bioihbjkbjnl/mcl2 huggingface dataset:
A Placebo-controlled Four Way Crossover Study to Asses the Effect of a Single Oral Dose of NKTR-118 on QTc Interval in Healthy Male Subjects
Condition: Amount of NKTR-118 in Blood; Variation in the Heart's Electrical Cycle
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects on QTc interval in healthy males when
      administered a single dose of NKTR-118 compared with placebo and moxifloxacin. (QTc is a
      specific time interval that can be measured in a heart beat by taking Electrocardiogram
      (ECG))
    

Detailed description: 
      A Single Center, Randomized, Double-blinded, Placebo-controlled, Open-label,
      Positive-controlled, Four-way Crossover Study to Assess the Effect of a Single Oral Dose
      NKTR-118 Administration on QTc Interval Compared to Placebo, Using AVELOX (moxifloxacin) as a
      Positive Control, in Healthy Male Subjects
    

Intervention name(s): NKTR-118; moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mg tablet; 400 mg tablet; tablet
Intervention MeSH terms: Moxifloxacin; Naloxegol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; healthy male volunteers; cross-over study; NKTR-118
Pharmacokinetics of FDL169 in Healthy Female Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetics of single and multiple doses of FDL169 in healthy female
      subjects.
    

Detailed description: 
      This is a two-part study.

      Part 1:

      Part 1 of the study is a single-dose, dose-escalation, study to assess the safety,
      tolerability and PK profiles following oral administrations of FDL169 to healthy female
      volunteers in the fed state. Up to five doses will be assessed.

      Part 2:

      Part 2 of the study is a multiple-dose study to assess the safety, tolerability and PK
      profiles following oral administrations of FDL169 to healthy female volunteers in the fed
      state.
    

Intervention name(s): FDL169
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Prediction and Prevention of Asymptomatic Cardiovascular Insult in Type 1 Diabetic Children: Comparative Effectiveness of Cardioprotective Drugs
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Diabetic cardiomyopathy (DCM) is a distinct clinical entity of diabetic heart muscle that
      describes diabetes associated changes in the structure and function of the myocardium in the
      absence of coronary artery disease, hypertension, and valvular disease. Oxidative stress
      plays a critical role in DCM development. DCM can be diagnosed using the novel methods of
      echocardiography (tissue Doppler imaging, Speckling tracking techniques and more recent real
      time 4D echocardiography). There is a possible cardioprotective effect of statins, Captopril
      and L-Carnitine in type 1 diabetic children and adolescents.
    


Intervention name(s): Atorvastatin; Captopril; L-carnitine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): cardio-protective agents; cardio-protective agents; cardio-protective agents
Intervention MeSH terms: Captopril; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Beta-glucan on Fecal Microflora in Polypectomized Patients
Condition: Polypectomized Patients
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of the potential prebiotic beta-glucan on
      the intestinal microflora, the bacterial enzyme activity (beta-glucuronidase and
      beta-glucosidase) in the feces, the fecal pH and the concentration of fecal short-chain fatty
      acid in polypectomized patients. Also the in vitro anti-cyto- and anti-genotoxicity of fecal
      water will be examined on human cell culture (HT29). During the trial, patient's clinical
      symptoms (intestinal habits), physical activity, well-being and food intake will be recorded.
    

Detailed description: 
      Prebiotics, such as short- and long-chain fructo-oligosaccharides are fermented by the
      microflora colonizing the gastrointestinal tract, and they selectively stimulate the growth
      or the activity of one or limited number of bacteria within the intestine. Beta-glucans are
      polysaccharides occurring in the bran of cereal grains, the cell wall of Saccharomyces
      cerevisiae and bacteria, certain types of fungi, seaweed and many kinds of mushrooms. The aim
      of this study is to determine the effect of the potential prebiotic beta-glucan on the
      intestinal microflora, the bacterial enzyme activity (beta-glucuronidase and
      beta-glucosidase) in the faeces, the faecal pH, and the concentration of faecal short-chain
      fatty acid in polypectomized patients.
    

Intervention name(s): wheat bread with beta-glucan; wheat bread without beta-glucan
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 g beta-glucan in approximately 200 g of wheat bread per day for 3 months; Approximately 200 g of wheat bread (without beta-glucan supplementation) per day for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Beta-glucan; faecal microflora; polypectomized; Precancerous Nonmalignant Condition
Kinematical and Muscular Fatigue in Swimmers
Condition: Healthy
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      During a submaximal task, gradual muscle fatigue occurs, which inevitably results in a
      decline in performance (mechanical failure). Elite athletes are known to employ unconscious
      compensatory strategies during fatiguing submaximal tasks in an attempt to delay the onset of
      mechanical failure as long as possible.

      The purpose of this study was to gain valuable insight into the strategies used by elite
      swimmers to cope with mechanical failure. Twenty-two swimmers were subjected to a swim test
      consisting of swimming as long as possible at a predetermined and controlled pace. A light
      strip positioned at the bottom of the pool allows athletes to get feedback on which gait to
      keep. The kinematics (stroke rate, stroke length, and efficiency index) and electrical
      activity of 10 muscle groups were analyzed and compared at the beginning of the test
      (non-fatiguing conditions), just before the athlete lost the ability to maintain the
      predetermined pace (pre-mechanical failure), and after the athlete lost the ability to
      maintain the pace (mechanical failure). It is hypothesized that as fatigue becomes more
      pronounced and the point of inability to maintain a predetermined speed is approached,
      increased EMG activity will occur in key muscles while other muscle groups may show more
      obvious signs of fatigue. In addition, changes in the rhythm and coordination of upper limb
      movements may occur.
    


Intervention name(s): Swimming Fatigue Task
Intervention type(s): Other
Intervention description(s): Swim freestyle at a steady, controlled pace until mechanical failure (i.e., inability to maintain the predetermined speed) is reached.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: muscle fatigue; Neuromuscular Strategy; performance; sEMG; swimming
Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients
Condition: Vascular Calcification; Atherosclerosis; Dyslipidemia; Inflammation
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Dyslipidemias; Calcinosis; Vascular Calcification; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      This prospective, randomized, controlled study aims to investigate the effects of
      atorvastatin treatment in hemodialysis patients concerning progression of coronary artery
      calcification, progression of carotid artery intima-media thickness, endothelial function,
      and inflammation.
    

Detailed description: 
      The effects of statin treatment on coronary artery calcifications, carotid artery
      intima-media thickness, and endothelial functions have never been investigated in
      hemodialysis patients. Regarding inflammation, the present data in hemodialysis patients are
      derived from small studies with short follow-up.

      We postulate that atorvastatin would reduce progression of coronary calcification and carotid
      artery intima-media thickness, decrease inflammation, and improve endothelial function.

      In this prospective, controlled, randomized study, four hundred forty-six prevalent
      hemodialysis patients who meet inclusion and exclusion criteria will be randomized to
      atorvastatin (20 mg/day in first month; increased to 40 mg/day afterwards) and placebo arms
      (each arm consists of 223 patients), after completion of baseline investigations.
      Randomization will be performed with random permuted blocks and will be stratified according
      to dialysis center, age, sex, diabetic status, duration of dialysis, high flux dialyser use,
      and dialysate calcium level. Follow-up period will be twelve months.

      It is estimated that 446 patients would provide 90% power with a two-sided, alpha error rate
      of 5%, of detecting a significant difference between treatment arms. Dropout rate is expected
      to be 20%, not to be replaced.
    

Intervention name(s): atorvastatin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): atorvastatin 40 mg/day; 1 tb/day
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hemodialysis; endothelial function; coronary artery calcification; atherosclerosis; statin
A Single Dose Study Of PF-05161704 In Healthy Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety, tolerability and
      pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.
    


Intervention name(s): PF-05161704 or placebo; PF-05161704 or placebo
Intervention type(s): Drug; Drug
Intervention description(s): PF-05161704 will be administered as an extemporaneously prepared suspension in the initially planned dose range of 1.5 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension; PF-05161704 will be administered as an extemporaneously prepared suspension in the initially planned dose range of 1.5 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Single Ascending Dose; Phase 1; Safety and Tolerability; PK; Healthy Subjects
Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device by Emergency Medical Technician in Ambulance
Condition: Chest Pain; Electrocardiography
MeSH terms: Emergencies; Chest Pain
Study type: Interventional

Summary: 
      In this study, the investigators compare timely acquirement and effectiveness of 12-lead ECG
      using patchy-type wireless versus using defibrillator which contain ECG examination function
      in ambulance.

      The purpose of this study is to determine the difference of timely acquirement of 12-lead ECG
      using two different systems and the difference of efficiency of ECG examination in ambulance
      between two groups.

      The participants in this simulation study were divided randomly into 2 groups :

      Group A is performing an ECG examination on mock patient using defibrillator which contained
      12-lead ECG checking function. And take a 15 minutes wash out period. After the wash out
      period, group A subject performing an ECG examination using patchy-type wireless device.

      Group B subject is performing an ECG examination on mock patient using patchy-type wireless
      device first, and take a 15 minutes wash out period. After the wash out period, group B
      performing an ECG examination using defibrillator which contain 12-lead ECG function.

      Both group's ECG examination is performing in the ambulance.
    


Intervention name(s): patchy-type wireless ECG; defibrillator ECG
Intervention type(s): Device; Device
Intervention description(s): This device consists of a single patchy and save the ECG result as a Potable Document Format. Also can transfer to hospital using wifi-network.; This device is essential equipment in ambulance. For 12-lead ECG examination the connector need to replace for specific cable.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: 12-lead electrocardiography; Emergency medical technician; chest pain; wireless technology; simulation study
Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different
      tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent
      pivotal bioequivalence (BE) study between capsule and tablet formulations.
    


Intervention name(s): UHAC 62 XX - TF1 tablet; UHAC 62 XX - TF2 tablet; UHAC 62 XX - capsules
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Thrombosis Risk Assessment and Clinical Presentation of Covid-19 Pneumonia
Condition: Corona Virus Infection; Thromboembolic Disease
MeSH terms: COVID-19; Pneumonia; Coronavirus Infections; Thrombosis; Thromboembolism
Study type: Observational

Summary: 
      Covid-19 mainly affects the respiratory system. Multiple organ dysfunction and a particularly
      progressive respiratory insufficiency along with a widespread coagulopathy presumed to be due
      to infection-associated inflammation and the resulting cytokine storm, are strongly
      associated with high mortality rates. In this study, the association between thrombosis risk
      and clinical presentation of Covid-19 is investigated.
    

Detailed description: 
      The severe acute respiratory distress syndrome related coronavirus-2 (SARS-CoV-2) and its
      clinical presentation as Coronavirus disease 2019 (COVID-19) was first reported in Wuhan,
      Hubei, China in December 2019. It has spread rapidly from its origin in Wuhan City to other
      countries of the world over the last several months.

      Although it mainly affects the respiratory system , multiple organ dysfunction and a
      particularly progressive respiratory insufficiency along with a widespread coagulopathy
      presumed to be due to infection-associated inflammation and the resulting cytokine storm, are
      strongly associated with high mortality rates. SARS-CoV-2 infection may also lead to
      thrombotic disease both in the venous and arterial circulation of patients apart from
      respiratory system due to excessive inflammation, thrombocyte activation, endothelial
      malfunction, and stasis.

      Investigators have reported that both CHADS2 and CHA2DS2-VASc scores were related to
      mortality in individuals that had stable coronary angina, acute coronary syndrome, Takotsubo
      syndrome or sick sinus syndrome, apart from atrial fibrillation . In addition,
      thrombocyte/lymphocyte (PLT/LYM) and neutrophil/lymphocyte (NEU/LYM) ratios on admission were
      also related with thromboembolic complications in former studies which found them useful to
      predict prognosis of acute pulmonary embolism, as being one of the thromboembolic
      complications of Covid-19.

      Investigators suggest that the parameters mentioned above should also be studied in terms of
      thrombotic complications of Covid-19. Thus they aimed to find out potential associations
      between markers of prothrombotic or inflammatory conditions and some clinical features of
      Covid-19 pneumonia cases on admission and follow-up.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with COVID - 19 pneumonia diagnosed in the emergency, internal medicine and
        cardiology outpatient clinics will be included
      
Keywords: covid-19 pneumonia; thromboembolism risk; length of hospitalization
Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins
Condition: Hypertriglyceridemia; Diabetes Mellitus
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      The study examines the effect of two diets on fasting and post fat load lipoproteins of
      subjects with type 2 diabetes with moderate hypertriglyceridemia.
    


Intervention name(s): Low Fat/High Carbohydrate; High Monounsaturated Fat/Low Carbohydrate
Intervention type(s): Other; Other
Intervention description(s): Low Fat/High Carbohydrate for 6 week period; High Monounsaturated Fat/Low Carbohydrate for 6 week period
Other intervention name(s): Diet; Diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of and immune response to an
      investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational
      HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.
    

Detailed description: 
      The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and
      effective vaccine that will prevent HIV infection. This study will evaluate the safety and
      immunogenicity of an experimental adenovirus-vectored multiclade HIV vaccine,
      VRC-HIVADV014-00-VP, followed with either a similarly structured DNA plasmid HIV vaccine,
      VRC-HIVDNA016-00-VP, or a placebo. The DNA plasmids in both vaccines code for proteins from
      HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world.
      HIV uninfected volunteers will be recruited in Kenya and Rwanda.

      Volunteers will participate in this study for 1 year. Participants will be randomly assigned
      to one of four groups:

        -  Group A participants will receive a low dose of the adenovirus-vectored vaccine or
           placebo at study entry.

        -  Group B participants will receive a higher dose of the adenovirus-vectored vaccine or
           placebo at study entry.

        -  Group C participants will receive the DNA plasmid vaccine or placebo at study entry and
           Months 1 and 2. They will receive either a low dose of the adenovirus-vectored vaccine
           or placebo at Month 6.

        -  Group D participants will receive the DNA plasmid vaccine or placebo at study entry and
           Months 1 and 2. They will receive either a higher dose of the adenovirus-vectored
           vaccine or placebo at Month 6.

      All participants will undergo vital signs measurements before and after receiving each
      vaccination.

      Participants in Groups A and B will have 9 study visits over 12 months. A physical exam,
      adverse events reporting, and medical and medication history will occur at each visit. HIV
      testing and counseling and blood and urine collection will occur at selected visits.

      Participants in Groups C and D will have 17 study visits over 12 months. A physical exam,
      adverse events reporting, and medical and medication history will occur at each visit. HIV
      testing and counseling and blood and urine collection will occur at selected visits.
    

Intervention name(s): VRC-HIVADV014-00-VP; VRC-HIVDNA016-00-VP
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: HIV Seronegativity; HIV Preventive Vaccine
Immediate Detection of Helicobacter Infection With a New Electrochemical System.
Condition: H. Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional

Summary: 
      Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general
      population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and
      gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen
      tests, histology or the Helicobacter urease test (HUT).

      The aim of our study is to access the clinical reliability of a new, electrochemical device
      for rapid H. pylori detection.
    

Detailed description: 
      The newly developed electrochemical device for H. pylori detection consists of a working and
      reference electrode between which a biopsy sample is administered. Afterwards, acquired
      voltage-values could be analysed for characteristics typical for H. pylori infection
      (ammonia). According to Sydney classification, biopsies are taken from gastric antrum and
      corpus for electrochemical H. pylori detection, HUT and immunohistochemistry (IHC). HUT
      results are evaluated after 24 hours. Furthermore, every patient will receive 13C-urea breath
      test. IHC is designated as the gold standard of H. pylori diagnosis.
    

Intervention name(s): Electrochemical H. pylori detection method; IHC; C13-urea breath test; HUT
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Determination of H. pylori infection.; Determination of H. pylori infection.; Determination of H. pylori infection.; Determination of H. pylori infection.
Other intervention name(s): Determination of H. pylori infection.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic