bioihbjkbjnl/mcl2 huggingface dataset:
Genetic, Environment and Its Interaction Analysis for Cardiovascular Autonomic Neuropathy
Condition: Cardiovascular Autonomic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Nervous System Diseases
Study type: Observational

Summary: 
      A large-scale, community-based, cross-sectional study was conducted to explore the extent to
      which genetic, environment and its interactions associated with cardiovascular autonomic
      neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were
      recruited by using multiple stages sampling (first cluster sampling and then simply
      sampling). Data involved in variables of genetic, environment were collected. Every
      participants was complete DNA extracted and genotyped by using single nucleotide polymorphism
      (SNP). Cardiovascular autonomic functions were measured by using short-term heart rate
      variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed to evaluate
      genetic variants, environmental risk factors and its interactions for CAN.
    

Detailed description: 
      A large-scale, community-based, cross-sectional study was conducted to explore the extent to
      which genetic, environment and its interactions associated with cardiovascular autonomic
      neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were
      recruited by using multiple stages sampling (first cluster sampling and then simply
      sampling). Data involved in variables of genetic, environment were collected. Every
      participant was complete DNA extracted and genotyped by using single nucleotide polymorphism
      (SNP). Cardiovascular autonomic functions were measured by using short-term heart rate
      variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed to evaluate
      genetic variants, environmental risk factors and its interactions for CAN.Univariate and
      multiple variables analysis have been performed to examine potential environmental and
      genetic risk factors of CAN.
    

Intervention name(s): not intervention
Intervention type(s): Other
Intervention description(s): This is a cross-sectional study, no intervention was performed.
Other intervention name(s): nothing
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The investigators recruited participants from rural and urban communities in Shanghai.
        Survey participants with undiagnosed CAN, aged 30-90 years, were included in this study.
        Our study invited a total of 3,012 subjects to a screening visit between 2011 and 2012.
      
Biospecimen description: 
      DNAs were extracted and genetyped by using SNP.
    
Keywords: Genetic; environment; interaction analysis; cardiovascular autonomic neuropathy; CAN
Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554
Condition: HEPATITIS C (HCV)
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that
      hepatic impairment will modify PF-00868554 plasma concentrations. Hence, it is important to
      determine the impact of varying degrees of hepatic impairment on the pharmacokinetics, safety
      and toleration of 200 mg PF-00868554 administered as a single-dose.
    


Intervention name(s): PF-868554; PF-868554; PF-868554
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg, Child-Pugh Class A; 200 mg, Child-Pugh Class B; 200 mg, healthy volunteers
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on
      the immune system i.e on the regulation of immune cells important in diseases such as obesity
      and diabetes.

      The hypotheses are:

        -  Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in
           the blood

        -  Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood

        -  Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine
           profile in the blood
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with type 2 diabetes undertaking treatment with liraglutide
      
Biospecimen description: 
      Blood samples
Resistance Training in Diabetic Elder Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of a 12-week progressive resistance
      training program on the skeletal muscle function, glycemic control, functional capacity, and
      quality of life in the elderly with type 2 diabetes mellitus.
    


Intervention name(s): Resistance exercise; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Progressive resistance exercise training, 3 times a week for 12 weeks.; Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus; Resistance exercise; Elderly; Skeletal muscle dysfunction; Metabolomics
A Study to Assess the Relative Bioavailability of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared to Clarityne Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish the relative bioavailability of Xisimin
      (loratadine) compared to Clarityne in healthy participants receiving a single dose of 10
      milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of
      Cohort 2.
    


Intervention name(s): loratadine (Xisimin [Test Treatment]); loratadine (Clarityne [Reference Treatment])
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence.; Participants will receive 10 mg loratadine as Clarityne (reference treatment) as per the treatment sequence.
Other intervention name(s): JNJ-1754415-AAA
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether low-dose peg-interferon plus ribavirin
      therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had
      the curative resection of primary HCC.
    


Intervention name(s): interferon-alfa-2b and ribavirin
Intervention type(s): Drug
Intervention description(s): Interferon, pnce per week plus daily ribavirin
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hepatocellular carcinoma
Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
Condition: Stone, Kidney; Urolithiasis
MeSH terms: Urolithiasis; Kidney Calculi; Nephrolithiasis
Study type: Observational

Summary: 
      Retrograde intrarenal surgery (RIRC) is used as standard treatment for stones less than 2 cm.
      In some cases, the ureteral access sheath cannot be placed due to ureteral stricture. In this
      case, a double j stent (DJ) is placed to passively dilate the ureter, and the RIRC is
      postponed for post-dilatation. The aim of the study is to determine the optimal time for RIRC
      operation in cases where a double j stent was placed for passive dilatation.
    


Intervention name(s): Retrograde intrarenal surgery after DJ stent placement
Intervention type(s): Procedure
Intervention description(s): Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a DJ stent for passive dilatation and subsequent RIRC
Irinotecan and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of irinotecan and docetaxel in treating
      patients who have metastatic or locally recurrent head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate in patients with metastatic or locally recurrent head and
           neck cancer treated with irinotecan and docetaxel.

        -  Determine the progression-free and overall survival of patients treated with this
           regimen.

        -  Determine the toxic effects of this regimen in these patients.

        -  Correlate angiogenesis markers and cyclooxygenase-2 expression with response and
           survival in patients treated with this regimen.

        -  Correlate UGT1A1 genotype with the toxic effects of this regimen in these patients.

      OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy
      (no prior chemotherapy for locally recurrent or metastatic disease or more than 6 months
      since prior chemotherapy as primary therapy vs 1 prior chemotherapy regimen for locally
      recurrent or metastatic disease or less than 6 months since prior chemotherapy as primary
      therapy).

      Patients receive docetaxel IV over 60 minutes followed by irinotecan IV over 30 minutes on
      days 1 and 8. Courses repeat every 21 days in the absence of disease progression or
      unacceptable toxicity.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 32-72 patients (16-36 per stratum) will be accrued for this
      study within 6-14 months.
    

Intervention name(s): docetaxel; irinotecan hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Docetaxel; Irinotecan
Primary purpose: Treatment
Keywords: recurrent metastatic squamous neck cancer with occult primary; metastatic squamous neck cancer with occult primary squamous cell carcinoma; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent salivary gland cancer; salivary gland squamous cell carcinoma; stage IV salivary gland cancer
A Roll-over Observational Study for the Extended Follow-up of the Volunteers of the ISS T-003 Trial
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      A roll-over observational study (ISS T-003 EF-UP) is being conducted to extend the follow-up
      of the volunteers of the ISS T-003 trial in order to evaluate the persistence of vaccine
      immunogenicity as well as of the immunological and virological effects induced by the
      therapeutic immunization with Tat.
    

Detailed description: 
      An open label, non-interventional study roll-over study (ISS T-003 EF-UP) is being conducted
      to follow-up the persistence of vaccine humoral responses as well as of the immunological and
      virological effects induced by the therapeutic immunization with Tat.To this aim volunteers
      of the ISS T-003 study are included in one year study, with visits at weeks 0 and 24 and 54.

      To assess the anti-Tat humoral immune response by the determination and titration of IgM, IgG
      and IgA anti-Tat antibodies (primary endpoint) and to evaluate CD4+ T cell counts and HIV-1
      plasma viraemia (as secondary endpoint).

      In addition, depending on the availability of residual specimens (PBMC, serum and plasma),
      further laboratory tests (i.e. HIV DNA copies in blood) to investigate in-depth the
      immunological and virological profile of the volunteers is being performed.

      Physical examination is being performed to monitor the clinical status of the volunteers and
      to record the appearance of clinical signs and symptoms of disease progression as well as
      AIDS-defining events, data or records related to ARV treatment compliance. Pregnancy onset
      for female participants will also be recorded.
    

Intervention name(s): No intervention
Intervention type(s): Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HAART-treated patients who participated to the therapeutic phase II trial of the Tat
        vaccine "ISS T-003"
      
Biospecimen description: 
      Blood samples
    
Keywords: HAART-treated participants; Tat; Therapeutic immunization
Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine
Condition: Migraine; Classic Migraine; Common Migraine
MeSH terms: Migraine Disorders; Migraine with Aura; Migraine without Aura
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the impact of topiramate (migraine prevention
      medicine) on the effectiveness of almotriptan malate (acute migraine medicine) when treating
      acute migraine headaches.
    

Detailed description: 
      Migraine afflicts greater than 28 million adults in the United States. Acute treatments, such
      as almotriptan malate, target the symptoms of a migraine attack. Preventive treatments, such
      as topiramate, primarily target the generation of attacks and may decrease use of acute
      treatments. Preventive treatments, by a process of neurostabilization, may result in an
      additive effect on almotriptan malate to improve acute treatment intervention response during
      a migraine attack. This is a randomized, double blind, parallel group multicenter study that
      will enroll patients 18-65 years old with a history of 3-12 migraine headaches each month for
      the past 3 months. The total study duration will be approximately 32 weeks. The study is
      divided into 4 phases as follows: A Screening Phase that lasts one month; An Open Label Phase
      where all patients will be treated with topiramate gradually dosed to 100mg a day lasting 6
      weeks; A Double Blind Phase lasting 19 weeks at which time patients will be randomized to
      stay on topiramate 100mg per day or switch to placebo topiramate (50:50 chance) and a
      Taper/Exit Phase lasting 2 weeks. Almotriptan malate will be used for all migraine headaches
      during the study as needed. The study hypothesis is that the combination of almotriptan
      malate and topiramate will have a better clinical response than the combination of
      almotriptan malate and placebo topiramate. Migraine pain information will be collected from
      each patient with the use of a Personal Digital Assistant (PDA or Palm Pilot) throughout the
      study for each migraine attack. Commercial Topiramate will be gradually increased to
      100mg/day in approximately 4-6 weeks. You will then be randomized to either Topiramate or
      Placebo, dosed at 100mg a day, for the remainder of the study (18 weeks). AXERT 12.5mg may be
      taken to treat migraine headaches during the study.
    

Intervention name(s): topiramate; almotriptan malate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate; Almotriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Migraine headache; Topiramate, Almotriptan malate
Chronic Plaque Psoriasis (Ps) Registry
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients
      with Chronic Plaque Psoriasis (Ps).
    

Detailed description: 
      ESPRIT is a 10 year registry of patients taking HUMIRA® for Psoriasis. Patients who volunteer
      to participate will be asked to provide information about their medical history and
      experiences with HUMIRA®. No registry specific testing will be performed. Patients will be
      asked to provide data on their experiences with HUMIRA® approximately every 6 months, or as
      determined by the study doctor. No drug will be provided as a result of participation in the
      registry. All treatment decisions are independent of participation in the registry.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic, departments of dermatology
      
Keywords: Psoriasis; Moderate Psoriasis; Severe Psoriasis; Chronic Plaque Psoriasis; Severe Chronic Plaque Psoriasis; Registry
Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study)
Condition: Disturbances in Initiating and Maintaining Sleep; Behavior Problem
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The aim of this feasibility study is to determine whether a nutritional intervention in
      children and their parents can improve their sleep quality and behavior. The study is a
      randomized, double-blind, placebo-controlled parallel trial of omega-3 supplementation to
      children and their mothers.
    

Detailed description: 
      Previous studies show omega-3 fatty acid supplements improve adolescent's antisocial
      behavior. However it is less known whether the same effect could be achieved in younger
      children. Furthermore it is not known whether omega-3 fatty acids could also improve parental
      behavior and parenting style which could further reduce behavioral problems in children.
      Moreover, we recently found that children who consume fish more frequently have less sleep
      problems but it is not known whether omega-3 supplements could also potentially improve
      children's sleep. We aim to test several hypotheses in this random controlled trial of
      omega-3 fatty acids.

      The study design will consist of a double-blind, randomized placebo-controlled trial of
      children and their caregivers in a community sample in the city of Philadelphia. It will
      utilize a random parallel design, in which child and mother pairs will be randomly assigned
      to either omega-3 supplementation (treatment condition) or a placebo (control condition).
      This results in 2 groups: (1) child and caregiver both receiving omega-3 and (2) both parent
      and child receiving the placebo. Treatment will last 45 days. Assessments will take place at
      0 months (baseline), 45 days (end of supplementation) and 90 days (45 days after the end of
      treatment).
    

Intervention name(s): Omega-3 fatty acids; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 200 ml drink. The drink contains 840 mg total of omega-3 (360 mg of DHA, 240 mg of EPA, 200 mg of alpha-linolenic acid, and 40 mg of DPA).; 200 mL placebo fruit juice with no effect on the hypothesized outcome.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Omega-3 fatty acids; Sleep; Behavior; Parenting
Combination of Sulfonylureas and Insulin Glargine Outpatient Therapy for Unstable Diabetes and Impending DKA
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare two simple and safe emergency department discharge
      therapy for Type 2 Diabetes patients with severe hyperglycemia and with no indications for
      inpatient admission.
    

Detailed description: 
      This study is an open label randomized controlled trial in adult DM2 patients seen in ED
      services at John H. Stroger Hospital of Cook County serving a largely uninsured/underserved
      population. Individuals more than 18 years of age with DM2, either with new onset DM2 or
      known diabetics who did not take oral hypoglycemic agents for more than 2 weeks, presenting
      with fasting blood glucose (FBG) 300-500 mg/dl or random blood glucose (RBG) 400-700 mg/dl
      and who did not have any exclusion criteria listed in Table 1, were eligible for the study.
      Subjects were randomized to one of the two fixed dose treatment groups: 1) Glipizide XL 10 mg
      orally daily prior to breakfast (G group), 2) Glipizide XL 10 mg orally daily along with
      Insulin Glargine 10 units at bedtime, subcutaneously (G+G group).
    

Intervention name(s): Glipizide; Glipizide and Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Glipizide XL 10 mg once daily 30 mins before breakfast; Glipizide XL 10 mg daily 30 minutes before breakfast Insulin Glargine 10 units subcutaneously at bedtime daily
Other intervention name(s): Glucotrol XL; Insulin Lantus
Intervention MeSH terms: Glipizide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperglycemia; Glucose toxicity; Glargine; Glipizide
Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A reduced response to inhaled corticosteroids (ICS) has been reported in smoking compared to
      non-smoking asthmatic patients. However, the comparative response to other currently
      prescribed medications such as combination therapy of long-acting beta agonists and ICS
      remain to be further evaluated.

      No significant differences were found between our group of subjects in regard to changes in
      asthma control pulmonary function and airway inflammation following budesonide or the
      association of budesonide with formoterol for a period of 2 months. This should be further
      explored in larger groups of subjects.
    


Intervention name(s): budesonide and budesonide/formoterol
Intervention type(s): Drug
Intervention MeSH terms: Budesonide; Formoterol Fumarate