bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses
      implantation are supposed to have sufficient uncorrected vision capacity for activities of
      daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is
      known that light intensity and temperature has a great impact on near vision capacity.
      Primary objective of this study is to identify the optimal task lighting conditions (in terms
      of light intensity and temperature) for ADLs that demand near vision acuity for a sample of
      patients who underwent presbyopic correction with bilateral trifocal intraocular lenses
      implantation
    

Detailed description: 
      Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses
      implantation are supposed to have sufficient uncorrected vision capacity for activities of
      daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is
      known that light intensity and temperature has a great impact on near vision capacity.
      Primary objective of this study is to identify the optimal task lighting conditions (in terms
      of light intensity and temperature) for ADLs that demand near vision acuity for a sample of
      patients who underwent presbyopic correction with bilateral trifocal intraocular lenses
      implantation. The following light intensities will be evaluated: 25, 50, and 75 foot candles.
      Moreover, the following light temperatures will be evaluated: 3000, 4000, and 6000 Kelvins.
    

Intervention name(s): Phaco / Panoptix
Intervention type(s): Procedure
Intervention description(s): Phacoemulsification with bilateral diffractive trifocal lens implantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810
      in the treatment of impulsive aggression in patients with Attention Deficit/Hyperactivity
      Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged
      6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study.
      The frequency of impulsive aggression behaviors will be assessed as a primary outcome.
      Additionally, the severity and improvement in impulsive aggression, and quality of life
      measures for the subject and caregiver will be assessed using validated scales.
    


Intervention name(s): SPN-810; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of PDL-0101 in Patients With Hyperlipidemias: a Pilot Study.
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      This will be an 8 week multicenter, randomized, double-blind, placebo controlled trial.
    

Detailed description: 
      This will be an 8 week, multicenter, randomized, double blind, placebo controlled trial. The
      screening visit will be divided into two parts, a "pre-screen" in-clinic rapid lipid test
      (Cholestech) followed by a full screening blood draw to be sent to the central reference
      laboratory (CRL) for subjects meeting the Cholestech inclusion values for TG and LDL (see
      inclusion criteria below) on the pre-screen test. Subjects who do not meet the pre-screen
      criteria will be discharged from further participation in the study. Subjects must have
      pre-screen lipid values of LDL >/=70 mg/dl and triglyceride (TG) >/=180 and </=499. Subjects
      who meet these Cholestech criteria will have blood drawn for central reference laboratory
      (CRL) screening testing. For randomization, 80% of the subjects must have TG>/=200 mg/dl to
      proceed to the next screening step while up to 20% will be allowed to proceed to the next
      screening step with TG=150-199 mg/dl as long as the LDL is>/=70 mg/dl. Subjects who meet the
      CRL pre-screen lipid inclusion criteria will return 2-14 days later for the remainder of the
      full screening procedures. Subjects who meet all screening criteria will be randomized at
      this visit. Thus, the prescreening and screening-1 visits will occur at the same time and the
      screening 2 visit will also be the baseline visit. BMI will be calculated but is not a
      criterion for participation.

      Subjects who meet all inclusion and exclusion requirements at the screening 2/baseline visit
      will be randomized to receive one of the two (2) study products. Randomization will proceed
      in groups of 5 with 4 subjects having TG between 200-499 mg/dl before randomizing a subject
      with TG between 150-199 mg/dl. Subjects will return for evaluation 4 and 8 weeks after the
      baseline visit at which times adverse events (AEs) will be recorded, blood lipid studies will
      be done and subjects will complete a VAS for product tolerability. Laboratory studies will be
      drawn after subjects have been sitting for at least 5 minutes.
    

Intervention name(s): PD-L0101; placebo
Intervention type(s): Other; Other
Intervention description(s): 92% EPA+6 mg ATX+50 mg TCT GG BID; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fibrin Sealant in Esophageal Surgery
Condition: Anastomotic Leak
MeSH terms: Anastomotic Leak
Study type: Interventional

Summary: 
      Anastomotic leakage remains a major complication after esophageal surgery. Amongst other
      preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic
      techniques. The investigators aimed to investigate feasibility of additional sealing by means
      of autologous fibrin sealant of the esophageal anastomosis.
    


Intervention name(s): Autologous activated fibrin sealant
Intervention type(s): Device
Intervention description(s): Application of fibrin sealant
Intervention MeSH terms: Fibrin Tissue Adhesive
Intervention model: Single Group Assignment
Intervention model description: Pilot study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Esophagogastric anastomosis; Fibrin sealant; Sealing
Laparoscopic Versus Open Appendectomy
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Appendectomy is the most common surgical procedure performed in emergency surgery. Because of
      lack of consensus about the most appropriate technique, appendectomy is still being performed
      by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the
      investigators aimed to compare the laparoscopic approach and the conventional technique in
      the treatment of acute appendicitis.
    


Intervention name(s): Open appendectomy; Laparoscopic appendectomy
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexmedetomidine for Laryngeal Mask Airway Insertion
Condition: Drug Usage
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators attempted to determine the optimal dose of dexmedetomidine required for the
      successful insertion of LMA during propofol induction without a neuromuscular blocking agent.
    

Detailed description: 
      After a predetermined bolus dose of dexmedetomidine was injected over 2 min, anesthesia was
      induced with propofol 2.0 mg/kg. After confirming the loss of eyelash reflex and the
      bispectral index (BIS) score decreased below 60, the insertion of LMA was attempted.
    

Intervention name(s): dexmedetomidine; propofol; laryngeal mask airway (LMA)
Intervention type(s): Drug; Drug; Device
Intervention description(s): The dose of dexmedetomidine was determined by modified Dixon's up-and-down method, starting from 0.5 μg/kg (0.1 μg/kg as a step size).; Propofol 2.0 mg/kg was administrated; The insertion of laryngeal mask airway (LMA) was attempted, after confirming the loss of eyelash reflex,the bispectral index (BIS) score decreased below 60.
Other intervention name(s): precedex; 2% fresofol
Intervention MeSH terms: Dexmedetomidine; Propofol
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LMA insertion; dexmedetomidine; propofol
Improving Medical Training for the Care of Chronic Conditions
Condition: Diabetes Mellitus
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      While medical training has increasingly included chronic care management, quality care
      necessitates education approaches that go farther. In April 2005, the Louis Stokes Cleveland
      Veterans Affairs Medical Center (VAMC) implemented a weekly Diabetes Shared Medical
      Appointment (SMA). SMAs offer an important opportunity to improve chronic care and a unique
      setting for training physicians. In order to equip physicians with needed resources to manage
      chronic care, the ways in which SMA experiences are processed and integrated into learning
      about interdisciplinary approaches and expanding trainees' understanding of chronic care
      issues need to be examined.
    

Detailed description: 
      : Most physicians receive training in and about an acute care-oriented health care system
      that cannot adequately address the challenges of chronic care management. While medical
      training has increasingly included chronic care management, quality care necessitates
      education approaches that go farther. In April 2005, the Louis Stokes Cleveland VAMC
      implemented a weekly Diabetes Shared Medical Appointment (SMA). Results indicate that SMAs
      are sustained and, as such, SMAs offer an important opportunity to improve chronic care and a
      unique setting for training physicians. SMAs offer the potential to provide training in
      crucial skills that have to date remained less amendable to traditional educational
      practices. In order to equip physicians with resources to effectively and efficiently manage
      chronic care, the ways in which SMA experiences are processed and integrated into learning
      about interdisciplinary approaches and expanding trainees' understanding of chronic care
      issues need to be examined. Without addressing this gap, it is not possible to develop a
      comprehensive care model that links education and patient outcomes for chronic conditions,
      such as diabetes. Building on previous pilot work, we continued to address evaluating and
      validating instruments. The proposed pilot project included using a think-aloud protocol to
      evaluate and validate new items and scales assessing interdisciplinary team and chronic
      care/diabetes beliefs, and evaluating and adjusting direct observation coding tools for
      chronic condition care.
    

Intervention name(s): Shared Medical Appointments
Intervention type(s): Behavioral
Intervention description(s): Participated in shared appointments for patients as part of interprofessional team providing care for diabetes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Shared Medical Appointments; Diabetes; Education
Energy Expenditure in Golf
Condition: Healthy
Study type: Observational

Summary: 
      Structured exercise and physical activity are well known to not only improve physical
      fitness, but also alter various health parameters in a positive fashion. To yield health
      benefits, exercises need to meet certain characteristics e. g. specific levels of intensity
      or duration.To evaluate intensity levels and therefor possible improvements in physical
      conditioning in golf the investigators conducted this study with two groups of each 10
      subjects. The groups differed in age and skill level (handicap, hcp). Each group went through
      a exercise session on the driving range (DR) and a 9-hole compeition round of golf. The
      investigators assessed spirometrical data (breath-by-breath) to evaluate energy expenditure
      (EE) and intensity levels of physical activity according to the ACSM guidelines.
    


Intervention name(s): EE Golf
Intervention type(s): Other
Intervention description(s): Exercise in Golf and Playing 9 holes
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Members of German golf clubs with an active playing status.
      
Keywords: Physical activity; Golf; Exercise; Energy consumption; METs
Ziprasidone in the Psychosis Prodrome
Condition: Psychosis Prodrome
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for
      patients with the psychosis prodrome.
    


Intervention name(s): ziprasidone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20-160 mg/d; placebo
Other intervention name(s): Geodon
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psychosis; schizophrenia; prodrome; ziprasidone; placebo
Pre-sleep Protein Supplementation and Load Carriage Recovery in British Army Recruits
Condition: Protein-energy; Imbalance; Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      Load carriage is a common military activity and has been shown to induce acute
      exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can
      accelerate muscle recovery by attenuating EIMD and muscle function loss. This study
      investigated the impact of an additional daily bolus of protein prior to sleep throughout
      training on acute muscle recovery following a load carriage test in British Army recruits.
      Muscle function (maximal jump height), perceived muscle soreness and urinary markers of
      muscle damage were assessed before (PRE), immediately post (POST), 24-hours post (24h-POST)
      and 40-hours post (40h-POST) a load carriage test.
    

Detailed description: 
      British Army basic training (BT) is physically demanding with new recruits completing
      multiple bouts of physical activity each day with limited recovery. Load carriage is one of
      the most physically demanding BT activities and has been shown to induce acute
      exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can
      accelerate muscle recovery by attenuating EIMD and muscle function loss. This study
      investigated the impact of an additional daily bolus of protein prior to sleep throughout
      training on acute muscle recovery following a load carriage test in United Kingdom (UK)
      British Army recruits. A mixed group (men/women) over over 120 new recruits were randomised
      to dietary control (CON), carbohydrate placebo (PLA), moderate (20g; MOD) or high (60g; HIGH)
      protein supplementation. Muscle function (maximal jump height), perceived muscle soreness and
      urinary markers of muscle damage were assessed before (PRE), immediately post (POST),
      24-hours post (24h-POST) and 40-hours post (40h-POST) a load carriage test. The underlying
      aim of this study was to assess whether additional protein intake could attenuate aspects of
      muscle damage from an acute load carriage test including muscle function, muscle soreness and
      biomarkers of muscle damage during short term recovery.
    

Intervention name(s): High protein intake; Moderate protein intake; Carbohydrate maltodextrin placebo; Control no supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): The participants received a 60g whey protein bolus each evening prior to sleep pre and post a military load carriage test.; The participants received a 20g whey protein bolus each evening prior to sleep pre and post a military load carriage test.; The participants received an isocaloric carbohydrate bolus each evening prior to sleep pre and post a military load carriage test.; Control group, no supplementation, only basic training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Effects of Virtual Reality MRI Preparedness
Condition: Anxiety; Educational Problems
Study type: Interventional

Summary: 
      Magnetic resonance imaging is an important and increasingly prevalent imaging modality used
      in healthcare. Children often find the procedure anxiety provoking causing difficulty in
      staying still and providing quality images. The use of preparation techniques including play
      therapy and role play utilizing such tools as a fiberglass mock MRI have shown to reduce
      anxiety and facilitate better image quality. Modalities of preparation including Virtual
      Reality (VR) pose as an alternative to habituate children for a MRI procedure.
    


Intervention name(s): Pico G2 4k
Intervention type(s): Device
Intervention description(s): On this virtual reality headset, it will be loaded with an educational virtual reality mock MRI training titled "Ready Teddy". This training explains the procedure to the viewer and addresses common questions that individuals often have regarding an MRI. Furthermore, using audio/visual cues, when the viewer moves their head too much in a MRI like setting they are reminded to stay still. Biofeedback training is aimed to mimic the experience of the MRI with real audio recordings of image acquisition, in order to adequately train the view to stay still in an MRI procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A schedule of randomization matching and stratified in age and gender will be computer generated and used to determine which group the child will be placed in. Neither the investigator nor child will know which group they are in until after the parent and child complete the first set of questionnaires
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Virtual Reality; Magnetic resonance imaging; Radiology
Preventing Weight Gain in African American Reproductive-Aged Women
Condition: Weight Gain; Women's Health; Obesity
MeSH terms: Body Weight; Weight Gain
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate the effect of a Facebook-delivered
      weight-gain prevention program versus a Facebook-delivered program with general women's
      health information.
    

Detailed description: 
      Weight gain is an important health concern, and disparities in the prevalence of obesity
      between African American and White women increase throughout the reproductive period. This
      study is a randomized, controlled trial testing the feasibility and acceptability of a
      peer-coach-administered, Facebook-delivered intervention to prevent weight gain in overweight
      and obese African American women. Study visits lasting approximately 1 hour will occur at
      baseline, post-intervention, and 1-month follow-up, to assess effectiveness and
      acceptability. The core intervention will occur over a 4-week period. Educational content in
      both the weight-gain prevention program and women's health program will be delivered via
      Facebook, with new content posted each weekday related to that week's topics. The peer
      coaches may contact participants via private messaging, when needed, to provide support and
      encourage engagement. If successful, this intervention could be easily disseminated to
      populations in under-served and community settings.
    

Intervention name(s): Weight-gain Prevention; Women's Health
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 4-week weight-gain prevention curriculum will be delivered via Facebook. Participants will be provided tips to prevent weight-gain and will be given the opportunity to engage with the peer coaches and other participants in the group.; A 4-week women's health curriculum will be delivered via Facebook. Participants will be provided tips for staying healthy and will be given the opportunity to engage with the peer coaches and other participants in the group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Facebook; Weight Gain Prevention; Women's Health; Online; Weight Gain; Weight Loss; Female Contraception; Obesity; Body Weight; Internet
The Platinum Study Comparison Group
Condition: Testicular Neoplasms
MeSH terms: Testicular Neoplasms
Study type: Observational

Summary: 
      The patients enrolled on this new study will serve as an appropriate comparison group
      consisting of patients with the diagnosis of germ cell testicular cancer who were cured with
      surgical resection and did not receive cisplatin-based chemotherapy with a group of patients
      from another study who did receive cisplatin-based chemotherapy.
    

Detailed description: 
      Primary Objective

      To compare the prevalence of ototoxicity and neurotoxicity in GCT cancer survivors who only
      had surgery to a similar population from The Platinum Study (RSRB45410/1305011509) who
      received cisplatin-based combination chemotherapy.

      Secondary Objective

      To compare the prevalence of obesity, hypertension, and use of antidepressants/anxiolytics in
      GCT cancer survivors who only had surgery to a similar population from The Platinum Study who
      received cisplatin-based combination chemotherapy.
    

Intervention name(s): Questionnaire
Intervention type(s): Behavioral
Intervention description(s): Neurotoxicity
Medications of interest
General health
Family history
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male patients with testicular germ cell tumor diagnosis at the age of 18-55 who were
        treated with surgery only and not chemotherapy.
      
Keywords: Cisplatin-based therapy; Ototoxicity; Neurotoxicity