bioihbjkbjnl/mcl2 huggingface dataset:
Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?
Condition: Pediatric Emergence Agitation and Pain
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      Preoperative anxiety is characterized by subjective feelings of tension, apprehension,
      nervousness and worry. In children, preoperative anxiety is reported to result in
      postoperative negative psychological effects, including nightmares, eating problems and
      increased fear of doctors. Previous studies have assessed anxiety in children during the
      preoperative period and the effects of premedication and parental presence. Midazolzam has
      been shown to reduce preoperative anxiety in children but post operative recovery maybe
      delayed for children undergoing a short operative procedure. Distraction may be particularly
      helpful in children ages 6-12 as these children are curious about their environment. An
      association between preoperative anxiety and emergence agitation has been suggested.
      Emergence agitation in children is not well understood but is a frightening experience for
      child and parent. A previous study demonstrated the efficacy of hand held video games used as
      an interactive distraction to allay preoperative anxiety. The purpose of this study is to
      treat preop anxiety with premedication, or video game and to evaluate the impact of these
      interventions on the incidence and severity of emergence agitation.
    


Intervention name(s): Midazolam; Game Boy
Intervention type(s): Drug; Device
Intervention description(s): Midazolam 0.5mg/kg; Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction
Other intervention name(s): Nintendo-DS Game Boy
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: pediatric emergence agitation and pain
The STAR Prospective Clinical Series
Condition: Metastasis to Vertebral Column
MeSH terms: Neoplasm Metastasis
Study type: Observational [Patient Registry]

Summary: 
      Prospective clinical series to gather post tumor ablation clinical outcomes from subjects
      with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment
      with the STAR™ Tumor Ablation System.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with painful spinal metastases following t-RFA with the STAR™ Tumor Ablation
        System.
As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of as-needed Budesonide/formoterol Turbuhaler 160/4.5
      µg/d in the period of step down in well controlled asthmatic patient comparing with standard
      maintenance therapy in step-2 management in asthma guildeline which is low dose inhaled
      corticosteroid.
    

Detailed description: 
      The study will measure the efficacy of as-needed low dose ICS/ LABA in well controlled
      asthmatic patient comparing with low dose ICS in step down circumstance.
    

Intervention name(s): Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder; Budesonide 200Mcg Inhalation Powder
Intervention type(s): Drug; Drug
Intervention description(s): After the patients who have all criteria, they will be randomized to take Budesonide/formoterol (160/4.5 μg/d) as need when they have symptoms.; After the patients who have all criteria, they will be randomized to take Budesonide (200 μg) twice daily
Other intervention name(s): Symbicort Turbuhaler (160/4.5 ug); Pulmicort Turbuhaler (200 ug)
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; allergy
Human Challenge Model Refinement With Enterotoxigenic Escherichia Coli Strain B7A
Condition: Healthy Volunteer
MeSH terms: Escherichia coli Infections
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safe and optimal dose and regimen (fasting
      duration) for administering the challenge ETEC strain B7A, a CS6 expressing ETEC strain.

      Additionally, an assessment of homologous protection following rechallenge with B7A will be
      assessed.
    

Detailed description: 
      Enterotoxigenic Escherichia coli (ETEC) is the most common causes of infectious diarrhea in
      children in resource limited countries, and is also a frequent cause of traveler's diarrhea
      in civilian and military travelers to endemic countries. ETEC strains express one or both of
      two enterotoxins (heat labile toxin (LT) and heat stable toxin (ST)) that cause help the
      bacteria cause the main symptom of watery diarrhea. They also express a variety of
      colonization factors (CF) that help them attach to the intestinal wall. Each colonization
      factor has one or more surface antigens (CS).

      Vaccines and treatments to prevent ETEC disease are under development. Some of these target
      specific enterotoxins or colonization factors. For over 40 years, we have used ETEC human
      challenge studies to understand the ETEC disease process, immune response, and more recently,
      to determine whether treatments or vaccines are protective or effective in mitigating
      disease. One concern about these challenge study is the use of high doses of bacteria given
      may overwhelm the protective efficacy of the vaccine or treatment. Several strains of ETEC
      have been used in these challenge studies; a frequently used strain is B7A (CS6+, LT+, ST+.
      O148:H28).

      This study will explore the optimal dosing strategy for B7A, in order to minimize the dose of
      ETEC necessary to produce disease in healthy adult volunteers. There will be two inpatient
      admissions. The first will examine 4 dosing and fasting regimens in healthy volunteers. The
      second admission will include volunteers who became ill during the first admission, as well
      as a new group of volunteers. This second admission will validate the optimal dose from the
      first admission, as well as to determine if previous infection with B7A ETEC will protect
      against a new infection. Trying to understand the immune response to this challenge organism
      may help us optimize vaccine design and delivery to protect people from this infection.
    

Intervention name(s): ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer
Intervention type(s): Biological
Intervention description(s): ETEC Bacteria
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: ETEC; Escherichia coli; enteritis; Challenge; CS6; Enterotoxigenic
The Effects of a Novel Lifestyle Intervention Program on Insulin Sensitivity in Type 2 Diabetes
Condition: Type 2 Diabetes; Fatty Liver, Nonalcoholic
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Moderate weight reduction by a moderately hypocaloric very-low-fat diet resulted in
      normalization of fasting hyperglycemia and reversal of hepatic insulin resistance in patients
      with poorly controlled type 2 diabetes. The Diabetes Remission Clinical Trial (DiRECT)
      revealed that utilizing a total diet replacement by a low-energy formula diet for 3 months
      led to a 15 kg or more weight loss in 24% participants and diabetes remission 46% of the
      participants. To date it remains unknown whether similar results can be achieved with a
      natural, non-formula based diet in connection with an educative smartphone application and
      telephone coaching
    

Detailed description: 
      24 patients with type 2 diabetes from the German Diabetes Study (GDS) with less than 4 years
      disease duration and not receiving insulin were included in this study. Before the start of
      the intervention, participants documented their dietary intake by recording a food diary.
      During the 12-week intervention participants were asked to adhere to a real food-based
      low-calorie diet supported by an app-guided digital education program as well as a
      low-calorie recipe book and received weekly coaching calls by nutritionists. Patients were
      instructed to adhere to a balanced low calorie diet during the intervention. Nutritionists
      provided structured behavior change focusing on dietary advice, adherence to logging dietary
      intake and tracking weight. At first visit, patients installed the Changing Health App
      (Changing Health, Newcastle, UK) and completed an app-based digital education program. This
      program focused on type 2 diabetes education and behavioral change in combination with weight
      tracking and dietary monitoring. Patients used the app throughout the study and adherence was
      monitored via logins. Comprehensive testing before and after the intervention comprised a
      mixed-meal tolerance test and liver fat.
    

Intervention name(s): Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone
Intervention type(s): Behavioral
Intervention description(s): During the 12-week intervention participants were asked to adhere to a real food-based low-calorie diet supported by an app-guided digital education program as well as a low-calorie recipe book and received weekly coaching calls by nutritionists
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Getting Malaria "Off the Back" of Women and Children in Western Uganda
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the
      incidence of P. falciparum malaria among infants in a rural area of western Uganda.
      Participants will be recruited from four villages immediately adjacent to the Bugoye Level
      III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of
      western Uganda.

      The purpose of the study is to assess the feasibility and tolerability of using
      insecticide-treated lesus to reduce the incidence of P. falciparum malaria infection among
      infants.
    

Detailed description: 
      This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the
      incidence of P. falciparum malaria among infants in a rural area of western Uganda.
      Participants will be recruited from four villages immediately adjacent to the Bugoye Level
      III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of
      western Uganda.

      The first phase will consist of a series of focus group sessions with mothers of young
      children and their male partners to gain further insight into lesu use, to include location
      of purchase and frequency of washing, as well as exploring initial perceptions of
      insecticide-treated clothing and inform the protocols for the open-label study.

      The second phase will consist of a prospective, open-label study. Twenty-five (25) mothers
      and their young children will be provided with insecticide-treated lesus and twenty-five (25)
      controls who will be provided untreated lesus. After an initial visit, bi-weekly follow up,
      including finger-prick blood collections will continue for a period of twelve (12) weeks.

      Collected blood spots will be transported to Epicentre for real-time PCR to identify
      sub-microscopic parasitemia and to the French Research Institute for Development
      (https://en.ird.fr) in Marseille, France for quantification of the mosquito salivary antigen
      (gSG6-P1 peptide). Remaining samples will be stored for future analysis.
    

Intervention name(s): Permethrin-treated Lesu (baby wrap); Untreated Lesu (baby wrap)
Intervention type(s): Other; Other
Intervention description(s): 0.5% permethrin application; Matching untreated lesu
Other intervention name(s): Placebo
Intervention MeSH terms: Permethrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to control (25) or intervention group (25)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; P. Falciparum; Permethrin; Rapid diagnostic test
Atorvastatin and Sympathetic Activity in Chronic Kidney Disease
Condition: Stable Chronic Kidney Disease; Hypertension
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity which
      appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage.
      Experimental studies and some clinical studies have shown that statin therapy can reduce
      central sympathetic activity. Blockade of the renin-angiotensin system (RAS), which is
      standard treatment for CKD, is known to lower sympathetic activity.

      The investigators hypothesize that adding a statin for 6 weeks to RAS blockade would further
      lower sympathetic activity in hypertensive stage 2-4 CKD patients.

      Methods: In ten stable CKD patients who are on chronic treatment with renin-angiotenis
      blockers, blood pressure and sympathetic activity (quantified by assessment of muscle
      sympathetic nerve activity, MSNA) will be assessed at baseline and 6 weeks after atorvastatin
      20mg/day added.

      Ten other CKD patients will serve as time control and will be studied twice with an interval
      of 6 weeks without any change in medication, to quantify within subject reproducibility.
    

Detailed description: 
      see above
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): 6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sympathetic activity; chronic kidney disease; atorvastatin; lipitor
Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Little is known regarding the association of individual components of the metabolic syndrome
      (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional
      markers in women with this syndrome. Less is known about adequate treatment as the
      pathological mechanism of this syndrome is not well understood.

      The purpose of this study is two fold;

        1. To determine basic differences in biochemical and cardiovascular structural markers in
           women with and those without MBS and their association with the individual components of
           MBS.

        2. To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome.
           Atorvastatin is one of the most effective drugs approved by the United States Food and
           Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class
           of drugs called statins and its role in primary prevention is still unclear. Thus this
           population seems to be an ideal group that may benefit from this intervention.
    

Detailed description: 
      The first phase of the study is an observational phase as previously described. The second
      phase was a prospective evaluation of the effect of a well known "statin" drug (Lipitor) on
      different biochemical factors measured in the blood. The eligible study participants had
      blood work done upon enrollment and if criteria was met(according to the Adult Treatment
      Panel III), they were given dietary counseling (NYHA - New York Heart Association Step 1
      diet) as a lead in phase. Lab work was repeated at 3 weeks to evaluate the impact of the diet
      and if participant's profile still met criteria for MBS,randomization for either atorvastatin
      (Lipitor) 80mg or placebo (sugar pill) for 12 weeks took place.
    

Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 80mg; 80mg
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: metabolic syndrome; atorvastatin; women
Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults
Condition: Gastroduodenal Ulcerations; Erosion
MeSH terms: Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of
      PL3100 versus Naproxen in normal healthy volunteers.
    


Intervention name(s): PL3100; Naproxen
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: NSAID-induced gastroduodenal ulcerations or erosion
Specific or Non-Specific Manipulation for Patients With Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy
      applied in a vertebral region-specific or region nonspecific level immediately after
      treatment and 3 and 6 months after randomization.
    

Detailed description: 
      To evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a
      vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6
      months after randomization.

      148 patients with chronic non-specific low back pain will be enrolled for this clinical
      trial. Patients will undergo to a specific physical examination in order to determine the
      ideal lumbar spine level to be manipulated. The outcomes of interest are pain intensity, pain
      pressure threshold, global perceived effect and disability associated with back pain. After
      the first assessment patients will be randomly assigned to two groups that will receive 10
      sessions of spinal manipulation over a period of four weeks, and may receive manipulation
      according to the findings on physical examination (specific manipulation) or may receive
      manipulation in the upper thoracic region, disregarding the physical examination findings
      (nonspecific manipulation).
    

Intervention name(s): Specific manipulation; Non-specific manipulation
Intervention type(s): Other; Other
Intervention description(s): Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation.; Patients allocated to the specific manipulation group will receive spinal manipulation on the upper thoracic spine that will be not related to the physical examination performed prior to the treatment allocation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Back pain; spinal manipulation
Study of the QUadratus Lumborum Bloc in Total Hip ARthroplasty: Efficacy and Safety
Condition: Postoperative Pain; Total Hip Replacement
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this prospective research study is to determine the best way to manage
      post-operative pain after a total hip arthroplasty. Currently, there is no standard of care
      for managing post-operative pain in these patients. The quadratus lumborum block (QLB) first
      described by Blanco in 2007, is a promising technique in this indication: recently, there is
      a growing evidence for the use of the QLB as an alternative technique for pain management
      after hip surgery.
    

Detailed description: 
      A sample size of 100 patients (50 per group) was calculated based on 20% reduction in
      morphine consumption with 0.05% significance and a power of 0.8.

      After ethical committee approval, eligible patients scheduled to have a fast-track total hip
      arthroplasty are screened during preoperative evaluation clinic. Informed written consent
      will be obtained from all patients during pre-anesthesia visit the day before surgery (J-1).
      Consenting patients will be randomized the day of surgery (J0) to undergo QLB with
      ropivacaine ("ropivacaine group") or normal saline ("saline group").

      Before general anesthesia, all patients will have a needle-insertion posterior to the
      quadratus lumborum muscle avec injection of either ropivacaine in the "ropivacaine group" or
      normal saline in the "saline group".

      After general anesthesia induction, dexamethasone and ketamine will be given to all patients.
    

Intervention name(s): posterior Quadratus Lumborum Block (QLB)
Intervention type(s): Procedure
Intervention description(s): Procedure (experimental): ultrasound guided posterior Quadratus Lumborum Block (QLB) Procedure (experimental): Sham Block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being
      developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long
      duration of action of GSK233705 when administered via inhalation in animal models supports
      the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary
      disease.
    


Intervention name(s): GSK233705
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: plethysmography; muscarinic receptor antagonist; COPD; repeat dosing