bioihbjkbjnl/mcl2 huggingface dataset:
Enteral Nutrition After Pancreaticoduodenectomy
Condition: Cancer of Pancreas; Cancer of Duodenum; Ampulla of Vater Cancer; Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma; Pancreatic Neoplasms; Duodenal Neoplasms
Study type: Interventional

Summary: 
      Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer.
      PD is still associated with a relatively a high incidence of delayed gastric emptying. And,
      there are no acknowledged strategies to avoid DGE. Several feeding strategies have been
      investigated to cope with this problem. However, there is still no consensus concerning the
      best nutrition support method after pancreaticoduodenectomy. The purpose of this study is to
      determine the effect of nutrition support methods on DGE after pancreaticoduodenectomy: early
      enteral nutrition or total parenteral nutrition.

      Patients undergoing pancreatoduodenectomy will be randomized to receive early enteral
      nutrition (EN group), or Saline administration (Saline group), or oral intake only (Natural
      control). The EN group will receive standard enteral diet administered through a nasojejunal
      tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by
      20-40 ml up to the estimated level. The Saline group will receive saline administered through
      a nasojejunal tube beginning from the 1st postoperative day. Oral intake will not be
      restricted in all three group.
    


Intervention name(s): Early enteral nutrition; Saline; nasojejunal tube insertion; Oral intake
Intervention type(s): Other; Other; Device; Other
Intervention description(s): Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament. Standard enteral diet, administered through a nasojejunal tube, is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level.
After PD, enteral nutrition liquid regimen will be used step by step from postoperative day 1 to postoperative day 7.Patients are targeted to receive calories for 25 kcal/kg/day. Meanwhile, oral food intake was not restricted.; Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament.
After PPPD,Only Normal Saline were given through nasojejunal tube. Entral nutrition was not administrated. Patients intake food orally at will.; Patients was encouraged to drink water on postoperative day 1, to eat liquid diet on postoperative day 2, to eat semi-solid on postoperative day 3, to eat solid food on postoperative day 4.
Other intervention name(s): Naso-jejunal tube will be placed intraoperatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to
      assess pain following subcutaneous (SC) administration of gantenerumab as a
      high-concentration liquid formulation (HCLF) at different injection speeds. The total
      duration of the study for each healthy participant will be up to approximately 21 weeks.
    


Intervention name(s): Gantenerumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence.; Gantenerumab Placebo solution will be administered via SC injection according to assigned treatment sequence.
Other intervention name(s): RO4909832
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Leveraging Mobile Health Technology to Optimize Early Stimulant Medication Treatment: A Feasibility Pilot
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The goal of this study is to develop and test a mobile web application to optimize early
      stimulant medication treatment for children receiving care for Attention/Deficit
      Hyperactivity Disorder (ADHD) in a publicly-funded mental health clinic.
    

Detailed description: 
      In other words, the study will find out whether it is feasible and acceptable for parents to
      receive reminders for clinic visits and ADHD medication and enter daily ratings of their
      child's ADHD symptoms and medication side effects into a smart phone. It will also examine
      whether it is feasible and acceptable for doctors to use this information summarized on a
      tablet (iPad) screen during a medication follow-up visit. If the parent consents, the study
      will also examine whether it is feasible and acceptable for the child's teacher to enter
      their ratings of ADHD symptoms twice a week using a link on their email. This information
      will also be included in the doctor's iPad screen. If this technology is found to be
      promising, then a larger study will be done to examine if medication treatment is safer, more
      consistent, and more effective using this technology compared to usual care. This is
      important because the technology may remove the burden on parents and teachers to report ADHD
      symptoms and medication side effects using paper forms, and for doctors to record this
      information in the medical record. In total, there will be 12 parent/ child dyads, 6
      clinicians and up to 12 teachers enrolled. Each parent/child dyad will be videotaped for up
      to 3 visits with the clinician (n=36 videotaped sessions). The study time period is from the
      first visit that ADHD medication is prescribed to the time of the third follow-up medication
      visit. We anticipate that the follow-up visits will be every 1-2 weeks during this early
      phase of stimulant medication treatment. Thus, the study time period for each parent/child
      dyad will be between 4-8 weeks. We anticipate that data collection will occur between August
      19, 2013 and June 31, 2014.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parents taking their children to Augustus Hawkins Mental Health Center for treatment of
        ADHD who were prescribed stimulant medication for the first time. The attending physicians
        will work at the clinic.
      
Keywords: ADHD
Single Ascending-dose Study to Evaluate Safety, Tolerability, and PK of MYMD1 in Healthy Male Adult Subjects
Condition: Undefined
Study type: Interventional
Phase: Phase 1

Summary: 
      Double-blind, placebo-controlled, First-in-Human, single ascending-dose study. Approximately
      40 healthy adult male subjects will be given a single capsule of MYMD1 to determine its
      safety, how well it is tolerated, how the body acts on the experimental drug, and how the
      experimental drug acts on the body. This will be based on blood and urine sample analysis and
      other physical measurements.
    

Detailed description: 
      A single-center, double-blind, placebo-controlled, first-in-human, single ascending-dose
      study to evaluate the safety, tolerability, and pharmacokinetics of single oral dose capsules
      of MYMD1 in healthy male adult subjects. Each subject will participate in the study for
      approximately 7 weeks, including a Screening period of up to 30 days, a confinement period of
      4 days, and a follow-up period of approximately 2 weeks. In each cohort, 8 subjects will be
      administered a single dose of either MYMD1 (N=6 in each cohort) or Placebo (N=2 in each
      cohort), under fasted conditions, and each subject will participate in only 1 of the 5
      cohorts during the study. Anticipated dosing levels will be 5mg (Cohort 1), 10mg (Cohort 2),
      15mg (Cohort 3), 20mg (Cohort 4), and 25mg (Cohort 5). Sentinel dosing will be used to
      initiate each cohort, and the first 2 subjects will be randomized 1:1 to receive either MYMD1
      or Placebo. The remaining subjects will be dosed 5:1 to receive either MYMD1 or Placebo,
      respectively.
    

Intervention name(s): MyMD1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Isomyosamine 5mg capsules; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled, single ascending dose study.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Pharmacokinetics; Phase I; First-in-Human; Safety; Tolerability; Hashimoto thyroiditis; Autoimmune
Comparison Between Clear Aligners and Traditional Fixed Appliances in the Treatment of Four-premolar-extraction Cases
Condition: Malocclusion, Angle Class I; Malocclusion; Displaced or Missing Teeth; Crowding
MeSH terms: Malocclusion; Tooth Loss; Anodontia; Malocclusion, Angle Class I
Study type: Interventional

Summary: 
      Patients who have severe crowding that require four premolars extraction will be treated in
      this study. The efficacy of the clear aligners and vestibular fixed appliances will be
      assessed. The treatment result of these two different methods will be explored using the Peer
      Assessment Rating (PAR) in two different times (T0: Before treatment, T1: After treatment)
      and the American Board of Orthodontics Objective Grading System (ABO-OGS) after treatment
      (T1).

      There are two groups:

      First group (Experimental): the patients in this group will be treated using clear aligners.

      Second group (Control): the patients in this group will be treated using fixed appliances.
    

Detailed description: 
      For years, orthodontists and dentists have used removable appliances for orthodontic
      treatment. Today, with the CAD/CAM technology, clear aligners treat a broader range of cases
      with greater precision. They consist of a series of plastic aligners that are intended to
      replace conventional wire and bracket technology for many orthodontic cases. Each custom
      manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their
      original state to a final, treated state. Each aligner is worn for about two weeks, then
      replaced by the next in the series until the final position is achieved.
    

Intervention name(s): Fixed Appliances; Clear Aligners
Intervention type(s): Device; Device
Intervention description(s): Using an MBT-prescription of metallic brackets, patients will be treated in the conventional way; Using a sequence of clear aligners, patients will be give an aligner every two weeks until the completion of treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Naldebain for Pain Management After Knee Arthroplasty
Condition: Arthropathy of Knee Joint
MeSH terms: Joint Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and
      Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve
      a sustained-release long-acting analgesic on the market in Taiwan. This study hopes to use a
      rigorous double-blind randomized controlled experiment to understand whether the new
      sustained-release analgesic Naldebain can achieve effective pain relief for patients
      undergoing knee replacement surgery, and to evaluate the patient's functional recovery status
      .
    

Detailed description: 
      Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and
      Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve
      a sustained-release long-acting analgesic on the market in Taiwan. At present, it is the only
      analgesic injection that has an efficacy of up to seven days. The currently approved drug
      indication is to relieve moderate and severe acute pain after surgery. Pharmacological
      mechanisms and experiments show that its analgesic effect is equivalent to morphine, but its
      side effects are much lower than morphine. Because of its special pharmacological mechanism,
      it has extremely high potential to improve patients undergoing knee replacement surgery.
      Therefore, this study hopes to use a rigorous double-blind randomized controlled experiment
      to understand whether the new sustained-release analgesic Naldebain can achieve effective
      pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's
      functional recovery status .
    

Intervention name(s): Nalbuphine Sebacate (Naldebain); Placebo medication
Intervention type(s): Drug; Drug
Intervention description(s): Nalbuphine Sebacate (Naldebain) 2mL/150mg would be intramuscularly injected during knee arthroplasty surgery.; Placebo medication, Nalbuphine Sebacate not contained
Intervention MeSH terms: Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines
Condition: Skin Aging
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the hypothesis that the efficacy and safety of
      Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.
    

Detailed description: 
      The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle
      of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up
      visits.
    

Intervention name(s): Botulinum Toxin Type A(Meditoxin®); Botulinum Toxin Type A(Botox®)
Intervention type(s): Drug; Drug
Intervention description(s): single administration, Day 0, 20U; single administration, Day 0, 20U
Other intervention name(s): Neuronox®, Siax®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Changes in Microbiome and Metabolites Regarding Physical Activity in Middle-aged Korean Women
Condition: Healthy
Study type: Interventional

Summary: 
      This study aimed to examine the effect of physical activity (PA) on health through changes in
      multi-omics biomarkers during 6 months of exercise intervention.
    

Detailed description: 
      This study aimed to examine the effect of physical activity (PA) on health through changes in
      multi-omics biomarkers during 6 months of exercise intervention. Twenty-seven healthy
      middle-aged women were recruited and 14 subjects completed the exercise intervention. A total
      of three blood and stool samples were collected at 3-month intervals. The amount of PA was
      measured with an accelerometer. Clinical variables were used, including blood pressure, grip
      strength, flexibility, and blood glucose levels and lipid markers obtained from laboratory
      tests. The concentration of blood metabolites was measured by targeted metabolomics. Fecal
      microbiome data were obtained by 16S rRNA gene amplicon sequencing. During the second half
      period (period 2), Coronavirus disease 2019 (COVID-19) occurred and spread out in Korea, and
      PA decreased compared with the first half period (period 1). Blood pressure, hemoglobin A1c
      (HbA1c), and low-density lipoprotein cholesterol (LDL-C) decreased in period 1 and tended to
      increase again during period 2. Forty metabolites were changed significantly during period 1,
      and investigators found that 6 of them were correlated with changes in blood pressure, HbA1c,
      and LDL-C via network analysis. Our results may suggest the relationship between changes in
      biomarkers at multi-omics levels during exercise and a message that reduced PA due to
      COVID-19 can adversely affect health.
    

Intervention name(s): Physical activity
Intervention type(s): Behavioral
Intervention description(s): The exercise intervention program consisted of two distinct periods. During period 1, subjects participated in a moderate to vigorous intensity exercise program for 40 minutes a day, 4 days a week. The exercise program was conducted in Tabata format targeting 70% of the maximum heart rate. Recovery was then induced for 1 minute and 30 seconds, allowing the heart rate to return to resting levels. The exercise routine primarily consisted of full-body exercises, functional training, and power exercises.
During period 2, a low-intensity static exercise program was implemented. Similar to period 1, the subjects exercised for 40 minutes a day, 4 days a week. The exercise program included static exercises. The maximum heart rate was maintained below 50%. The detailed exercise program consisted of stretching movements and balance movements.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Microbiome; Metabolite; Physical activity
Application of Ectoin Allergy Nasal Spray in Comparison to Beclomethasone Nasal Spray
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      This is a comparative, open label, parallel group, non interventional study to further
      demonstrate the effectiveness and tolerability of Ectoin® Allergy Nasal Spray. In addition
      the effectiveness and safety shall be compared to a Beclomethasone nasal spray. The patient
      applies Ectoin® Rhinitis Nasal Spray or Beclomethasone nasal spray according to the
      instructions for use. The observation takes place over a period of 14 days. Response to
      treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a
      dairy.
    


Intervention name(s): Medical Device, drug-like; Beclomethasone
Intervention type(s): Other; Drug
Intervention description(s): Ectoin Allergy Nasal Spray; Beclomethasone nasal spray
Intervention MeSH terms: Beclomethasone
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinic
      
Keywords: Allergic Rhinitis; Ectoine; bitop; Ectoin
IV Haloperidol for the Treatment of Headache in the ED
Condition: Headache; Migraine Disorders
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain
      scores in patients who present to the emergency department (ED) with a complaint of headache.
      A total of 150 patients age 13-55 presenting to the emergency department with headache will
      be enrolled from October 2015 - October 2016. Patients will be randomized and pain scores and
      side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will be performed by
      telephone at 24 hours.
    


Intervention name(s): Haloperidol; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): 0.9% Sodium Chloride
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Partial Rebreathing in the Treatment of Migraine With Aura
Condition: Migraine With Aura
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Interventional

Summary: 
      A study to test the efficacy of a partial rebreathing device in treating and/or preventing
      migraine pain
    


Intervention name(s): Active partial rebreathing device; Dummy partial rebreathing device
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Understanding Substance Use and Incident HIV/STI Among Young Black MSM
Condition: HIV; Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      The scientific purpose of this study is to look at how substance use may relate to human
      immunodeficiency virus (HIV) infection among young black men who have sex with men in
      Atlanta.
    

Detailed description: 
      Young black men who have sex with men (YBMSM) are a critically at-risk population in the
      United States and Atlanta that faces extremely high incidence rates of HIV and other sexually
      transmitted infections (STIs). The understanding of what places this group of men at high
      risk is incomplete, and the role of substances in amplifying that risk is unclear. This study
      will fill a number of gaps about how substances and partnerships place YBMSM at increased HIV
      risk. The study includes several innovative aspects. First, the investigators are using a
      theoretical framework to understand multilevel associations between substance use and HIV
      risk behavior in YBMSM in the southeastern United States, a critically at-risk but
      understudied population. Second, the investigators are using a variety of enhanced
      measurement methods to understand these associations. The investigators are supplementing
      self-reported substance use with objective measures to enhance the sensitivity of classifying
      recent use. The investigators will analyze incident HIV/STI endpoints in addition to
      self-reported sexual behaviors. The investigators will use detailed, event-based and dyadic
      measures of substance use and its covariates, which will capture both sexual and non-sexual
      contexts of use. Although previous cohort studies have explored alcohol and drug use during
      sexual events among men who have sex with men (MSM), few studies have described both sexual
      and non-sexual patterns of, and motivations for, substance use among YBMSM, and none have
      incorporated longitudinal biomarkers of substance use and related these to incident infection
      outcomes. Finally, the investigators are using a mixed-methods approach to provide context to
      the quantitative findings. By recruiting subjects to a nested qualitative study within the
      larger cohort based on their interval-specific risks, the investigators will gain in-depth
      information regarding the emergence, persistence, and resolution of these complex
      relationships between substances and sexual risk behaviors among YBMSM and how these
      relationships emerge and are resolved over time.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young black men who have sex with men in Atlanta, Georgia will be recruited in a variety of
        venues in Atlanta. If needed, there will be targeted recruitment via Facebook.
      
Biospecimen description: 
      Dried blood spot testing, whole blood