bioihbjkbjnl/mcl2 huggingface dataset:
Open Clinical Trial of CBT-based Multiprofessional Rehabilitation for Exhaustion Disorder
Condition: Exhaustion; Syndrome; Burnout, Professional; Burnout Syndrome; Adjustment Disorders
MeSH terms: Syndrome; Burnout, Professional; Burnout, Psychological; Adjustment Disorders
Study type: Interventional

Summary: 
      Stress-related mental disorders are today the leading cause of long-term sick leave in
      Sweden, and a large part of this increase is due to Clinical burnout, in Sweden called
      "Exhaustion disorder" (ED). Even though clinical guidelines recommend multi-professional
      rehabilitation (MPR) for ED, few studies have evaluated the effects of these treatment
      programs in clinical practice. This large-scale open clinical trial investigates whether MPR
      for ED seems to alleviate symptoms of ED and if it results in return-to-work.
    

Detailed description: 
      This study is carried out at two specialized stress rehabilitation centers in Stockholm. All
      patients included in the clinics stress rehabilitation program are asked to participate in
      the study and are recruited consecutively from October 2017 throughout December 2018. An
      estimate of 400 patients will be included. The treatment program is a 24-week
      Multiprofessional standardized CBT-rehabilitation consisting of a nine-session CBT group
      treatment (stress management) followed by a seven-session group treatment in applied
      relaxation. Parallel to the group treatments patients receives nine sessions of individual
      CBT, three visits to an MD (for medication, follow-up, and sick-listing), two individual
      sessions to a physiotherapist and a three session-exercise group. Also, vocational measures
      are taken through rehabilitation meetings together with the patient's employer (if an
      employer exists). Primary treatment outcomes will be return-to-work (RTW) and symptoms of ED,
      anxiety, and depression. Secondary treatment outcomes will be quality of life, pathological
      worry, psychological flexibility, clinical perfectionism, insomnia, burnout, and symptoms.
      Predictors of symptom development and RTW will be explored. Also, comorbidity of chronic
      pain, negative effects of psychotherapy and treatment credibility will be investigated.
    

Intervention name(s): Multi-professional CBT-rehabilitation
Intervention type(s): Behavioral
Intervention description(s): See "Detailed description"
Intervention model: Single Group Assignment
Intervention model description: Open Clinical Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exhaustion Disorder; Burnout; Clinical Burnout
Body Weight Assessment in Swiss Primary School Children: Trend Analysis Over 10 Years
Condition: Overweight; Obesity
MeSH terms: Overweight; Body Weight
Study type: Observational

Summary: 
      Background: Recent evidence from several countries has emerged suggesting that the increase
      in the prevalence of childhood obesity has slowed down substantially, or even leveled off.
      Also in Switzerland this trend has been observed. In 2002, 20.3% and 19.1% of boys and girls,
      respectively, were overweight or obese in Switzerland. In 2007, the prevalence of overweight
      was significantly lower, with 11.3% and 9.9% of school-aged boys and girls, respectively,
      being overweight or obese. Further trend analyses are necessary to confirm that the
      stabilizing trend observed reflects a long-term change in the rates of childhood overweight
      and obesity.

      Objective and Methods: The aim of the present study is to repeat the 2002 and 2007 national
      studies, in order to monitor the trend in the prevalence of overweight and obesity in 6-12
      year old children in Switzerland during this 5 respectively 10 year time period. Height and
      weight will be measured and used to calculate body mass index (BMI). BMI references form the
      Centers for Disease Control and Prevention will be used to determine the prevalence of
      underweight (< 5th percentile), overweight (≥ 85th and < 95th percentile) and obesity (≥ 95th
      percentile). Waist and hip circumference will be measured. Moreover, skinfold thicknesses and
      bioelectrical impedance analysis will be performed to calculate body fat percentage.
    


Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        3 classrooms each from 60 randomly selected schools
      
Keywords: childhood obesity prevalence
Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus; Prediabetic State; Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      With this design, this study hypothesizes that; (i) ICG-PDT would produce superior clinical,
      microbiological, and immune-inflammatory outcomes as compared to RSD and (ii) ICG-PDT would
      produce equal efficacy among different forms of diabetes as produced in non-diabetic subjects
      and that diabetes mellitus would not produce negative impact on the therapeutic outcomes of
      ICG-PDT. Therefore, the aim of this randomized controlled clinical trial was to evaluate the
      efficacy of ICG-mediated aPDT in the treatment of stage III grade C periodontitis among
      patients with prediabetes, T2DM and non-diabetic subjects.
    


Intervention name(s): Indocyanine green
Intervention type(s): Drug
Intervention description(s): Single application of PDT will be performed. A diode laser (HELBO®TheraLite - Bredent Medical, Germany) with 670 nm wavelength, power of 150 mW, fluency of 22 J/cm2 and density of 1.1 W/cm2 will be used in this study. Indocyanine-green photosensitizer (Sigm Aldrich, USA) with 0.005% concentration will be used as a photosensitizer which will be applied inside the periodontal pockets in a depth of 3 mm with the help of a blunt needle for 10 s. Laser irradiation will be performed for 60 s using a flexible tip. Laser irradiation will be performed at 2 points each on buccal and lingual with the tip stabilized perpendicular to the gingival tissues.
Other intervention name(s): Photodynamic therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety & PK of Single Doses of MT1980
Condition: Neuroinflammatory Response
Study type: Interventional
Phase: Phase 1

Summary: 
      MT1980 is being developed as a treatment for neuroinflammation (an inflammatory response in
      the brain and/or spinal cord). Much research has focused on the central role of
      neuroinflammation in the pathogenesis of many conditions relating to the CNS, including eg,
      traumatic brain injury, stroke, Alzheimer's disease, post-operative cognitive decline
      (POCD)/perioperative neurocognitive disorder, and now even long-term cognitive side effects
      from severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Current
      anti-inflammatories do not easily cross the blood-brain barrier from the systemic circulation
      to the brain, making neuroinflammation a difficult condition to treat.

      This will be a Phase 1, single dose, randomized, placebo-controlled study in healthy
      subjects. The study will provide information on the safety of MT1980, the systemic
      bioavailability of the active drug, and levels of the active drug in the CSF. The study will
      be conducted in two parts. In Part 1, subjects will be randomized to receive a single oral
      dose of MT1980 or placebo in a parallel design. An interim PK and safety data analysis will
      be performed after Part 1 prior to dose selection in Part 2. In Part 2 subjects will be
      randomized to receive either placebo or a single oral dose of MT1980 at one of 2 strengths in
      a parallel design.
    


Intervention name(s): MT1980; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose; single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pharmacokinetics; neuroinflammation
Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to study new ways to treat post-traumatic stress disorder
      (PTSD). Current treatments for PTSD do not work for everyone and it can take time to
      determine whether a person responds to a chosen treatment. The purpose of this study is to
      see whether ketamine, when given repeatedly intravenously can produce a quick and persistent
      improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an
      anesthetic for medical procedures, and at lower doses may be an effective treatment in
      patients with major depression and PTSD. Ketamine given for PTSD is investigational, which
      means that the FDA has not yet approved the drug for treating this condition. In this study,
      the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute
      anesthetic effects compared to ketamine but has not been shown to treat or alleviate any
      symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can
      treat or alleviate PTSD symptoms thereby acting as what we call an active control.
    

Detailed description: 
      Ketamine is an approved medication in several countries for the induction of general
      anesthesia and for use as adjunct to other anesthetics. Intravenous ketamine is being
      developed and tested for the treatment of posttraumatic stress disorder (PTSD).

      All subjects will be administered the study medication by the study anesthesiologists and
      under the direct supervision of the investigator or designee. On all dosing days, all
      subjects must remain at the clinical site until at least 4 hours post-dose (or longer if
      required for study procedures) and will be accompanied by a responsible adult when discharged
      from the clinical site. The end of study will occur when the last subject in the trial
      completes his/her last study assessment.
    

Intervention name(s): Ketamine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): This arm will receive 0.5mg/kg repeated dose ketamine (6 intravenous infusions, 3 per week for 2 weeks).; This arm will receive 0.045mg/kg repeated dose intravenous midazolam (6 intravenous infusions, 3 per week for 2 weeks).
Other intervention name(s): Generic only; Generic only
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: posttraumatic stress disorder; PTSD; ketamine; trauma; treatment; New York; NYC
Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy and performance of the C2 Focal
      Cryoablation System in patients with BE.
    

Detailed description: 
      The purpose of this study is to assess the efficacy and performance of the C2 Focal
      Cryoablation System in patients with BE. The study will involve up to 50 subjects with each
      subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation
      System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's
      epithelium with a maximal length of 6 cm.

      At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted
      for analysis according to Histopathology Protocol.

      This study is:

        -  Prospective

        -  Multi-center

        -  Non-randomized
    

Intervention name(s): C2 CryoBalloon Focal Ablation System
Intervention type(s): Device
Intervention description(s): The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken.
Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.
Evaluations include, but are not limited to the following:
Device malfunctions
Adverse events
Patient Pain
Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Non-invasive Ventilation on the Oxygenation of Peripheral Muscle in Hypercapnic COPD Patients
Condition: COPD; Hypercapnia
MeSH terms: Hypercapnia
Study type: Interventional

Summary: 
      In this study, 20 hypercapnic COPD patients will perform two constant workrate endurance
      cycle tests. One test will be while using non-invasive Ventilation (NIV) support, one without
      in a randomized cross-over design. The aim is to measure, whether NIV is able to change
      peripheral and respiratory muscle oxygenation.
    

Detailed description: 
      In this study patients will perform one incremental work rate test to obtain peak work rate.
      On the following days two constant work rate cycle endurance tests (CWRT) will be performed
      at 60% of Peak work rate using a randomised cross-over design. Between the two CWRTs there
      will be one hour of recovery time in between.

      One of the CWRTs will be performed with the support of non-invasive Ventilation (NIV), the
      other one without. Respiratory and cardiovascular parameters will be observed through
      transcutaneous measurement of CO2 (Sentec device) and near-infrared spectroscopy devices.

      The purpose of this study is, to examine whether the use of NIV not only decreases patients
      dyspnoea, but also has positive effects on the patients cardiovascular System, exercise
      capacity and muscle oxygenation. The investigators will examine the tissue oxygen saturation
      in the 7th intercostal space (reflecting a respiratory muscle) and on the M. vastus lateralis
      of the leg during both CWRTs. With the Support of NIV, it is expected to see a change in the
      oxygenation towards a better perfusion of the leg muscle, due to a facilitation of the work
      of breathing. This may result in a later onset of leg fatigue and an increased exercise
      capacity of the patients. To have an equivalent workload all parameters will be compared
      during isotime.

      To conclude, aim of this study is to record the interplay of Oxygenation and Perfusion
      between the Intercostal muscles and the peripheral leg muscle during exercise. The
      investigators hypothesize, that the use of NIV may change the oxygenation in favour of the
      leg muscle through relieving the respiratory muscles.
    

Intervention name(s): non-invasive ventilation (NIV)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; NIRS; NIV; Exercise
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      The primary objective of this trial is to compare the clinical efficacy of BI 695501 with
      EU-approved Humira® in patients with active Crohn's disease (CD).

      Secondary Objectives:

      The secondary objectives of this trial are to compare the efficacy and safety of BI 695501
      with EU-approved Humira® across the induction and maintenance phases.
    


Intervention name(s): BI 695501; HUMIRA
Intervention type(s): Drug; Drug
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Octreotide on the Colonic Motility in Pediatric Patients
Condition: Colonic Motility Index; Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The research study is designed to test how a medication called octreotide affects the
      motility (contraction or squeezing) of the colon (large intestine). Investigators are
      investigating whether octreotide can increase contraction and movement in the colon.
    

Detailed description: 
      As mentioned above.
    

Intervention name(s): Octreotide; Bisacodyl
Intervention type(s): Drug; Drug
Intervention description(s): Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide
Other intervention name(s): post octreotide
Intervention MeSH terms: Octreotide; Bisacodyl
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Observational

Summary: 
      The purpose of this study is to examine differences in fetal neurobehavior at peak (2 hours
      after oral dose) vs. trough (2 hours before oral dose) maternal plasma methadone levels.
    

Detailed description: 
      This study will examine differences in fetal neurobehavior at peak (2 hours after oral dose)
      vs. trough (2 hours before oral dose) plasma methadone levels. Anecdotal clinical
      observations suggest that fetal activity is increased at trough methadone levels and
      decreased at peak methadone levels, yet the investigators do not understand how in utero
      methadone exposure affects fetal neurobehavioral state development.
    

Intervention name(s): Toitu 320/325
Intervention type(s): Device
Intervention description(s): Fetal monitor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Methadone exposed pregnancies
      
Keywords: methadone; fetus
Early Oral Immunotherapy in Infants With Cow's Milk Protein Allergy
Condition: Hypersensitivity, Milk
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional

Summary: 
      Cow's milk (CM) allergy is the most frequent food allergy in the first years of life, with
      prevalence rates estimated in the range of 2-3%.

      The elimination of CM is the mainstay of treatment, but accidental exposure to CM proteins is
      not uncommon, with a considerable risk of severe allergic reactions.

      Recent evidence suggests that early oral exposure in young children may protect to the
      development of allergy. On the same way, strategies have been developed for the use of oral
      exposure as immunotherapy for the treatment of children with established food allergy even if
      available data on the use of oral immunotherapy in infants with food allergy are very
      limited.

      The aim of this study is to evaluate the feasibility of an oral immunotherapy protocol,
      started in the first year of life, in children with CM allergy.
    


Intervention name(s): Oral immunotherapy protocol
Intervention type(s): Other
Intervention description(s): In hospital setting: three increasing doses every 30 minutes of 1ml, 5ml and 10ml of cow milk (CM). Oral food challenge (OFC) stopped at 10ml even if no clinical reactions occurred.
At home: every child will take the dose tolerated in hospital, starting the day after the OFC, for 3-4 weeks.Once reached the dose of 40ml of CM without reactions for at least 2 weeks, families increment the dose of 5 ml every week, till the tolerance of 50 ml, then of 10 ml every week, till the tolerance of 100ml and then, of 10 ml every 3 days till the tolerance of 150 ml of milk.
Other intervention name(s): Oral food challenge (OCD)
Intervention MeSH terms: Immunomodulating Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypersensitivity, Milk; Cow's Milk; Immunotherapy; Infant
The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age
Condition: Mortality; Vaccines
MeSH terms: Measles
Study type: Interventional
Phase: Phase 4

Summary: 
      The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts
      exclusively on children below 12 months of age; children who have reached 12 months of age
      are no longer entitled to vaccines through the EPI program. This has affected the measles
      vaccination coverage, approx. 30% of the children in the rural area do not receive measles
      vaccine (MV).

      Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on
      survival, reducing mortality by approximately 50% - far more than can be explained by
      prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on
      survival, and the current policy may have important consequences for overall child mortality.

      To test the implications of the current policy of only vaccinating children below 12 months
      of age, the investigators will conduct a cluster randomized trial, in which children will
      receive their vaccines according to the current national EPI policy (National policy) or
      receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy).

      The investigators hypothesise that among children enrolled after 12 months of age, mortality
      is 50% lower in children randomised to receive MV compared with children randomised to follow
      the national policy and not receive MV.
    


Intervention name(s): Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine
Intervention type(s): Biological
Intervention description(s): Normal measles vaccines licensed for distribution through the national EPI program
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mortality; Vaccines