bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Snack Size and Variety on Appetite Control, Satiety, and Eating Behavior in Healthy Adults.
Condition: Snacking
Study type: Interventional

Summary: 
      The investigators propose a randomized snack study in normal to obese adults that will test
      whether snack size, choice, or variety has an influence on daily snack intake.

      Aim 1: To validate the in-house packout methodology with 3-day dietary recalls. Aim 2: To
      examine whether snack variety or snack package size will influence free-living snacking
      behavior.

      Aim 3: To identify whether a correlation exists between mindful eating and free-living
      snacking behavior.
    

Detailed description: 
      Participants will complete 4 different snack patterns. Each pattern will include 3
      nonconsecutive weekdays (i.e., Monday/Wednesday/Friday; Tuesday/Thursday/Monday, etc.). The
      snack patterns will be performed at home/work.

      The first pattern will simply be a measurement of typical snack habits. For each of the 3
      days, the participant will enter all foods and beverages consumed using the online program,
      Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24).

      For the other 3 patterns, different snack packouts will be provided to the participant for 3
      nonconsecutive weekdays/pattern. The only difference between the packouts is the type of
      foods provided. The packouts contain commercially available foods commonly eaten by people
      who snack. Following lunch, the participant will be permitted to eat as much or as little as
      he/she chooses from the packout until going to bed. Beverages will not be provided and the
      participant could drink whatever he/she typically consumes.

      For all patterns, the participant will be provided with a standardized breakfast, lunch, and
      dinner to consume at home/work for each of the 3 days/pattern.
    

Intervention name(s): Packout
Intervention type(s): Behavioral
Intervention description(s): Each packout provided during 3 of the 4 snack patterns will contain a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. There are 3 different packouts that will be provided for 3 nonconsecutive weekdays (for a total of 9 packouts). Each packout contains the same calories and types of foods. However, they differ in packaging size and variety.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: tightly-controlled, randomized cross-over design
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intuitive eating; package size; food variety
DETERMINE-reduced - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Reduced Ejection Fraction
Condition: Heart Failure With Reduced Ejection Fraction (HFrEF)
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled,
      Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure
      Patients with Reduced Ejection Fraction (HFrEF)
    


Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.; Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Chronic Pain Incidence After Elective and Urgent Cesarean Sections
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      The purpose of this study is to determine the effects of whether urgent or elective cesarean
      section on the occurrance of chronic pain.
    

Detailed description: 
      The purpose of this study is to determine the effects of whether urgent or elective cesarean
      section on the occurrance of chronic pain. Patients aged between 18 - 45 years whose
      underwent urgent or elective cesarean section will be invited to participate in the study.
      Preoperatively in operating theatre, patients will be asked to complete the pain
      catastrophizing scale (PCS) questionnaire. In postoperative 6 months after discharge,
      patients will be called by an investigator who is blind to the study to evaluate the presence
      of chronic pain. Patients will be asked to grade the pain that they suffer using a numeric
      rating scale for the intensity of pain.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  Female

          -  18 - 45 years of age

          -  underwent elective or urgent cesarean section
Combined, Intensified and Modulated Adjuvant Therapy in Prostate Carcinoma
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Patients with high risk prostate cancer may benefit from radiotherapy after radical
      prostatectomy. The investigators postulated that adjuvant androgen deprivation therapy (ADT),
      radiation dose escalation, and selective pelvic irradiation may improve outcome. A phase II
      trial was designed to prove that combined-intensified-modulated-adjuvant (CIMA) treatment may
      improve 5-year biochemical relapse free survival (bRFS) from 75% to 90% in high risk
      patients. The delivered dose to tumor bed and pelvic nodes was 64.8-70.2 Gy and 45 Gy (57% of
      patients), respectively, and 69% received ADT.
    

Detailed description: 
      Prostate cancer patients at high risk of loco-regional recurrences may benefit from
      postoperative radiotherapy (RT) following radical prostatectomy (EORTC trial 22911). However,
      despite an improvement in biochemical relapse-free survival (bRFS), the risk of recurrences
      remained high for those patients. The investigators postulated that adjuvant androgen
      deprivation therapy (ADT), radiation dose escalation, and selective pelvic irradiation for
      patients at risk for regional failures may improve the outcome. The
      combined-intensified-modulated-adjuvant (CIMA) as described may improve survival through a
      reduction of loco-regional and systemic failures.

      A phase II trial was designed to test the hypothesis that CIMA treatment may improve 5-year
      bRFS by 15%. Patients less than 80 years old, with a histological diagnosis of prostate
      adenocarcinoma without distant metastases, stage pT2-4 N0-1, no previous treatments and an
      ECOG performance status of 0-2 were selected. All patients had at least one of these
      pathologic features: extracapsular extension, positive surgical margins, or seminal vesicle
      invasion. Radiation dose to the tumor bed ranged from 64.8 to 70.2 Gy. Pelvic lymph nodes
      were treated to 45 Gy in selected patients at risk of regional failures (57%). Selected
      patients at risk for distant metastases (69.1%) received hormonal therapy.
    

Intervention name(s): Combined, intensified and modulated adjuvant radiotherapy
Intervention type(s): Radiation
Other intervention name(s): adjuvant androgen deprivation therapy
Intervention MeSH terms: Androgens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adjuvant; androgen suppressive therapy; literature review; phase II; prostate neoplasms; radiotherapy
Diagnosing Invasive Aspergillosis by Polymerase Chain Reaction (PCR) Based Investigation of Bronchoalveolar Lavage Samples During Antifungal Therapy
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis
Study type: Observational

Summary: 
      Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in
      patients (pts) with hematologic malignancies. As culture-based methods only yield results in
      a minority of patients, using non-culture-based methods for detection of aspergillosis in
      clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL)
      samples with polymerase chain reaction (PCR) is promising, however, the influence of current
      antifungal drugs on the performance of this diagnostic tool remains controversial.

      The aim of the trial is to elucidate on the performance of BAL PCR under antifungal
      treatment.
    

Detailed description: 
      Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in
      patients (pts) with hematologic malignancies. As culture-based methods only yield results in
      a minority of patients, using non-culture-based methods for detection of aspergillosis in
      clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL)
      samples with polymerase chain reaction (PCR) is promising, however, the influence of current
      antifungal drugs on the performance of this diagnostic tool remains controversial.

      The aim of the trial is to elucidate on the performance of BAL PCR under antifungal
      treatment.

      Patients with high risk of invasive aspergillosis and lung infiltrates are sampled via BAL,
      the sample is analyzed for fungal DNA by Apsergillus specific PCR. Clinical data including
      treatment data is assessed and evaluated.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        immunocomprimised patients with lung infiltrates and high risk for invasive aspergillosis
      
Biospecimen description: 
      Aliquots of BAL Samples including fungal DNA
Myopia Assessment of Two Manufacturing Processes
Condition: Juvenile Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial
      of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT)
      spectacle lens manufacturing processes in reducing the progression of juvenile myopia.
    


Intervention name(s): SightGlass Vision DOT Spectacle Lenses
Intervention type(s): Device
Intervention description(s): Subjects randomized to test vs control, left eyes and right eyes
Other intervention name(s): SightGlass Vision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myopia
Post-stroke Delirium in Ischemic Stroke Patients
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Delirium; Ischemia
Study type: Observational

Summary: 
      This study is to investigate the predictors of post-stroke delirium, develop and validate a
      nomogram of post-stroke delirium in the ischemic stroke patients.
    

Detailed description: 
      Introduction: Post-stroke delirium (PSD) is associated with unfavorable prognosis.
      Effectively identifying risk factors of PSD and predicting PSD is of essential.

      Methods: This is a prospective, single-centered, cohort study.
    

Intervention name(s): Test delirium state
Intervention type(s): Diagnostic Test
Intervention description(s): use scale to test whether ischemic stroke patients have post-stroke delirium
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ischemic stroke patients were recruited from a Grade 3A hospital in Southern China.
Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers
Condition: Blood, Injection, Injury Type Phobia; Gastrointestinal Ulcer Haemorrhage; Adverse Reaction to Epinephrine
MeSH terms: Peptic Ulcer; Ulcer; Hemorrhage
Study type: Interventional

Summary: 
      Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.
    

Detailed description: 
      To test the hypothesis that endoscopic injection of autologous blood is superior to
      endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal
      ulcers.
    

Intervention name(s): Epinephrine; Blood
Intervention type(s): Drug; Biological
Intervention description(s): 10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer.; 5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous blood; epinephrine; endoscopy; ulcer; hemostasis
Adipocytokines and Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Inflammation may play a role in the development of polycystic ovary syndrome (PCOS). In this
      study, the investigators investigated the expression of different mediators of inflammation
      in fatty tissue and in blood in women with and without PCOS.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        36 women (17 lean and 19 obese)with PCOS and 24 (8 lean and 16 obese) control women
      
Keywords: The independent effect of PCOS and obesity on adipose expression and plasma levels of adipocytokines
Open-trial on the Prevention of Chronic Migraines With the CEFALY Device
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS
      device as a prophylactic treatment of chronic migraine in adult patients.
    

Detailed description: 
      The purpose of this pilot study was to assess the safety and efficacy of the Cefaly® e-TNS
      device in the prophylactic treatment of chronic migraine in adult patients prior to implement
      a control trial where the size and final protocol will be specified thanks to the outcomes of
      this pilot trial.
    

Intervention name(s): CEFALY
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Proposal for Parental Guidance and Early Stimulation in Children With Congenital Heart Disease: Randomized Trial
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Problem: With the increased survival rate of children with congenital heart disease, other
      health problems, in addition to the clinic, have emerged, such as the risks of developmental
      delay to which these children are exposed. There is a need for low-cost intervention studies
      that seek to minimize these risks.

      Objective: To evaluate the effect of an early stimulation program using parents as vectors of
      intervention, on the neurodevelopment of children with CHD Methodology: Randomized clinical
      trial, conducted with 44 dyads of parents-babies with CH considered as medium and high risk
      for developmental delays according to the guidelines of the American Heart Association
      (2012). The study will consist of two groups G1 (Intervention) and G2 (controls). G1 parents
      will receive guidance for 6 weeks of stimulation activities and will be instructed to keep an
      online execution diary, direct with the researcher through videos, and messages via cell
      phone. G2 parents will receive the standard guidelines currently used in pediatric cardiology
      clinics. Children from both groups will be assessed at the beginning and end of the 6 weeks
      by the Bayley Baby and Toddler Development Scales (3rd Edition). A questionnaire on the
      applicability of the protocol will be administered to the parents of the intervention group
      Expected results: Better neuropsychomotor performance in children after applying the early
      stimulation protocol.

      Perspectives: Create a body of information that can serve as a basis for the formulation of
      policies for intervention and surveillance of the development of this population.
    


Intervention name(s): Early stimulation protocol on neuropsychomotor development of children with congenital heart disease
Intervention type(s): Other
Intervention description(s): A parenting guidance booklet will be prepared. It will contain a specific program of stimulation activities for each stage of development in simple language and with illustrations. Subdivided into 4 areas: Cognition, Language, Large Motor and Fine Motor. The duration will be 6 weeks. Parents will participate in 1 individual face-to-face meeting, where they will receive information and clarification on the application of the booklet and will have a mobile communication channel to answer questions throughout the process. Parents will be instructed on the capabilities and limitations of their babies according to the child's congenital heart disease, as well as what is expected within the typical development for this age group and the importance of early stimulation activities in each child in 4 areas of development.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Congenital heart disease; Children developmental; Parents training
A Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece
Condition: Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      This study estimates the treatment goal achievement rate, depicts the implementation of the
      Progressive Psoriasis Initiative (PPI) recommendations regarding treatment modifications and
      transitioning, and assesses patient adherence and persistence with adalimumab therapy in the
      routine clinical practice in Greece.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with Moderate to Severe Plaque Psoriasis in Greece
      
Keywords: Moderate Plaque Psoriasis; Severe Plaque Psoriasis; Plaque Psoriasis
Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The authors designed a randomized, controlled, double-blind clinical trial after the ethical
      approval by the University Ethics Committee. The patients with temporomandibular joint
      osteoarthritis (TMJ-OA) randomly assigned one of the two treatment groups: intra-articular
      injection of injectable platelet-rich fibrin (i-PRF) after arthrocentesis procedure as i-PRF
      group and arthrocentesis procedure alone as control group. The primary outcome variable was
      pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The
      secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive
      movements.
    

Detailed description: 
      The authors designed a randomized, controlled, double-blind clinical trial after the ethical
      approval by the University Ethics Committee. The patients with TMJ-OA randomly assigned one
      of the two treatment groups: intra-articular injection of i-PRF after arthrocentesis
      procedure as i-PRF group and arthrocentesis procedure alone as control group. All treatment
      procedures were completed by the same experienced surgeon under the local anesthesia. The
      procedure of arthrocentesis was performed using the standard technique and after
      arthrocentesis procedure, the i-PRF injection was performed in the test group.

      The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st,
      2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening
      (MMO), lateral and protrusive movements.
    

Intervention name(s): i-PRF; Arthrocentesis
Intervention type(s): Procedure; Procedure
Intervention description(s): intra-articular i-PRF injection after arthrocentesis; Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; injectable platelet-rich fibrin; Arthrocentesis
Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia
Condition: Pregnancy
Study type: Interventional

Summary: 
      Pre-procedural ultrasound for Spinal & Epidural anesthesia is now being increasingly
      performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to
      facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar
      punctures, performance of spinal anesthesia in non-obstetric patients and accurate
      identification of the interspace at which the puncture is being performed. This is especially
      important during spinal anesthesia, where puncture below the ending of the spinal cord is
      recommended for safety.

      The purpose of this study is to compare the performance of spinal anesthesia between the
      pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in
      term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe
      sonoanatomic features of the spine that could predict the ease of insertion of spinal
      anesthesia in that patient population.

      We hypothesize that in term pregnant women undergoing elective cesarean delivery,
      pre-procedural ultrasound assessment of the spine will improve the success rate of spinal
      anesthesia at first attempt, compared to the traditional palpatory technique.
    


Intervention name(s): Ultrasound; The spinal needle
Intervention type(s): Procedure; Device
Intervention description(s): Ultrasound applied to the lumbar region to determine spinal needle placement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ultrasound; Spinal anesthesia; Cesarean section