bioihbjkbjnl/mcl2 huggingface dataset:
Personalized Smoking Cessation Tool Based on Patient Lung CT Image
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT
      lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate
      the Report's effectiveness at motivating smokers to call a Quitline.
    

Detailed description: 
      Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT
      lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate
      the Report's impact on: (a) Lung screening participants' motivation to make a quit attempt by
      calling a Quitline, and (b) the effectiveness of a 45-minute telephone smoking cessation
      counseling session for motivating an actual quit attempt and abstinence. The RCT will enroll
      approximately 400 randomly selected participants from lung screening programs at
      HealthPartners and University of Michigan. Participants will be randomly assigned to one of
      four conditions: 1) Usual Care + quitline phone number (created specifically for the trial
      and maintained for the length of the trial); 2) Usual Care + Report (Report will list
      Quitline number) 3) Usual Care + Counseling, or 4) Usual Care + Report + Counseling. Follow
      up assessment calls will be conducted with participants at three weeks, three months, and six
      months following the mailing of the report.
    

Intervention name(s): Imbio Smoking Cessation Report; Smoking Cessation Counseling; Usual Care
Intervention type(s): Device; Behavioral; Other
Intervention description(s): Research coordinators at the University of Michigan and HealthPartners will be provided access to the research version of LDA via an Imbio website. Following consent and lung screen, research coordinators will manually upload the study participants' images and download a resulting Report. Radiologists have been designated at both sites to review and approve the Report prior to mailing to participants. The Report will include information including the percent of damaged lung volume.; 45 minute counseling session with a tobacco treatment specialist.; Usual Care for Lung Cancer Screening patients.
Other intervention name(s): Smoking Cessation Report; Report
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
Condition: Pneumonia
MeSH terms: Pneumonia; Respiratory Insufficiency
Study type: Interventional

Summary: 
      High-flow nasal oxygen (HFNO) therapy is an upcoming and beneficial modality for patients
      with acute hypoxemic respiratory failure (AHRF).

      To evaluate whether early use of HFNO in pneumonia patients with (AHRF) can reduce the need
      for invasive ventilation.
    

Detailed description: 
      -  Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after
           conventional oxygen therapy failure.

        -  The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR)
           more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial
           pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a
           conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum
           for Venturi mask) administered for at least 60 minutes.

      Eligible patients were randomized to receive either HFNO or NIV respiratory support
      throughout the hospitalization period. Randomization was stratified by a laboratory scientist
      not involved in the study using the technique of shuffled sealed envelopes.
    

Intervention name(s): High flow nasal cannula (HFNC); Noninvasive ventilation (NIV)
Intervention type(s): Device; Device
Intervention description(s): High-flow nasal cannula device was utilized. Humidifier temperature was set at 37°C via large-bore bi-nasal prongs, and inspired oxygen (FiO2) was adjusted to maintain oxygen saturation by pulse oximetry (SpO2) ≥ 90%.The flow was initially set at 10 L/min and titrated upward in 5 L/min steps until patients experienced discomfort.
Patient will be evaluated every 8 hours and discontinued the device for eating, drinking and coughing up secretion and returned back to the device for 72 hours.; Patients initiated NIV; Inspiratory positive airway pressure (IPAP) was initiated at 10-12 cmH2O, and expiratory positive airway pressure (EPAP) started at 4-5 cmH2O. FIO2 was adjusted to maintain SpO2 ≥ 90%. The same protocol as done in HFNC, patient will be evaluated every 8 hours and discontinued the device and returned back to the device for re- evaluation within 72 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)
Condition: COVID-19; Severe Acute Respiratory Syndrome
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Double blinded randomized clinical trial designed to evaluate the security and efficacy of
      hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators
      hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause
      hospital mortality in patients with severe respiratory COVID-19 disease.
    

Detailed description: 
      Since hydroxychloroquine is a low cost and safe anti-malaria drug that has proven effects
      against COVID-19 in vitro. The investigators aim to study the security and efficacy of this
      drug in trough a double blinded randomized clinical trial. Recruited patients with severe
      respiratory disease from COVID-19 will be randomized to an intervention group (400mg per day
      dose of hydroxychloroquine) and placebo. The investigators' main outcome will be all cause
      hospital mortality. The investigators hypothesize that a 400mg per day dose of
      hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with
      severe respiratory COVID-19 disease. Results will be compared in an intention to treat
      analysis. All clinical, analysis and data team members will be blinded to treatment
      assignment.
    

Intervention name(s): Hydroxychloroquine; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): hydroxychloroquine 400mg day for 10 days; Placebo oral tablet
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID-19; Severe acute respiratory syndrome
The Effects of Wearing a Face Mask During Exercise in Youth Hockey Players During COVID-19
Condition: Hypoxemia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      There is concern that wearing a face mask during COVID will affect oxygen uptake, especially
      during intense exercise. COVID transmission is especially prevalent in sports such as hockey,
      where there is close contact between players and arena ventilation is poor. This study will
      assess the effect of wearing a surgical face mask on simulated hockey performance and blood
      and muscle oxygenation during cycling exercise.
    

Detailed description: 
      The sport of ice hockey involves close contact between players in poorly ventilated arenas.
      This increases susceptibility for transmission of viruses, such as COVID-19. Face masks can
      reduce the risk of virus transmission; however, there is concern that wearing a face mask
      during exercise will reduce oxygen uptake or increase carbon dioxide re-breathing, which can
      result in low blood oxygen levels, reduced oxygen delivery to muscle and reduced exercise
      capacity. The purpose of the study is to determine the effect of wearing a surgical face mask
      during exercise that simulates ice hockey play on exercise performance and blood and muscle
      oxygenation in boys and girls. Twelve boys and twelve girls (age 9-14y) who are experienced
      playing hockey, will take part in this randomized cross-over study that will assess exercise
      performance, blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near
      infrared spectroscopy) during an exercise test on a cycle ergometer with workloads and work
      to rest intervals that simulates hockey performance. Participants will also be tested for
      repeated-sprint performance on ice while wearing full hockey equipment. The conditions
      include no mask (a "sham" mask) and a surgical mask. Outcome variables include power output
      during the cycle ergometer testing, skating distance during the on-ice test, rating of
      perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total
      hemoglobin at the quadriceps muscle.
    

Intervention name(s): Wingate exercise test and on-ice testing while wearing a face mask; Wingate exercise test and on-ice testing while wearing a sham face mask
Intervention type(s): Other; Other
Intervention description(s): Power output during 2 x 20s Wingate cycle tests and total distance during an on-ice skating test while wearing a face mask; Power output during 2 x 20s Wingate cycle tests and total distance during an on-ice skating test while wearing a face mask
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Joint Mobilization in the Treatment of Chronic Ankle Instability
Condition: Ankle Sprain
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of a gentle pressure movement performed
      at the ankle by a physical therapist on muscle function and ankle motion in individuals who
      frequently twist (sprain) their ankle.
    

Detailed description: 
      Novel rehabilitation methods, that specifically target decreased muscle activation due to
      joint pathology prior to strength training, have elicited greater improvements in muscle
      function and self-reported disability compared to traditional therapies. Preliminary evidence
      suggests ankle joint mobilization can improve contributions of spinal influences on ankle
      muscle activation in individuals with ankle joint pathology, but there is a considerable gap
      in understanding cortical contributions to muscle activation following joint injury. It is
      unknown how joint mobilization concurrently affects cortical and spinal neural motor
      pathways, as well as clinical measures of patient function. The overall aim of this grant is
      to determine the immediate effects of talocrural joint mobilization on cortical and spinal
      muscle activation of the fibularis longus (peroneus) and soleus muscles in individuals with
      chronic ankle instability (CAI). The secondary aims of this study will examine changes in
      ankle dorsiflexion range of motion (ROM) and dynamic balance. This innovate approach will
      provide the necessary scientific knowledge regarding the potential mechanism and efficacy of
      joint mobilization.
    

Intervention name(s): Small amplitude (Grade IV) mobilization; High velocity, low amplitude (Grade V) mobilization
Intervention type(s): Other; Other
Intervention description(s): The subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets.; The subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time.
Other intervention name(s): Manipulation; Grade V mobilization; High velocity, low amplitude thrust
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ankle Sprain; Chronic Ankle Instability; Ankle Mobilization; Talocrural Joint Mobilization; Cortical Muscle Activation; Spinal Muscle Activation
Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer
Condition: Superficial Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of
      abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder
      cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor
      remission and the influence on the one-year recurrence rate.
    

Detailed description: 
      A dose-escalation-study according ICH/GCP (International Conference on Harmonisation/Good
      Clinical Practice) with different concentrations of abnobaVISCUM® Fraxini is conducted in two
      hospitals in Germany and Egypt. Patients with superficial bladder cancer TaG1/G2 or T1G1/G2
      are enclosed after TUR-B (transurethral resection bladder). The tolerability of the different
      concentrations is assessed after weekly instillations into the urinary bladder for 6 weeks. A
      direct antitumoral effect is assessed on a single marker tumor left in the bladder after a
      complete TUR of all other lesions according a study design established by the
      EORTC-GENITO-URINARY GROUP (European Organisation for Research and Treatment of Cancer). A
      re-TUR is conducted after 12 weeks. Tumor response is measured by biopsy of the marker lesion
      and by cytology. Safety of the instillations is measured by analysis of adverse events, vital
      signs and clinical laboratory tests. After treatment of a cohort is finished a safety
      evaluation is conducted to decide about the increase to the next dosage.
    

Intervention name(s): abnobaVISCUM Fraxini
Intervention type(s): Drug
Intervention description(s): intravesical instillation 6 times, once weekly, in increasing dosages until dose-limiting-toxicity occurs
Other intervention name(s): viscum album extract; mistletoe extract; abnobaVISCUM
Intervention MeSH terms: Viscum album peptide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: superficial bladder cancer; mistletoe extract; maximum tolerated dose; marker tumor; remission; recurrence rate
Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Patients with Crohn's disease (CD) could develop complications such as stricture, intestinal
      fistula and abdominal abscess. Some CD patients had poor response to medical therapy. The
      efficacy of exclusive enteral nutrition (EEN) to these adult active CD patients is still
      unclear. The investigators aim to study the efficacy of EEN in induction of remission in
      adult active CD patients with complications or poor response to drugs.
    

Detailed description: 
      Active CD patients following up in our center who had been diagnosed as complicated disease
      with stricture, intestinal fistula, abdominal abscess and no response to drugs, were
      recruited since July 2013. Patients were only offered EEN for 12 weeks without using other
      drugs except that patients with abscess could use antibiotic therapy with or without
      percutaneous drainage. The disease activity was assessed by the Crohn's disease activity
      index (CDAI). CDAI<150 was taken as achieving clinical remission. Demographics and clinical
      variables were recorded. Nutritional (body mass index, albumin) and inflammatory (High
      sensitivity C-reactive protein and platelet) index were evaluated at baseline, week 4 and
      week 12. Some patients performed colonoscopy and/or computed tomography enterography (CTE)
      /resonance enterography(MRE) before and after EEN. Mucosal healing was assessed under
      endoscopy with SES-CD and the size of abscess was detected by CTE /MRE.
    

Intervention name(s): exclusive enteral nutrition treatment group
Intervention type(s): Dietary Supplement
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All consecutive adult active CD patients followed up in our center and had been diagnosed
        with disease complications including stricture, intestinal fistula, abdominal abscess or no
        response to drugs. Patients were recruited from July 2013 to July 2015.
Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
Condition: Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effect of calorie and fat content on the
      pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder,
      or schizophreniform disorder.
    


Intervention name(s): Lurasidone HCl
Intervention type(s): Drug
Intervention MeSH terms: Lurasidone Hydrochloride
Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A
Condition: Human Immunodeficiency Virus (HIV)-1 Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in
      combination with background antiretroviral therapy (ART) in participants who completed Study
      ACH443-014A and meet the inclusion and exclusion criteria.
    

Detailed description: 
      This study is an open-label extension study for participants who have completed 14 days of
      treatment in Study ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine
      treatment (10 mg) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for
      all consenting participants in combination with background ART as determined by the Principal
      Investigator. Participants will have clinical and laboratory assessments every 2 weeks for
      the first 8 weeks and then every 4 weeks to Week 48.
    

Intervention name(s): Elvucitabine; Lamivudine; Emtricitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Elvucitabine 10 mg in combination with background ART
Intervention MeSH terms: Lamivudine; Emtricitabine; Dexelvucitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extension study to Study ACH443-014A
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
Condition: Chronic Allograft Nephropathy
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the
      development of chronic allograft nephropathy and changes in allograft function in prevalent
      renal transplant recipients
    


Intervention name(s): prostaglandin I2 analogue
Intervention type(s): Drug
Intervention MeSH terms: Epoprostenol; Tezosentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers
Condition: Urothelial Carcinoma; Head and Neck Cancer; Melanoma; Bladder Urothelial Carcinoma
MeSH terms: Carcinoma; Melanoma; Head and Neck Neoplasms; Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is designed as a cell dose escalation trial in HLA-A*02:01 and HLA-A*02:06
      subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will
      enroll subjects between the ages of 18 and 75 using a modified 3+3 cell dose escalation
      design, to evaluate dose limiting toxicities and determine the target cell dose range.
      Following the dose escalation phase, additional subjects will be enrolled at the target cell
      dose range to further characterize safety and the effects at this cell dose.

      The study will take the subject's T cells, which are a natural type of immune cell in the
      blood, and send them to a laboratory to be modified. The changed T cells used in this study
      will be the subject's own T cells that have been genetically changed with the aim of
      attacking and destroying cancer cells. When the MAGE-A10ᶜ⁷⁹⁶T cells are available, subjects
      will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by
      T cell infusion. The purpose of this study is to test the safety of genetically changed T
      cells and find out what effects, if any, they have in subjects with urothelial, melanoma or
      head and neck cancer.

      Subjects will be seen frequently by the Study Physician after receiving their T cells for the
      next 6 months. After that, subjects will be seen every 3, 6, or 12 months according to the
      Schedule of Procedures. All subjects completing or withdrawing from the interventional
      portion of the study will enter a long term follow-up phase for observation of delayed
      adverse events and overall survival for 15 years post-infusion.
    


Intervention name(s): Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells
Intervention type(s): Genetic
Intervention description(s): Infusion of autologous genetically modified MAGE A10ᶜ⁷⁹⁶T on Day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cell Therapy; T Cell Therapy; SPEAR T Cell; MAGE-A10; Immuno-oncology; Metastatic; Urothelial Cancer; Previously Treated; T Cell Receptor; Inoperable; Advanced; Cancer; Bladder; Head and neck; Melanoma