bioihbjkbjnl/mcl2 huggingface dataset:
Gardner Packard Healthy Lifestyles Program
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Gardner GOALS is a 6 month program for treatment of childhood obesity that consists of twice
      monthly telehealth meetings with a health educator. Potential participants enter the study
      using a randomly ordered list of eligible patients based on BMI, age and number of clinic
      visits in 2020.
    

Detailed description: 
      The Gardner GOALS curriculum focuses on healthy eating and activity. The study participants
      are kids 6 to 14 years old with BMI ≥95th percentile who are patients at the Gardner Packard
      Children's Health Center, a federally qualified health center. Lessons contain educational
      materials and behavioral change strategies to promote healthy eating and physical activity
      and reduce screen time. Patients are encouraged to continue routine clinic visits with their
      primary care physicians during the course of the study.
    

Intervention name(s): Gardner GOALS
Intervention type(s): Behavioral
Intervention description(s): 12 lesson curriculum focusing on healthy eating, increased physical activity and decreased screen time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combined Focused Ultrasound and Calcium Hydroxylapatitie Filler for Skin Laxity and Volume Restoration
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional
Phase: Phase 1

Summary: 
      Non-invasive treatment options such as focused ultrasound has been used with success for the
      treatment of skin laxity in various parts of the body including the face, neck, décolletage,
      arms, buttocks, thighs, and legs. With the increasing demand for greater results, researchers
      have started combining modalities together such as focused ultrasound and intradermal filler,
      with promising effects for skin laxity and volume restoration. This study aims to elucidate
      the efficacy and added benefits of a combination therapy using focused ultrasound (Ulthera)
      and calcium hydroxylapatite (Radiesse) for the treatment of skin laxity and volume
      restoration of the lower thighs, specifically the lower anterior third of the thigh.
    


Intervention name(s): calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)
Intervention type(s): Combination Product
Intervention description(s): Patients will receive IFUS to a randomly chosen side. Immediately after IFUS treatment, patients will receive the first CaHA injection. Injections will be given in the lower, anterior third of the thigh, above the knee. Only dermatology faculty will perform the filler injections. The patients will be instructed to return to the office in 6 weeks, 12 weeks, and 24 weeks (+/- 5 business days) for their next appointment for follow-up and injection of CaHA if deemed necessary by the investigator. At all visits (Visits 1-4) patients will have photographs and unblinded physician/patient questionnaires will be completed. At Visit 4 (24 weeks +/- 5 business days), patients will be given the option to receive treatment for skin laxity to the previously untreated side. If the patient chooses to receive treatment, patients will receive their second IFUS and CaHA combination treatment at this time. They will not receive further treatment after this visit.
Other intervention name(s): intense microfocused ultrasound
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development of a Youth Healthy Living Program With Underserved Adolescents at Rochester Alternative Learning Center
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Approximately one third of the children and adolescents in the United States are either
      overweight or obese. Childhood obesity disproportionately affects specific racial and ethnic
      groups and households with low socioeconomic status and low parental education. The
      Alternative Learning Center (ALC) within Rochester School District 535 provides viable
      educational options for students who are experiencing difficulty in regular educational
      systems. A greater proportion of students at ALC are minorities, qualify for free and reduced
      lunch and receive special education services. These children are likely to have unique
      barriers to physical activity and healthy eating.

      Specific Aims:

      Aim 1: Examine the association between BMI and ethnic/ socioeconomic variables and behaviors
      related to physical activity and eating in ALC students.

      Aim 2: Develop an age and culturally appropriate on-site program that promotes healthy
      lifestyle.
    

Detailed description: 
      Investigators will assess the relationship between BMI and ethnicity, socioeconomic variables
      and behaviors related to nutrition and physical activity among 200 ALC students.
      Investigators will also conduct 6 gender stratified (3 boys, 3 girls) focus groups with
      students (n=24), up to 3 focus groups with their parents (n=24) and one focus group with
      staff and volunteers in order to understand perceived barriers towards healthy
      weight/nutrition/physical activity. Investigators will then utilize this information to
      co-develop a healthy living program at ALC. Investigators will finally test the feasibility
      of the program they develop over a period of 3 months in ALC students. Study findings will
      inform further research to test the efficacy and validity of the program developed at ALC in
      a subsequent school based trial with the future goal of obtaining funding for cluster
      randomized controlled trials among other schools in the region.
    

Intervention name(s): Healthy Youth Living Program
Intervention type(s): Behavioral
Intervention description(s): Physical activity and healthy eating program at the Alternative Learning Center co-developed by students, school staff and academic partners.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity prevention; CBPR; high risk youth; school health
Insole Sensor to Determine Optimal Limb Loading
Condition: Lower Extremity Fractures
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      The purpose of this study is to use a novel load monitoring technology to correlate limb
      loading to OTA type 42IIIB and IIIC tibial fracture outcomes. This study will be the first to
      collect continuous limb loading data and will provide the first objective insight into how
      limb loading directs fracture healing. To meet this purpose, two specific aims have been
      developed.

      Specific Aim 1: Preclinical validation of a load-monitoring insole

      The Hitchcock laboratory has overcome the greatest technical hurdle for continuous limb load
      monitoring: development of load sensor technology that is affordable, accurate and capable of
      monitoring for over four weeks. To develop this sensor technology into a load-monitoring
      insole, the Hitchcock lab will incorporate consumer type electronics into the design,
      including a microprocessor, battery, and data storage media.

      Following construction of a functional load-monitoring insole, a pilot human study with
      orthopaedic trauma patients from the University of Utah (N=20) will be conducted to identify
      modes of device failure, improve device interfacing and develop data handling protocols and
      software for the clinical arm of the proposed study.

      Specific Aim 2: Conduct a prospective, direct observational cohort study.

      Thirty (30) open tibial fracture patients will be recruited at two centers: University of
      Utah (N=15) and William Beaumont Army Medical Center (N=15). Participants will wear a walking
      boot instrumented with the load-monitoring insole that will continuously record limb loading
      and serve as a step counter. X-rays collected at standard-of-care follow-up visits will be
      used by Drs. Kubiak and Orr to subjectively evaluate fracture healing. A questionnaire
      regarding subjective perception of patient compliance will be collected at the first and last
      follow-up visits. Data collected from the insole sensor will be correlated to objective
      measures of fracture healing and subjective measures of patient compliance to determine the
      effect of patient limb loading on injury outcome. The Hitchcock laboratory will develop
      software to process and summarize data from the load monitoring insole and continually
      improve human interfacing factors of the load monitoring insole based off of feedback from
      the clinical team and study participants.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who present to the University of Utah with an Open Tibial Fractures.
      
Keywords: Insole Sensor; Optimial Limb Loading; 42IIIB; IIIC; Lower Extremity Fractures
Improving Contraceptive Counseling in the United States
Condition: New Behavioral Protocol; Treatment as Usual
Study type: Interventional

Summary: 
      This project develops a contraceptive counseling protocol (CCP) grounded in scientific
      evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended
      pregnancy among women. The project develops and refines the CCP using focus groups and
      in-depth interviews with (a) key administrators in the national office of Planned Parenthood
      (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and
      (d) clients of the health centers. The CCP uses scientifically grounded principles for
      guiding effective decision making and provider-client communication. Ten Title X clinics are
      randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual
      (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study
      participation in each clinic, yielding about 1,400 participants (half control and half CCP).
      Immediately following their counseling session, women complete a computer-administered
      interview that serves as a fidelity check and permits evaluation of the effects of the CCP on
      variables associated with counseling satisfaction. All women are re-interviewed by phone 6
      months later and 12 months later. The effect of the CCP on method-choice effectiveness,
      method switching, gaps in protection, and use accuracy are evaluated.
    


Intervention name(s): Evidence informed birth control counseling
Intervention type(s): Behavioral
Intervention description(s): Counselors underwent training on the use of 10 best practices for contraceptive counseling.
Other intervention name(s): Improving contraceptive counseling in the United States
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Contraception; Reproductive and Sexual Health; Counseling; Contraceptive Counseling
Zonisamide vs. Placebo in the Treatment of Alcohol Dependence
Condition: Alcoholism; Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study designed to examine the potential efficacy and tolerability of
      zonisamide compared to placebo for the treatment of alcohol dependence.
    

Detailed description: 
      Zonisamide is an antiepileptic medication which has similar clinical and pharmacologic
      effects to topiramate, a medication that has demonstrated efficacy in a randomized clinical
      trial for treatment of alcoholism. Because zonisamide is potentially better tolerated and
      easier to titrate in the outpatient setting than topiramate, it may offer important clinical
      advantages in the treatment of alcoholism.

      This is a small 12-week placebo-controlled pilot study examining tolerability and potential
      efficacy in anticipation of a larger, placebo-controlled trial of zonisamide for treatment of
      alcohol dependence. It is a randomized, double-blind trial of zonisamide vs. placebo at
      flexible dosages of 100-500mg/day in alcoholics receiving ambulatory psychosocial treatment.
      Participants will take part in six individual Cognitive-Behavioral based therapy sessions,
      which are focused on learning coping skills. Participants must endorse a goal of either
      cutting down their drinking to non-hazardous levels, or abstinence.
    

Intervention name(s): zonisamide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): flexible dosages of 100-500mg/day; Placebo
Other intervention name(s): Zonegran
Intervention MeSH terms: Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Zonisamide; Pharmacotherapy; Alcohol dependence; anticonvulsant
A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease
Condition: COPD
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by
      pressurized metered dose inhaler (pMDI), in patients with moderate to severe chronic
      obstructive pulmonary disease (COPD).
    

Detailed description: 
      The study will consist of two parts. Part A is a parallel group, placebo-controlled single
      dose study to ascertain the Pharmacokinetics (PK) profile, safety and bronchodilator effect
      of a single dose of RPL554 administered via pMDI. Five of the 6 treatment arms will be
      double-blind and one will be single-blind (due to the different number of capsules
      administered). Part B is a 7-day placebo-controlled, complete block cross-over, repeat dose
      study to assess the bronchodilator effect of repeat doses of RPL554 delivered via pMDI.
    

Intervention name(s): Part A: RPL554; Placebos; Part B: RPL554
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose RPL554 via metered dose inhaler.; Part A: Single dose placebo via metered dose inhaler. Part B: Repeat doses of placebo via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.; Part B: Repeat doses via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.
Other intervention name(s): Part A; Part B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; Adults; Phase II; RPL554; Ensifentrine
A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn about how food affects selpercatinib in healthy
      participants. The selpercatinib will be administered in fed and fasted states. Participation
      could last about 7 weeks.
    


Intervention name(s): Selpercatinib
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): LY3527723; LOXO-292
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Selpercatinib; Food; Pharmacokinetics
Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed
      combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison
      to the single agents (and placebo for the single dose phase only) Approximately 600 male and
      female patients presenting moderate to severe pain after an elective primary hip arthroplasty
      are eligible to be randomised provided that they experience moderate to severe pain on the
      day after surgery.
    

Detailed description: 
      In this clinical trial patients were randomized to the described 6 treatment arms, where each
      arm define the treatment to be received in the first single dose phase (lasting 8 hours after
      the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second
      treatment intake up to the 8 hours after the last intake). Namely:

        -  DKP/TRAM followed by DKP/TRAM;

        -  DKP followed by DKP;

        -  TRAM followed by TRAM;

        -  placebo followed by DKP;

        -  placebo followed by TRAM;

        -  placebo followed by DKP/TRAM;

      The analyses of endpoints pertinent to the single dose phase were performed combining all the
      3 treatment arms including placebo into one group, which resulted in the following 4 analysis
      groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.

      The analysis of endpoints pertinent to the multiple dose phase were performed combining the
      treatment arms including the same active treatment, which resulted in the following 3
      analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
    

Intervention name(s): Placebo; Tramadol-single dose; Dexketoprofen-single dose; Dexketoprofen/Tramadol-single dose; Tramadol-multiple doses; Dexketoprofen-multiple doses; Dexketoprofen/Tramadol-multiple doses
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo single oral dose (first 8 hours); Tramadol single oral dose (first 8 hours); Dexketoprofen single oral dose (first 8 hours); Dexketoprofen/Tramadol oral single dose (first 8 hours); Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses); Dexketoprofen multiple oral doses t.i.d. for 5 days (total 12 doses); Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)
Intervention MeSH terms: Dexketoprofen trometamol; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Moderate to severe acute pain; Postoperative pain; Hip arthroplasty; Analgesics; Dexketoprofen; Tramadol
Manual Therapy Techniques on Cervical Spine and Psychological Interaction
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Manual therapy (MT) techniques applied over cervical region have over both local (neck) and
      distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological
      mechanisms are hypothesized to explain the underlying effects, with effects originating from
      peripheral mechanisms, spinal cord and supraspinal mechanisms.

      There is also an increasing interest in the study of the role of psychological variables in
      the treatment success in neck pain. Psychological variables, like anxiety catastrophizing or
      kinesiophobia are related to poor prognosis in the development of pain outcomes and
      disability in neck pain, being the Fear-Avoidance Model of pain one of the most tested models
      in this field.
    


Intervention name(s): Cervical manipulation; Cervical lateral glide; Cervical mobilisation
Intervention type(s): Other; Other; Other
Intervention description(s): The therapist cradled the subject´s head with the other hand. Gentle ipsilateral side flexion and contralateral rotation to the targeted side were introduced until slight tension was perceived in the tissues at the contact point. The High velocity, low amplitude (HVLA) manipulation was directed upward and medially in the direction of the subject´s contralateral eye. The therapist monitored for cavitation or 'popping sound' accompanying the manipulations. If an audible popping sound was not heard during the first manipulative attempt, the procedure was repeated in the second time.; The upper limb of the right side of subjects was maintained in rest, with the arm along the trunk and the hand over the abdominal wall. The right hand of the treating therapist was positioned over scapula region, to depress the scapula while left hand cradled the occiput and neck above C5-C6 and left hand produced a passive lateral movement of the occipital and neck region.; The patients received a passive cervical mobilization that involved a grade III oscillatory unilateral posteroanterior mobilization to the right articular pillar of C5/C6 segment as described Maitland at a frequency of 2Hz. All the subjects were positioned in prone position as the protocol described by Sterling et al. for 3 sets of 2 minutes with 1 minute rest between sets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck pain; Manual therapy; psychological interaction
Impact of Maternal Iron Status on Neonatal Iron Status and Auditory Brainstem Response in the Newborn
Condition: Anemia
MeSH terms: Anemia
Study type: Observational

Summary: 
      This study aims to determine how maternal Fe status influences placental and neonatal Fe
      status in pregnant adolescents and to assess the impact of the Fe endowment of birth on
      functional outcomes as assessed by auditory brainstem responses within 48 h of delivery in
      neonates born to these adolescents.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant adolescents in Rochester, NY.
      
Biospecimen description: 
      At delivery a 15 mL maternal blood sample, 20 ml cord blood sample and the placenta are
      collected.
    
Keywords: iron; pregnancy; adolescents; auditory brainstem responses; anemia; neonate