bioihbjkbjnl/mcl2 huggingface dataset:
Improving Health-Promoting Behaviors in Adolescent Cancer Survivors Using AWAKE: A Feasibility Trial
Condition: Health Behavior
Study type: Interventional

Summary: 
      A behavioral intervention called Achieving Wellness After Kancer in Early Life (AWAKE)
      focused on increasing hope in order to improve quality of life and health-promoting behaviors
      in survivors of young adult cancer. The goals of this project are to adapt the AWAKE platform
      into an intervention acceptable for use in adolescent cancer survivors and their guardians in
      order to improve survivors' hope, quality of life, and health-promoting behaviors, and to
      generate the preliminary data needed for a randomized control trial to test the efficacy of
      the AWAKE platform in this population.
    

Detailed description: 
      A behavioral intervention called Achieving Wellness After Kancer in Early Life (AWAKE)
      focused on increasing hope in order to improve quality of life and health-promoting behaviors
      in survivors of young adult cancer. Adaptation of this intervention to incorporate messaging
      for adolescents and their guardians has the potential to have a long-term impact on
      adolescent cancer survivors. The goals of this project are to adapt the AWAKE platform into
      an intervention acceptable for use in adolescent cancer survivors and their guardians in
      order to improve survivors' hope, quality of life, and health-promoting behaviors, and to
      generate the preliminary data needed for a randomized control trial to test the efficacy of
      the AWAKE platform in this population.
    

Intervention name(s): AWAKE
Intervention type(s): Behavioral
Intervention description(s): Behavioral intervention called Achieving Wellness After Kancer in Early Life (AWAKE) is focused on increasing hope in order to improve quality of life and health-promoting behaviors in survivors of young adult cancer. The AWAKE mobile app contains eight modules for participants to complete over 8 weeks with the ability to review prior modules. Participants receive a prompt on their mobile device weekly to complete each module and/or they will receive a text reminder. The app includes health education messaging, weekly homework assignments, the ability to track progress towards goals with self-monitoring and graphical depictions of progress, videos of inspirational materials, and a portal for interacting with their coach.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer Survivors; Adolescent; Achieving Wellness After Kancer in Early Life; AWAKE; Health-Promoting Behaviors
Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in
      glabellar rhytides (frown lines) using a new treatment satisfaction measure.
    


Intervention name(s): botulinum toxin Type A; normal saline (placebo)
Intervention type(s): Biological; Drug
Intervention description(s): botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.; Normal saline (placebo) injected into the glabellar region on Day 0.
Other intervention name(s): BOTOX® Cosmetic, Vistabel®, Vistabax®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      AUDs are difficult to treat, and relapse rates are high, with an estimated 80% of individuals
      with AUDs returning to alcohol use after completing addictions treatment. Novel treatment
      approaches are needed to enhance long term sobriety. The investigator's research team has
      been investigating the use of acamprosate to prevent relapse to alcohol use. Unfortunately
      despite being FDA approved and endorsed by the American Psychiatric Association only 10% of
      patients treated for AUD are prescribed acamprosate or other antidipsotropic medications. The
      number is higher for patients treated in programs affiliated with Mayo Clinic Addiction
      Services (approximately 20%) but is way less than expected. The most common reasons behind
      these low numbers are the understanding that not every patient benefits from the use of
      specific medication and the lack of biomarkers predictive of response. The purpose of this
      project is to identify such biomarkers by discovery of genomic and metabolomic markers
      associated with response to acamprosate treatment.
    


Intervention name(s): Acamprosate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.; The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor
      outcome, however, it is challenging for monitoring. The current study is designed to explore
      whether data generated using Suremedix Device including a pump and non-invasive sensors
      including, chest motion sensor, photoplethysmography (PPG), and Electrocardiography (ECG),
      can be used to identify detectable oscillations that are correlated with the mean, the
      diastolic and the systolic pressure values of the pulmonary artery, as measured using the
      gold-standard Swan-Ganz method.
    


Intervention name(s): Suremedix Device
Intervention type(s): Device
Intervention description(s): Performing measurements using the Suremedix Device by applying gradually ascending air pressure to the subject lungs through a mouse piece while measuring respiratory chest motion, PPG and ECG.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Dose Response Study of a Fermented Yogurt on the Immune System and Gut Health
Condition: Immune System
Study type: Interventional

Summary: 
      The purpose of this study is to determine the dose-response effect of a yogurt containing a
      combination of bifidobacterium Lactis (BB-12) and Lactobacillus Acidophilus (LA-5) and green
      tea extract on markers of the immune system and gut health in healthy subjects. We
      hypothesize that the response of the immune function will be dose-dependent of the probiotics
      found in the fermented yogurt.
    

Detailed description: 
      There is an increasing list of food containing probiotics on the market. Several studies have
      emphasized the health benefits of single probiotics, particularly on the immune system.
      However, it is unclear how a combination of two different probiotics complemented with green
      tea extract can beneficially modify markers of the immune.

      The aim of this study is to determine the dose-response effect of a yogurt containing a
      combination of bifidobacterium lactis (BB-12) and Lactobacillus Acidophilus LA-5 and green
      tea extract on immune system in healthy subjects. More specifically, this randomized,
      parallel placebo controlled study will investigate the impact of increasing doses (109 and
      1010) of these probiotics on phagocytosis activity, oxidative metabolism and on the
      antipneumococcics antibody specific serotype response S. pneumoniae vaccination. Finally,
      this study will also examine the effect of increasing dose of these probiotics on intestinal
      microflora and blood lipids.
    

Intervention name(s): Yogurt with 1X10E9 BB-12 and LA-5; Yogurt with 1X10E10 BB-12 and LA-5; Yogurt Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 100g of yogurt containing the probiotics L.acidophilus and B.lactis (concentrations of 1x10E9 of each probiotics) with 40 mg of green tea extract, once a day for 10 weeks.; 100g of yogurt containing the probiotics L.acidophilus and B.lactis (concentrations of 1x10E10 of each probiotics) with 40 mg of green tea extract, once a day for 10 weeks.; 100g of yogurt placebo containing no probiotics and no green tea extract, once a day for 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Probiotics; Immunity; Immune response; Intestinal microflora; Blood lipids; Phagocytosis activity
Immunogenicity of an Inactivated COVID-19 Vaccine
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is an open phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac)
      manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to
      evaluate the immunogenicity of the CoronaVac in healthy children aged 3-11 years old.
    

Detailed description: 
      This study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated
      COVID-19 vaccine(CoronaVac)in healthy children aged 3-11 years old.A total of 400 healthy
      subjects who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured
      by Sinovac Research & Development Co., Ltd and is currently 28-42 days after the second dose
      will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years
      old.All of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the
      CoronaVac.
    

Intervention name(s): Inactivated COVID-19 Vaccine
Intervention type(s): Biological
Intervention description(s): 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other intervention name(s): CoronaVac
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Sedative and Hypnotic Effects Induced by EA
Condition: Bypass Complications
Study type: Interventional
Phase: Phase 1

Summary: 
      Insomnia is a common clinical disease.The serious patients could not sleep all night, often
      accompanied by headache, dizziness, forgetfulness and so on. All of these increase the mental
      burden of insomnia patients and seriously affected the normal work and quality of life of
      patients. Modern medical treatment to treat insomnia is using sedative and hypnotic drugs,
      mainly benzodiazepine, zopiclone. But long-term use of these drugs can induce the adverse
      reactions, including resistance, dependence and addiction. Many articles indicate that
      electroacupuncture can effectively improve insomnia, play the role of sedative and hypnotic
      effect and avoid many adverse reactions and side effects. Then there are no more objective
      indicators to affirm that which part of brain takes place the appropriate changes when
      electroacupuncture induces the sedative effect. So we designed this experiment.
    


Intervention name(s): Electroacupuncture
Intervention type(s): Procedure
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Electroacupuncture, Sedation
Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics (PK) of Digoxin in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the PK of digoxin administered alone and in
      combination with AMG 510 in healthy participants.
    


Intervention name(s): AMG 510; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral tablet
Other intervention name(s): Sotorasib
Intervention MeSH terms: Sotorasib; Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AMG 510; Healthy Participants; Digoxin
Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects
Condition: Healthy Volunteer
MeSH terms: Dermatitis, Phototoxic
Study type: Interventional
Phase: Phase 1

Summary: 
      Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects
    

Detailed description: 
      A baseline evaluation of the patch sites will be performed immediately prior to application
      of the patches to ensure that no conditions, markings, or coloration of the skin will
      interfere with interpretation of the study results.

      A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back,
      placing 2 sites for KX01KX2-391 ointment 1% and 2 sites for Placebo vehicle ointment. One set
      (KX01 ointment 1% IP and Placebo ointment vehicle patches) will be designated for irradiation
      and the other set will remain non-irradiated under open conditions. The distance between the
      patches will be no less than one centimeter.

      The numbering of the test sites will remain the same throughout the study. The sites will be
      marked with an indelible, surgical marker.
    

Intervention name(s): KX01 ointment 1%; Placebo ointment
Intervention type(s): Drug; Drug
Intervention description(s): A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions.; A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin Irritation; Phototoxicity
Hypothermia to Treat Severe Brain Injury
Condition: Brain Injuries; Hypothermia
MeSH terms: Brain Injuries; Hypothermia; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this trial is to determine if hypothermia (body cooling), administered very
      soon after a severe brain injury improves functional outcome. This pilot trial ended in July
      2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of
      the trial (see link below).
    

Detailed description: 
      After brain injury, the brain produces certain chemicals that are harmful to the injured
      tissues. Moderate hypothermia-also called body cooling-may slow or prevent the production of
      these chemicals. Hypothermia also decreases the amount of oxygen needed by the brain, which
      may provide some protection during this critical period. Earlier studies have shown that
      maintenance of moderate hypothermia may have a helpful effect in head injury patients ages 16
      to 45 who arrive at the hospital with a low body temperature suggesting that very early
      cooling may be beneficial.

      In this study scientists will initiate hypothermia or body cooling to 35˚C within two hours
      of severe brain injury to determine if body cooling improves functional outcome.

      Patients may enter the study in one of two ways. They may be evaluated and surface cooling
      begun at the scene by emergency medical services (EMS) personnel affiliated with the study;
      or patients who arrive in the emergency department (ED) of the study hospital within 2 hours
      of injury-and who have not already been evaluated by EMS personnel affiliated with the
      study-will be evaluated and cooling begun, if applicable, by NABISH study personnel.

      NABISH-trained EMS personnel who reach a patient with a suspected severe head injury within 2
      hours of injury will induce hypothermia to 35˚C at the scene, in transit, or in the ED.

      NABISH study personnel will induce hypothermia to 35˚C in the ED in patients with suspected
      severe head injury who reach the ED within 2 hours of injury if cooling has not already
      begun. Patients who meet entry criteria (based upon past studies) for moderate hypothermia
      for 48 hours will then be cooled to 33˚C and then gradually rewarmed after 48 hours at 33˚C.
      Patients initially cooled to 35˚C within 2 hours of injury who prove during trauma evaluation
      to have exclusion criteria for 48 hours of moderate hypothermia will be warmed from 35˚C to
      37˚C.

      This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711
      for the Phase III version of the trial (see link below).
    

Intervention name(s): hypothermia (body temperature lowered to 33°C or 91.4°F)
Intervention type(s): Procedure
Allocation: Non-Randomized
Primary purpose: Treatment
Keywords: brain injury; hypothermia; body cooling; body temperature
Feasibility and Acceptability of a Soy-fiber-maize Complementary Food in Malawi.
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this intervention study is to assess the feasibility and acceptability of
      soy-fiber-maize versus soy-maize complementary foods on bowel movement frequency, transit
      time, growth, gastrointestinal symptoms, microbiota composition and activity.
    

Detailed description: 
      This is a 6-month randomized study to assess the feasibility and acceptability of
      soy-fiber-maize complementary food. Participants (caregiver/mother - child pairs) will
      complete a 2-week baseline period during which stool frequency, and stool consistency will be
      collected by paper questionnaire, and participants will collect a single stool. Dietary data
      will be obtained at baseline, 3 months and at 6 months during the study period. Participants
      will receive soy-fiber-maize or maize complementary foods twice a day for 6 months.
      Participants will attend a study visit every week for study food collection. During the study
      visit at baseline, 3 and 6 months, participants will complete a 24-hour dietary recall and
      height, weight and Mid Upper Arm Circumference will be measured on the children. At these
      same times, participants will provide stool samples. Participants will complete weekly
      questionnaires to assess gastrointestinal health, stool frequency and stool form.
      Furthermore, participants will participate in a focus group discussion at the end of the 6
      months' study period to assess the feasibility and acceptability of soy-fiber-maize
      complementary foods for their children. Stool samples will be analyzed for differences in the
      microbiota.
    

Intervention name(s): Soy-fiber-maize; Maize
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two servings of soy-maize porridge fortified with soy fiber (1.3 g per serving) will be consumed by the children each day for a period of six months.; Two servings of maize porridge will be consumed by the children each day for a period of six months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children 6-36 months will be fed soy-fiber-maize or soy-maize complementary foods for 6 months.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: healthy
Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD
Condition: Colonic Polyp
MeSH terms: Colonic Polyps
Study type: Interventional

Summary: 
      The purpose of this randomized study is to compare ESD procedural time and cost facilitated
      with a dual balloon accessory device versus ESD procedures performed without the accessory
      device. Study is designed to detect if the double balloon interventional platform helps to
      perform removal of benign complex colonic lesions safer and in more efficient way.
    

Detailed description: 
      This is a prospective, post-market, randomized clinical trial comparing colonic ESD
      procedures utilizing the DiLumen™ Endolumenal Interventional Platform to colonic ESD
      procedures that are performed without use the DiLumen™ device.

      The study participants will be randomly assigned to study group and control group The
      treatment group will consist of up to 100 subjects treated with the DiLumen™ device. The
      control group will consist of up to 100 subjects treated without DiLumen™ device. Assessments
      will include procedure timepoints, anesthesia use, polyp location and classification,
      over-all cost assessment, and general complications.

      The primary outcome will be analyzed using parametric statistics to compare the means of the
      study and control groups. P-values and confidence intervals will be reported. Descriptive and
      summary statistics will also be employed. Secondary outcomes will be summarized with
      descriptive statistics.
    

Intervention name(s): double balloon interventional platform (DiLumen); no double balloon interventional platform (DiLumen)
Intervention type(s): Device; Device
Intervention description(s): double balloon interventional platform (DiLumen) is used for removal of colonic polyp; double balloon interventional platform (DiLumen) is not used for removal of colonic polyp
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be assigned into study group [procedure performed with use of double balloon interventional platform (DiLumen)] or control group [procedure done without the use of double balloon interventional platform (DiLumen)]
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Endoscopic Submucosal Dissection