bioihbjkbjnl/mcl2 huggingface dataset:
ADPKD Alterations in Hepatic Transporter Function
Condition: ADPKD; Autosomal Dominant Polycystic Kidney Disease; Renal Disease
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Observational

Summary: 
      This is a single center, comparative cohort study to investigate alterations in hepatic
      transporter function in subjects with autosomal dominant polycystic kidney disease (ADPKD)
      compared to healthy subjects and subjects with non-ADPKD renal disease. Eligible subjects
      will be 18-65 years of age and of any race/ethnicity and gender.
    

Detailed description: 
      ADPKD is a relatively common genetic disease affecting about 1 out of every 1000 people
      worldwide. Progression of ADPKD is characterized by the proliferation of fluid-filled kidney
      cysts. Development of these cysts is progressive and can lead to end-stage renal disease and
      ultimately, renal failure in many patients. The most common extra-renal complication of ADPKD
      is the formation of liver cysts, which can vary from minor to extensive. Hepatic cysts can
      develop from medium-sized bile ducts and complications (i.e., cyst rupture, infection,
      obstruction of bile ducts, and compromised portal venous flow) can arise from increasing
      cystic burden. Previous studies have shown that elevated levels of endogenous molecules such
      as bile acids in ADPKD may indicate altered transporter function. Other endogenous molecules
      such as coproporphyrin (CP) I and III may be used as probes to assess hepatic transporter
      function.

      The objective of this study is to investigate and quantify ADPKD-associated alterations in
      endogenous molecule profiles (e.g., bile acids, CP) relative to subjects with non-ADPKD renal
      disease and healthy individuals, and to investigate specific hepatic transporter
      polymorphisms that may be related to the alterations. This is important because subjects with
      ADPKD may be predisposed to adverse reactions associated with some medications that require
      hepatic transporters for excretion.

      Potential study participants will be pre-screened over the phone and then scheduled for a
      2-hour study visit. All urine samples within the 2-hour interval will be collected from all
      participants along with clinical, physical and questionnaire data. Fasting blood samples will
      be collected at time 0 and 120 min.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Healthy vs. ADPKD vs. non-ADPKD renal disease subjects
      
Biospecimen description: 
      Blood samples used for potential studies will not be labeled with personal identifiers and
      will be stored for up to 10 years.
    
Keywords: hepatic transporters
Study of Carotid Occlusion and Neurocognition
Condition: Carotid Artery Diseases
MeSH terms: Carotid Artery Diseases
Study type: Interventional

Summary: 
      To determine the relationship between cognitive functioning and blood flow in the brain among
      patients randomized to either extracranial-intracranial (EC-IC) bypass or medical therapy
      alone in the Carotid Occlusion Surgery Study (COSS).
    

Detailed description: 
      The Carotid Occlusion Surgery Study (COSS) evaluates whether a surgical operation, EC-IC
      bypass surgery, can reduce the chance of a stroke in someone who has complete blockage in one
      main artery in the neck that supplies blood to the brain (the carotid artery). The operation
      bypasses the blockage so more blood can flow to the brain. Only people with decreased blood
      flow to the brain, as demonstrated on a PET (positron emission tomographic) scan, are
      randomized into the COSS study. Among patients randomized into the COSS study, RECON will
      evaluate whether restoring the blood flow to the brain (with EC-IC bypass surgery) will also
      improve mental functioning. Participants in both the surgical and medical groups of the COSS
      study will participate in the RECON study. By comparing the mental functioning of the
      participants in both treatment groups over the course of 2 years, the investigators hope to
      determine whether the EC-IC bypass operation also helps improve or maintain mental
      functioning.
    

Intervention name(s): EC-IC Bypass in the COSS study
Intervention type(s): Procedure
Intervention description(s): EC-IC Bypass surgery involves taking an artery from the scalp outside the skull, making a small hole in the skull, and then connecting the scalp artery to a brain artery inside the skull. In this way, the blockage of the carotid artery in the neck is bypassed and more blood can flow to the brain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carotid Occlusion; Cognition
Clamp Study Comparing Inhalation of Technosphere®/Insulin in Smokers and Non-Smokers With Type 2 Diabetes
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Twelve smoking and twelve non-smoking subjects with Type 2 Diabetes Mellitus will be enrolled
      in this study to determine the effect of Technosphere® Insulin Inhalation Powder on insulin
      in the body during a clamp procedure.
    

Detailed description: 
      MKC-TI-016 is a parallel, prospective, controlled, open-label, 1-period, single-dose trial
      utilizing a hyperinsulinemic-euglycemic clamp procedure to evaluate the bioavailability and
      bioeffect of inhaled TI Inhalation Powder in type 2 diabetic subjects who smoke compared to
      nonsmoking type 2 diabetic subjects.
    

Intervention name(s): Technosphere Insulin Inhalation Powder
Intervention type(s): Drug
Intervention description(s): 30U
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lean Beef Consumption and Insulin Sensitivity in Men and Women With Risk Factors for Diabetes
Condition: Metabolic Syndrome; PreDiabetes
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      The objective of this trial is to compare the effects of a healthy, lean beef diet and an
      average American, United States Department of Agriculture (USDA) style diet, that is low in
      saturated fatty acids (SFA), on insulin sensitivity in men and women with risk factors for
      diabetes mellitus.
    

Detailed description: 
      This is a randomized, controlled, crossover study that includes two screening visits, one
      baseline visit, two 28-d test periods and an end-of-washout visit. A 2-week washout period
      will separate the two treatments. Subjects will be screened to identify metabolic syndrome
      and/or prediabetes at the screening visits. Eligible subjects will be randomly assigned to a
      test sequence (USDA/lean beef or lean beef/USDA diets) and the appropriate calorie menu
      within each test diet, which will be determined based on each subject's calculated energy
      needs for weight maintenance. Study foods will be dispensed, and subjects will be instructed
      to consume all of the foods in their entirety for the duration of each 28-d test period, and
      avoid consuming any additional food or drink items that has not been provided to them.
      Compliance will be assessed through a Food Deviation Log where subjects will record any
      non-study food/beverages consumed, and any portions of the study foods not consumed.

      An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of
      each treatment period, and fasting glucose and insulin will also be measured at screening and
      at the first test visit in each treatment period. Fasting blood samples will be collected for
      lipid profile and high-sensitivity C-reactive protein (hs-CRP) measurements at all treatment
      visits. Additionally, fasting blood will be drawn for measurement of apolipoprotein B and A1
      and lipoprotein particles and subfractions at baseline and the end of each treatment period.

      Assessments of vital signs, body weight, evaluation of inclusion and exclusion criteria,
      medication/supplement use, and adverse effects will be performed throughout the study.
    

Intervention name(s): USDA Style Diet; Lean Beef Diet
Intervention type(s): Other; Other
Intervention description(s): USDA style healthy diet, low in saturated fats.; A lean beef containing healthy diet, low in saturated fats.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to assess the single-dose relative bioavailability of Mylan
      Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine
      mesylate capsules, following the administration of a 10 mg dose, under fed conditions.
    


Intervention name(s): BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg; Parlodel® (bromocriptine mesylate) capsules, USP 5 mg
Intervention type(s): Drug; Drug
Intervention description(s): 2x5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection; 2x5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection
Intervention MeSH terms: Bromocriptine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Evaluation of the Immediate Effect of Acupuncture on the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain.
Condition: Nonspecific Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain,
      cervical range of motion and electromyographic activity of the upper trapezius muscle in
      patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy
      subjects will be enrolled in a randomized, single-blind, crossover study. Each patient will
      receive two forms of treatment in random order: a single session of traditional acupuncture
      and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period
      will be respected between sessions. Surface electromyography will be used to determine motor
      control in the upper trapezius muscle before and after treatment. The outcome measures in the
      group with neck pain will be a numerical pain rating scale (range: 0 [no pain] to 10 [maximum
      pain]), documentation of the pain area on a body chart and cervical range of motion. Linear
      regression analysis will be applied for each individual to investigate associations between
      the sEMG variables and force (excluding the sixth step). The slopes of the regression lines
      will be used to measure the sensitivity of the sEMG variables regarding changes in force. The
      Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS
      and MDF values in the third and sixth step of the step contraction. Paired samples (Student's
      t-test or Wilcoxon test) will be used to test differences between third and sixth contraction
      step. A mixed linear model will be used to analyze and compare the sEMG data during sustained
      contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2)
      evaluations. These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the
      activity of the upper trapezius muscle, as hypothesized. The pain (NRS, PPT and area) and
      cervical ROM data collected during the four evaluations will also be compared using a mixed
      linear model. The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows)
      will be employed for the statistical analysis, with the level of significance set to 5% (p <
      0.05).
    


Intervention name(s): Acupuncture; Sham acupuncture
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Physical Therapy Modalities; Neck pain; Acupuncture
Physiologic Variables in Healthy Women in Shuttle Walk Test
Condition: Healthy
Study type: Observational

Summary: 
      To analyze the alterations of physiologic variables in healthy sedentary women in the Shuttle
      Walk Test, verify the distance reached and interruption causes of the test.
    

Detailed description: 
      The Shuttle Walk Test requires patients to walk at a gradually increasing speed, up and down
      a 10 meter corridor identified by two marker cones, until they reach a symptom limited
      maximum. The walking speed was externally paced and controlled by a series of beeps played on
      a compact disk.
    

Intervention name(s): Shuttle walk test
Intervention type(s): Other
Intervention description(s): the test requires patients to walk at a gradually increasing speed, up and down a 10 m course identified by two marker cones, until they reach a symptom limited maximum. The walking speed was externally paced and controlled by a series of beeps played on a compact disk.
Other intervention name(s): Shuttle Walking Test; Exercise Capacity Test
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women, between 20 and 30 years old, healthy and sedentary
      
Keywords: healthy sedentary women
Comparison of Laser Assisted Epidermal to Intradermal Administration of Seasonal Influenza Vaccine
Condition: Influenza in Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      It is the aim of the present study to compare the immunogenicity induced by a laser-assisted
      epidermally administered seasonal influenza vaccine to an intradermally administered seasonal
      influenza vaccine.
    

Detailed description: 
      The skin is an attractive tissue for vaccination due to the impact of the cutaneous
      micro-environment on the adaptive and non-adaptive immune responses. Conventionally many
      vaccines are administered subcutaneously. Immune-competent cells however are not resident in
      the subcutaneous fat tissue, but instead are located in the epidermis and the dermis of the
      skin. Depending on the targeted skin layer and administration method, different immunological
      outcomes are thus anticipated following vaccination.

      In the present study, the immunogenicity (in terms of activation of B-cell mediated and
      T-cell mediated immune responses) of laser-assisted epidermally administered seasonal
      influenza vaccine will be compared to needle-based intradermal administration of the same
      seasonal influenza vaccine.
    

Intervention name(s): seasonal influenza vaccine; fractional Er:Yag laser
Intervention type(s): Biological; Device
Intervention description(s): influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO; Fraction laser device to apply micorpores of defined depth and density into skin.
Other intervention name(s): INTANZA; Pantec P.L.E.A.S.E.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Treatment of Hamstring Muscle in Patients With Low-back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study evaluates the treatment of hamstrings in the management of patients with
      mechanical low back pain of non-specific origin. Half of the participants will received the
      application of a dry needle technique in the most hyperalgesic areas of the muscle, while the
      other half will received the same technique in areas not hyperalgesic.
    

Detailed description: 
      Shortening of the hamstrings could be related to low back pain.Therefore, the treatment of
      these muscles may improve pain.

      The dry needling technique seems to improve the extensibility of the muscles. This technique
      seems to be more effective when is applied in the most hyperalgesic areas related to the
      participant's pain.

      In order to demonstrate this hypothesis, the investigators will check if the dry needling
      technique produces the same effects when is applied in other areas of those same muscles
    

Intervention name(s): Dry needling in hamstring muscle trigger points; Dry needling in hamstring muscle not trigger points
Intervention type(s): Other; Other
Intervention description(s): Participants with nonspecific mechanical low back pain will be assessed for the hamstring muscle. Subsequently, the most sensitive areas associated with the shortening of the muscle will be located and the technique will be applied to this area.; Participants with nonspecific mechanical low back pain will be assessed for the hamstring muscle. Subsequently, the most sensitive areas associated with the shortening of the muscle will be located and the technique will be applied out of this area.
Other intervention name(s): intramuscular stimulation of muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; Back; Hamstrings
Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme
Condition: Adverse Effect of Unspecified General Anesthetics
Study type: Interventional
Phase: Phase 4

Summary: 
      Laryngeal mask airway is a widely used device in routine anesthesia for airway management
      during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth
      after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal
      mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway
      Supreme is a newer version of the laryngeal mask airway.

      The research is being done to compare two variants of the laryngeal mask airway: the Proseal
      laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the
      newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned
      than the older model, the Proseal laryngeal mask airway. Both models are approved for use by
      the FDA, and are routinely used to assure the airway during general anesthesia.
    


Intervention name(s): Supreme Laryngeal mask airway; Proseal laryngeal mask airway
Intervention type(s): Device; Device
Intervention description(s): Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant; Proseal is a multiple use, variant of the laryngeal mask airway
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: laryngeal mask, proseal
Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children
Condition: Stool Output
Study type: Observational

Summary: 
      Evaluate the effect of probiotics on stool output in children 1 - 18 months old.
    

Detailed description: 
      Evaluate the effect of probiotics on stool output in children 1 - 18 months old.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        CPPHO [Centro Pediátrico Professor Hosannah de Oliveira (Professor Hosannah de Oliveira
        Pediatirc Center] C-HUPES [Complexo Hospitalar Professor Edgar Santos (Professor Edgar
        Santos Hospital Complex)]
Combining Medications for the Treatment of Alcohol Dependence: An Inpatient Preliminary Study
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      We propose to conduct an inpatient pilot study to test the safety and potential efficacy of
      topiramate and naltrexone in combination for the treatment of alcoholism.
    

Detailed description: 
      Eight (n = 8) alcohol-dependent research volunteers, not seeking treatment, will complete a
      placebo-controlled, within-subject cross-over design in which alcohol-related and control
      cues are presented as stimuli to induce alcohol-seeking behavior under controlled laboratory
      conditions after repeated dose (chronic) treatment with double-blind doses of placebo or
      topiramate + naltrexone.Subjects will reside in an inpatient environment for two separate
      9-day blocks interspersed by a 1-week washout period. During separate blocks, topiramate +
      naltrexone and placebo doses will be administered orally on a twice-daily regimen (08:00 h
      and 20:00 h) for 8 days.Doses will start the evening of day 1 and the last dose will be given
      the morning of day 8. No doses will be given the evening of day 8 or the morning of day 9. On
      Days 7 and 8 of the dosing regimen, subjects will receive alcohol and alcohol-related cues or
      the corresponding control cues.
    

Intervention name(s): Topiramate and Naltrexone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Topiramate 200 mg and Naltrexone 50 mg; Placebo Comparator
Other intervention name(s): Topamax and Revia; Sugar Pill
Intervention MeSH terms: Topiramate; Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol; Alcoholism; Alcohol Dependence
Randomized Controlled Clinical Trial of Cinnamon to Lower Hemoglobin A1c
Condition: Diabetes
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will randomize diabetics with hemoglobin A1c greater than 7.0 to receive either
      cinnamon plus usual care or usual care alone. Hemoglobin A1c will be measured at intake and
      after 90 days.
    

Detailed description: 
      As the worldwide incidence of diabetes increases, the search for dietary adjuncts to treat
      this life-altering disease becomes far ranging. Cinnamon is purported to be a natural insulin
      sensitizer without any known adverse events. Both in vitro and in vivo animal studies have
      shown that cinnamon is an insulin sensitizer1. Several compounds within cinnamon have been
      identified as possible sources of this sensitization process.

      To-date, three small randomized trials studying cinnamon in human diabetics have been
      published. Khan et al. reported that fasting serum glucose could be reduced by 18-29% after
      40 days of supplementation with 1, 3, or 6 g of cinnamon (Cinnamomum cassia) in type 2
      diabetics. 2 This study had several limitations that included failure to measure hemoglobin
      A1C, all patients were Pakistani, and no power analysis was documented. Vanschoonbeek, et
      al.3 report a small RCT of postmenopausal women with well-controlled type 2 diabetes which
      showed no change in HbA1C or fasting glucose. Once again no power analysis is reported. Mang
      et al. 4 conducted a RCT of type 2 diabetics treated with aqueous extract of cinnamon for 4
      months. They report a 15% decrease in fasting glucose and no change in HbA1C over the
      duration of this trial. Subjects had HbA1C less than 7% and again no power analysis was
      included in this study.

      This study will address whether cinnamon at the dose of 1g daily in addition to usual care
      lowers hemoglobin A1c compared to usual care. Power analysis indicates that 63 per group are
      needed and we will recruit 70 patients.
    

Intervention name(s): cinnamon
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: cinnamon; diabetes; hemoglobin a1c