bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetic and safety profiles of an
      experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.
    


Intervention name(s): ABT-450; ritonavir; placebo for ABT-450; Placebo for ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): capsules,QD, one dose, see Arm Descriptions for more information; capsules, QD, one dose, escalating doses, see Arm Descriptions for more information; capsules, QD, one dose; capsules, QD, one dose
Other intervention name(s): ABT-538; Norvir; placebo; placebo
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: FIH; SAD
CCRT for Esophageal Cancer.
Condition: Esophageal Cancer; Concurrent Chemoradiotherapy; Oxaliplatin; Paclitaxel
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy
      (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced
      esophageal cancer patients.
    


Intervention name(s): Paclitaxel; Oxaliplatin; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): PTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications.; oxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1.; Radiotherapy was given concurrently on the first day of the first cycle of chemotherapy. The GTV received 60Gy (30 fractions at 2Gy per fraction) and CTV was 40 Gy (20 fractions at 2Gy per fraction). Radiotherapy was delivered in three-dimensional conformal technique (3D-CRT) and no intensity-modulated radiotherapy was used.
Intervention MeSH terms: Paclitaxel; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal cancer; Concurrent chemoradiotherapy; Oxaliplatin; Paclitaxel; Survival; Toxicity
Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons
Condition: Hypertension
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The overall hypothesis of this trial is that screening for chronic kidney disease, followed
      by education or treatment program will improve blood pressure control among hypertensive
      non-diabetic persons.
    

Detailed description: 
      To evaluate a CKD screen-and-educate program in primary care for improving blood pressure
      management compared with usual care, among non-diabetic adults with hypertension.
    

Intervention name(s): Screen-Educate; Screen-Educate and Intensify Treatment
Intervention type(s): Other; Other
Intervention description(s): Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note.; This arm adds option of a pharmacist. PCPs randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education. A primary care clinical pharmacist will schedule a series of appointments with patients found to have confirmed higher-risk CKD (defined as eGFRcreat-cys <45, or eGFR 45-59 and ACR ≥ 30 mg/g). The pharmacist will follow treatment algorithms recommended by the 2012 KDIGO international CKD guidelines, and designed by a team of internists and nephrologists.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Internal Jugular Vein Distensibility in Assessment of Fluid Responsiveness in Donors of Living Donor Liver Transplantation
Condition: Monitoring During Anesthesia
Study type: Observational

Summary: 
      Egypt has a very high prevalence of HCV and a high morbidity and mortality from chronic liver
      disease, cirrhosis, and hepatocellular carcinoma. Approximately 20% of Egyptian blood donors
      are anti-HCV positive. Egypt has higher rates of HCV than neighboring countries as well as
      other countries in the world with comparable socioeconomic conditions and hygienic standards
      for invasive medical, dental, or paramedical procedures.

      Donor safety is on the top of our priorities as a team and it is widely recognized
      intraopertively during hepatectomy, there are several potential risks during the
      Perioperative period .
    

Detailed description: 
      to a conclusion that intraoperative fluid management aids to the reduction of the
      intraoperative bleeding during the procedure, adequate and guided fluid management is
      considered one of the important strategies to reduce the blood loss besides of the other
      anesthetic techniques like hemodilution, normovolemia, cell salvage usage , high Stroke
      volume variation (SVV) method ,and low CVP technique , the last method is considered the most
      applicable, simpler, and cost effective technique which could be easier to be performed.
    

Intervention name(s): Internal Jugular Vein Distensibility
Intervention type(s): Diagnostic Test
Intervention description(s): . 40 donor candidates for right lobe hepatectomy for living donor liver transplantation were enrolled. During period of hypovolemia (T0) left IJV scanned and measured. After a given fluid bolus in the form of ringer acetate 5 ml / Kg. ultrasonic and hemodynamic measurements were reassessed 10 minutes (T 10) after the fluid resuscitation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Prospective blinded observational study
BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, double-blind, randomized study with up to 11 treatment groups evaluates
      the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of
      single ascending doses of BAY2328065
    


Intervention name(s): BAY2328065; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets; Matching placebo, once daily in an escalating manner as LSF or tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS
Condition: Relapsing-Remitting Multiple Sclerosis; Fatigue
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Fatigue
Study type: Observational

Summary: 
      The primary objective of this trial is to observe the Multiple Sclerosis (MS) related fatigue
      during treatment with Tysabri as measured by changes in the fatigue scale for motor and
      cognitive functions (FMSC) over the course of 12 months. The secondary objectives are: To
      investigate changes in fatigue, capacity for work, Health Related Quality of Life (HRQol),
      sleepiness, cognitive impairment, physically activity induced exhaustion, speed of walking,
      status of MS disease progression and amount of walking at different times points after
      initiation of Tysabri treatment in participants diagnosed with Relapsing-Remitting Multiple
      Sclerosis (RRMS). Changes in fatigue are measured at 3, 6 and 9 months, whereas changes in
      capacity for work, HRQoL, sleepiness, cognitive impairment, physical activity induced
      exhaustion, speed of walking, status of MS disease progression and amount of walking are
      measured at 6 and 12 months. To investigate correlation between fatigue and cognitive
      impairment, depression and physically activity induced exhaustion and status of MS disease
      progression in participants at baseline, 6 and 12 month of treatment with Tysabri and to
      document any changes in fatigue related medication.
    


Intervention name(s): Natalizumab
Intervention type(s): Other
Intervention description(s): Participants treated with Tysabri
Other intervention name(s): BG00002; Tysabri
Intervention MeSH terms: Natalizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects diagnosed with Relapsing Remitting Multiple Sclerosis initiating treatment with
        Tysabri
Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors
Condition: Breast Cancer Female
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Preventing or reducing obesity is one factor that has been hailed as a way to improve quality
      of life, reduce recurrence, and increase survival rates among breast cancer survivors. An
      experienced team of multi-disciplinary researchers has developed an innovative and unique
      approach to encourage enhanced nutrition and exercise behaviors in this population using
      principles of behavioral economics. In particular, the use of social norms or exemplars has
      been shown in other applications to be effective, and if successful in this population could
      be inexpensively scaled up for widespread adoption. The proposed pilot study develops a
      system of text messages for social/mobile media that will provide ongoing reinforcement of
      desired behavior in breast cancer survivors. These messages would focus on achieving
      compliance with the expert-developed nutrition and exercise recommendations of the American
      Cancer Society. In the main study, 310 breast cancer survivors will be randomly placed in
      intervention and control groups for the 12 week study. Behavior change will be measured using
      established measures of self-reported behavior. In a sub-study, 60 of the breast cancer
      survivor participants will also provide blood and urine samples so changes in biomarkers can
      be assessed. The impact of the study will be measured by biomarkers and self-reported survey
      responses.
    


Intervention name(s): placebo text message; nutrition physical activity text message
Intervention type(s): Other; Other
Intervention description(s): The subjects in the control group will receive placebo text messages which will be timed as the intervention group that are unrelated to the study or topics of exercise and nutrition.; The subjects in the intervention group will receive text messages with nutrition and physical activity-related information throughout the study period on a daily basis, varying text message arrival over a 10 am to 7 pm time frame. The American Cancer Society recommends a set of exercise and nutrition behaviors for cancer survivors based upon developed expert evidence. These behaviors have been structured to achieve healthier lifestyles, improve quality of life and reduced mortality. The intervention will provide via text messaging exemplars and social norms designed to improve compliance with this advice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Behavioral economics; Breast cancer survivors; nutrition; physical activity
Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effectiveness and the safety of sarilumab in
      patients with glucocorticoid-dependent sarcoidosis.
    

Detailed description: 
      The purpose of this study is to compare the effectivness and the safety of sarilumab in
      patients with glucocorticoid-dependent sarcoidosis. To demonstrate that sarilumab treatment
      will be effective for inducing and maintaining glucocorticoid-free remission in male or
      female patients with biopsy proven active, glucocorticoid-dependent sarcoidosis affecting the
      lungs, lymph nodes, liver, kidneys, spleen, bone, soft tissues, skin, and/or eyes.
    

Intervention name(s): Sarilumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sarilumab 200 mg administered subcutaneously; Placebo administered subcutaneously
Other intervention name(s): Kevzara
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects will all receive sarilumab 200 mg subcutaneously every two weeks for the first 16 weeks of the study. At Week 16, those patients who were able to successfully taper off of prednisone will then be assigned randomly to receive either sarilumab 200 mg subcutaneously every two weeks (study drug) or placebo subcutaneously for an additional 12 weeks.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: glucocorticoid-dependent
Association Between Perioperative Platelet Function and Major Adverse Perioperative Events
Condition: Surgery
Study type: Observational

Summary: 
      This study will examine the degree of blood thinning (platelet function) in patients coming
      for non-cardiac surgery on antiplatelet agents using platelet function tests called
      thromboelastography (TEG) and platelet mapping assay (PMA) and major cardiac complications
      that occur any time after surgery (perioperative).
    

Detailed description: 
      Patients who have had stents in their coronary arteries (PCI) have to stay on antiplatelet
      agents to prevent clotting of their stents. These patients often require non-cardiac surgery
      (NCS) at some stage after their PCI. The rate of major cardiac complications (MACE)in this
      population is very high and it is unclear why they are at higher risk than the general
      population. It is possible their antiplatelet is not adequate, or that surgery causes them to
      be more clot prone. This is a prospective, multicentre observational study.
    

Intervention name(s): Blood drawn
Intervention type(s): Procedure
Intervention description(s): Blood samples will be taken once in the preoperative clinic and once again at the end of the surgery in the post anesthetic care unit to do the TEG and PMA tests.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have PCI have to stay on antiplatelet agents to prevent clotting of their
        stents. These patients often require NCS at some stage after their PCI.
      
Keywords: platelet function; perioperative complications; thromboelastography; coronary stents; non-cardiac surgery
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study
Condition: Mild-To-Moderate Alzheimer's Disease; Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered
      Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease
    


Intervention name(s): Plasma
Intervention type(s): Other
Intervention description(s): 1 unit of Plasma From Young Donors (Male, aged 30 or younger)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The TOBY Children Study
Condition: Cerebral Palsy; Hypoxia-Ischemia, Brain
MeSH terms: Cerebral Palsy; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Study type: Observational

Summary: 
      The aim of this study is to determine the efficacy of therapeutic hypothermia following
      perinatal asphyxia on neurological and neuropsychological outcomes and also to assess
      academic attainment and any additional health, societal or educational costs associated with
      changes in outcome as a result of the intervention. This study will determine whether the
      apparent initial benefits of cooling are maintained in the longer term.

      Perinatal asphyxia (a lack of oxygen occurring around the time of birth) may have long term
      consequences on brain functioning, which may be altered by treatment with hypothermia
      (cooling). Currently, there is no information on the effect of cooling on outcome beyond 18
      months of age. We intend to assess at 6 - 7 years of age, the children that participated in
      the TOBY trial of whole body cooling following perinatal asphyxia and compare between the
      children that had received the cooling treatment soon after birth and those that were not
      treated with cooling, the number that survived with an intelligence quotient (IQ) greater
      than 84, the presence and severity of disabilities, educational attainment and the economic
      impact on families and service providers. If possible, children will be assessed in their
      school, with the option of alternative venues such as home or clinic if required.

      During the assessment a paediatrician will conduct a neurological examination. A psychologist
      will administer psychometric tests to evaluate cognitive, behavioural and motor development.
      Questionnaires completed by parents and teachers will complete the data collection. Economic
      factors will also be assessed in the parent questionnaire.

      Each child will have contact with the assessors during one school day with appropriate
      breaks. Assessments will take place over a period of 3 years.
    

Detailed description: 
      -  Assessment tools used:

             -  Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III;
                2004) or Wechsler Intelligence Scales for Children

             -  NEPSY Second Edition

             -  Working Memory Test Battery for Children

        -  Neurological examination by paediatrician

        -  Questionnaire data from parents/guardians and teachers
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All participants were recruited to the TOBY randomised controlled trial as newborns, with
        confirmed moderate or severe hypoxic ischaemic encephalopathy.

        They were allocated either standard intensive care or standard intensive care plus moderate
        whole body hypothermia within 6 hours of birth.
Rapid Sequence Induction Czech Republic: Survey
Condition: Rapid Sequence Induction
Study type: Observational

Summary: 
      Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However
      several steps of RSI are not based on evidence based data (EBM) and are considered
      controversial. In an electronic evaluation form that will be send to Czech society of
      anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4
      clinical scenarios in which RSI should be used. In the questionnaire the participants have to
      choose RSI or no and they have to describe all the next steps on anesthesia induction process
      in each single clinical scenario.
    

Detailed description: 
      Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However
      several steps of RSI are not based on evidence based data (EBM) and are considered
      controversial. In an electronic evaluation form that will be send to Czech society of
      anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4
      clinical scenarios in which RSI should be used. In the questionnaire the participants have to
      choose RSI or no and they have to describe all the next steps on anesthesia induction process
      in each single clinical scenario.

        -  1st. scenario - adult patient with acute abdomen in the OR to be anesthetized

        -  2nd. scenario - 4 years old child with acute abdomen in the OR scheduled for an acute
           surgery

        -  3rd. scenario - pregnant women scheduled for an elective caesarean section in the OR

        -  4th. scenario - geriatric patient with hiatal hernia scheduled for an elective
           laparoscopic cholecystectomy.

      In each scenario the several steps of the RSI sequence has to be answered:

      Is RSI indicated? Y N

      Peripheral vein line before induction? Y N

      Nasogastric tube before/after induction or without?

      Patients position: neutral, head-up, head-down?

      Preoxygenation - 3/5minutes, breaths, (CPAP)/Positive end-expiratory pressure (PEEP)?

      Sellick manoeuver? Y N

      Drugs for induction (order with the number in the row) - propofol, etomidate, ketamine,
      thiopental, midazolam, suxamethonium, rocuronium, cisatracurium, atracurium, vecuronium

      Manual hand-bag ventilation after induction: with limited pressure/contraindicated

      Airway: tracheal tube with the cuff/without cuff/laryngeal mask

      Comments
    

Intervention name(s): questionnaire
Intervention type(s): Other
Intervention description(s): The questionnaire will be send to all members of ČSARIM with the selected 4 controversial clinical scenarios in which the RSI should be used
Other intervention name(s): survey
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Anesthesiologists - members of the ČSARIM and www.akutne.cz
      
Keywords: crush induction, RSI