bioihbjkbjnl/mcl2 huggingface dataset:
Enhancing Independence Using Group-based Community Interventions for Healthy AGing in Elders: the ENGAGE Pilot Study
Condition: Mobility Limitation
MeSH terms: Mobility Limitation
Study type: Interventional

Summary: 
      This study will be conducted to determine the safety and feasibility of translating a
      physical activity intervention (LIFE Study) into a community setting. Study outcomes include
      physical performance, safety, and feasibility of conducting the LIFE PA intervention in a
      community setting.
    

Detailed description: 
      Older adults who lose their mobility experience a poorer quality of life, are less likely to
      remain independent in the community and have higher rates of chronic disease, falls and
      mortality. Recent results from the Lifestyle Interventions and Independence for Elders (LIFE)
      study demonstrated that a structured program of physical activity (PA) reduced the onset of
      major mobility disability in at-risk older adults by up to 28% over a 2.6 year period.
      Despite the public health significance of this study, to-date no study has attempted to
      translate LIFE PA to broader populations of at-risk older adults in community-based settings.
      To address this knowledge gap, and to aid the design of a larger pragmatic trial of LIFE PA
      in community-based settings, the investigators conducted the ENhancing independence using
      Group-based community interventions for healthy AGing in Elders (ENGAGE) pilot study. The
      investigators examined the safety and feasibility of translating LIFE PA into the existing
      infrastructure of a community-based senior center. The investigators also explored the
      preliminary real-world effectiveness of PA on physical performance and several other
      important health related outcomes for older persons, including cognitive function, quality of
      life, depressive symptoms and frequency of falling.
    

Intervention name(s): Physical Activity Intervention; Healthy Aging Intervention
Intervention type(s): Other; Other
Intervention description(s): Participants in this arm will complete exercise sessions 1 time per week for 24 weeks. An optional, second PA session will also be offered to PA participants. The exercise sessions will be multimodal and involve walking, lower extremity strengthening exercises, flexibility and balance training.; Participants will attend health education workshops on topics of relevance to older adults. Workshops will be offered weekly in a group setting, and participants will be required to attend biweekly.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The ENGAGE Somerville Study is designed as a single blind, randomized-controlled, parallel-group pilot study. This study plans to enroll up to 50 participants to be randomized into the PA or health aging intervention.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition
Condition: Liver Diseases
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      The purpose of this study is to determine plasma phytosterols half-lives in preterm infants
      who received intravenous soy oil-based lipid emulsions.
    

Detailed description: 
      Several studies reported the relationship between plasma phytosterol concentrations and
      parenteral nutrition-associated cholestasis (PNAC). Information on plasma phytosterols
      half-lives in very-low-birth-weight (VLBW) preterm infants on lipid parenteral nutrition (PN)
      are lacking. In a prospective cohort study, plasma phytosterols (campesterol, stigmasterol
      and sitosterol) of VLBW preterm infants on routine PN will be measured by gas
      chromatography-mass spectrometry (GC-MS) during PN administration and after only lipid
      stopping. Plasma phytosterols half-lives will be calculated from the monoexponential decay
      curves. Blood samples will be weekly collected from 1st to 7th week of life during routine
      metabolic tolerance analysis or gas-analysis in order to avoid burden of additional
      phlebotomy. Samples will be collected in ethylenediaminetetraacetic acid-tubes and
      immediately centrifugated. Plasma will be stored in pyrogallol added-tubes at -20°C until
      analysis. Saponification reaction will be done using 5-alpha-cholestane as internal standard.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Preterm infants (24 weeks < gestational age < 32 weeks; 500 g ≤ birth weight < 1250 g) who
        received intravenous soy oil-based lipid emulsions from the first hours of life.
      
Biospecimen description: 
      Plasma.
    
Keywords: Preterm Infants; Phytosterols; Parenteral Nutrition
High Protein Weight Loss Diet, High Sensitivity C-Reactive Protein and Cardiovascular Risks Among Obese Women
Condition: Body Mass Index Quantitative Trait Locus 8 Disorder; Tangier Disease
MeSH terms: Tangier Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP
      among overweight and obese women.
    

Detailed description: 
      Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD)
      risk factors have reported contradictory results.

      Objective: In present study, we aimed to determine the effects of HP diet on CVD risk factors
      and hs-CRP among overweight and obese women.

      Design: In this randomized controlled trial, we recruited 60 overweight and obese women, aged
      20-65 years into HP or control energy restricted diets for three months (protein,
      carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount,
      divided to animal and plant sources in 50%-50% and animal sources distributed (half/half)
      between meats and dairy products. Fasting blood samples, hs-CRP, lipid profile, systolic and
      diastolic blood pressure and anthropometric measurements were measured based on the standard
      guidelines.
    

Intervention name(s): nutrition intervention
Intervention type(s): Other
Intervention description(s): high protein diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: body weight; Low-density-lipoprotein-type
Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)
Condition: Spinal Cord Injuries; Pain
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      A number of studies suggest that training to increase different types of brain waves is
      related to pain relief. The purpose of the second phase of this study is to see if
      neurofeedback training might help people with chronic pain control their pain better. The
      information from the study may help the investigators treat chronic pain better in the
      future.
    

Detailed description: 
      During this phase of the study, research personnel will provide up to 15 of the subjects with
      SCI-related pain with a full course (up to 40 sessions) of NF training to determine the
      effects of this treatment on (a) chronic daily pain, (b) EEG-assessed frequency band
      amplitudes, and (c) other measures of quality of life (specifically, sleep quality, fatigue,
      and pain interference).

      Standard NF training procedures will be used that involve simply asking participants to relax
      while looking at the feedback screen and to "Do whatever is necessary to make and keep the
      color bar wide." EEG bandwidth activity that is associated with being pain-free or with
      experiencing less pain will be reinforced. This protocol will be repeated for up to 40
      30-minute sessions, scheduled at least weekly (but more often if the participant and study PI
      can arrange this with their schedules. Brain wave activity will be measured three times
      during the study: once before treatment begins, once immediately after treatment ends, and
      three months following treatment. Research staff will collect data regarding pain intensity
      and quality of life from subjects via the telephone three times: before treatment,
      immediately after treatment, and three months after treatment ends.
    

Intervention name(s): Neurofeedback
Intervention type(s): Behavioral
Intervention description(s): Electrodes will be placed over the temporal lobes bilaterally and a ground electrode placed on the left earlobe. EEG activity will be amplified using a Procomp 2 or Nexus amplifier, and EEGer software will be used to provide subjects with feedback. Contingencies will be set such that alpha brain activity will be reinforced, and high beta and theta brain activity will be inhibited. Standard NF training procedures will be used, which involve simply asking subjects to relax while looking at the feedback screen and "Do whatever is necessary to make and keep the bar wide." This protocol will be repeated for up to 40 60-minute sessions (that will include 30 minutes of NF training), scheduled at least weekly.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurofeedback
The Efficacy of Automated Intermittent Boluses for Continuous Femoral Nerve Block: a Prospective, Randomized Comparison to Continuous Infusions
Condition: Arthroplasty, Replacement, Knee; Nerve Block
Study type: Interventional

Summary: 
      The optimal infusion technique (continuous rate vs. intermittent bolus) for peripheral nerve
      blocks has not been established. To our knowledge, this is the first study to compare the
      efficacy of an automated intermittent bolus technique to a continuous rate of infusion of
      local anesthetic in femoral nerve catheters. We hypothesized that the intermittent bolus
      technique would provide enhanced analgesia compared to a continuous infusion rate as assessed
      by intravenous patient-controlled analgesia (IV-PCA) hydromorphone consumption and visual
      analog scale (VAS) pain scores.
    


Intervention name(s): Automated intermittent bolus
Intervention type(s): Other
Intervention description(s): Automated intermittent bolus delivery method of 0.2% ropivacaine at 5 mL every 30 minutes with a basal infusion of 0.1 mL/hr.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators designed a randomized double-blind placebo-controlled trial to evaluate the
      effect of preoperative single dose of oral melatonin and vitamin C administration on
      postoperative analgesia in patients undergoing elective major abdominal surgery.
    

Detailed description: 
      The investigators designed a randomized double-blind placebo-controlled trial to evaluate the
      effect of preoperative single dose of oral melatonin and vitamin C administration on
      postoperative analgesia in patients undergoing elective major abdominal surgery. One
      hundred-sixty five ASA I-II adult patients between 18-65 years of age, undergoing elective
      major abdominal surgery with general anesthesia will be included in this double blinded,
      randomised, controlled study. Patients will randomly divided into equal (n=55) three groups.
      Preoperatively, one hour before surgery, patients will receive melatonin (6 mg) in group M,
      vitamin C (2 gr) in group C or placebo tablet in group P orally. A standard anesthetic
      protocol will be administered to all patients. At the end of surgery, postoperative pain
      control will be provided via a patient controlled analgesia (PCA) device including morphine
      in all groups. Hemodynamic parameters, pain, sedation, patient satisfaction, total morphine
      consumption, supplement analgesic requirement, incidence of nausea and vomiting and other
      side effects will be recorded at 5, 10, 30 min and 1, 2, 4, 6, 8, 12, 24 hr after surgery.
    

Intervention name(s): Melatonin; Vitamin C; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated; Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated; Preoperative placebo tablet will be given and postoperative pain scores will be evaluated
Other intervention name(s): Melatonina 3 mg tb,; Vitamin C 1000 mg tb; Placebo tb
Intervention MeSH terms: Vitamins; Ascorbic Acid; Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Melatonin; Vitamin C; Morphine consumption
Ultrasound Biomicroscopy Study Of Accommodative State In Smartphone Abusers
Condition: Spasm of Accommodation
Study type: Observational

Summary: 
      Detection if there is association between spasm of accommodation and smart phone abuse by
      ultrasound biomicroscopy on anterior segment of the eye
    


Intervention name(s): Ultrasound Biomicroscopy of anterior segment of the eye
Intervention type(s): Diagnostic Test
Intervention description(s): 5150 Vumax (Sonomed, USA) under standard illumination
Other intervention name(s): UBM
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Group (A): 40 smart phone abuser subjects (According to the smartphone questionnaire).

        Group (B): 40 smart phone non user subjects.
Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 100 μg/ 75 μg Tablets
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the area under the curve (AUC0-48h; extent of
      systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine
      (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as
      tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered
      as a reference solution without iodine.
    


Intervention name(s): levothyroxine; levothyroxine
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: levothyroxine; bioavailability
Discerning Pseudoprogression vs True Tumor Growth in GBMs
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Observational

Summary: 
      One-third of all primary brain tumors are astrocytomas, the most common type of glioma. Grade
      4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of all
      gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates
      and median patient survival of just 12-15 months post-diagnosis. Treatment response is
      assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance
      images (MRI). However, radiation and chemotherapy cause inflammatory and necrotic changes
      which, like actual tumor progression itself, demonstrate contrast enhancement on the first
      post-treatment MRI scan. This enhancement eventually subsides (typically within 6 months of
      treatment) and is known as pseudoprogression (PsP). Currently, there is no gold standard
      noninvasive tool for distinguishing between pseudoprogression and progressive disease.
      Dynamic susceptibility-weighted contrast-enhanced perfusion MRI (DSC perfusion MRI) permits
      measurement of hemodynamic imaging variables. Previous literature reports attempted to use
      some or all of these metrics to assess their utility in distinguishing PsP from true cancer
      progression. These studies showed mixed results, likely due to a number of factors, including
      poor statistical power, poorly defined PsP, analysis of multiple cancer grades and types, and
      varied analysis methodologies. The investigators aim to address these issues in this study.
    

Detailed description: 
      See BRIEF SUMMARY section
    

Intervention name(s): Study subjects
Intervention type(s): Other
Intervention description(s): This study does not include an intervention it is only observational.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals who have or might have a brain tumor which may be a glioblastoma.
      
Keywords: Pseudoprogression; Brain Cancer
Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the
      treatment on quality of life of long-acting methylphenidate in adult participants with
      Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in
      childhood and is characterized by inadequate levels of attention, hyperactivity and
      impulsiveness.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multi-center (when
      more than one hospital or medical school team work on a medical research study), single arm
      study of multiple doses of long-acting methylphenidate in participants with ADHD. The study
      will consist of 2 phases; a screening phase and a treatment phase. The duration of
      participation in the study for an individual participant will be up to 12 weeks. Participants
      will be given 18 milligram (mg) of long-acting methylphenidate daily in the morning and
      titrated up (slow increase in drug dosage guided by participant's responses) to 36 mg per day
      (mg/day) on Day 8. Depending on response, tolerability and clinician's judgment, the dose
      could be escalated to the next dose level of 54 mg/day on Day 28 to a maximum of 72 mg/day on
      Day 56, until each participant achieved optimal dose. Participant's safety will be monitored
      throughout the study.
    

Intervention name(s): Long-Acting Methylphenidate
Intervention type(s): Drug
Intervention description(s): Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56.
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate; Concerta; CONQoL
Adaptive Treatment for Adolescent Anorexia Nervosa
Condition: Eating Disorder; Anorexia; Anorexia Nervosa; Anorexia in Adolescence; Anorexia in Children; Anorexia Nervosa Restricting Type; Anorexia Nervosa, Atypical; Eating Disorders in Adolescence
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Interventional

Summary: 
      The investigators are conducting a randomized controlled trial using an adaptive design for
      adolescents (ages 12-18) with anorexia nervosa to compare standard Family Based Treatment
      (FBT) to adaptive FBT with an Intensive Parental Coaching (IPC) component. If participants do
      not reach expected milestones by session 4 of treatment, participants may be randomized to
      receive additional IPC or continue treatment as usual with regular FBT.
    

Detailed description: 
      Potential subjects aged 12 to 18 with anorexia nervosa (AN) will be recruited from Stanford
      University, University of California, San Francisco, other bay-area medical programs and
      clinics, and online advertisement to the population at large. If participants are deemed
      eligible, participants will be invited for a baseline interview (about 2 hours in duration)
      during which the investigators will conduct interviews and collect questionnaire measures.
      Then, participants and participants' families will begin Family Based Treatment (FBT) with a
      study therapist at Stanford University or University of California, San Francisco,
      respectively. All assessments and treatments are conducted through tele-health.

      At session 4, if participants have not gained 2.4kg, an indicator of early treatment
      response, participants and participants' families will be randomized to receive either
      treatment as usual (FBT) or an adaptive form of FBT, during which families will receive
      additional Intensive Parental Coaching (IPC). If participants have reached weight milestones
      (i.e., 2.4kg at session 4), participants will continue FBT as usual.

      At 3 months of treatment and end of treatment, the investigators will collect the same
      measures taken at baseline. The investigators also ask that families participate in 6- and
      12-month follow-up, respectively.
    

Intervention name(s): Family Based Treatment; Family Based Treatment + Intensive Parental Coaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Family Based Treatment of adolescent Anorexia Nervosa; Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.
Other intervention name(s): Maudsley Method; FBT + IPC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anorexia; anorexia nervosa; eating disorder; weight; eating; weight loss; family based treatment; FBT; family treatment; therapy; Maudsley method
A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Volume Plus Versus YVOIRE Volume in Nasolabial Fold Injection
Condition: Wrinkles
Study type: Interventional

Summary: 
      The objective of this study was to evaluate the efficacy and safety of HA IDF II plus (with
      lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine).
    


Intervention name(s): HA IDF II plus; HA IDF II
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Split-face design. Subjects were decided by randomization which side of the face would be injected with the test device. According to this randomization result, the other side would be determined to be injected with a comparator. It was determined just by one randomization.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: the facial nasolabial fold