bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasound Comparison of the Surface of the Subclavian and the Axillary Vein Versus the Surface of the Subclavian Vein
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The main objective of this study is the demonstration of an increase of over 50% of the
      surface visible on ultrasound (mm2) of the axillary vein and subclavian vein in arm abduction
      (90 °) and external rotation (90 °) with respect to the surface of the subclavian vein along
      the arm body.
    

Detailed description: 
      The secondary objective of this study is to investigate the anatomical relationships of these
      veins with the subclavian artery, the brachial plexus and the pleura, and assess the depth of
      the vein to the skin. Specifically, the following will be assessed:

        -  the depth of the vein (mm)

        -  the length of the minor axis (mm)

        -  the length of the major axis (mm)

        -  artery-vein distance (mm)

        -  vein-pleural distance (mm)

        -  the distance of the brachial plexus (mm)
    

Intervention name(s): Ultrasound measures
Intervention type(s): Procedure
Intervention description(s): Ultrasound will be used to measure the surfaces of the axillary and subclavian veins with the arms in different positions. Our goal is to compare the vein surface area available among different vein-position combinations. Our goal does not include testing specific devices.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Axillary vein ultrasound; Subclavian vein ultrasound
Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
Condition: Refractory Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to explore the combination of nal-IRI and TAS-102, which is expected to be an
      effective regimen that could be applied to various cancers
    

Detailed description: 
      Primary Objectives

        -  to determine the maximum tolerated dose (MTD) of nal-IRI (ONIVYDE®) in combination with
           TAS-102 (LONSURF®)

        -  to evaluate the toxicity profile of the combination therapy Secondary Objectives

        -  to evaluate the preliminary efficacy of the combination therapy of nal-IRI (ONIVYDE®)
           and TAS-102 (LONSURF®)

        -  to study the pharmacokinetics of the combination therapy

      A phase 1 study with a classical 3 + 3 dose escalation design. The target population is
      patients who have pathologically confirmed malignant solid tumors with no standard treatment
      available.
    

Intervention name(s): Nanoliposomal Irinotecan
Intervention type(s): Drug
Intervention description(s): Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)
Other intervention name(s): TAS-102
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Inhaled corticosteroids (ICS) have a number of known class effects including
      hypothalamic-pituitary-adrenocortical (HPA) axis suppression. Although the safety of inhaled
      Fluticasone Furoate (FF) on the HPA axis of adults and adolescent asthmatic patients has been
      established, it is important to assess the risk of suppression in children so as to establish
      whether this medicine can be safely used in this young population. This study aims to
      evaluate the effect of inhaled FF on the HPA axis of children 5-11 years of age (inclusive)
      with persistent asthma compared with placebo. Approximately 143 subjects will be enrolled.
      Subjects will enter a 7 to 14 day run-in period on oral montelukast 4 milligrams (mg) (5 year
      old subjects) or 5 mg (6-11 year old subjects) once daily. Eligible subjects will be
      randomized to receive once-daily FF inhalation powder 50 micrograms (mcg) or once-daily
      placebo inhalation powder in the morning via the ELLIPTA™ inhaler for 42 days. Subjects will
      continue to receive open label montelukast during the treatment period. All subjects will be
      provided albuterol/salbutamol inhalation aerosol, to use as needed to treat acute asthma
      symptoms throughout the study.

      ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.
    


Intervention name(s): FF; Placebo; Montelukast; Albuterol/Salbutamol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): FF will be provided as a dry powder inhaler with 30 doses per device, each containing 50 mcg of FF as a dry white powder per blister, to be inhaled orally via ELLIPTA.; Placebo will be provided as dry powder inhaler with 30 doses per device, each containing placebo as a dry white powder per blister, to be inhaled orally via ELLIPTA.; Montelukast will be provided as 4 mg and 5 mg chewable tablets.; Albuterol/Salbutamol will be provided as inhalation aerosol.
Intervention MeSH terms: Albuterol; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fluticasone Furoate; Asthma; HPA axis; Children; Inhaled corticosteroid
Intrathecal Enzyme Replacement for Hurler Syndrome
Condition: Hurler Syndrome
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis I; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol will examine whether the enzyme alpha-L-iduronidase (Laronidase), delivered
      into the spinal fluid of patients with Hurler syndrome at intervals before and after bone
      marrow transplant, is a safe and effective approach to slow the neurologic degeneration seen
      in Hurler patients undergoing transplantation.
    

Detailed description: 
      Subjects will receive an infusion of Laronidase into his/her spinal fluid approximately 12
      weeks before, 2 weeks before, 100 days after and 6 months after transplant. This procedure is
      done by lumbar puncture (also called a "spinal tap").
    

Intervention name(s): IRT Laronidase
Intervention type(s): Drug
Intervention description(s): Laronidase belongs to a class of drugs called enzyme replacement therapies or ERT that provides people with sufficient quantities of an important enzyme that they cannot create on their own. The main ingredient in laronidase is a protein that is identical to a naturally occurring form of the human enzyme alpha-L-iduronidase. Laronidase replaces the missing enzyme alpha-L-iduronidase and restores sufficient enzyme activity to break down GAG buildup.
Subjects will receive an infusion of Laronidase into his/her spinal fluid approximately 12 weeks before, 2 weeks before, 100 days after and 6 months after transplant. This procedure is done by lumbar puncture
Other intervention name(s): Aldurazyme
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hurler Syndrome; mucopolysaccharidosis type I; Iduronidase deficiency
Colesevelam for Children With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy and safety of the study drug in treating type 2
      diabetes in children 10 to 17 years old.

      The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children
      will have a 2 in 5 chance of being assigned to the low-dose group. They will have a 3 in 5
      chance of being assigned to the high-dose group.

      We believe the study drug will be safe, well tolerated, and improve blood sugar control in
      children 10 to 17 years old.
    

Detailed description: 
      Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM)
      to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have
      been treated with Metformin or have had no antidiabetic drug treatment in the previous three
      months.

      Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well
      tolerated, and shows improved blood sugar control (as evidenced by a significant change from
      baseline in hemoglobin A1C [HbA1c]).
    

Intervention name(s): High-dose colesevelam; Low-dose colesevelam
Intervention type(s): Drug; Drug
Intervention description(s): 3.75 grams colesevelam hydrochloride in oral suspension; 0.625 grams colesevelam hydrochloride in oral suspension
Other intervention name(s): Welchol oral suspension; Welchol oral suspension
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Blood glucose; Anti-diabetic; Bile acid sequestrant; Colesevelam HCl; Oral suspension; Pediatric; Add-on therapy; Add-on to metformin; Metformin; Adolescent; Lipid
Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)
Condition: Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma
    

Detailed description: 
      Since currently there is no standard therapy for untreated advanced-stage low-grade B-cell
      lymphoma, Phase 2/3 study was planned. Comparison(s): An intensified bi-weekly version by
      shortening the intervals of both rituximab and CHOP therapies using G-CSF, compared to the
      tri-weekly R-CHOP regimen.
    

Intervention name(s): Rituximab + Standard CHOP; Rituximab + Bi-weekly CHOP
Intervention type(s): Drug; Drug
Intervention description(s): Rituximab + Standard CHOP; Rituximab + Bi-weekly CHOP
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rituximab; CHOP; Bi-weekly; low-grade B-cell lymphoma; advanced stage; follicular lymphoma; G-CSF; Untreated stage III/IV low-grade B-cell lymphoma
An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesize that duloxetine treatment will be associated with improvement in symptoms of
      IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder.

      During this 12-week, open-label, outpatient study, male and female subjects between the ages
      of 18 and 65 years who have been diagnosed with irritable bowel syndrome (IBS) will be
      treated with open-label duloxetine.
    

Detailed description: 
      IBS is a chronic gastrointestinal disorder characterized by abdominal pain, altered bowel
      habits, and abdominal bloating for which no organic cause can be determined. Duloxetine has
      demonstrated efficacy in the treatment of depression as well as in several pain syndromes
      including diabetic peripheral neuropathy and fibromyalgia. We hypothesize that it will be a
      safe and efficacious treatment for the symptoms of IBS, in particular abdominal pain.

      We plan to study 15 male and female subjects between the ages of 18 and 65 years who have had
      gastrointestinal symptoms at least 2 days/week for greater than six months and who have been
      diagnosed with IBS by a physician. During the 12-week study, subjects will receive open-label
      duloxetine titrated up to 60mg/day. Subjects will be asked to complete a total of ten study
      visits during the 12-week study period. All study visits will be conducted at McLean
      Hospital.
    

Intervention name(s): duloxetine
Intervention type(s): Drug
Intervention description(s): 30mg oral duloxetine per day for one week, titrated up to 60mg per day at day 8, concluded by a one week taper period of 4 days of 30mg pills at the conclusion of the study, followed by 3 days on no medication (4+3 days=1 week), concluded with a post-taper follow-up appointment with a study physician.
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IBS; irritable bowel syndrome; irritable bowel
Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics,
      pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with
      moderate to severe chronic plaque psoriasis.
    

Detailed description: 
      A) To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1

      B) To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days

      C) To evaluate the efficacy and pharmacodynamics of Apo805K1
    

Intervention name(s): Apo805K1
Intervention type(s): Drug
Intervention description(s): Sequential parallel dose escalation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild to Moderate Chronic Plaque Psoriasis
Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms; Polyps
Study type: Interventional

Summary: 
      To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard
      view colonoscopy.

      To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard view
      colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and
      overall procedure time will be analyzed and reported for each group.
    

Detailed description: 
      Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be
      recruited to the study and randomized to one of two groups. Each enrolled subject will
      undergo two "back-to-back" procedures.

      Subjects in Group A (study group) will undergo a Standard view colonoscopy followed
      immediately by an EndoRings™ colonoscopy. Subjects in Group B (control group) will undergo an
      EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.

      Results from the two groups will be analyzed and compared, with primary outcome measures
      being adenoma miss rate and polyp miss rate. Secondary outcome measures will include
      withdrawal time, total procedure time and characteristics of polyps detected, including size
      and histological results.

      Subjects will be followed through a 24 hour and a 7-days telephone interview for analysis of
      unexpected adverse events. Clinical results will be analyzed using various statistical
      measures of significance.

      Multi-center study with up to 126 patients. Up to 126 treated patients (2 groups of 57
      patients +6 drop-out patients) will be enrolled into the study.
    

Intervention name(s): Tandem Colonoscopy
Intervention type(s): Device
Intervention description(s): Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order.
Other intervention name(s): Colon screening
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: polyp/adenoma miss rate; colonoscopy add-on device; enhanced screening
Thermal Comfort of Different Desktop Materials
Condition: Office Desk Ergonomics
Study type: Interventional

Summary: 
      The aim of this study is to test the suitability of different types of desk surfaces. The
      investigators will test 10 different surfaces (oak-ruff, oak-varnished, oak-oiled,
      spruce-ruff, spruce-varnished, spruce-oiled, particleboard laminate, particleboard veneer,
      corian and glass). Firstly, the investigators will perform tests to assess physical
      characteristics of the materials (thermal conductivity, hardness, roughness, skid measures).
      Secondly, the investigators will measure the participants' forearm skin temperature after
      20-minutes of using each desk surface. During those 20 minutes the participants will solve an
      attention test.
    

Detailed description: 
      People are surrounded by objects that are made of different materials. These materials should
      be carefully chosen, especially the ones that are in direct contact with user's skin. Office
      workers are constantly in contact with desk surface (while reading, typing, filling in forms,
      etc.). Therefore, it is important that the material of desk surface is suitable and properly
      chosen. It should be both functional and aesthetic. The aim of this study is to evaluate the
      suitability of different desk surfaces for sedentary workers. The investigators will test 10
      different surfaces (oak-ruff, oak-varnished, oak-oiled, spruce-ruff, spruce-varnished,
      spruce-oiled, particleboard laminate, particleboard veneer, corian and glass). All surfaces
      will be square shaped (800x800 mm). Firstly, the investigators will perform tests to assess
      physical characteristics of the materials (thermal conductivity, hardness, roughness, skid
      measures). Secondly, the investigators will measure the participants' forearm skin
      temperature after 20-minutes of desk use. Every participant will test all 10 sample desk
      surfaces (cross-over design). The investigators will use thermal IR camera to measure the
      temperature of participant's skin surface. The investigators will measure the temperature
      before and after the contact with desk surface. During those 20 minutes the participant will
      solve an attention test to assess the impact of different materials on attention. At the end,
      the participants will answer a questionnaire about the suitability of the material.
    

Intervention name(s): Desk surface
Intervention type(s): Other
Intervention description(s): The participants will test all 10 desk surfaces and will be randomly allocated to one of the desks each time.
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: desk surface; thermal comfort; ergonomics; attention
Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability and exposure of SB-751689 when administered
      alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a
      PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable
      the planning and conduct of a QTc study for SB-751689.
    


Intervention name(s): SB-751689 oral tablets (100 and 400 ng); Ketoconazole (NIZORAL) oral tablets (200 mg)
Intervention type(s): Drug; Drug
Other intervention name(s): SB-751689 oral tablets (100 and 400 ng)
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: SB-751689,; Calcium-sensing receptor antagonist (CaR),; Osteoporosis,; Parathyroid hormone (PTH),; Oral dose
My Body is Fit and Fabulous at School
Condition: Overweight; Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      In order to address and curb the high prevalence of childhood obesity in Malaysia, a
      school-based intervention program, MyBFF@school is developed for implementation in all
      schools in the country. The program is specific for overweight and obese students and it is
      hypothesized that by participating in this program, students will be able to control their
      body mass index.
    

Detailed description: 
      A nationwide Nutrition Survey of Malaysian Children carried out between 2008-2009 among 3542
      children aged from 6 months to 12 years showed a prevalence of 9.8% overweight and 11.8%
      obesity while in a more recent 2011 Global School-based Student Heath Survey showed that the
      percentage of overweight and obese Malaysian school children age 13-15 years old was 25.4%
      and 10.9% respectively . If left unchecked, these children will grow up to be obese adults,
      developed various obesity-related complications such as cardiovascular diseases, diabetes
      etc. Realising the urgent needs to address the problems, the Ministry of Health Malaysia with
      the cooperation of the Ministry of Education, proposed to implement MyBFF@school in all
      schools in Malaysia. Students participating in MyBFF@school will take part in a structured
      physical activity in the form of small sided football game (SSG), and are to attend
      intensified and interactive nutrition and psychology classes aimed at improving their
      knowledge, self-esteem and self-empowerment.
    

Intervention name(s): MyBFF@school program
Intervention type(s): Other
Intervention description(s): Students will be required to participate in all 3 components of MyBFF@school (SSG, nutrition and psychology sessions) for 16 weeks under the supervision of trained researchers, then for another 16 weeks supervised by their respective teachers-in-charge of physical education and/or co-curriculum activity. Each SSG session will be for an hour, thrice weekly while the nutrition or psychology session will be for 30-45 minutes once a week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: school based intervention; overweight; obese; BMI z score; fat mass
A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this study was to investigate the total
      exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult
      subjects with type 1 diabetes.
    


Intervention name(s): insulin degludec/insulin aspart
Intervention type(s): Drug
Intervention description(s): Insulin degludec/insulin aspart administered as a single subcutaneous injection (under the skin).
Intervention MeSH terms: Insulin; Insulin Aspart
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment