bioihbjkbjnl/mcl2 huggingface dataset:
H7N9 Mix and Match With AS03 and MF59 in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II randomized, double-blinded, controlled study in up to 1000 males and
      non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all
      eligibility criteria is designed to provide data on an A/H7N9 vaccine made with HA antigen
      derived from the influenza A/Shanghai/2/2013 virus.
    

Detailed description: 
      This Phase II randomized, double-blinded, controlled study in up to 1000 males and
      non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all
      eligibility criteria is designed to provide data on an A/H7N9 vaccine made with HA antigen
      derived from the influenza A/Shanghai/2/2013 virus. The study aims to address several
      critical questions, including the safety, reactogenicity, and immunogenicity of a monovalent
      influenza A/H7N9 virus vaccine manufactured by Sanofi Pasteur: 1) two doses administered at
      different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with AS03 adjuvant
      manufactured by GlaxoSmithKline Biologicals or without adjuvant (15 mcg of HA/0.5 mL dose and
      45 mcg of HA/0.75 mL dose); and 2) a combination of two doses of the A/H7N9 vaccine (15 mcg
      of HA/0.5 mL dose) each administered with a different adjuvant (AS03 or MF59 manufactured by
      Novartis Vaccines and Diagnostics); and 3) two doses administered at 15 mcg of HA/0.5 mL dose
      given with MF59 adjuvant manufactured by Novartis Vaccines and Diagnostics.
    

Intervention name(s): AS03; MF59; Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Intervention type(s): Drug; Drug; Biological
Intervention description(s): Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.; Subjects will receive two doses of the A/H7N9 vaccine with or without MF59 delivered intramuscularly 21 days apart.; Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza, Immunogenicity, Monovalent, A/H7N9, Vaccine, AS03, Adjuvant
The Relationship Between CMV* Reactivation and Anti-cytokine Treatment in Critical COVID-19 Patients
Condition: COVID-19, Cytomegalovirus (CMV), Tocilizumab, Anakinra, Mortality
MeSH terms: COVID-19; Cytomegalovirus Infections
Study type: Observational

Summary: 
      The risk of secondary infection is high in critical patients hospitalized with the diagnosis
      of COVID-19. Immunosuppressive treatments are commonly used in critical COVID-19 patients,
      and immune dysfunction and CMV reactivation can be unnoticed in these patients.
    

Detailed description: 
      The records of critical patients were reviewed retrospectively. Whether these patients used
      tocilizumab and/or anakinra and their relationship with CMV reactivation were examined.
      Furthermore, the relationship between CMV reactivation and mortality and anti-cytokine
      treatment in patients was also examined. A total of 167 critical COVID-19 patients were
      included in the study, of which 38 (22.7%) were found to be CMV DNA positive. CMV positivity
      in patients treated with anti-cytokines (31.11%) was found to be significantly higher than in
      patients who were not treated with it (16.88%) (p:0.033). There was no significant difference
      in viral load levels (p:0.513). Furthermore, it was determined that anti-cytokine treatment
      significantly decreased mortality (p: 0.003) and that there was no significant relationship
      between CMV reactivation and mortality (p: 0.399). Even though CMV reactivation was high in
      critical COVID-19 patients who received anti-cytokine treatment, positive developments in
      morbidity and mortality were observed with early diagnosis and effective treatment.
    

Intervention name(s): CMV DNA analysis
Intervention type(s): Diagnostic Test
Intervention description(s): CMV DNA quantitative viral load levels were studied
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The mean age of the patients was 59.2 (26-91 years), 63.7 years for women, and 58.6 years
        for men. The study included 167 critical and/or intensive care patients, 24 of whom were
        female (14%), and 143 of whom were men.
Evaluation of Mesenchymal Stem Cells to Treat Avascular Necrosis of the Hip
Condition: Avascular Necrosis of the Femoral Head
MeSH terms: Osteonecrosis; Femur Head Necrosis; Necrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to assess the safety and feasibility of cellular therapy derived from bone
      marrow, to help bone healing in patients with avascular necrosis of the hip.
    

Detailed description: 
      To assess the safety and feasibility of an in situ single injection of a high dose of
      autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its
      contribution to the resolution of the early stages of avascular osteonecrosis of the femoral
      head.
    

Intervention name(s): Cultured autologous Mesenchymal Cells
Intervention type(s): Biological
Intervention description(s): Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: avascular necrosis of femoral head; cell therapy; Mesenchymal stem cells
A Study of IMP4297 in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumours; Breast Cancer; Ovarian Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Ovarian Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, first-in-human, open-label, dose-escalation study of IMP4297 administered
      orally once every day to patients with advanced solid tumors for whom standard therapy either
      does not exist or has proven to be ineffective or intolerable. Patients with advanced breast
      cancer, ovarian cancer or prostate cancer are preferred. There are two stages to this study:
      a dose-escalation stage and a dose-expansion stage.
    


Intervention name(s): IMP4297
Intervention type(s): Drug
Intervention description(s): The dose levels will be escalated following a modified 3+3 dose escalation scheme.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Ovarian Cancer; Prostate Cancer; Advanced solid tumours
Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a fixed sequence drug-drug interaction study in healthy postmenopausal
      females, conducted at multiple study sites
    

Detailed description: 
      Participants will be randomized to one of 3 treatment arms on Day 1 prior to Investigational
      Medicinal Product (IMP) administration:

        -  Arm A: single oral doses of midazolam and omeprazole administered together + repeated
           doses of AZD9833 .

        -  Arm B: single oral doses of dabigatran etexilate + single oral dose of AZD9833 .

        -  Arm C: single oral doses of celecoxib + repeated oral doses of AZD9833.

      Each participant will be involved in the study for up to 7 to 8 weeks
    

Intervention name(s): AZD9833; Midazolam; Omeprazole; Dabigatran Etexilate; Celecoxib
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): AZD9833 tablets will be administered orally once daily on Days 1 - Day 5 (Treatment Period 2) and Day 1 (Treatment Period 3) for participants recruited to Arms A and C and Day 1 for those in Arm B; Midazolam will be administered orally as a syrup once on Day 1 of Treatment Periods 1 and 3; administered together with Omeprazole; An Omeprazole capsule will be administered once on Day 1 of Treatment Periods 1 and 3; administered together with Midazolam; A Dabigatran Etexilate capsule will be administered once on Day 1 of Treatment Periods 1 and 2; A Celecoxib capsule will be administered once on Day 1 of Treatment Periods 1 and 3
Intervention MeSH terms: Celecoxib; Midazolam; Omeprazole; Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug-Drug interaction; Midazolam; Omeprazole; Dabigatran etexilate; Celecoxib; Postmenopausal; Breast Cancer
A Brain Imaging Study With Positron Emission Tomography and the Radiotracer [11C]UCB-J to Estimate How Fast Brivaracetam and Levetiracetam Enter the Brain in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will estimate how fast two antiepileptic drugs (Levetiracetam and Brivaracetam)
      enter the human brain. Brain imaging will be used to measure how quickly the radioactive
      probe [11C]UCB-J exits the brain when Levetiracetam or Brivaracetam are given. This will be
      used to estimate how fast the antiepileptic drugs enter the brain.
    


Intervention name(s): [11C]UCB-J; Brivaracetam; Levetiracetam; Brivaracetam
Intervention type(s): Radiation; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: Sterile solution for intravenous infusion
Concentration: 20 mCi
Route of Administration: iv; Pharmaceutical form: Sterile solution for intravenous infusion
Concentration: 10 mg/ml
Route of Administration: iv; Pharmaceutical form: Sterile solution for intravenous infusion
Concentration: 100 mg/ml
Route of Administration: iv; Pharmaceutical form: Tablets for oral intake
Concentration: 25 mg
Route of Administration: oral
Other intervention name(s): [11C]APP311; UCB34714; Keppra; L059; UCB34714
Intervention MeSH terms: Levetiracetam; Brivaracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: SV2A; Levetiracetam; Brivaracetam; PET
Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      To evaluate the accuracy of the Flash Glucose Monitoring system (FGM), Abbot FreeStyle Libre,
      used today in clinical practice in Sweden in estimating plasma glucose levels. Data will be
      collected in ambulatory patients with type 1 diabetes to determine safety, accuracy, and
      reliability.
    


Intervention name(s): Flash Glucose Monitor
Intervention type(s): Device
Other intervention name(s): Abbott Freestyle Libre
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood Glucose; Blood Glucose Self-Monitoring
Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat
Condition: Stability & Variability of Lipid-derived Molecules in Sweat
Study type: Interventional

Summary: 
      The purpose of this study is to see what the differences are in sweat (amount and small
      molecule content) collected from different sites of the body and by different methods of
      sweat stimulation. Additionally, the investigators want to know whether the amount and small
      molecule content of the sweat is the same in an individual over time, and the same across
      individuals at a given time. Finally, the investigators want to know how consumption of
      over-the-counter anti-inflammatory drugs such as ibuprofen will affect the inflammatory
      mediator content of sweat and how that compares to blood. This information will help to
      better understand the composition and behavior of sweat and assess its potential utility as a
      routine clinical tool in skin research.
    

Detailed description: 
      Subjects will participate in 4 study day visits that will be scheduled about 1- week apart.
      During the first study visit, the investigators will compare sweat collected following
      pharmacological stimulation of sweating (using the drug pilocarpine) to sweat collected
      following physiological stimulation of sweating (using a stationary bicycle). During the
      second study visit, the investigators will collect sweat following stimulation of sweating by
      the drug pilocarpine from the inner part of the forearm (near the wrist) and also the upper
      surface of the thigh (near the knee). During the third study visit, the investigators will
      collect sweat following stimulation of sweating by the drug pilocarpine from the inner part
      of both forearms (near the wrist). During the fourth study visit, the investigators will
      collect a sweat sample following stimulation of sweating by the drug pilocarpine from the
      inner part of the forearm (near the wrist) and a blood sample (about one teaspoon) from the
      other arm. After blood and sweat collection, participants will consume 400 mg (two tablets)
      of ibuprofen. The investigators will then collect blood and sweat from 30 minutes, 2 hours
      and 4 hours after participants consume the ibuprofen.
    

Intervention name(s): Ibuprofen; Physiological induction of sweating; Pilocarpine
Intervention type(s): Drug; Other; Drug
Intervention description(s): 400 mg ibuprofen given to inhibit cyclooxygenase metabolism; 15 minutes exercise at 60-80% oxygen consumption to induce sweating; Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine nitrate solution to induce sweating
Other intervention name(s): Exercise; Pilogel
Intervention MeSH terms: Ibuprofen; Pilocarpine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: oxygenated lipids; metabolic profiling; sphingoid bases; ceramides; endocannabinoids; non-invasive sampling
DiaPort Closed-Loop Artificial Pancreas
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The primary purpose of this pilot study is to test an artificial pancreas system which uses
      the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.
    

Detailed description: 
      During this study, the investigators would like to evaluate the intra-peritoneal insulin
      delivery as a potential breakthrough method for delivering insulin within the artificial
      pancreas system.

      The intent is to exploit the rapid action achieved by IP insulin to compensate for meals and
      for management of the basal insulin needs. Patients will come for two closed-loop admissions
      of 24 hours. The first closed-loop will be performed using subcutaneous route, whereas the
      second one will be performed using the intra-peritoneale route.
    

Intervention name(s): Artificial Pancreas for DiaPort system with Zone-MPC algorithm
Intervention type(s): Device
Intervention description(s): Artificial pancreas system uses the intraperitoneal route to deliver insulin (through DiaPort) in type 1 diabetic patients treated by basal-bolus insulin and external pumps.
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes,; diaport,; artificial pancreas,; zone mpc algorithm,; ap system,; intraperitoneal insulin
Removal Wichita Fusion Nail After Knee Arthrodesis
Condition: Removal Wichita Fusion Nail After Knee Arthrodesis
Study type: Observational

Summary: 
      The purpose of this study is to make clear how difficult it is to remove osteosynthesis
      materials afterwards, so surgeons will think twice before inserting intramedullary nails.
      Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis has
      become.
    


Intervention name(s): Proposed technique for removal of the Wichita Fusion Nail
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who had to have their Wichita Fusion Nail extracted
Acceptance and Value Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The aim of the study is to study how using acceptance and value based group intervention
      helps the wellbeing of teenagers with type in diabetes.

      The investigators created an ACT-group intervention consisting of five sessions, based on
      earlier research. 12-16 years- old diabetics who are treated at KSSHP pediatric policlinic
      are invited to join the groups. The participants are randomized to research and control
      groups. The HbA1c-level is monitored for both groups as well as the psychological
      flexibility, diabetes related acceptance, depression and quality of life.
    


Intervention name(s): acceptance and commitment therapy, ACT
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: type 1 diabetes; ACT; adolescents; value based methods; acceptance
Tolerance of Healthy Term Infants Fed Infant Formulas #4
Condition: Healthy Term Infants
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the comparative gastrointestinal (GI)
      tolerance of normal term infants to two experimental powdered formulas compared with a
      commercially available powdered formula.
    


Intervention name(s): Hydrolysate based infant formula; Investigational Infant Formula A; Investigational Infant Formula B
Intervention type(s): Other; Other; Other
Intervention description(s): Infant formula ad lib; Investigational infant formula ad lib; Investigational infant formula ad lib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16
Condition: Hearing Loss; Normal Hearing
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      An EEG study using continuous speech stimuli to assess neural language processing in a
      hearing impaired population. Participants listen to short radio excerpts in different Signal
      to Noise Ratios (SNR) and answer comprehension questions as well as listening effort
      questions. We assess the effect of different algorithms on neural language processing as well
      as subjective listening effort. Each participant hears 12 randomized segments of speech
      (about 4min long each) with different settings on their hearing aid (reference condition,
      noise reduction algorithm, beam forming algorithm). This will be a controlled, single blinded
      and randomized active comparator clinical evaluation which will be conducted mono centric at
      Sonova AG Headquarter based in Stäfa.
    


Intervention name(s): Hearing Aid without NR and BF; Hearing Aid with NR; Hearing Aid with BF
Intervention type(s): Device; Device; Device
Intervention description(s): Each participant will be fitted with the Noise Reduction (NR) and Beamforming (BF) disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.; Each participant will be fitted with the Noise Reduction (NR)(Sound Changing) program on the same hearing aid. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The Noise Reduction is working spatially independent.; Each participant will be fitted with a beam forming program on the same hearing aid. Beam forming (BF) principle is a sound processing algorithm to remove noise from certain directions to improve the speech intelligibility and comfort.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a proof of concept study to determine the safety and efficacy of dronabinol for the
      treatment of obstructive sleep apnea syndrome (OSA).
    


Intervention name(s): Dronabinol; Placebo (for Dronabinol)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
Condition: Epilepsy With Partial-onset Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide
      administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for
      children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled
      partial-onset seizures.
    

Detailed description: 
      The trial consists of a 7-day Baseline Period, a 20-day Titration Period, a 7-day Maintenance
      Period, and a 12-day Transition Period for subjects who complete the study and choose to
      enter the extension study. Subjects who will not enter the extension study will continue
      after the Maintenance Period with a 16-day Taper Period followed by a 30-day Safety Follow-Up
      Period. The Taper Period and Safety Follow-Up are also applicable for subjects not eligible
      for continuation and therefore ending the study earlier.

      If subjects meet the eligibility criteria, they will be randomized to receive either
      lacosamide 8 mg/kg/day to 12 mg/kg/day, or placebo during the Maintenance Phase. The dose of
      lacosamide will be titrated from 4 mg/kg/day at study start to maximum of 12 mg/kg/day at
      4-day intervals of 1-2 mg/kg/day.

      All subjects who complete the 20-day Titration Period will enter the 7-day Maintenance
      Period. No dose adjustment is allowed during the Maintenance Phase. The Treatment Phase is
      defined as the combined Titration and Maintenance Phases.
    

Intervention name(s): Lacosamide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Active Substance: Lacosamide Pharmaceutical Form: Syrup Concentration: 10 mg/mL Route of Administration: oral; Active Substance: Placebo Pharmaceutical Form: Syrup Concentration: N/A Route of Administration: oral
Other intervention name(s): Vimpat; UCB Code: SPM 927; Abbreviated name: LCM; PBO
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; children; partial-onset seizures; lacosamide; LCM; pediatric