bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort
Condition: Pneumococcal Conjugate Vaccine
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the "late" immune response to further doses of
      pneumococcal conjugate vaccine more than 10 years after primary immunization with Prevnar
      (7vPnC) in infancy, as compared with individuals who did not receive Prevnar in infancy (the
      Prevnar naive cohort which received MnCC). The study will take place at a single study
      center. Study participants must have participated previously in a specific Wyeth Prevnar
      study (Study D118-P8) and must still be enrolled in the Northern California Kaiser Permanente
      (NCKP) health plan.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): single injection, single dose, single site, 0.5 mL per dose.; single injection, single dose, single site, 0.5 mL per dose.
Other intervention name(s): 13vPnC; 13vPnC
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Single site; single dose; Participated in Wyeth D118-P8
OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine how prior therapy with alendronate or risedronate in postmenopausal women with
      osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of
      the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change
      from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP),
      between subjects previously treated with risedronate and those previously treated with
      alendronate.
    

Detailed description: 
      All subjects will be treated with teriparatide (human, recombinant PTH[1-34])(human,
      recombinant PTH[1-34]), 20 microgram subcutaneously daily for 12 months. Subjects will
      consist of 290 postmenopausal women previously treated with either risedronate or alendronate
      for at least 24 months. An approximately equal number of subjects will have been previously
      treated with risedronate and alendronate, and the subjects will be balanced with regard to
      duration of previous treatment.
    

Intervention name(s): risedronate sodium
Intervention type(s): Drug
Intervention MeSH terms: Risedronic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of GSP3 on Body Weight in Overweight and Obese Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      The FLOW (First Loss Of Weight) study is designed to assess the effects of repeated
      administration of GSP3, an investigational product, on body weight. It is a multicenter,
      randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. FLOW is being
      conducted in 5 medical centers in Italy, Czech Republic, and Denmark, and will randomize 123
      overweight and obese adult males and females to receive either placebo, GSP3 (2.25g), or GSP3
      (3.75g) in addition to a hypocaloric diet (-600 kcal/day) for 12 weeks.
    


Intervention name(s): GSP3; Avicel (modified Cellulose)
Intervention type(s): Device; Dietary Supplement
Intervention description(s): Each capsule of GSP3 (previously Attiva) contains 700 mg of a mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.; Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: weight loss; body composition; glycemic control; satiety
Nitroglycerin Skin Patches for Facilitating Cervical Ripening: A Randomized Controlled Trial
Condition: Induction of Labor Affected Fetus / Newborn
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to establish the efficacy of transdermal glyceryl trinitrate as a nitric
      oxide donor in addition to dinoprostone for induction of cervical ripening in the third
      trimester through progression in the Bishop's score during 24 hour period.
    

Detailed description: 
      Objectives: The primary outcome of the study is to compare the changes occurring to the
      cervix through the progression in the Bishop's score between NO donor (nitroglycerine patch)
      vs placebo; in combination with a well-established method of induction (Dinoprostone).

      The secondary objective of the study is to observe and report possible fetal and maternal
      side effects that may be associated. This will establish the safety and tolerability of NO
      donors.

      Research Question: Does the usage of Nitroglycerine skin patch enhance cervical ripening and
      facilitate induction of labor by Dinoprostone?

      Null hypothesis: Nitroglycerine skin patch does not cause advantage for ripening of the
      cervix nor facilitate the process of labor induction.

      Alternative hypothesis : Nitroglycerine skin patch has favorable effect in enhancing cervical
      ripening and the outcome of induction of labor.
    

Intervention name(s): Nitroderm TTS; Dinoprostone
Intervention type(s): Drug; Drug
Intervention description(s): Transdermal nitroglycerin 5mg skin patch; Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction
Other intervention name(s): Nitroglycerin transdermal patch; Prostaglandin E2 Analogue
Intervention MeSH terms: Nitroglycerin; Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy
Condition: Spastic Diplegia
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      This study will help to determine the beneficial effects of high frequency vibration on
      children with diplegic cerebral palsy in improving balance ,spasticity, strength of lower
      limb and quality of life and a comparison between the effect of simple conventional treatment
      and conventional management with the usage of vibrational therapy in cp patients.
    

Detailed description: 
      A study "Effect of whole body vibration training on mobility in children with cerebral palsy
      "states Whole body vibrational therapy induce an improvement in independent ambulation and
      mobility of lower limb by strengthening of muscles along with the refinement of walking
      pattern ,gait speed and stride length in children with cerebral palsy. On the basis of our
      study a better treatment protocol can be designed for future in diplegic spastic cerebral
      palsy children.
    

Intervention name(s): Whole Body Viberation
Intervention type(s): Other
Intervention description(s): WBV device (frequency of 40 Hz), 3 Minute vibration with 3 minute rest
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine Dosage of OPTISON in Pediatric Patients
Condition: Study to Determine Dosage of OPTISON in Children Between ≥9 and <18 Years of Age Weighing ≥20 kg
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to determine the safety and appropriate dosage of OPTISON in pediatric patients since
      OPTISON has been tested in adult patients only during the clinical development
    


Intervention name(s): Optison
Intervention type(s): Drug
Intervention description(s): Optison is administered intravenously
Other intervention name(s): Perflutren Microspheres Injectable Suspension, USP
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Contrast-enhanced echocardiography (CE-ECHO); Transthoracic echocardiogram; Child; Left ventricular opacification (LVO); Left ventricular ejection fraction (LVEF); Left ventricular endocardial border delineation (LV EBD)
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population
Condition: Asbestos Exposure
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-arm phase II trial to assess the biological activity (in a sub-cohort using
      a Simon two-stage Phase II design) and toxicity of Artichoke Whole Phytocomplex Concentrate
      (WPC). The objective of the study is to explore the potential for a non-toxic phytocomplex
      extract from the artichoke plant as a chemoprevention agent.
    

Detailed description: 
      In individuals exposed to asbestos and affected with asbestosis or asbestos-related benign
      pleural disease, and therefore at increased risk of mesothelioma, the investigators will
      evaluate whether the treatment with the commercially-available Artichoke Whole Phytocomplex
      Concentrate (Artichoke WPC) for 90 days will decrease mesothelin serum levels.

      Although the investigators have general information on toxicity in humans, the investigators
      will monitor and assess the potential toxicity of Artichoke WPC in this patient population.

      In addition to mesothelin, the investigators plan to evaluate the effects of Artichoke WPC on
      serum microRNAs (miRNAs). The use of miRNAs as minimally-invasive biomarkers has opened new
      opportunities for the diagnosis of cancer. A number of studies have addressed the potential
      association of disregulated miRNA profiling and benign asbestos-related disease and
      mesothelioma. Thus, the investigators will evaluate serum miRNA profiling before and after
      treatment with Artichoke WPC.
    

Intervention name(s): Artichoke WPC
Intervention type(s): Drug
Intervention description(s): Artichoke WPC 500 mg capsules. Dose = 1000 mg (2 - 500 mg capsules) just before breakfast and 1000 mg (2 - 500 mg capsules) before dinner. Duration: daily for a period of 90 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention; non-malignant asbestos-related disease; benign pleural disease; asbestosis
Assessing Inherited Markers of Metabolic Syndrome in the Young
Condition: Metabolic Syndrome; Diabetes Mellitus, Type 2; Obesity
MeSH terms: Metabolic Syndrome; Diabetes Mellitus, Type 2; Syndrome
Study type: Observational

Summary: 
      The AIMM Young study is a collaboration between Children's National Medical Center (CNMC) and
      colleges/universities nationwide--currently including Howard University (HU), East Carolina
      University (ECU), and University of Massachusetts, Amherst (U Mass). This study obtains a
      variety of baseline measures (such as serum biomarkers related to metabolic syndrome,
      anthropometrics, muscle strength, and fitness testing) along with genetic information from
      healthy college-age (18-35 years) young adults in efforts to identify phenotype-genotype
      associations that may predispose individuals to developing metabolic syndrome, type 2
      diabetes, and/or related diseases such as obesity.

      We hypothesized that certain genetic variations will be protective against metabolic
      syndrome, while others will show a strong correlation with specific components of metabolic
      syndrome disease. We expect that the study of "pre-symptomatic," young individuals will
      facilitate the identification of genetic risk loci for metabolic syndrome and type 2
      diabetes. Younger populations typically have less confounding variables, and this facilitates
      normalizing of metabolic syndrome features and environment/lifestyle. Additionally, young
      subjects can provide more robust longitudinal data, and be recruited into subsequent
      interventions to reverse the trend towards metabolic syndrome, rather than the more difficult
      task of reversing type 2 diabetes in older populations. The data collected will be stratified
      according to gender, age, ethnicity, genotype, and other phenotypic measures to determine how
      these factors influence disease risk.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The population from which cohorts will be selected include students, residents, staff,
        and/or faculty who are present on Howard University, East Carolina University, and/or
        University of Massachusetts, Amherst campuses and surrounding areas.
      
Biospecimen description: 
      Blood samples are obtained for DNA extraction and measuring various biomarkers (including
      fasting glucose, insulin, lipid profile, and hemoglobin A1c)
    
Keywords: Metabolic Syndrome; Obesity; Genetic risk markers; Single Nucleotide Polymorphisms; Young adults; Fitness testing
Relationship of Trunk Control and Endurance With Balance and Functional Mobility in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      It is predicted by studies that the motor and cognitive performance disorders seen in
      children with Cerebral Palsy (CP) may lead to loss of balance, postural control and mobility.
      At the same time, trunk muscle fatigue seen in children with CP is a critical motor problem
      and may cause deficits in adjusting the proper connection between the trunk and pelvis
      stabilizers.These deficits can lead to impairments in balance, postural control and mobility.
      Considering the relationship between the deficits seen in children with CP and postural
      control and postural control with the trunk, the idea that there is a need for studies that
      evaluate the trunk in every way and reveal its relationship with balance, postural control
      and mobility in order to organize the rehabilitation program effectively in children with CP.
      Therefore, in the planning of our study, it was aimed to evaluate trunk control and endurance
      in children with CP and to examine their relationship with balance and functional mobility
      parameters, as well as to reveal their relationship with functional health and quality of
      life.
    


Intervention name(s): Evaluations
Intervention type(s): Other
Intervention description(s): Within the scope of the study, the participants will be evaluated for 30 minutes in a single session. The participants' trunk stabilization and endurance, balance, functional mobility, upper extremity endurance, functional health and quality of life will be questioned by questionnaires, scales and tests. Evaluation will begin with a literature-supported demographic data form prepared for the participants.
Assessments to be made are listed below. Trunk Control Measurement Scale (TCMS) Pediatric Balance Scale (PBS) Time Up and Go test (TUG) Trunk Flexor Test (TFT) The Pediatric Outcomes Data Collection Instrument (PODCI)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Being diagnosed with Cerebral Palsy. Being at level 1 and 2 according to Gross Motor
        Function Classification System (GMFCS) (Level 1-2). Be between the ages of 6-18.
      
Keywords: Cerebral Palsy; Trunk Control; Mobility; Balance; Functional Health; Endurance
Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1; Diabetic Cardiomyopathies; Autonomic Neuropathy, Diabetic
MeSH terms: Diabetic Neuropathies; Cardiomyopathies; Diabetic Cardiomyopathies; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Type 1 diabetes mellitus is a chronic autoimmune disease, associated with an increased risk
      of cardiovascular diseases. The development of cardiomyopathy in type 1 diabetes, independent
      of hypertension and coronary heart disease, is still controversial. A possible mechanism for
      diabetic cardiomyopathy is autonomic dysfunction. This study aims to evaluate cardiac
      function and structure, and to relate them with autonomic dysfunction in type 1 diabetes.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Selection of patients from a tertiary hospital.
Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.
Condition: Sedation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Oral trans-mucosal administration is relatively easy and convenient, it also reduces first
      pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam
      premedication.
    

Detailed description: 
      The alpha2-adrenoceptor agonist, dexmedetomidine, was originally developed as a sedative and
      analgesic drug for use in intensive care. However, it has a number of unique pharmacodynamic
      properties, which also make it useful in anesthesia including; decreased MAC, analgesia
      without respiratory depression and a significant reduction in catecholamine secretion. Also
      it has been used off-label as an adjunctive agent for sedation and analgesia in patients in
      the critical care unit and for sedation during non-invasive procedures in radiology. It also
      has a potential role as part of anesthesia care to prevent emergence delirium and
      post-anesthesia shivering.

      Oral trans-mucosal administration is relatively easy and convenient, it also reduces first
      pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam
      premedication.

      The current literature is focused in studying the sedative and analgesic effects of
      intravenously administered dexmedetomidine. Pharmacodynamics and pharmacokinetic studies
      undertaken on alternative routes of dexmedetomidine administration are lacking. The
      pharmacokinetic properties of trans-mucosal administration of dexmedetomidine have been
      demonstrated in one study only, and the clinical effects of non-parenteral administration of
      dexmedetomidine have been described in anecdotal case reports.
    

Intervention name(s): OTM Dexmedetomidine 1µg/ kg.; OTM Dexmedetomidine 0.75µg/ kg.; OTM Dexmedetomidine 0.5µg/ kg.
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.; Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.; Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
Other intervention name(s): Precedex; Precedx; Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pharmacokinetic and pharmacodynamic study of three different doses of oral transmucosal dexmedetomidine
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase I, single centre, open-label, non-randomised study and was designed to be
      conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499
      that would provide an optimal dosing regimen in patients. The purpose of Part 2 of the study
      was to generate repeat dose information for the selected MR formulation of PCS499 in order to
      provide additional PK information for future patient studies.
    


Intervention name(s): PCS499; Trental
Intervention type(s): Drug; Drug
Intervention description(s): MR tablet; comparator tablet
Intervention MeSH terms: Pentoxifylline
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Reducing Asthma Disparities by Improving Provider-Patient Communication
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study will be to assess the impact of a culturally-sensitive,
      patient-focused asthma communication instrument (ACCI) designed to enhance provider-patient
      communication by prompting and guiding providers in assessments of disease severity and
      discussion of adherence behaviors with minority patients with asthma.
    

Detailed description: 
      Improving communication between health care providers and their patients is the critical
      first step in efforts designed to reduce asthma-related health disparities in urban areas.
      Improving communication will help providers tailor asthma therapies to their patients' needs,
      and help providers and patients to overcome barriers (e.g., concerns about adverse effects)
      to adherence with those asthma treatment plans.
    

Intervention name(s): Asthma Control and Communication Instrument
Intervention type(s): Device
Keywords: Asthma
Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds
Condition: Diabetic Foot Ulcer; Wound
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries
Study type: Interventional

Summary: 
      Exercise studies with patients with diabetic foot ulcers are very few. In this disease group,
      since it is considered dangerous to put a load on the foot, a barrier has been placed between
      the patients and the exercise. With the study investigators plan to do, investigators will
      try to exercise in these patients in a controlled manner. Among the patients divided into 3
      groups, the 1st group will apply the control group, the 2nd group will perform aerobic
      exercise, and the 3rd group will apply the exercises investigators have determined as the
      protocol group. 12 weeks, 2 sessions a week will be exercised with the help of a
      physiotherapist. Patients will be evaluated at baseline, at the end of week 4, at the end of
      week 8, and at the end.
    


Intervention name(s): standard treatment; aerobic exercise; exercise protocol
Intervention type(s): Other; Other; Other
Intervention description(s): The control group will be provided with the necessary approaches for diabetic foot ulcer care and diaphragmatic breathing exercises.; The aerobic exercise group will be provided with the necessary approaches for diabetic foot ulcer care and in addition to diaphragmatic breathing exercises, they will be provided with aerobic exercise twice a week with a physiotherapist.; The protocol exercise group will be provided with the necessary approaches for diabetic foot ulcer care and exercises suitable for the physical condition of the wound and the patient, in addition to diaphragmatic breathing exercises. This group will also work with a physiotherapist twice a week.
Other intervention name(s): control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups to be applied two different exercises progressing together with the control group
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diabetes mellitus, exercise, ulcer