bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Safety, Tolerability and Pharmacokinetics of AD 452 [(+)-Mefloquine] Compared With Racemic Mefloquine
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Mefloquine is a quinolinemethanol antimalarial that is effective as therapy and prophylaxis
      for all species of malaria infecting humans, including multi-drug resistant Plasmodium
      falciparum. The marketed anti-malaria drug consists of two enantiomers of mefloquine.

      Mefloquine's clinical utility has been impaired by its association with neuropsychiatric side
      effects. The pharmacological basis of mefloquine's side effects is not known but two of the
      most reported hypotheses relate to its action on (i) the adenosine receptor and (ii) its
      effect on the cholinesterase enzyme. For both of these mechanisms, there is a significant
      stereoselective activity of the two enantiomers. In vitro studies show that the (-) isomer is
      50-100 fold more potent towards adenosine receptors compared with the (+) isomer. In
      addition, (-)-mefloquine has considerably more anti-cholinesterase activity. It has therefore
      been hypothesised that (+)-mefloquine may have a better central nervous system (CNS) safety
      profile compared with either the racemate or (-)-mefloquine.

      This study is a randomized, ascending dose, double-blind, active and placebo-controlled,
      parallel group study in healthy male and female volunteers designed to investigate this
      hypothesis and to describe the comparative pharmacokinetics of the racemate and the single
      enantiomer.
    


Intervention name(s): AD 452 (+) mefloquine; Racemic Mefloquine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose delivered as over-encapsulated tablet at ascending doses; Single dose delivered as over-encapsulated tablet at ascending dose; Over-encapsulated placebo to maintain blinding
Intervention MeSH terms: Mefloquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Mefloquine; Malaria; (+) Mefloquine; Pharmacokinetics
Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery
Condition: Cardiac Surgical Procedures; Blood Transfusion; Tranexamic Acid
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compares the effect of three different dose levels of tranexamic acid（TXA）in
      reducing blood loss and transfusion requirements in cardiac valve surgery.
    

Detailed description: 
      The effect of TXA to reduce perioperative blood loss and blood transfusion has been well
      established in many trials, but the optimal dosage of TXA in cardiac surgery has always been
      a problem of debate. This is a single-center randomized controlled trial to study different
      dose regimens of TXA in cardiac surgery. We use three different dose levels of TXA in cardiac
      valve surgery with CPB, and see if there are any differences in perioperative blood loss and
      transfusion requirements. Serious adverse events and seizure attacks are also recorded until
      three months after surgery.
    

Intervention name(s): Tranexamic acid
Intervention type(s): Drug
Intervention description(s): The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.
Other intervention name(s): Cyklokapron; Transamin
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac Surgery; Blood transfusion; Blood loss; Tranexamic Acid; Dose regimen
Application of Platelet Function Test in Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms
Condition: Unruptured Intracranial Aneurysm; Stents; Antiplatelet Drugs
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to identify high platelet reactivity (HPR) who might have in-stent
      thrombosis in unruptured aneurysm with intracranial stent placement with light transmittance
      platelet aggregometry (LTA). For HPR patients, higher ischemic stroke rate maybe occurred,
      and we hypothesis that dose adjustment of aspirin and clopidogrel based on LTA monitoring
      maybe reduces the rate of ischemic stroke compared to a standard strategy after intracranial
      stent implantation at early periprocedural period and 1 month follow-up period.
    

Detailed description: 
      For the patients of unruptured intracranial aneurysms with stent placement, standard
      antiplatelet therapy (100mg aspirin + 75mg clopidogrel) is considered to be the most
      effective antiplatelet regimen in reducing ischemic complications. However, despite the use
      of standard antiplatelet therapy, a number of patients continue to have ischemic events. A
      hypothesis is that high platelet reactivity (HPR) patients identified by platelet function
      test have higher ratio of the ischemic events, and dose adjustment of HPR patients reduces
      the rate of the ischemic complications at early periprocedural period and follow-up period.

      Objectives: The study aim to evaluated the superiority of the strategy of platelet function
      test(Monitoring Arm) with the modified strategy in HPR patients compared to the standard
      strategy (Conventional Arm) whether reduce the primary endpoint after intracranial stent
      implantation at early periprocedural period (7 days) and 1 months follow-up period.
    

Intervention name(s): Aspirin and clopidogrel/Ticagrelor; Light transmittance aggregometry; Aspirin and clopidogrel/Ticagrelor
Intervention type(s): Drug; Device; Drug
Intervention description(s): The modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays.; point-of-care method to assess platelet function by light transmittance aggregometry.; maintenance dose of aspirin, clopidogrel and ticagrelor.
Intervention MeSH terms: Aspirin; Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet function test; high platelet reactivity; light transmittance platelet aggregometry
COVID-19 Vaccination in Oncologic Patients
Condition: Covid19; Oncologic Disorders
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Evaluating the vaccination willingness in oncologic patients over six months as well as
      estimating the effects of radiotherapy/systemic anticancer treatment on the efficacy and
      toxicity of currently approved SARS-CoV-2 vaccines
    

Detailed description: 
      All patients that present themselves newly at the outpatient-clinic of the Department of
      Radiooncology at the Ordensklinikum Linz GmbH, Barmherzige Schwestern during a period of six
      months are eligible for participation. After being informed about the study, the participants
      answer a short structured interview regarding vaccination status and vaccination willingness.
      Patients who already received one or two doses of SARS-CoV-2 vaccine are eligible for the
      study's subpopulation 1, with the main focus of quantifying SARS-CoV-2 S binding antibody
      titres after at least 35 days from initial vaccination. Patients who are to receive at least
      one dose of vaccine during or up to six weeks after radiotherapy are eligible for
      subpopulation 2, comprising serial measurements of SARS-CoV-2 S binding antibody titres
      before and after vaccination.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        new patients of the department for radiooncology at the Ordensklinikum Barmherzige
        Schwestern Linz
      
Biospecimen description: 
      serum samples
    
Keywords: radiotherapy; SARS-CoV-2 vaccine; immune response; oncologic therapies; immunosuppression; SARS-CoV-2 S binding antibodies; vaccination willingness; vaccination side effects
13C-Pyruvate Breath Test
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the test is to measure an enzyme called pyruvate. Subjects will fast for 12
      hours and then undergo a breath test, have blood drawn, and cells from the inside of the
      mouth collected over a 12 hour period. The tests will be repeated at least a week later and
      subjects receive a dose of dichloroacetate (DCA)
    

Detailed description: 
      Subjects will be screened with a history and physical and have baseline laboratory values
      drawn to assure that the subject is healthy.Subjects will fast for 12 hours before the test.
      The next day they will receive a dose of 25mg of pyruvate dissolved in 80ml of Crystal Light.
      The pyruvate used in this study will be prepared with a nonradioactive form of carbon, called
      a stable isotope. It poses no hazard to the subject's health. About 50 mls of blood will be
      drawn over a 120 minute time period from an IV catheter placed in the arm. Subjects will also
      be asked to exhale into a plastic tube about 12 times in 120 minutes to collect 13C carbon
      dioxide (13CO2). Cells from inside of the mouth will be collected by subjects swishing a
      tablespoon of mouth wash for one minute and then spitting it into a sterile plastic tube. At
      least one week following the first admission subjects will return to repeat the above
      procedure and receive 25mg of dichloroacetate (DCA) one hour before receiving the pyruvate.
      Then the same samples will be collected. Subjects have the option of doing the tests 4 times
      receiving the DCA on the last visit.
    

Intervention name(s): 13C-Pyruvate 13C-lactate and dichloroacetate
Intervention type(s): Drug
Intervention description(s): Subjects will receive pyruvate and have blood,CO2, and buccal cell samples collected. The second visit the subjects will receive a dose of dichloroacetate before the pyruvate is given
Other intervention name(s): dichloroacetate; pyruvate; CO2 collection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: dichloroacetate; pyruvate; lactate; pyruvate dehydrogenase
Bioavailability of Tipranavir/Ritonavir Paediatric Solution Compared to Tipranavir/Ritonavir Capsules in Healthy Female and Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir (TPV/r)
      oral solution compared to 500/200 mg of TPV/r capsules following oral administration and to
      investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with food
      versus without food.
    


Intervention name(s): Tipranavir oral solution; Tipranavir capsules; Ritonavir oral solution; Ritonavir soft gel capsules; High fat breakfast
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention MeSH terms: Ritonavir; Tipranavir; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome
Condition: Sleep Apnea Syndromes
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in
      adults is now well documented as well as its cardiovascular repercussions. Previous studies
      showed a conclusive link between SAHS and severe cardiovascular diseases such as
      hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health
      issue in adults.

      In this context, early detection of such a disease is crucial if the management is tailored
      to the patient, the practitioner's choice of therapy moving towards continuous positive
      airway pressure (CPAP) or mandibular advancement device. The detection is based on full
      nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold
      standard but it is a time consuming and costly examination. Polygraphic recording is a test
      that allows simplified the diagnosis of severe patients, but may not be sufficient for mild
      form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation
      of a technique for identifying patients most at risk to either limit the number of
      polysomnographic examination is requested.
    

Detailed description: 
      In this perspective, the development of a product screening sleep related breathing disorders
      for physicians, cardiologists, internists (not specialized sleep experts) would fill this
      need. It allows for a reliable first screening for their patients in parallel with a routine
      cardiological examination. Imposing a minimal human and material, the ECG Holter recorder
      "VistaO2" (NOVACOR, Rueil-Malmaison, France) is a device designed to meet these requirements.
      This device fits into the daily management of patients with cardiac arrhythmias or
      sinus/atrioventricular conduction disorders, and of patients suffering myocardial infarction
      (arrhythmic risk stratification, detection of silent myocardial ischemia).

      Analysis of heart rate variability (HRV) has already shown interest in screening SAHS. We
      therefore wish to evaluate the performance of the analysis of data from the screening tool
      VistaO2 face what the gold standard synchronized polysomnography.
    

Intervention name(s): VistaO2 device
Intervention type(s): Device
Intervention description(s): Full night VistaO2 device monitoring synchronized with the gold standard polysomnography.
Other intervention name(s): VistaO2 : ECG Holter recorder (Novacor, Rueil-Malmaison, France).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Sleep Apnea Syndromes; Polysomnography; Holter ECG; Thoracic impedance; Heart rate variability
Tangji Gastric Bypass Stent Study for Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity
      in patients with a BMI ≥ 30 kg/m2. In this clinical investigation the Sponsor seeks to
      demonstrate the safety and performance of the Gastric Bypass Stent System for its proposed
      indication in weight loss treatment for obesity in the China.
    


Intervention name(s): Gastric Bypass Stent System; Dietary Intervention
Intervention type(s): Device; Behavioral
Intervention description(s): Subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy. Following a 3-month treatment period, the device is removed, and subjects are followed for 6 months.; The patients in the trial group or in the control group,have 9-month dietary intervention in the syudy period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TMC125-TiDP2-C197: A Phase I Trial to Investigate the Pharmacokinetic Interaction Between Lopinavir/Ritonavir and TMC125 Both at Steady-state in Healthy Volunteers.
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the effect of steady-state concentrations of LPV,
      co-administered with a low dose of ritonavir, on the steady-state pharmacokinetics of TMC125
      and to determine the effect of steady-state concentrations of TMC125 on the steady-state
      pharmacokinetics of LPV, co-administered with a low dose of ritonavir.
    

Detailed description: 
      This is a Phase I, open-label, randomized (patients are assigned different treatments based
      on chance), 2-period, 2-way cross-over interaction trial to investigate the pharmacokinetic
      interaction (study of the bodily absorption, distribution, metabolism, and excretion of
      drugs) between lopinavir/ritonavir (LPV/rtv) and TMC125, both at steady-state.The trial
      population will consist of 16 healthy volunteers. In 2 consecutive sessions, healthy
      volunteers will receive Treatment A and Treatment B, in a randomized sequence. In Treatment
      A, 200 mg TMC125 b.i.d.will be administered for 7 days (from Day 1 to Day 7) with an
      additional morning dose on Day 8. In Treatment B, 400/100 mgLPV/rtv twice a day will be
      administered for 15 days (from Day 1 to Day15) with an additional morning dose on Day 16,
      while 200 mgTMC125 b.i.d. will be co-administered from Day 9 to Day 15 with an additional
      morning dose on Day 16. Subsequent sessions will be separated by a washout period of at least
      2 weeks. Full pharmacokinetic profiles of TMC125 will be determined over the 12-hour dosing
      interval after the morning intake on Day 8 of Treatment A and on Day 16 of Treatment B. Full
      pharmacokinetic profiles of LPV and ritonavir will be determined over the 12-hour dosing
      interval after the morning intake on Days 8 and 16 of Treatment B. All treatments will be
      administered under fed conditions and will be taken within 10 minutes after a meal. Safety
      and tolerability evaluations will be recorded continuously. Treatment A = 200 mg TMC125
      b.i.d. will be administered for 7 days (from Day 1 to Day 7) with an additional morning dose
      on Day 8. Treatment B = 400/100 mg LPV/rtv b.i.d. will be administered for 15 days (from Day
      1 to Day 15) with an additional morning dose on Day 16, while 200 mg TMC125 b.i.d. will be
      co-administered from Day 9 to Day 15 with an additional morning dose on Day 16.
    

Intervention name(s): Etravirine; Lopinavir; Ritonavir
Intervention type(s): Drug
Intervention MeSH terms: Ritonavir; Lopinavir; Etravirine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC125-C197; TMC125-TiDP2-C197; HIV; DDI; Lopinavir; Intelence; Kaletra; Ritonavir; Etravirine; Interaction; Pharmacokinetics; Steady-state
Electrical Stimulation of Cutaneous Lesions
Condition: Chronic Ulcer; Burns
Study type: Interventional

Summary: 
      Skin lesions, such as chronic ulcers and burns, represent a serious public health problem due
      to high government costs, and scarce successful conservative treatments.There is a growing
      scientific literature on the use of electrotherapy in the process of wound healing, but in
      return there is a dearth of scientific studies on the use of various types of currents and
      the different parameters in the proposed treatments.
    

Detailed description: 
      This project proposes the use of polarized currents to increase the speed of healing in
      chronic ulcers and donor sites in burn patients. Will be included 30 patients with chronic
      ulcers and 30 burn patients undergoing skin graft surgery, will be randomized into control
      and treated groups. For the ulcer chronic group treatment will be with 50 minutes high
      voltage and 10 minutes diadynamica current and the burn group only 50 minutes high voltage
      current.
    

Intervention name(s): Control group; Treatment group
Intervention type(s): Other; Other
Intervention description(s): will be turn on the equipment, positioning the patient but no put intensity; This group will receive electrostimulation
Other intervention name(s): Sham group; Electrical stimulation; polar current; Current treatment; current stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Electrical stimulation; wound healing; Polarity current; Burn; Chronic ulcer
An Open Label Phase 2 Extension Study of Higher Dose Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy
Condition: GNE Myopathy; Hereditary Inclusion Body Myopathy (HIBM)
MeSH terms: Muscular Diseases; Distal Myopathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The safety objectives of the study are to: evaluate additional long-term safety of SA-ER
      treatment of participants with GNE myopathy previously treated with SA-ER at dose of 6g/day
      (Part I); evaluate the safety of 12g /day SA (delivered by 1.5g of SA-ER tablets and 1.5g of
      SA-IR capsules 4 times per day) in the treatment of participants with GNE myopathy (Part II)
      over a 6 month treatment period; evaluate the safety of SA treatment at both 6g/day and 12
      g/day (Part III [SA-ER/SA-IR] and Part IV [SA-ER]).
    


Intervention name(s): SA-ER 500 mg; SA-IR 500 mg
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets; oral capsules
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Parent Training for Youth With Chronic Symptoms
Condition: Medically Unexplained Symptoms
MeSH terms: Medically Unexplained Symptoms
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of a parent-only, group-based
      intervention intended to treat youth with chronic, unexplained medical symptoms such as (but
      not limited to) chronic fatigue, musculoskeletal pain, headache, and abdominal pain. Prior to
      and following the intervention, the child and parent(s) will be asked to complete several
      questionnaires about their well-being and functioning. The investigators predict that
      participation in this intervention will lead to change in relevant outcomes, including youth
      symptoms and functional impairment, and parenting stress and accommodation of symptoms. The
      investigators also predict that this group will be acceptable and feasible for parents.
    


Intervention name(s): Parent training
Intervention type(s): Behavioral
Intervention description(s): Parents will learn evidence-based techniques for increasing support and decreasing accommodation of children's chronic symptoms.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment