bioihbjkbjnl/mcl2 huggingface dataset:
Investigating the Use of a Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To provide patients with bladder cancer who are scheduled to undergo radical cystectomy with
      a preoperative high-arginine nutritional supplement. The investigator will measure patient
      adherence to the regimen, tolerability of the supplement and feasibility of supplementation.
      Secondary outcome measures will include differences in length of stay and complication rate
      between groups.
    

Detailed description: 
      The purpose of this study is to investigate the use of a high-arginine protein supplement
      prior to surgery for patients undergoing radical cystectomy for treatment of bladder cancer.
      As many as 50% of patients who undergo radical cystectomy experience a postoperative
      complication, and poor preoperative nutritional status is known to increase the risk of
      complications. Preoperative use of a high-arginine protein shake has been shown to reduce the
      risk of postoperative complications for patients undergoing surgery for colon cancer, and
      this study seeks to determine whether this is also true for patients undergoing radical
      cystectomy for bladder cancer.

      Subjects will drink four protein shakes (Nestle Impact AR) per day for 5-7 days prior to
      radical cystectomy. Shakes will be provided to patients free of charge. On the date of
      surgery, subjects will turn in a log of shake consumption. Surgery will then proceed in
      typical fashion, and no changes will be made to surgery or postoperative care. Clinical
      outcomes for the first 90 postoperative days will be collected. Patient outcomes will be
      compared to those of contemporary controls who do not undergo supervised nutritional
      supplementation. Primary study outcome is to assess safety, tolerability and adherence to
      supplementation regimen. Secondary outcomes include differences in complication rates and
      length of postoperative hospital stay between groups.
    

Intervention name(s): high arginine nutritional supplement (Nestle's Impact AR)
Intervention type(s): Dietary Supplement
Intervention description(s): Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Urinary diversion; Bladder Neoplasm; Nutritional Supplement; Cystectomy
Diet, Genetic Variation and Prostate Cancer Among African Americans
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      This is a single center pilot study to asses the feasibility of conducting a larger
      population-based study. It is an investigator-initiated study funded yb the UC Davis Cancer
      Center's Development Award Program. The hypothesis is that the percent african ancestry in an
      individual may determine their prognosis if diagnosed with prostate cancer.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        African American males between the ages of 35 and 75.
      
Biospecimen description: 
      Serum collected for Ancestry Imformative Markers (AIMS) testing along with PSA and CRP.
    
Keywords: Prostate Cancer
A Study of LY3209590 in Chinese Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of a study drug known as LY3209590
      in Chinese participants with type 2 diabetes mellitus who are on a stable dose of basal
      insulin. Side effects and tolerability will be documented. Blood samples will be taken to
      assess how the body processes the study drug and the effect of the study drug on blood sugar
      levels. The study will last up to 18 weeks and may include 18 visits for each participant.
    


Intervention name(s): LY3209590; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography
Condition: Acute Coronary Syndrome; Acute Chest Pain
MeSH terms: Acute Coronary Syndrome; Chest Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether cardiac CT can improve triage of acute
      chest pain patients in the emergency department.
    

Detailed description: 
      Myocardial infarction remains one of the most important causes of death and disability.
      Therefore it is important that individuals with acute chest pain are accurately assessed
      without delaying appropriate treatment. Acute coronary syndrome is only one cause for sudden
      chest pain, which is a very common complaint in the ER. Other life threatening causes such as
      pulmonary embolism and aortic dissection may also be the cause, although most chest
      discomfort has a benign reason (musculoskeletal, hyperventilation, oesophageal reflux, etc).

      The current work-up of suspected acute coronary syndrome, based on presentation, symptoms,
      ECG and biomarkers, is not efficient and results in unnecessary diagnostics and hospital
      admissions, as well as errors or delayed diagnoses, in a substantial number of patients.
      Computed tomography angiography (CTA) images atherosclerosis, coronary obstruction as well as
      myocardial hypoperfusion. We hypothesize that early use of CTA is of incremental value and
      allows for accurate and immediate triage of patients with acute chest pain.
    

Intervention name(s): Cardiac CT
Intervention type(s): Radiation
Intervention description(s): Calcium scan and CT coronary angiography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Acute coronary syndrome
Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, active-controlled,
      comparator controlled, multi-dose, parallel-group study divided into three treatment periods
      and a follow-up period with five treatment groups. This study will be conducted at 1 clinical
      research unit (CRU) in the United States (US).

      Period 1 will consist of daily escalating doses of tyramine administered until tyramine
      pressor response (defined as the tyramine dose required to increase systolic blood pressure
      by at least 30 mm Hg from the daily defined baseline in 3 consecutive measurements within 4
      hours after tyramine dosing) is achieved or Day 7.

      Participants who achieve tyramine pressor response at tyramine doses >/= 200mg and </= 700mg
      are eligible for continuation into Period 2 and will be randomized accordingly.

      Depending on the group to which a participant is randomized, participants will receive
      rasagiline, phenelzine, ozanimod (therapeutic dose), ozanimod (supra-therapeutic dose), or
      placebo in Period 2. The duration of dosing depends on the group to which a participant is
      randomized.

      In Period 3, all participants will undergo a sham tyramine challenge and receive a single
      dose of tyramine placebo. Participants who do not achieve tyramine pressor response following
      the sham challenge will continue with the tyramine challenge (ie, tyramine pressor tests) for
      up to 12 additional days.

      Participants who receive at least one dose of study drug in Period 2 will participate in a
      follow-up phase during which 2 follow-up telephone calls will be performed, the last of which
      will occur approximately 80 to 100 days after the last dose of study drug.
    


Intervention name(s): Placebo; Rasigiline; Phenelzine; Ozanimod
Intervention type(s): Other; Drug; Drug; Drug
Intervention description(s): Placebo; Rasigiline; Phenelzine; Ozanimod
Intervention MeSH terms: Phenelzine; Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Phase 1
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether BA058 is effective in building bone in
      postmenopausal women with osteoporosis.
    

Detailed description: 
      This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the
      effects of BA058 in the treatment of otherwise healthy postmenopausal women with
      osteoporosis.
    

Intervention name(s): teriparatide; Placebo; BA058 20 µg; BA058 40 µg; BA058 80 µg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): teriparatide 20 µg subcutaneous daily; Placebo subcutaneous daily; BA058 20 µg subcutaneous daily; BA058 40 µg subcutaneous daily; BA058 80 µg subcutaneous daily
Other intervention name(s): PTH
Intervention MeSH terms: Teriparatide; Abaloparatide; Parathyroid Hormone-Related Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: osteoporosis; postmenopausal; bone loss
Feasibility and Safety of a Virtual-Reality Based Job Interview Training Tool in Teenagers With High-Functioning Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The current project involves the application of a VR job training software. We propose to use
      an interactive VR job interview practice system, Virtual Reality Job Interview Training
      (VR-JIT), in youths with ASD at the highschool level. This system was developed to bolster
      job interview practice skills and to help reduce anxiety in adults with ASD. However, it has
      never before been used in individuals under the age of 18. Our hope is that if this program
      is utilized in individuals while they are still in highschool, we can target those persons
      before the window for which risk of unemployment appears to be highest for ASD youths,
      immediately after high school graduation.
    


Intervention name(s): VR-JIT
Intervention type(s): Other
Intervention description(s): Job interview with virtual interviewer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Radiofrequency Ablation Using Cooled-Wet Electrode
Condition: HCC; Metastasis
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      To determine safety, ablative zone, technical success rate and early safety data of recently
      introduced cool-wet electrode in eligible patients who are indicative for radiofrequency
      ablation (RFA) for liver tumors.
    

Detailed description: 
      To determine safety, ablative zone, technical success rate and early safety data (12 months
      local tumor progression rate) of recently introduced cooled-wet electrode in eligible
      patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison
      with currently used separable clustered electrode in our institution. Owing to tissue cooling
      effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients
      would be randomized into two groups (cool-wet electrode group and separable clustered
      electrode in switching monopolar mode). The results from this preliminary study would be used
      for main study to compare the efficacy and safety data between two electrodes in the future.
    

Intervention name(s): cooled-wet electrode; separable clustered electrode
Intervention type(s): Device; Device
Intervention description(s): RFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy.; RFA is performed using separable clustered electrode in switching monopolar mode.
Other intervention name(s): Octopus(R)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RFA
Pilot Dispensing Evaluation of a Plus Power Lens
Condition: Hyperopia
MeSH terms: Hyperopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses
      against ACUVUE® ADVANCE® lenses in the plus power parameters.
    


Intervention name(s): Acuvue Advance Plus; Acuvue Advance
Intervention type(s): Device; Device
Intervention description(s): Silicone hydrogel contact lens.; Silicone hydrogel contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PF-06372865 In Subjects With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      PF-06372865 In Subjects With Chronic Low Back Pain
    


Intervention name(s): PF-06372865; Placebo; Naproxen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks; Placebo for PF-06372865 and placebo for naproxen daily; 500 mg BID for 4 weeks
Intervention MeSH terms: Naproxen; PF-06372865
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate atrophogenic potential of long-term use of Tri-Luma Cream on facial Melasma through
      biopsy examination.
    

Detailed description: 
      Same as above.
    

Intervention name(s): Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%
Intervention type(s): Drug
Intervention description(s): Apply topically daily for 12 weeks and continue until condition is clear or almost clear for up to 24 weeks; Maintenance phase: Apply topically twice weekly until the end of study (24 weeks) or condition relapses
Other intervention name(s): TriLuma Cream
Intervention MeSH terms: Fluocinolone Acetonide; Tretinoin; Hydroquinone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study in Healthy Men to Investigate the Uptake of Buprenorphine and Its Elimination From the Body After Dermal Application as Patches for 96 Hours and for 72 Hours
Condition: Pain; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study was to investigate the pharmacokinetics (i.e. the uptake,
      distribution and elimination from the body) of dermally applied buprenorphine during and
      after different application periods, i.e., a 96-hour and a 72-hour application of the
      Transtec (Registered Trademark) patch (release rate 35 micrograms per hour [µg/hour]). In the
      Transtec summary of product characteristics (prescribing information for the physician), the
      wearing time per patch is restricted to three days (72 hours) after which the patch has to be
      replaced. However, market experience has shown that the Transtec patches are sometimes worn
      for a period longer than three days, i.e. they sometimes happen to be only replaced every
      four days. There was currently no data available as how to evaluate this longer wearing
      period.
    


Intervention name(s): Transtec 35 µg/hour transdermal patch
Intervention type(s): Drug
Intervention description(s): Transdermal patch containing 20 mg buprenorphine in an active surface area of 25 squared centimeters. Buprenorphine release rate 35 µg/hour.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant will apply Transtec 35 µg/hour transdermal patch, once for 96 hours (Treatment A) and once for 72 hours (Treatment B) in randomized order. Between removal of the first patch and application of the second patch, there will be a washout period of at least 10 days.
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in participants with type 1 diabetes mellitus to investigate how
      the human body processes LY900014, a new blood sugar lowering insulin, and its effect on
      blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability
      will be documented. The study will last about 4 to 11 weeks for each participant.
    


Intervention name(s): LY900014; Insulin Lispro (Humalog)
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (SC); Administered SC
Other intervention name(s): Ultra-Rapid Lispro; LY275585; Humalog
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and compare the pharmacokinetic
      parameters from the fixed dose combination ABT-143 relative to that from the
      co-administration of the two monotherapies.
    


Intervention name(s): ABT-143; ABT-335; rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once, please see Arm Description for more details.; Once, see Arm Description for more detail; once, see Arm Description for more detail
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adverse events; Pharmacokinetic
Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Condition: Lung Diseases, Obstructive
MeSH terms: Lung Diseases, Obstructive; Lung Diseases
Study type: Interventional

Summary: 
      The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive
      pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas
      analysis showed pH = 7.35, PO2 < 60mmHg,PaCO2>45mmHg) or have achieved the traditional
      noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter,
      venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen
      concentration methods with inadequate heating and humidifying lead to poor patient tolerance
      and adverse reactions such as airway secretions discharge disorders. The high flow nasal
      respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional
      low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of
      up to 60 litres per minute via nasal cannulas with low level continous positive airway
      pressure. This study is a prospective randomized study. AECOPD patients with no severe
      respiratory failure are treated with NHF and conventional oxygen therapy respectively. The
      target is that NHF can increase the comfort degree of patients,reduce the rate of
      endotracheal intubation, and shorten the time of hospitalization.
    


Intervention name(s): Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand); nasal catheter or Venturi mask
Intervention type(s): Device; Device
Intervention description(s): Nasal high flow therapy; Conventional oxygen therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute exacerbation of chronic obstructive pulmonary disease; Nasal high flow therapy; Oxygen therapy
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in
      the management of opioid withdrawal symptoms while initiating outpatient treatment with
      naltrexone. The initiation procedure will be a flexible detoxification lasting 2 to 10 days
      concluding with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting
      injection that contains enough medicine to last for one month blocking the effects of
      opioids.
    

Detailed description: 
      This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in
      the management of opioid withdrawal symptoms while initiating outpatient treatment with
      naltrexone. Lofexidine is a nonopioid prescription medicine used in adults to help with the
      symptoms of opioid withdrawal that may happen when a person stops taking an opioid suddenly.
      The initiation procedure will be a flexible detoxification lasting 2 to 10 days concluding
      with the injection of XR-Naltrexone (Vivitrol). Vivitrol is a long-acting injection that
      contains enough medicine to last for one month blocking the effects of opioids. Lofexidine
      will be fixed-flexible dosing started on day 1 with maximum dose being three 0.18mg tablets
      taken orally 4 times daily at 4-to 6-hour intervals. Lofexidine treatment will continue
      throughout the detoxification, up to 10 days, and will be discontinued with a gradual dose
      reduction over 2 to 4 days. Precipitated withdrawal symptoms are treated with lofexidine,
      clonazepam, and other comfort medications. After the induction patients will be seen at the
      clinic for 8 weeks. Twice weekly for the first month and weekly for weeks 5-8. A second
      Vivitrol injection will be provided at week 4.
    

Intervention name(s): Lofexidine 0.18 MG
Intervention type(s): Drug
Intervention description(s): Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.
Other intervention name(s): Lucemyra
Intervention MeSH terms: Lofexidine
Intervention model: Single Group Assignment
Intervention model description: open label treatment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid use disorder; lofexidine; naltrexon-xr