bioihbjkbjnl/mcl2 huggingface dataset:
First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.
Condition: Metastatic Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen
      is more effective and tolerate than the treatment by Gemcitabine alone in patients with
      metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel
      improve the objective response rate.

      Primary objective of this study is to identify the maximun tolerated dose and the recommended
      phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by
      folfirinox in metastatic pancreatic adenocarcinoma.
    

Detailed description: 
      Estimated enrollment:

      Phase I: 60 Phase II: 53

      Study start Date: August 2013 Estimated study completion date: March 2016

      Treatment:

      Gembrax: albumin-bound paclitaxel over 30 minutes IV followed by Gemcitabine 10mg/m²/min IV
      on day 1, 8 and 15 followed by 2 weeks of rest Folfirinox: Oxaliplatin IV associated with
      LeucovorinIV. After the end of leucovorin administration, bolus injection of 5FU and
      subsequent continuous 5FU 46-hour infusion at day 29 and 43.

      Day 1=Day 57
    

Intervention name(s): GEMBRAX; FOLFIRINOX
Intervention type(s): Drug; Drug
Other intervention name(s): Albumin bound paclitaxel 125 mg/m²; Gemcitabine 1000 mg/m²; Oxaliplatin 85 mg/m²; Irinotecan 180 mg/m²; Leucovorin 200 mg/m²; 5FU bolus 400mg/m²; 5FU continuous 2400 mg/m²
Intervention MeSH terms: Leucovorin; Paclitaxel; Gemcitabine; Oxaliplatin; Irinotecan; Albumin-Bound Paclitaxel; Folfirinox
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of Supermicrosurgical LVA for Lower Limb Lymphedema
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Observational

Summary: 
      Vascularized lymph node flap transfer (VLNT) was believed to be the treatment of choice for
      moderate-to-severe lymphedema. Recent publications have supported the use of
      supermicrosurgical lymphaticovenous anastomosis (LVA) for treating severe lymphedema. This
      study hypothesizes whether LVA can be performed on post-VLNT patients seeking further
      improvement.
    


Intervention name(s): Vascularized lymph node flap transfer; Patients without prior lymphedema surgery
Intervention type(s): Other; Other
Intervention description(s): Patients who have received VLNT as their primary treatment but with minimal improvement; Patients without prior lymphedema surgery
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From November 2014 to January 2019, a total of 131 lower limb lymphedema patients were
        enrolled.
Study to Assess the Optimal Renoprotective Dose of Aliskiren in Hypertensive Patients With Type 2 Diabetes and Incipient or Overt Nephropathy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Kidney Diseases; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the optimal renoprotective dose of Aliskiren in hypertensive type 2
      diabetes patients with incipient or overt nephropathy
    


Intervention name(s): Aliskiren; Aliskiren; Aliskiren; Aliskiren
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): SPP100; SPP100; SPP100; SPP100
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized; double-blind; cross-over; 4-period; 4 treatment; within-subject placebo-controlled study; assess optimal renoprotective dose of Aliskiren; hypertensive type 2 diabetes patients; incipient or overt nephropathy
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
Condition: Cryopyrin-associated Periodic Syndromes; Familial Cold Autoinflammatory Syndrome; Muckle-Wells Syndrome; Neonatal Onset Multisystem Inflammatory Disease
MeSH terms: Cellulitis; Eosinophilia; Cryopyrin-Associated Periodic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will assess the safety, efficacy and tolerability of ACZ885 in patients aged 4
      years and younger with cryopyrin associated periodic syndromes (CAPS)
    


Intervention name(s): ACZ885
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cryopyrin-associated periodic syndromes (CAPS); Familial Cold Autoinflammatory Syndrome (FCAS); Muckle-Wells Syndrome (MWS) or Neonatal Onset Multisystem Inflammatory Disease (NOMID); children; systemic autoinflammatory disease; CIAS-1 gene; NALP-3; NLRP3; ACZ885; Ilaris; human monoclonal anti-human interleukin-1 beta (IL-beta); antibody; autosomal dominant; familial autoinflammatory syndrome
Lifestyle Online Re-Intervention On Blood Pressure, BMI, And Physical Activity On Obese Hypertensive Patients
Condition: Hypertension; Overweight and Obesity
MeSH terms: Hypertension; Obesity; Overweight
Study type: Interventional

Summary: 
      This research will constitute a 3 years follow-up which includes a re-assessment and
      re-intervention of obese or overweight adults with hypertension, recruited from a
      hypertension unit of a public hospital, that already participated in a similar program 3
      years ago. At the same time, the aim of the study is to analyze the effects of the current
      program, which will take 3 months and promotes lifestyle changes focusing on healthy eating
      and increased physical activity in their 9 modules, comparing the results obtained in 2018.
      These patients will be allocated into one experimental group. Assessment will include: Blood
      Pressure, Body Mass Index, Physical Activity levels, and adherence to the Mediterranean diet.
    

Detailed description: 
      Hypertension incidence and overweight or obesity related, constitute a worrying public health
      problem nowadays. In this sense, healthy eating and regular physical activity have
      demonstrated a relevant role maintaining health while ageing. Information and Communication
      Technologies (ICTs) have been shown as a useful way to promote health, improving motivation
      and overcoming difficulties to maintain a healthy lifestyle. ICTs also reach a wider audience
      at a lower cost, due to their good cost-benefit relationship and the possibility of
      increasing the efficiency of interventions.

      This research will constitute a 3 years follow-up which includes a re-assessment and
      re-intervention of obese or overweight adults with hypertension, recruited from a
      hypertension unit of a public hospital, that already participated in a similar program 3
      years ago. At the same time, the aim of the study is to analyze the effects of the current
      program, which will take 3 months and promotes lifestyle changes focusing on healthy eating
      and increased physical activity in their 9 modules, comparing the results obtained in 2018.
      These patients will be allocated into one experimental group. Assessment will include: Blood
      Pressure, Body Mass Index, Physical Activity levels, and adherence to the Mediterranean diet.
    

Intervention name(s): Reintervention
Intervention type(s): Behavioral
Intervention description(s): This self-applied online program will take three months and comprise 9 behavioural modules developed gradually, achieving the changes needed on eating and physical activity habits, supported by audiovisual instructions given by an hypertension specialist doctor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Obesity; Internet; Exercise; Nutrition; Reintervention
The Role of the Gut Microbiota in the Systemic Immune Response During Human Endotoxemia
Condition: Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether treatment with antibiotics, which harm the
      gut flora, causes the immune system to be less effective.
    

Detailed description: 
      Rationale: Sepsis ranks among the top ten leading causes of death worldwide. Most
      nonsurvivors die in a state of immunosuppression. The gut microbiota exerts numerous
      beneficial functions in the host response against infections. Gut flora components express
      microorganism-associated molecular patterns (MAMPs) such as lipopolysaccharide (LPS), which
      are recognized by pattern recognition receptors (PRRs) expressed by neutrophils and
      macrophages. MAMPs from the intestinal microbiota constitutively translocate to the
      circulation and prime bone marrow derived neutrophils via PRRs. Antibiotic treatment, which
      is standard of care for all patients with sepsis, depletes the gut microbiota and leads to a
      diminished release of MAMPs and other bacteria derived products. This causes diminished
      priming of systemic immunity, which may attribute to sepsis associated immunosuppression and
      an increased susceptibility to invading bacteria.

      Objective: To investigate the role of the gut microbiota in the systemic priming of immune
      effector cells during human endotoxemia

      Study design: Randomized, between- and within-subject-controlled intervention study in human
      volunteers

      Intervention: All subjects will receive lipopolysaccharide (endotoxin; 2 ng/kg bodyweight)
      intravenously to induce experimental endotoxemia. Eight subjects will be pretreated with
      broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven days (washout
      period of 36 hours before endotoxemia), in order to deplete the gut microbiota. Blood and
      faeces will be sampled before, during and after endotoxemia.
    

Intervention name(s): Endotoxin; Vancomycin, Metronidazole, Ciprofloxacin
Intervention type(s): Drug; Drug
Intervention description(s): Both groups will receive 2 ng/kg LPS (endotoxin) intravenously; ciprofloxacin 500mg 2 times per day, vancomycin 500mg 3 times per day metronidazole 500mg 3 times per day All together during 7 days
Other intervention name(s): LPS
Intervention MeSH terms: Metronidazole; Vancomycin; Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: antibiotics; gut microbiota; endotoxemia; innate immunity
Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the effect of multiple doses of FG-4592 on the
      plasma pharmacokinetic of rosiglitazone in healthy adult subjects.
    


Intervention name(s): FG-4592
Intervention type(s): Drug
Intervention description(s): FG-4592 on days 3,5,7,9
Rosiglitazone maleate on days 1 and 9
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane
Condition: General Anesthesia
Study type: Interventional

Summary: 
      Analgesia Nociception Index（ANI）which is derived from heart rate variability can be used to
      detect noxious stimulation during propofol while changing remifentanil concentrations. The
      aim of this study is to verify the effectiveness of ANI predictability for actual surgical
      noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI
      determination during sevoflurane while changing remifentanil concentrations.
    

Detailed description: 
      General anesthesia with sevoflurane and remifentanil is widely used in minor surgeries.
      Monitoring noxious stimulation during general anesthesia is still worth further studies and
      reaching clinical consensus. Analgesia Nociception Index can be used to detect noxious
      stimulation during propofol while changing remifentanil concentrations. Previous studies
      suggest that an ANI≥50 can be useful in detecting sufficient analgesia for patients who
      cannot self-report pain. The aim of this study is to verify the effectiveness of ANI
      predictability for actual surgical noxious stimuli while satisfying the individual analgesic
      status by pre-tetanus-induced ANI determination during sevoflurane while changing
      remifentanil concentrations.
    

Intervention name(s): Tetanic stimulation; Skin incision
Intervention type(s): Device; Procedure
Intervention description(s): For each participant, record the first concentration that ANI≥50 after the tetanic stimuli, as the sufficient concentration.; Infuse the sufficient concentration for at least 5min of the steady-state period, then surgical stimulus is applied. The surgical stimulus is defined as the first skin incision to establish pneumoperitoneum.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Best Rest: Rest Time Before Blood Pressure Measurement Trial
Condition: Hypertension; Blood Pressure; Cardiovascular Diseases; Cardiovascular Risk Factor
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objectives of this study are to:

        1. Determine the impact of wait time before initiating BP measurement on BP variability

        2. Determine the difference in BP variability between measurements by amount of initial
           rest.

      The investigators also aim to:

      1. To determine the total time required to obtain a BP measurement.
    

Detailed description: 
      Hypertension guidelines recommend a minimum of five minute rest time prior to blood pressure
      (BP) measurements obtained for screening, diagnosis and management of hypertension. This
      recommended wait time is often not adhered to and is cited as a barrier to regular screening
      due to length of time, clinic workflow and provider burden. It is unclear if BPs obtained at
      different rest intervals would provide clinically similar measurements. This study therefore
      aims to determine if BPs obtained immediately or after 2 minutes are rest are non-inferior to
      the BPs obtained after the guideline recommended 5 minutes of rest. It also aims to determine
      the time required to measure BP from start to finish, to allow for easier identification of
      other potential barriers to regular BP screening practices in busy clinical settings.
    

Intervention name(s): Timing of rest prior to blood pressure measurement
Intervention type(s): Other
Intervention description(s): Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which they rest prior to each set of measurements.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71
Condition: Hand, Foot and Mouth Disease
MeSH terms: Enterovirus Infections; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immune response of an inactivated
      vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).
    

Detailed description: 
      Hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71) can be severely
      debilitating for some children with a risk of paralysis and death. The most susceptible age
      group is the 1 to 5 year olds, and the disease is spread via the oral-fecal route. Currently,
      there is no antiviral therapy nor there is a vaccine available to prevent HFMD. In this
      study, an inactivated vaccine (INV21) based on the EV71 antigen will be evaluated in terms of
      safety and immune response that is generated after two doses of the vaccine are given to
      healthy adults. Safety assessments include the frequency and severity of systemic adverse
      events as well as local reactions. Immune response will be assessed by measurement of EV71
      neutralizing antibody levels at specified time points throughout the study.
    

Intervention name(s): INV21 Low Dose; INV21 High Dose; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.; Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.; Phosphate Buffered Saline (PBS)
Other intervention name(s): INV21; INV21
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HFMD; EV71; Enterovirus; INV21; Encephalitis
Anxiety Sensitivity Treatment for Heroin Users
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Anxiety Sensitivity Treatment for Heroin Users is a development project targeting mild and
      above levels of anxiety sensitivity that will involve the testing of a specialized protocol
      for improving treatment retention and outcomes for heroin dependent individuals in a
      residential substance use treatment. ASTH-HR will integrate established treatment modules
      such as Healthy Relationships, along with interoceptive exposure, affect management, and
      psycho-education exercises developed for anxiety prevention and treatment programs with
      standard substance use treatment.
    


Intervention name(s): Anxiety sensitivity therapy
Intervention type(s): Behavioral
Intervention description(s): ASTH consists of 6 sessions of individual treatment, each lasting approximately 75 minutes over 3 weeks. In general, each session consists of the following components1) psychoeducation regarding the anxiety response, with a focus on increasing awareness of the ways in which the patient interprets or evaluates that response 2) assistance in developing healthy emotion regulation strategies that can be used to increase acceptance and tolerance of the anxiety response (including associated catastrophic thoughts), as well as understanding the consequences associated with avoidance or control of anxiety 3) a minimum of 3 interoceptive exercises tailored to activate feared anxiety-related sensations and 4) daily homework assignments (i.e., daily anxiety monitoring and interoceptive exercises).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anxiety sensitivity; heroin
Single Rising Oral Doses of BI 10773 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI
      10773 administered to healthy Japanese male subjects with single rising oral doses (1, 5, 10,
      25, and 100 mg).
    


Intervention name(s): BI 10773 - single rising dose; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
Condition: Pneumococcal Infection
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal
      serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured
      1 month after the infant series, and to evaluate the acceptability of the safety profile of
      13vPnC as measured by the incidence rates of local reactions, systemic events and adverse
      events.
    


Intervention name(s): 7-valent Pneumococcal Conjugate Vaccine; 13-valent Pnumococcal Conjugate vaccine; 13-valent Pnumococcal Conjugate vaccine; 13-valent Pnumococcal Conjugate vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively; suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively; suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively; suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
Other intervention name(s): 7vPnC; 13vPnC; 13vPnC; 13vPnC
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: 13vPnC; 7vPnC; Healthy subjects; China
A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Respiratory Aspiration; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to show how well tobramycin inhalation powder works and how safe it is
      when produced by a modified manufacturing process
    


Intervention name(s): Tobramycin Inhalation Powder; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP. TIP was provided in hard capsules each containing 28 mg active ingredient (tobramycin); Capsules were packaged in blister cards and administered by the T-326 Inhaler.; Placebo inhalation powder consisting of the excipients used for TIP. Placebo was provided in hard capsules, containing 20 mg placebo powder, which were packaged in blister cards, matching in appearance to TIP. Capsules were administered by the T-326 Inhaler.
Intervention MeSH terms: Tobramycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tobramycin Inhalation Powder; Cystic fibrosis; Lung diseases; Anti-Bacterial Agents; Treatment of infections with P. aeruginosa in cystic fibrosis subjects