bioihbjkbjnl/mcl2 huggingface dataset:
Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy
Condition: Breast Neoplasms; Neoplasm Recurrence, Local
MeSH terms: Neoplasms; Breast Neoplasms; Neoplasm Recurrence, Local; Recurrence
Study type: Observational

Summary: 
      A prospective, multicenter study:

        -  Primary objective: to assess the diagnostic yield of screening MRI compared to physical
           examination, mammography or ultrasonography in the detection of recurrence in patients
           treated with breast conserving therapy

        -  Secondary objective: to describe the size, type, grade, and nodal status of cancers seen
           only on MRI and to estimate the rate of benign biopsies and short interval follow-up
           induced only by MRI in this population.
    

Detailed description: 
      -  Patients treated with breast conserving therapy will be followed for recurrence in the
           ipsilateral or contralateral breast by physical examination every six month and imaging
           studies performed annually.

        -  The imaging including mammography, physician-performed bilateral whole breast
           ultrasonography and a dynamic breast MRI with gadolinium-containing contrast medium will
           be performed according to a standard protocol. Interpretation will be conducted
           independently and classified according to the Breast Imaging Reporting and Data System
           (BI-RADS) by experienced radiologists.

        -  Definitive information about the presence of malignancy will be obtained by biopsy
           directed by the imaging method best depicting the lesion with 14-g or 11-g needle
           devices or needle localized excision. The absence of breast cancer was determined by
           means of biopsy, the absence of positive findings on repeat imaging and clinical
           examination, or both at follow-up.

        -  After three rounds of annual screening, the diagnostic yield of screening MRI compared
           to physical examination, mammography or ultrasonography will be assessed.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Breast cancer patients undergoing conservation surgery and radiation therapy
Mitochondrial Impairment in Muscle Insulin Resistance
Condition: Diabetes; Obesity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This investigation is being carried out to learn more about research findings from a study
      that was completed last year. Those findings revealed that within the skeletal muscle cells
      of individuals with type 2 diabetes, there was often damage to the mitochondria (the muscle
      cell's power source or the machinery of the muscle cell that produces energy). In individuals
      with type 2 diabetes, the liver continues to release sugar even when sugar levels are normal;
      the pancreas is not able to produce and release insulin normally; and the muscle and fat
      cells no longer respond as effectively to insulin. These defects lead to an abnormal rise of
      sugar in the blood. In this study, we want both to look more closely at the mitochondria and
      see if there is potential for improving mitochondrial functioning (improving the machinery of
      the muscle cell that produces energy) and reversing mitochondrial damage through a weight
      loss or a combined exercise/weight loss program. The program you get assigned to will be
      determined by a process called randomization (like a flip of a coin).
    

Detailed description: 
      Recent research from our laboratory has detected novel findings concerning damage to
      mitochondria within skeletal muscle in type 2 diabetes (type 2 DM), damage that is evident
      morphologically and by functional criteria. In this project, we propose, firstly, to more
      fully test this hypothesis of an impaired bio-energetic capacity, and to begin to examine the
      pathogenesis of damage to mitochondria in type 2 DM. We are also interested in assessing the
      potential for reversing damage, and improving functional capacity of mitochondria through a
      weight loss or a combined exercise and weight loss intervention.

      The first specific aim is to measure the functional capacity of mitochondria in human
      skeletal muscle in type 2 DM and in those at apparent risk for type 2 DM (obese, sedentary,
      non-diabetic adults with the Metabolic Syndrome and/or impaired glucose tolerance). The
      second specific aim is to examine the morphology of mitochondria in human skeletal muscle in
      type 2 DM and in those at apparent risk for type 2 DM. The third specific aim is to examine
      the pathogenesis of mitochondrial damage in type 2 DM and in those at apparent risk for type
      2 DM. The fourth specific aim is to assess whether exercise and diet can improve
      mitochondrial function and morphology in type 2 DM and in those at apparent risk for type 2
      DM.
    

Intervention name(s): weight loss/ exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mitochondria
A Phase I Study to Assess Cardiac and General Safety and Pharmacokinetics of 60 mg MGN1703
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      MGN1703 is being developed for use in treating cancerous tumors effecting the colon, skin,
      kidneys and lungs. The dosage form of MGN1703 under investigation is an injection.

      The goal of this study is to evaluate the effects of MGN1703 on the electrical activity of
      the heart in healthy subjects and to look at general safety.
    


Intervention name(s): MGN-Placebo; Placebo-MGN
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac Safety; General Safety; Pharmacokinetics
Effect of Psychoeducation on Motivation to Change in Traumatized Alcoholics
Condition: Alcoholic Intoxication, Chronic
MeSH terms: Alcoholic Intoxication; Alcoholism
Study type: Interventional

Summary: 
      Many people suffering from alcohol dependence have a history of exposure to stressful life
      situations, such as childhood physical or emotional misuse. Often, there's a functional
      relationship between drinking and emotional problems related to past traumatic experiences,
      i.e. drinking to forget. However, alcohol treatment often does not include interventions to
      support patients to cope better with past life experiences. On the other hand, most
      alcoholics are poorly motivated to participate in long-term rehabilitative treatments after
      detoxification. In the proposed study, the investigators will study the effects of a brief
      psycho-educational group intervention during detoxification treatment on motivation to change
      and the willingness to accept further treatment.

      The investigators will use a group comparison design (intervention versus "TAS" control
      group). In month 1, patients take part in Treatment as Usual (TAS), including a unspecific
      information group. In month 2, the information group is replaced by the psychoeducational
      group (intervention). Ward staff selects patients for the groups, irrespective of
      intervention or TAS. Selection criteria are: absence of severe withdrawal and cognitive
      impairment. Absence of severe co-morbid psychiatric disorder (e.g. schizophrenia or suicidal
      crisis). The group sessions will take place in groups of up to 15 patients and will include 4
      structured sessions (45 min each). Main content if the intervention group is to highlight and
      discuss the association between stress, Posttraumatic Stress Disorder and drinking. Patients
      will also be informed about the different treatment options available in the region.

      At entry, patients are asked to fill in the German versions of the University of Rhode Island
      Change Assessment (URICA; McConnaughy, Prochaska, & Velicer, 1983; German: Heidenreich, Hoyer
      & Fecht; 2001) and the Trauma History Questionnaire (THQ; Green, 1996; German: Maercker,
      2002). At discharge, patients are asked to fill in the URICA.

      The investigators expect that specific information on the association between stress and
      drinking will increase the patients' motivation to participate in further treatment.
    


Intervention name(s): Psychoeducation
Intervention type(s): Behavioral
Intervention description(s): Psychoeducation group on stress and how it relates to alcohol use, 4 sessions a 45 minutes
Other intervention name(s): The manualized group intervention we developed for this study recently was named TARGET,; which reads as "Trauma- and Alcohol-Related Group Education and motivation Therapy"
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Psychoeducation; Group Control
Assistive Device for Hand Osteoarthritis
Condition: Hand Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Randomized clinical trial , blind for evaluators, to assess the effectiveness of a self-care
      program using assistive technology for treatment of hand osteoarthritis.
    

Detailed description: 
      This program aims to:

        -  Encourage the use of assistive devices on a daily basis as the main form of joint
           protection.

        -  Encourage individual motivation, from the group in attendance, behavior change,
           developing the capacity of self-management of individuals of their health problems.

      Will be held for 4 meetings with an average duration of 90 minutes. Meeting 1: Its proposal
      address the importance of self-care in the treatment of chronic diseases; knowing the OA of
      the hands and their main characteristics; recognize the importance of hand function for
      carrying out activities; understand the meaning of self-care and joint protection; motivation
      adherence to the program and behavior change.

      Meeting 2: Present assistive devices as a protection feature; teach joint protection
      techniques and energy conservation focusing on the assistive device; deliver and demonstrate
      the use of assistive devices.

      Meeting 3:Encouraging the adhesion of the techniques presented; making workshop for daily
      activities; verify the difficulties with devices use by the volunteers.

      Meeting 4: Strengthening guidance given in previous meetings; make closing with the group to
      in connection with the program; motivated to continue carrying out the activities at home.
    

Intervention name(s): Self care program focusing on the assistive device
Intervention type(s): Other
Intervention description(s): self-heed program focusing on the assistive device will consist of four weekly meetings lasting approximately 90 minutes. it will be stimulated the self-heed through knowledge of pathology and guidelines of protection articulate, and will be supplied, and trained the use of assistive devices to improve the performance of volunteers in their daily activities. Assistive devices are devices, not attached to the body, which help people with limited movements and restrictions on participation in the activities of everyday life. Example: thickening of tableware, tin openers. These volunteers will be evaluated in three stages: 1-initial assessment 2-after completion of the program and 90 days after the initial assessment. The questionnaires that will be used are: EVA; SACRAH; COPM; WHOQOL-Bref.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hand osteoarthritis; self care program; assistive tecnology
Implementation of a Pediatric-to-adult Asthma Transition Program
Condition: Asthma; Education
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Despite the clear and often stated need, a formal transition program does not exist for
      asthma patients as they move from pediatric to adult care in Western Canada. This population
      is not having their health care needs met. The investigators proposed study would evaluate a
      well structured transition program designed to facilitate continuity of care for this at risk
      patient population.

      Primary hypothesis: A pediatric-to-adult asthma transition program will improve the
      asthma-specific quality of life of young asthma patients in the Calgary area over a 1 year
      period.

      Secondary hypothesis: A pediatric-to-adult asthma transition program will improve asthma
      control, decrease asthma exacerbations, and reduce health care utilization in young asthma
      patients in the Calgary area over a 1 year period.
    


Intervention name(s): Asthma Transition Program
Intervention type(s): Other
Intervention description(s): Asthma Education.
Other intervention name(s): Asthma Education and Referral.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Asthma; Transition program; Pediatric; Adult
Impact of Telerehabilitation Training on Pediatric Cystic Fibrosis Patients: An Exploratory Study
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Fitness in patients with Cystic fibrosis (CF) is an important biomarker associated with
      higher survivability and improved quality of life. CF patients are encouraged to maintain an
      active lifestyle, however, while physicians are able to prescribe airway clearance measures
      or specific medications, there is no prescription for exercise or avenue to promote exercise
      outside the clinic or hospital.
    

Detailed description: 
      The advent of ubiquitous computing has transformed the landscape of healthcare delivery. Thus
      far, exercise training in CF have either required patients travel to a gym or relied on home
      visits or telephone calls. Virtual visits provide a novel and innovative platform to deliver
      a live stream of exercise sessions with two-way video and audio capabilities, allowing
      individualized attention to exercise for CF patient from the comfort and privacy of their
      homes. Applications of tele-exercise, or tele-rehabilitation, have been shown to be as
      effective as in conventional physical therapy following orthopedic surgeries and, in stroke
      patients, to optimize patient outcome by prolonging duration of treatment and preventing the
      observed decline after the termination of therapy. For CF patients, the latter is especially
      important given the impact of hospitalizations for acute exacerbations on exercise tolerance.
      In this particular population, where cross-contamination risks limit use of group exercise
      activity, using two-way video telecommunication allows participation in exercise programs
      while adhering to the standards of CF management regarding infection control.

      This study would be the first to evaluate implementing tele-exercise and remote monitoring
      program on pediatric CF patients. Pediatric CF patients will be enrolled in a six-week
      exercise program that is streamed live from an instructor into their computers at home via a
      HIPAA compliant telemedicine platform. Remote monitoring devices, such as accelerometers and
      wireless heart rate monitors, will evaluate baseline habitual activity and intensity of
      exercise, respectively. The goal of this study is to show that tele-exercise program is a
      feasible and convenient and cost-effective method to enhance CF care.
    

Intervention name(s): Tele-exercise
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Impaired Decision-making in Adolescents
Condition: Adolescent Psychiatry; Antisocial Personality Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Personality Disorders; Antisocial Personality Disorder
Study type: Observational

Summary: 
      There is clear evidence that aggressive behavior and disruptive behavior disorders (DBD) in
      middle childhood are associated with an increased risk for substance abuse in adolescence.
      However, the exact underlying mechanism of this increased risk is unknown. It is likely that
      a biopsychological vulnerability in some aggressive children and children with DBD makes them
      liable to substance use and abuse. The investigators hypothesize that deficient decision
      making is such a biopsychological factor. In this study the investigators aim to test the
      latter hypothesis by investigating the decision making ability in a group of adolescents with
      DBD with and without substance use disorders. Decision-making is assessed with the IOWA
      Gambling Task (GT). This task mimics real-life situations in the way it factors uncertainty,
      reward and punishment. The GT is specifically designed to assess impaired decision-making in
      individuals who are unable to learn from their mistakes and make decisions that repeatedly
      lead to negative consequences. This characteristic may be common to individuals with
      externalizing disorders such as DBD, psychopathy, and substance use disorders.
    

Detailed description: 
      This study consists of two substudies with adolescents in the age of 14-21 years. The first
      study group consist of adolescents with DBD with (n=30) and without (n=30) substance use
      disorders. These adolescents are recruited from orthopsychiatric, forensic psychiatric, and
      judicial institutions.

      The second study group consists of a) ex-patients of the Utrecht Coping Power Program
      (UCPP)who previously participated to a follow-up study, and b) ex-patients who were treated
      as a child at an outpatient clinic of the UMC Utrecht. These latter groups were taken
      together and subdivided into a group with (n=30) and without (n=30) substance use problems.

      For both studies healthy controls (n=80) are recruited. The investigators will start with
      healthy controls from earlier studies, and those are extented and will serve as control group
      for both studies.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        DBD adolescents were recruited from judicial and forensic institutions. Healthy controls
        consisted of volunteers.
      
Keywords: Disruptive Behavior Disorders, Substance abuse,; Iowa Gambling Task, Decision Making.
Primary Birmingham Hip Resurfacing Arthroplasty Using a Metal-on-Metal Couple in the Young Active Patient
Condition: Indications for a Total Hip Prosthesis
Study type: Interventional

Summary: 
      To prospectively obtain data about the clinical and radiological results of the resurfacing
      technique as primary hip prosthesis in young active patients
    


Intervention name(s): Primary Birmingham hip resurfacing arthroplasty using a metal-on-metal couple
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head
Condition: Avascular Necrosis of the Femoral Head
MeSH terms: Osteonecrosis; Femur Head Necrosis; Necrosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy and safety of autologous
      transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with
      avascular necrosis of the femoral head.
    


Intervention name(s): Autologous Adipose Tissue derived MSCs Transplantation
Intervention type(s): Procedure
Intervention description(s): Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laparoscopic Skills and Cognitive Function Are Not Affected by Night Shifts in Surgeons
Condition: Effect of Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Observational

Summary: 
      The aim of the study was to asses the effect of sleep deprivation during nightshift by
      monitoring 30 surgeons in unit of surgical gastroenterology in 4 consecutive days. The first
      day was pre call= day 1, second day was on call= day 2, third day was the first post call day
      = day 3 and fourth day was the second post call= day 4. The surgeons were monitored in order
      to asses how performance was on call compared to pre call and post call. The hypothesis was
      that they would perform worse on call than pre call, and again slightly worse post call.
    

Detailed description: 
      The surgeons wore an actigraph consecutively on all 4 days, and would fill out a sleep diary
      on all 4 days as well. The surgeons were heart monitored consecutively on day 1 and 2.

      The surgeons were tested in a laparoscopic simulator at 8 a.m. day 1, 4 a.m. day 2, and again
      at 8 a.m. day 4. At the same given times they would perform the d2 test of attention and
      prescribe medicine in the Electronic Patient Medication system in accordance with a case they
      were given. Furthermore they delivered a salivary sample for the determination of salivary
      cortisol, at the given times.

      They sampled urine from 9 pm - 9 am all 4 days, in order to measure the production of
      melatonin in urine.

      The surgeons would fill out the Karolinska sleepiness scale, VAS (Visual Analog Scale)
      fatigue, VAS sleep quality and VAS general well being at 8 a.m. day 1, 4 a.m. day 2, and
      again at 8 a.m. day 4. The Karolinska Sleepiness scale was filled out every second hour on
      day 2 from 4pm - 8 am on day 3.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Surgeons at a surgical unit of gastroenterology in Denmark.
      
Biospecimen description: 
      Urin (melatonine) Saliva (cortisol)
    
Keywords: Sleep deprivation in surgeons during night shifts and the effect on performance.