bioihbjkbjnl/mcl2 huggingface dataset:
Hyperoxygenation in Anesthetized Children
Condition: Hyperoxia
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      This study is aiming at assessing the effect of inspired oxygen fraction during general
      anesthesia on children's lung mechanics and volume. More specifically, the temporal change in
      end-expiratory lung volume (EELV) and respiratory system resistance and elastance during the
      perioperative period will be characterized in order to define the the effect of high inspired
      fraction of oxygen on lung function.
    

Detailed description: 
      High-enriched oxygen fractions (FiO2)are common practice during general anesthesia both to
      ensure normoxemia despite intrapulmonary shunts and to provide security in case of adverse
      events. However, high-inspired oxygen fraction may decrease ventilation-perfusion ratios and
      its benefits are still unproven in children.

      The investigators aim at assessing the benefits and potential adverse effects of
      high-inspired oxygen fraction in two groups of children receiving either 30% FiO2 or 80% FiO2
      during maintenance of anesthesia. Nitrogen multiple breath washout technique and forced
      oscillation technique will be used to measure end-expiratory lung volume (EELV) and airway
      resistance (Rrs) and respiratory elastance (Xrs) respectively. These measurements will be
      obtained before the general anesthesia, one hour and one day after the procedure.
    

Intervention name(s): Oxygen
Intervention type(s): Other
Intervention description(s): Delivery of high concentration of oxygen at induction, maintenance and extubation of children under general anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Lung Volume Measurements; airway resistance; general anesthesia
Screen Free Time With Friends Feasibility Trial
Condition: Screen Media Use; Time With Friends
Study type: Interventional

Summary: 
      The Screen Free Time with Friends Feasibility Trial is a study designed to inform development
      of a definitive trial. The feasibility trial aims to 1) examine the feasibility of an
      intervention aimed to limit recreational screen media use and promote more time with peers
      after school and during weekends among 10-11 year old children, 2) examine participant
      recruitment and retention rates, 3) examine the feasibility of the data collection plan and
      completeness of the compliance and outcome assessment, and 4) obtain baseline and follow-up
      data on the planned full trial primary outcome. The Screen Free Time with Friends Feasibility
      Trial will be conducted as a non-randomized single group feasibility trial including
      children, their parents and school and afterschool personal from 3rd grade school classes
      from different schools in the Region of Southern Denmark. The goal is to include a
      representative sample of children and parents in the participating 3rd grades, and thus there
      will be no individual level inclusion and exclusion criteria. A process evaluation and
      outcome measurements will be conducted to evaluate the feasibility and acceptability of the
      intervention, the data collection plan, and compliance. A baseline- and follow-up assessment
      will be carried out for some measurements, while others will be collected continuously during
      the intervention period.
    


Intervention name(s): School-based extracurricular intervention focusing on screen media use and time spent with friends
Intervention type(s): Behavioral
Intervention description(s): The intervention includes the following components:
Within each class parents will engage in two meetings combining education and parent-to-parent communication about 1) the children's leisure time activities, and 2) family and class screen time culture. Parents will engage in a short exercise focusing on screen media dilemmas conducted by the teacher in the beginning of 4th grade.
Children will engage in school hour workshops focusing on the class culture related to screen media use and leisure time activities.
Afterschool club personal will engage in mini actions learning program consisting of three workshops aimed to increase participation rate in the afterschool club.
Local stakeholders, e.g., parents, school- and afterschool club personal and others relevant to children's leisure time (e.g., sports clubs) will engage in workshops to adjust the predetermined intervention components (1-3 above) to fit their local context and to develop a local action plan.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Behavioral Smoking Cessation Treatment - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment
      strategy in promoting longer-term smoking abstinence. We will also conduct secondary analyses
      of mediators and moderators of treatment response.
    

Detailed description: 
      400 adult smokers will be randomized. Our primary goal is to examine the effectiveness of a
      multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. All
      smokers will receive the same "Acute Phase Treatment" that combines nicotine patch, bupropion
      and intensive self-regulatory skills training. Nicotine patches will be provided for 8 weeks
      and bupropion and skills training will be provided for of 9 weeks. Participants will then
      enter a "Maintenance Treatment Phase" during which half (n=200) will receive three
      individualized relapse prevention training sessions spread over a 12 week period. They will
      also receive 12 weeks of self-administered RPT administered via written treatment modules.
      Finally, telephone counseling will be provided in conjunction with an Interactive Voice
      Response system (IVR) that will allow early detection of smoking "slips" and rapid response
      by treatment staff. The other half (n=200) will be assigned to a control condition that
      consists of three counselor-led sessions of "supportive therapy" spread over a 12 week
      period. P
    

Intervention name(s): Cognitive Behavior Therapy
Intervention type(s): Behavioral
Intervention description(s): extended treatment with cognitive behavior therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Propofol Versus Sevoflurane on Acute Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study was performed to compare the acute postoperative pain intensity and opioid
      consumption after total shoulder arthroplasty between propofol-remifentanil and
      sevoflurane-remifentanil anesthesia.
    

Detailed description: 
      After approval of the Institutional Review Board and written informed consent, 48 patients,
      aged 18-65 years for shoulder arthroplasty were enrolled in this prospective, randomized,
      double-blinded study.

      Patients were assigned to one of two groups : group PR, the propofol-remifentanil group; and
      group SR, the sevoflurane-remifentanil group.

      In the group PR, anesthetic induction was achieved with an initial target concentration of
      propofol 4 ㎍/mL and remifentanil 3-4 ng/mL using target controlled infusion (TCI) devices and
      rocuronium 0.8 mg/kg. After intubation, anesthesia was maintained with fixed target
      concentration of propofol 2-4 ㎍/mL and remifentanil 2-3 ng/mL to keep acceptable hemodynamic
      response and bispectral index (BIS) values 40-60.

      In the group SR, anesthetic induction was achieved with thiopental 5 mg/kg and initial target
      concentration of remifentanil 3-4 ng/mL using TCI and rocuronium 0.8 mg/kg. Anesthesia was
      maintained with 1.5-2.5% end-tidal concentration sevoflurane in 50% oxygen with air and
      remifentanil 2-3 ng/mL was continuously infused adjusting to maintain an acceptable
      hemodynamics and BIS values 40-60.

      The administration of propofol or sevoflurane with remifentanil was stopped at the surgery
      ended.

      Postoperative pain intensity was assessed using a numerical rating scale (NRS: 0; no pain,
      10; worst pain) at the 30 min, 2, 6, 12, 24 h. Also, the patient-controlled analgesia (PCA)
      was infused immediately after post anesthetic care unit arrival. The PCA device was set to
      deliver 0.38 ㎍/kg/h of fentanyl as a basal infusion rate and 20 ㎍ on demand with a 15 min
      lockout time. The total PCA volume, number of patients to need rescue analgesics was
      recorded.
    

Intervention name(s): propofol and remifentanil; sevoflurane and remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): intravenous propofol and remifentanil using target-controlled infusion (TCI) devices; inhalator sevoflurane and remifentanil using target-controlled infusion (TCI) devices
Intervention MeSH terms: Remifentanil; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: propofol; sevoflurane; anesthesia; shoulder arthroplasty
TYPE 2 HEPATORENAL SYNDROME
Condition: Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS
MeSH terms: Hepatorenal Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal
      syndrome (HRS). However, there are very few studies on vasopressors in the management of type
      2 HRS. Terlipressin has been used commonly; however it is costly and not available in some
      countries. In the present study, the investigators evaluated safety and efficacy of
      terlipressin and noradrenaline in the treatment of type 2 HRS
    


Intervention name(s): Noradrenaline; Terlipressin
Intervention type(s): Drug; Drug
Intervention description(s): Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour; Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour
Intervention MeSH terms: Terlipressin; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: noradrenaline terlipressin type 2 HRS
Pilot Study of Tolerability and Effectivity of Two Combination Topical Acne Products
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to compare two gels that are used to treat acne vulgaris. It will be compared the
      tolerability and effectivity following application of two combination topical acne products
      clindamycin 1% and 0.025% tretinoin gel (Acnatac® Gel), adapalen 0,1% and benzoyl peroxide
      2,5% gel (Epiduo® Gel).
    

Detailed description: 
      At baseline, data will be collected regarding demographics and medical/medication histories,
      lesions will be counted and a medical examination will be done. Female patients who could be
      pregnant will be tested by using a pregnancy test. Each patient receives two tubes with
      different medication that has to be applied on the left or right side of their face each by
      themselves at home once a day(Acnatac® Gel, Duac® Gel, Epiduo® Gel).

      Patients and study-center staff will be instructed not to reveal the treatment allocation to
      the investigator, and patients will be instructed not to apply the product in their presence
      Follow-up visits will be conducted on days 0, 7 and 21. On these days the investigator
      measures erythema and dryness/scaling using the Investigators´Global Assessment, the severity
      of burning/ stinging and itching by using Study Subject Self-Assessment, records the number
      of acneiform lesions, measures health-related quality of life using DLQI-Score, skin
      hydration using Corneometer, transepidermal water loss (TEWL) using Tewameter®, skin surface
      pH using pH-Meter and skin sebum excretion using Sebumeter.

      On days 0, 7, and 21 it will be collected information about current use of any other
      medication. Adverse events (AEs) and serious adverse events (SAEs) will be monitored at each
      visit. On day 21 there will be made a last pregnancy test. Checking compliance will be made
      regularly.
    

Intervention name(s): Acnatac® Gel left face; Epiduo® Gel right face; Acnatac® Gel right face; Epiduo® Gel left face
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): topical application; topical application; topical application; topical application
Other intervention name(s): Clindamycin 1%, Tretinoin 0,025%; Adapalen 0,1% and Benzoylperoxid 2,5%; Clindamycin 1%, Tretinoin 0,025%; Adapalen 0,1% and Benzoylperoxid 2,5%
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene, Benzoyl Peroxide Drug Combination; Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: acne; vulgaris; Clindamycin; Tretinoin; Adapalen; Benzoylperoxid; Epiduo; Acnatac
Relationship Between Dysphonia And Anxiety In Fibromyalgia
Condition: Dysphonia; Fibromyalgia; Anxiety Disorders
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Dysphonia; Hoarseness; Anxiety Disorders
Study type: Observational

Summary: 
      Our aim in conducting this study is to determine the relationship between voice disorders and
      anxiety in patients with fibromyalgia syndrome (FS).
    

Detailed description: 
      This case controlled study was performed at the Physical Medicine and Rehabilitation
      outpatient clinic between April 2022 and June 2022. 25 patients who were diagnosed with FS
      according to the 2010 American College of Rheumatology (ACR) criteria were included in the
      study. For the control group 25 healthy volunteers with no previous chronic disease history
      were included . The investigators planed to investigate the relationship between the anxiety
      level of the FS patients and dysphonia. Thus an acoustic voice analysis (fundamental
      frequency (F0), jitter, shimmer, noise to harmonic ratio (NHR), harmonic to noise ratio
      (HNR)) and an aerodynamic analysis (maximal phonation time (MPT)) were performed by an
      experienced otolaryngologist specialized in voice disorders for evaluation of objective voice
      quality and function. These analyses were performed on all the volunteers from both groups,
      and the results obtained were compared between the groups.
    

Intervention name(s): Assessment of Voice Quality and Function
Intervention type(s): Diagnostic Test
Intervention description(s): An acoustic voice analysis (fundamental frequency (F0), jitter, shimmer, noise to harmonic ratio (NHR), harmonic to noise ratio (HNR)) and an aerodynamic analysis (maximal phonation time (MPT)) were performed by an experienced otolaryngologist specialized in voice disorders for evaluation of objective voice quality and function. These analyses were performed on all the volunteers from both groups, and the results obtained were compared between the groups.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        25 patients diagnosed with fibromyalgia syndrome
      
Keywords: anxiety; fibromyalgia; dysphonia
Comparing Two Respiratory Drugs in Combination and Separately From a Novel Inhaler Device in Healthy Japanese Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is
      being developed for once daily administration for the maintenance treatment of asthma and
      COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and
      compared with GW642444M and GW685698X administered separately in order to determine whether
      co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics
      of either compound in healthy Japanese subjects.
    


Intervention name(s): Fluticasone foroate/ vilanterol; Fluticasone foroate; Vilanterol; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fluticasone foroate/ vilanterol 800 micrograms/ 50 micrograms will be available as dry powder inhaler.; Fluticasone foroate 800 micrograms will be available as dry powder inhaler.; Vilanterol will be available as dry powder inhaler.; Placebo will be supplied as dry powder inhaler.
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Healthy Japanese volunteers
Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile
Condition: Acute Diarrheal Disease; Rotavirus Infection
MeSH terms: Rotavirus Infections; Emergencies; Diarrhea
Study type: Observational

Summary: 
      The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes
      associated with moderate to severe disease (requiring emergency room (ER) consult or
      hospitalization) in a large public hospital from Valparaiso and another from Santiago.
    

Detailed description: 
      Rotavirus is the leading cause of gastroenteritis in children. Our group has developed a
      surveillance system for acute rotavirus diarrhea in two large hospitals in Chile since 2006.
      Patients visiting the ER for acute non-bloody diarrhea will be enrolled after an informed
      consent is signed by parents. A fresh stool sample will be collected to prospectively
      determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease
      (requiring emergency room (ER) consult or hospitalization. Stool samples will be tested for
      rotavirus by ELISA IDEIA - Rotavirus - OXOID. Rotavirus positive samples will be genotyped as
      described previously (Iturriza-Gomara et al. J. Clinical Virol 2004). Overall medical visits
      and hospitalizations, proportion of visits and hospitalizations caused by acute diarrhea,
      estimated numbers of rotavirus visits and hospitalizations will be calculated for each site.
      Proportion of rotavirus VP7 and VP4 genotypes will be calculated for three month periods per
      center. Differences in proportion will be compared by chi square and Fischer's exact test
      when appropriate.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children younger than 5 years of age with acute diarrhea or related diagnosis requiring
        emergency room and hospital admission in two large cities in Chile
      
Biospecimen description: 
      stool
    
Keywords: diarrhea; rotavirus; genotype; VP4; VP7
Hypersensitivity to Opening of ATP-Sensitive Potassium Channels in Post-Traumatic Headache
Condition: Post-Traumatic Headache
MeSH terms: Post-Traumatic Headache; Hypersensitivity; Headache
Study type: Interventional

Summary: 
      The aim is to investigate whether opening of ATP-sensitive potassium (KATP) channels induces
      headache with migraine-like features in people with persistent post-traumatic headache (PTH)
      attributed to mild traumatic brain injury (mTBI).
    


Intervention name(s): Levcromakalim; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study participants will be allocated to receive continuous intravenous infusion of 0.05 mg/min (20 ml of 50 mg/ml) levcromakalim.; Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline).
Other intervention name(s): Isotonic Saline
Intervention MeSH terms: Cromakalim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Headache; Pain
Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study is a multicenter, prospective phase II-study investigating the combination
      of treosulfan, etoposide, and cyclophosphamide as conditioning regimen for patients with
      acute lymphoblastic leukemia who are not eligible for a TBI-containing regimen.
    


Intervention name(s): Hematopoietic stem cell transplantation
Intervention type(s): Procedure
Intervention description(s): conditioning regimen:
day -7: 12g/m^2 Treosulfan
day -6: 12g/m^2 Treosulfan
day -5: 12g/m^2 Treosulfan
day -4: 30mg/kg BW Etoposide
day -3: 20mg/kg ATG Fresenius (OPTIONAL), 60mg/kg BW Cyclophosphamide
day -2: 20mg/kg ATG Fresenius (OPTIONAL), 60mg/kg BW Cyclophosphamide
day -1: 20mg/kg ATG Fresenius (OPTIONAL)
day 0: SCT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Lymphoblastic Leukemia; Hematopoeitic Stem Cell Transplantation