bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Acetazolamide on Right Ventricular Function at Rest in Patients With Respiratory Disease at Altitude
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right
      ventricular function at acute altitude exposure in patients with COPD.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect
      of acetazolamide (375 mg per day) vs. placebo on right ventricular function at rest in
      lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants
      living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the
      Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day
      (or placebo) will be administered 24 hours before departure at 760 m and during the stay at
      altitude. Outcomes will be assessed during the stay at 3200 m.

      Right ventricular function will be assessed by transthoracic echocardiography.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: right ventricular function; echocardiography; obstructive airway disease; emphysema; acetazolamide; altitude
Benefits of a Cognitive Behavioral Therapy Intervention for Smoking Cessation Supported by Virtual Reality Smoking Cue Exposure
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      Cognitive-behavioral therapy (CBT) combined with medication is an established intervention
      for smoking cessation. However, long-term abstinence rates of maximum 35% are yielded.
      Moreover, acceptance of drug treatment is partly very low. Professional recommendation of
      drug treatment besides nicotine-replacement aids is restrained considering side effects and
      contraindications. Currently, cue exposure is highly discussed as intervention for craving
      reduction supporting CBT. There is evidence for benefits of cue exposure optimizing smoking
      cessation outcomes, as well as evidence for efficacy of exposure in virtual reality (VR) up
      to date.

      However, this is the first randomized controlled study focusing on efficacy increases by VR
      cue exposure supporting an established CBT smoking cessation manual. The control group
      receives a specific stress reduction treatment (independent of smoking cues), namely, the
      Progressive Muscle Relaxation (PMR, according to Jacobson) additionally to the established
      smoking cessation CBT.
    


Intervention name(s): CBT smoking cessation; virtual reality based cue exposure; progressive muscle relaxation
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): an established protocol for smoking cessation based on cognitive behavioral therapy; smoking cue exposure in virtual reality; Progressive muscle relaxation for unspecific stress reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: virtual reality; cue exposure; progressive muscle relaxation
Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who
      had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance.
      The main objective is to assess the effect of breakfast cereals intake with omega-3 on women
      lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the
      small dyslipidemia.
    

Detailed description: 
      The investigators performed an intervention including 133 women (age 25-70 years).
      Participants were randomly and single-blind distributed into three groups: Group 1 (n=38)
      consumed cereal with omega-3 (Cw-3 + D), cereal (C) and diet (D), Group 2 (n=38). Volunteers
      consumed (C) + (D) and Group 3 (n=37) consumed only diet. All groups followed a limit
      levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol,
      triglycerides and glucose were determined at the beginning and end of a 30-day test.

      Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint
      Technologies, Inc. Warrington, VA, USA); likewise, significance was defined at p ≤ 0.05. Data
      are reported as mean ± standard error of the mean (sem). Intra-group statistical comparisons
      were performed using the following hypothesis tests, both parametric and non-parametric:
      t-test, sign test and signed rank test for paired samples. Inter-group statistical
      comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis
      hypothesis tests. Also, Fisher's least significant difference (LSD) Multiple Range Test and
      Tukey's honestly significant difference (HSD) were used in order to determine which means
      were significantly different from the others. In addition, Generalized Multiple Regression
      was used to statistically analyze the relationships between the variations in the lipid
      profile and the different factors included in the study.
    

Intervention name(s): Cereals
Intervention type(s): Dietary Supplement
Intervention description(s): The participants were randomly single blind controlled trial distributed into three groups: (1, n =38), (2, n =38), (3, n =37). For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet.
Other intervention name(s): Papilla multicereales con Omega-3 0628413; Papilla multicereales 0528413
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: breakfast cereal; omega-3; cholesterol; lipidic profile; consumption; acceptability
Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor
Condition: Gastrointestinal Stromal Tumor
MeSH terms: Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining
      tumor cells. It is not yet known whether imatinib mesylate is more effective than observation
      only in treating gastrointestinal stromal tumor.

      PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it
      works compared to observation only in treating patients who have undergone surgery for
      localized gastrointestinal stromal tumor.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess whether there is a difference in overall survival between intermediate and
           high-risk localized GIST patients undergoing complete surgery alone and those undergoing
           complete surgery plus adjuvant imatinib mesylate 400 mg daily for two years Secondary

        -  Assess whether there is a difference in relapse-free survival and relapse-free interval
           between GIST undergoing complete surgery alone and those undergoing surgery + adjuvant
           Imatinib mesylate 400 mg daily for two years.

        -  Determine the safety of this drug in these patients.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to participating center, risk category (high vs intermediate), tumor site (gastric
      vs other), and resection level (R0 vs R1).

        -  Arm I: Patients receive adjuvant oral imatinib mesylate once daily for 2 years in the
           absence of disease progression or unacceptable toxicity.

        -  Arm II: Patients are observed (without receiving further antitumoral therapy) every 3
           months for 2 years.

      After completion of study treatment, patients in arm I are followed every 3 months for 2
      years. All patients are then followed every 4 months for 3 years and at least annually
      thereafter.

      PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study within 3.5 years.
    

Intervention name(s): imatinib mesylate
Intervention type(s): Drug
Intervention description(s): 400 mg/day for 2 years
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastrointestinal stromal tumor
Evaluation of Mitochondrial Function in Myofascial Trigger Points Cohort Pilot Study Using High-resolution Respirometry
Condition: Pain, Neck; Pain, Back; Myofascial Trigger Point Pain; Myofascial Pain; Mitochondrial Pathology
MeSH terms: Myofascial Pain Syndromes; Back Pain; Neck Pain
Study type: Interventional

Summary: 
      This pilot study established a minimally invasive biopsy technique to obtain high-quality
      MTrP tissue samples to evaluate mitochondrial function via high-resolution respirometry.
    

Detailed description: 
      Myofascial trigger points (MTrPs) are hyperirritable areas in the fascia of the affected
      muscle, possibly related to mitochondrial impairment. They can result in pain and hypoxic
      areas within the muscle. This pilot study established a minimally invasive biopsy technique
      to obtain high-quality MTrP tissue samples to evaluate mitochondrial function via
      high-resolution respirometry. Secondary objectives included the safety of the biopsy
      procedure assessed via clinical wound healing (number of patients with signs for local
      infection and inflammation). For this purpose, twenty healthy males participated in this
      study, 10 with a diagnosis of myofascial pain in the musculus (m.) trapezius MTrP (TTP group)
      and 10 with a diagnosis of myofascial pain in the m. gluteus medius (GTP group). The affected
      muscle was biopsied followed by a biopsy from the vastus lateralis to be used as a control.
      Measurements of oxygen consumption were carried out using high-resolution respirometry.
    

Intervention name(s): Muscle biopsy
Intervention type(s): Procedure
Intervention description(s): Local anesthesia was applied to the superficial skin covering the MTrP of each participant. Percutaneous biopsy sampling optimized with a suction-enhancement technique was used to obtain muscle biopsies of the m. trapezius MTrP or the m. gluteus medius MTrP from each participant using small Bergstrom muscle biopsy needle, 8 swg (4.0mm) x 100 mm (Dixons Surgical Instruments, Essex, United Kingdom).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sativex Thorough QT/QTc Study
Condition: Effects of Sativex on ECG
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was to evaluate effects of Sativex on electrocardiogram (ECG) traces when
      administered at its therapeutic dose of 8 sprays per day and at multiples of the therapeutic
      dose (24 or 36 sprays per day), and to evaluate its safety and tolerability.
    

Detailed description: 
      This is a multiple-dose, randomized, double-blind, double-dummy, placebo- and
      active-controlled, four arm, parallel group study to evaluate the effect of Sativex on the
      QT/QTc interval.

      Within 30 days of screening, eligible subjects were randomized to one of four treatment
      groups. Baseline ECG measurements were recorded at specified times and the following day,
      subjects commenced five days treatment with Sativex or placebo. On Day 5, subjects then
      received either moxifloxacin 400 mg (Group 4) or moxifloxacin placebo (Groups 1, 2 and 3).
      Triplicate ECG measurements and pharmacokinetic samples were collected on Day 5. On days 1-5,
      Safety ECG measurements were also collected at pre-dose and 2 hours post-dose. Subjects
      returned to the study centre for an outpatient safety follow-up visit approximately 10-14
      days after their last dose of study medication.
    

Intervention name(s): Placebo spray and oral moxifloxacin placebo; Sativex spray and oral moxifloxacin placebo; Sativex spray and oral moxifloxacin placebo; Placebo spray and moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 24 or 36 placebo sprays (12 or 18 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin placebo on Day 5.; 8 Sativex sprays (4 sprays twice daily every 12 hours) + 16 or 28 placebo sprays (8 or 14 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin placebo on Day 5.; 24 or 36 Sativex sprays (12 or 18 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin placebo on Day 5.; 24 or 36 placebo sprays (12 or 18 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin 400 mg tablet on Day 5.
Intervention MeSH terms: Moxifloxacin; Nabiximols; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Sativex; Cannabinoid; Electrocardiogram; QT interval
Acute Effects of Moderate Intensity Aerobic Exercise on Cognitive Functions in Young Adult Males
Condition: Cognitive Change
Study type: Interventional

Summary: 
      60 healthy male university students will be included in this study. Physical fitness
      parameters, fluid intelligence, and physical activity level will be measured at baseline.
      Participants will be randomised to one of two testing schedules, groups will complete either
      a 30-minutes aerobic exercise session or a resting control condition. Cognitive measures
      (simple reaction time task, go/nogo task, spatial cueing, n-back task) will be tested before
      and after the intervention.
    


Intervention name(s): aerobic exercise
Intervention type(s): Other
Intervention description(s): 30-minutes aerobic exercise intervention on the bicycle ergometer. The exercise protocol includes 5 minutes of warm-up, 20 minutes of loading and 5 minutes of cool-down. The intensity of the exercise will be adjusted to be between 46% and 63% of the VO2max calculated according to the exercise programming guide published by the American College of Sports Medicine (ACSM), and the perceived effort level on the Borg scale will be 12-13. Warm-up and cool-down periods will be set to 46% of VO2max and Borg perceived exertion level below 9.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group comparison, before and after intervention
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: acute aerobic exercise; cognition; university students; physical fitness
The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis
Condition: Sepsis Newborn
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Interventional

Summary: 
      The goal of this clinical trial is to assess the effect of melatonin on MDA serum, IL-6, IL-8
      levels, ANC, and sepsis score in preterm neonates with sepsis. The main question aim to
      answer :

      • Does melatonin affect MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm
      neonates with sepsis?

      The participants in the treatment group will receive a single dose of oral melatonin 20 mg,
      meanwhile those the control group will receive placebo.

      The researchers will compare MDA serum, IL-6, IL-8 levels, ANC, and sepsis score before and
      after receiving melatonin, whether there are decreases of MDA serum, IL-6, IL-8 levels, ANC
      and increase of sepsis score
    


Intervention name(s): Control Group; Treatment Group
Intervention type(s): Other; Drug
Intervention description(s): The control group will receive standard therapy and placebo.; The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: melatonin; sepsis; preterm neonates
The Impact of Early Norepinephrine Administration on Outcomes of Patients With Sepsis-induced Hypotension
Condition: Norepinephrine; Sepsis; Hypotension
MeSH terms: Sepsis; Toxemia; Hypotension
Study type: Interventional

Summary: 
      Septic shock is defined as sepsis with persistent hypotension requiring vasopressors to
      maintain mean arterial pressure (MAP)≥ 65 mmHg and a serum lactate level of > 2 mmol/L (18
      mg/dL) despite sufficient volume resuscitation

      . Hypovolemia (both relative and absolute) and reduced vascular tone have a role in
      determining the severity of hypotension in septic shock
    

Detailed description: 
      Septic shock is defined as sepsis with persistent hypotension requiring vasopressors to
      maintain mean arterial pressure (MAP)≥ 65 mmHg and a serum lactate level of > 2 mmol/L (18
      mg/dL) despite sufficient volume resuscitation . Hypovolemia (both relative and absolute) and
      reduced vascular tone have a role in determining the severity of hypotension in septic shock

      . When mean arterial pressure (MAP) falls below a specific critical level organ blood flow is
      physiologically dependent on perfusion pressure. Fluid resuscitation and vasopressors have an
      influence on hypovolemia and the vascular tone in the early phase, as fluid resuscitation
      aims to correct hypovolemia and vasopressors-norepinephrine (NE)- as a first-line drug aiming
      to restore vascular tone to assure organ perfusion

      . Norepinephrine is both an alpha1- and beta1-agonist so it is able to increase vascular tone
      and contractility

      . Nevertheless, a large amount of fluids will increase the risk of fluid overload, which is a
      common complication during septic shock resuscitation

        -  After the early phase, only fifty percent of patients respond to fluid administration,
           meaning that fluid treatment cannot boost cardiac output (CO) The current data indicate
           that the time from the onset of septic shock to the initiation of norepinephrine
           administration is a significant survival predictor; however, a suggestion for the
           optimal time to provide norepinephrine support was not explicitly expressed
    

Intervention name(s): Crystalloid; noradrenaline
Intervention type(s): Drug; Drug
Intervention description(s): received (30ml /kg) ringer's lactate solution after first presentation then norepinephrine was added when persistent mean arterial pressure (MAP)> 65 mmHg despite adequate fluid resuscitation; received ( 30ml /kg) ringer's lactate solution after first presentation combined with norepinephrine infusion (0.05 mic/kg/min)
Other intervention name(s): late noradrenaline infusion; early noradrenaline infusion
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The patients will be divided into two groups: in the first group the patient will be
      submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer
      (subtotal or total gastrectomy), while in the second group will be submitted to standard
      gastric surgery only.
    

Detailed description: 
      The incidence of gallstones and gallbladder sludge is known to be higher in patients after
      gastrectomy than in general population. This higher incidence is probably related to surgical
      dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction.
      Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery
      for gastric malignancies. However, not all the patients who are diagnosed to have
      cholelithiasis after gastric cancer surgery will develop symptoms or require additional
      surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those
      patients who underwent previous gastric surgery.
    

Intervention name(s): cholecystectomy
Intervention type(s): Procedure
Intervention description(s): prophylactic cholecystectomy during standard gastric surgery for cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gastric cancer, surgery, prophylactic cholecystectomy