bioihbjkbjnl/mcl2 huggingface dataset:
Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence
Condition: Stress Disorders, Post-Traumatic; Anxiety; Depression
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study will determine whether trauma-focused cognitive behavioral therapy (TF-CBT) is
      more effective than child-centered therapy (CCT) in reducing post traumatic stress disorder
      (PTSD) in children exposed to domestic violence (DV).
    

Detailed description: 
      Up to 10 million children in the United States are exposed to DV directed at their mothers by
      intimate partners. DV exposure puts these children at an increased risk for developing
      behavioral problems, depression, anxiety, and PTSD. While studies targeting PTSD in
      DV-exposed children are limited, data indicates that TF-CBT is effective in improving PTSD as
      well as depression, anxiety, and behavioral symptoms. This study will determine the
      effectiveness of TF-CBT in reducing PTSD and other DV-related psychological symptoms in
      children from a community DV agency in Pittsburgh, Pennsylvania.

      This study will last 8 weeks. Children and their mothers will be randomly assigned to receive
      8 weeks of either TF-CBT or CCT. In TF-CBT, patients recall the events of their trauma and
      try to deal with the emotions that arise. Supportive treatment empowers children to deal with
      their emotions in general. Both the children and their mothers will complete questionnaires
      at study entry and at Week 8. Children will also complete self-report scales at study entry
      and at Week 8. The questionnaires and self-report scales will be used to assess symptoms of
      PTSD, depression, anxiety, and behavioral problems. Children and their mothers will be
      contacted 6 and 12 months after study completion for follow-up interviews.
    

Intervention name(s): Trauma-focused cognitive behavioral therapy (TF-CBT); Child-centered supportive therapy (CCT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): TF-CBT is a psychotherapeutic intervention designed to help children, youth, and their parents overcome the negative effects of traumatic life events. It was developed by integrating cognitive and behavioral interventions with traditional child abuse therapies that focus on enhancement of interpersonal trust and empowerment. It targets PTSD symptoms, which often co-occur with depression and behavioral problems. TF-CBT also targets other issues experienced by those suffering a trauma including poor self-esteem, mood instability, and difficulty trusting others.; CCT demonstrates an empathic approach to healing. An environment consisting of empathy, unconditional positive regard and acceptance are key elements in this mode of therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder; Domestic Violence; Children; Cognitive Behavioral Therapy; CBT
Chronic Graft-versus-host Disease (cGvHD) Prophylaxis With or Without ATG Prior to Stem Cell Transplantation (SCT) From HLA-identical Siblings in Patients With Acute Leukemia
Condition: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicenter, prospective phase III-study is to compare the administration of ATG
      FRESENIUS to the NON-administration of ATG FRESENIUS in a myeloablative conditioning regimen
      followed by allogeneic hematopoeitic stem cell transplantation from an HLA-identical sibling
      in patients with acute Leukemia. This clinical trial is to show that the administration of
      ATG FRESENIUS reduces the risk of chronic Graft-versus-Host disease after allogeneic stem
      cell transplantation from HLA-identical siblings.
    


Intervention name(s): ATG FRESENIUS (Anti-Lymphocyte-Globulin); ATG FRESENIUS (Anti-Lymphocyte-Globulin)
Intervention type(s): Drug; Drug
Intervention description(s): conditioning regimen with ATG: ATG FRESENIUS dosing: 10mg/kg/day, (day -3, -2,-1) when randomised Arm A; conditioning regimen WITHOUT ATG when randomised Arm B
Intervention MeSH terms: Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematopoietic Stem Cell Transplantation
The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content
Condition: NAFLD; Overweight and Obesity; Metabolic Syndrome; Diabetes
MeSH terms: Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate dietary compositions effect on liverfat measured
      by magnetic resonance imaging.
    

Detailed description: 
      Overweight but otherwise healthy men will be included in the study which is a randomized diet
      intervention study in a cross over design.

      The study involves 2 intervention periods of 5 days each, during which the participant
      ingests two different types of experimental diet. Participants will in randomized order
      (determined by block randomization) ingest a diet with low carbohydrate and high fat content,
      and a diet with high carbohydrate and low fat content.
    

Intervention name(s): High Carb Low Fat Diet; Low Carb High Fat Diet
Intervention type(s): Other; Other
Intervention description(s): The participants will be randomized to a diet of low carb/ high fat og high carb/low fat; The participants will be randomized to a diet of low carb/ high fat og high carb/low fat
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized diet intervention study in a cross over design
Masking: None (Open Label)
Primary purpose: Basic Science
Peripheral for Quantify Strength of Children Functional During the Pinch Movement
Condition: Hand Strength
Study type: Interventional

Summary: 
      This study has developed a peripheral to quantify the functional strength of children without
      motor change during the movement of grip and pinch. It was possible to know the exact values
      of these strengths, the range of motion that was made, and also if the grip strength was
      maintained during all the arc of motion.
    

Detailed description: 
      Since childhood, it has been necessary to produce sufficient force to grip and pinch, for
      performing daily tasks independently; therefore, measurements of these forces end up being
      useful markers to evaluate the performance and the physical development of the child. It was
      developed a peripheral containing three devices and instrumented for analyzing the force
      applied during execution of the cylindrical grip movement, pinch pulp-side and pinch
      pulp-pulp in different situations of the daily life of the volunteer. The data acquisition
      interface was developed in a software for data recording. For the peripheral functionality
      tests, thirty volunteers of both genders were selected. They were also students of the Sports
      Secretary, with no motor abnormalities, between seven and ten years old.
    

Intervention name(s): Door handle device; Linear switch device; Door key device
Intervention type(s): Device; Device; Device
Intervention description(s): To evaluate the cylindrical grip movement, it was used a door handle, which evaluated all the strength at the arc of motion; To evaluate the pulp-pulp pinch movement, it was used one linear switch, which evaluated all the strength at the motion displacement.; To evaluate the pulp-side pinch movement, it was used a door key, which evaluated all the strength at the arc of motion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Phase I Dose Finding and Safety Study of Oral LDE225 in Children and a Phase II Portion to Assess Preliminary Efficacy in Recurrent or Refractory MB
Condition: Medulloblastoma; Rhabdomyosarcoma; Neuroblastoma; Hepatoblastoma; Glioma; Astrocytoma
MeSH terms: Neuroblastoma; Astrocytoma; Rhabdomyosarcoma; Medulloblastoma; Hepatoblastoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and
      pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent
      or refractory medulloblastoma, or other tumors potentially dependent on Hedgehog signaling
      pathway.

      Phase II study is to assess preliminary efficacy in both adult and pediatric patients with
      recurrent or refractory MB.
    


Intervention name(s): LDE225
Intervention type(s): Drug
Intervention description(s): LDE225/sonidegib capsules were supplied to the Investigators at dose strengths of 50 mg, 100 mg, 200 mg, and 250 mg.
Other intervention name(s): sonidegib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent,; refractory,; medulloblastoma,; rhabdomyosarcoma,; neuroblastoma,; hepatoblastoma,; astrocytoma,; children,; pediatric,; hedgehog pathway inhibitor, adult
Stress Resilience Study
Condition: Oxidative Stress; Aging
Study type: Observational

Summary: 
      The purpose of this study is to test the hypothesis that physiological adaptations to regular
      exercise training (i.e. physical fitness) attenuates age-related decline in stress resilience
      to both oxidative stress and the neuroendocrine responses to psychosocial stress.
    

Detailed description: 
      Aging is associated with diminished stress resilience, as in reduced ability to manage or
      recover from acute changes in homeostasis. Increased oxidative damage to cells and tissues
      and dysregulation of stress hormones have been linked to age-associated chronic diseases
      including atherosclerosis, cancer, cardiovascular disease and Alzheimer's disease.
      Interventions to improve the body's resistance to stress, resulting in lower oxidative stress
      and better regulation of the stress hormones, may prevent or delay the onset of age-related
      diseases and improve quality of life.

      Oxidative stress is believed to be a key mechanism in the aging process, with free radicals
      also implicated in many pathological processes. Similarly, dysregulation of the
      hypothalamic-pituitary-adrenal (HPA) axis is thought to play a role in aging and is linked to
      the increased risk for age-related chronic disease.

      The hormesis theory suggests that a certain amount of stress can lead to better survival and
      reduced tissue damage following a subsequent, more severe stress. One way to stress the
      system is through acute exercise. Regular exercise training, however, results in adaptive
      responses that increase the tolerance for successive (exercise) stress.

      A relevant question is whether adaptations to regular exercise training translate to greater
      resilience to psychosocial stress and an increased capacity to resist acute oxidative stress,
      thereby providing increased protection from diseases associated with dysregulation of these
      systems.

      This study will investigate stress resilience in two areas related to aging: oxidative stress
      and the neuroendocrine response to psychosocial stress. The effects of physical fitness on
      oxidative stress compensation and neuroendocrine stress reactivity will be determined by
      comparing fit and unfit older men and women. The overall aim of this study is to provide
      enhanced understanding of the mechanisms by which physical fitness modifies stress resilience
      in older men and women.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      Blood, saliva, and urine samples
    
Keywords: VO2 max; stress; cortisol; fitness
Secondary Adjuvant Long Term Study With Arimidex
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The study assesses the effect of further 2 years vs further 5 years of adjuvant treatment
      with anastrozole after initial 5 years of adjuvant endocrine therapy.
    

Detailed description: 
      ABCSG 16 S.A.L.S.A is assessing the effect of further 2 years vs further 5 years of adjuvant
      treatment with anastrozole after initial 5 years of adjuvant endocrine therapy. S.A.L.S.A. is
      a randomized open multicentered phase III study comparing the efficacy of secondary adjuvant
      endokrine treatment of Arimidex® (Anastrozol) for 2 or 5 years after primary adjuvant
      endokrine therapy in patients with hormonreceptor positive mammakarzinom. Patients are
      examined at screening, after 6 months, then every year until 5 years. The subsequent yearly
      follow up with mammographie and clinical examination ends 10 years after the screening.
      S.A.L.S.A. started in February 2004 and has recruited 3484 patients until June 2010 at 78
      sites all over Austria.

      Primary Endpoint:

      1. Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant
      endocrine therapy on the disease free survival

      Secondary endpoint:

        1. Proof of the effect of 2 years versus 5 years of Anastrozol after 5 years of adjuvant
           endocrine therapy on the overall survival

        2. Comparison of fracture rate in both therapy groups

        3. Comparison of incidence of

             1. a secondary carcinoma except the contralateral mammacarcinoma

             2. contralateral mammacarcinoma in both therapie groups
    

Intervention name(s): Anastrozole
Intervention type(s): Drug
Intervention description(s): 1mg tablet daily
Other intervention name(s): Arimidex
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hormone receptor positive breast cancer
Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler
      with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
    


Intervention name(s): Seretide Diskus and charcoal; Seretide Diskus; SF Easyhaler and charcoal; SF Easyhaler
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 inhalations as a single dose; 2 inhalations as a single dose; 2 inhalations as a single dose; 2 inhalations as a single dose
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
The Role of Impact Activity in Peripubertal Bone Accrual
Condition: Bone Mineral Density
Study type: Observational

Summary: 
      Osteoporosis has been established as a major public health problem, primarily effecting
      women. The attainment of maximal peak bone mass is crucial in the prevention of osteoporosis,
      yet little is known about the specifics of bone accrual. Physical activity has been
      identified as an important modifiable factor controlling bone accrual. It is has been shown
      that increased activity during peri-pubertal years increase bone mineral content during
      adulthood. Thus, strategies designed to increase peak bone mass should target the
      peri-pubertal years of critical bone acquisition.

      Hypothesis 1a: The amount of bone mineral accrued during the peri-pubertal years is greater
      in girls who engage in impact activity than in those who do not.

      Hypothesis 1b: The positive effects of impact activity on bone accrual are maintained after
      cessation of the activity, resulting in greater bone mineral density in girls who participate
      in impact activity during a portion of the peri-pubertal years than in those who never
      participated in impact activity.
    

Detailed description: 
      As above
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects were recruited into the following three groups based on their exposure to
        gymnastic activity. A) control, no gymnastic activity. B)retired gymnasts, who participated
        at study onset, but stopped gymnastics activity during the course of the study. C) active
        gymnast, who continues participation in gymnastics throughout the duration of the study.
The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test
Condition: Dyslipidemias; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Dyslipidemias
Study type: Interventional

Summary: 
      This study aims to evaluate the reliability of a shortened fat tolerance test ("abbreviated
      fat tolerance test", or "AFTT") for measuring post-meal lipids in human blood. The
      reliability of the triglyceride results in this test are compared to the reliability of the
      glucose results from an oral glucose tolerance test (OGTT), a widely-used and clinically
      accepted metabolic test.
    


Intervention name(s): High-fat shake; Pure glucose solution
Intervention type(s): Other; Other
Intervention description(s): Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.; Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Physical Activity and Immigrant Health
Condition: Physical Activity
Study type: Interventional

Summary: 
      There is today a growing need for culturally adapted initiatives among immigrants to prevent
      and treat T2D. Others have failed to increase the level of physical activity in this sedate
      group. The investigators believe this is due to missing assistance and lack of influence from
      the Pakistani milieu. To improve this, a culturally adapted physical activity will be
      established in this project in close cooperation with the Pakistanis themselves.

      Through this program it is the investigators' goal to increase their physical activity level
      and prevent lifestyle diseases among Pakistanis in Oslo with a high risk of developing these
      diseases.
    


Intervention name(s): Physical activity (PA) and immigrants
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Activity Level
The Effect of Awareness on Preoperative Anxiety
Condition: Anxiety; Anesthesia
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      In the majority of patients, anxiety and fear are observed at different levels before
      surgery. Preoperative anxiety was reported in 60-80% of the patients who underwent surgery.
      This anxiety and fear can be attributed to many factors. Some of these are mainly anesthesia,
      previous experience of the patient, personality traits, concerns about surgical intervention,
      and postoperative pain. Patients' anxiety levels can be influenced by a variety of factors,
      including previous experience, type of hospital arrival, sex, age, and type of
      surgery.Anesthesia-related awareness among the experiences of anesthesia is described in the
      literature. In a study of 20,402 patients in the United States, the awareness rate was 0.13%.
      Being aware is that the patient is awake during the surgery and recalls seeing bad dreams. At
      that time the patient could not specify this because he was immobile. Being awake is that the
      patient is awake and showing it through his movements. The patient may not remember this
      situation later. It is a condition that can always be overlooked in previous experience,
      which is an important parameter of anxiety in the preoperative period. The patients included
      in the study were planned to use the modified Brice awareness score, first mentioned in 1970
      as the name of the person who used the anesthesia and anesthesia for awareness. In this
      study, investigators aim to reveal the effect of anesthesia awareness on preoperative anxiety
      in patients with previous anesthesia story.
    

Detailed description: 
      in this study will include 300 patients. 300 patients will be enrolled in the anesthesia
      outpatient clinic scheduled for elective surgery for any reason at the age of 18-65 years.
      Patients with dementia and psychiatric disorders, anxiolytic and psychiatric drug users and
      patients who can not receive written approval will be excluded from the study.
    

Intervention name(s): awareness and anxiety
Intervention type(s): Behavioral
Intervention description(s): before operation awareness and anxiety will recorded with STAIX-I score
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        elective surgery for any reason
The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children
Condition: Metabolic Syndrome; Inflammation; Obesity
MeSH terms: Metabolic Syndrome; Syndrome; Inflammation
Study type: Interventional

Summary: 
      Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and
      it is likely that this is also the case in children (Ley et al., 2005). It has also been
      shown that the gut microbiota is different in obese individuals compared to normal weight
      individuals and that the microbiota seems to have a role in fat storage (Backhead et al,
      2004).

      Intervention study with overweight and normal weight school age children. The children will
      be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be
      collected, and anthropometric measurements (weight, height, skin folds) will be recorded
      before and after the intervention. The dynamic of the microbiota of the GI will be monitored
      by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will
      be analysed. Blood samples will be analysed to evaluate how the intervention influence the
      systemic polarization of the immune response by means of cytokine analyses. Furthermore,
      blood pressure, blood lipid profile and early markers of metabolic syndrome will be
      evaluated. Hypotheses This study will examine if overweight in children is associated with a
      different intestinal microbiota and if a change in microbiota caused by probiotics can modify
      inflammation and risk factors for the metabolic syndrome.
    


Intervention name(s): Ls-33
Intervention type(s): Dietary Supplement
Intervention description(s): 10~10 CFU/day
Other intervention name(s): L. salivarius Ls-33
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care