bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 open-label, randomized, two-period, crossover study to evaluate the effect
      of repeated oral doses of SCY-078 (Ibrexafungerp) on the pharmacokinetics of dabigatran
      administered orally to healthy subjects.
    

Detailed description: 
      The two-period crossover study will consist of two treatments administered in random order.
      Treatments will be separated by a minimum of 10 day wash-out (between last dose in the first
      period and first dose in the subsequent period). Healthy male and female subjects will will
      be enrolled to assess the effects on a single dose of dabigatran mesylate (DAB).

      Subjects will be screened within 4 weeks prior to dosing and randomized to a treatment
      sequence (AB or BA) in a crossover fashion.

      Treatment A: Single oral 150mg dose of DAB. Treatment B: Twice daily (BID), every 12 hours
      (Q12H) oral doses of SCY-078 750mg on Day and Day 2; and single oral AM doses of SCY-078
      750mg on Day 3 and Day. On Day 3, a single 150mg dose of DAB will be administered 1 hour
      after the AM dose of SCY-078.

      Subjects will fast overnight after being admitted to the clinic on Day -1 and will remain in
      the clinic until the final procedures are complete.

      Twenty eight male and female subjects between 18 and 55 years (inclusive) will be enrolled
      into the study. Subjects who discontinue may be replaced.
    

Intervention name(s): DAB; SCY-078 plus DAB
Intervention type(s): Drug; Drug
Intervention description(s): Single oral 150-mg dose of DAB on Day 1 AM.; Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078.
Intervention MeSH terms: Ibrexafungerp
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomized to a treatment sequence (AB or BA) in a crossover fashion with a minimum 10-day washout period between treatments.
Treatment A = Single oral 150-mg dose of DAB on Day 1 AM. Treatment B = Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078.
Masking: None (Open Label)
Primary purpose: Other
Keywords: SCY-078; Dabigatran; Ibrexafungerp; Pharmacokinetics; Healthy Subjects
Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To demonstrate the non-inferiority of insulin glargine 300 units per milliliter (U/ml) in
      comparison to insulin degludec 100 U/ml on glycemic control and variability in participants
      with diabetes mellitus.

      Secondary Objective:

      To evaluate the glycemic control and variability parameters in each treatment group at Week
      12 using Continuous Glucose Monitoring.

      To evaluate the safety of insulin glargine 300 U/ml in comparison to insulin degludec 100
      U/ml.
    

Detailed description: 
      The duration of the study per participant was around 18 weeks: 1 or 2 weeks of screening
      followed by a 4-week run-in period, a 12-week treatment period and a 2 to 4 days follow-up
      period.
    

Intervention name(s): Insulin glargine, 300 U/ml; Insulin degludec, 100U/ml; Background therapy: Rapid acting insulin analogs
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection in a prefilled pen
Route of administration: SC injection; Pharmaceutical form: solution for injection in a prefilled pen
Route of administration: SC injection; Route of administration: SC injection
Other intervention name(s): Toujeo; HOE901-U300; Tresiba
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Short-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery
Condition: Valvular Heart Disease Patients
MeSH terms: Heart Diseases; Heart Valve Diseases
Study type: Interventional

Summary: 
      Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is
      a common problem which influence poor outcome in subjects undergoing valvular heart surgery.
      The incidence of postoperative renal dysfunction was reported as high as 7~8% in heart
      surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote
      ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury
      in previous animal studies and stoke patients. Therefore, the investigators are trying to
      evaluate the clinical effect of remote ischemic postconditioning on postoperative renal
      dysfunction in subjects undergoing valvular heart surgery with bypass.
    


Intervention name(s): remote ischemic postconditioning; valvular surgery with bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Remote ischemic postconditioning post group will take a remote ischemic postconditioning with tourniquet in their lower extremity under thigh. The conditioning is 5 minutes of inflation, and 5 minutes of deflation, repeated 3 cycles.; valvular surgery with bypass
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Conversion to Monotherapy Study With Keppra XR for Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the efficacy of two doses of Keppra XR
      compared with a historical control as the placebo, in the monotherapy treatment of partial
      onset seizures.
    


Intervention name(s): Keppra XR; Keppra XR
Intervention type(s): Drug; Drug
Intervention description(s): Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks; Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Keppra XR; conversion to monotherapy; partial seizures
Anderson Study 1 - Tart Cherry Study
Condition: Health Services Research
Study type: Interventional

Summary: 
      The purpose of this study is to examine if tart cherry reduces food-induced elevations in
      serum uric acid.
    

Detailed description: 
      Gout is a painful form of arthritis that is caused by hyperuricemia (high uric acid levels)
      that form crystals in the joints. Ingestion of food and/or beverages containing high purine
      levels (e.g., beef, game meats, liver, shellfish, herring, mackerel, anchovies, sardines,
      mushrooms, dried beans and peas, sweetbreads, excessive alcohol, etc.) increase uric acid
      levels and thereby can complicate the management of uric acid levels in individuals with
      hyeruricemia and/or gout. Prior research has shown that ingestion of a chrysanthemum flower
      oil containing a high level of polyphenols significantly reduced the uricemic response to
      ingesting a meal high in purines. Additionally, black cherry and grape juice extracts are
      purported to have uric acid lowering properties. We have previoulsy reported that tart cherry
      powder, another naturally occuriring source of phlyphenols, lessens exercise-induced
      inflammation. This study will examine if tart cherry can also reduce the uricemic response to
      ingesting a high purine containing meal. If so, this may provide another dietary approach to
      help individuals manage their uric acid levels.
    

Intervention name(s): Placebo; Active
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dextrose (480 mg); Tary Cherry (480 mg)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment,
      moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics,
      safety, and tolerability in these subjects
    


Intervention name(s): BMS-986177
Intervention type(s): Drug
Intervention description(s): Single oral dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Association Between Deficiency of MBL (Mannose-Binding Lectin) and Polymorphisms in MBL2 Gene to Urinary Tract Infection
Condition: Recurrent Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Observational

Summary: 
      Due to genetic polymorphism about 15%-30% of the world population have low levels of MBL
      (Mannose Binding Lectin) in serum (below 500ng/mL). Different studies reported correlation
      between polymorphism in the MBL gene with low levels of MBL in serum and higher frequency of
      recurrent infections, severity of sepsis, ARDS and other infections. Urinary Tract Infection
      (UTI) is one of the very common infection in women. Since MBL is part of the innate immunity
      and there are proofs of relation between patients with recurrent infections and lack of MBL,
      we decided to explore a possible relation between low levels of MBL and different genotypes
      of MBL in young women and the risk to develop recurrent UTI.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        young women with recurrent UTI - study group and young women witout recurrent UTI - a
        control group
      
Biospecimen description: 
      whole blood for genetic test and serum for MBL test
    
Keywords: MBL, UTI
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism
Condition: Healthy Adults; Postmenopausal Women
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether there are differences in postprandial
      metabolic indices following interesterified fats used commercially versus the corresponding
      un-interesterified blend.
    

Detailed description: 
      Aim: The current study aims to investigate the acute effects of commercially relevant
      interesterified 'hardstock' versus the corresponding un-interesterified blend on 8 h
      postprandial fat metabolism.

      Hypothesis: Interesterification of a palm kernel and palm stearin fat blend, to produce a fat
      with a higher proportion of palmitic acid in the middle position of the triglyceride (TAG;
      but the same fatty acid composition), will alter postprandial lipid metabolism.

      Subjects: Participants will include 24 healthy male and female (postmenopausal) volunteers
      aged between the ages of 45 and 75 years (since during this age metabolic changes start to
      take place).

      Power calculation: Based on previous studies carried out by our group at King's College
      London, a sample size of 10 males and 10 females is required to detect a (clinically
      relevant) difference (for males and females separately) between means of 0.3 mmol/L maximal
      difference in 8 h plasma TAG concentration (standard deviation 0.33 mmol/L, significance
      level (alpha) of 0.05 and 80% power). 12 males and 12 females will be recruited to allow for
      a 20% drop out rate.

      Expected value:The study will provide novel information on the acute effects of commercially
      relevant processed fats on postprandial lipaemia.
    

Intervention name(s): Interesterified blend of palm kernal and plam stearin; Un-interesterified blend of palm kernal and plam stearin; Rapeseed oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 50 g fat provided as interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water); 50 g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water); 50 g fat provided as rapeseed oil in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)
Other intervention name(s): Interesterified blend; Un-interesterified blend; Control fat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Interesterified; Postprandial; Lipid
Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is
      bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5
    


Intervention name(s): D961H; D961H
Intervention type(s): Drug; Drug
Intervention description(s): Oral gelatin capsule; Oral HPMC capsule
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer; Japanese males; homo-EM; Bioequivalence study
A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is
      to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the
      progression of the disease. Since there is no placebo in this study, all patients will be
      taking lithium carbonate.
    

Detailed description: 
      This is a Phase II Screening study. There is no placebo (inactive or 'fake' drug) in this
      study, meaning that all participants will be taking lithium carbonate. The purpose of this
      study is to find out if lithium carbonate is safe to be used in people with ALS and if it can
      slow the progression of the disease.

      A recent article was published in a highly regarded medical journal that showed a positive
      effect of lithium carbonate on an ALS type mouse. The researchers then studied a very small
      number of people with ALS, giving 16 people lithium carbonate with riluzole and giving 28
      people only riluzole. The people who took lithium remained stronger for a considerably longer
      period of time. However, the study was very small and we cannot really tell if lithium works
      unless a larger study is performed. It is not well understood why lithium carbonate might be
      helpful but it is believed that it may play a role in protecting the motor nerves from the
      damage of ALS.

      If you choose to participate, you will need to go to your study clinic for research study
      visits 7 times in one year and you will have 4 telephone interviews during that time. These
      visits and phone calls could take up to 17 hours in total.

      Caution: Lithium is an FDA approved drug used for some psychiatric disorders. It is not FDA
      approved for ALS. Lithium has many potentially serious side effects and must only be taken
      under close supervision of your physician.
    

Intervention name(s): lithium carbonate
Intervention type(s): Drug
Intervention description(s): The dosage of lithium carbonate will be adjusted for each individual. The maximum dose is 450mg/day.
Intervention MeSH terms: Lithium Carbonate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig's Disease; Lithium; Lithium Carbonate
SOKARY Mobile Application With Type II Diabetes
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Android mobile application named (SOKARY)
    

Detailed description: 
      Android mobile application named (SOKARY) which means diabetes was selected as an example of
      mobile health application as it has the advantage of Arabic interface, free use it allows
      users to record his/their blood glucose level, nutrition and physical activity, then provide
      the user with statistics for those readings. The application also sends notifications to the
      users such as medication reminders and healthy lifestyle advice.
    

Intervention name(s): SOKARY Mobile
Intervention type(s): Device
Intervention description(s): Effectiveness of using SOKARY Mobile Application on compliance of patient with Type II diabetes
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patient with type II DM
      
Keywords: Mobile phone application; DM type II; EGYPT; Compliance
A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Xanamem® is being developed as a potential drug for Mild Cognitive Impairment in Alzheimer's
      disease. This study drug has been designed to change the cortisol levels in the brain.
      Cortisol is a naturally occurring hormone in the body. It is believed that reducing the level
      of cortisol will be a benefit in the treatment of Mild Cognitive Impairment in Alzheimer's
      disease.

      The purpose of this study in older volunteers is to investigate the smallest dose of Xanamem®
      (5 mg or 10 mg) which works and to investigate which dose in this study will be used in the
      upcoming clinical trials in patients.
    


Intervention name(s): Xanamem® 5 mg; Placebo; Xanamem® 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Xanamem® ("UE2343") capsules 5 mg, administered orally once daily.; Matching placebo which is identical in appearance to the test product (5 mg, 10 mg Xanamem® QD) except that it contains no active ingredient.; Oral Xanamem® ("UE2343") capsules 10 mg, administered orally once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Volunteer subjects will be randomly assigned to 1 of 3 treatment groups to receive either 5 mg Xanamem®, 10 mg Xanamem® or placebo in the ratio of 1:1:1 with approximately 35 subjects in each treatment group. This sample size has been selected to allow for approximately 30 subjects per treatment group to complete the study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Function; Healthy Volunteers
Precision Diagnosis of Acute Infectious Diseases; Neuroinflammatory Cohort
Condition: Encephalitis; Meningitis
MeSH terms: Communicable Diseases; Infections; Meningitis; Encephalitis
Study type: Interventional

Summary: 
      This study aims to use a clinically validated metagenomic next-generation sequencing (mNGS)
      assay to provide a demonstration of precision medicine for diagnosis of acute infectious
      disease in hospitalized patients. From June 2016 to June 2017, 200 patients will be enrolled
      from multiple hospitals in California and outside of California. Patients will be evaluated
      to determine the impact on the mNGS assay on diagnostic yield, hospital costs and clinical
      outcomes.
    

Detailed description: 
      This study aims to use a clinically validated metagenomic next-generation sequencing (mNGS)
      assay to provide a demonstration of precision medicine for diagnosis of acute infectious
      disease in hospitalized patients, with the goal of directly impacting clinical care and
      improving patient mortality. This diagnostic test has been previously validated in a Clinical
      Laboratory Improvement Amendments (CLIA)-certified laboratory, the University of California,
      San Francisco Clinical Microbiology Laboratory. From June 2016 to June 2017, investigators
      will prospectively enroll 200 patients from multiple hospitals in California (University of
      California, San Francisco; University of California, Los Angeles; University of California,
      Davis; Children's Hospital Los Angeles) and outside California (Children's National Medical
      Center, Children's Hospital Colorado, St. Jude Children's Research Hospital) for mNGS
      testing, and evaluate the impact on the assay on diagnostic yield, hospital costs and
      clinical outcomes.
    

Intervention name(s): mNGS for pathogen detection
Intervention type(s): Device
Intervention description(s): This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.
Other intervention name(s): Sequence-Based Ultrarapid Pathogen Identification (SURPI)+; UCSF metagenomic next-generation sequencing testing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: metagenomic next-generation sequencing; microbiological diagnosis; bacterial infections; viral infections; fungal infections; parasitic infections
A Study to Investigate the Safety of AB680 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomized, placebo-controlled, single- and multiple-ascending dose
      study to investigate the safety, tolerability, and pharmacokinetic profile of AB680 in
      healthy volunteers.
    

Detailed description: 
      AB680 will be administered as single and multiple intravenous doses to the healthy
      volunteers. In each group of 8 participants, 6 will receive AB680 and 2 will receive matching
      placebo.

      The participants will be closely observed to monitor the general tolerability of AB680.
    

Intervention name(s): AB680; Placebo
Intervention type(s): Drug; Other
Intervention description(s): AB680 is a Cluster of Differentiation (CD)73 Inhibitor; Matching Placebo
Intervention MeSH terms: Quemliclustat
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment