bioihbjkbjnl/mcl2 huggingface dataset:
Diabetes Prevention Program Pilot
Condition: Pre-diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional

Summary: 
      This initiative, which is a partnership between State College area Penn State Health
      ambulatory care clinics located off campus in the State College area, has two primary goals:
      1) improve the health and quality of life of Penn State Health patients with pre-diabetes and
      2) decrease associated health care costs due to type 2 diabetes and its complications. The
      results from the study may serve as a model for additional chronic disease prevention
      programs to implement in additional Penn State Health clinics in the future.
    

Detailed description: 
      Through this initiative, providers in Penn State Health ambulatory health care clinics (PSH
      clinics) will identify pre-diabetic patients to take part in a Diabetes Prevention Program
      (DPP), modeled after the Centers for Disease Control's (CDC) program.

      The DPP is a CDC-recognized lifestyle change program developed specifically to prevent type 2
      diabetes. It is designed for people who have prediabetes or are at risk for type 2 diabetes,
      but who do not already have diabetes. We will be using the DPP distance learning program
      which allows online delivery of classes. A trained lifestyle coach leads the program to help
      subjects change certain aspects of their lifestyle, like eating healthier, reducing stress,
      and getting more physically activity. The program also includes group support. The DPP is a
      year-long program focused on long-term changes and lasting results. Key components of the
      program include a CDC-approved curriculum with lessons, handouts, and other resources; a
      lifestyle coach, specifically trained to lead the program; and a support group of people with
      similar goals and challenges.

      To that end, this study has multiple arms that will test whether participation in the PSH DPP
      - and exposure to motivational messages that encourage physical activity or participation in
      lotteries, an increasingly common strategy for behavioral motivation, - significantly
      improves program retention and health-related outcomes, compared to those who only
      participate in the PSH DPP.
    

Intervention name(s): Financial Incentives; Motivational Message; DPP Program
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will be entered into a lottery to receive a gift card for class attendance.; Participants will be sent motivational messages through out their participation in the PSH DPP program.; All Participants will be enrolled in the DPP program.
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Registry Study of Clinical Application of MRI Compatible CIED
Condition: Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance
      Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ProMRI CIED implanted，including ProMRI Pacemaker/CRT and ProMRI ICD/CRTD
Superficial Dry Needling Versus Deep Dry Needling on the Upper Trapezius
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study investigates the effect of two different techniques (deep dry needling and
      superficial dry needling) on the latent myofascial trigger point in the upper trapezius.
      Subjects with latent Myofascial trigger point in this location of the muscle will be
      identified and will be randomly assigned to one out of the three groups: deep dry needling,
      superficial dry needling or sham dry needling in gastrocnemius muscle. cervical range of
      motion and pain pressure threshold in the upper trapezius will be registered before,
      immediately after the intervention, at 24 hours after the intervention, at 72 hours after the
      intervention and a week after the intervention
    


Intervention name(s): Experimental: Deep dry needling; Experimental: Superficial dry needling; Placebo Comparator: Placebo Gastrocnemius dry needling
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Deep dry needling until achieving twitch response of the muscle; Superficial dry needling to achieve sensitive pain with needle rotation; Simulate pain with de plastic needle guard in the gastrocnemius muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Frequency of Metabolic Syndrome in Down Syndrome Patients
Condition: Metabolic Syndrome X; Down Syndrome
MeSH terms: Down Syndrome; Microvascular Angina; Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of this study is to assess the frequency of metabolic syndrome in Down syndrome
      patients because the prevalence of diabetes mellitus and obesity is higher in individuals
      with Down syndrome than in the general population.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      Whole blood
    
Keywords: Down syndrome; Metabolic syndrome X; Insulin resistance
Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether the administration of propranolol is
      effective in the treatment of the retinopathy of the prematurity.
    

Detailed description: 
      Retinopathy of Prematurity (ROP) is still a major cause of blindness in children in developed
      countries around the world, and an increasing cause of blindness in developing countries. The
      ablation of the retina with photocoagulation by laser or cryotherapy reduces the incidence of
      blindness by suppressing the neovascular phase of ROP. However, the visual outcomes after
      treatment are often poor. The development of ROP depends largely from vascular endothelial
      growth factor (VEGF). The reduction of VEGF expression in the neovascular phase might prevent
      destructive neovascularization in ROP.

      The purpose of this study is to evaluate whether the administration of propranolol is safe
      and is able to reduce the incidence of blindness by suppressing the neovascular phase of ROP
      compared to a control group receiving conventional laser therapy.
    

Intervention name(s): Propranolol
Intervention type(s): Drug
Intervention description(s): Dosage of 0.5mg/Kg oral, every 6 hours. The study will be discontinued immediately in the presence of serious adverse effects attributable to the pharmacological actions of propranolol (severe hypotension, bradycardia or bronchospasm).
In case such events occur in any of the 3 groups of gestational age, the study could start again with half dose (0.25mg/Kg oral, every 6 hours) after notification to the Ethics Committee.
In case of surgery or induction of anesthesia during the administration of propranolol, the drug should be discontinued at least 24 hours before surgery.
In cases of severe hypotension or bradycardia may be administered one or more of the following drugs:
Atropine.
Isoproterenol hydrochloride (isoprenaline.
Terlipressin.
Glucagon In case of severe bronchospasm may be used salbutamol aerosol or salbutamol + ipratropium bromide. Betamethasone could be used for aerosol or systemic (intravenous or intramuscular).
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Newborn; Retinal Diseases; Angiogenesis Modulating Agents; Adrenergic beta-Antagonists
Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease
Condition: Type 2 Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with type 2 diabetes mellitus suffer from accelerated coronary artery disease. We
      will assess the effects of exercise training on coronary endothelial function, vascular
      structure, and inflammation both in serum and skeletal muscle biopsies, as well as expression
      of diabetes candidate genes.
    


Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): 4 weeks in-hospital exercise training (6x15 min bicycle/day, 5 days/week) followed by a 5 months ambulatory exercise program (30 min ergometer/day, 5 days/week, plus 1h group exercise/week)
Allocation: Randomized
Effect of Training on Brain Volume in Ataxia
Condition: Spinocerebellar Ataxias
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
Study type: Interventional

Summary: 
      The primary aim is to show balance training improves DCD individual's ability to compensate
      for their activity limitations, but does not impact disease progression.

      The second aim is to demonstrate aerobic exercise improves balance and gait in DCD persons by
      affecting brain processes and slowing cerebellar atrophy.
    

Detailed description: 
      Individuals with degenerative cerebellar disease (DCD) exhibit gradual loss of coordination
      resulting in impaired balance, gait deviations, and severe, progressive disability. With no
      available disease-modifying medications, balance training is the primary treatment option to
      improve motor skills and functional performance. There is no evidence, however, that balance
      training impacts DCD at the tissue level.

      Aerobic training, on the other hand, may modify DCD progression as evident from animal data.
      Compared to sedentary controls, aerobically trained DCD rats have enhanced lifespan, motor
      function, and cerebellar Purkinje cell survival. Numerous animal studies also document that
      aerobic training has a direct, favorable effect on the brain that includes production of
      neurotrophic hormones, enhancement of neuroplasticity mechanisms, and protection from
      neurotoxins.

      The effects of aerobic training in humans with DCD are relatively unknown, despite these
      encouraging animal data. A single study to date has evaluated the benefits of aerobic
      exercise on DCD in humans, and this was a secondary outcome of the study. Although
      participants performed limited aerobic training during the study, modest functional benefits
      were still detected.

      The main objective of this project will be to compare the benefits of aerobic versus balance
      training in DCD. We hypothesize that both aerobic and balance training will improve function
      in DCD subjects, but that the mechanisms in which these improvements occur differ. 1) Balance
      training improves DCD individual's ability to compensate for their activity limitations, but
      does not impact disease progression. 2) Aerobic exercise improves balance and gait in DCD
      persons by impacting the cerebellum
    

Intervention name(s): Aerobic training; Balance training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Aerobic training on stationary bike 5x a week for 30 minutes a day; Training 5x a week for 30 minutes. Standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blinded randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ataxia; Cerebellum; Cerebellar degeneration
Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer
Condition: Resectable Rectal Cancer Clinical Stage II and III
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II study aimed to evaluate the efficacy and toxicity of preoperative
      chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.
    

Detailed description: 
      Preoperative chemoradiation has become a standard part of treatment protocols in stage II and
      III rectal cancer. Compared to postoperative chemoradiotherapy, the advantage of preoperative
      application of chemotherapeutics and irradiation includes improved compliance, reduced
      toxicity and downstaging of the tumour in a substantial number of patients. The latter may
      enhance the rate of curative surgery, permit sphincter preservation in patients with
      low-sited tumours and have a positive impact on the quality of life of these patients. Orally
      administered capecitabine (Xeloda®, Hoffmann - La Roche Ltd, Basel, Switzerland) mimics the
      pharmacokinetics of continuous 5-FU infusion and makes chemoradiotherapy more
      patient-friendly. The mechanism of capecitabine activation, preferably in tumour cells, may
      further enhance its efficacy and tolerability, offering the potential for an enhanced
      therapeutic ratio.The aim of the present phase II study was to evaluate the efficacy and
      toxicity of preoperative chemoradiotherapy with capecitabine in patients with locally
      advanced rectal cancer. The primary endpoint of the study is a pathologically determined
      complete remission rate (pCR) of the disease locally and regionally. Secondly, the rate of
      sphincter preservation in low-sited tumours, overall downstaging rate,toxicity and survival
      parameters will be analysed.
    

Intervention name(s): Capecitabine
Intervention type(s): Drug
Intervention description(s): Chemotherapy with capecitabine of 1650 mg/m2 daily dose will be administered orally, divided into two equal doses given 12 hours apart, during radiotherapy(45 Gy 1,8 Gy/fr), including weekends
Other intervention name(s): Xeloda
Intervention MeSH terms: Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: capecitabine; chemoradiation; rectal cancer; phase II study
The Impact of Vaginal and IM Progestins on the Cervix
Condition: Preterm Birth; Short Cervical Length
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to analyze how the body handles and responds to progesterone
      treatment in parous and nulliparous women at risk of pre-term birth.
    

Detailed description: 
      17-hydroxyprogesterone caproate (17-OHPC) has recently been shown to reduce the rate of
      recurrent preterm birth while intravaginal progesterone has been shown to reduce the rate of
      preterm birth in women with short cervix. While these interventions have reduced the rate of
      preterm birth, the mechanisms of action of these medications are unknown. The objective of
      this study is to collect and analyze blood and cervicovaginal fluids from pregnant women
      receiving these medications or other interventions such as cerclage, pessary, NSAIDs, and
      combinations thereof. The goal of the analyses is to assess the impact of these interventions
      on the cervical proteome, cervical cytokines and cervical structure and to identify potential
      biomarkers of response and non-response thus providing insights into the mechanisms of action
      of these drugs.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study consists of 4 groups of women who are between 16 0/7 - 23 6/7 weeks gestation.
        The allocation of a subject to a group is based on two objective assessments (history of
        preterm birth and cervical length) and the joint clinical decision of the woman and her
        physician regarding treatment options.

        Study participants who have no prior preterm births and a normal cervical length will be
        assigned to Group 1. If the participant has no prior preterm births and a short cervical
        length, she will be assigned to Group 2 regardless of treatment or no treatment. Group
        assignment for women with a prior preterm birth and normal cervical length is based on
        17-OHPC use. Participants who elect to use 17-OHPC will be assigned to Group 3 and those
        who choose not to receive any treatment will be assigned to Group 4.
      
Biospecimen description: 
      Blood for DNA extraction, hormone, and metabolomic analyses

      Cervicovaginal fluid for proteome, cytokines, and matrix metalloproteins (MMPs)
    
Keywords: 17-OHPC, Prometrium, Cerclage, Pre-term birth, Short cervix
A Study to Determine Effective and Tolerable Titration Scheme for OROS-Methylphenidate in Children With Attention-deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate the clinical benefit of switching children with
      ADHD from immediate-release methylphenidate (IR-MPH) to OROS-methylphenidate under the
      correct dosage conversion scheme.
    

Detailed description: 
      This is a prospective, non-comparative study. Each patient will be treated for 10 weeks
      including 6-week titration phase and 4-week maintenance phase. After an initial baseline
      evaluation, patients currently receiving IR-Methylphenidate (IR-MPH) therapy will switch to
      receiving OROS-methylphenidate once daily. Patients receiving IR-MPH =15 mg per day will
      switch to receive 18 mg once daily OROS-methylphenidate. For patients on IR-MPH daily dosage
      >15 mg and =30 mg, the initial dose of OROS-methylphenidate will be 36 mg once daily. Other
      patients receiving IR-MPH higher than 30 mg per day, will switch to receive 54 mg once daily
      OROS-methylphenidate. During the 6-week titration phase, those patients who do not achieve
      the criteria of "Optimal Response" will be titrated by biweekly increase to next dose level
      (36 mg per day, and then 54 mg per day). The maximum dose of OROS-methylphenidate per day is
      54 mg as package insert indicates. However, dose decreases are allowed if clinically
      intolerable adverse events emerge. At the end of 6-week titration phase, the final titration
      dose should be maintained for the last 4 weeks of the trial regardless of the optimal
      response. In summary, all patients will attend bi-weekly clinic visits for the first 6 weeks
      (visit 2 to 4) and monthly clinic visits for the subsequent 4 weeks (visit 5). Patients will
      receive 18 mg or 36mg or 54 mg once daily OROS-methylphenidate for 10 weeks.
    

Intervention name(s): OROS-methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Methylphenidate; Attention Deficit Hyperactivity Disorder
Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms
Condition: Hematopoietic and Lymphoid System Neoplasm; Malignant Breast Neoplasm; Malignant Head and Neck Neoplasm; Malignant Solid Neoplasm; Malignant Thoracic Neoplasm
MeSH terms: Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Thoracic Neoplasms
Study type: Interventional

Summary: 
      This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy
      infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic,
      hematologic, and breast cancers. Virtual reality headsets provide the ability for users to
      explore a simulated, three-dimensional environment with which users can interact. In virtual
      reality users can play interactive games, enjoy relaxing experiences, and watch immersive
      videos. The use of VR goggles may help with anxiety management during chemotherapy infusion.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To evaluate the effectiveness of VR therapy in reducing severity of anxiety symptoms
      during chemotherapy infusion, compared to participants utilizing a smartphone as a control.

      SECONDARY OBJECTIVES:

      I. To evaluate whether there is a short-term effect of VR use in anxiety levels.

      II. To assess participant satisfaction with their chemotherapy infusion experience in the
      control and treatment groups.

      EXPLORATORY OBJECTIVE:

      I. To assess participants' reported adverse effects associated with VR headset use.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP 1: Patients use VR during chemotherapy infusion on study.

      GROUP 2: Patients use smartphone during chemotherapy infusion on study.
    

Intervention name(s): Questionnaire Administration; Telephone-Based Intervention; Virtual Technology Intervention
Intervention type(s): Other; Behavioral; Other
Intervention description(s): Ancillary studies; Use smartphone; Use VR headset
Other intervention name(s): Virtual Reality Intervention; Virtual Technology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Condition: Pneumococcal Vaccines
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of
      manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale
      13vPnC in healthy infants when given with routine pediatric vaccines.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine
Intervention type(s): Biological
Intervention description(s): 1 dose at 2,3,4 and 12 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention