bioihbjkbjnl/mcl2 huggingface dataset:
Measurements of Exhaled Nitric Oxide in Healthy Subjects in Thailand
Condition: Normal Non-fluency
Study type: Observational

Summary: 
      The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in
      healthy subjects among Thai populations.
    

Detailed description: 
      Fractional exhaled nitric oxide (FeNO) were produced from epithelial cells of inflammatory
      airways and eosinophils and this gas was discovered since 1991.

      Fractional exhaled nitric oxide (FeNO) has direct association with severity of inflammation
      of bronchial trees and sputum eosinophils and use for additional investigation for diagnosis
      asthma or inflammatory airway diseases.

      There are many factors from previous studies that associate with level of fractional exhaled
      nitric oxide (FeNO), one of that factors is race therefore we can't use level from another
      studies with different race for use as reference and there is no study about level of
      fractional exhaled nitric oxide in Thai population.

      It is therefore desirable to examine level of fractional exhaled nitric oxide (FeNO) in
      healthy subjects among Thai population and will be the main objective of this research.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Keywords: healthy people; fractional exhaled nitric oxide (FeNo); factors
Self-control and Mindfulness Within Ambulatorily Assessed Network Systems Across Health Related Domains
Condition: Self Regulation
Study type: Interventional

Summary: 
      The aim of this trial is to test a novel network approach (Bringmann et al., 2013), which
      enables to investigate the complex, interdependent network of self-control and its influences
      in everyday life. By adding an intervention to the network, such as mindfulness training, it
      is also possible to explore the way mindfulness changes connection strengths between network
      variables.

      For six weeks, an ambulatory assessment and additional seven weekly laboratory sessions are
      conducted with 120 students from the Johannes Gutenberg University Mainz who are randomized
      to a control (n=60) or intervention condition (n=60). Pre and post measurement sessions take
      place to assess self-reported trait self-control and mindfulness and a behavioral measure of
      mindfulness (Levinson, Stoll, Kindy, Merry & Davidson 2014). Participants of both the
      experimental and control condition come to five weekly lab meetings in which they fill out
      questionnaires to assess changes in self-reported self-control and mindfulness. But only
      participants of the experimental condition take part in weekly computer based mindfulness
      trainings. During the ambulatory assessment, participants complete questionnaires six times a
      day via mobile phones that are randomly prompted and answer questions about state
      self-control, motivation, affect, and current situation.
    


Intervention name(s): Mindfulness intervention
Intervention type(s): Behavioral
Intervention description(s): Mindfulness is practiced with a weekly computer based guided breathing meditation in which one's own breath has to be counted repetitively from 1 to 9. Participants have to press a specific button for breaths 1 to 8 and then press another button for breath 9 on a keyboard. During this practice they put on headphones and listen to a voice that guides them through breathing meditation. A "click" sound will occur if breath is miscounted (Levinson et al., 2014). After each computer based breathing meditation the experimenter and participants exchange meditation experiences and views. After the first mindfulness training participants in the experimental group are also able to practice mindfulness at home by listening to audio files on the mobile phone (bodyscan or breathing meditation).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Network approach; mindfulness; self-control; ambulatory assessment
Comparison of Ertapenem Distribution in the Muscle of Six Healthy Volunteers and Six Critically Ill Patients by Microdialysis
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Ertapenem is an antibiotic that is highly bound to plasma protein (> 95%). The effects of
      this high protein binding on tissue distribution of antibiotics have been few evaluated yet.

      In this study, two groups of subjects will be compared: 6 healthy volunteers and 6 critically
      ill patients (patients with infection due to an Ertapenem susceptible bacteria). Indeed,
      these 2 populations show changes in binding capacity of drugs to plasma proteins due to a
      decrease of protidaemia and of the affinity of drugs to transport proteins.

      It seems therefore important to clarify the consequences of a modification in protein binding
      on distribution of antibiotics. That's why we have decided to characterize tissue
      distribution of ertapenem in healthy volunteers and critically ill patients by assessing:
      free and total concentrations in plasma and free concentrations in muscle by microdialysis.
    


Intervention name(s): Ertapeneme
Intervention type(s): Drug
Keywords: patients infected with a bacteria sensible to ertapeneme
Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer
Condition: Colorectal Cancer; Chemotherapy-induced Neutropenia
MeSH terms: Colorectal Neoplasms; Neurotoxicity Syndromes; Neutropenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the efficacy of
      monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in
      colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.
    

Detailed description: 
      Oxaliplatin is a key agent in the treatment of colorectal cancer. However, peripheral
      neuropathy markedly limits the use of oxaliplatin. Many drugs have been tried to decrease the
      development of oxaliplatin induced peripheral neurotoxicity, however, the results remain
      disappointing. This multi-center, randomized, placebo-controlled trial was performed to
      assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin
      induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant
      chemotherapy.
    

Intervention name(s): GM1; placebo; mFOLFOX6 or XELOX
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GM1 will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of GM1 for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.; Placebo will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of placebo for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.; mFOLFOX6: Patients will receive mFOLFOX6 every 14 days, Oxaliplatin 85mg/m2 IV over 3 hours on Day1; Calcium Folinate IV over 2h on Day 1(Leucovorin 200mg/m2 or CF 400 mg/m2); 5-Fluorouracil 400mg/m2 IV on Day1; followed by 5-Fluorouracil 2.4g/m2 for 46 hours continuous infusion on Day1.
XELOX: Patients will receive XELOX every 21 days, Oxaliplatin 130mg/m2 IV over 3 hours on Day1;followed by Capecitabine 1000mg/m2 oral twice daily for 14 days.
The optimum chemotherapy regimen is at the discretion of the investigators based on the condition of each patient.
Other intervention name(s): monosialotetrahexosylganglioside; Oxalipaltin; Leucovorin; Calcium Folinate; 5-Fluorouracil; Capecitabine
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Vasoactive Intestinal Peptide in COPD
Condition: COPD; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary
Study type: Observational

Summary: 
      This study, a new immunomodulatory therapy of COPD with vasoactive intestinal peptide (VIP)
      was evaluated. Based on preliminary unpublished clinical and experimental results, the course
      of disease under VIP treatment and the molecular mechanisms involved were assessed.

      34 patients with severe COPD were treated either with VIP inhalation in addition to
      conventional therapy or inhalation of placebo plus conventional therapy for a period of 3
      months. The trial was conducted as a double blind, comparative study with two parallel
      groups.
    

Detailed description: 
      Chronic obstructive bronchitis is a chronic inflammatory disease of the airways, which
      affects as many as 8% of individuals in industrialized nations. There is an increase in the
      number of woman and men suffering from COPD. Pulmonary hypertension and cor pulmonale are
      common sequelae of chronic airflow obstruction, but the precise mechanisms of increased
      vascular resistance are unclear. Potential causes of pulmo-nary hypertension in COPD include
      emphysematous destruction of the capillary bed, remodeling of pulmonary vessels and hypoxic
      pulmonary vasoconstriction. This proposal, a new immunomodulatory therapy of COPD with
      vasoactive intestinal peptide (VIP) was evaluated. Based on preliminary unpublished clinical
      and experimental results, the course of disease under VIP treatment and the molecular
      mechanisms involved were assessed.

      34 patients with severe COPD were treated either with VIP inhalation in addition to
      conventional therapy or inhalation of placebo plus conventional therapy for a period of 3
      months. The trial was conducted as a double blind, comparative study with two parallel
      groups.

      In the absence of acute infection or acute worsening of the disease due to other conditions,
      2 transbronchial biopsies were collected before treatment, and after 3 months of treat¬ment
      for assessment of the regulation of a) the immune response, b) the extracellular matrix and
      c) the epithelial growth. This assessment will be performed in fully equipped and experienced
      laboratories at the University of Vienna.
    

Intervention name(s): Vasoactive Intestinal Peptide (VIP)
Intervention type(s): Drug
Intervention MeSH terms: Vasoactive Intestinal Peptide
Time perspective: Prospective
Keywords: COPD; Vasoactive Intestinal Peptide; Lung Function
The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Condition: Edematous Fibrosclerotic Panniculopathy; Cellulite
MeSH terms: Cellulite; Edema
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of
      AA4500 at increasing doses and concentrations in the treatment of adult women with cellulite.
    


Intervention name(s): COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Intervention type(s): Biological
Intervention description(s): Subdermal dose
Other intervention name(s): XIAFLEX; XIAPEX
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cellulite; Xiaflex
A1 Versus A2® Milk on the Gastrointestinal Physiology, Symptoms and Cognitive Behaviour for the Preschool Children
Condition: Gut Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multiple-sites, double-blinded, randomized, controlled, parallel-designed,
      cross-over study among healthy preschoolers with 5 days consumption of A2 or A1 milk to
      compare the effects on gut inflammation, gastrointestinal symptoms and behavioral well-being.
    

Detailed description: 
      Gut inflammation is reflected by serum C-Reactive Protein (CRP), hemoglobin (HB),
      interleukin-4 (IL-4), Immunoglobulin G (IgG), Immunoglobulin E (IgE), Immunoglobulin G1
      (IgG1), Immunoglobulin G2a (IgG2a), β-Casomorphin-7 (BCM-7), Glutathione, calcium (Ca), iron
      (Fe) and zinc (Zn) concentration; gastrointestinal (GI) symptoms are measured via Visual
      Analog Scale (VAS) for gut tolerance, including borborygmus, bloating, break wind, abdominal
      pain, and diarrhea; behavioral well-being is assessed using Subtle Cognitive Impairment Test
      (SCIT).

      The total duration of study was 24 weeks, including subject enrollment, study intervention,
      laboratory testing, and providing clinical study report. The cross-over study consisted of 5
      days of each product intervention; 10 days of wash-out in phase 1 and phase 2, respectively;
      and then followed by 6 weeks of statistical analysis and clinical report completion.
    

Intervention name(s): Oral consumption of milk A1 in study phase 1; Oral consumption of milk A2 in study phase 1; Oral consumption of milk A1 in study phase 2; Oral consumption of milk A2 in study phase 2
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Oral consumption of 250 ml of milk containing both A1 and A2 type beta casein 2 times per day after meal for 5 days in study phase 1.; Oral consumption of 250 ml of milk containing only A2 type beta casein 2 times per day after meal for 5 days in study phase 1.; Oral consumption of 250 ml of milk containing both A1 and A2 type beta casein 2 times per day after meal for 5 days in study phase 2.; Oral consumption of 250 ml of milk containing only A2 type beta casein 2 times per day after meal for 5 days in study phase 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Chitinases and Transforming Growth Factor Beta (TGFB) in Human Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to find out the roles of two specific gene families (the
      chitinase gene family and the TGFB family). We hypothesize that chitinases and TGFb pathway
      genes will be differentially expressed in the airways of non-asthmatic subjects and subjects
      with asthma. We further hypothesize that genetic variants in CHIT1, AMCase, and TGFb pathway
      genes that show associations with asthma and related phenotypes will change the expression
      and/or function of the protein of these genes in the airway in several ways, including the
      transcript numbers for full length genes and splice variants and, for the chitinase genes,
      the levels of chitinase activity in airway secretions.
    

Detailed description: 
      This is a cross-sectional study in patients with asthma and healthy controls in which we will
      analyze how the expression or function of CHIT1, AMCase, and TGFb pathway genes in the
      asthmatic airway is affected by genetic variation in these genes. We propose detailed
      phenotyping of the asthmatic subjects and the healthy controls, including collection of
      induced sputum, exhaled air and detailed physiologic measures including measures of airflow,
      lung volumes, and methacholine responsiveness as well as collection of airway cells and
      tissues by bronchoscopy. We will determine the relative expression of CHIT1 and AMCase in
      specific lung compartments (large airways, small airways, epithelial cells, macrophages) and
      the effects of genetic variants in CHIT1 and AMCase on expression of splice variants and
      levels of chitinase activity in the airway. These human samples will also allow us to
      determine if any of the multiple TGFb pathway genes analyzed show differential expression in
      the lung in asthma.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      sputum, blood, saliva, DNA, RNA, Plasma
Pharmacokinetics of AGO178 in Participants With Liver Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      AGO178 was developed for the treatment of depression. A new formulation is being tested in
      the present study: a tablet to be placed and dissolved under the tongue (sublingual tablet).
      The goal of this trial was to study the pharmacokinetics of agomelatine given as sublingual
      tablet in participants with liver impairment and to compare the results to those of healthy
      volunteers who receive the same treatment.
    


Intervention name(s): AGO178
Intervention type(s): Drug
Intervention description(s): AGO178 is administered as a sublingual tablet.
Other intervention name(s): Agomelatine
Intervention MeSH terms: Agomelatine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Liver impairment; Major Depression Disorder; Sublingual tablet
Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With STEMI
Condition: ST-Segment Elevated Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction; Ventricular Remodeling
Study type: Observational

Summary: 
      The study intends to investigate the alteration of regional myocardial work in patients with
      acute anterior myocardial infarction underwent primary percutaneous coronary intervention
      (PCI), and compare the distribution of regional myocardial work in patients with/without
      early remodeling at acute phase and 3-month follow-up.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with anterior STEMI who underwent primary PCI <12 hours after symptom onset were
        consecutive enrolled in our center.
      
Keywords: ST-segment elevated myocardial infarction; myocardial work; left ventricular remodeling
A Study of FB2001 for Inhalation in Healthy Chinese Adults
Condition: COVID-19 Pandemic
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      FB2001 is a novel inhalable preparation being developed for COVID-19 treatment. A
      Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety,
      Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of FB2001 in
      Healthy Chinese Adults
    

Detailed description: 
      Coronaviruses belong to the genus of coronavirus of the family coronaviruses. The viruses of
      the coronavirus genus are positive-sense single-stranded RNA viruses with envelopes, which
      are approximately 80-160 nm in diameter. Their genetic material is the largest among all RNA
      viruses and can infect both humans and animals. Coronaviruses can cause respiratory,
      intestinal, hepatic, and nervous system diseases of different severities. A total of 7
      coronaviruses have been found, in which HCoV-229E, HCoV-OC43, HCoV-NL63 and HCoV-HKU1 mainly
      lead to mild and self-limiting upper respiratory tract infections in infected humans, such as
      common cold; two new types of β-coronaviruses have emerged in the past 12 years, namely
      severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV),
      and these two viruses can cause severe human diseases.

      This is a Phase 1, randomized, double-blinded, placebo controlled, dose escalation study of
      FB2001 in healthy adult volunteers.The study aims to evaluate the safety, tolerability and
      pharmacokinetic profile of FB2001 administered by aerosol inhalation after single and
      multiple ascending doses.Approximately 32 participants will be sequentially enrolled into
      either 1 of 2 SAD cohorts (n=8 per cohort), or 1 of 2 MAD cohorts (n= 8 per cohort). An
      adaptive dose escalation schedule will be employed for both SAD and MAD parts of the study.
    

Intervention name(s): FB2001 for inhalation; FB2001 for inhalation placebo
Intervention type(s): Drug; Drug
Intervention description(s): FB2001 once or twice daily inhalation; FB2001 placebo once or twice daily inhalation
Other intervention name(s): DC402234
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lymphadenectomy In Ovarian Neoplasms
Condition: Ovarian Cancer
MeSH terms: Neoplasms; Ovarian Neoplasms
Study type: Interventional

Summary: 
      To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with
      advanced ovarian cancer and intra-abdominal complete debulking.

      Secondary: progression-free survival, complications and quality of life; Exploratory: Role of
      number of resected lymph nodes for primary and secondary objectives
    


Intervention name(s): No Lymphadenectomy (LNE); Lymphadenectomy (LNE)
Intervention type(s): Procedure; Procedure
Intervention description(s): No lymphadenectomy is performed in patients of the control group; Patients allocated to the lymphadenectomy group undergo systematic lymphadenectomy in addition to surgery for complete resection. Complete mobilization of the colon by resection of the paracolic gutters is necessary for the preparation of the lymphadenectomy. Afterwards the peritoneum has to be opened until the Treitzsche's Band for visualization of the renal vein. Systematic pelvic and para-aortic lymphadenectomy is based on anatomical studies and defined according to a recently published single centre series as systematic resection of lymph nodes in the following regions [24, ].
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian cancer, FIGO stage IIB-IV
Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to determine whether the hydrocodone and acetaminophen exposures following
      oral dosing of Vycavert are comparable to those following oral dosing of Norco.
    


Intervention name(s): Vycavert; Norco
Intervention type(s): Drug; Drug
Intervention description(s): single dose Vycavert containing 10 mg hydrocodone bitartrate/325 mg acetaminophen; single dose Norco containing 10 mg hydrocodone bitartrate/325 mg acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; bioequivalence; hydrocodone; acetaminophen; moderate to moderately severe pain
Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients
Condition: Gout Patients
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in
      combination with febuxostat or allopurinol when administered to gout patients.
    


Intervention name(s): Group 1: AR882 Alone and in Combination with Febuxostat (FBX); Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
Intervention type(s): Drug; Drug
Intervention description(s): AR882 + Febuxostat, AR882 alone, Febuxostat alone; AR882 + Allopurinol, AR882 alone, Allopurinol alone
Other intervention name(s): Febuxostat (Adenuric®, Uloric®); Allopurinol (Allosig®, Progout®, Zyloprim®)
Intervention MeSH terms: Allopurinol; Febuxostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperuricemia; Gout; URAT1