bioihbjkbjnl/mcl2 huggingface dataset:
Medial Tab Flap for Soft Tissue Defects of the Leg
Condition: Leg Coverage Defects
Study type: Observational

Summary: 
      Selecting the right technique for lower limb soft tissue reconstruction is a therapeutic
      challenge. Despite having several reconstruction options, it's important to choose a
      technique that is effective and with the least possible donor site morbidity for the patient.

      Objective: demonstrate the therapeutic efficacy of the medial tab flap in soft tissue
      reconstruction on the leg, compared to conventional flaps.

      Materials and methods: Cohort study matched with Propensity Score Matching (PSM) by age. 64
      patients with soft tissue defects were selected and followed up to one year postoperatively.
      Outcome variables: surgical time in minutes, healing, healing time in days, complications.
    


Intervention name(s): Medial tab-type fasciocutaneous flap
Intervention type(s): Procedure
Intervention description(s): The flap can be taken in different ways depending on the defect. Once the base of the flap is identified, the posterior edge of the tibia is taken as reference; marking of the tab is performed considering that the posterior incision is located 5 cm from the posterior edge of the tibia, and the anterior incision is located longitudinally of the medial region of the tibial diaphysis, the length of the incision depends on the base of the flap and the defect's size.
The posterior incision is made first in the skin, subcutaneous cellular tissue until the fascia is identified; the subfascial flap is dissected to avoid injuring perforators, dissection is completed up to the anterior edge of the flap, if needed direct cutaneous perforators are ligated; once the subfascial plane has been identified and dissected, the tab is completed in its proximal or distal part according to the previous surgical planning. Later, the tab is rotated to the anterior region of the tibia to cover the defect.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A total of 216 patients with soft tissue defects on the anterior aspect of the leg
        underwent surgery during the study period, of these 18 patients were treated with medial
        tab-type fasciocutaneous flaps, this group constituted the intervention group. 198
        underwent surgery with conventional flaps, of which 46 patients were randomly chosen,
        through Propensity Score Matching (PSM) the matching was performed with the age variable.
        The types of flaps considered were: 15 cases with sural flap, 18 with soleus flap, and 13
        with a gastrocnemius flap
      
Keywords: Lower extremity reconstruction; leg coverage defects; fasciocutaneous flaps; muscular flaps; orthoplastic
Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia
Condition: Spasticity
MeSH terms: Muscle Hypertonia
Study type: Interventional

Summary: 
      The main purpose of this study is to compare treatment efficacy of focused and radial
      extracorporeal shock waves on spasticity in chronic stroke patient
    

Detailed description: 
      This study is a prospective and double-blinded randomized control trial. Thirty-two stroke
      patients with spastic equinus were randomly assigned to receive three sessions of either
      focused shockwave therapy or radial shockwave therapy at 1-week intervals. The intensities
      that were used during FSWT (0.1 mJ/mm2) and RSWT (2 bar) were comparable. Patients were
      evaluated at baseline and at 1, 4, 8 weeks after the final shockwave treatment. The primary
      outcome measure was modified Ashworth scale (MAS) score. Secondary outcome measures were
      Tardieu scale, ankle passive range of motion, plantar contact area during gait, and gait
      speed. A linear mixed model with repeated measures was used to compare each outcome measure
      between the two groups.
    

Intervention name(s): Focused shock wave; Radial shock wave
Intervention type(s): Device; Device
Intervention description(s): The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.; The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hypoglycemia Associated Autonomic Failure in Type 1 DM
Condition: Type 1 Diabetes
MeSH terms: Pure Autonomic Failure; Hypoglycemia
Study type: Interventional

Summary: 
      It is unclear what effect selective serotonin reuptake inhibitors (SSRIs) have on
      hypoglycemia. Thus, the American Hospital Formulary Service recommends careful monitoring of
      blood glucose levels in all patients with diabetes initiating or discontinuing SSRIs (Katz et
      al., 1996). Because of the increased prevalence of depression in those with diabetes, it is
      critical to discover what affect the antidepressant therapy may have on counterregulatory
      responses to hypoglycemia. This study hypothesizes that chronic administration of SSRIs may
      result in a blunted counterregulatory response to hypoglycemia, thereby leaving individuals
      more susceptible to hypoglycemia.
    

Detailed description: 
      Because selective serotonin reuptake inhibitors are commonly prescribed to treat depression,
      it is vital to understand how these antidepressants affect hypoglycemia- the most feared
      complication in diabetes. This study's aim is to determine whether individuals who are
      chronically taking selective serotonin reuptake inhibitors have a reduced ability to defend
      against hypoglycemia compared to individuals not taking the medication, thus leaving them
      more susceptible to hypoglycemia. Both healthy volunteers and volunteers with type 1 diabetes
      mellitus will be studied. The results could potentially be important to diabetic patients, by
      demonstrating to physicians how to modify therapy for those taking antidepressants in order
      to avoid hypoglycemia.

      The known effects of SSRI on the hypothalamo pituitary axis(HPA)may be important to the
      counterregulation of hypoglycemia. Prior research has demonstrated in healthy volunteers that
      antecedent increases in plasma cortisol result in significant blunting of neuroendocrine and
      autonomic responses to subsequent hypoglycemia. Thus, by activating the HPA axis, SSRIs could
      cause blunting of the counterregulatory response to hypoglycemia.
    

Intervention name(s): Fluoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg fluoxetine orally one per day for 1 week, 40 mg fluoxetine orally once per day for one week, 80 mg Fluoxetine orally for remaining 4 weeks of treatment; 20 mg placebo pill taken orally once per day for one week, 40 mg placebo pill taken orally one per day for one week, 80 mg placebo pill taken orally once per day for remaining 4 weeks.
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Characterization of Bovine Adrenal Medulla as a Model of Non-histaminergic Itch
Condition: Itch
Study type: Interventional

Summary: 
      With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic
      itch induced by BAM8-22
    

Detailed description: 
      With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic
      itch induced by BAM8-22 2 (Bovine Adrenal Medulla), which is found naturally in the human
      body and which has proved to evoke itch. To evaluate the role of TRPA1 it will be used a
      TRPA1 agonist
    

Intervention name(s): CA and BAM8-22; Vehicle and BAM8-22 application; CA; vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CA (tran-cinnamaldheyde) solution (in ethanol 5%) application and BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules; Vehicle (ethanol) application and BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules; CA (tran-cinnamaldheyde) solution (in ethanol 5%) application to a previously determined area on the volar forearm; Vehicle (ethanol) application and inactivate cowhage spicules will be applied to a previously determined area on the volar forearm
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Casinomacropeptide and Satiety
Condition: Lack of Satiety; Excess Intake of Macronutrients; Appetite Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Assessing 5 different milk derived proteins versus placebo for appetite regulation and
      satiety, delivered via shake vehicle.
    

Detailed description: 
      Assessing 5 different milk derived proteins versus placebo for appetite regulation and
      satiety, delivered via shake vehicle. Subjects will attend a 5 hour post-prandial study day.
      Subjects will keep food records 1 and 3 days prior to study visit, day of visit, and day
      after visit; food to be weighed using study provided dietary scale.
    

Intervention name(s): Whey; Whey-CMP; Control; CMP; MPI; CPI
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Preload containing complete whey protein.; Preload containing complete whey protein which is missing the CMP/GMP portion of the protein.; Preload control matched for energy to the other 5 preloads.; Preload containing the CMP (casinomacropeptide) portion cleaved from complete whey protein.; Preload containing whole milk protein.; Preload containing sodium caseinate.
Other intervention name(s): Whey.; casinomacropeptide; Whole milk protein; Casein
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Satiety; Food intake regulation; Appetite regulation; Dairy Protein
High Intensity Interval Training in UK Cardiac Rehabilitation Programmes
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Interventional

Summary: 
      The purpose of the trial is to compare the effects of high intensity interval training (HIIT)
      with usual care - moderate intensity steady state training (MISS) - in UK cardiac
      rehabilitation (CR) programmes.
    

Detailed description: 
      Current cardiac rehabilitation (CR) guidelines recommend moderate intensity, steady state
      exercise training (MISS). However, this guideline predates significant advances in
      interventional and medical treatment for coronary heart disease (CHD) and may not, therefore,
      be the most effective strategy for the 'modern' patient with CHD. Recent research has
      indicated that greater benefit may be attained by participating in high intensity interval
      training (HIIT) which involves repeated short bursts of harder exercise interspersed with
      short recovery periods. Studies suggest that this can be performed without any compromise in
      exercise adherence or patient safety. The benefit of this approach in 'real world' CR
      programmes in the UK cannot be confirmed, as studies have been predominantly conducted in the
      laboratory and exclusively outside the UK.

      In patients attending CR programmes in the UK, the investigators hypothesise that HIIT will
      improve VO2 peak to a greater extent than MISS. The investigators also hypothesise that HIIT
      will: 1) be more palatable than MISS and demonstrate greater patient compliance and
      adherence; 2) improve cardiovascular health to a greater extent than MISS; 3) improve HR-QoL
      to a greater extent than MISS; 4) lead to more positive motivation and attitudes to exercise
      than MISS; 5) increase short and medium-term participation in lifestyle physical activity to
      a greater extent than MISS; 6) be a cost effective alternative to MISS; 7) be as safe as
      MISS.

      The HIIT or MISS study is a pragmatic single-blind, multi-centre, longitudinal, randomised
      controlled trial. Participants will be randomly allocated to 8 weeks of HIIT or MISS (usual
      care). Outcomes will be assessed at baseline, 8 weeks and 12 months by assessors blinded to
      group allocation. Study interventions will be delivered by clinical (not research) staff.
    

Intervention name(s): High intensity interval training
Intervention type(s): Other
Intervention description(s): High intensity interval training within a standard cardiac rehabilitation programme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High intensity interval training; Coronary heart disease; Exercise training; Cardiac rehabilitation; Interval training
Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes
Condition: type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A brief, nurse-led educational intervention using motivational interviewing substantially
      improved general and disease-specific self-management skills in youth with type 1 diabetes.
    

Detailed description: 
      Introduction and Objectives: For youth with chronic health conditions, adolescence is
      associated with a deterioration of disease self-management and poor health outcomes.
      Effective interventions are needed to prepare youth for transition to adulthood and adult
      care. To prospectively assess the impact of an education program based on motivational
      interviewing on self-management skills and glycemic control in youth with Type 1 diabetes
      (T1D).

      Methods: After parental consent and youth assent, investigators prospectively randomized 66
      adolescents 13-18 years old with type 1 diabetes to either usual care (regular medical
      consultation) or usual care supplemented by sessions with a nurse educator using a
      motivational interviewing (MI) approach and goal setting based on responses to the Transition
      Readiness Assessment Questionnaire (TRAQ) and T1D specific self-management skills. Primary
      outcomes were TRAQ change scores and HbA1c levels between baseline and 6 months.
    

Intervention name(s): Motivational interviewing
Intervention type(s): Other
Intervention description(s): a health education program based on motivational interviewing provided by a nurse
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 78 were screened and 66 youth were randomized to 2 groups of 33 each and followed for 6 months with data collection at time zero, 3 months and 6 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: adolescent; transition to adult care; type 1 diabetes
Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the safety and efficacy of Perrigo's product to an FDA approved product for the
      treatment of Acne Vulgaris
    


Intervention name(s): Adapalene and Benzoyl Peroxide Topical Gel; Epiduo Topical Product; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Test product; RLD product; Placebo gel
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of a Neuromuscular Training Ankle Preventive Program in Soccer Player
Condition: Prevention and Control
Study type: Interventional

Summary: 
      Objetive:To determine the effects of a functional ankle instability prevention neuromuscular
      training (PENMT) program compared to the conventional FIFA 11+ program on the occurrence of
      ankle sprains, flexibility, balance and muscle activation in 17-year-old male youth soccer
      players to 20 years.

      Subjects and Methods: An experimental investigation, controlled, randomized and single-blind
      clinical trial was carried out in 40 subjects randomized to start the control or experimental
      group (soccer Players). The trial compared the effects of a differential intervention with a
      protocol focused on an ankle neuromuscular training program vs the usual FIFA 11+ program, in
      order to strengthen functional ankle stability in youth soccer in male players. In each
      subject, 2 measurements were taken: Pre-intervention and Post-intervention. For each
      measurement, a hypothesis test was performed.

      Results: The FIFA11+ is expressed as an injury risk factor when buying it with the PENMT
      after their participation.

      Conclusion:The neuromuscular training program for the ankle or PENMT applied in the
      experimental group did not generate a negative effect with respect to the FIFA 11+ program,
      in addition to the time of departure in the post test, the PENMT program is expressed as a
      protection factor of player injuries when contrasted with the FIFA 11+ program, that is, it
      presents effectiveness against the risk factor of functional ankle instability.
    


Intervention name(s): PENMT (Experimental Group); FIFA 11+ (Control Group)
Intervention type(s): Other; Other
Intervention description(s): The neuromuscular injury prevention intervention protocol contains field work activities that involve proprioceptive exercises, flexibility, and specific and general muscle strength of the MMII and trunk soccer players.; Treatment or experimental condition. 1: FIFA 11+ Program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: G1: Neuromuscular training program of prevention of functional ankle instability PEMNT; G2: FIFA 11+ Program Group (control).
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Ankle injuries; Physical therapy; Neuromuscular training; Functional ankle instability; Prevention; Unstable joint.
Effect of Email Nudges on Plan Switching and Healthcare Utilization Among Unemployment Insurance Recipients
Condition: Health Behavior
Study type: Interventional

Summary: 
      In March 2021, President Biden signed into law the American Rescue Plan Act of 2021 (ARP), a
      landmark federal economic relief and stimulus package designed to provide support to
      Americans hit by the economic recession brought about by the COVID-19 global pandemic. The
      law provides increased federal premium tax credits (PTC), and ensures that consumers will pay
      no more than 8.5 percent of household income on health insurance premiums in 2021 and 2022,
      if enrolled through an Affordable Care Act marketplace like Covered California.

      The ARP also provides additional PTC and cost-sharing reduction (CSR) benefits to eligible
      marketplace enrollees who report receiving unemployment insurance benefits (UIB) for at least
      one week in 2021. Under the law, for 2021 only, Covered California consumers will have their
      household income level treated as if it were at 138.1 percent of the federal poverty level
      (FPL), regardless of their projected annual income, which will make them eligible for a
      Silver 94 plan, and which offers the greatest value on cost-sharing benefits.

      But in order to access those cost-sharing benefits, households must be in silver tier plans,
      but over 40,000 were not. This project's goal is to assess the effects of an informational
      email on plan switching into Cost Sharing Reduction Silver plans and downstream healthcare
      utilization.

      The project's research design is a randomized intervention among approximately 42,500
      enrolled households with an email address in non-silver tier plans. The investigators
      randomly assigned to either two informational emails or to a no email control group. The
      investigators then collected administrative data to examine plan switching behavior and
      healthcare utilization among households in the study.
    


Intervention name(s): Two informational emails with plan information; Standard notice of eligibility determination
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Informational emails about the benefits of Cost-Sharing Reduction Silver plans.; No extra outreach during intervention period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Affordable Care Act; randomized controlled trial; nudge; American Rescue Plan; unemployment insurance
Randomized Trial of Prolonged Exposure for the Treatment of Posttraumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This project will examine the impact of PE therapy for the treatment of PTSD with a sample of
      Latinos. The need to provide effective treatment to Spanish-speaking Latinos with PTSD is
      critical given the high prevalence of PTSD among Latinos. Furthermore, PTSD remains an under
      detected and under treated condition. Untreated PTSD has a substantial impact on health,
      functioning and quality of life. PE is one of the most empirically supported psychological
      interventions for PTSD. However, most studies that evidence the efficacy of PE have been
      conducted mainly with English-speaking Caucasian populations. This study has the potential to
      contribute to improvements in the well-being of Spanish-speaking Latinos with PTSD.
    


Intervention name(s): Prolonged Exposure; Applied Relaxation
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder (PTSD); Prolonged Exposure (PE)