bioihbjkbjnl/mcl2 huggingface dataset:
Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children
Condition: Children; Chemotherapy-induced Nausea and Vomiting; Malignant Tumor
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      Poor control of chemotherapy-induced nausea and vomiting has a major clinical and
      psychological impact in patients treated with chemotherapy. Metabolic, nutritional and
      mechanical complications, as well as psychological repercussions, complicate the therapeutic
      management of the patient and can lead to poor compliance, a deterioration in the general
      condition or even prolongation of hospitalizations and a delay in the implementation of
      chemotherapy cures. The control of induced chemo- and radio-induced nausea and vomiting rests
      above all on their prevention. At present and in most centers, the prevention of nausea and
      vomiting in the pediatric onco-hematology department of the CHU de Nice is based exclusively
      on drug treatments, according to a protocol established according to the emetogenic risk of
      the chemotherapy received.

      We propose a study evaluating the effectiveness of the stimulation of acupuncture points by
      low frequency laser therapy associated with antiemetics in the management of chemotherapy
      induced nausea and vomiting in patients of 2 to 20 years followed in the service of
      analgesics. pediatric onco-hematology.
    


Intervention name(s): laser therapy
Intervention type(s): Other
Intervention description(s): stimulation of the acupuncture point P6 by laser therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose
      study in male and female patients ages 50 to less than 89 years with mild to moderate AD.
      Approximately 230 study sites in the US and Canada and up to 35 sites outside of North
      America will be involved. Patients will be randomized to receive either bapineuzumab or
      placebo. Each patient's participation will last approximately 1.5 years.

      Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid
      peptide, and is designed to provide antibodies to beta amyloid directly to the patient.
    


Intervention name(s): Bapineuzumab 0.5 mg/kg; Placebo Control; Bapineuzumab 1.0 m/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): infusion every 13 weeks for a total of 6 infusions; given by infusion every 13 weeks for a total of 6 infusions.; infusion every 13 weeks for a total of 6 infusions
Other intervention name(s): AAB-001; AAB-001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Βeta-adrenoceptor Inverse Agonist and Biased Ligand, Nadolol, In Smoking Cessation of Patients With Chronic Cough With or Without Airflow Obstruction
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      To test the hypothesis that treatment with the inverse agonist nadolol will improve smoking
      cessation in patients with chronic cough associated with long-term smoking, with or without
      airflow obstruction, including those with established chronic obstructive pulmonary disease
      (COPD) (chronic bronchitis dominant) or non-obstructive chronic bronchitis (NCB), compared to
      placebo and standard of care, while undergoing a validated smoking cessation program.
    


Intervention name(s): Nadolol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nadolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Acetaminophen IV vs Hydromorphone IV in the ED
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the current study is to compare the analgesic efficacy of intravenous
      acetaminophen and intravenous hydromorphone in the treatment of acute pain in the ED.
    

Detailed description: 
      This is a randomized, double-blind placebo-controlled clinical trial comparing intravenous
      acetaminophen and intravenous hydromorphone in the treatment of acute pain in the Emergency
      Department. Enrolled subjects presenting to the ED with acute pain will be randomized to
      receive either acetaminophen 1g IV or hydromorphone 1mg IV.
    

Intervention name(s): Acetaminophen; Hydromorphone
Intervention type(s): Drug; Drug
Intervention description(s): Acetaminophen 1g IV; Hydromorphone 1mg IV
Intervention MeSH terms: Acetaminophen; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acetaminophen; Hydromorphone; Emergency Department; Narcotics; Analgesics, Opioid; Analgesics, Non-Narcotic
Use of Real-time Continuous Glucose Monitoring System in Patients With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a real-time continuous glucose monitoring
      system is able to improve HbA1c in patients suffering from type 1 diabetes compared to
      conventional finger prick glucose measurements. In addition it will investigate whether
      number of episodes with serious hypoglycemia is changed in those same patients, and whether
      quality of life (health status and treatment satisfaction) increases.
    


Intervention name(s): Guardian REAL-Time Continuous Glucose Monitoring System; Conventional self-monitoring of plasma glucose
Intervention type(s): Device; Other
Intervention description(s): One group will use the glucose monitoring system for 1 month; Finger prick blood glucose measurements
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Real-time glucose monitoring system; HbA1c; Quality of life; Hypoglycemia
ACTolog in Patients With Solid Cancers
Condition: Cancer; Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      The study purpose is to learn about the safety and tolerability of IMA101 alone (Cohort 1) or
      in combination with atezolizumab (Cohort 2) in patients with advanced solid cancers that
      express pre-defined Immatics tumor targets.
    

Detailed description: 
      SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) and the
      main biomarkers screening. If the patient is eligible, white blood cells will be collected
      with a leukapheresis for the manufacture of the IMA101 product.

      MANUFACTURE: IMA101 product will be made from the patient's white blood cells.

      TREATMENT: IMA101 product will be administered to the patient intravenously after
      lymphodepleting pre-conditioning with chemotherapy (fludarabine and cyclophosphamide).

      Low-dose IL-2 will be self-administered twice daily for a total of 28 doses after infusion of
      IMA101 product. In Cohort 2, atezolizumab will be administered every 3 weeks, starting no
      earlier than 3 weeks after the IMA101 product infusion and after hematologic recovery.

      Patients will be monitored closely throughout the study.
    

Intervention name(s): Fludarabine; Cyclophosphamide; IMA101 product; Recombinant human interleukin-2; IMADetect; Atezolizumab
Intervention type(s): Drug; Drug; Biological; Biological; Diagnostic Test; Drug
Intervention description(s): Fludarabine infusion; Cyclophosphamide infusion; i.v. infusion of IMA101 product(s).; Low dose IL-2 Infusion for two weeks; IMADetect is a laboratory test that is part of screening used to determine the mRNA expression of ACTolog target source genes in tumor biopsies from solid tumors. IMADetect is intended for investigational use only.; Atezolizumab infusion will be given no earlier than 3 weeks post IMA101 infusion and after hematologic recovery is achieved, thereafter every 3 weeks until 1 year after IMA101 infusion.
Other intervention name(s): Fludarabine monophosphate; Cytoxan; Aldesleukin; Proleukin; Tecentriq
Intervention MeSH terms: Aldesleukin; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Atezolizumab; Interleukin-2
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian Cancer; Esophageal Cancer; Head and neck squamous cell carcinoma; non-small cell lung cancer; Gastric Cancer; T-cell Therapy; immunotherapy; adoptive cellular therapy; T-cell receptor; cell therapy; cytotherapy; IMA101; atezolizumab; Tecentriq
Validation of a Novel Cortical Biomarker Signature for Pain
Condition: TMD
Study type: Observational

Summary: 
      The study aims to undertake analytical validation of an brain biomarker in healthy
      participants experiencing a model of sustained temporomandibular pain. The biomarker could
      detect participants at greater risk of developing more severe pain.
    

Detailed description: 
      Chronic pain is a major health burden associated with immense economic and social costs.
      Predictive biomarkers that can identify individuals at risk of developing severe and
      persistent pain, which is associated with worse disability and greater reliance on opioids,
      would promote aggressive, early intervention that could halt the transition to chronic pain.
      The investigative team has uncovered evidence of a unique cortical biomarker signature that
      predicts pain susceptibility (severity and duration). The biomarker signature combines
      resting state sensorimotor peak alpha frequency (PAF) measured using electroencephalograph
      (EEG) and corticomotor excitability (CME) measured using transcranial magnetic stimulation
      (TMS). This PAF/CME biomarker signature could be capable of predicting the severity of pain
      experienced by an individual minutes to months in the future, as well as the duration of pain
      (time to recovery). In the current study, the investigators aim to undertake analytical
      validation of this biomarker in healthy participants using a standardized model of the
      transition to sustained myofascial temporomandibular pain (masseter intramuscular injection
      of nerve growth factor). The investigators will record PAF/CME at multiple time points before
      and during the development of pain and use online diaries and in-laboratory assessments of
      pain, sleep, stress, and other psychosocial variables. Specifically, the investigators will
      test if the biomarker signature predicts an individual's pain sensitivity (high- or low-pain
      sensitive).
    

Intervention name(s): Injection of Nerve Growth Factor
Intervention type(s): Other
Intervention description(s): Injection of Nerve Growth Factor to the right masseter
Intervention MeSH terms: Mitogens
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy men and women with no medical complaints, no history of chronic pain and no current
        acute pain between the ages of 18 and 44 years will be included.
In Vivo Assessment of Silver Biomaterial Nano-Toxicity
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Nanotechnology is the controlled generation and manipulation of matter in dimensions less
      than 100 nm. Silver has been used for its bactericidal properties. The investigators propose
      to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in human
      volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of this
      solution.
    


Intervention name(s): 10ppm Oral Silver Particle; 32ppm Oral Silver Particle
Intervention type(s): Drug; Drug
Intervention description(s): Silver nanoparticles at 10ppm; Silver nanoparticles at 32ppm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Drug Interaction Study of Apixaban With Cyclosporine or Tacrolimus in Transplant Recipients
Condition: Pharmacokinetics; Kidney Transplant; Lung Transplant
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to evaluate the pharmacokinetics (PK) of apixaban in kidney and lung
      transplant recipients stabilized on either cyclosporine or tacrolimus as part of their
      immunosuppressive therapy.
    

Detailed description: 
      Solid organ transplantation is a lifesaving option for many patients with end-stage organ
      disease. After transplant surgery, patients must take immunosuppressive therapy, which
      carries significant risk for drug-drug interactions and adverse medication-related events.

      Transplant recipients are at an increased risk for co-morbidities traditionally managed with
      warfarin, such as venous thromboembolism and atrial fibrillation. Apixaban has the potential
      to provide safer and more effective treatment, without additional monitoring of the INR, but
      it has not been studied in conjunction with anti-rejection agents in this population.
      Apixaban is metabolized by CYP3A4 and P-gp and BCRP transporters. As part of their
      immunosuppressive therapy, solid organ transplant recipients are maintained on calcineurin
      inhibitors, which are weak CYP3A4 as well as potent P-gp and BCRP inhibitors. A study was
      recently undertaken to evaluate the potential drug-drug interaction between cyclosporine or
      tacrolimus and apixaban in healthy subjects (ClinicalTrials.gov Identifier: NCT03083782) .
      The results indicated that the change in apixaban exposure was not clinically relevant.

      PK studies in healthy volunteers are a first step for determining the nature and extent of
      potential drug-drug interactions. However, follow-up studies in the actual patient
      populations are essential for ensuring safety and tolerability, and providing clinicians the
      confidence to use these combinations. The purpose of this study is to confirm the
      pharmacokinetic characteristics and safety of apixaban in combination with tacrolimus and
      cyclosporine in stable kidney and lung transplant recipients.
    

Intervention name(s): Apixaban
Intervention type(s): Drug
Intervention description(s): Study subjects given a single-dose of apixaban 10 mg.
Other intervention name(s): Eliquis
Intervention MeSH terms: Apixaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Minimum Effective Volume of Local Anesthetic for Peribulbar Block.Does it Differ With the Eyeball Axial Length?
Condition: Peribulbar Block
Study type: Interventional

Summary: 
      The aim of this study is to calculate the minimum effective volume of local anesthetic for
      peribulbar block in patients undergoing cataract extraction surgery.
    

Detailed description: 
      The main goal of this study is to estimate the minimum effective volume(MEV90) of local
      anesthetic and hyaluronic acid given for local anesthesia of the eye for 2 different axial
      length groups of patients undergoing eye surgery. Volume assignment was carried out using a
      biased coin design (BCD) up-and-down sequential method (UDM), where the volume given to each
      patient depends on the response of the previous one. The MEV90 was calculated using isotonic
      regression with bias-corrected 95% confidence interval (CI) derived by boots trapping. The
      mean value of the estimate was obtained from 3000 bootstrap samples.
    

Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention description(s): peribulbar block
Other intervention name(s): hyaluronic acid
Intervention MeSH terms: Bupivacaine; Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Peribulbar block; minimum effective volume; axial eye length
Computer Vision System for the Blind Veteran
Condition: Blindness
MeSH terms: Blindness
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a feasibility study involving a small number of blind subject to evaluate the
      effectiveness of using a software and associated hardware components to assist the blind in
      identifying and locating objects of interests and to assist in way finding tasks. After the
      system has been successfully tested by the blindfolded engineers, it will be evaluated in a
      small number of blind subjects.
    

Detailed description: 
      This is primarily an engineering project to develop computer vision algorithms for an
      integrated system comprising of a laptop computer, webcam, gps, digital compass, microphone,
      and stereo earphones. The system will be voice controlled. The algorithm will be trained to
      identify and located objects and navigationally landmarks in real-time, previously selected
      by sighted developers. After the system has passed objective engineering milestones, blind
      subjects will be tested to determine whether the novel system will improve the ability of the
      blind to travel over a test course in a hospital setting.
    

Intervention name(s): initial system; modified system
Intervention type(s): Device; Device
Intervention description(s): The computer vision system is used to assist blind subject to navigate an extended path with multiple turns within a hospital setting.The initial prototype system would have been successfully tested for outdoor navigation and basic object recognition tasks.; The problems associated with the initial system were identified and modified. This modified system was tested with a second separate group of subjects. The redesigned system is used to assist blind subject to navigate the same extended path with multiple turns within a hospital setting.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With COVID-19 Vaccine Messages to Minority Populations
Condition: Vaccine Preventable Disease
MeSH terms: Vaccine-Preventable Diseases; Emergencies
Study type: Interventional

Summary: 
      A cluster randomized trial will be conducted prior to widespread vaccine availability to the
      general public. Community-informed COVID-19 vaccine messages will be disseminated to
      participants. At baseline, 2 weeks and 4 weeks, the study team will survey participants to
      assess knowledge and attitudes about COVID-19 vaccines, including intention to be vaccinated.
    

Detailed description: 
      A cluster randomized trial with 80 participants from the social networks of 8 CLs will be
      conducted prior to widespread vaccine availability to the general public. Four CLs and social
      networks (cluster of 10 per network) will be randomly assigned to receive the intervention
      immediately or after a delay of 2 weeks. Intervention participants will be invited to a
      closed social media group on the platform of their choice. CLs, selected for trustworthiness
      within vulnerable populations, will disseminate community-informed COVID-19 vaccine messages
      to members of their social networks and engage in bidirectional communication with CEnR
      partners to refine messages. At baseline, 2 weeks and 4 weeks, participants will be surveyed
      to assess knowledge and attitudes about COVID-19 vaccines, including intention to be
      vaccinated.
    

Intervention name(s): Educational, culturally appropriate COVID-19 messages
Intervention type(s): Other
Intervention description(s): Educational, culturally appropriate COVID-19 messages will be developed and shared by RHCP.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: hesitancy
A Study of JNJ-70033093 (BMS-986177) in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetic (PK) of multiple twice-daily
      doses of JNJ-70033093 in healthy participants and to assess the effects of dosing time and
      food on the PK of single-dose of JNJ-70033093 in healthy participants.
    


Intervention name(s): JNJ-70033093; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-70033093 capsules will be administered orally .; Matching placebo in capsule will be administered orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn about a drug-drug interaction. When two medications are
      taken together at the same time, one medication may change the activity of the other
      medication in the body - this is called a drug-drug interaction. This study is looking at the
      effect the Bayer study drug, copanlisib, has on metformin, a commonly used medication to
      treat diabetes. During the study, blood and urine samples will be collected and analyzed to
      learn about pharmacokinetics (how copanlisib changes metformin levels in the body) and
      pharmacodynamics (the effect metformin has on the body when taken together with copanlisib)
      when someone takes both copanlisib and metformin together.
    


Intervention name(s): Copanlisib (Aliqopa, BAY80-6946); Metformin
Intervention type(s): Drug; Drug
Intervention description(s): The copanlisib dose for this study is the standard dose recently approved and also used in Phase 1, 2 and 3 studies across the copanlisib development program: 60 mg i.v. infusion administered intermittently on Days 1, 8 and 15 of a 28-day cycle.
In this study subjects will receive a single i.v. dose of 60 mg copanlisib on day 8.; Single dose of 1000 mg is administered orally.
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment