bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Short-term L-citrulline Supplementation on Blood Pressure and Arterial Stiffness
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The goal of this clinical trial is to examine the effect of short-term L-Citrulline on
      central and peripheral blood pressure in healthy older adults. The main questions it aims to
      answer are:

        -  Does L-citrulline favorably affect blood pressure at rest and during exercise?

        -  Does L-citrulline favorably affect arterial stiffness?

        -  Does L-citrulline favorably affect muscle oxygenation at rest and during exercise?

      Participants will be asked to consume L-citrulline and a placebo for six days and participate
      in the evaluation of their blood pressure, arterial stiffness, and muscle oxygenation before
      and after each intervention.

      Researchers will compare L-citrulline and placebo groups to examine whether L-citrulline
      supplementation affects the above health parameters.
    


Intervention name(s): L-Citrulline; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6 g (3 g every 12 h) of L-citrulline for six days; 6 g (3 g every 12 h) of maltodextrin for six days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI 1181181 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to evaluate
      pharmacokinetics, safety and tolerability following single oral doses of BI 1181181.
    


Intervention name(s): BI 1181181 high dose; BI 1181181 low dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): two tablet; one tablet; tablet
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Low-dose Protocol for Computed Tomography-guided Lung Biopsy
Condition: Lung Cancer, Adenocarcinoma; Lung Inflammatory Pseudotumor
MeSH terms: Adenocarcinoma of Lung; Plasma Cell Granuloma, Pulmonary; Granuloma, Plasma Cell
Study type: Interventional

Summary: 
      The purpose of this study is to compare the diagnostic accuracy and complication rate between
      low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.
    

Detailed description: 
      With the comprehensive usage of computed tomography examination, patients are more and more
      aware of the radiation dose of computed tomography. Concerns over the potential for radiation
      induced malignancies have increasingly been published in the scientific literature and
      reported in the popular press. The risk is highest for younger patients, who have more
      radiation-sensitive tissues and longer life expectancies than adults. Recently, the United
      States Food and Drug Administration announced an initiative to reduce unnecessary radiation
      exposure from medical imaging. At present, low-dose computed tomography protocol is widely
      used for the diagnosis of cardiovascular and cerebrovascular diseases.

      Computed tomography-guided lung biopsy is widely used for diagnosis of lung nodules and
      masses. However, it requires repeating scanning to guide the needles, which inevitably
      increases the radiation dose. Therefore, low-dose protocol was also used in the computed
      tomography-guided lung biopsy procedure.

      The purpose of this study is to compare the diagnostic accuracy and complication rate between
      low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.
    

Intervention name(s): Low-dose protocol computed tomography; Standard-dose protocol computed tomography
Intervention type(s): Radiation; Radiation
Intervention description(s): Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds); Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Cytochrome P450 2C19 Variant is Related to Pharmacokinetics of Glipizide Extended Release Tablet in Chinese Subjects
Condition: Genotype; Pharmacokinetic
Study type: Interventional

Summary: 
      Diabetes mellitus is a growing global disease now and future, and in China, 1.2 million
      peoples per year have been diagnosed as diabetes mellitus. 90% diabetes mellitus patient is
      Type 2 diabetes mellitus. Glipizide is a potent drug to service patients who suffer from Type
      2 disease. Little information has been presented for the relationship between CYP2C19 genetic
      polymorphism and glipizide, since recently the investigators reported that there existed a
      tendency. In this study the investigators found that CYP2C19 polymorphism significantly
      influenced the pharmacokinetics of glipizide.
    

Detailed description: 
      Blood samples were obtained from 127 unrelated healthy male Chinese subjects in Gansu
      Province. After genotyping, 14 subjects (age, 19-26; weight, 59.5-70.0 kg) were enrolled in
      the study. They were divided into two groups, EMs homo and PMs group. There were no
      significant differences in age or body weight seen in the two groups.

      Each subject received 5 mg glipizide extended release tablet once daily for 7 days. For the
      first 6 days, glipizide was administered just after a standard breakfast. On day 7, after an
      overnight fast, each subject received a glipizide extended released tablet (Glucotrol XL,
      Pfizer, USA) with 100 mL water. Standard meals were given in 4 h and 10 h after dosing.
      Venous blood samples were collected immediately before and at 2, 4, 6, 8, 10, 12, 14, 16, 20,
      24, 36, and 48 h after dosing. Blood samples, collected in EDTA tubes, were centrifuged (2500
      g) immediately for 10 min and plasma samples separated were stored at -80ºC until assay.

      For safety, blood glucose levels were determined directly by use of a Glucose Meter
      (Accu-Chek, Roche, Germany) at 0, 2, 4, 6, 8, 10, 12, 14, 16, 20and 24 h after last dosing
      (on day 7).
    

Intervention name(s): Glipizide
Intervention type(s): Drug
Intervention description(s): Each subject received 5 mg glipizide extended release tablet once daily for 7 days.
Other intervention name(s): Glucotrol XL®
Intervention MeSH terms: Glipizide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength
Condition: Muscle
Study type: Interventional

Summary: 
      This study will investigate the effects of a soy/dairy protein blend on muscle growth and
      strength. In sports nutrition and in aging it is important to have healthy muscles. This can
      be achieved with exercise and nutrition. Consumption of protein following resistance exercise
      can promote healthy muscle growth and help improve strength. Young healthy men will be
      studied during a 12 week resistance exercise training program and be given protein
      supplements every day during the study. The hypothesis is that a blend of soy, whey and
      casein will induce a greater muscle gain and strength increase than the control.
    


Intervention name(s): Blend; Whey; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 22 grams of protein/day; 22 grams of protein/day; 22 grams of carbohydrate/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: soy; whey; casein; muscle; strength; protein
Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the pharmacokinetic profile of rivaroxaban administered as granules for
      suspension formulation and to document safety and tolerability
    


Intervention name(s): Rivaroxaban (Xarelto, BAY59-7939
Intervention type(s): Drug
Intervention description(s): Single dose of reconstituted rivaroxaban granules
Intervention MeSH terms: Rivaroxaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)
Condition: Hypophosphatasia (HPP)
MeSH terms: Hypophosphatasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial studies the long term safety and efficacy of asfotase alfa in children
      with HPP who completed Study ENB-006-09 (NCT00952484).
    

Detailed description: 
      Asfotase alfa was formerly referred to as ENB-0040

      Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease
      characterized by defective bone mineralization and impaired phosphate and calcium regulation
      that can lead to progressive damage to multiple vital organs, including destruction and
      deformity of bones, profound muscle weakness, seizures, impaired renal function, and
      respiratory failure. There are limited data available on the natural course of this disease
      over time, particularly in patients with the juvenile-onset form.
    

Intervention name(s): Asfotase Alfa
Intervention type(s): Biological
Other intervention name(s): human recombinant tissue nonspecific alkaline phosphatase fusion protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypophosphatasia; HPP; Bone Disease; Soft Bones; Low Alkaline Phosphatase; genetic metabolic disorder; alkaline phosphatase; tissue non-specific alkaline phosphatase; rickets; osteomalacia
Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers
Condition: Eye Infections, Bacterial
MeSH terms: Bacterial Infections; Eye Infections; Eye Infections, Bacterial
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one
      instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day
      2).

      To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day
      treatment period
    

Detailed description: 
      The aim of the present study was to compare ocular tolerance and safety after repeated
      instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual
      azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12
      hours after the last Investigational Medicinal Product instillation.
    

Intervention name(s): Azithromycin (T1225)
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Weight Loss on Nutritional Mediated Hormone Secretion
Condition: Weight Loss; Hormone Disturbance; Weight Gain
MeSH terms: Endocrine System Diseases; Body Weight; Weight Loss; Weight Gain
Study type: Interventional

Summary: 
      Investigative trial with aim of

        1. the description of the hormonal and metabolic response to meals containing different
           compositions of macronutrients

        2. the metabolic response to these test meals in dependance of the hepatic and muscular
           insulin sensitivity and abdominal adipose tissue and

        3. effects of a weight loss on the hormonal response to these test meals containing
           different compositions of macronutrients

      Primary endpoint:

      Glucagon-like-peptide 1 (GLP-1), Glucose dependent insulinotropic peptide (GIP) and Ghrelin
      response to a nutritive stimulation characterized by different nutritional composition

      Secondary endpoints:

        -  differences of substrate utilization depending on the nutritive composition

        -  effects of different hepatic and muscular insulin sensitivity as well as impact of
           visceral fat mass on the hormonal and metabolic response

        -  effect of weight loss on the hormonal and metabolic response to different test meals

      Study procedure:

      After primary characterization 50 probands (male and female) will receive 3 different test
      meals within a randomised (meal order) controlled trial.

      The three different test meals differ in nutritional composition. During consumption of the
      test meal a characterization of the endogenous hormonal response and appetite behaviour is
      performed.

      A nutritional counselling is performed according to the guidelines of the German Nutrition
      Society (DGE) to ensure a stable nutritive behaviour in the three days before the test meal
      administration.

      After analysis of the hormonal response to these 3 different testmeals follows a weight
      reduction period over 3 months. Afterwards reevaluation of the probands (again administration
      of 3 different test meals over a period of 3 weeks) will be performed.

      Principal aim of the study:

      Gain of information leading to the understanding of the hormonal regulation of food intake.
      The individual variability shall be determined with the aim of an identification of patient
      groups which show various intensities of the responses to different macronutrients.
    


Intervention name(s): nutritional stimulation via different testmeals; Nutritional counseling; formula diet
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): nutritional stimulation of hormonal response through different testmeals; nutritional counseling for healthy eating behaviour; formula diet to help weight loss
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      The HBsAg clearance rate in interferon-treated responders is significantly higher than that
      in lamivudine-treated responders, implying immune control is the key to HBsAg clearance.
      There is a good chance to further increase the cure rate if the investigators can enhance the
      HBV-specific immune response when the HBsAg level already comes to a low level.

      Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients
      whose HBsAg already <=2000 IU/ml.

      Patients and methods:

      This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no
      hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine
      (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one
      year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose
      during the treatment period and every 3 months for another year following the last dose.
      Viral and cellular factors will be studied to discover determinants affecting HBsAg
      clearance.

      Aims

        1. To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate
           chronic HBV infection in patients with low titer HBsAg.

        2. To delineate the doses to response (HBsAg clearance or decline rate) correlation so as
           to design a feasible schedule for future clinical trials in a larger group of patients.

        3. To discover viral and host factors which can be used as biomarkers for personalized
           vaccine therapy.
    

Detailed description: 
      Vaccination schedule:

      Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) will be administered intramuscularly at 0,
      2, 4, 6, 8, 10, 12 months or until HBsAg clearance. The dosage will be 20μg in those <= 20
      years old and 40μg in those > 20 years old.

      HBsAg and anti-HBs:

      qHBsAg will be checked by commercial kits (Elecsys, Roche Diagnostics, Indianapolis, IN) at
      baseline, right before every dose, and every 3 months following the last dose for one year.
      ALT, AST, Alpha-fetoprotein, bilirubin and anti-HBs will be checked simultaneously.
    

Intervention name(s): HBV vaccine (Engerix B)
Intervention type(s): Biological
Intervention description(s): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Therapeutic vaccine; HBsAg clearance; Immune clearance; HBsAg clearance induced by vaccination; s seroconversion in carriers after vaccination
Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment
Condition: Chronic Myelogenous Leukemia, BCR-ABL Positive; CML, Chronic Phase
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of patients response and expression levels of CITED2 and HIF2a genes on adding
      pioglitazone to imatinib therapy.
    

Detailed description: 
      Eligible denovo CML patients will be treated by combination drug therapy of imatinib 400 mg
      plus pioglitazone (15 - 30mg).They will be on follow up for their complete blood count (CBC),
      chemistry profile and random blood sugar every 2 weeks. After 3, 6 and 12 months of treatment
      the patients response will be evaluated and compared with the obtained responses of a
      historical control group. Assessment of the hypoxia induced factor 2 alpha (HIF2a) gene and
      CBP/p300-interacting transactivator with glutamic acid (E) and aspartic acid (D)-rich tail 2
      (CITED2) gene expression levels before and after 6 months of treatment will be additionally
      evaluated.
    

Intervention name(s): Pioglitazone 15mg
Intervention type(s): Drug
Intervention description(s): pioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months
Other intervention name(s): Imatinib 400mg
Intervention MeSH terms: Pioglitazone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Corelation Between Circulating Nuclearsome and SIRS Happened After Congential Cardiac Surgery
Condition: Congential Cardiac Surgery
Study type: Observational

Summary: 
      In this study，the investigators want to determine the corelation between circulating
      nuclearsome and the development of SIRS occured after congenital cardiac surgery, including
      the serverity of organ damage and inflamation.
    

Detailed description: 
      Blood was collected from study participants at 6 time points; 1) post-anesthesia induction,
      2) post-op hour 0, 3) post-op hour 4, 4) post-op hour 24, 5) post-op hour 48, and 6) post-op
      hour 72. At each of the 6 time points blood was analyzed for levels of the
      following:histone,blood routine test , c-reaction protein, procalcitonin, N-terminal
      pro-brain natriuretic,the hepatorenal function，cardiac function and pulmonary function
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1-36 months 2.5-15 kilogram accepted congential cardiac surgery
      
Biospecimen description: 
      Whole Blood, plasma, serum
    
Keywords: congential cardiac surgery; nuclearsome; systemic inflammation response syndrome
Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and
      effective treatments for mild-to-moderate atopic dermatitis (AD).
    


Intervention name(s): AN2728 ointment, 2%; AN2898 ointment, 1%; AN2898 ointment vehicle; AN2728 ointment vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): AN2728 ointment, 2%, applied twice daily for 6 weeks; AN2898 ointment, 1%, applied twice daily for 6 weeks; AN2898 ointment vehicle applied twice daily for 6 weeks; AN2728 ointment vehicle applied twice daily for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atopic dermatitis
Omnitram Pharmacokinetic Study In Healthy Volunteers
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety, pharmacokinetic properties (the
      absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets),
      Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.
    

Detailed description: 
      A Phase 1, single-center, randomized, double-blind, placebo-controlled, three-period
      cross-over study to compare the safety, steady-state oral pharmacokinetics, and clinical
      activity of overencapsulated: 20 mg Omnitram (2x10 mg tablets), 50 mg Tramadol (1x50 mg
      Ultram tablet), and placebo.

      Forty male subjects in normal health, 21 to 55 years of age, will be randomized to three
      parallel arms (N=~13 each) to ingest a total of 9 doses of Omnitram, Tramadol, or placebo in
      a first treatment segment (one dose every 6 hours). Around the 9th dose blood samples are
      collected to quantify plasma Tramadol and Metabolite 1 (M1) enantiomers. After the 9th dose,
      pain tolerance is assessed with a cold pressor test (ice cold water immersion). After the 7th
      dose abuse liability measures and pupil diameter will be assessed. Subjects will washout for
      7 days after the first treatment segment and second treatment segment.
    

Intervention name(s): Omnitram; Tramadol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nine 20 mg doses administered every 6 hours; Nine 50 mg doses administered every 6 hours.; Nine doses administered every 6 hours.
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia; Pharmacokinetics; Treatment