bioihbjkbjnl/mcl2 huggingface dataset:
Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer
Condition: Breast Cancer; Obesity
MeSH terms: Breast Neoplasms; Overweight
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This randomized clinical trial studies metformin hydrochloride in overweight or obese
      patients at elevated risk for breast cancer. Metformin hydrochloride may decrease the
      expression of early tumor makers in breast tissue of patients at increased risk for breast
      cancer
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the changes in the signal pathway profiling of breast tissue using reverse
      phase proteomics in tissue biopsy of overweight or obese women at elevated risk for breast
      cancer treated with metformin (metformin hydrochloride) (850mg orally twice a day) for 12
      cycles.

      SECONDARY OBJECTIVES:

      I. To determine the effect of metformin on breast tissue density of overweight or obese women
      at elevated risk for breast cancer using qualitative mammographic fat density criteria.

      II. To determine the effect of metformin on the insulin axis in serum of overweight or obese
      women at elevated risk for breast cancer treated with metformin (850mg orally twice a day)
      for 12 cycles.

      III. To determine the toxicities associated with metformin.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive metformin hydrochloride by mouth once daily on days 1-30 in course 1
      and twice daily on days 1-30 thereafter. Treatment repeats every 30 days for 12 courses in
      the absence of disease progression or unacceptable toxicity.

      ARM II: Patients receive placebo by mouth once daily on days 1-30 in course 1 and twice daily
      on days 1-30 thereafter. Treatment repeats every 30 days for 12 courses in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 6 months for up to 5
      years.
    

Intervention name(s): metformin hydrochloride; placebo; laboratory biomarker analysis
Intervention type(s): Drug; Other; Other
Intervention description(s): Given PO; Given PO; Correlative studies
Other intervention name(s): Glucophage; PLCB
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional

Summary: 
      The objective of this clinical investigation is to evaluate the 6-month outcome of the
      Selution Sirolimus-coated Balloon for the treatment of long tibial occlusive disease (TASC C
      and D) in patients with Critical Limb Ischemia (CLI)
    

Detailed description: 
      Extensive arterial occlusion significantly reduces arterial perfusion, and may eventually
      lead to Critical Limb Ischemia (CLI). The pathology gives rise to symptoms such as ischemic
      pain, slow healing wounds at lower extremity and gangrene. It places patients with
      multi-segment occlusion at high risks of amputations and mortality.

      The treatment methods for such long occlusive lesions are limited. Traditionally, the
      standard of care would be surgical revascularization. This is because lesion length have bee
      identified in several studies as an independent risk factor for the development of restenosis
      after angioplasty and/or stenting. However, thanks to recent advances in endovascular
      techniques, such as the utilization of subintimal technique for crossing long segment
      occlusions, it is now possible to employ endovascular techniques for suitable patients.

      The re-establishment of an in-line flow, even if only temporary, can allow tissue healing,
      which is vital in achieving limb salvage. In addition, the use of Drug Coated Balloons (DCB)
      and Drug Eluting Stents (DES) can potentially reduce restenosis rate.

      To date, there are few studies that have evaluated the performance of DCB in lesions that are
      longer than 10cm. We hope to evaluate the performance of the Selution DCB when used in
      treatment of such lesions.
    

Intervention name(s): Drug Coated Balloon
Intervention type(s): Device
Intervention description(s): SELUTION DCB will be used during lower limb angioplasty for treatment of lesions that are TASC C and D, in patients with Critical Limb Ischemia
Other intervention name(s): SELUTION
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Angioplasty
Technology-supported Behavioral Feeding Intervention
Condition: Feeding and Eating Disorders of Childhood
MeSH terms: Feeding and Eating Disorders; Feeding and Eating Disorders of Childhood
Study type: Interventional

Summary: 
      This investigation proposes to examine the effectiveness of a technology supported treatment
      manual for pediatric feeding disorders. Children with pediatric feeding disorders display
      intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent
      appropriate nutritional intake during meals and lead to a number of negative and potentially
      life threatening medical outcomes, including chronic malnutrition, growth retardation, and
      placement of a feeding tube. To date, behavioral intervention involving extinction-based
      procedures represents the only treatment for pediatric feeding disorders supported by
      research to improve mealtime behaviors. Due to the chronic and extreme nature of food
      refusal, treatment typically requires intensive, daily intervention conducted at highly
      specialized clinics to improve feeding behaviors. The cost and duration of intervention can
      total as much as $60,000 per child requiring up to 6 to 8 weeks, respectively. The potential
      for serious consequences associated with chronic food refusal, combined with the high cost of
      treatment, intensifies the need to identify means to disseminate effective treatment
      approaches to the broader community of healthcare providers.

      The proposed study represents the first attempt to systematically investigate the use of a
      treatment manual to address chronic food aversion through a randomized, waitlist control
      trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders Program.
      This study will involve a total of 20 participants randomly assigned to experimental
      conditions: technology supported treatment manual or waitlist control group (10 in each
      group). Children assigned to the waitlist control group will receive the technology supported
      treatment manual after the specified time on the waitlist. All participants will receive the
      same behavioral protocol involving three treatment sessions per day (45 minutes in length),
      for a total of 15 sessions across five consecutive days. Data will be collected on feeding
      behaviors during each treatment session and at follow-up using trained observers to collect
      data on mealtime behaviors, including acceptance, swallowing, disruption, expulsion, and
      grams consumed. This type of data collection and treatment is standard practice in the
      feeding disorders program; however, the use of a touch screen application for data capture
      with integrated manual is novel to this project.
    


Intervention name(s): Technology Supported Manual
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric feeding disorders; behavioral intervention; treatment manual; feeding; food refusal; diet
Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
Condition: Anisometropia
MeSH terms: Anisometropia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the safety, efficacy, predictability, and stability
      of laser in situ keratomileusis (LASIK) to correct high anisometropia in patients 8 to 15
      years old in whom conventional treatments have failed.
    

Detailed description: 
      Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were
      included in this study. Minimum follow-up was 10 years. All patients were treated with the
      Chiron Technolas 217 excimer laser.
    

Intervention name(s): LASIK
Intervention type(s): Procedure
Intervention description(s): Nine eyes of nine patients (3 male and 6 female) with high anisometropia (>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LASIK; safety; efficacy; stability; high anisometropia; patients 8 to 15 years old; conventional treatments have failed
Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial
Condition: Lymphatic Diseases; Chylothorax
MeSH terms: Chylothorax; Lymphatic Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study aims to investigate whether octreotide, a medication used off-label to treat
      chylothorax, has a direct effect on human lymphatic drainage. To study the effects of
      octreotide, the researchers conducted a pre-clinical experiment using human lymphatic vessels
      mounted in a myograph chamber and a clinical experiment in which a double-blinded,
      randomized, cross-over trial was conducted in 16 healthy adults. The results of the study
      will be used to determine the role of octreotide in the treatment of chylothorax and other
      lymphatic disorders.
    

Detailed description: 
      This study aimed to investigate whether octreotide, a medication used off-label to treat
      chylothorax, has a direct effect on human lymphatic drainage. Chylothorax is a condition in
      which there is an accumulation of lymphatic fluid in the chest cavity, and the mechanism
      through which octreotide helps to resolve this condition is not well understood. It has been
      speculated that the drug may reduce lymph production, but this has not been directly
      demonstrated. To study the effects of octreotide on human lymphatic vessels, the
      investigators conducted two experiments: a pre-clinical experiment using human lymphatic
      vessels mounted in a myograph chamber, and a clinical experiment in which a double-blinded,
      randomized, cross-over trial was conducted in 16 healthy adults, assessed by using
      plethysmography and near-infrared fluorescence imaging. The results of the study will be used
      to determine the role of octreotide in the treatment of chylothorax and to clarify the
      mechanism through which it acts. It is important to continue researching and developing
      effective treatments for chylothorax, as it can be a difficult condition to manage and may
      cause serious complications if left untreated.
    

Intervention name(s): Octreotide infusion; Saline infusion
Intervention type(s): Drug; Drug
Intervention description(s): Octreotide infusion for 2,5 hours. 300 ng/kg/min bolus was given for the first 15 minutes and then a continuous infusion of 100 ng/kg/min for the remaining 135 minutes.; Saline Infusion
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blinded cross over study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
DreaMed Advisor Pro System in Subjects With Type 1 Diabetes Treated With MDI Therapy
Condition: Insulin-dependent Diabetes Mellitus; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A multi center, open label, prospective study that will include up to 100 subjects with Type
      1 Diabetes treated with Multiple Daily Injections (MDI) of insulin according to a predefined
      sliding scale plan or carbohydrate ratio (CR) and correction factor (CF) plan, and
      Self-Monitoring of Blood Glucose (SMBG) or Continuous Glucose Monitoring (CGM).

      The study will include screening, a 3-4 weeks run-in period and a 6 weeks intervention
      period. Subjects will be asked to record their insulin delivery during basal/bolus insulin
      treatment (using dedicated apps and/or connected pens) and their daily activities (meals,
      physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total
      period of 9-10 weeks.
    


Intervention name(s): Advisor Pro
Intervention type(s): Device
Intervention description(s): The DreaMed Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data which consists of glucose levels and insulin delivery history. the Advisor Pro algorithm identifies glucose patterns and their possible causes, which may hamper the patient's glucose control, and recommend on adjustment to the patient-specific insulin treatment profiles as well as suggestions for personalized diabetes management tips (such as timing of meal boluses, bolus delivery compliance and personalized glucose targets).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Type 1; Multiple Daily Injections
A Comparison of Language Intervention Programs
Condition: Language Disorders
MeSH terms: Language Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Brief Summary:

      Nearly 7% of elementary school children present with difficulties learning and using
      language. Unfortunately, language impairments are often long lasting and may have serious
      social, academic, and vocational ramifications. More than 1 million children receive language
      intervention in the public schools each year, and many more are seen in hospitals and other
      clinical settings.

      This randomized clinical trial compares the language outcomes of Fast ForWord to two other
      interventions (computer assisted language intervention without acoustically modified speech
      and individual language intervention) and to the outcomes of an academic enrichment (control)
      condition. Each year for 3 years, children will be randomly assigned to each of the four
      conditions at three regional sites (Austin, Texas, Dallas, Texas, and Lawrence, Kansas). The
      treatments will be administered in special summer programs. The primary research question is
      which intervention results in the most improvement in the composite language score from the
      Oral and Written Language Scales. Secondary questions include which intervention results in
      the greatest gains in conversational language,which intervention results in the greatest
      gains 3 and 6 months after training, which intervention results in the greatest improvement
      in auditory perception, and which intervention is the most cost effective.

      The results of the study will have theoretical and practical value. Theoretically, the study
      tests the temporal processing hypothesis of language impairment. Practically, the study will
      describe and compare the language, communication, auditory processing and academic outcomes
      of different language interventions. The study will help clinicians and administrators choose
      the most effective and least expensive treatment for the children they serve.
    


Intervention name(s): Fast ForWord; Computer Assisted Language Intervention; Individual Language Intervention; Academic enrichment
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Specific Language Impairment; Fast ForWord; Language therapy; Auditory processing
The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study aimed to compare the impact of anticipatory guidance on the caries incidence of
      2-3-year-old preschool children and their 4-6-year-old siblings, as well as on their mothers'
      oral health literacy, as compared to the conventional Ministry of Health (MOH) programme.
    

Detailed description: 
      This quasi-experimental study was conducted at two government dental clinics in Batu Pahat
      District, Malaysia. The samples comprised of 478 mother-child-sibling trios (233 families in
      the intervention group, and 245 families in the control group). An oral health package named
      the Family Dental Wellness Programme (FDWP) was designed to provide anticipatory guidance to
      the intervention group at six-month intervals over three years. The control group received
      the standard MOH oral health education activities. The impact of FDWP on net caries
      increment, caries prevented fraction, and mother's oral health literacy was assessed after
      three years of intervention.
    

Intervention name(s): Dental health education
Intervention type(s): Other
Intervention description(s): Anticipatory guidance given to mothers to promote their children's oral health.
Other intervention name(s): Anticipatory guidance
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The model is an oral health education package that covers the following aspects: (i) cognitive component (for example, the provision of basic oral health knowledge using an anticipatory guidance technique); (ii) psychomotor component (for example, the demonstration of basic oral health skills such as toothbrushing skills with a hands-on practical); and (iii) attitude component (activities that help to improve the children's attitude towards oral health). Children (along with their older siblings and mothers) in the study group were required to make six-monthly visits to the dental clinic in the three-year study period. Those in the control group received the conventional Ministry of Health programme.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dental caries; Oral health literacy
Evaluation of Approved and Investigational Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover,
      dispensing clinical trial. During the study, each test article will be worn in a daily wear
      modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The
      subject will wear either the Test or Control article twice and the other study article once.
      The primary objective of this study is to demonstrate that the Test lens works as well, if
      not better compared to the Control lens with respect to CLUE (Contact Lens User Experience)
      comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will
      also aim to show acceptable lens fit for subjects wearing the Test lens.
    


Intervention name(s): CONTROL; TEST
Intervention type(s): Device; Device
Intervention description(s): ACUVUE OASYS; senofilcon A with new UV blocker
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
Condition: Kidney Cancer; Melanoma (Skin)
MeSH terms: Melanoma; Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill
      tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.

      PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin
      1 in treating patients who have melanoma or kidney cancer that cannot be removed during
      surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the dose of bryostatin 1 that, when administered in conjunction with low-dose
           interleukin-2, maximizes in vitro interleukin-2- stimulated peripheral blood stem cell
           proliferation in patients with melanoma or renal cell carcinoma.

        -  Assess other intermediate markers of immune response in patients treated with this
           regimen.

        -  Determine tumor responses, response durations, progression-free intervals, and survival
           of patients treated with this regimen.

      OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three
      bryostatin 1 dose levels.

      Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1
      hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease
      progression or unacceptable toxicity.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study within 2 years.
    

Intervention name(s): aldesleukin; bryostatin 1
Intervention type(s): Biological; Drug
Intervention MeSH terms: Aldesleukin; Bryostatin 1
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer; stage III melanoma; stage IV melanoma; recurrent melanoma
A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Asia and Europe. The aim of the trial is to investigate the
      pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single
      dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A.
      Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part
      B) (NCT00840086).
    


Intervention name(s): turoctocog alfa
Intervention type(s): Drug
Intervention description(s): A single dose will be administered i.v. (into the vein). Subjects will be randomised to one of two lots of NNC 0155-0000-0004.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment