bioihbjkbjnl/mcl2 huggingface dataset:
Piperacillin/Tazobactam for Empirical Therapy of Febrile Neutropenia
Condition: Febrile; Neutropenia; Hematopoietic Stem Cell Transplantation
MeSH terms: Neutropenia; Hyperthermia; Fever
Study type: Interventional

Summary: 
      Neutropenia is very common in patients received hematopoietic stem cell transplantation, with
      median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as
      first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the
      data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell
      transplantation is very limited.

      The current study will evaluate the efficacy of piperacillin/tazobactam compared with
      imipenem/cilastatin for febrile neutropenia after transplantation.
    

Detailed description: 
      1. Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room
           after transplantation.

        2. Randomize the febrile patients into 2 groups.

        3. Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive
           imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.
    

Intervention name(s): Piperacillin-tazobactam combination product; Imipenem
Intervention type(s): Drug; Drug
Intervention description(s): 4.5g q6h, 5-10 days; 0.5g q6h, 5-10 days
Other intervention name(s): Tazocin; Tienam
Intervention MeSH terms: Tazobactam; Piperacillin; Imipenem; Piperacillin, Tazobactam Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Insulin Treatment in Patients With Latent Autoimmune Diabetes
Condition: Diabetes, Autoimmune; Diabetes Mellitus, Adult-Onset
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Among adult patients diagnosed with type 2 diabetes, about 6% have autoantibodies directed
      against the insulin producing beta cells in the pancreas. These patients have a progressive
      beta cell destruction and most of them will be insulin dependent within 3-5 yrs. Patients
      with this latent autoimmune diabetes in adults (LADA) have a considerable remaining beta cell
      mass at diagnosis, and are suitable for evaluating new therapies for autoimmune diabetes
      Animal studies in diabetes prone mice have demonstrated potential positive effects of early
      insulin treatment, with a lower incidence of diabetes or a delay before diagnosis. The aim of
      this study was to investigate the effect of early insulin treatment of LADA patients, in
      respect to residual beta-cell function and metabolic control, compared to a group who were
      conventionally treated with diet and/or oral hypoglycaemic agents (OHA) and insulin not
      before it was clinically needed.
    

Detailed description: 
      All adult newly diagnosed diabetic patients in the certain areas are screened for pancreatic
      antibodies. Patients clinically classified as Type 2, not insulin requiring at diagnosis and
      positive for at least one autoantibody are eligible for inclusion. After randomisation to
      insulin treatment or diet and/or OHA, the patients are followed up with fasting C-peptide
      every third month. A glucagon test is performed, and stimulated C-peptide and HbA1c, +
      clinical data and body weight are recorded at baseline and after 12, 24 and 36 months. The
      final outcome of the study is C-peptide, and change in C-peptide compared to baseline level,
      and HbA1c, after 36 months.
    

Intervention name(s): Insulin
Intervention type(s): Drug
Intervention description(s): Insulin treatment in accordance to glucose values
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause
Condition: Vaginal Atrophy; Sexual Dysfunction; Dyspareunia; Vaginal Dryness; Chronic UTI
MeSH terms: Dyspareunia
Study type: Interventional

Summary: 
      This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid
      fractional 2940 nm and 1470 nm lasers for treatment of symptoms of Genitourinary Syndrome of
      Menopause.
    

Detailed description: 
      Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are
      cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of
      soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established
      method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue
      intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue
      exhibit similarities that suggest the clinical results seen with skin resurfacing may be
      translated to the vaginal tissue. Improved vaginal tissue health may lead to improvement of
      symptoms of Genitourinary Syndrome of Menopause (GSM). This multi-centered, 18-month
      prospective clinical trial will evaluate the safety and long-term effectiveness of hybrid
      fractional 2940 nm and 1470 nm lasers (HFL) as an alternative non-surgical, non-hormonal
      treatment for symptoms of GSM.
    

Intervention name(s): Hybrid Fractional Laser
Intervention type(s): Device
Intervention description(s): Consecutive and coincident fractional 2940 nm and 1470 nm lasers
Other intervention name(s): diVa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PERCI- Medium Cut Off (MCO)
Condition: Chronic Kidney Failure; Chronic Inflammation
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Inflammation
Study type: Interventional

Summary: 
      The medium cut-off dialysis membrane has been developed to provide a significantly extended
      molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane
      allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a
      still limited permeability for albumin (68 kDa).

      The main goal of this project is the evaluation of the new, highly porous and selective
      dialysis membrane (MCO-Ci 400) for the treatment of patients with end-stage renal disease in
      hemodialysis mode and to study its potential to improve chronic inflammation.
    


Intervention name(s): MCO-Ci 400; Revaclear 400
Intervention type(s): Device; Device
Intervention description(s): hemodialysis; hemodialysis
Other intervention name(s): standard high flux dialyzer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD5, dialysis, high porous membranes
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
Condition: Eosinophilic Duodenitis; Eosinophilic Gastroenteritis
MeSH terms: Gastroenteritis; Eosinophilic Esophagitis; Duodenitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess
      the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult patients
      with active eosinophilic duodenitis. Subjects who complete the randomized, double-blind,
      placebo-controlled treatment may have the option to receive 6 doses of open-label
      lirentelimab (AK002) through the OLE Period of the study.
    


Intervention name(s): AK002; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8.; Placebo
Other intervention name(s): Lirentelimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eosinophil; Eosinophilic; Eosinophilic gastrointestinal disorders; EGID; EoD
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-sequence, multiple-dose, 3 cohort study to investigate the
      effects of DRV/RTV and/or ETR on the pharmacokinetics (PK) of GSK3640254 and the effects of
      GSK3640254 on the PK of DRV/RTV and/or ETR. This study will aid in understanding these
      interactions and resulting changes in exposure (if any) when given in combination with
      GSK3640254.
    


Intervention name(s): GSK3640254; Darunavir/Ritonavir (DRV/RTV); Etravirine (ETR)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK3640254 will be available as oral tablets.; DRV/RTV will be available as oral tablets.; ETR will be available as oral tablets.
Intervention MeSH terms: Ritonavir; Darunavir; Etravirine
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is an open-label, single-sequence, multiple-dose and 3-cohort study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Darunavir; Ritonavir; Etravirine; GSK3640254; Pharmacokinetics
Symptomatic Trial of Angina Assessment Prior to Revascularization
Condition: Coronary Artery Disease; Angina, Stable
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable
Study type: Observational

Summary: 
      The principal objective of this research is to determine whether symptoms, induced by
      confirmed experimental ischaemia, can help us predict which patients will respond to PCI.
    


Intervention name(s): Percutaneous coronary intervention
Intervention type(s): Procedure
Intervention description(s): Coronary artery stenting for stable angina
Other intervention name(s): PCI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with single-vessel coronary artery disease with symptoms of stable
        angina
      
Biospecimen description: 
      Serum troponin samples
Effects of a Mediterranean Style Diet on Vascular Health in Type 2 Diabetes
Condition: Type 2 Diabetes; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this study we will compare the effects of a Mediterranean diet, high in fruit and
      vegetables with the more conventional diet recommended for diabetes therapy (a high
      carbohydrate, low fat diet) on glycaemic and lipid control and on markers of inflammation, in
      people with newly diagnosed Type 2 diabetes. The hypothesis is that, over a six-month
      intervention period, a HVM diet will be more effective than a conventional HCLF diet in
      improving glycaemic and lipid control, and in reducing markers of vascular inflammation in
      people with Type 2 diabetes.
    

Detailed description: 
      Chronic inflammation affecting both small and large blood vessels is an important factor
      increasing the risk of heart disease in people with Type 2 diabetes. Good markers present in
      the blood are now available to detect this inflammatory state. Recent evidence suggests that
      a Mediterranean-type diet, high in plant foods and with monounsaturated fat from olive oil
      has beneficial effects on blood vessels as well as on blood glucose and blood lipid control.

      In this study we will compare the effects of a Mediterranean diet, high in fruit and
      vegetables with the more conventional diet recommended for diabetes therapy (a high
      carbohydrate, low fat diet). Twenty-four people with Type 2 diabetes will be randomised to
      one of these diets and followed for six months. At the end of this time, the effect of the
      diets on markers for inflammation will be compared.
    

Intervention name(s): Dietary Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Dietary Intervention
AZD1775 Continued Access Study to Assess Safety and Tolerability for Patients Enrolled in AZD1775 Clinical Pharmacology Studies
Condition: Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, non-randomised study to provide continued access to AZD1775 for patients with
      advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study
      and to investigate the safety of AZD1775.
    

Detailed description: 
      This is an open-label, non-randomised study designed to provide continued access to AZD1775
      for eligible patients with advanced solid tumours who have previously completed an AZD1775
      clinical pharmacology study and to investigate the safety of a once daily monotherapy regimen
      of AZD1775 in patients with advanced solid tumours.

      All patients who completed 1 of the parent clinical pharmacology studies are eligible for
      this study after a washout period of at least 4 days (minimum duration defined in the parent
      study protocol) and meet the eligibility criteria specified in this protocol. Patients who
      discontinue early from the parent study will be considered by the Sponsor and treating
      physician on a case-by-case basis.

      During the study, patients will continue to receive AZD1775 as long as they are benefiting
      from treatment in the Investigator's opinion and do not meet any other discontinuation
      criteria.
    

Intervention name(s): Wee-1 kinase inhibitor AZD1775
Intervention type(s): Drug
Intervention description(s): Patients will receive AZD1775 300 mg orally once daily. Days 1 to 5 and 8 to 12 of a 21 day cycle (ie, 5 days on and 2 days off for Weeks 1 and 2 of a 21-day cycle). All patients must receive a serotonin receptor 3 (5-HT3) antagonist, ondansetron (Zofran) 8 mg orally/IV or granisetron (Kytril) 1 mg orally/IV prior to each dose of AZD1775. Dexamethasone 4 mg orally/IV will be given with each AZD1775 dose at a minimum on the first day of dosing of AZD1775 of every 5 day dosing period, unless contraindicated or not well-tolerated.
Intervention MeSH terms: Adavosertib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continued access, safety assessments
Food Effect Study of Febuxostat XR in Healthy Participants
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of food on the bioavailability of
      febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the
      pharmacokinetics (PK) of febuxostat after single oral doses of 40 and 80 mg febuxostat XR.
    

Detailed description: 
      The drug being tested in this study is called febuxostat extended- release (XR). This study
      is evaluating the effect of food on how febuxostat-XR moves throughout the body. This study
      will also look at the side effects and all safety results in people who took the study drug.

      This 3-way crossover study will enroll approximately 36 participants. Eligible participants
      will be randomly (by chance) assigned to one of the 3 treatment sequences at 1:1:1 ratio.
      Sequence defines the order in which participants receive Regimens A (febuxostat XR 80 mg
      after a high fat meal), B (febuxostat XR 40 mg after fasting) and C (febuxostat XR 80 mg
      after fasting):

      Sequence 1: A, B, C

      Sequence 2: B, C, A

      Sequence 3: C, A, B The dose in a period and the dose in the subsequent period will be
      separated by a minimum 7-day washout interval. This single-centre trial will be conducted in
      the United States.

      Participants will make multiple visits to the clinic including three 4-day periods of
      confinement to the clinic, and will be contacted by telephone 30 days after last dose of
      study drug for a follow-up assessment.

      .
    

Intervention name(s): Febuxostat XR
Intervention type(s): Drug
Intervention description(s): Febuxostat XR capsules
Intervention MeSH terms: Febuxostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Evaluation of a Low-cost CPAP Device on Hospitalized COVID-19 Patients
Condition: Covid19; Hypoxemia
MeSH terms: COVID-19; Hypoxia
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the preliminary safety and performance of a low-cost
      locally-made Venturi-based Non-invasive Positive Pressure Ventilator (NIPPV) device for
      hypoxemic COVID-19 patients. The device administers Continuous Positive Airway Pressure
      (CPAP) therapy using the jet-mixing or Venturi effect to increase the volume flow rate of
      oxygenated air from a pressurized cylinder by entraining the atmospheric air. To provide CPAP
      therapy, this high flow of oxygenated air is delivered to the patient via a low-cost
      non-vented mask with a tight seal with a High-Efficiency Particulate Air (HEPA) filter
      connected to the exhalation limb. The tight seal and HEPA filter ensures a minimal risk of
      aerosol generation and thus the device can be used without a negative pressure room. The
      system consists of the developed Venturi-based flow-generator, a standard 22mm breathing
      tube, a standard Y-connector, a non-vented CPAP mask (e.g., snorkel mask, helmet), a HEPA
      filter, and a Positive End Expiratory Pressure (PEEP) valve. The bench-top testing of the
      device is done in the laboratories of BUET and was verified that the device performs within
      the CPAP guidelines provided by the Medicines and Healthcare products Regulatory Agency
      (MHRA), UK. This study aims to assess the safety of and efficacy of the device in three
      different steps: (1) design validation, (2) clinical feasibility and (3) pilot clinical trial
      for safety and efficacy evaluation. Only if the device successfully passes the parts 1 and 2,
      the investigators will proceed to the final clinical trial in step 3. In this final step, the
      investigators aim to conduct a randomized controlled trial (RCT) evaluating for
      non-inferiority of the CPAP intervention compared to standard HFNO treatment. The number of
      ventilator-free days will be used as the primary outcome for efficacy, while patient
      recovery, death, or need of intubation and other adverse events will be used as secondary
      outcomes.
    


Intervention name(s): High Flow Nasal Oxygen (HFNO) treatment; Continuous Positive Airway Pressure (CPAP) therapy using OxyJet
Intervention type(s): Device; Device
Intervention description(s): Administration of High Flow Nasal Oxygen (HFNO) to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). Adjust flow-rate and FiO2 as per standard HFNO treatment protocol.; Administer CPAP to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). CPAP initiated with FiO2 at 40% and a 10cm PEEP. Titrate PEEP to 15 cm if required. Deliver additional oxygen via secondary port if a higher FiO2 is required.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Repeated Short-term Microgravity During Parabolic Flight Conditions on Neuro-endocrine, Immune and Metabolic Changes
Condition: Healthy
Study type: Interventional

Summary: 
      From previous parabolic flight campaigns completed by our research group investigators
      gathered data showing important changes in neuro-endocrine and also immunological changes.
      This experiment now will complete the data set-up obtained during the MARS500 study on how
      these respective individuals will re-act to highly physically and emotionally challenging
      situations during a parabolic flight.

      This add-on experiment to MARS500 will enable answering to the following questions i) if the
      stress response systems - when compared for two conditions but in the same individuals - do
      react uniformly and ii) if those subjects prone to have adequate stress response pattern will
      show gradually less immune modulation effects.

      The understanding of the complex interactions of stress and immunity under chronic and acute
      stress conditions might help to enable adequate health and immune monitoring and might as
      well suggest suitable countermeasures for the prevention of the unwanted immunological
      effects during long-term confinement and space missions.
    


Intervention name(s): Parabolic flight; neuro-endocrine measurements; immunological measurements; cellular energy metabolism measurements
Intervention type(s): Other; Other; Other; Other
Intervention description(s): psychic stress tests, stress hormones: prolactin, cortisol, endo-cannabinoids; blood cell counts, B2 integrins, cytokines, C-reactive protein; purines, lactate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: volunteers
Interactions Between Diet, Microbiome and Abiotic Conditions in the Gut
Condition: Diet, Healthy; Metabolic Disease
MeSH terms: Metabolic Diseases
Study type: Observational

Summary: 
      The aim of this study is to explore the interplay between environmental (abiotic) factors in
      the gut and the gut microbiota composition, diversity and metabolism. Such insights could
      help us understand personal responses to diets and be a first step towards personalized
      dietary recommendations targeting the gut microbiome.
    

Detailed description: 
      The study is a 9-day trial including 85 healthy adults in age between 18 and 75. The
      participants will throughout the trial register their dietary intake, gastrointestinal
      symptoms including stool frequency and Bristol stool scale, physical activity, and medicine
      and supplements intake. Participants will on day 3 and day 5, respectively, consume sweet
      corns to estimate intestinal transit time by the time it takes sweet corn to travel through
      the gastrointestinal system. Furthermore, the participants will collect daily urine and stool
      samples.

      On day 2 and day 9, participants will arrive fasting at the department in the morning and
      have their anthropometry, breath hydrogen and methane levels measured, and a blood sample
      will be collected from each participant.

      The first visit (day 2) also includes a standardized meal test (rye bread, butter, jam, egg,
      and yogurt with nuts and berries) and intake of paracetamol (250 mg). Subsequently, the
      participants will stay at the department for the following 6 hours and have their
      postprandial breath hydrogen and methane measured and urine collected at specific intervals.

      Moreover, a sub-set of the participants will on the first visit (day 2) immediately after
      intake of the standardized meal swallow a single-use gastrointestinal SmartPill capsule,
      which will monitor their gastrointestinal pH, transit time, temperature and pressure.
    

Intervention name(s): 9-days habitual diet
Intervention type(s): Other
Intervention description(s): 9-days study with habitual diet including one standardized breakfast on a single day
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: Microbiome; Metabolomics; Nutrition