bioihbjkbjnl/mcl2 huggingface dataset:
Primary Care Obesity Prevention and Treatment
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The overall objective of this pilot is to demonstrate the feasibility of a low-cost
      intervention targeting obesity prevention among children in a primary care setting.

      Specifically, the investigators aim to answer the following questions:

      Can the investigators recruit and retain patients using the methods proposed, and how easy or
      difficult will this process be?

      Can physicians deliver the proposed intervention messages in the time the investigators have
      proposed?

      Can the phone counselor reach participants and accomplish the goals outlined for these calls?

      Can the investigators obtain the data proposed and within the proposed time frame?
    


Intervention name(s): Healthy eating and physical activity; Safety and injury prevention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parent counseling and coaching regarding healthy eating and physical activity habits for their child; Parent counseling and coaching regarding general personal and household safety
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of a range of doses of oral
      sumatriptan for the acute treatment of migraine in children ages 10 to 17.
    


Intervention name(s): Sumatriptan 25 mg; Sumatriptan 50 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One Sumatriptan 25mg tablet and one Matching Placebo tablet should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.; Two Sumatriptan 25mg tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.; Two Matching Placebo tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: adolescent; sumatriptan; children; migraine
Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial 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.

      PURPOSE: Phase II trial to study the effectiveness of letrozole in treating women who have
      recurrent or metastatic endometrial cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of letrozole, in terms of objective tumor response and
      time to progression, in women with recurrent or metastatic endometrial cancer. II. Determine
      the toxicity of letrozole in these patients. III. Determine the relationship between tumor
      receptor status, histologic grade, tumor aromatase activity, and tumor response in these
      patients.

      OUTLINE: Patients receive an oral letrozole tablet daily. Treatment continues for patients
      with complete or partial response until disease progression or unacceptable toxicity.
      Patients with stable disease may discontinue therapy after 24 weeks. Patients are followed at
      1 month and then every 3 months until death.

      PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study within 12-18 months.
    

Intervention name(s): letrozole
Intervention type(s): Drug
Intervention description(s): 2.5 mg of letrozole per day
Intervention MeSH terms: Letrozole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV endometrial carcinoma; recurrent endometrial carcinoma; endometrial adenocarcinoma; endometrial adenosquamous cell carcinoma
To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC3102C' Administered Intramuscularly in Healthy Adults
Condition: Prophylaxis Against Influenza
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to demonstrate the immunological non-inferiority between GC3102C and
      GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults
    


Intervention name(s): GC3102C; GC FLU inj.
Intervention type(s): Biological; Biological
Intervention description(s): a single dose (0.5 mL) intramuscularly on the deltoid muscle; a single dose (0.5 mL) intramuscularly on the deltoid muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Randomized Controlled Trial of Tenofovir in Patients of Reactivation of Hepatitis B Presenting as Acute on Chronic Liver Failure
Condition: Acute on Chronic Liver Failure; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis; Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Reactivation of hepatitis B is a well-characterized syndrome marked by the abrupt
      reappearance or rise of hepatitis B virus (HBV) DNA in the serum of a patient with previously
      inactive or resolved HBV infection. Reactivation can be spontaneous, but is most commonly
      triggered by cancer chemotherapy, immune suppression, or alteration in immune function.
      Spontaneous acute exacerbation of chronic hepatitis B infection is seen with a cumulative
      probability of 15±37% after 4 years of follow-up.2 Significant number of patients of
      spontaneous acute exacerbation of chronic hepatitis B may present with very high ALT levels,
      jaundice and liver failure.3 This condition should be defined as acute-on-chronic liver
      failure (ACLF) according to a recent Asia-Pacific consensus recommendation.

      The short term prognosis of patients of spontaneous acute exacerbation of chronic hepatitis B
      leading to ACLF like presentation is extremely poor, with a mortality of 30-70% in different
      series.8,9,10 Liver transplantation has been the only definitive therapy available to salvage
      this group of patients. However ,this is not readily available and affordable. Another
      therapeutic option is antiviral therapy but has limited data. The efficacy of lamivudine was
      evaluated and compared by historical control but was not found to be beneficial.8,9,10
      However ,a study from Taiwan showed a survival benefit in a subgroup of patients who were on
      lamivudine and had baseline bilirubin below 342 mmol/L (20 mg/dL).11 Tenofovir disoproxil
      fumarate (TDF) is a potent, rapidly acting, oral acyclic nucleotide analogue, reverse
      transcriptase inhibitor that has been shown to be highly effective in suppressing hepatitis B
      virus replication.12 Tenofovir has also shown excellent activity against HBV in both LAM-
      naïve and LAM-resistant patients.13,14. Its efficacy has not been evaluated in patients of
      reactivation of hepatitis B who present as ACLF Hypothesis: The investigators hypothesis that
      Tenofovir reduces the morbidity and mortality in patients with Spontaneous reactivation of
      hepatitis B by reducing HBV DNA.
    


Intervention name(s): Tenofovir disoproxil fumarate (TDF)
Intervention type(s): Drug
Intervention description(s): Tenofovir 300mg/day for 3 month
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acute-on -chronic liver failure; Reactivation of hepatitis B; Spontaneous reactivation of chronic hepatitis B presenting as to acute-on-chronic liver failure
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy, safety, and tolerability of three
      different strengths of SM04690 injected in the target knee joint of moderately to severely
      symptomatic osteoarthritis (OA) subjects.
    


Intervention name(s): SM04690; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lorecivivint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Samumed; SM04690
Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic Test Variables
Condition: Healthy Subjects; Diet, Healthy
Study type: Interventional

Summary: 
      The overall goal is to increase the knowledge that can be used for the development of food
      products with antidiabetic properties, with the aim of facilitating healthier food choices
      for people. More specifically, the primary aim of this project is to evaluate the effects of
      different varieties of quinoa on postprandial glucose tolerance and subjective appetite
      markers. The crossover, randomised dietary intervention study will be conducted in healthy
      adults.
    


Intervention name(s): Bread products
Intervention type(s): Other
Intervention description(s): Four intervention products were included in the study. Three experimental breads (quinoa 1, quinoa 2, quinoa 3) were developed, and consisted of white wheat breads substituted with the differrent quinoa types. The reference product included was a white wheat bread without quinoa. All intervention products contain 50 g available starch.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Anxiety is known to be one of the most common health concerns in in the general population,
      and the most common mental health issue, and has been associated with several health
      consequences. Medications are known to be effective, and currently serve as the primary
      treatment for anxiety but comes with a risk of adverse effects. Cognitive Behavioral Therapy
      (CBT-1) has also been shown to be effective and safer in the treatment of anxiety but
      presents its own limitations such as the time, cost, and training required. The relationship
      between vestibular stimulation and anxiety continues to be explored, however its usefulness
      in the treatment of anxiety is still unknown. Vestibular stimulation itself has been shown to
      be safe across multiple populations. If vestibular stimulation is shown to be effective in
      the treatment of anxiety, it could serve as a safer alternative to medications. It could also
      require less cost, time, and training than CBT-1, providing a treatment option that is not
      only safe and effective, but broadly available to the general population. It also could
      present an alternative intervention for patients who are non-responsive or refuse medication.
      Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular
      nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham
      control, in patients newly diagnosed with anxiety.
    


Intervention name(s): VeNS
Intervention type(s): Device
Intervention description(s): The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity and Safety of a Candidate Tuberculosis (TB) Vaccine Given to Healthy Adults in a TB-endemic Region
Condition: Tuberculosis (TB); Tuberculosis Vaccines
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB
      vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region. The
      Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    


Intervention name(s): GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342)
Intervention type(s): Biological
Intervention description(s): Intramuscular injection, 2 doses at 0, 1 month
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis vaccine
A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy male subjects to investigate whether administration of rifampicin can
      affect the fate in the body (amount and time of presence in the blood) of clazosentan
    


Intervention name(s): Clazosentan; Rifampicin; Saline (0.9% sodium chloride)
Intervention type(s): Drug; Drug; Other
Intervention description(s): Continuous i.v. infusion of 15 mg/h of clazosentan for 3 h; Single i.v. dose of 600 mg rifampicin for 30 min; Single i.v infusion of 500 mL saline for 30 min
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, two-period, cross-over Phase 1 study
Masking: None (Open Label)
Primary purpose: Other
Delayed Puberty in Boys; Clinical and Biochemical Characteristics and Effect of Testosterone Treatment
Condition: Delayed Puberty
MeSH terms: Puberty, Delayed
Study type: Observational

Summary: 
      To evaluate the phenotype and biochemical characteristics of boys referred for delayed
      puberty, to describe the frequency of associated co-morbidities and diseases, to evaluate the
      diagnostic criteria and the effect of testosterone treatment.
    

Detailed description: 
      Delayed Puberty in Boys; Clinical and biochemical characteristics and effect of testosterone
      treatment, is a retrospective study in a large case series of Danish boys with delayed
      puberty.

      All boys were referred to the Department of Growth and Reproduction to be evaluated for
      delayed puberty.

      Medical history: Birth length, birth weight, gestational age at birth, medical history
      (including cryptorchidism and hypospadias), family history of delayed puberty in mother,
      father and possible siblings.

      Physical examination: Pubertal staging according to Tanners classification of boys, genitalia
      development (G1-G5), pubic hair development (PH1-PH6), axillary hair (yes/no), axillary sweat
      (yes/no), gynecomastia (yes/no), micropenis (yes/no), height, mother height, father height,
      target height, weight, BMI, bone age and predicted adult height.

      Blood sampling for measurement of hormone levels: Follicle stimulating hormone (FSH),
      luteinizing hormone (LH), estradiol, anti-mullerian hormone, sex hormone-binding globulin,
      testosterone, dehydroepiandrosterone-sulfate, androstenedione, inhibin A, inhibin B, growth
      hormone, insulin like growth factor-1 and insulin like growth factor binding protein-3.

      Gonadotropin-releasing hormone stimulation test for measurement of peak FSH and peak LH.

      Retrospective DNA analysis looking for common polymorphisms.

      If testosterone treatment were initiated, route of administration, dose and duration of
      treatment were registered.
    

Intervention name(s): retrospective data collection
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consisted of boys who were referred to be evaluated for delayed
        puberty at the Department of Growth and Reproduction between January 1990 and February
        2013.
      
Biospecimen description: 
      serum and white cells
    
Keywords: Delayed Puberty; Boys; Hormones; Polymorphism, Genetic
The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
Condition: Upper Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      comparing the exercise induced immune response after two weeks on a low carbohydrate
      (ketogenic) diet with the response after two weeks on a high carbohydrate diet.
    

Detailed description: 
      A cross-over intervention study, with a total duration of 6 weeks. An athlete follows a high,
      or low carbohydrate (ketogenic) diet. After 2 days a test day takes place where the athlete
      performs an exercise test and blood samples are taken at different time points. After that,
      the athlete continues following the diet for another 12 days, after which he comes back again
      for another identical test day. Then a 2 weeks wash-out period. After that, the athlete
      follows the same protocol but then with either the low (ketogenic), or high carbohydrate
      diet.
    

Intervention name(s): diet
Intervention type(s): Other
Intervention description(s): low carbohydrate diet (< 10 EN% carbs) vs high carbohydrate diet (>50 EN% carbs)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Comparison of Volume Controlled Ventilation and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
Condition: Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General Anesthesia
MeSH terms: Pneumoperitoneum
Study type: Interventional

Summary: 
      The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the
      potential to cause an adverse effects on respiratory mechanics and gas exchange.
      Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak
      pressure. Therefore, the aim of this study is to evaluate whether Autoflow-volume controlled
      ventilation improves gas exchange and respiratory mechanics in patients undergoing
      robot-assisted laparoscopic radical prostatectomy.
    


Intervention name(s): Volume controlled ventilation; Autoflow-volume controlled ventilation
Intervention type(s): Other; Other
Intervention description(s): During anesthesia and surgical procedure, volume-controlled ventilation will be applied with an inspiration:expiration ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg) without ventilatory mode change.; After tracheal intubation, volume-controlled ventilation will be initiated with an I:E ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg). Immediately after CO2 pneumoperitoneum with steep Trendelenburg positioning, Autoflow-volume controlled ventilation will be applied instead of volume-controlled ventilation. Immediately after CO2 desufflation and supine positioning, volume-controlled ventilation will be applied again.
Other intervention name(s): VCV; Autoflow-VCV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: robot-assisted laparoscopic radical prostatectomy; Autoflow; trendelenburg position; pneumoperitoneum
Irritation and Sensitization Study of d-Amphetamine Transdermal System
Condition: Cumulative Irritation and Sensitization
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess skin irritation as well as sensitization for d-ATS patch in healthy
      subjects.
    

Detailed description: 
      This is a randomized, evaluator-blinded study consisting of one (1) group. The study will
      assess skin irritation as well as sensitization for d-ATS patch in healthy subjects. All
      three (3) articles (d-ATS patch, placebo patch, and saline patch) will be applied
      simultaneously on the back of each subject. Healthy subjects will be enrolled to participate
      in two (2) phases: A Screening Phase and a Treatment Phase. The total duration of the study
      for each subject will be about 10 - 16 weeks. The Re-challenge Test will only be performed
      for subjects who experience any type of sensitization during Challenge Period.
    

Intervention name(s): dATS
Intervention type(s): Drug
Intervention description(s): d-Amphetamine Transdermal System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other