bioihbjkbjnl/mcl2 huggingface dataset:
Stress Management and Resiliency Training (SMART) Integrated Into Treatment of Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The investigators are doing this research study to find out if the Stress Management and
      Resiliency Training (SMART) therapy will help subjects with their major depression treatment.
    

Detailed description: 
      The investigators propose to conduct an initial feasibility study in a sample of patients in
      treatment for major depression using SMART. The intervention will be weekly group therapy
      session of SMART for 8 weeks duration. Once enrolled, participants will complete a Structured
      Clinical Interview for Diagnosis (SCID). The SCID will primarily serve to confirm a diagnosis
      of Major Depressive Disorder. Each study intervention group (3-4 groups) will be composed of
      6-8 research participants per group. There will be no comparison group. The investigators aim
      to assess adherence with goal of 75% completion of the 8 sessions of SMART and of the
      homework assignments. Resilience will be measured with the Connor-Davidson resilience scale.
      Secondary outcomes will include subjective and objective clinical rating scales for major
      depression.
    

Intervention name(s): Stress Management and Resiliency Training
Intervention type(s): Behavioral
Intervention description(s): Subjects will undergo an 8 week behavioral program. Treatment will consist of weekly group therapy sessions in small groups with core practices to apply the principles of SMART.
Other intervention name(s): SMART
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
Condition: Age-associated Memory Impairment
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may
      affect cognitive function parameters in older healthy individuals with evidence of
      age-related cognitive decline.

      In a double blind, randomized manner, 40 free living males and females between 55 to 75 years
      with age-associated memory decline will ingest Brainphyt supplement or Placebo for 12 weeks.
      Cognitive function battery will be realized after 4 and 12 weeks of supplementation.
    


Intervention name(s): Brainphyt high dose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will take BrainPhyt capsules during 3 months; Participants will take placebo capsules during 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Elderly; Microalgae; Cognitive function; inflammation
Acute Pain and Inflammation After Surgery
Condition: Knee Injuries
MeSH terms: Acute Pain; Knee Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is

        1. to observe acute pain after surgery and measure the natural course of inflammatory
           mediators

        2. study pain relieving effects and local anti-inflammatory effects of systemically
           administered ketorolac
    

Detailed description: 
      Randomizized controlled trial
    

Intervention name(s): 1 Ketorolac intraarticular; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ketorolac intraarticular 5 mg; Saline
Other intervention name(s): Ketorolac; Saline
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute pain; Inflammatory pain; Inflammatory mediators; Pain relief; Microdialysis
Rehabilitation in Parkinson Disease Cyclone in Life
Condition: Parkinson Disease; Physical Disability
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Comparison of two rehabilitation protocols in patients with Parkinson's disease and,
      therefore, identification of innovative rehabilitation protocols of proven and validated
      efficacy, through which it is possible to achieve:

        -  Improved joint function and gait pattern

        -  Reduction of the risk of falling or reduction of energy expenditure during physiological
           gait

      Evaluation of the increase in maximal effort tolerance

      · Improved cognitive performances

      Evaluation of the impact on the quality of life of the patient and family members

      Identification of morpho-functional markers predictive of clinical and rehabilitative
      out-come through neuroimaging study.
    

Detailed description: 
      rehabilitation protocols in patients with Parkinson's disease and, therefore, identification
      of innovative rehabilitation protocols of proven and validated efficacy, through which it is
      possible to achieve:

      Improved joint function and gait pattern Reduction of the risk of falling or reduction of
      energy expenditure during physiological gait Evaluation of the increase in maximal effort
      tolerance

      · Improved cognitive performances

      Evaluation of the impact on the quality of life of the patient and family members

      Identification of morpho-functional markers predictive of clinical and rehabilitative
      out-come through neuroimaging study.
    

Intervention name(s): IRMA
Intervention type(s): Device
Intervention description(s): For patients in an advanced state of illness, advanced neuromotor rehabilitation treatment included 1) robot therapies, 2) specific water courses (e.g. walking pools, hydrokinesiotherapy pools, etc.), 3) advanced cognitive treatments (e.g. virtual reality courses); 4) augmentative immersive therapy in a virtual environment; 5) courses also dedicated to social reintegration and inclusive activities (theatre-therapy, art-therapy, dance-therapy, agro-therapy, etc.).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Virtual Reality Distraction in Patients Undergoing Periodontal Surgery
Condition: Virtual Reality; Oral Surgery; Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The goal of this randomized controlled clinical trial is to evaluate the effect of virtual
      reality technology on anxiety and pain levels in patients undergoing periodontal surgery.

      Participants will be randomly assigned into test and control groups. While the patients in
      the test group will undergo periodontal surgery with virtual reality distraction, the
      patients in the control group without distraction. After treatment, the groups will be
      compared regarding anxiety and pain levels.
    


Intervention name(s): Periodontal surgery with virtual reality distraction; Periodontal surgery without virtual reality distraction
Intervention type(s): Procedure; Procedure
Intervention description(s): Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets; Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Humidified Culture and Live Birth After ICSI
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Humidity for human embryo culture has been raised as essential with advantageous effect on
      clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether
      the deleterious effect of dry culture would have an extended effect reaches the live birth
      rate needs to be examined. This RCT is to examine the effect of dry and humidified culture on
      live birth rates after ICSI.
    


Intervention name(s): Human embryo culture
Intervention type(s): Other
Intervention description(s): humidifed or dry incubator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Occupational Therapy With Ayres Sensory Integration Approach for School-age Children
Condition: Children, Only
Study type: Interventional

Summary: 
      Introduction:

      Sensory Integration (SI) is a theory and framework conceptualized by Dr. Jean Ayres, a highly
      experienced occupational therapist, with its main objective as enhancing the brain's capacity
      to perceive and organize sensory information to produce a more normal, adaptive response;
      thus, to provide the foundation for mastering academic tasks (Case-Smith and O'Brien, 2010).

      Objectives:

      The aim of the study is to investigate the effectiveness of ASI interventions for school-aged
      children with sensory modulation and sensory processing deficits.

      Methodology:

      A cross-clustered single-blinded randomized controlled trial was conducted in 5 occupational
      therapy outpatient department within Hospital Authority, to assess the difference in clinical
      outcomes between subjects in experimental group (received ASI) and control group (on usual
      waitlist for treatment). Participants in experimental group (EG) would receive 16 sessions
      (45 minutes each) of individualized ASI. The sessions were scheduled on weekly basis and
      would be completed within five months once treatment was initiated. Post-assessment outcomes
      would be measured at this time-point. Post-assessment outcomes would also be measured for
      subjects in control group (CG) at the same time-point. ASI would then be initiated for
      participants in CG according to usual clinical scheduling.
    


Intervention name(s): Sensory Integration
Intervention type(s): Other
Intervention description(s): Sensory Integration (SI) is a theory and framework conceptualized by Dr. Jean Ayres, a highly experienced occupational therapist, with its main objective as enhancing the brain's capacity to perceive and organize sensory information to produce a more normal, adaptive response; thus, to provide the foundation for mastering academic tasks.
Other intervention name(s): Ayres Sensory Integration Approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Protein Intake & Insulin Action
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this proposal is to determine whether dietary protein restriction has
      beneficial effects on skeletal muscle insulin sensitivity and β-cell function in obese men
      and women.
    

Detailed description: 
      Insulin resistance, impaired pancreatic β-cell function, and diabetes are important
      complications associated with obesity. Although excess energy intake and body fat
      accumulation are considered the major culprits responsible for obesity-associated metabolic
      abnormalities, it is possible that insulin resistance and impaired β-cell function are also
      due to increased dietary protein intake.

      Protein intake is ~15 to 25% greater in obese than lean adults and exceeds the current
      Institute of Medicine Recommended Daily Allowance (RDA) of 0.8 g protein/kg body weight by
      ~75%. An increase in habitual protein intake of only 10 to 40%, assessed using dietary recall
      methods, been shown to increase the risk of developing diabetes by up to 2.2 fold.
      Additionally, the ability to stimulate glucose disposal during insulin infusion is reported
      to be impaired in individuals consuming double the recommended protein intake as part of an
      isoenergetic diet. However, it is not known whether decreasing protein intake can improve
      insulin sensitivity and β-cell function in weight-stable, obese individuals.

      Accordingly, obese men and women will be randomized to 8 weeks of treatment with a weight
      maintaining diet containing either i) 0.8 g protein/kg body weight (as recommended by the
      Institute of Medicine; protein restriction group)or ii) 1.4 g protein/kg body weight (control
      group). All subjects will receive a standardized "base-diet" with or without protein
      supplementation to avoid potential food selection bias that could confound the results when
      using high- and low-protein diets.
    

Intervention name(s): Weight maintenance with normal protein intake; Weight maintenance with protein restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Control group will consume 1.4 g/kg/d of protein; consistent with the average protein intake in the US population.; Protein restriction group will receive the Institute of Medicine RDA of 0.8 g protein/kg body wt/d.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
Condition: Brain Stem Gliomas
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the
      patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
      beneficial in the treatment of brain stem gliomas.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on children (> 6 months of age) and adults with newly-diagnosed or
      recurrent brain stem gliomas.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in patients with a brain stem
           glioma, as measured by an objective response to therapy (complete response, partial
           response or stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in patients with a brain
           stem glioma.

      OVERVIEW: This is a single arm, open-label study in which patients receive gradually
      escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the
      maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence
      of disease progression or unacceptable toxicity. After 12 months, patients with a complete or
      partial response or with stable disease may continue treatment.

      To determine objective response, tumor size in measured utilizing MRI scans, which are
      performed every 8 weeks for the first 2 years, every 3 months for the 3rd and 4th years,
      every 6 months for the 5th and 6th years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult brain stem glioma; untreated adult brain stem glioma; untreated childhood brain stem glioma; recurrent childhood brain stem glioma
Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      In this study the investigators aim to evaluate the ability of i-scan OE together with
      magnification endoscopy to detect and assess microscopic inflammation in patients with
      inflammator bowel diseases (IBD).
    

Detailed description: 
      In this study the investigators aim to evaluate the ability of i-scan OE together with
      magnification endoscopy to detect and assess microscopic inflammation in patients with
      inflammator bowel diseases. For this purpose, IBD patients will be prospectively enrolled and
      inflammatory changes will be assessed using optical magnification endoscopy in conjunction
      with optical chromoendoscopy. Endoscopic scoring of inflammatory changes in IBD patients will
      be done on a newly developed magnification score resulting as a consensus from experts in
      optical diagnosis and endoscopy in IBD patients. Results will be correlated against
      histopathology.
    

Intervention name(s): Magnification endoscopy
Intervention type(s): Diagnostic Test
Intervention description(s): All IBD patients will undergo magnification endoscopy with 136-fold optical magnification in conjunction with optical chromoendoscopy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        IBD patients treated in the outpatient department of the University Hospital Erlangen
Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against
      diabetic nephropathy. We hypothesise that this is also the case in humans. This study will
      investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2
      diabetic patients. Impact on basic kidney physiological will be determined and kidney injury
      markers will be measured as surrogate parameters of kidney protection.
    


Intervention name(s): Liraglutide; Placebo-liraglutide
Intervention type(s): Drug; Drug
Other intervention name(s): Victoza; Isotonic saline
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: liraglutide; victoza; GLP-1; kidney; diabetes; renal; diabetic nephropathy
PV-10 Chemoablation of Recurrent Breast Carcinoma
Condition: Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the
      treatment of recurrent breast carcinoma. This study will also include a preliminary
      assessment of response of injected lesions by histologic assessment upon lesion excision at
      1-3 weeks following IL PV-10 administration. Post-excision wound healing will be assessed
      clinically at 1 week and 4 weeks following excision of PV-10 injected lesions.
    

Detailed description: 
      This is a single center, open label, ascending dose study. Subjects with at least one
      recurrent, histologically confirmed measurable soft tissue breast carcinoma who are
      candidates for lumpectomy (removal of the lesion from the site of recurrence in the breast or
      at another site) or mastectomy will receive a single intralesional injection of PV-10 into a
      single target lesion to uniformly infiltrate the target lesion and up to a 0.5 cm margin at a
      dose of up to 1.0 mL/cc lesion volume. Systemic and locoregional adverse events will be
      monitored over the study interval. Subject accrual and PV-10 administration will be stopped
      if more than 1 subject has a treatment related Grade 3 non-hematological or Grade 4
      hematological toxicity within a period of two weeks after PV-10 administration.
    

Intervention name(s): PV-10 (rose bengal disodium 10%)
Intervention type(s): Drug
Intervention description(s): PV-10 ablation of study lesion
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent soft tissue breast carcinoma
Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years
Condition: Childhood Obesity; Child Obesity
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      Obesity, which is an important public health problem of the last century globally, affects
      not only adults but also children and young people. Reducing childhood obesity requires
      effective lifestyle changes and behavioral interventions aimed at healthy nutrition, physical
      activity and stress management.

      to reduce childhood obesity, including school-based multi-component behavioral research in
      Turkey it has not been demonstrated to parents.

      The program, which is planned to be carried out and aims to reduce overweight and obesity in
      children, is a school-based parenting lifestyle intervention involving multiple behaviors.
      The program includes family visits, game-based physical activity activities with children,
      healthy eating recommendations and healthy eating activities with parent participation. The
      program planned to be implemented was developed to evaluate whether healthy preferences and
      lifestyle intervention reduce obesity. The aim of this study is to make the positive health
      behaviors permanent in children, to be a guide for combating childhood obesity and to be
      useful for future research. to be applied to the research, nutrition consists of 10 sessions,
      physical activity, including issues such as coping with healthy ways with stress Child
      Obesity Program (COP), it is thought to overcome this deficiency was needed in Turkey.
    


Intervention name(s): Child Obesity Program
Intervention type(s): Behavioral
Intervention description(s): The program consists of 10 sessions, each lasting 40 minutes. An EOP booklet containing session programs will be distributed to children.
The topics of the sessions are as follows:
Session 1: Healthy lifestyles
Session 2: Self-esteem and positive thinking, Setting goals Session 3: Stress and Coping, Coping with Emotions in Healthy Ways Session 4: Personality and effective communication
Session 5: Activity: Time for action Session 6: Nutrition basics Session 7: Reading tags Session 8: Portion size, nutrition and healthy food choices in schools Session 9: Snacks can also be healthy: Healthy choices
Session 10: Together for a healthy life (Melnyk et al., 2006; 2007; 2009). Detailed information about the sessions is given in annex -3.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Child Obesity Program (COP), The program consists of 10 sessions, each lasting 40 minutes. An EOP booklet containing session programs will be distributed to children.The research was determined as randomized controlled pretest-posttest control group design type.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: childhood obesity; school based; obesity intervention