bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent
      abdominal pain in children. This will be an open-labeled study and all participants will
      receive SAM-e therapy. Given that SAM-e has been demonstrated to improve symptoms of
      depression and pain with minimal side effects as compared to other antidepressant therapy, we
      hypothesize that SAM-e will reduce pain symptoms among children with recurrent abdominal
      pain.
    


Intervention name(s): S-adenosyl methionine
Intervention type(s): Drug
Intervention description(s): S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
Other intervention name(s): SAM-e; Mood Plus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: abdominal pain; children
Low-frequency Electrical Muscle Stimulation vs Cycle Training During Haemodialysis
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The purpose of the trial is to compare the effects of intra-dialytic low-frequency electrical
      muscle stimulation and intra-dialytic cycling, with usual care haemodialysis without exercise
      training.
    

Detailed description: 
      End stage renal disease is associated with reduced functional capacity. Dynamic exercise
      training i.e. cycling, performed between dialysis sessions or during dialysis
      (intra-dialytic) can be effective in improving functional capacity and quality of life.
      However, many patients are unable to engage in intra-dialytic cycling due to limiting
      comorbidities. Other exercise modalities should be considered. Low-frequency electrical
      muscle stimulation of the quadriceps is well tolerated and may improve functional capacity in
      clinical populations.

      The trial is a longitudinal, randomised controlled trial. Participants will be randomly
      allocated to 10 weeks of 1) intra-dialytic low-frequency electrical muscle stimulation, 2)
      intra-dialytic cycling, or 3) usual care haemodialysis without exercise training. Outcomes
      will be assessed at baseline and 10 weeks by assessors blinded to group allocation.
    

Intervention name(s): Intra-dialytic LF-EMS; Intra-dialytic cycle training
Intervention type(s): Other; Other
Intervention description(s): Electrical muscle stimulation during haemodialysis; Cycle training during haemodialysis
Other intervention name(s): Electrical muscle stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Canadian rTMS Treatment and Biomarker Network in Depression Trial
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Repetitive transcranial magnetic stimulation (rTMS) is an emerging treatment for medically
      refractory major depressive disorder (MDD). rTMS involves direct stimulation of cortical
      neurons using externally applied, powerful, focused magnetic field pulses. Dozens of studies
      and several meta-analyses over the last 15 years have shown that rTMS of the dorsolateral
      prefrontal cortex (DLPFC) produces statistically significant improvements in MDD, even when
      medications have failed. However, other possible targets may also yield improvement in
      symptoms.

      In an attempt to enhance the therapeutic efficacy of current interventions for TRD, attention
      has turned to identifying domain-specific biomarkers in hopes of ultimately individualizing
      and predicting treatment response. Unfortunately, the precise nature of this relationship is
      less than clear, as reflected by the fact that even now there are no established biomarkers
      that are used routinely in clinical practice to aid in diagnosis. This study also seeks to
      examine a comprehensive suite of biomarker measurements (MRI, neurophysiology, and
      genomics/proteomics) before and after rTMS treatment.
    

Detailed description: 
      rTMS is a Health-Canada- and FDA-approved treatment for treatment-resistant depression (TRD),
      using focused magnetic field pulses to stimulate brain regions involved in emotion
      regulation, safely and non-invasively. Though rTMS is often effective where medications or
      therapy fail, it requires a series of lengthy (~30-40 min) treatment sessions. A new form of
      rTMS called theta burst stimulation (TBS) has been shown to have greater effects on neural
      activity than conventional stimulation, despite requiring as little as 40 s of stimulation.
      The purpose of this study is to assess the efficacy and tolerability of an accelerated TBS
      protocol, administered 2 times a day in patients with TRD. In addition, the investigators aim
      to identify candidate biomarkers from a multimodal suite of neuroimaging, neurophysiologic
      and molecular measures that are predictors and correlates of response to rTMS treatment.
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): intermittent theta burst stimulation (iTBS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; treatment resistance; biomarkers; repetitive transcranial magnetic stimulation
Allergic Rhinitis Changes the Sinus Microbiome
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that treatment with QNASL will reduce nasal mucosal
      inflammation induced by the allergy season and prevent the changes in the microbiome caused
      by the allergy season.
    


Intervention name(s): QNASL; Placebo nasal spray
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks
Condition: Starvation
MeSH terms: Starvation
Study type: Interventional

Summary: 
      Surgical patients are usually starved for 8 to 12 hours before operation in order to reduce
      the chances of vomiting and other complications during the anaesthetic. Recent studies have
      suggested that this period of starvation might be harmful as it 'weakens' or 'stresses' the
      body before the operation. To avoid these harmful effects of starvation, patients are now
      given carbohydrate drinks (sugar-containing drinks that provide energy for the body) up to 2
      hours before the operation. These drinks have been shown to make patients feel better, reduce
      sickness after the anesthetic/surgery and result in quicker recovery from operation. But the
      ways in which the sugar drinks have these beneficial effects on the body are unknown. The
      optimum time of giving these drinks to patients before operation is also unknown. This study
      will investigate the hormone responses of the body, following intake of 2 different
      carbohydrate drinks, in order to determine the optimum time of intake of these drinks in
      order to obtain the maximum benefits for the body.
    


Intervention name(s): PreOP Booster; PreOP (Nutricia Clinical Care, Trowbridge, UK)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 serving of 400 ml per study arm; 1 serving of 400 ml per study arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Dietary supplement; healthy volunteers; Anaesthesia for surgery
Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MR Compared to Invasive Assessment
Condition: Portal Hypertension; Liver Diseases; Liver Cirrhoses; Cirrhosis
MeSH terms: Liver Diseases; Liver Cirrhosis; Hypertension, Portal; Fibrosis
Study type: Observational

Summary: 
      Liver cirrhosis is a chronic disease characterized by a progressive accumulation of fibrosis,
      loss of liver function and portal hypertension leading to several hemodynamic changes.The
      exact pathophysiological mechanisms causing the hyperdynamic alterations in cirrhosis are not
      fully elucidated.

      Aim:

      The aim of the study is to assess hemodynamic alterations in liver cirrhosis by non-invasive
      MRI and echocardiography compared to portal hypertension measured with liver vein
      catheterization (HVPG, hepatic vein pressure gradient). Furthermore, the aim is to explore
      hemodynamic differences between cirrhotic patients and healthy subjects.

      Study design and cohort:

      The study has a cross-sectional design and a cohort with 99 patients with liver cirrhosis -
      with and without complications and 27 healthy volunteers. The patients are recruited at the
      Gastrounit Hvidovre University Hospital.

      The day before the first visit patients are hospitalized and fasting overnight. At first
      visit liver vein catheterization (LVC) and echocardiography are performed. Second visit must
      be performed within 4 weeks after first visit. At the second visit patients are fasting
      minimum 6 hours before having MR-flow scanning, cardiac-MR and MR-Elastography (MR-E).

      The healthy volunteers are only offered MR-flow scanning, cardiac MR and MR-E as well as
      urine- and blood tests

      Follow-up for liver-related clinical outcome and mortality in medical records
    

Detailed description: 
      MR elastography, cardiac scan, phase contrast MRI of blood flow compared to LVC
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A cohort with 99 cirrhotic patients with and without complications and 27 healthy
        volunteers. The patients are recruited at the Gastrounit Hvidovre University Hospital
      
Biospecimen description: 
      Standard clinical blood tests and pertinent bioactive substances is measured in blood and
      urine
    
Keywords: Hemodynamic assessments; Echocardiography; MR-Elastography; Liver vein catheterization; Liver Cirrhosis; Cirrhotic cardiomyopathy; Cirrhotic complications; Magnetic Resonance Imaging
To Assess the Pharmacokinetics, Safety and Tolerability of Abediterol Administered Once Daily for 9 Days, in Patients With Asthma on Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 study to assess pharmacokinetics (PK) and safety of abediterol 5 μg dry powder
      inhaler (DPI) given once daily (QD) for 9 days, compared to placebo, in patients with asthma
      on inhaled corticosteroids (ICSs).
    

Detailed description: 
      This is a randomized, single-blind, placebo-controlled study to assess PK and safety of
      abediterol 5 μg DPI given QD for 9 days, compared to placebo, in patients with asthma on
      ICSs. It is planned that 12 patients with asthma will be randomized into the study, of which
      9 will receive abediterol 5 μg and 3 will receive placebo. The entire study period is
      scheduled to take a maximum of 41 days (follow-up included) for each individual patient.
      During the screening period, all patients will take their own baseline inhaled
      corticosteroids. Patients on long-acting β2-agonist/inhaled corticosteroids will be switched
      over to the respective inhaled corticosteroid mono-component at Visit 1. Patients will be
      provided salbutamol as rescue medication for use throughout the study. Each patient will
      receive a single inhaled dose of abediterol or placebo in the morning of Days 1 to 9 (Visits
      3 to 8) under supervision of the Investigator or designee.
    

Intervention name(s): Abediterol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A β2-adrenoceptor agonists, produce smooth muscle relaxation in the airways and improves lung function.; Abediterol matching placebo without any pharmacological activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Asthma, placebo, abediterol, DPI, corticosteroids
Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effect of two root-conditioning agents used in
      conjunction with subepithelial connective graft technique on root coverage outcomes. One is
      citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.
    

Detailed description: 
      Citric acid plus tetracycline has properties of root surface decontamination, surface
      demineralization and exposure of collagen fibers.

      Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction
      of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial
      resistance. Also, it has properties of root demineralization and exposure of collagen fibers.
      These properties may enhance root coverage in procedures of subepithelial connective graft.
    

Intervention name(s): Control; citric acid plus tetracycline; antimicrobial photodynamic therapy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with scaling and root planing; Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with citric acid plus tetracycline; Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with antimicrobial photodynamic therapy
Intervention MeSH terms: Anti-Infective Agents; Tetracycline; Anti-Bacterial Agents; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventions in different patients
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingival recession
Dasotraline Adult ADHD Study
Condition: Adult Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating
      the efficacy and safety of dasotraline in adults with ADHD.
    

Detailed description: 
      This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating
      the efficacy and safety of dasotraline in adults with ADHD using 2 doses of dasotraline (4
      mg/day or 6 mg/day) versus placebo over an 8 week treatment period (8 weeks of active
      treatment followed by a 2-week withdrawal phase).
    

Intervention name(s): Dasotraline; Dasotraline; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Dasotraline 4 mg once daily; Dasotraline 6 mg once daily; Placebo once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration
Condition: Cytomegalovirus Retinitis; Acute Renal Failure
MeSH terms: Cytomegalovirus Retinitis; Retinitis; Acute Kidney Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      Cidofovir is an acyclic nucleotide analog with broad-spectrum antiviral activity against
      herpesviruses. Its potency in inhibiting HCMV has been shown in conventional in vitro
      studies. It is approved for the systemic treatment of human cytomegalovirus (HCMV) retinitis
      in patients with AIDS and as a second line therapy for HCMV infections not responding to
      ganciclovir or foscarnet.

      In intensive care patients continuous venovenous haemofiltration (CVVH) is a well-established
      extracorporal renal replacement therapy with a high clearance rate.

      Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVH are
      rare. Elimination of any given drug by renal replacement therapy is determined by several
      major factors which are membrane specific, due to physico-chemical properties of the drug and
      characteristics of the renal replacement technique used.

      Study objective The trial is conducted to investigate the pharmacokinetics of cidofovir
      during CVVH in critically ill patients. It is suspected that Hemofiltration will influence
      cidofovir plasma levels.
    


Intervention name(s): Cidofovir pharmacokinetics
Intervention type(s): Other
Intervention description(s): Blood samples were drawn before and 15, 30, 60, 120, 240, 360, 720 and 1440 minutes after the start of the cidofovir infusion. Plasma and ultrafiltration samples were collected from the outlet of the ultrafiltrate compartment of the hemofilter.
Intervention MeSH terms: Cidofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: cidofovir; cvvh; renal replacement therapy; HCMV; Pharmacokinetics of cidofovir during CVVH; continuous venovenous hemofiltration
Comparison of Two Anatomic Landmarks With Ultrasonography in Spinal Anesthesia
Condition: Arthropathy of Knee
MeSH terms: Joint Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The most used anatomical landmark for application of spinal anesthesia is Tuffier's line.
      Other alternative landmark is tenth rib. However there is no trial that compare these
      landmarks based on using ultrasonography.
    

Detailed description: 
      The investigators aim to compare two landmarks (Tuffier's line and tenth rib line) for
      accuracy by using ultrasonography. 40 patients will be included in each groups. all of them
      will be assessed by ultrasonography during application of spinal anesthesia. And the
      investigators will examine the percentage of successful estimation of correct vertebral
      space.
    

Intervention name(s): ultrasonography
Intervention type(s): Device
Intervention description(s): spinal anesthesia guided with ultrasonography
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: spinal anesthesia; ultrasonography; anatomical landmark
A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and
      Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in
      Children Ages 6 to <12 Years with Asthma during 12 weeks.
    

Detailed description: 
      A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating
      the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort
      pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations
      Twice Daily, in Children Ages 6 to <12 Years with Asthma
    

Intervention name(s): Symbicort pMDI; Symbicort pMDI; Budesonide pMDI
Intervention type(s): Drug; Drug; Other
Intervention description(s): Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily; Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily; Budesonide pMDI 80µg, 2 acuations twice daily
Other intervention name(s): Active comparator
Intervention MeSH terms: Budesonide; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma, children, budesonide pMDI
A Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 2

Summary: 
      This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of
      MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal
      residual disease after autologous haematopoietic stem cell transplantation (bone marrow or
      peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients
      with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal
      B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2
      intravenously once every week. The anticipated time on study treatment is 4 weeks.
    


Intervention name(s): rituximab [MabThera/Rituxan]
Intervention type(s): Drug
Intervention description(s): 375 mg/m2 intravenously once a week for 4 weeks
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on E-diary on a Smartphone Application and Actigraphy
Condition: Atopic Dermatitis Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      Atopic dermatitis is a chronic disease with a high impact on patient's quality of life.
      Nocturnal pruritus is one of the main symptoms affecting quality of life. Treatment efficacy
      is generally measured by healthcare professionals during consultations with both questioning
      and visual examination of the lesions. Quality of Life (QoL) can also be evaluated
      retrospectively with the Dermatology Life Quality Index (DLQI) scale. Collecting data
      retrospectively introduces a significant recall bias that can be addressed by collecting data
      in Real World (RW). Real World data collection is prospective and take place within the
      patient's own environment. While data collection is generally done with diaries, it has been
      demonstrated that smartphone and connected devices were able to produce more precise and
      granular data than traditional methods.
    

Detailed description: 
      The main objective of the study is to demonstrate a medical hypothesis using a wristband
      actigraph: patients with moderate to severe atopic dermatitis have a poorer quality and
      quantity of sleep than healthy subject.

      Secondary objetives are to assess the interest of a smartphone application in evaluating the
      quality of life of patients with moderate to severe atopic dermatitis in regard of those of
      healthy volunteers.
    

Intervention name(s): electronic-Patient Report Outcome and wear of a wristband actigraph
Intervention type(s): Other
Intervention description(s): Measurement of sleep quality and quantity with wristband actigraph and evaluation of quality of life with electronic-Patient Report Outcome
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Investigators will first enroll patients, then healthy volunters. Healthy volunters will be matched to patients on age, sexe and wake up at a programmed time
Masking: None (Open Label)
Primary purpose: Other