bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Postprandial Inflammation in Lean and Obese Subjects
Condition: Nutritional Intervention; Nutritional and Metabolic Diseases; Obesity
MeSH terms: Metabolic Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to quantify the systemic inflammatory and metabolic response of
      lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.
    


Intervention name(s): High-fat meal
Intervention type(s): Dietary Supplement
Intervention description(s): Three caloric doses of high-fat meal (500, 1000, 1500 kcal)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of the study is comparatively analyze the advantages and disadvantages of banded
      versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB).

      The outcome variables of the general study included morbidity, maximal weight loss, and late
      weight regain.
    

Detailed description: 
      Obesity is a public health problem that has grown exponentially worldwide. Bariatric surgery
      has been recognized as the most effective treatment for morbid obesity. However, the debate
      about the best surgical procedure is still considerable.

      Among a wide range of operations that have been used for morbid obesity, Roux-en-Y gastric
      bypass (RYGB) has shown an appropriate risk/benefit balance and has achieved a high degree of
      acceptance in America.

      The weight loss pattern in RYGB is characteristic and includes significant eight loss during
      the first 2 years after surgery, followed by some weight regain after the second or third
      postoperative year. To prevent this some authors suggest the placement of a premeasured band
      or ring around the gastric reservoir, adjacent to the gastroenterostomy. This procedure has
      been called banded RYGB.
    

Intervention name(s): Banded Laparoscopic Roux-en-Y gastric bypass; Unbanded Laparoscopic Roux- en-Y gastric bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): A 6.5-cm polypropylene Marlex mesh was placed immediately cephalad to the gastrojejunostomy. The gastrojejunostomy was hand-sewn in 2 layers using 3-0 Polyglactin for the internal and 3-0 silk for the external layer.
The length of alimentary and biliopancreatic limbs was approximately 150 cm and 50 cm, respectively.; A hand-sewn gastrojejunostomy in 2 layers using 3-0 Polyglactin for the internal and 3-0 silk for the external layer.
To ensure a diameter of 1-1.5 cm,a 32F bougie was used to calibrate the gastro jejunum anastomosis. The length of alimentary and biliopancreatic limbs was approximately 150 cm and 50 cm, respectively.
Other intervention name(s): BLRYGB; banded gastric bypass; Gastric bypass; LRYGB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Morbid obesity; Obesity surgery; Gastric bypass; Banded gastric bypass
Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The goal of this project is to characterize changes in emotion regulation pathways associated
      with healthy behaviors in people who have recently lost weight and are seeking to maintain
      weight loss over a 1-year period.
    

Detailed description: 
      Unhealthy behaviors such as overeating and a sedentary lifestyle are largely responsible for
      overweight and obesity which substantially increase risk for chronic conditions such as heart
      disease, high blood pressure, stroke, diabetes, arthritis and certain cancers. The rapid rise
      in obesity threatens to reverse recent gains in life expectancy and account for a large
      percentage of premature deaths in the U.S. Although there is evidence for the short-term
      efficacy of a number of methods for initiating health behavior change to lose weight, these
      interventions have shown only limited ability to affect significant, long-term behavioral
      changes in the majority of adults. In part this may be because they fail to adequately
      address how psychological factors that lead to relapse to unhealthy behaviors and failure to
      maintain long-term behavior change.

      The purpose of the study is to understand brain changes that accompany participation in
      programs that foster healthy behaviors in people seeking to maintain weight loss. We will use
      MRI scans to study brain function in men and women 25-60 years old who have lost weight in
      the last year without surgery. Participants will be assigned to one of two programs to help
      them maintain weight loss and will be compensated for their time. Our goal is to gain a
      better understanding of the brain changes that lead to long-term success in keeping weight
      off, in the hope that this knowledge will assist in the development of improved treatments.
    

Intervention name(s): Mindfulness; Psychoeducation
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight Loss; Body Weight Changes; Body Weight; Magnetic Resonance Imaging; Emotions; Emotion regulation; Health Behavior; Eating behavior
Integrative Exercise for Post-Deployment Stress
Condition: PTSD Symptoms
Study type: Interventional

Summary: 
      Despite the considerable efforts of the DoD and VA to improve awareness of mental health
      problems and access to care, many returning veterans still report substantial barriers to
      seeking traditional mental health care. Research suggests that a significant barrier to
      pursuing treatment is the perception of stigma (Hoge at al., 2004). The primary objective of
      this 12-week pilot, randomized controlled trial (RCT) is to obtain pilot data on the
      utilization and efficacy of a standardized, integrative exercise protocol (aerobic exercise
      and mindful breath training) in addressing global post-traumatic stress disorder (PTSD)
      symptoms, sleep disturbances, and non-sleep PTSD symptoms in veterans with PTSD.
      Specifically, this study will examine whether a 12-week course of Integrative Exercise
      therapy, a treatment lacking stigma, 1) produces significant pre-post improvements in PTSD
      symptoms and sleep disturbances (compared to a Monitor Only Waitlist condition) 2) improves
      other clinical outcomes including mood, alcohol and non-alcohol substance use, psychological
      distress, mindfulness, and overall quality of life (compared to a Monitor Only Waitlist
      condition) and 3) whether such treatment is feasible and acceptable.

      A secondary aim of this study is to evaluate possible mechanisms underlying these effects
      such as chemicals in the blood related to stress, changes in brain imaging markers, aerobic
      capacity, and improved sleep.
    


Intervention name(s): Integrative Exercise; Monitor Only Waitlist
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
COVID-19 Vaccines and the Menstrual Cycle
Condition: Menstrual Irregularity
MeSH terms: Menstruation Disturbances
Study type: Observational

Summary: 
      The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle
    

Detailed description: 
      This is a descriptive cross-sectional study that took place between September 2021 and
      December 2021. The study aimed to explore the effect of different COVID-19 vaccines on
      menstrual cycle. It used an anonymous questionnaire distributed via social media platforms;
      Facebook, Twitter, and WhatsApp across different cities of Jordan. A total of 732 responses
      were received with a 59% response rate.

      The questionnaire was distributed over four months directed at women who have received at
      least one dose of the COVID-19 vaccine and who live in Jordan. It took 10 minutes to complete
      all the questions.

      Data collection did not involve direct contact with participants to prevent the spread of
      COVID-19.
    

Intervention name(s): Naser Al-Husban
Intervention type(s): Biological
Intervention description(s): COVID-19 vaccines
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Our study included 617 Menstruating females. 74.55% of participants were of the age group
        between 20-35 years. 59.64% had normal BMI (18.5-24.9 Kg/m2), while 11.99% were underweight
        (BMI less than 18.5 Kg/m2), 19.77% were overweight (BMI>24.9 Kg/m2 but less than 30 Kg/m2),
        and 8.59% were obese (BMI more than 30 Kg/m2). Largest BMI was 39.79 Kg/m2. Most of
        participants were single ladies (79.25%). 82.01% were nulliparous. 17.83% were multiparous,
        including 1.62% ladies that had 5 or more children (grand multiparous).
Stimulant Drug Treatment of Attention-Deficit Hyperactivity Disorder (AD/HD), Inattentive Type
Condition: ADHD
Study type: Interventional

Summary: 
      The purpose of this study is to compare the response to methylphenidate treatment of children
      with two different subtypes of ADHD.
    

Detailed description: 
      The Inattentive subtype (IN) of Attention-Deficit/Hyperactivity Disorder was newly defined in
      DSM-IV (1994). Recent epidemiological studies suggest that IN is at least as common and as
      impairing academically and socially as the more commonly recognized Combined type (CB).
      However, little is known about the etiology, course and outcome, or treatment of the IN type.
      Notably, although stimulant drugs are commonly used clinically to treat the disorder, there
      have been no systematic studies of its efficacy in the IN subtype. Differences between the IN
      and CB subtypes in behavioral phenotype, as well as in gender ratio, age of onset, and
      comorbidity suggest there may be critical differences in neurobiology, which may have
      relevance for response to drug treatments. The lack of data concerning stimulant drug
      efficacy in the IN type thus constitutes an important issue from the perspective of public
      health and quality of care. The proposed research is responsive to the current RFA in that it
      will study the efficacy of an established treatment (stimulants) in a new patient population
      (the IN subtype). A second specific aim is to test a hypothesis, emerging from a review of
      the literature, of divergence between dose-response curves for effects on activity and
      attention. We predict that the dose that optimizes performance on ratings of
      hyperactivity-impulsivity will be lower than that which optimizes performance on ratings of
      academic function and on the neuropsychological tests. We will similarly examine whether
      differences in dose-response curves for specific functions extend to differences between
      subtypes in optimal dose. The final aim of the current study is to compare the IN and CB
      subtypes with respect to selected measures of neurocognitive function on placebo and in
      response to drug treatment. We predict that the IN subtype will perform more poorly on
      measures of spatial orienting and stimulus encoding, whereas the CB subtype will show greater
      deficits on measures of cognitive inhibitory control, and that both types of cognitive
      deficit will respond to drug treatment.
    

Intervention name(s): methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): (15 mg daily), medium (25 mg daily) and high (40 mg daily)
Intervention MeSH terms: Methylphenidate
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study of the Pharmacokinetic Profile of Deferiprone Sustained-Release Formulation in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the pharmacokinetic and safety profile of the
      sustained-release formulation of deferiprone under both fasting and fed conditions, and
      evaluate the relative bioavailability of this sustained-release formulation when compared to
      immediate-release formulation of deferiprone under fasting conditions.
    

Detailed description: 
      This was an open-label, single-dose, randomized, three-way crossover study under fed and
      fasting conditions designed to determine the pharmacokinetics, safety, and tolerability of
      deferiprone sustained-release tablets in healthy volunteers. Subjects were randomized to
      receive the following 3 treatments in different orders, with a washout period of 7 days
      between treatments:

        -  2000 mg of deferiprone sustained-release tablets under fed conditions

        -  2000 mg of deferiprone sustained-release tablets under fasted conditions

        -  2000 mg of Ferriprox immediate-release tablets under fasted conditions

      In each period, blood samples for pharmacokinetics (PK) assessment were collected prior to
      dosing and at specified time points up to 24 hours post-dose. Safety assessments were
      conducted throughout the study.
    

Intervention name(s): Deferiprone sustained-release; Deferiprone immediate-release
Intervention type(s): Drug; Drug
Intervention description(s): Deferiprone sustained-release tablets; Deferiprone immediate-release tablets
Other intervention name(s): Deferiprone; Ferriprox
Intervention MeSH terms: Deferiprone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deferiprone; Deferiprone sustained-release tablets; Pharmacokinetics
The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty
Condition: Arthroplasty, Replacement, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      It has been postulated that use of a larger femoral head could reduce the risk of dislocation
      after total hip arthroplasty, but only limited clinical data have been presented in third
      generation alumina bearings.

      The purpose of this study is to evaluate the effect of femoral head size for total hip
      arthroplasty using third generation alumina bearings on the joint stability and clinical
      results.

      The investigators hypothesized that larger ceramic head group has a similar rate of
      dislocation and clinical results in smaller ceramic head group.
    


Intervention name(s): 32mm ceramic head group; 28mm ceramic head group
Intervention type(s): Device; Device
Intervention description(s): we performed THA using 32mm ceramic head in this group.; we performed THA using 28mm ceramic head in this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Dose of Labeled Cholesterol for Kinetics: A Pilot Study
Condition: Lipid Metabolism
Study type: Interventional

Summary: 
      This is a pilot study to determine the optimum time and dose to draw blood samples using a
      tracer for HDL kinetics.
    


Intervention name(s): stable isotope of cholesterol
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Lipid; Apolipoproteins; Cardiovascular disease risks
The Effects of Vasopressin on Attention Control
Condition: Healthy
Study type: Interventional

Summary: 
      The main aim of the present study is to investigate whether intranasal vasopressin (20IU)
      could influence attention control in a social-emotional saccade/antisaccade eye-tracking
      paradigm.
    

Detailed description: 
      A number of previous studies have reported vasopressin's effect on human social behavior and
      social cognition, although it remains unclear whether vasopressin could modulate attention
      allocation including stimulus-driven bottom-up control and goal-directed top-down control. In
      the current randomized, between-subject, placebo controlled study, 89 healthy male subjects
      will be recruited and receive either vasopressin (20 IU) or placebo control administered
      intranasally. 45 minutes after treatment subjects will be required to complete a
      social-emotional saccade /antisaccade eye-tracking paradigm. The paradigm uses social (happy,
      sad, angry, fear, and neutral faces) as well as non-social (oval shapes) stimuli to explore
      social- and emotion-specific effects of vasopressin.
    

Intervention name(s): Vasopressin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of vasopressin (20 IU) intranasally; Administration of placebo intranasally
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Acupuncture for Postoperative Urinary Retention After Hemorrhoidectomy: a Randomized Controlled Trial
Condition: Postoperative Complications; Postoperative Urinary Retention
MeSH terms: Urinary Retention; Postoperative Complications
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to examine the efficacy of acupuncture in the management of acute
      postoperative urinary retention.

      Clinical question:

      Is acupuncture efficacious for postoperative urinary retention after hemorrhoidectomy
      compared with sham acupuncture and neostigmine.

      Study design:

      The participants who undergo hemorrhoidectomy and report postoperative urinary retention will
      receive one session of acupuncture or sham acupuncture or one injection of 1-mg neostigmine.
      The primary outcome was the time to first urination after surgery.
    


Intervention name(s): Acupuncture; Sham acupuncture; Neostigmine Injectable Product
Intervention type(s): Other; Other; Drug
Intervention description(s): Acupuncture is a technique that inserts a needle into the acupuncture point to treat a condition. In this trial, we will use acupuncture to treat postoperative urinary retention.; Participants will receive sham acupuncture at sham points.; Neostigmine was injected once after postoperative urinary retention.
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table
Condition: Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis; Spondylolisthesis; Spinal Fractures; Scoliosis or Tumors
MeSH terms: Scoliosis; Spinal Stenosis; Spondylolisthesis; Spinal Fractures
Study type: Interventional

Summary: 
      Appropriate fluid management is an important part of anesthesia in patients undergoing
      surgery, and several dynamic indices have been suggested to have high predictability for
      fluid responsiveness in patients receiving mechanical ventilation. Among various surgical
      positions, the prone position is known to cause unique physiologic and hemodynamic changes
      and affect the predictability and cut-off values of dynamic indices for fluid responsiveness.
      A previous study reported that pulse pressure variation (PPV) and corrected flow time were
      able to predict fluid responsiveness with relatively high accuracy in patients undergoing
      spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known
      to have less effects on the cardiovascular system compared to the Wilson frame, and therefore
      may be physiologically more appropriate in patients undergoing surgery in the prone position.
      The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in
      patients under mechanical ventilation. The present study aims evaluate the validity of PPV
      and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and
      prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson
      table.
    


Intervention name(s): Philips Intelivue MP70 monitor; Pleth Variability Index (PVI)
Intervention type(s): Device; Device
Intervention description(s): Philips Intelivue MP70 monitor (Intellivue MP70, Philips medical Systems, Suresnes, France) -a radial arterial cannula is inserted and arterial pressure waveforms are monitored through Philips Intelivue MP70 monitor. In the monitor, PPVauto is displayed in real-time. It is based on automatic detection algorithms, kernel smoothing, and rank-order filters.; PVI is the measure of the dynamic changes in the Perfusion Index (PI) that occur during one or more complete respiratory cycles. A rainbow Pulse CO-Oximetry sensor is attached to the patient's finger and the PVI is displayed in real-time on the Root monitor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Fluid responsiveness; corrected flow time; pleth variability index; prone position
Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids
Condition: Hearing Loss, Sensorineural; Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      This clinical investigation is designed to compare audiological performance (i.e.,
      measurements of sound quality and speech understanding) between Starkey's new
      receiver-in-canal device and a commercially available legacy receiver-in-canal device.
    

Detailed description: 
      Starkey is investigating a new hearing aid with several new audiological features. These
      features have been assessed for benefit, individually, but this clinical investigation will
      serve as a test for safety and efficacy with all hearing aid features, together. The design
      of this study is a single-blinded, crossover design and will be conducted at Starkey's
      headquarters in Eden Prairie, MN.
    

Intervention name(s): New Receiver-in-Canal Device; Legacy Receiver-in-Canal Device
Intervention type(s): Device; Device
Intervention description(s): Successor of previous device generation; Receiver-in-canal device available on the market
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment - Each participant will experience both test conditions (counterbalanced)
Masking: Single (Participant)
Primary purpose: Treatment