bioihbjkbjnl/mcl2 huggingface dataset:
Association Between Genetic Variant Scores and Warfarin Effect
Condition: Atrial Fibrillation; Deep Vein Thrombosis; Intracardiac Thrombus; Pulmonary Embolism; Venous Thromboembolic Disease
MeSH terms: Pulmonary Embolism; Atrial Fibrillation; Thrombosis; Embolism; Venous Thrombosis; Thromboembolism
Study type: Observational

Summary: 
      Study objective is to determine whether there is an association between genetic variant risk
      scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic
      international normalized ratio (INR), INR ≥ 4, bleeding event, ischemic stroke, death) in
      participants taking warfarin for atrial fibrillation, deep vein thrombosis (DVT), pulmonary
      embolism (PE), and/or intracardiac thrombosis.
    

Detailed description: 
      It is anticipated that next generation genomic sequencing will identify rare genetic variants
      in ethnically diverse populations, which otherwise would not have been detected using
      commercially available warfarin tests. Furthermore, retrospective review of clinical outcomes
      (percent time in therapeutic range, time to reach therapeutic international normalized ratio
      (INR), INR ≥ 4, major bleeding event, ischemic stroke) of study participants will determine
      the clinical utility of genetic variant risk scores. Study outcomes will provide guidance on
      future directions for optimizing dosing algorithms for warfarin that combine pharmacogenetic
      principles with clinical dosing.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1. Participants with a known disease that predisposes them to bleeding will be excluded,
             since it will be a confounder (trying to link abnormal genetic variant risk score to
             bleeding).

          2. Participants taking medications or on a diet that increases bleeding propensity will
             also be excluded.

          3. Pediatric participants will be excluded from this study, since atrial fibrillation
             and/or venous thromboembolism are rare in this cohort.
      
Biospecimen description: 
      Sample collection:

      One 3 mL venous blood sample will be taken from each study participant and collected in EDTA
      tubes on the day of the one-time study visit, when the participant is reporting to the
      SCVH&HS laboratory to undergo INR testing per Anticoagulation Clinic protocol.

      This 3 mL venous blood sample will be taken from each study participant, in addition to the
      standard of care blood draw for INR. Each sample tube will be labeled with the protocol study
      number, along with the date and time of collection.
    
Keywords: Warfarin; Coumadin; Pharmacogenomics; Pharmacogenetics; Adverse Drug Reactions; Bleeding/hemorrhaging
RCT on Necessity of Cholecystectomy for Patients After Clearance of Bile Duct Stones
Condition: Gallbladder Stones; Complication; Cholecystectomy
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones; Calculi
Study type: Interventional

Summary: 
      To discuss necessity of cholecystectomy for patients with stones in their bile ducts and
      gallbladders in the absence of absolute operation indications of cholecystectomy after
      clearance of bile duct stones with ERCP.
    

Detailed description: 
      Cholecystectomy was recommended for patients with stones in their bile ducts and gallbladders
      in European and American countries after clearance of bile duct stones with ERCP, which
      reduced the incidence of biliary events. However, some researches showed that the incidence
      of biliary events was not reduced but increased.The purpose of this study is to discuss the
      necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in
      the absence of absolute operation indications of cholecystectomy after clearance of bile duct
      stones with ERCP.
    

Intervention name(s): gallbladder preserved; cholecystectomy
Intervention type(s): Other; Procedure
Intervention description(s): Gallbladders will be remained after clearance of bile duct stones with ERCP and conventional therapy, such as fluid replacement and prophylactic anti infection, will be accepted.; Cholecystectomy will be done right now after clearance of bile duct stones with ERCP, and then conventional therapy will be accepted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: gallbladder stones; common bile duct stones; Endoscopic retrograde cholangiopancreatography
Evaluation of an Ascensia Diabetes Care Blood Glucose Meter and App System
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used
      with the Contour Next One meter (the Onyx system).
    

Detailed description: 
      The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used
      with the Contour Next One meter (the Onyx system) in the hands of subjects with type 1
      diabetes or insulin-using subjects with type 2 diabetes. It is designed to determine the
      subjects' self-reported success in utilizing the features of the system. Each feature will be
      evaluated independently, by including a series of statements about each feature set for which
      a numerical score or rating will be provided by subjects.
    

Intervention name(s): Onyx BG Meter / App System
Intervention type(s): Device
Intervention description(s): Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Pharmacogenetic-Directed Treatment for Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive
      report improves outcomes when compared with standard treatment without the availability of
      genetic information.
    

Detailed description: 
      This study is designed to evaluate the clinical impact of pharmacogenetic (PGx)-directed
      treatment, as guided by interpretive, algorithmic report in the Pine Rest outpatient
      behavioral health clinics. The PGx algorithm utilized in this study is the foundation of a
      novel method of interpreting genetic testing results and reports them in a rapidly delivered
      format that provides enhanced guidance to psychiatrists in their selection of antidepressant
      medications
    

Intervention name(s): GeneSightRx; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Multi-genetic pharmacogenomic panel; Treatment as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: GeneSight; Assurex; AssureRx
Peripheral Blood DNA Methylation Markers for the Early Detection of Colorectal Carcinoma in the Egyptian Population
Condition: Colorectal Neoplasms; Adenoma; Colorectal Tumors
MeSH terms: Adenoma; Colorectal Neoplasms
Study type: Observational

Summary: 
      The incidence of colorectal cancer (CRC) is on the rise on a global scale. The number of
      cancer-related deaths related to CRC is also rising to an alarming level. This picture is
      similarly seen in Egypt where the incidence of colorectal carcinoma is increasing annually,
      moreover, CRC in Egypt exhibits an alarming characteristic which is the affection of much
      younger patients than their counterparts worldwide. Fortunately, the early detection of CRC
      and its precursor (adenoma) has been shown to markedly decrease morbidity and mortality
      related to this tumor, this has prompted the development of robust screening programs for CRC
      in several western countries. The implementation of a CRC screening program in Egypt has been
      hampered by the low compliance of the patients and the relatively high cost of colonoscopy.
      There is a need for an affordable, non-invasive, simple, accurate and socially accepted
      screening test to allow such a program to succeed in Egypt. Recent studies have shown that
      DNA is the future target of screening tests for several malignancies. Particularly for CRC a
      few preliminary studies have shown encouraging results with separate DNA methylation markers
      both in blood and stool. In our efforts to develop a screening test with the criteria stated
      above, the investigators have decided to join the forces of 2 of the largest medical centers
      in Egypt and the middle-east: Kasr-Alaini hospital and the National cancer institute (NCI).
      The investigators plan to test a panel of 7 DNA methylation markers in peripheral blood for
      their performance as an early marker for CRC and colorectal adenomas. Data from this study
      will pave the way for the development of a screening test for CRC "tailored" to the Egyptian
      population, moreover, it will supply essential data about the genetic alterations occurring
      in CRC in Egyptian patients.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients refered to Kasr-Alaini endoscopy unit and National cancer institute endoscopy
        department for colonoscopy.
      
Biospecimen description: 
      10cc blood sample and tissue biopsies from colorectal lesions when present.
Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      In recent years, the importance of the gut microbiota to human health has been demonstrated.
      In adulthood, the microbial profile is relatively stable, yet can be transiently altered by
      factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut
      microbiota has been shown to differ in normal versus disease states including inflammatory
      bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship,
      there is intense interest in designing interventions that positively influence the gut
      microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that
      alter the colonic environment in favour of health-promoting bacterial species, such as
      bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to
      beneficially alter the microbial profile, there is a need to identify the dosing requirements
      to positively modulate the gut microbiota. This study will test the effect of two doses of
      prebiotic on gut microbiota taxonomy and diversity.
    

Detailed description: 
      The primary objective is to determine the effect of 4 week intake of a moderate dose (7 g/d)
      or low dose (2.5-3 g/d) of prebiotic on gut microbiota profiles in healthy adults compared to
      a non-prebiotic containing control.

      The primary outcome is change in microbial composition (measured via 16S rRNA sequencing).

      The secondary outcomes are change in gastrointestinal (GI) tolerance (measured via
      questionnaire); change in fecal short chain fatty acids; and change in quality of life.

      This study will consist of two separate trials of 12 week duration. Each trial will be
      performed in a double-blind, randomized, placebo-controlled crossover manner with a 4 week
      intervention period followed by a 4 week wash-out period and final 4 week cross over.
    

Intervention name(s): Control; Prebiotic
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Isocaloric food without the test prebiotic.; Prebiotic consumed as 7 g/d in a snack food in Group 1 and consumed as 2.5-3 g/d in a snack food in Group 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover design with 4 week washout period.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prebiotic; Gut microbiota; Dietary fiber; Gastrointestinal tolerance
FLOX in Combination With Cetuximab in First-line Treatment of Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this trial is to explore the effect of combining an established
      chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin
      (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of
      metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab,
      in which FLOX is given continuously or intermittently, compared to standard FLOX without
      cetuximab.
    


Intervention name(s): FLOX (5-fluorouracil/folinic acid/oxaliplatin); FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab; FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FLOX every 2nd week; FLOX every 2nd week Cetuximab weekly; FLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced.
Cetuximab weekly.
Intervention MeSH terms: Leucovorin; Folic Acid; Fluorouracil; Oxaliplatin; Cetuximab; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic colorectal cancer; FLOX; Cetuximab
Effect Of Rilapladib (SB-659032) On Platelet Aggregation
Condition: Healthy Subjects; Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the effects of repeat doses of SB-659032 with placebo
      on platelet aggregation in subjects.
    


Intervention name(s): Rilapladib (SB-659032)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: platelet aggregation; SB-659032; rilapladib
ADASUVE 2-dose Thorough QT/QTc Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE
      administered 2 hours apart, in relation to placebo and an active control in healthy
      volunteers.
    

Detailed description: 
      It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation
      does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc
      prolongation following repeat dosing is unknown. Therefore the current study will assess the
      potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours
      apart, in relation to placebo and an active control in healthy volunteers.

      The study hypothesis H0: Placebo-subtracted max mean dQTc > 10 msec
    

Intervention name(s): ADASUVE 10 mg 2 doses 2 hours apart; Inhaled Placebo; Oral moxifloxacin 400 mg; Oral placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhaled loxapine 10 mg 2 doses 2 hours apart; Staccato placebo via inhalation x 2 at 2 hours apart; Oral moxifloxacin 400 mg single dose; Oral capsule identical in appearance to moxifloxacin
Other intervention name(s): Staccato Loxapine; AVELOX
Intervention MeSH terms: Moxifloxacin; Loxapine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center, randomized, double-blind, double-dummy, 2-dose, 3-period, active- and placebo-controlled, crossover QT/QTc and pharmacokinetic (PK) study of ADASUVE in healthy volunteers. All dosing and treatment-day follow-up in the study was conducted in the clinical research unit (CRU)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ADASUVE; inhaled loxapine; thorough QT/QTc study
Biomechanical Analysis of Gait in Individuals With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      The purpose of this research study is to understand the walking patterns, strength and
      function changes of boys with Duchenne muscular dystrophy on/off corticosteroids to determine
      the best timing and treatment options to maintain walking for as long as possible.
    

Detailed description: 
      Duchenne muscular dystrophy (DMD) is an X-linked recessive disease of muscle characterized by
      a progressive loss of functional muscle mass, which is replaced with fibrofatty tissue.
      Historically, boys with DMD lose the ability to walk between the ages of 8-12 years, due to
      progressive weakness of the quadriceps coupled with the development of contractures at the
      hip, knee and ankle. This progressive loss in function necessitates individuals with DMD to
      spend less time walking and more time in wheelchairs, leading to the development of spinal
      deformities. Recently, corticosteroids have been shown to reduce the expected loss of muscle
      strength, extend the time that ambulation and standing are maintained, and minimize or
      eliminate spinal deformity in individuals with DMD; yet, the side effects of such treatment
      preclude use in some patients. To date, differences in gait patterns and other markers of
      disease progression between boys on corticosteroids and those not utilizing such treatment
      have not been objectively quantified. This lack of knowledge is a major obstacle to
      determining the most effective treatment for subsets of boys with DMD.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Boys with DMD who are ambulatory starting at the age of 4 until ambulation ceases
      
Keywords: Walking; Muscle Strength; Energy Cost; Quality of Life
Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury
Condition: Symptomatic Urinary Tract Infection; Spinal Cord Injury
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are
      a frequent problem, leading to significant morbidity and to a decreased quality of life.

        -  until today, there is no effective prophylaxis for UTI for patients with spinal cord
           injury.

        -  homeopathy has been shown to be an effective treatment option in several chronic
           diseases

        -  study hypothesis: the addition of homeopathic assessment and treatment to a standard
           prevention strategy for recurrent UTI will significantly reduce the number of
           symptomatic UTI per year in this group of patients compared to standard prevention alone
    


Intervention name(s): individual homeopathic treatment; standard treatment without homeopathy
Intervention type(s): Other; Other
Intervention description(s): participants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis; participants receive standard UTI prophylaxis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: urinary tract infection; spinal cord injury; homeopathy; prevention
Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis Subjects
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety and tolerability of TOP1288 rectal single and multiple
      ascending doses in healthy subjects and multiple doses in subjects with ulcerative colitis.
    

Detailed description: 
      TOP1288, a narrow spectrum protein kinase inhibitor, is being developed as a novel,
      non-absorbed treatment for ulcerative colitis (UC). UC is a disease of unknown cause
      characterised by inflammation of the lining of the large intestine and manifesting with
      abdominal pain and bloody diarrhoea. TOP1288 given rectally has a local anti-inflammatory
      action in experimental models of UC. The present study will be the first time TOP1288 has
      been given to humans and explores the safety, tolerability and how the body handles (absorbs,
      distributes and eliminates) TOP1288 and seeks evidence of the biochemical effect of the drug
      in the body. The study is in three parts: Part 1 investigates single doses in groups of
      healthy volunteers, each group dosed with an increased dose provided the drug was safe and
      well tolerated at the previous level. Part 2 investigates multiple ascending doses in healthy
      volunteers each group dosed with an increased dose provided the drug was safe and well
      tolerated at the previous level. Part 3 investigates one dose level by administering that
      dose in patient volunteers with UC. The study design is adaptive - that is after the first
      dose level in Part 1, which is predefined, the exact dose and dose-intervals can be modified
      from a pre-set plan by a Safety Review Committee in the light of the emerging results.
    

Intervention name(s): TOP1288
Intervention type(s): Drug
Other intervention name(s): TOP1288 Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment