bioihbjkbjnl/mcl2 huggingface dataset:
Healthy Futures Project: A Community Based Obesity Prevention Program
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this research is to increase community awareness about the relationship
      between physical activity, screen time, and nutrition and how these factors influence healthy
      weight management.

      The problem of obesity is at epidemic proportions and has become the most important public
      health problem confronting the United States today. Of greatest concern is the 300% increase
      in obesity rates among children and youth over the past twenty years. Childhood obesity is a
      precursor of adult obesity.
    

Detailed description: 
      The Switch™ Program is a unique community and family-based behavior change initiative that
      helps motivate children to change three critical health behaviors that are risk factors for
      childhood overweight and obesity. Through community education, family-based strategies and
      partnerships with schools, 3rd, 4th and 5th graders are encouraged to: Switch what you Do™
      Switch what you View™ Switch what you Chew™.
    

Intervention name(s): Switch active lifestyles brought to you by MediaWise; Switch active lifestyles from MediaWise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Switch™ Program is a unique community and family-based behavior change initiative that helps motivate children to change three critical health behaviors that are risk factors for childhood overweight and obesity.; 1300 students (male and female) were recruited through two separate school districts in Lakeville, Minnesota and Cedar Rapids, Iowa. Informed consents went to all students who chose to participate. Demonstration and Control school were randomly selected. Baseline data was collected regarding physical activity, screen time, and nutrition, standard body measurements, and baseline data, and salivary cortisol levels were taken. Parent and teacher surveys were also conducted. After baseline selected demonstration sites and students were provided with information focused on improving healthy behaviors while the control sites served as matched comparison groups.
Other intervention name(s): Iowa State University; Michigan State University; National Institute on Media and the Family; Switch; Switch program; The Switch program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Screen time; Fruits and Vegetable Consumption; Physical Activity; Obesity; Overweight
The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using Single-site for Surgical Treatment of Early Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Gastric cancer is one of the most common malignancy worldwide. Surgical resection of the
      tumor is the only curative treatment for gastric cancer. However, surgical procedure
      accompanies postoperative pain and prolonged hospitalization. To lessen the surgical trauma
      and stress, minimally invasive surgery were introduced. Laparoscopic gastrectomy was accepted
      as safe and effective alternative to open gastrectomy. Furthermore, reduced port and single
      port laparoscopic gastrectomy are considered to minimize the surgical trauma during
      gastrectomy. However, limitations of laparoscopic approach using reduced port includes
      unergonomic posture of surgeon, physiologic tremor and collision of instruments. To overcome
      these limitations, robot surgery using novel single-site technology enabled surgeons to
      perform the surgical procedure reducing the number of trocar from three to one for insertion
      of scope and two robotic arms. Previously, successful application of single-site technology
      for cholecystectomy and hysterectomy were reported. The aim of this study is to validate the
      safety and feasibility of reduced port robotic distal gastrectomy using single-site
      technology for the surgical treatment of gastric cancer.
    


Intervention name(s): Reduced port robotic distal gastrectomy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: robot surgery; reduced port; single-site; safety; feasibility
Brady MX a Quality Improvement Study
Condition: Sinus Node Disfunction
MeSH terms: Sick Sinus Syndrome
Study type: Observational [Patient Registry]

Summary: 
      Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that
      lack of awareness of treatment and diagnostics pathways result in lower number of referrals
      to implanters of IPG.
    


Intervention name(s): IPG
Intervention type(s): Device
Intervention description(s): Patient might require IPG device to be implanted under standard of care
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Bradycardia symptomatic patients
Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study was to evaluate the effect of an herbal extract on postprandial
      glycemia following a meal.
    


Intervention name(s): herbal extract; root of woody shrub grown in India/Sri-Lanka
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more that one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in
      treating patients who have locally advanced or metastatic cancer of the pancreas.
    

Detailed description: 
      OBJECTIVES: I. Determine the objective response rate of patients with pancreatic
      adenocarcinoma treated with combination gemcitabine and docetaxel. II. Determine the toxicity
      profile of this combination therapy in these patients. III. Assess the survival rate of these
      patients.

      OUTLINE: Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30
      minutes. Patients receive treatment every other week for 8 weeks (4 courses). Patients may
      continue treatment in the absence of unacceptable toxicity or disease progression. Patients
      are followed every 12 weeks until death.

      PROJECTED ACCRUAL: This study will accrue approximately 10 patients per month for a maximum
      of 33 patients.
    

Intervention name(s): docetaxel; gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Docetaxel
Primary purpose: Treatment
Keywords: stage III pancreatic cancer; stage IV pancreatic cancer; recurrent pancreatic cancer; adenocarcinoma of the pancreas
"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"
Condition: Need for Tracheal Tube Exchange; Presence of Post-extubation Laryngeal Oedema
MeSH terms: Laryngeal Edema
Study type: Interventional

Summary: 
      This randomized controlled multi-centre trial in children from birth up to < 5 years of age
      aims to demonstrate equivalence as to the major outcome of post-extubation airway injury
      (stridor) comparing uncuffed tracheal tubes to current tracheal tubes with modern high volume
      - low pressure cuff combined with a cuff pressure release valve.
    

Detailed description: 
      The use of cuffed tracheal tubes is a controversial topic in paediatric anaesthesia and
      intensive care medicine. Cuffed tubes have traditionally been recommended for children older
      than 8 to 10 years. During the past decade, however, several authors have argued for the use
      of cuffed tracheal tubes in younger children and infants. A frequently cited argument against
      their use is the fear from post-extubation morbidity, allegedly caused by cuff induced
      tracheal and laryngeal airway injury. Using modern improved designed cuffed tracheal tubes,
      data from randomised prospective studies, performed in paediatric anaesthesia and intensive
      care units, suggest that using cuffed tracheal tubes do not carry an increased risk for
      airway morbidity as compared to uncuffed tracheal tubes in children below 8 years of age if
      correctly used. However, all these studies are based on single-centre experiences and/or
      included only a few neonates, infants and small children. Hence, there is equipoise as to the
      question, whether cuffed tubes are preferable over uncuffed standard tubes.

      So, this randomized controlled multi-centre trial in children from birth up to < 5 years of
      age aims to demonstrate equivalence as to the major outcome of post-extubation airway injury
      (stridor) comparing uncuffed tracheal tubes to current tracheal tubes with modern high volume
      - low pressure cuff combined with a cuff pressure release valve.

      The primary hypothesis relates to the main outcome criteria of this study, which is
      post-extubation morbidity as measured by the presence or absence of stridor after tracheal
      extubation. The null-hypothesis Ho is defined as no difference in the incidence rates of
      post-extubation morbidity between cuffed and uncuffed groups. The null-hypothesis (Ho: u-Diff
      = 0) will be compared with the alternative hypothesis (H1: u-Diff <> 0). The study is
      designed to detect a clinically unacceptable deterioration of 1.5% above the baseline
      airway-injury rate of 2.5% when using uncuffed tubes with a power of 90% and a type I error
      probability of less than 5%.
    

Intervention name(s): Intubation using tracheal tubes with or without cuff
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: intubation; trachea; tube; cuff; children
Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults
Condition: Intestinal Microbiota; Blood Markers
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study aims to investigate the direct effect of high amounts of dietary fibre and high
      amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity markers
      in healthy adults.
    

Detailed description: 
      Human gut microbiota composition and its bacterial pathways are involved in many metabolic
      processes, including digestion of actually indigestible food components and fat storage. Due
      to that it may contributes to the developement of obesity being one of the most important
      risk factors for many chronic diseases. Gut microbiota is under the influence of nutrition,
      consumption of pro- and prebiotics can promote the growth of certain bacterial strains. In a
      cross over dietary intervention this work will investigate the effect of defined diets on the
      intestinal microbiota in 20 healthy adults. The diets contain either high amounts (more than
      40g/d) of dietary fibre and low red meat (less than 30g/d) or low amounts (less than 20g/d)
      of dietary fibre and high amounts of red meat (200g/d). Intervention periods last 3 weeks
      each interrupted by a 3 weeks wash out period. Examination of participants will happen at the
      beginning and at the end of both interventions and will contain anthropometry, blood sample,
      faecal sample, urine sample and saliva sample.
    

Intervention name(s): low meat high fibre; high meat low fibre
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): less than 30g red meat and at least 40g dietary fibre per day; at least 200g red meat (pork, beef or other mammals) and not more than 20g dietary fibre per day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cross over; dietary intervention; fibre; red meat; microbiota
Safety and Tolerability of CDX-6114 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of an oral solution of
      CDX-6114 when administered as a single dose in healthy volunteers.
    

Detailed description: 
      This is a Phase 1, double-blind, placebo-controlled study in approximately 32 healthy
      volunteers who are 18 to 55 years old. Four cohorts are planned, each consisting of 8
      subjects; the cohorts as planned are 0.225, 0.75, 2.25, and 7.5 g in oral solution.
      Increasing doses of CDX-6114 will be assessed sequentially until the final dose is evaluated
      or any of the stopping criteria are reached. Subjects will each receive a single dose and
      then will be followed for a total of 22 days (3 weeks).
    

Intervention name(s): CDX-6114; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CDX-6114 will be administered as a single, oral dose solution at dose levels of 0.225, 0.75, 2.25, and 7.5 g.; Phosphate Buffer Diluent oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose-escalating, Randomized, Double-blinded, Placebo-controlled.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Very-low-density-lipoprotein Triglyceride (VLDL-TG) Uptake in Visceral Fat
Condition: Healthy; Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Purpose:

      To investigate the uptake of VLDL-TG in visceral fat in lean and overweight individuals
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      Blood samples Adipose tissue samples
    
Keywords: Obesity; Lipid metabolism; VLDL
Effects of Menthol Gum Chewıng on Postoperatıve Nausea, Vomiting, and Length Of Hospital Stay in Children Undergoing Appendectomy: A Randomızed Controlled Trıal
Condition: Postoperative Nausea and Vomiting; Hospitalism in Children
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The study was conducted as an experimental study to determine the effect of menthol chewing
      gum application on postoperative nausea, vomiting and hospital stay in children with
      appendectomy. The population of the study consisted of children aged 7-18 who underwent
      appendectomy in Bursa Yüksek İhtisas Training and Research Hospital Pediatric Surgery clinic
      between April and June 2022. In the sample of the study, a total of 60 children (menthol gum
      group- intervention group=30, control=30) who had postoperative nausea-vomiting, accepted to
      participate in the study and met the sample selection criteria were included. Starting from
      the second hour after the child was brought to the clinic after appendectomy, the children in
      the chewing gum group with nausea and vomiting were chewed gum for an average of 15 minutes.
      The patients in the study group were not intervened except for routine nursing care. During
      the chewing gum (between 5-10. minutes), up to 30., 60. and 120. Minutes after the chewing
      gum.The patient was re-evaluated in terms of nausea with the BARF nausea scale. Episodes of
      vomiting were recorded in patients with vomiting. After the quantitative stages of the study
      were completed, the patient's level of relief was evaluated using a verbal descriptive scale.
      Nausea and vomiting were also evaluated before the patient was discharged.
    


Intervention name(s): intervention
Intervention type(s): Other
Intervention description(s): After filling out the patient information form, the patients who met the research criteria were chewed gum for an average of 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: child; appendectomy; nausea and vomiting; chewing gum; length of hospitalization
Developing Interview Questions to Estimate Workplace Exposure to Electric and Magnetic Fields
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Electric and magnetic fields may increase the risk of cancer. Developing interview
      questions that accurately estimate a person's exposure to electric and magnetic fields may
      help doctors learn about the long-term effects of workplace exposure.

      PURPOSE: This clinical trial is developing interview questions that can be used in estimating
      workplace exposure to electric and magnetic fields.
    

Detailed description: 
      OBJECTIVES:

        -  Validate an interview-based electric and magnetic field exposure (EMF) assessment
           algorithm against measurements of the time-weighted average magnetic field magnitude
           used in previous epidemiologic studies.

        -  Calibrate the parameters in the algorithm in order to improve the exposure estimates.

        -  Correlate EMF exposure estimates from the algorithm with biologically based metrics
           measured by new instrumentation.

      OUTLINE: Participants respond to questions during a 5- to 15-minute telephone interview
      concerning workplace exposure to electric and magnetic (EMF) fields. Data is collected during
      the interview using an exposure assessment algorithm designed to estimate EMF workplace
      exposure based on participants' responses. The interview-based estimates are then validated
      against actual field measurements of magnetic field exposure captured by Emdex multiwave
      monitors located at participating sites.
    

Intervention name(s): questionnaire administration; study of high risk factors
Intervention type(s): Other; Procedure
Keywords: brain tumor
Three Dimensional Versus Two Dimensional Laparoscopic Salpingectomy in Patients With Hydrosalpinx Undergoing IVF-ET
Condition: Hydrosalpinx
Study type: Interventional

Summary: 
      A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being
      utilized in daily practice despite debates about its success.
    

Detailed description: 
      A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being
      utilized in daily practice despite debates about its success. in our study we will compare
      operative data and early postoperative outcomes of laparoscopic salpingectomy operations
      conducted using standard 2-D and 3-D laparoscopic vision systems
    

Intervention name(s): Laparoscopy
Intervention type(s): Biological
Intervention description(s): 3 D laparoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hydrosalpinx; Infertility; In vitro fertilization; Laparoscopy
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing
      Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a
      Vehicle Control in the Treatment of Acne Vulgaris
    


Intervention name(s): Tazarotene Cream 0.1%; Tazorac®; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.; Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.; Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Other intervention name(s): Tazarotene; Tazarotene; Vehicle
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Effect of Cholestyramine on LOXO-783 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to conduct blood tests to measure how much LOXO-783 is in
      the bloodstream and how the body handles and eliminates LOXO-783 when administered alone or
      in combination with cholestyramine in healthy participants. The study will also evaluate the
      safety and tolerability of LOXO-783 with and without cholestyramine. Participation could last
      up to 63 days including screening period.
    


Intervention name(s): LOXO-783; Cholestyramine
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): LY3849524
Intervention MeSH terms: Cholestyramine Resin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cholestyramine; LOXO-783
Study of the Effect of Food Intake on the Bioavailability of XC8 10 mg Film-coated Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective of the study: evaluation of the effect of food intake on the
      bioavailability of XC8, film-coated tablets, 10 mg after a single oral administration in fed
      or fasted condition at a dose of 20 mg (two tablets).

      Additional objective of the study: evaluation of pharmacokinetic parameters, safety and
      tolerability of XC8, film-coated tablets, 10 mg in healthy volunteers after single oral
      administration in fed or fasted condition in a dose of 20 mg (two tablets).
    


Intervention name(s): XC8
Intervention type(s): Drug
Intervention description(s): XC8 10 mg film-coated tablets, 3 discrete doses of 20 mg each separated by 7-day wash-out periods
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment