bioihbjkbjnl/mcl2 huggingface dataset:
Complex Problem Solving Training in Schizophrenic Patients
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The primary purpose of the study is to assess whether a planning and problem-solving training
      is more effective in improving work therapy performance in patients with schizophrenia than
      traditional training programs addressing basic cognitive functions.
    

Detailed description: 
      In patients with schizophrenia, cognitive deficits often lead to an impairment in daily life.
      This observation has led to the development of cognitive training packages aiming a improving
      these deficits. However, it is far from clear which level of cognitive functioning provides
      the best target for cognitive interventions. Traditionally, training has aimed a basic
      cognitive functions like attention and memory. In the present study we aim at a higher-level
      of function, namely planning and problem-solving skills, which are trained using the software
      package Plan-A-Day. The primary hypothesis is that complex problem solving training improved
      functional capacity more than traditional training programs addressing basic cognitive
      function.
    

Intervention name(s): Complex Problem Solving Training; Basic Cognitive Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10 sessions of 45 minutes complex problem solving training over 3 weeks (including 30 minutes of computerized planning and problem-solving training with Plan-A-Day and 15 minutes group session for transfer to everyday situations); 10 sessions over 3 weeks of 45 min basic cognitive training (including 45 min computerized training of attention, processing speed, memory)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Training; Complex Problem Solving; Goal Management; Planning
The Impact of Chiropractic Activator Adjustments on Mental Rotation and Line Judgment Reaction Time
Condition: Cognition - Other
Study type: Interventional

Summary: 
      The purpose of this pilot study will be to assess the impact of chiropractic Activator
      adjustments on spatial cognitive abilities through initial assessment and testing in a
      healthy population aged 18 to 35.
    

Detailed description: 
      This study seeks to assess the impact of chiropractic on cognition. Participants must be
      between 18 and 35 years of age. Within the past six months individuals may not participate if
      they have had any broken bones, accidents, or surgeries to their spine. Additionally,
      participants cannot have any mental disabilities, be pregnant, or have other conditions of
      the spine such as bone mineral loss.

      Patients will receive a chiropractic exam and will be randomized to a sham (simulated
      chiropractic adjustment) or chiropractic adjustment intervention group. Prior to receiving
      either the sham or chiropractic adjustment, the participants will sit in front of a computer
      screen and will be asked to follow instructions and press a button on a keypad. There will be
      three different types of computer assessments that will take approximately fifteen minutes
      total. After the computer assessments the participant will receive either the sham or
      chiropractic adjustment. The chiropractic adjustment and the sham will both utilize a
      handheld instrument called an Activator. After the adjustment or sham the participant will
      take the computer assessments again. The total time this may take is ninety minutes.
    

Intervention name(s): Chiropractic adjustment; Sham chiropractic adjustment
Intervention type(s): Other; Other
Intervention description(s): Participant will receive a chiropractic adjustment utilizing a handheld chiropractic instrument called an Activator.; Participants will receive a simulated chiropractic adjustment with a handheld adjusting instrument called an Activator.
Other intervention name(s): Chiropractic Activator adjustment; Chiropractic manipulation; Sham manipulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chiropractic, cognition
Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers
Condition: Healthy Adult Males Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002%
      (1 drop once daily for 7 days) in healthy adult male subjects.
    


Intervention name(s): STN1012600 ophthalmic solution 0.002%
Intervention type(s): Drug
Intervention description(s): 1 drop STN1012600 ophthalmic solution 0.002% once daily for 7 days
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Carer Skills Training for Inpatients With Anorexia Nervosa (iCASK)
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      To improve treatment for patients with severe anorexia nervosa admitted for inpatient care,
      and to help their families. Inpatients and their families will be offered a novel
      intervention which includes multimedia training materials. These materials provide guidance
      in how families can provide support to maintain and build on changes made during inpatient
      care
    

Detailed description: 
      Problem to be solved: Hospital Episode Statistics reveal that admissions for anorexia nervosa
      are increasing [1]. Admission restores nutrition in a timely manner [2], but psychosocial
      problems remain and relapse following discharge is common [3]. The mortality post discharge
      is high [4]. We have found that relapse and bed use post discharge are reduced by a parenting
      intervention giving the family skills to manage eating disorder behaviours [5].

      Innovation: Through a process of co-production, in collaboration with service users and their
      families, we have developed tools exemplifying emotional coaching behaviour change strategies
      for patients and their carers (texts, DVDs and podcasts; iCASK programme). These aim of these
      tools is to improve the transition to outpatient care. These are hosted on a user-friendly,
      confidential and NHS-compliant platform.
    

Intervention name(s): iCASK
Intervention type(s): Behavioral
Intervention description(s): Materials and support to aid transitions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.
Condition: Alpha 1-Antitrypsin Deficiency; Emphysema; COPD
MeSH terms: Alpha 1-Antitrypsin Deficiency; Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of alvelestat (an oral neutrophil
      elastase inhibitor) on blood and sputum biomarkers in patients with PiZZ, null or rare
      variant phenotype/genotype alpha-1 anti-trypsin deficient lung disease. Change in a number of
      different blood and sputum biomarkers related to lung damage, inflammation and elastase
      activity will be measured over a 12 week period. The effect on lung function and respiratory
      symptoms will also be measured.
    


Intervention name(s): Placebo Oral Tablet; Alvelestat oral tablet - dose 1; Alvelestat oral tablet - dose 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): twice daily administration; twice daily administration; twice daily administration
Other intervention name(s): MPH966; MPH966
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: placebo-controlled, dose ascending, sequential group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PiZZ or Null; Neutrophil elastase inhibitor; Alpha-1; Alvelestat; AZD9668; MPH966; Rare variant genotype; Astraeus; AATD; Alpha 1-Antitrypsin Deficiency; Lung Disease
HITT Device Pilot Testing for Traumatic Brain Injury
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The purpose of this research study is to collect data from the eyes of traumatic brain injury
      (TBI) patients. Patients will look at a green target that will measure the fixation of the
      eye for 30 seconds. In that 30 seconds, the location of the green target will change and the
      participant is to track, with their eyes, the light as best they can. The device will measure
      how well fixation was maintained and the speed of the saccadic movements of the eye. Data
      will then be used to determine whether there is correlation between these measures and known
      TBI.
    


Intervention name(s): HITT device
Intervention type(s): Device
Intervention description(s): Device scans the fovea of the eye to measure fixation. Patients will then be asked to track the fixation target across an area the size of a playing card, with the device tracking the participant's fixation throughout.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Detection of Acetylsalicylic Acid and Omega-3 Fatty Acids in Schirmers' Test Strips Using Mass Spectrometry
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of tear fluid production using Schirmers' tests is a well-known and frequently
      used examination method in ophthalmology. Schirmers' test objectively indicates the tear
      fluid production over five minutes by insertion of a filter paper strip in the lower
      conjunctival fornix. Commonly, this method is used to quantify tear fluid production, but not
      tear fluid composition. The development of novel, very precise analytical methods opens up
      new possibilities in the use and application of Schirmers' test strips. A recently introduced
      analytical method is mass spectrometry. This method allows the detection and quantification
      of proteins, lipids, and metabolites in very low amounts of samples. Whether systemically
      ingested agents such as omega-3 fatty acids or acetylsalicylic acid can be detected in tear
      fluid using this method remains unclear. The aim of this study is to investigate the
      detectability of 2 different agents (acetylsalicylic acid and omega-3 fatty acids) in
      Schirmers' test strips from healthy subjects after intake for 1 week by use of untargeted
      mass spectrometry. Participating healthy subjects will receive either acetylsalicylic acid or
      omega-3 fatty acids.
    


Intervention name(s): Aspirin 500Mg Tab; Dr. Böhm® Omega 3 complex 870 mg
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Dose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening; Dose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Enhanced Recovery After Surgery Protocols in Total Knee Arthroplasty Via Midvastus Approach
Condition: ERAS; Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The study aimed to investigate the impact of enhanced recovery after surgery (ERAS) protocols
      on the clinical effect of total knee arthroplasty (TKA) via the midvastus approach
    

Detailed description: 
      In this study, a randomized controlled study was conducted to further investigate the impact
      of ERAS protocols in the clinical efficacy of TKA with the midvastus approach. The ERAS
      protocols were adopted for the ERAS group and consisted of pure juice drinking 2 hours before
      the surgery, optimization of the preoperative anesthesia plan, phased use of tourniquets, and
      the use of tranexamic acid as well as a drug cocktail. The operative time, first
      postoperative walking time, first straight leg elevation time, postoperative hospitalization
      time, visual analogue scale score (VAS score), New York Hospital of Special Surgery knee
      score (HSS score), Knee Society Score (KSS score), and knee range of motion were used to
      assess the clinical effects in the two groups. All the included patients were followed up for
      12 months.
    

Intervention name(s): ERAS protocols for TKA
Intervention type(s): Procedure
Intervention description(s): ERAS protocols for TKA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
S0916, MLN1202 in Treating Patients With Bone Metastases
Condition: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such MLN1202, can block tumor growth in different ways.
      Some block the ability of tumor cells to grow and spread. Others find tumor cells and help
      kill them or carry tumor-killing substances to them.

      PURPOSE: This phase II trial is studying how well MLN1202 works in treating patients with
      bone metastases.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the urinary n-telopeptide (uNTX) response to anti-CCR2 monoclonal antibody
           MLN1202 in patients with bone metastases.

      Secondary

        -  To assess the feasibility of performing cross-disease site trials within the Southwest
           Oncology Group.

        -  To explore the effect of anti-CCR2 monoclonal antibody MLN1202 on markers of tumor cell
           proliferation, monocytes/macrophage trafficking, and osteoclast maturation.

        -  To estimate allele frequencies of defined SNPs occurring in the CCL2 and CCR2 genes in
           these patients.

      OUTLINE: This is a multicenter study.

      Patients receive anti-CCR2 monoclonal antibody MLN1202 IV over 1 hour on days 1, 15, and 29
      in the absence of disease progression or unacceptable toxicity.

      Patients undergo urine and blood sample collection at baseline and on days 15, 29, and 43 for
      correlative biomarker and polymorphism studies.

      After completion of study treatment, patients are followed up for ≥ 30 days.
    

Intervention name(s): anti-CCR2 monoclonal antibody MLN1202; polymorphism analysis; laboratory biomarker analysis
Intervention type(s): Drug; Genetic; Other
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone metastases; unspecified adult solid tumor, protocol specific
EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Use of the EnSite NavX system to map the coronary vasculature during CRT implant
    

Detailed description: 
      Objective(s):

      To determine the feasibility of CS mapping with NavX during Biventricular Implantable
      Cardioverter Defibrillator (BiV ICD) implantation.

      Inclusion Criteria:

        -  Subject is between the age of 18 and 75 years

        -  Subject is willing and able to sign a study specific informed consent

        -  Subject is able to fulfill study requirements

        -  Meet the conventional criteria for implant of a BiV ICD, including; LVEF of ≤35%, QRS ≥
           120 ms and NYHA III-IV

        -  Have persistent CHF symptoms despite contemporary CHF medical therapy

        -  Stable and optimal medical therapy (stability is no changes in past 3 months).

        -  Documented history of ischemic or non-ischemic cardiomyopathy.

      Exclusion Criteria:

        -  Have any standard device exclusions including tricuspid valve prosthesis/ replacement.

        -  Have a positive urine or serum pregnancy test (if female and of childbearing potential)

        -  Be currently participating in an IDE or IND study.
    

Intervention name(s): EnSite NavX System
Intervention type(s): Other
Intervention description(s): EnSite NavX system is a 3D Mapping system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary
      therapeutic efficacy of oral administrations of CDZ173 in patients with primary Sjögren's
      syndrome.
    

Detailed description: 
      This study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary
      therapeutic efficacy of oral administrations of CDZ173, a selective PI3K delta inhibitor, for
      12 weeks, in patients with primary Sjögren's syndrome. Data from this study will provide the
      basis for further development of the compound for the treatment of primary Sjögren's
      syndrome.
    

Intervention name(s): CDZ173; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Head Rotation on Overlap and Relative Position of Internal Jugular Vein to Carotid Artery in Infants and Children: A Study of the Anatomy Using Ultrasonography
Condition: Surgery
Study type: Observational

Summary: 
      Effect of head rotation on overlap and relative position of internal jugular vein to carotid
      artery in infants and children: A study of the anatomy using ultrasonography.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        infants and children undergoing surgery with general anesthesia
      
Keywords: infants and children undergoing surgery with general anesthesia
28-day Repeat Dose Study of GSK573719
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with
      placebo in subjects with COPD
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to
      evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.
    

Intervention name(s): GSK573719 125mcg; GSK573719 250mcg; GSK573719 500mcg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 125mcg once-daily; 250mcg once-daily; 500mcg once-daily; once-daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Bronchitis; Anticholinergic; Emphysema; Long-acting muscarinic antagonist; COPD
Symbicort in Asthmatic Children - SEEDLING
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone
      in the treatment of asthma in children aged 6 to 11 years
    


Intervention name(s): budesonide/formoterol; budesonide; formoterol
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Symbicort
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Symbicort; budesonide/formoterol; budesonide; formoterol; children
Non Coeliac Gluten Sensitivity in Children
Condition: Diet, Gluten-Free; Gluten-Sensitive Enteropathy
MeSH terms: Celiac Disease; Hypersensitivity
Study type: Interventional

Summary: 
      Irritable Bowel syndrome (IBS) is a very frequent condition in children. Its management is
      difficult, often resulting in a persistence of chronical abdominal pain.

      In adults, many patients affected by IBS improve under a gluten-free diet, even in the
      absence of Celiac Disease (CD) or wheat allergy. This condition is called Non Coeliac Gluten
      Sensitivity (NCGS). However, it is still not clear how to diagnose and manage NCGS, and the
      pathophysiological mechanisms also remain elusive.

      The aim of this study is to determine if NCGS exists in children with IBS and to identify the
      clinical, serological, and histological characteristics, which could distinguish patients
      with NCGS from conventional IBS and CD patients.

      This is a prospective cohort study in a population of children affected by a moderate to
      severe IBS for more than 6 months. All children had a Gluten Free Diet (GFD) for 6 weeks.
      Then, children who improved under GFD were randomized in two groups for a double-blind
      placebo-controled trial. One group had a reintroduction of gluten followed by a wash-out
      period, then a placebo reintroduction, whereas the other group had the placebo first, then
      the wash-out and the gluten reintroduction.
    


Intervention name(s): gluten
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Gluten-Sensitive; Diet, Gluten-Free; Irritable Bowel Syndrome; non Coeliac Gluten sensitivity; children
Spinal Anesthesia Induced Hypotension During Cesarean Section
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare two methods for preventing low blood pressure
      associated with spinal anesthesia during Cesarean sections.
    

Detailed description: 
      Many women experience low blood pressure after spinal anesthesia for Cesarean section. This
      low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood
      flow.The purpose of this study is to compare two methods for preventing low blood pressure
      associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt
      to prevent low blood pressure using phenylephrine infusion that has been shown to be
      effective in recent research. In addition to receiving phenylephrine one group of patients
      will receive standard salt solution (Ringer's lactate solution), while the other group will
      receive a different, intravenous fluid called hydroxyethylstarch.
    

Intervention name(s): Colloid administration; Crystalloid administration; phenylephrine infusion
Intervention type(s): Other; Other; Drug
Intervention description(s): The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.; The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.; A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal anesthesia; cesarean section