bioihbjkbjnl/mcl2 huggingface dataset:
Midlife Cholesterol Study
Condition: Menopause; Postmenopause; Premenopause; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The postmenopausal state is associated with an increase risk for heart disease. Much of this
      increase in risk may be due to the loss of estrogen (the main female hormone) and the effect
      of this loss on lipids (blood fats). This loss of estrogen is often treated by estrogen
      replacement therapy. Estrogen replacement therapy seems to have a beneficial effect on lipid
      levels. The purpose of this research study is to understand 1) how menopause affects lipids
      and 2) how hormone replacement therapy effects the lipid metabolism of postmenopausal women.
    

Detailed description: 
      Women with the Metabolic Syndrome (central obesity, insulin resistance, and dyslipidemia) are
      at especially high risk for coronary heart disease (CHD). The prevalence of the Metabolic
      Syndrome increases with menopause and may partially explain the acceleration in CHD after
      menopause. Menopause is associated with increased central adiposity, insulin resistance,
      dyslipidemia (hypertriglyceridemia, increased low density lipoprotein (LDL), reduced high
      density lipoprotein (HDL) and small dense LDL particles), and increased
      thrombotic/inflammatory states, but there are no studies investigating the mechanisms that
      mediate these changes. The objectives of the proposed project are to investigate the
      emergence of the features of the Metabolic Syndrome in women followed prospectively through
      the menopause and determine if these features can be reversed with transdermal estrogen. We
      hypothesize that the increase in central adiposity with menopause will be a major contributor
      to the increased prevalence of the Metabolic Syndrome with menopause. This is the first
      prospective study to investigate the 1) effects of menopause and 2) estrogen replacement
      therapy (ERT) (oral vs. transdermal) on features of the Metabolic Syndrome. We will determine
      if the increase in central (intraabdominal)fat with menopause is associated with changes in
      lipids, insulin resistance, adipocytokines, and fibrinolytic/inflammatory markers. We will
      then determine if these changes can be reversed with transdermal ERT, as compared to oral
      ERT, which has pharmacologic effects on the liver.
    

Intervention name(s): transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium)
Intervention type(s): Drug
Intervention MeSH terms: Estradiol; Estrogens; Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Perimenopause; Abdominal adipose tissue; Women's health; Cholesterol; Lipid Metabolism
The Effects of Dry Needling on the Superficial Neck Musculature
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The term myofascial pain refers to the existence of myofascial trigger points (MTP), which
      are defined as hypersensitive points in a tense band of skeletal muscle, which can cause
      referred pain or autonomous phenomena.

      To address the treatment of myofascial trigger points, conservative and invasive techniques
      have been proposed. Dry needling is one of the invasive techniques that have been shown to be
      effective in improving pain and function in patients with myofascial trigger points.

      This trial aims to analyse the effectiveness of dry needling in patients with myofascial neck
      pain.
    

Detailed description: 
      The main objective of the study is to analyze the effects of dry needling on the superficial
      neck musculature in patients with chronic myofascial neck pain in terms of pain, functional
      capacity, mobility, psychosocial variables and motor control compared with both sham dry
      needling group and control group.

      In addition, a secondary objective is to analyze the relationships between the psychosocial
      variables and the results obtained in the variables analyzed in the patients belonging to the
      three groups.

      For this purpose the investigators conduct a randomized controlled trial double-blind.
      Patients included are randomized into 3 groups. One receives dry needling, another one
      receives sham dry needling, and the last one is a control group.

      The hypothesis of this study is that patients in the real dry needling group will improve
      more compared to patients in the sham dry needling group and the control group.
    

Intervention name(s): Dry needling; Sham dry needling; Electrotherapy + therapeutic exercise
Intervention type(s): Other; Other; Other
Intervention description(s): Dry needling is a technique used by physiotherapists.; Sham dry needling is a technique used by physiotherapists to compare the effects of dry needling.; Standard care of neck pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: physical therapy
Efficacy Study of the Use of Sequential DFP-DFO Versus DFP
Condition: Beta-Thalassemia; Thalassemia Major
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Changes in chelation treatment and transfusion practices, during the past two decades, have
      dramatically improved the prognosis of thalassemia major patients.Deferiprone (DFP) has been
      compared with deferoxamine (DFO), using different schedules of treatment, in the majority of
      the 13 clinical trials published between 1990 and 2008.No statistically significant
      difference was shown between these two interventions during, at most, 18 months of
      treatment.Three randomised trials that compared sequential DFP-DFO treatment versus DFO alone
      reported controversial results but this could be due to small sample sizes and short
      treatment duration. In fact, no trial with treatment duration longer than 18 months15, which
      reported on mortality, adverse events, serum ferritin concentrations, as well as costs has so
      far been published.

      This long-term sequential DFP-DFO treatment versus DFP alone treatment trial was conducted to
      assess the impacts of these chelation treatments on serum ferritin concentrations, mortality,
      adverse events, and costs in thalassemia major patients.
    

Detailed description: 
      The trial was designed as a multicentre randomised open-label trial with blinded data
      management and data analyses, to assess whether either treatment was superior to the other.
      The trial was performed on behalf of the Italian Society for the study of Thalassemia and
      Haemoglobinopathies (SoSTE). The investigators initiated, carried out, and controlled the
      trial, which was conducted without influence of the non-commercial sponsor.16
    

Intervention name(s): Deferiprone (DFP) and Deferoxamine (DFO); Deferiprone (DFP)
Intervention type(s): Drug; Drug
Intervention description(s): Sequential treatment including DFP at 75 mg/kg for four days per week and DFO by subcutaneous infusions (8-12h) at 50mg/kg/day for the remaining three days per week; DFP alone at 75 mg/kg divided into three oral daily doses
Other intervention name(s): DFP (Apotex, Canada); DFO (Biofutura Pharma S.p.A.,Italy); DFP (Apotex, Canada)
Intervention MeSH terms: Deferiprone; Deferoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thalassemia major; chelation treatment; secondary hemochromatosis
Development of a Model to Evaluate Regenerative Endodontic Techniques Using Extract Human Teeth
Condition: Dental Pulp Regeneration; Dental Pulp Diseases
MeSH terms: Dental Pulp Diseases
Study type: Observational

Summary: 
      Millions of teeth are saved each year by root canal therapy. Although current treatment
      modalities offer high levels of success for many conditions, an ideal form of therapy might
      consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and
      replaced with healthy pulp tissue in order to revitalize teeth.
    

Detailed description: 
      The long term goal of this research project is to develop a method to regenerate dental
      pulp-like tissue as an alternative method to conventional root canal treatment. The objective
      of this study is to identify the methods necessary to regenerate dental pulp-like tissue in
      human teeth. We will collect small (~4X4mm) pieces of oral mucosa that are normally removed
      during surgical tooth extractions, isolate human postnatal progenitor/stem cells and, using
      an in vitro cell culture system, combined isolated cells with various scaffolds and test
      compounds to determine optimal conditions to differentiate pulp-like tissue (eg,
      odontoblasts, fibroblasts, endothelium, etc) grown in segments of human roots.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting for surgical removal of impacted teeth
      
Biospecimen description: 
      extracted teeth 10ml of blood for DNA banking
    
Keywords: Dental Pulp; Regenerative Medicine; Odontoblasts; Stem Cells; Growth factor differentiation of stem/progenitor cells; Odontoblast-specific cell phenotypes
Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With CVD
Condition: Cardiovascular Diseases; Lifestyle Risk Reduction
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Implement an intensive cardiac rehabilitation program at Arkansas Heart Hospital (AHH) to
      find out if the AHH-ICR is equivalent to the CMS approved programs when it comes to results.
    

Detailed description: 
      Implement the ICR Program to determine if

        1. AHH-ICR will increase patients physical and psychological well-being and is
           non-superior/comparable to current ICR programs.

        2. To determine the most appropriate ICR program protocols to improve fitness and decrease
           cardiovascular risk factors.

        3. To determine if the ICR program has a direct relationship to improvements in the health
           of cardiovascular patients.

        4. To determine non-inferiority to already established ICR programs in the United States.
    

Intervention name(s): lifestyle modification
Intervention type(s): Behavioral
Intervention description(s): Participants will undergo an exercise program designed by AHH
Other intervention name(s): exercise
Intervention model: Single Group Assignment
Intervention model description: Groups will be assigned to the exercise treatment group
Masking: None (Open Label)
Primary purpose: Prevention
Exercise and Neutrophil Function in COPD
Condition: Chronic Obstructive Airway Disease; Neutrophil Function Disorder
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Exercise is a cornerstone of pulmonary rehabilitation in the treatment of Chronic Obstructive
      Pulmonary Disease (COPD). Although researchers have shown numerous benefits with exercise in
      COPD patients, most studies have only looked at exercise tolerance and psychological outcomes
      following training. COPD is characterised by persistent inflammation that can cause
      progressive decline in lung function and multisystemic complications. This inflammation can
      be amplified in patients when they suffer acute exacerbations. There is a wellknown
      relationship between exercise, immune function and risk of infection. Exercise has also been
      shown to have an antiinflammatory effect when performed regularly. There is a lack of
      research looking into the inflammatory or immune response to exercise in patients with COPD.
      The exercise within this study will be individually tailored to patients with COPD based on
      their validated 6 minute walk test (6MWT) but the protocol will involve interval exercise
      that has been used previously. This type of exercise is considered most appropriate for
      research into mechanisms of benefit because it maintains the exercise training effects of
      other modalities (e.g. continuous low intensity aerobic exercise) while avoiding the
      occurrence of limitations to exercise in people with lung problems (e.g. dynamic
      hyperinflation). It also closely mirrors daily activity of someone with COPD.

      The investigators want to explore the effects of exercise specifically on immune function in
      15 people COPD and compare any changes to 15 Controls. By better understanding the mechanisms
      of how exercise affects inflammation, the investigators could eventually design better
      Pulmonary Rehabilitation interventions, especially for those most at risk.
    


Intervention name(s): Interval Exercise
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Neutrophil; Exercise; COPD; Pulmonary Rehabilitation
A Study of Azidothymidine (AZT) in the Treatment of HIV Infection in Patients Receiving a Bone Marrow Transplant
Condition: Lymphoma, Non-Hodgkin; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Lymphoma, Non-Hodgkin
Study type: Interventional

Summary: 
      To determine whether zidovudine (AZT) in conjunction with bone marrow transplantation
      prevents the reinfection of donor hematopoietic/lymphoid cells in patients with positive HTLV
      III antibody and large cell/diffuse histiocytic lymphoma. Patients who are candidates will be
      evaluated for HTLV III activity and drug levels.
    


Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Primary purpose: Treatment
Keywords: Lymphoma, Large-Cell; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Bone Marrow Transplantation
Dose-effect of HIIT on Cardiovascular Health of Children
Condition: Cardiovascular Diseases Risk; Adiposity
MeSH terms: Cardiovascular Diseases; Obesity
Study type: Interventional

Summary: 
      An adequate physical activity level has important effects on cardiovascular health of
      children. However, the scientific literature suggests that few children meet the physical
      activity recommendations to obtain these cardiovascular benefits which may have immediate and
      long term consequences in public health. High intensity interval training (HIIT) has emerged
      as an effective strategy for improving physical and mental health in children. To note that
      HIIT can be completed in a shorter period of time and its results in physical health seem to
      be equivalent to those obtained in longer sessions of traditional aerobic training. However,
      there is no information about the dose of HIIT needed to obtain significant effects on
      cardiovascular health of children.

      The adoption of healthy dietary habits is also important in the prevention of obesity and
      cardiovascular diseases.

      School-based programs including physical activity and nutritional education have been
      recommended as important components of programs aiming to prevent obesity and cardiovascular
      diseases.
    


Intervention name(s): High intensity interval training; Nutritional education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Two schools with four classes/groups of 4th degree of children will participate in the pilot study (i.e., age of children 9-10 years old). One of them has two physical education (PE) sessions per week and the other has only one PE session per week. In the school with two PE sessions, two classes will be randomly assigned to HIIT (2 sessions/week) +nutrition group, and two to the nutrition group. Similarly, in the school with one PE session per week, two classes will be randomly assigned to HIIT (1 session/week) + nutrition and two classes to the nutrition goup. Both HIIT and nutritional education sessions will be integrated integrated into the physical education and sciences sessions of the schools. The duration of the intervention will be of eight weeks.; School-based nutritional education on healthy dietary habits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIIT; nutritional education; Dose-effect; school; children; cardiovascular; adiposity; blood pressure; fitness
Cognitive Behavioral Therapy for Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate a new form of counseling for pathological gambling
      and to see if the counseling is more effective than attending Gamblers Anonymous.
    

Detailed description: 
      Subjects will be assigned to counseling or be given a referral list of available Gamblers
      Anonymous meetings at the first visit based on answers to questions. Assignment to counseling
      or Gamblers Anonymous will be randomly selected (i.e. chance) with an equal chance of
      receiving either one. For those assigned to counseling, you will meet with the therapist for
      60 minutes weekly. You will receive 5 sessions of counseling.

      All subjects will be assessed with gambling questionnaires twice during the 5-week period and
      again at 3 and 6 months following the 5-week period.

      For those assigned to Gamblers Anonymous, they will be offered 5 weeks of counseling at the
      end of the 6-month follow-up.
    

Intervention name(s): Cognitive Behavioral Therapy; Wait-list
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5-weeks of Cognitive Behavioral Therapy; subjects assigned to wait-list condition for six-weeks
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gambling
Relationship Between Gluteus Medius Muscle Strength, Balance and Jumping Performance in Professional Female Handball Players
Condition: Gluteus Medius Muscle Strength; Handball Players; Balance; Jumping Performance
Study type: Observational

Summary: 
      Background Balance and jumping mechanisms are important to prevent injuries in sports such as
      handball, which require immediately change of direction, jumping and landing strategy. Strong
      proximal stability is required for accurate jump performance and stability.

      Objective To investigate the relationship between gluteus medius strength and static, dynamic
      balance, horizontal and vertical jump performance.

      Design Prospective field trial study.

      Setting: Elite women handball players in Turkish Handball Super League. Patients (or
      Participants): Forty-two elite women handball players from Turkish Handball Super League were
      included in this study.

      Interventions (or assessment of risk factors) The Lafayette Hand-Held Dynamometer was used to
      determine the strength of the gluteus medius. Single leg hop (SLH) test was used for
      horizontal jump and Lafayette Vertimetric device was used for vertical jump (VJ) evaluation.
      Y Balance Test (YBT) was used for the dynamic balance with direction of anterior,
      posteriomedial, posteriolateral and Standing Stork Test (SST) with eyes closed for the
      measurement of static balance.

      Main outcome measurements Gluteus medius strength with hand dynamometer compared with YBT,
      SST, VJ and SLH tests.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Thirty-nine professional female handball players from Turkish Handball Super League were
        included in this study
Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg
      twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as
      add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient
      glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily
      compared to 5 mg once daily and each treatment's superiority over placebo.
    


Intervention name(s): linagliptin low dose; placebo; linagliptin medium dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patient to receive tablets containing low dose linagliptin twice daily; patient to receive placebo tablet(s) matching linagliptin; patient to receive a tablet containing medium dose linagliptin once daily
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study Of The Effects Of SB 480848 (Darapladib) On The Electrical Conduction Of The Heart
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the effects of darapladib on the cardiac conduction of the heart as
      compared to placebo and moxifloxacin. This a four period crossover design with each period
      lasting about 10 days. There will be a 7 to 10 day wash out in between each period.
    


Intervention name(s): Darapladib
Intervention type(s): Drug
Intervention MeSH terms: Darapladib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: darapladib; moxifloxacin; QT study