bioihbjkbjnl/mcl2 huggingface dataset:
Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery.
Condition: Colorectal Cancer; Liver Metastasis; Liver Disease
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis; Liver Diseases
Study type: Interventional

Summary: 
      The ORANGE II trial is a double blinded randomised controlled trial that will provide
      evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic
      sectionectomy in terms of time to functional recovery, hospital length of stay, quality of
      life, readmission percentage, morbidity and mortality, hospital costs, body image and
      cosmesis, and long term incidence of incisional hernias.
    

Detailed description: 
      Recent developments in liver surgery include the introduction of laparoscopic surgery and
      enhanced recovery programmes. Laparoscopic surgery and enhanced recovery programmes both
      focus on faster recovery and consequently shorter hospital length of stay.

      The ORANGE-II trial is a prospective randomised controlled parallel group superiority trial
      with a double-blinded experimental and a prospective registry design to determine whether
      laparoscopic surgery is to be preferred over open surgery in patients undergoing a left
      lateral hepatic sectionectomy within an enhanced recovery programme. The experimental design
      produces two randomised arms; (a) open LLS and (b) laparoscopic LLS. An additional registry
      arm will be based on surgeons/patients that do not want to be randomised because they have an
      explicit preference for either the laparoscopic LLS or for the open LLS (c).

      The primary endpoint of the ORANGE II trial is time to functional recovery. The functional
      recovery criteria consist of adequate pain control with oral analgetics only, mobility
      restored to an independent level, absence of intravenous fluid administration, ability to eat
      solid foods and finally a normal or decreasing serum bilirubin level. A patient is fully
      functionally recovered when all of the five criteria are satisfied.

      Secondary endpoints of this trial are postoperative length of hospital stay, readmission
      percentage, (liver specific) morbidity, quality of life, body image and cosmetic result,
      hospital and societal costs during one year and long-term incidence of incisional hernias.

      The ORANGE-II trial is a randomised controlled multicentre trial that will provide evidence
      on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic
      sectionectomy and participating in an enhanced recovery programme.
    

Intervention name(s): laparoscopic left lateral hepatic sectionectomy; open left lateral hepatic sectionectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): laparoscopic left lateral hepatic sectionectomy; open left lateral hepatic sectionectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Colorectal cancer liver metastasis; Benign liver disease
A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic Sclerosis
Condition: Systemic Sclerosis
MeSH terms: Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the safety, and evaluate the efficacy of
      GS-248 versus placebo on Raynaud's Phenomenon (RP) in subjects with Systemic Sclerosis (SSc).
    

Detailed description: 
      The primary objective of this study is to determine the safety, and evaluate the efficacy of
      GS-248 versus placebo on Raynaud's Phenomenon (RP) in subjects with Systemic Sclerosis (SSc).

      This is a randomized, double-blind, placebo-controlled study conducted in multiple sites in 4
      countries in Europe. Approximately 80 subjects will be randomized in a 1:1 allocation to
      receive either GS-248 (120 mg) or placebo once daily. The study will comprise an enrolment
      period, a treatment period, and a follow-up period, with a total of 5 study visits over
      approximately 10 weeks.
    

Intervention name(s): GS-248; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 120 mg, capsule, once daily for 4 weeks; capsule, once daily for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I, single-dose, randomized, parallel-group, open-label study will evaluate the
      safety, tolerability, and pharmacokinetics of MABT5102A following subcutaneous (SC) and
      intravenous (IV) administration in healthy volunteers.
    


Intervention name(s): MABT5102A; MABT5102A
Intervention type(s): Drug; Drug
Intervention description(s): single SC dose; single IV dose
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Observational [Patient Registry]

Summary: 
      Fractional flow reserve (FFR) is a physiologic index for the determination of
      ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even
      multiple anatomic imaging parameters have been widely used in clinical practice for the
      assessment of optimal stent procedure. Prognostic value of post-stent FFR (FFRpost) have been
      rarely evaluated in patient treated with 2nd generation DES. This multicentre, prospective
      registry was aimed to evaluate the influence of physiologic parameters on the clinical
      outcome after 2nd generation DES implantation.
    

Detailed description: 
      Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR
      examination would be enrolled, consecutively. FFR measurement would be required at the
      baseline and at the end of index PCI procedure. PCI procedure would be performed upon local
      routine. Any available 2nd generation DES could be used. Informed consent should be obtained
      and protocol should be approved by each collaborator's institutional review board (IRB).
      Web-based electronic-case record form (CRF) system will be used for collecting data. All data
      will be handled and analyzed by blind fashion at independent core lab. Patient will be
      followed-up at each collaborator's hospital at least 2 year after index procedure. Any
      adverse event will be reported and addressed immediately by appropriate medical treatment to
      protect patient.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR
        examination at the index procedure
      
Keywords: fractional flow reserve; drug eluting stent; coronary atherosclerosis
Effect of Nitrous Oxide on Cisatracurium Infusion Demands
Condition: Neuromuscular Blocking Agents
Study type: Observational

Summary: 
      Background: Recent studies have questioned our previous understanding on the effect of
      nitrous oxide on muscle relaxants, since nitrous oxide has been shown to potentiate the
      action of bolus doses of mivacurium, rocuronium and vecuronium. This study was aimed to
      investigate the possible effect of nitrous oxide on the infusion requirements of
      cisatracurium.

      Methods: 70 ASA physical status I-III patients aged 18-75 years were enrolled in this
      randomized trial. The patients were undergoing elective surgery requiring general anesthesia
      with a duration of at least 90 minutes. Patients were randomized to receive propofol and
      remifentanil by target controlled infusion in combination with either a mixture of oxygen and
      nitrous oxide (Nitrous oxide/TIVA group) or oxygen in air (Air/TIVA group). A 0.1 mg/kg
      initial bolus of cisatracurium was administered before tracheal intubation, followed by a
      closed-loop computer controlled infusion of cisatracurium to produce and maintain a 90%
      neuromuscular block. Cumulative dose requirements of cisatracurium during the 90-min study
      period after bolus administration were measured and the asymptotic steady state rate of
      infusion to produce a constant 90% block was determined by applying nonlinear curve fitting
      to the data on the cumulative dose requirement during the study period.

      Results: Controller performance, i.e. the ability of the controller to maintain neuromuscular
      block constant at the setpoint and patient characteristics were similar in both groups. The
      administration of nitrous oxide did not affect cisatracurium infusion requirements. The mean
      steady-state rates of infusion were 0.072 +/- 0.018 and 0.066 +/- 0.017 mg * kg-1 * h-1 in
      Air/TIVA and Nitrous oxide/TIVA groups, respectively.

      Conclusions: Nitrous oxide does not affect the infusion requirements of cisatracurium.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing elective surgery requiring general anesthesia with a duration of at
        least 90 minutes.
      
Keywords: Neuromuscular blockade; Neuromuscular blocking agents; Atracurium; Nitrous oxide
Search for New Genetic Mutations Major Effect in Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      This study highlight genetics mutations with major effect in Crohn's Disease (CD) by WES in
      individuals affected and healthy individuals from EPIMAD Inserm InVS registry families.
    

Detailed description: 
      The EPIMAD Registry covers a large area of Northern France (9 millions inhabitants) and
      collects all incident CD cases and data from CD multiplex families (families with 3 or more
      CD affected patients) in the Nord the Pas de Calais the Somme and the Seine Maritime. If the
      investigators could demonstrate that most CD cases from multiplex families were related to
      high frequency of NOD2 gene mutations, the investigators found some CD multiplex families
      without any NOD2 gene involvement. Thus in these families high prevalence of CD cases may
      rely on other major genetic susceptibility variant(s) that remain to be determined.

      this clinical research Whole Exome Sequencing protocol, aiming to highlight genetics
      mutations with major effect in CD has been initiated.

      This study is a familial genetic study with intra-familial controls. The genetics analyses
      are:

        -  Ascertain of no significant NOD2 mutation in the family members by Sanger DNA sequencing

        -  WES (CD patients and family controls unaffected subjects)

        -  Genotyping of all mutations found, case control and segregation analyses to validate
           their implication in CD.
    

Intervention name(s): genetic analysis; blood and stools samples
Intervention type(s): Genetic; Biological
Intervention description(s): genetic (Whole Exome Sequencing ); biological collection
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Crohn disease subject
      
Biospecimen description: 
      blood samples stools samples
    
Keywords: genetic
Effects Of Caffeine On Cognitive Performance
Condition: Caffeine
Study type: Interventional

Summary: 
      Caffeine is a potent central nervous system stimulant that increases the activity in the
      prefrontal cortex and can improve cognitive skills. An improvement in these cognitive skills
      can lead to further benefits in athletic performance. Therefore, it is necessary to clarify
      the dose-response of caffeine on cognitive performance.The aim of this research will be to
      determine the effects of different doses of caffeine on sport-related cognitive aspects.
    

Detailed description: 
      The investigators will require healthy, physically active young adults to complete three
      trials under the conditions: a) placebo, b) 3 mg/kg, or c) 6 mg/kg body mass of caffeine. In
      each trial, different cognitive abilities will be assessed using the following test
      batteries: reaction time (DynavisionTM D2), anticipation (Bassin Anticipation Timer),
      sustained attention (Go/No-Go and Eriksen Flanker Test) and memory tests. In addition, side
      effects and the perceived sensation index will be recorded 24 h after each test.
    

Intervention name(s): PLACEBO; 3 mg/kg of caffeine; 6 mg/kg of caffeine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 3 mg/kg of cellulose (0 mg/kg of caffeine); Ingestion of 3 mg/kg of body mass of caffeine; Ingestion of 6 mg/kg of body mass of caffeine
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ergogenic aid; sport performance; reaction time; anticipation; attention; memory
Nonivamide/Nicoboxil Ointment in Acute Low Back Pain
Condition: Acute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide
      ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of
      acute low back pain.
    


Intervention name(s): nicoboxil; placebo matching nonivamide + nicoboxil; nonivamide + nicoboxil (Finalgon); nonivamide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period; 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period; 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period; 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Intervention MeSH terms: Nicotinic Acids; Capsaicin; Nonivamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Evaluation of an Algorithm for Length Based Weight Estimation
Condition: Length Based Weight Estimation
MeSH terms: Body Weight
Study type: Observational

Summary: 
      The purpose of this prospective single center study is to investigate if a developed
      algorithm is more accurate than the pediatric emergency tape (Alpha 1 Werbedesign e.K.,
      Falkenberg, Germany). For this study 500 patients are required to collect anonymized data
      (length, weight, age, anaesthesia material used during anaesthesia) for achieving a power of
      80% during statistical analysis. The main hypothesis ist that the algorithm has a better
      accuracy than the pediatric emergency tape (53% are in a +/- 10% interval).
    

Detailed description: 
      This prospective single center study is performed at the university children's hospital
      zurich. Patients planned for surgery in general anaesthesia with intubation, aged 0 to 16
      years and with a body length suitable for the emergency tapes can be included in this study.
      Patient and parental information is performed during the pre-anaesthetic visit. After written
      consent the patient will be included. Patient´s length and weight will be measures earliest
      one day before data collection. Data collection during anaesthesia has no influence on the
      daily anaesthesia routine and has no impact on patient safety and anaesthesia. Patient's data
      is made anonymous for further inspection.

      Data is documented in Microsoft Excel and statistical analysis calculated with SPSS. 500
      patients are needed for a power of 80%. Primary outcome parameter is length-based weight
      estimation, secondary outcome parameters are length-based age estimation and the correctness
      of recommended anaesthesia material (endotracheal tube, laryngeal mask, oropharyngeal mask
      and face mask). Both tools (algorithm and pediatric emergency tape) will be compared with
      eachother regarding primary and secondary outcome parameters.
    

Intervention name(s): Accuracy of an algorithm and the pediatric emergency tape.
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients planned for elecitve surgery in general anaesthesia
      
Keywords: Broselow Tape; Weight estimation; Patient safety
Periodontal Infection and Systemic Inflammation in Renal Patients
Condition: Periodontitis; Chronic Kidney Disease
MeSH terms: Periodontitis; Kidney Diseases; Renal Insufficiency, Chronic; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to examine the role of gum disease in affecting the long term
      prognosis of renal patients. This disease if untreated causes inflammatory response
      throughout the body. If the subject has gum disease, he/she will be randomly assigned to one
      of the two treatment groups. The study investigates what happens to inflammatory markers in
      blood and saliva after you are treated for gum disease.
    

Detailed description: 
      The main goal of this project was to explore the contribution of chronic periodontitis to
      systemic inflammation in Chronic Kidney Disease (CKD). To achieve this goal, the project had
      two specific objectives:

        1. a) To compare the prevalence of periodontal infection between CKD and non-CKD
           populations and b) to explore the association between the presence of periodontal
           infection and the uremic status of CKD patients.

        2. a) To assess the levels of systemic inflammatory markers, IL-6 and CRP in the presence
           or absence of periodontal infection in CKD and b) to compare the serum IL-6 and CRP
           levels in response to periodontal intervention.
    

Intervention name(s): Scaling root planing; Supragingival Prophylaxis
Intervention type(s): Procedure; Procedure
Intervention description(s): Deep gum cleaning with local anesthesia; Plaque removal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the
      body does to the medication) and pharmacodynamics (what the medication does to the body) of
      treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus
      participants.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), double-blind (neither
      investigator nor participant knows the treatment that the participant receives), multicenter
      (study conducted at multiple sites), and placebo (an inactive substance that is compared with
      a medication to test whether the medication has a real effect in a clinical study) and active
      comparator (an established effective treatment that is compared with a medication to test
      whether the medication has a real effect in a clinical study) controlled study (placebo or
      active comparator is compared with the study medication to test whether the study medication
      has a real effect in clinical study). The study consists of 4 phases: screening phase (45
      days before administration of study medication); pre-dosing run-in phase (a phase before a
      clinical study is commenced when no treatment is given. In this study, participant's glucose
      level will be observed during run-in-phase: days 15 to 1 before administration of study
      medication); treatment phase, and follow-up phase (7 to 10 days after the last dose of the
      study medication). Approximately 88 participants will be enrolled in this study. All
      participants will be randomly assigned to 4 treatment arms: JNJ-41443532 250 mg; JNJ-41443532
      1000 mg; pioglitazone arm; and placebo. Safety evaluations will include assessment of adverse
      events including ocular assessments, clinical laboratory tests, electrocardiogram, vital
      signs, and physical examination which will be monitored throughout the study. The maximum
      study duration for each participant will be approximately 12 weeks.
    

Intervention name(s): JNJ-41443532; Pioglitazone 30 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.; Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days.; Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Hyperglycemia; JNJ-41443532; Pioglitazone; Placebo
Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to demonstrate that therapeutic and supratherapeutic plasma
      exposures to ponesimod do not have an effect on cardiac repolarization exceeding the
      threshold of regulatory concern as measured by the QTc (interval from beginning of the Q wave
      until end of the T wave corrected for heart rate) interval duration after administration of
      multiple oral doses of 40 mg and 100 mg to healthy male and female subjects.
    

Detailed description: 
      This is a Phase 1, single-center, double-blind, randomized, placebo and positive-controlled,
      double-dummy, parallel group, multiple-dose, up-titration study of the electrocardiographic
      effects of ponesimod in healthy male and female subjects with a nested cross-over comparison
      between moxifloxacin and placebo.

      Subjects will be randomly assigned to Group A (ponesimod treatment group) or Group B (placebo
      treatment group) in a 1:1 ratio. Subjects in Group B will be further randomized in a 1:1
      ratio to one of the following sequences: 400 mg moxifloxacin followed by
      moxifloxacin-matching placebo or moxifloxacin matching placebo followed by 400 mg
      moxifloxacin.
    

Intervention name(s): Ponesimod Placebo; Moxifloxacin Placebo; Ponesimod 10 mg; Ponesimod 20 mg; Ponesimod 40 mg; Ponesimod 60 mg; Ponesimod 80 mg; Ponesimod 100 mg; Moxifloxacin 400 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): ACT-128800; ACT-128800; ACT-128800; ACT-128800; ACT-128800; ACT-128800
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ponesimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Ponesimod; Safety