bioihbjkbjnl/mcl2 huggingface dataset:
Three-Year Clinical Evaluation of Bonded Posterior Restorations: Amalgam vs Resin Composite
Condition: Class II Lesions
Study type: Interventional

Summary: 
      Background: This 3-year clinical trial compared the performance and post-operative
      sensitivity of a posterior resin composite with that of bonded-amalgam in large sized
      cavities. Additionally, it was evaluated whether resin composite could be an alternative for
      bonded amalgam.

      Methods: This was a randomized clinical trial. Patients in need of at least two posterior
      restorations were recruited. Authors randomly assigned one half of the restorations to
      receive bonded-amalgam and the other half to composite restorations. Forty bonded-amalgams
      and composites were evaluated for their performance on modified Ryge criteria and
      post-operative sensitivity using VAS for 36-months.
    


Intervention name(s): posterior restoration
Intervention type(s): Procedure
Intervention description(s): restorations for caries effected teeth
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose of this study in humans with stable coronary artery disease (CAD) treatable by
      PCI (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to
      an instantaneous improvement of coronary collateral function.
    

Detailed description: 
      The existence of coronary collateral vessels and their benefit against cardiac events have
      been recognized for many years, but their functional capacity in response to physical
      exercise has partially remained elusive. Via endothelial shear stress, the fundamental
      stimulus for collateral development, exercise theoretically leads to collateral vasodilation
      and recruitment by an increase in heart rate and blood pressure during exercise. Moreover,
      the phenomenon of "walking through angina" indicates that collateral function and physical
      activity are related and their interaction is of clinical relevance.

      The purpose of the present study in humans with stable coronary artery disease was to assess
      the instantaneous response of coronary collateral function to dynamic physical exercise.
    

Intervention name(s): dynamic physical exercise
Intervention type(s): Other
Intervention description(s): dynamic supine bicycle exercise for 6 minutes
Other intervention name(s): rest first; ex first
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: CAD; prompt physical exercise; collateral function
The Effect of Education Provided to Family Members Caring for Colorectal Cancer Patients on Caregiving Reactions and Healthy Lifestyle Behaviors: A Prospective Quasi-experimental Study.
Condition: Evaluation of the Effects of Education Provided on Family Members Caring for Colorectal Cancer Patients
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The effect of education provided to family members caring for colorectal cancer patients on
      caregiving reactions and healthy lifestyle behaviors: A prospective quasi-experimental study
    

Detailed description: 
      The study was conducted as a pre-test-post-test, control group and quasi-experimental
      intervention research design in order to evaluate the effects of education applied to family
      members who provide care for patients with colorectal cancer on their healthy lifestyle
      behaviors and reactions towards caregiving. The study population consisted of 100 caregiver
      who provide primary care to patients with colorectal cancer. The study data were collected
      using the "Socio-Demographic Characteristics Data Collection Form", "Healthy Lifestyle
      Behaviors Scale II (HPLP-II)" and the "Caregiver Reaction Assessment (CRA)". The pre-test was
      applied to the experimental and control groups at the first interview. The preferred
      interview format was a booklet. Three times face to-face individual educational sessions were
      provided to the experimental group, accompanied by a education booklet. After the third
      educational session the post-test was applied to the caregivers in the experimental and
      control groups.
    

Intervention name(s): Educational sessions
Intervention type(s): Behavioral
Intervention description(s): Firstly, the literature was scanned and a education booklet prepared after the opinions of 5 academic nurses, who are experts in the field of oncology, was used. The booklet was included colorectal cancer treatment, symptoms that may develop due to chemotherapy and information on their control, psychosocial support of caregiving family members. Interviews and educational sessions with family members who agreed to participate in the study were held in one-on-one and face-to-face meeting room. These interviews lasted approximately 45 to 60 minutes for each family member. In the interviews, a educational booklet containing information on nutrition, exercise, symptom management, physical aspects of care and disease-specific care was used to present information to caregivers. All of educational sessions were performed by the single researcher.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Caregiver; Caregiving reactions; Colorectal cancer; Family member; Educational program
Dry Needling for Cervicogenic Headache
Condition: Headache; Cervicogenic Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      This is a single-blinded randomized clinical trial. The primary aim of this study is to
      compare the effectiveness of dry needling of myofascial trigger points in the muscles of the
      head and cervical spine in addition to an upper extremity strengthening/stretching exercise
      program compared to a dry needling group alone on pain scores, cervical range of motion, pain
      sensitivity and changes in severity and frequency of pain symptoms in individuals with
      cervicogenic headache.
    

Detailed description: 
      This is a single-blinded randomized clinical trial. Eligible participants who agree to enroll
      in the study will be asked to attend four testing sessions. Participants in both groups will
      receive dry needling to the involved head and cervical muscles and the other group, in
      addition to receiving a dry needling intervention, will be instructed in a standard home
      exercise program consisting of strengthening and stretching exercises for the upper quarter.
      All dry needling (using standard clean technique) will be performed by licensed physical
      therapists board certified in orthopaedic physical therapy and having a minimum of 5 years of
      experience treating patient populations with dry needling.

      The aim of this research study is to compare he effectiveness of dry needling alone with dry
      needling and a home exercise program on pain, pain sensitivity, cervical range of motion, and
      changes in the severity and frequency among individuals with headache symptoms.
    

Intervention name(s): Dry Needling; Upper extremity stretching program
Intervention type(s): Procedure; Other
Intervention description(s): Dry Needling is a treatment technique whereby a sterile, single-use, fine filament needle is inserted into the muscle to assist with decreasing pain and improving function through the release of myofascial trigger points (knots in the muscle).; A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter
Other intervention name(s): Myofascial trigger point dry needling; Intramuscular stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-blinded randomized clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Headache; Dry Needling
A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.
Condition: Controlled Ovarian Stimulation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase 2 dose-ranging trial is to investigate the effects of FE 999302 on
      parameters influencing pregnancy rates in women undergoing Controlled Ovarian Stimulation
      (COS) with follitropin delta in a long gonadotropin releasing hormone (GnRH) agonist
      protocol.

      Furthermore, the study intends:

        -  To investigate the safety of FE 999302 in women undergoing COS with follitropin delta in
           a long GnRH agonist protocol.

        -  To investigate the potential immunogenicity of FE 999302 in subjects undergoing COS with
           follitropin delta in a long GnRH agonist protocol.

        -  To estimate the impact of body weight on FE 999302 exposure in subjects undergoing COS
           with follitropin delta in a long GnRH agonist protocol.
    


Intervention name(s): FE 999302 (1 μg) and follitropin delta; FE 999302 (2 μg) and follitropin delta; FE 999302 (4 μg) and follitropin delta; FE 999302 (8 μg) and follitropin delta; FE 999302 (12 μg) and follitropin delta; Placebo and follitropin delta
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): Daily dose of 1 μg of FE 999302, a recombinant human chorionic gonadotropin (rhCG) solution for subcutaneous injection; individualized follitropin delta dose.; Daily dose of 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.; Daily dose of 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.; Daily dose of 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.; Daily dose of 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.; Daily dose of placebo; individualized follitropin delta dose.
Other intervention name(s): Choriogonadotropin beta; Choriogonadotropin beta; Choriogonadotropin beta; Choriogonadotropin beta; Choriogonadotropin beta
Intervention MeSH terms: Chorionic Gonadotropin; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Human Chorionic Gonadotropin (hCG); Recombinant Human Chorionic Gonadotropin (rhCG); Controlled Ovarian Stimulation (COS); Assisted Reproductive Technologies (ART)
Stress Management Training for Healthy Aging
Condition: Psychological Stress; Loneliness
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      This study is a two-arm randomized controlled trial comparing two 8-week stress management
      programs for reducing inflammation and improving well-being among older adults.
    

Detailed description: 
      A growing body of literature has demonstrated how stress can affect social relationships,
      health, and well-being during the aging process. Here, the investigators will test how two
      different programs can be used to facilitate healthy aging by helping individuals manage
      stress. One program will teach participants mindfulness meditation techniques while the other
      will educate participants about how to manage their health.

      N=188 older adults will visit the study's central laboratory for a baseline visit and
      complete several days of daily experience sampling before being randomized into one of the
      two 8-week stress management programs. Participants will complete several days of daily
      experience sampling at the midpoint and conclusion of the intervention before returning to a
      study site to complete a follow-up assessment at both 1-week and 3-months after the end of
      the program.

      This project will provide important information about how each training program can be used
      to promote well-being, health, and better social functioning in older adults. This work will
      ultimately inform the design of more efficacious and efficient stress-management
      interventions to facilitate healthy aging.
    

Intervention name(s): Mindfulness Training; Health Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Guided mindfulness meditation and stress management training; Guided health education and stress management training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Assessment of Functional Capacity, Pain, Cognitive and Respiratory Functions in Lung Cancer Survivors
Condition: Lung Neoplasm; Survivorship
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      Serious side effects occurs with disease and treatments in survival after lung cancer. For
      this reason, functional capacity, cognitive status, pain perception and respiratory functions
      may be affected in lung cancer. The purpose of this study was to evaluate respiratory
      function, respiratory muscle strength and endurance, functional capacity, pain, cognitive
      status level, and physical activity in lung cancer patients and compare with the findings of
      healthy subjects
    

Detailed description: 
      This study was participated lung cancer patients survivors. Patients' pulmonary function
      test, functional capacity, respiratory muscle strength and endurance, pain and cognitive
      status was assessed and recorded.

      Pulmonary function testing (PFT), mouth pressure measurement (MIP- maximal inspiratory
      pressure and MEP- maximal expiratory pressure), respiratory muscle endurance test, six minute
      walk test (6MWT) and pain threshold and tolerance test were used. In addition to
      physiological measurements, the Montreal Cognitive Assessment (MoCA) scale was used to
      evaluate cognitive status, the International Physical Activity Questionnaire (IPAQ) was used
      to determine the level of physical activity.
    

Intervention name(s): Functional capacity
Intervention type(s): Diagnostic Test
Intervention description(s): Six minute walk test used assessment of functional capacity. For respiratory function mouth pressures, for cognitive functions MoCA scale and for pain assessment pain threshold and tolerance test assessed.
Other intervention name(s): Exercise capacity
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Lung cancer patients -> patients who were not under active cancer treatments Healthy -> No
        lung disease and systemic disease that affected outcome measure
      
Keywords: Respiratory muscles; Pain; Cognitive dysfunction
A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.
Condition: Treatment for Prevention of Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the long-term safety and efficacy of erenumab.
    

Detailed description: 
      This was a multicenter, 52-week, open-label study designed to assess the long-term safety and
      efficacy of erenumab in adults with chronic migraine. Participants who completed the 12-week
      double-blind treatment of the parent Study 20120295 (NCT02066415) and met all Study 20130255
      eligibility criteria were eligible for enrollment into this study. Enrollment occurred within
      14 days after the parent study's week 12 visit.

      The initial dose used in the study was erenumab 70 mg every month (QM). The protocol was
      subsequently amended to increase the dose to erenumab 140 mg QM (Protocol Amendment 2).
      Participants who had already completed the week 28 visit (ie, midpoint of the study) at the
      time of Protocol Amendment 2 continued to receive open-label erenumab 70 mg QM for the
      remainder of the study. Participants who enrolled but had not completed the week 28 visit at
      the time of Protocol Amendment 2 increased the open-label erenumab dose from 70 mg QM to 140
      mg QM at the next visit. All participants who enrolled after Protocol Amendment 2 received
      open-label erenumab 140 mg QM throughout the study.

      Participants may elect to participate in a separate clinical home use (CHU) substudy to
      assess subjects' ability to self-administer 140 mg of erenumab for in-home use using either
      two prefilled syringes (PFS) or two prefilled autoinjector/pens (AI/pens). Enrollment in the
      12-week substudy occurred at either week 12 or week 40 of study 20130255. Participants were
      randomized to self-administer erenumab using either the PFS or AI/pen on CHU days 29 and 57
      at home.
    

Intervention name(s): Erenumab
Intervention type(s): Drug
Intervention description(s): Administered by subcutaneous injection once a month
Other intervention name(s): AMG 334; Aimovig™
Intervention MeSH terms: Erenumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Migraine
Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder
Condition: Bipolar Disorder; Suicidal Ideation
MeSH terms: Bipolar Disorder; Suicidal Ideation
Study type: Interventional

Summary: 
      Children and adolescents with early-onset bipolar disorder (BD) are at high risk for
      intentionally hurting themselves. Although there are therapies in existence for these youths
      with BD, they do not address suicide prevention specifically. Mentalization-based therapy for
      adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and
      adult population with borderline personality disorder. The investigators will modify the
      MBT-A treatment procedures for persons with BD who have had a recent period of suicidal
      ideation or behavior.
    

Detailed description: 
      Youth with early-onset bipolar disorder (BD) are at an elevated risk for intentional
      self-harm compared to healthy adolescents or adolescents with other psychiatric disorders.
      Adolescents vulnerable to emotion dysregulation and self-harm often have deficits in the
      ability to mentalize: to understand, acknowledge, and predict thoughts and feelings in
      oneself and others. Mentalization-based therapy for adolescents (MBT-A) has been shown to be
      more effective than 'usual care' in reducing self-harm for adolescents and adults with
      borderline personality disorder. MBT-A includes psychoeducational and coping strategies that
      may prove quite effective for bipolar adolescents who are at elevated risk for self-harm.

      Participation in this study will last 9 months. All participants will receive a thorough
      medical-psychiatric evaluation. All youth will be able to receive pharmacotherapy with a
      study psychiatrist in the CHAMP clinic. The MBT-A will consist of up to 21 weekly, biweekly
      and monthly individual sessions interspersed with 9 monthly family sessions (30 therapy hours
      total). Participants will also complete follow-up assessments every 3 months for 9 months.
      These assessments will include research interviews and questionnaires.
    

Intervention name(s): Mentalization-Based Therapy
Intervention type(s): Behavioral
Intervention description(s): Up to 21 individual MBT-A sessions plus 9 monthly family sessions. MBT-A sessions will focus on the adolescent's recent social experiences and the resulting mental states and managing interpersonal challenges, particularly those involving separation or loss. The goal of this intervention is to improve the adolescent's ability to mentalize: to understand, acknowledge, and predict thoughts and feelings in oneself and others.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Suicidal; Depression; Self-harm; Psychosocial intervention
Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial
Condition: Proportion of Anesthesia; Anxiety Level
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      MRI has been recognized for many years as the safest and the most precise imaging method,
      particularly for children. However, the accuracy of MRI demands from the patient to avoid any
      movement while the examination is in process. This task is accomplished with difficulty by
      children and requires the assistance of an anesthetizing staff. In this research, our main
      goal is to investigate an introductory instruction as an assistive tool in performing MRI
      without the need in anesthesia.
    

Detailed description: 
      This is a prospective randomized controlled trial in which the level of the child's exposure
      to instruction is controlled according to the group he is attributed to. The children are
      divided randomly, each Sunday (the day there is an available anesthesia staff) we change the
      extent of the instruction. We use two types of instructions: 1) Full interactive instruction-
      which will include an instructional booklet, a movie and a simulator's practice. 2) Partial
      instruction which will include the booklet only.

      Therefore, if it is a full instruction Sunday, all the children in that day receive full
      instruction and vice versa, if it will is a partial instruction Sunday, all the children in
      that day receive partial instruction.

      All participants provide written informed consent after the study aims and procedures are
      fully explained.
    

Intervention name(s): Full interactive instruction
Intervention type(s): Behavioral
Intervention description(s): This is a prospective randomized controlled trial in which the level of the child's exposure to instruction is controlled according to the group he is attributed to. The children are divided randomly, each Sunday (the day there is an available anesthesia staff) we change the extent of the instruction. In the intervention group, we use Full interactive instruction- which include an instructional booklet, a movie and a simulator's practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care