      This study aimed to investigate the effects of the mother-sung lullaby during vaccine
      administration on vaccine-induced pain in babies and anxiety in mothers. Two family health
      centers in Turkey between March 4, 2020, and August 28, 2020. A total of 60 babies who
      received the Bacille Calmette-Guérin vaccine and their mothers.These babies were randomly
      assigned to one of two groups, including 30 babies in the lullaby group and 30 babies in the
      control group. Data on descriptive information for all babies and mothers were collected
      through face-to-face interviews with the mothers before vaccination. Heart rate, oxygen
      saturation, and crying duration were measured in all babies. Heart rate and oxygen saturation
      of the babies were recorded using a pulse oximeter during and after vaccine administration.
      The crying time, measured for up to 30 seconds after vaccination, was recorded as the total
      cry time (using video seconds). The pain score was evaluated by two observers using the
      Neonatal Infant Pain Scale, based on video recordings obtained during and after vaccine
      administration. In addition, mothers' anxiety scores were measured using the "State Anxiety
      Inventory," both before and after vaccination.
    

Intervention name(s): The Lullaby Group
Intervention type(s): Behavioral
Intervention description(s): Approximately 15 seconds before the vaccination, each baby's mother began to sing a lullaby. Infant's mother continued to sing lullabies until all the vaccinations, which were given immediately after the BCG vaccination, were completed. Each mother touched her baby's hands and body while singing a lullaby and hugged her baby after the procedure. All the mothers sang the same lullaby, "Sleep and Grow". Mothers were reminded of the words to the lullaby before vaccine administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was an experimental, randomized controlled study. These babies were randomly assigned to one of two groups, including 30 babies in the lullaby group and 30 babies in the control group. Randomization was performed using a sealed envelope method. The video recordings were evaluated by two academicians in the field of child health and disease nursing, including a researcher and a research assistant with a doctorate in child health and disease nursing who were not blinded to the group assignment. These observers were blinded to the other's observations and did not discuss the scores.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Anxiety; Pain; Vaccination; Mother; Nursing
Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety and tolerability (how the body reacts to the drug) of REGN668
      and placebo (an inactive substance that contains no medicine) in healthy subjects.
    


Intervention name(s): REGN668
Intervention type(s): Biological
Intervention description(s): 4 IV Cohorts (Dose 1, 2, 3, & 4)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding
Condition: Dysfunctional Voiding
Study type: Interventional

Summary: 
      In this study, the effect of dynamic neuromuscular stabilization (DNS) exercise on urinary
      flow and quality of life in individuals with dysfunctional voiding was investigated. The 34
      participants included in the study were randomized into two groups: the experiment in which
      DNS exercises were applied and the standard therapy group in which the manual application was
      applied. Uroflowmetry, Voiding Symptom Score (DVSS), Short Form-36 Quality of Life Assessment
      Short Form were applied to all participants at baseline and at week 6.
    

Detailed description: 
      In this study, the effect of dynamic neuromuscular stabilization (DNS) exercise on urinary
      flow and quality of life in individuals with dysfunctional voiding was investigated. This
      experimental study was conducted with patients who applied to UroKlinik in Istanbul between
      March 2021 and June 2023 and were diagnosed with dysfunctional voiding. The 34 participants
      included in the study were randomized into two groups: the experiment in which DNS exercises
      were applied and the standard therapy group in which the manual application was applied.
      Voiding Symptom Score (DVSS), Short Form-36 Quality of Life Assessment Short Form and
      Uroflowmetry test were applied to all participants before and at week 6.
    

Intervention name(s): Exercise; Standard therapy
Intervention type(s): Other; Other
Intervention description(s): Dynamic Neuromuscular Stabilisation Exercise; Patient education, massage, diaphragmatic breathing, kegel exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: dysfunctional voiding; dynamic neuromuscular stabilization exercise
Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This pilot study plan to investigate the sympathovagal balance in women affected by Irritable
      Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve
      electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal
      permeability, systemic and local inflammation), symptoms and quality of life.

      The safety of the electrical stimulation of the left vagal nerve will also be evaluated.

      Ten women, age between 18 and 60, will be included.
    


Intervention name(s): Trans-cutaneous vagal nerve electrical stimulation
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Vagal nerve stimulation; Quality of life
The Effect of FODMAP Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement
Condition: Enteral Nutrition
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN)
      formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed
      patients through the randomized, double blind and placebo-controlled trial.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled study was conducted on 100 tube-fed patients.
      Over a 14-day test period, the test group consumed EN formula containing low FODMAPs, while
      the placebo groups consumed EN formula containing moderate or high FODMAPs .
    

Intervention name(s): low FODMAP; moderate FODMAP; high FODMAP
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention; consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention; consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Scapular Stabilization Exercise on Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Neck pain is a very common problem in the population. Most of the patients suffer from neck
      pain for long time and the problem becomes chronic. The investigators studied the effects of
      scapular stabilization exercise on mechanical neck pain.
    

Detailed description: 
      Neck is one of the most common musculoskeletal problem in the world. Yet the problem still
      haven't been understood and solved completely. Its incidence is also becoming higher and most
      people who have neck pain suffer from it for long time. Several problems have been related to
      neck pain. Hence, the investigators designed a study to see the effects of scapular
      stabilization exercise on neck pain.
    

Intervention name(s): classical approach for neck pain; scapular exercise on neck pain
Intervention type(s): Other; Other
Intervention description(s): Patients with mechanical neck pain were instructed to do cervical exercise; Patients with mechanical neck pain were instructed to do scapular stabilization and cervical exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Scapula; Neck; Pain; Therapy; Kinematic