bioihbjkbjnl/mcl2 huggingface dataset:
Effects of BKR-017 on Insulin Resistance in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of BKR-017 on insulin resistance in type
      2 diabetes (T2D) subjects during 28 days of active test product administration.
    

Detailed description: 
      The study consists of a screening period followed by a 28-day treatment period. All subjects
      will receive test product.

      There are a total of 4 study visits including screening. Visit 1 is the screening visit.
      Eligible subject must have an HbA1c between 6.5 -10.5% and with HOMA-IR ≥ 2.7 (calculated
      from fasting insulin and fasting glucose). Visits 2 and 4 are overnight visits during which
      time a Mixed Meal Tolerance (MMTT) will be performed after an overnight fast. The MMTT
      requires an indwelling IV catheter so that 11 blood draws can be more comfortably be obtained
      over a period of 4 hours. At Visit 3,subjects will be evaluated and test product will be
      replenished. Routine chemistry and hematology testing are done and two time periods during
      the study and a physical exam is performed at screening
    

Intervention name(s): BKR-017
Intervention type(s): Dietary Supplement
Intervention description(s): BioKier, Inc. is developing colon-targeted, oral formulations of natural gut hormone secretagogues as non-prescription medical foods or supplements for nutritional use for improvement of insulin sensitivity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Human Biological Responses to Low Level Ozone
Condition: Environmental Exposure; Nasal Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      To investigate if low level ozone exposure will cause measurable inflammation in nasal cells.
    

Detailed description: 
      Air pollutants including ozone have been implicated in affecting health outcomes. In
      particular, high level ozone exposure has been shown to affect pulmonary function and cause
      pulmonary inflammation. Troubling community-based work has implicated high ozone levels as
      being correlated with increased pediatric asthma emergency room visits. Because of adverse
      health effects, EPA standards for safe ozone levels have been set, currently at 0.07 ppm.
      Still, it is estimated that 100 million Americans live in areas where ozone levels
      periodically remain above the EPA standard. And while this EPA standard had been set based on
      available data, it remained unclear at the time whether naturalistic low-level ozone
      exposure, such as fluctuations between 0.06-0.08 ppm throughout the day, might affect health
      as well.

      This group previously examined lung function and inflammatory response in adults exposed to
      low-level ozone, 0.06 ppm exposure for 6.6 hours, while undergoing intermittent moderate
      exercise. The investigators found that in response to low-level ozone exposure (0.06 ppm)
      with exercise, lung function declines and neutrophilic airway inflammation is observed. What
      remains unclear, is whether low-level ozone alone - without exercise - will cause similar
      health effects.

      To mimic exposure to ozone on a typical summer day in a polluted city, the investigators will
      expose subjects to a varying level of ozone, form 0.06 ppm to 0.08 ppm, rather than a
      constant 0.07ppm. The variation from 0.06ppm to 0.08ppm, then back to 0.06ppm will occur each
      hour.
    

Intervention name(s): Ozone; Filtered Air; Health and Exposure Tracker (HET)
Intervention type(s): Other; Other; Device
Intervention description(s): Participants will be exposed to a concentration of ozone for 6.5 hours at a concentration that varies 0.06 to 0.08; Participants will be exposed to filtered clean air; Ozone and heart rate tracker
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Air pollution; Air pollutant exposure; Ozone
The Effects of Clinical Pilates Training in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      The objective of this study was to examine the effects of 8-week clinical Pilates training on
      disease-specific indices, core stability, and balance in ankylosing spondylitis (AS)
      patients.
    

Detailed description: 
      The objective of this study was to examine the effects of 8-week clinical Pilates training on
      disease-specific indices, core stability, and balance in ankylosing spondylitis (AS)
      patients. AS patients were randomly assigned to either the Pilates group (PG) or control
      group (CG). The PG participated in Pilates training 3 times a week for 8 weeks. Patients in
      the CG were instructed to follow a home exercise program 3 times a week for 8 weeks.
      Assessments were performed before and after the interventions. Outcome measures were
      disease-specific indices, core endurance, and balance. Disease-specific indices were: Bath AS
      Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Bath AS Spinal Mobility
      Index (BASMI), and the AS Quality of Life (ASqOL) questionnaire. Static core endurance was
      assessed with trunk flexor, extensor endurance, and lateral side bridge tests, while dynamic
      core endurance was assessed using modified sit-up test. Balance was assessed with static,
      dynamic, and single-leg stance postural stability (PS) and limits of stability (LOS) tests
      using the Biodex Balance System SD.
    

Intervention name(s): Pilates; Home exercises
Intervention type(s): Other; Other
Intervention description(s): The Pilates group participated in an 8-week clinical Pilates training program; Control group were given a home-based exercise program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ankylosing spondylitis; pilates; postural balance; physical endurance; flexibility
TElemedicine to Replace Face-to-face Physician Consultation in Patients With HyperTension : a Pilot Randomized-controlled Trial
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The investigators has developed a blood pressure telemonitoring system. It is hypothesized
      that, when optimal control of BP is confirmed on the telemonitoring system, the index
      physician's consultation can be safely deferred, and medications can still be prescribed
      without such face-to-face consultation. Despite potentially resource-saving for doctors and
      time-saving for patients, the feasibility and patients' acceptability of the use of the
      telemonitoring system to replace face-to-face physician consultation remains unclear.

      For primary outcome, the investigators hypothesize that this telemonitoring system will be
      feasible and acceptable to patients and can replace physicians' face-to-face consultations.
      For secondary outcomes, the investigators hypothesize that patients receiving care through
      telemonitoring have non-inferior BP control when compared with patients receiving usual care.
      Furthermore, the patients receiving telemonitoring may also have enhanced self-efficacy and
      compliance to drugs and lifestyle interventions
    


Intervention name(s): telemedicine; usual care
Intervention type(s): Device; Other
Intervention description(s): a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation; These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics
      of fimasartan.
    


Intervention name(s): Atorvastatin; Fimasartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fimasartan, Atorvastatin
The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion
Condition: Anesthesia Insertion Complication; Airway Morbidity
Study type: Interventional

Summary: 
      Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed.
      The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a
      soft, direct optical Foley airway stylet tool (FAST) and compared with the standard
      introducer-tool (I-Tool).
    


Intervention name(s): Foley Airway Stylet Tool; introducer-tool
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: LMA, Foley Airway Stylet Tool (FAST), introducer-tool (I-Tool)
Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

Summary: 
      Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to
      decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of
      allergy in family
    


Intervention name(s): galactooligosaccharide
Intervention type(s): Other
Intervention description(s): addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides
Other intervention name(s): GOS; prebiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: interventional; doubleblind; randomised; pediatric; prebiotic; atopic; dermatitis; infant
The Influence of High Impact Exercise on Musculoskeletal Health in Older Men
Condition: Bone Strength; Neuromuscular Function
Study type: Interventional

Summary: 
      Osteoporotic fractures are an extremely common and serious public health issue which
      contribute substantially to pain, impaired mobility and morbidity in the elderly. Declines in
      bone strength combined with an increase risk of falls (associated with decline in muscular
      function with age) are the main determinants of fracture risk. Exercise that is novel and
      involves impact loading has the potential to improve bone strength and neuromuscular function
      (strength, power and balance). It is thus imperative to evaluate potential benefits of
      exercise in older people. The musculoskeletal responses to exercise may also be influenced by
      vitamin D status. It is the purpose of this study to consider the influence of a one year
      unilateral (one limb) high impact exercise programme on musculoskeletal health, specifically
      bone structure, muscle strength and power in older caucasian men. It is also the purpose of
      this study to determine whether this differs according to vitamin D status. The findings will
      reveal whether exercise can improve bone health and/or neuromuscular function, and whether
      improvements are dependent upon vitamin D status.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): multidirectional unilateral hopping exercise
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's
      disease.
    

Detailed description: 
      A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess
      the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to
      Severely Active Crohn's Disease.
    

Intervention name(s): RHB-104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine; 5 placebo capsules administered orally BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Crohn's Disease; moderate to severe; remission; MAP; antibiotic
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's
      DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV
      according to a three-dose immunisation course and as a booster dose in infants born to
      hepatitis B antigen seronegative mothers and previously primed with a birth dose of GSK's HBV
      vaccine.
    


Intervention name(s): DTPa-HBV-IPV/Hib vaccine; DTPa-IPV/Hib vaccine; EngerixTM-B
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.; Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.; The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.
Intervention MeSH terms: Edetic Acid; Vaccines; Pentetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effects of Peer Co-led Educational Group Intervention for Adults With Attention-Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Peer co-led education describes educators who are expert patients, user representatives or
      former patients, participating and teaching in educational interventions in cooperation with
      health care professionals. Peer co-led education is included in the Norwegian national
      guidelines for treatment of mental disorders, but despite some promising results for the
      treatment of other conditions, still little is known about the efficacy of peer co-led
      educational group interventions interventions for adults with attention deficit and
      hyperactivity disorder (ADHD).

      This pilot trial will evaluate patient satisfaction with and preliminary efficacy of a
      2-session peer co-led educational group program designed to address specific challenges faced
      by adults diagnosed with ADHD at an outpatient clinics in mid-Norway.
    


Intervention name(s): Group-based education; Waiting list; Standard treatment
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): The group-based educational program consists of two sessions that run over two consecutive weeks. Each session consists of a lecture from a recruited expert on the topic of the session and by expert patients with a following discussion of the topic facilitated by the course leader.; No educational intervention for the duration of the 10 weeks. During this period participants can receive standard treatment.; Diagnostic treatment with medication. In addition, some patients receive cognitive behavioral therapy (not systematically given to every patient). If needed, patients are also offered assistance with regard to economy, housing, education, and work as well as contact with family and network.
Other intervention name(s): Patient education; Treatment as usual
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Pilot randomized clinical trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: Behavior therapy; Peer groups; Patient satisfaction; Feasibility studies
Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc
Condition: AIDS
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to estimate the effects of a single dose of vardenafil on the
      blood pressure (BP) in subjects receiving maraviroc (MVC) (dosed to steady-state) and to
      assess the safety and tolerability of MVC in subjects receiving a single dose of vardenafil.
    


Intervention name(s): Maraviroc; Vardenafil; Maraviroc; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.; Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.; Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.; Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.
Other intervention name(s): Celsentri, Selzentry; Selzentry, Celsentri
Intervention MeSH terms: Maraviroc; Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pharmacodynamics. maraviroc, vardenafil, blood pressure
Treatment of Schizophrenia Through Internet-Based Psychoeducation
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effectiveness of a Web-based psychoeducational
      program in helping people with schizophrenia and their families manage the disease.
    

Detailed description: 
      This study will provide a comprehensive psychoeducational program which includes education,
      social support, information, coping strategies, and guidance from mental health, social
      services, and medical professionals. This study will work to reduce relapse, facilitate
      patient rehabilitation, decrease family distress, and improve family well being.

      Patients and their families participate in an in-person Psychoeducational Survival Skills
      Workshop that is designed to provide patients and their families with basic information about
      schizophrenia and its treatment. After the workshop, participants are provided with 6
      Web-based modules that are designed to increase mental health and schizophrenia knowledge.
      Patient relapse, family distress, family knowledge of schizophrenia, and data on user's
      acceptance and utilization are measured to determine the intervention's effectiveness.
    

Intervention name(s): World Wide Web-Based Psychoeducation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Methylphenidate in Treating Patients With Melanoma
Condition: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Methylphenidate may relieve some of the side effects of chemotherapy in patients
      with melanoma. It is not known whether receiving methylphenidate is more effective than
      receiving no further therapy in treating patients with melanoma.

      PURPOSE: Randomized phase III trial to determine if methylphenidate is more effective than no
      further therapy for the relief of fatigue and drowsiness in treating patients with melanoma
      who have received high-dose interferon alfa for 8-24 weeks.
    

Detailed description: 
      OBJECTIVES: I. Determine whether methylphenidate decreases fatigue and lethargy in cancer
      patients receiving interferon alfa. II. Determine whether the use of methylphenidate in this
      patient population decreases the number of dose reductions of interferon alfa due to
      toxicities other than myelosuppression or elevated liver function tests. III. Assess whether
      efficacy or toxicity of methylphenidate in this patient population is concentration
      dependent. IV. Compare the fatigue subscale and the proposed Brief Fatigue Inventory.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, two arm study. Patients are
      stratified according to initial fatigue level (high vs moderate), and treatment with tumor
      vaccine (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients
      receive oral methylphenidate twice daily. Arm II: Patients receive oral placebo twice daily.
      Treatment is continued for 21 consecutive days with dose escalations as tolerated and as
      needed by patient judgement, followed by an additional week to evaluate the effect of drug
      withdrawal. Patients are contacted by telephone at least twice weekly during the 21 day
      treatment and 7 day washout phase to assess adverse or rebound effects. Before the study
      begins and at weekly clinic visits for the 4 week study period, patients complete a series of
      questionnaires to measure mood, levels of fatigue and lethargy, and sense of well being.
      Patients also keep a short daily diary of study medication doses and degree of tiredness.
      Patients are followed every 3 months for 2 years, then every 6 months for the next 3 years,
      and then annually thereafter.

      PROJECTED ACCRUAL: A total of 200 patients will be accrued into this study within 39 months.
    

Intervention name(s): methylphenidate hydrochloride; quality-of-life assessment
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Masking: Double
Primary purpose: Supportive Care
Keywords: unspecified adult solid tumor, protocol specific; fatigue
A Prospective, Multi-center Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of Vitamin D3 B.O.N. Intramuscular Injection within 12 weeks with
      that of placebo in adults with Vitamin D Deficiency.
    


Intervention name(s): Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment