bioihbjkbjnl/mcl2 huggingface dataset:
Acute Effects of Exercise at Different Temperatures in Allergic Rhinitis Patient
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effects of exercise at different temperatures
      on nasal blood flow and symptoms in allergic rhinitis patients.
    

Detailed description: 
      Fifteen patients with allergic rhinitis aged between 18 and 35 years who had a positive skin
      prick test to house dust mite (D. pteronyssinus). The experiment was a crossover design in
      which each participant was given aerobic exercise by ergometer in two difference temperatures
      room : 25 degree celsius and 34 degree celsius. Rhinitis symptoms, nasal blood flow, heart
      rate, and oxygen saturation were measured before, during exercise at 15, 30, and 45 minutes,
      and after exercise at 0, 15 and 30 minutes in each temperature. Moreover, blood pressure,
      peak nasal inspiratory flow, pulmonary functions, respiratory muscle strength, and fractional
      exhaled nitric oxide were measured before and after exercise at 0, 15 and 30 minutes in each
      temperature.
    

Intervention name(s): Cycling exercise in room temperature at 25 degree Celsius.; Cycling exercise in room temperature at 34 degree Celsius.
Intervention type(s): Other; Other
Intervention description(s): The participants received a aerobic exercise of cycling for 60 minutes in room temperature at 25 degree Celsius.; The participants received a aerobic exercise of cycling for 60 minutes in room temperature at 34 degree Celsius.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Fifteen patients with allergic rhinitis aged between 18 and 35 years who had a positive skin prick test to house dust mite (D. pteronyssinus). The experiment was a crossover design in which each participant was given aerobic exercise by ergometer in two difference temperatures room : 25 degree celsius and 34 degree celsius. Rhinitis symptoms, nasal blood flow, heart rate, and oxygen saturation were measured before, during exercise at 15, 30, and 45 minutes, and after exercise at 0, 15 and 30 minutes in each temperature. Moreover, blood pressure, peak nasal inspiratory flow, pulmonary functions, respiratory muscle strength, and fractional exhaled nitric oxide were measured before and after exercise at 0, 15 and 30 minutes in each temperature.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aerobic exercise; allergic rhinitis; nasal blood flow; peak nasal inspiratory flow; acute exercise
A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
Condition: HIV Infections; Measles
MeSH terms: Measles
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare measles seroconversion rates (development of antibodies) at 13 months of age in
      HIV-infected and uninfected children on one of two immunization schedules: attenuated
      measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine
      (Attenuvax) at 6 months plus M-M-R II vaccine at 12 months.

      Recommendations for the age at vaccination should balance the need to minimize the risk of
      morbidity and mortality with the benefit of achieving the highest seroconversion rates.
      Immunizing a more intact immune system at an earlier stage of HIV infection may in turn
      achieve better and long-lasting measles protection. This study will help define a more
      effective measles vaccine regimen for children diagnosed with HIV infection and will provide
      greater insight into the functional status of the HIV-infected children's humoral immune
      system.
    

Detailed description: 
      Recommendations for the age at vaccination should balance the need to minimize the risk of
      morbidity and mortality with the benefit of achieving the highest seroconversion rates.
      Immunizing a more intact immune system at an earlier stage of HIV infection may in turn
      achieve better and long-lasting measles protection. This study will help define a more
      effective measles vaccine regimen for children diagnosed with HIV infection and will provide
      greater insight into the functional status of the HIV-infected children's humoral immune
      system.

      Patients, HIV infected and uninfected, are randomized to one of two attenuated measles
      vaccine schedules: at 6 and 12 months of age, or at 12 months of age only. Attenuvax is
      administered as the month 6 vaccine and M-M-R II as the month 12 vaccine. Patients are
      followed for 24 months after the last vaccination.
    

Intervention name(s): Attenuvax; M-M-R-II
Intervention type(s): Biological; Biological
Intervention description(s): Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age; Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Measles-Mumps-Rubella Vaccine; Vaccines, Attenuated; Measles Vaccine; Immunization Schedule; Measles Virus; Measles
Efficacy of Dialectical Behavior Therapy in Patients With Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis:

      Primary hypothesis: Participants in the dialectical behavior therapy group have greater
      reductions in the frequency and severity of suicidal and non-suicidal self-injurious
      behaviors compared to participants in the alternative treatment group.

      Secondary Hypotheses: Participants in dialectical behavior therapy group have improved
      treatment outcomes compared to participants in alternative treatment, including mental health
      service utilization, symptoms of borderline personality and depression symptoms, suicidal
      thought and hopelessness, disability, and quality of life.
    

Detailed description: 
      This study will be a 3-year randomized control trial. Patients will be referred from any
      mental health services in Taipei area who meet Diagnostic and Statistical Manual of Mental
      Disorders, Fourth Edition, Text Revision criteria for Borderline Personality Disorder.
      Inclusion criteria include subjects who fulfill the Diagnostic and Statistical Manual of
      Mental Disorders, Fourth Edition, Text Revision criteria for Borderline Personality Disorder,
      18-60 years of age, sign the informed consent, have had at least two episodes of suicidal or
      non-suicidal self-injurious episodes in the past 5 years, and at least one of which is in the
      3 months preceding enrollment. The exclusion criteria include psychotic disorder, bipolar I
      disorder, severe physical illness, and mental retardation. Outcome measures will be obtained
      at pre-treatment, 4-month, 8-month and post-treatment (12-month) during 1-year protocol.
      Using semi-structured interview and a battery of self-report forms, a range of symptoms and
      behaviors associated with Borderline Personality Disorder will be assessed including suicidal
      thought, suicide attempt, depression, hopelessness, quality of life, disability, service
      utilization, and function. Measures are selected based on previous outcome studies of
      dialectical behavior therapy. Outcome variables will be evaluated by blinded assessors.
    

Intervention name(s): Dialectical behavior therapy (DBT)
Intervention type(s): Behavioral
Intervention description(s): Dialectical behavior therapy (DBT), developed by Marsha Linehan, has gained widespread popularity as a treatment for BPD, and its efficacy has been demonstrated in several trials.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Development of a Family-Based Treatment for Adolescent Methamphetamine Use
Condition: Behavior and Mental Disorders; Methamphetamine Disorders
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The AIMS study compares a methamphetamine-specific treatment intervention to a
      treatment-as-usual Functional Family Therapy (FFT) approach for adolescents ages 15 to 19.
      Adolescents are assigned to one of two treatment conditions: (1) 16 weeks of FFT designed to
      strengthen family relationships and develop skills for helping the adolescent avoid drug use;
      or (2) 16 weeks of a combination of FFT and a methamphetamine-specific intervention involving
      group and individual therapy sessions; Families are assessed using questionnaires and
      interviews, and adolescents participate in neuropsychological testing, before, during, and
      after treatment to provide information about family functioning, the adolescent's drug use,
      the adolescent's peers, and other factors that may contribute to treatment success.
      Adolescents also provide urine specimens for drug screening at assessment visits. Through a
      partnership with Oregon Health and Science University (OHSU), adolescents will participate in
      functional magnetic resonance imaging appointments at the hospital to examine regional brain
      blood flow during tasks designed to measure impulsivity and risk-taking behaviors. As a
      treatment development grant, study investigators will study adolescents' acceptance of and
      response to the newly developed methamphetamine-specific treatment approach.
    


Intervention name(s): Adolescent Methamphetamine Treament (AMT); Functional Family Therapy (FFT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): AMT Group Therapy plus Functional Family Therapy (FFT); FFT
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: methamphetamine abuse
Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women
Condition: Menopause
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with
      esterified estrogens tablets
    


Intervention name(s): esterified estrogens 0.625 mg and methyltestosterone 1.25 mg
Intervention type(s): Drug
Intervention MeSH terms: Methyltestosterone; Estrogens; Estrogens, Esterified (USP); Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Menopause; Postmenopause; Estrogen; Hormone Therapy
GLucose Monitoring Programme SingaporeE (GLiMPSE)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This phase 1 study is a non-randomized, single-arm, multi-center study that is designed to
      evaluate the feasibility and acceptability of the flash glucose monitoring system together
      with a structured education programme in individuals with Type 2 Diabetes.
    

Detailed description: 
      Up to 30 adults and 15 children will be recruited from 3 different sites in Singapore.

      For Adults, this phase consists of screening and intervention periods.

      Screening Period (Week -2 to -1):

      Participants will be asked to wear a blinded flash glucose monitoring system and will be
      asked to continue testing their capillary glucose readings at least once daily for 2 weeks
      (week -2 to week -1). Sensor glucose measurements are not available to both participants and
      investigators during this screening period. Participants who are able to wear the sensor for
      the 2 weeks, and are monitoring their capillary glucose levels at least 70% of the time for
      the 2 weeks (>10 readings/2weeks), will proceed on with the intervention period.

      Intervention Period (Week 0 - 26):

      Participants will wear a personal version of the flash glucose monitoring system continuously
      for the next 6 weeks. After these 6 weeks, they will wear the sensor intermittently (one
      sensor lasting 2 weeks, per 4 weeks) for the following 18 weeks.Participants in this arm will
      receive an education package that consists of Diabetes nurse educator and/or dietitian
      appointments during weeks 0, 2, 6 and 24. After week 24, they will put on a blinded sensor
      for the last 2 weeks of the intervention period (week 25 to week 26). HbA1c will be monitored
      at weeks 0, 14 and 24. Questionnaires will be administered to assess acceptability of wear,
      and perceived value to the end-user.

      Paediatric participants will not undergo blinded sensor wear but will undergo the
      intervention period, with the schedule of wear identical to the adults'. The education
      curriculum will be age-appropriate and will be delivered over weeks 0, 2, 6, 12, and 24.
      Their HbA1c will be monitored at week 0, 12 and 24. Questionnaires will be administered to
      assess acceptability of wear, and perceived value to the end-user.
    

Intervention name(s): Flash Glucose Monitoring and structured education
Intervention type(s): Combination Product
Intervention description(s): A feasibility study assessing the use of flash glucose sensing technology with structured education to improve glycemic outcomes in T2D adults and children
Intervention model: Single Group Assignment
Intervention model description: Feasibility study assessing the use of flash glucose monitoring together with structured education to improve outcomes in Type 2 diabetes.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Flash Glucose Monitoring
A Trial to Evaluate the Safety and Tolerability of a Novel Medical Food for Management of Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of a novel
      medical food utilizing a nutritional strain of yeast for management of Iron Deficiency
      Anemia.
    

Detailed description: 
      The investigational product is a medical food and is the result of discoveries following
      extensive research on two preclinical models carried out by a team of researchers at Penn
      State University. This study will utilize the standard "3+3" rule-based dose-escalation
      schemes, which use predetermined dose levels and cohorts of three patients. The total time
      commitment for each subject is approximately three months.
    

Intervention name(s): Novel Medical Food
Intervention type(s): Other
Intervention description(s): This medical food takes advantage of the stability and high level of solubility of the human H-ferritin protein to be absorbed by the body as an iron source; indeed H-ferritin is enriched in breast milk as the mechanism for transferring iron from mother to infants. Once the ferritin has been absorbed from the gut, uptake into each organ is regulated by a specific extracellular receptor pathway to deliver iron in the body's preferred bioavailable form.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Individuals will receive 300 mg capsules of the novel medical food. The iron content of these capsules is 7.4mg. Our initial dose is set at 22.2 mg of iron. This dose was chosen as the initial starting dose because it is within the range of the RDA for iron for adult women (18mg). Thus this dose is considered the minimum that would be utilized in any setting for maintenance of a healthy iron status. The dosing increases to a maximum of 88.8mg of iron per day which is significantly below the standard amount of iron (165-195mg per day) recommended for an iron deficient individual or the amount of iron given intravenously (1000 mg) for some iron deficient conditions. As mentioned, the total element iron given a patient treated with FAS is up to 190mg of iron. Assuming a 10% absorption rate these patients get 19mg of iron. So if our goal is approximately 19mg of iron absorbed per day and we assume a 50% absorption rate then our target dose is 6-9 capsules per day (44.4-66.6 mg iron).
Masking: None (Open Label)
Primary purpose: Other
Navelbine And Radiotherapy in Locally Advanced Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an open label randomized multi-centre phase II trial in patients with
      inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general
      criteria for curatively intended irradiation. The treatment plan consists of two courses of
      inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day
      1 of the last induction chemotherapy has been given. The patients will be included in the
      study after completing the induction chemotherapy. Randomization will take place only if an
      acceptable dose plan can be obtained.
    

Detailed description: 
      This study was an open label randomized multi-centre phase II trial in patients with
      inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general
      criteria for curatively intended irradiation. The treatment plan consisted of two courses of
      inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day
      1 of the last induction chemotherapy has been given. The patients was included in the study
      after completing the induction chemotherapy. Randomization took place only if an acceptable
      dose plan could be obtained.

      Primary endpoint: local recurrence free interval
    

Intervention name(s): Navelbine; 66 Gy/33F; 60 Gy/30F
Intervention type(s): Drug; Radiation; Radiation
Intervention description(s): Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks; irradiation to 66 Gy (2 Gy x 30, 5 F á weeks); irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
Other intervention name(s): Vinorelbine
Intervention MeSH terms: Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Induction chemotherapy; Non-small cell lung cancer; Randomized phase II study; Navelbine Oral (R); 3D-conformal radiotherapy; Chemo-radiotherapy; Local-regionally advanced non-small cell lung cancer
Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1%
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      Phase 4 commitment pharmacokinetic study to determine systemic exposure to adapalene.
    

Detailed description: 
      Multi-center, double-blind, randomized, parallel group study enrolling male or female
      subjects with acne vulgaris.

      Screening will take place within 14 days prior to Baseline. At the Baseline visit, and at
      each study day up to Day 30, a trained nurse or technician will apply 2 grams of study
      medication (either Differin® Gel, 0.3% or Differin® Gel, 0.1%) to the face, upper part of
      chest, and upper part of back of the subjects. To ensure maximal usage conditions, 2 grams
      study medication will be applied once daily to a total body surface area of approximately
      1000 cm², which is equivalent to 2 mg/cm2.

      Subjects will arrive at the clinic the night before on visit days (Day 1, Day 15 and Day 30)
      when PK blood samples will be drawn. Subjects will be discharged from the clinic on Day 2 and
      Day 16 following the 24-hour post-dose blood sample, and on Day 31 after the 36-hour
      post-dose blood samples.

      Cutaneous safety (local tolerability assessments) will be assessed, by recording erythema,
      scaling, dryness, and stinging/burning sensation as separate scores on the face, upper part
      of the chest, and upper part of the back using a 4-point scale (0 = None to 3 = Severe).
      Local tolerability assessments will be performed weekly on Day 1, 8, 15, 22 and Day 30, prior
      application of study medication.

      Efficacy will be evaluated by Inflammatory and Non-inflammatory lesion counts on the face
      performed at Screening, Baseline (Day 1), and on Day 30.

      Subjects will have routine laboratory tests (fasting hematology, blood chemistry) performed
      at Screening and at Day 30 visits.

      Blood samples for determination of adapalene plasma concentrations will be drawn on Day 1,
      Day 15, and Day 30 before the morning study medication application (pre-dose) and 1, 2, 4, 6,
      8, 10, 12, 16 and 24 hours after application of study medication; and additionally after the
      last study medication application (Day 31, 32, 33) at 32, 36, 48 and 72 hours post-dose.

      The adapalene plasma concentrations will be determined by a high performance liquid
      chromatography (HPLC) and fluorescence detection method.
    

Intervention name(s): Adapalene; Adapalene
Intervention type(s): Drug; Drug
Intervention description(s): Gel, 0.3%, 2g, once daily for 30 days; Gel, 0.1%, 2g, once daily for 30 days
Intervention MeSH terms: Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne vulgaris; Differin; Adapalene