bioihbjkbjnl/mcl2 huggingface dataset:
Drug-Drug Interaction Study of Pacritinib and CYP450,Transporter Substrates, and CYP450 3A4 in Healthy Male Subjects
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, fixed-sequence, 2-part DDI study. Subjects will participate in
      only 1 study part.
    

Detailed description: 
      This is a Phase 1, open-label, fixed-sequence, 2-part DDI study. Part 1 will evaluate the
      effect of 14 days of pacritinib 200 mg BID at steady state on the systemic exposure of a
      cocktail of single doses of cytochrome P450 (caffeine, midazolam, omeprazole) and transporter
      substrates (digoxin, rosuvastatin, metformin) in 18 healthy male subjects who will
      participate in 2 treatment periods sequentially separated by a washout period. Part 2 will
      evaluate the effect of a CYP450 3A4 inducer (bosentan BID) for 7 days and the effect of a
      CYP450 3A4 inhibitor (fluconazole QD) for 7 days, on the PK of multiple doses of pacritinib
      200 mg BID in 36 healthy male subjects. Safety and tolerability will be assessed by AEs,
      clinical laboratory tests, vital signs, ECGs, and physical examinations.
    

Intervention name(s): CYP450 Cocktail and Transporter Substrates with Pacritinib; Part 2 -Group A Bosentan 125 mg (CYP450 3A4 inducer) with Pacritinib; Part 2 Group B - Fluconazole (CYP450 3A4 inhibitor) with Pacritinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Day 1: Single oral dose of a cocktail of cytochrome P450 substrates (caffeine 100 mg, midazolam 2 mg, omeprazole 20 mg and metformin (transporter)
Day 3: Single oral dose of transporter substrates (digoxin 0.25 mg, rosuvastatin 5 mg)
Days 8-22: Oral doses of pacritinib 200 mg BID approximately 12 hours apart
Day 17: Single oral dose of transporter substrates (digoxin 0.25 mg and rosuvastatin 5 mg) will be coadministered with the AM dose of pacritinib 200 mg.
Day 21: Single oral dose of a cocktail of cytochrome P450 substrates (caffeine 100 mg, midazolam 2 mg, and omeprazole 20 mg) along with transporter substrate (metformin 500 mg) will be coadministered with the AM dose of pacritinib 200 mg.; Days 1-7: Oral doses of pacritinib 200 mg BID
Days 8-14: Oral doses of pacritinib 200 mg BID, coadministered with an oral dose of bosentan 125 mg BID; Days 1-7: Oral doses of pacritinib 200 mg BID
Days 8-14: Oral doses of pacritinib 200 mg BID, coadministered with an oral dose of fluconazole 200 mg QD.
Other intervention name(s): Vonjo; Vonjo; Vonjo
Intervention MeSH terms: Fluconazole; Bosentan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: An open-label, fixed-sequence, 2-part drug-drug interaction study of pacritinib in healthy adult males
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pacritinib; Cytochrome P450 and Transporters
Anti-Wrinkle Efficacy Study of an Eye-Cream
Condition: Aging; Wrinkle
Study type: Interventional

Summary: 
      The purpose of this study is to assess the anti-aging and reduction of dark circles efficacy
      of a cosmetic product after 8 weeks of application.
    


Intervention name(s): Face care product (Eye cream)
Intervention type(s): Other
Intervention description(s): The test material(s) will be cosmetic products to be applied around the eye region on both sides of the face daily. The test product will be applied twice daily in the morning and in the evening by the subjects
Intervention model: Single Group Assignment
Intervention model description: Intra-individual comparison
Masking: None (Open Label)
Primary purpose: Basic Science
Absorption, Distribution, Metabolism and Excretion of BIA 5-1058
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      the purpose of this study is:

        -  to determine the rate and routes of excretion of BIA 5-1058 and the mass balance in
           urine, feces and exhaled air, after a single oral dose of 400 mg 14C labeled BIA 5 1058
           containing 3.7 Megabecquerel (MBq) of radiocarbon;

        -  to determine the pharmacokinetics (PK) of total radioactivity (TRA) in plasma and whole
           blood and to assess the blood-to-plasma ratio;

        -  to determine the PK of BIA 5-1058 and its metabolites in plasma.
    

Detailed description: 
      This was a Phase 1, single-center, open-label, absorption, distribution, metabolism, and
      excretion study in 8 healthy adult male subjects. Subjects received a single oral dose of 400
      mg BIA 5-1058, containing approximately 3.7 MBq (0.08 milliSievert [mSv]) of 14C-BIA 5-1058
      as oral capsules. Screening was between Day -21 and Day -2 and confinement period was of one
      period in the clinic involving drug administration on Day 1, with admission on Day 1 and
      discharge on Day 15 (336 hours post-dose).
    

Intervention name(s): 400 mg BIA 5-1058
Intervention type(s): Drug
Intervention description(s): Capsules, oral administered to subjects between 08:00 and 09:00 hours in the morning of Day 1after an overnight fast of at least 10 hours. The study drug was swallowed together with 240 mL tap water (room temperature).
Other intervention name(s): Zamicastat
Intervention MeSH terms: Zamicastat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique
Condition: Anterior Cruciate Ligament Injuries
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is (1) To report, compare and corelate the patient reported
      outcomes (PRO) (IKDC score, Lysholm Score) and range of motion (ROM) among patients following
      hamstring autograft ACLR with and without independent suture tape reinforcement against
      objective laxity test using Lachmeter. (2) Rate of complications and reoperation.
    

Detailed description: 
      Investigators performed a randomized control trial in two groups utilizing All- inside ACLR.
      Group I was augmented by suture tape and Group 2 without suture tape augmentation. From
      October 2018 to June 2020, 20 patients underwent all-inside ACL reconstruction with internal
      suture augmentation technique (Group I, Brace group) and the other 18 patients underwent all-
      inside ACL reconstruction without internal suture augmentation technique (Group II, non-brace
      group). Demographic data (age, sex, side of injury, time since injury), manual assessment
      (Lachman test, pivot shift test, ROM), PROs (IKDC score, Lysholm score) and Lachmeter
      examination were collected and analyzed at fixed time points during follow-up period as mean
      duration of follow up in our series was 18 months ± 3.4 (range, 12-24 months).
    

Intervention name(s): all- inside anterior cruciate ligament reconstruction
Intervention type(s): Procedure
Intervention description(s): all- inside anterior cruciate ligament reconstruction with internal suture augmentation technique
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rolimeter; ACLR; internal suture augmentation; IKDC score; Lysholm score
Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening
Condition: Colonic Polyps; Colonic Neoplasms
MeSH terms: Colonic Neoplasms; Polyps; Colonic Polyps
Study type: Interventional

Summary: 
      The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a
      colonoscope improves the numbers of polyps detected during bowel cancer screening
      colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy
      with the cap attached.
    

Detailed description: 
      Problem statement:

      In England, everyone in the age group of 60-69 years is invited to participate in bowel
      cancer screening. Those who test positive in the initial screening stool test are invited to
      have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the
      absence of obvious cancers the purpose is to detect and remove all the polyps present in the
      colon, as polyps have the potential to develop into cancers. However, colonoscopy still
      misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still
      misses a significant number of polyps. There is a need for an improved cap design which will
      help improve polyp detection.

      Research question/hypothesis:

      Does using an endocuff on a colonoscope improve polyp detection as compared to standard
      colonoscopy in bowel cancer screening patients?

      Study design:

      Parallel group, single blinded randomised controlled trial

      Study participants:

      Patients attending for colonoscopy under the bowel cancer screening programme

      Planned sample size: 534

      Planned study period: 12 months

      Primary objective:

      To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per
      patient
    

Intervention name(s): Endo-cuff; Standard colonoscopy
Intervention type(s): Device; Other
Intervention description(s): Colonoscopy performed with endo-cuff attached to the colonoscope; Standard colonoscopy without end-cuff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Colonoscopy; early cancer detection; cancer screening
Efficacy and Mechanisms of Mobile-Delivered Alcohol Attentional Bias Modification
Condition: Alcohol; Harmful Use
Study type: Interventional

Summary: 
      This study evaluates the efficacy as well as psychological and neurobiological mechanisms of
      mobile-delivered alcohol attentional bias modification among heavy drinking adults.
    

Detailed description: 
      By testing the efficacy and neurobiological mechanisms of behavior change (MOBC) following
      attentional bias modification among heavy drinking adults, the proposed study has the
      potential to unify dual process models and neurobiological models of addiction. The cognitive
      retraining will be delivered via mobile electronic devices to ensure the cost-effectiveness
      of these procedures, to allow a large amount of retraining to be delivered in an ecologically
      valid manner, and to facilitate broad dissemination of such procedures if found to be
      efficacious. Using an intensive longitudinal experimental design, subjects will be randomly
      assigned into one of 2 groups (attentional bias modification vs. attentional bias control).
      Ecological momentary assessment (EMA) data will be used to assess changes in cognitive and
      behavioral measures in situ, and functional magnetic resonance imaging (fMRI) scans before
      and after cognitive retraining will be used to examine neural changes in specific regions of
      interest (ROI).
    

Intervention name(s): Attentional Bias Modification
Intervention type(s): Behavioral
Intervention description(s): Mobile-Delivered Cognitive Retraining Intervention
Other intervention name(s): Cognitive Retraining
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A FINEH Protein Trial - Part 1
Condition: Diabetes Prevention; Obesity Prevention
Study type: Interventional

Summary: 
      The objectives of this trial are to assess the health benefits of acute hemp protein
      consumption compared to soybean protein and a non-protein control on: 1) blood glucose,
      appetite and blood pressure for one hour following consumption, 2) food intake at an ad
      libitum meal one hour following consumption and 3) blood glucose, appetite and blood pressure
      following the ad libitum meal to determine the "second meal effect" of hemp protein.
    


Intervention name(s): Hemp shake; Soybean shake; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Hemp protein shake; Soybean protein shake; Non-protein shake
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Antibiotic Use in Distal Hypospadias Repair
Condition: Hypospadias
MeSH terms: Hypospadias
Study type: Interventional

Summary: 
      Hypospadias is a common condition where the opening of the penis is not located at the tip,
      but along the underside of the penis. It is estimated to occur in 1/300 live male births,
      making it one of the most common birth defects. Degrees of hypospadias ranged from minor to
      severe depending on the location of the opening. Surgical repair is often required and
      involves placement of a catheter for the urine to drain with known urinary colonization found
      on prior retrospective studies. The current practice of using preventative antibiotics as
      long as the catheter is in place is conflicting with resent studies that show antibiotics may
      not be necessary to prevent urinary tract infections (UTIs).

      The purpose of this study was to see how common symptomatic UTIs were after hypospadias
      repair surgery; and to see whether routine antibiotic use after surgery affected the rate of
      UTIs. Subjects were randomized to either receive antibiotics or no antibiotics after distal
      hypospadias repair. The research coordinator made follow-up phone calls with the family and
      the primary care provider (PCP) after stent removal, 30 days post surgery and after the 3
      month post surgical visit.
    

Detailed description: 
      Males undergoing distal hypospadias repair involving stent placement were randomized to
      either receive or not to receive antibiotics post-operative. All subjects did not receive
      intra-operative antibiotics. Routine follow-up included having the stent removed one week
      post-op and a return visit at 3 months. The research nurse made follow-up phone calls to the
      family or the (PCP) one week after the stent was removed and at one month post-op to see how
      things were going with the child and again after teh 3 month post surgical visit, if the
      subject did not return after multiple rescheduling attempts.
    

Intervention name(s): Randomization to not receive prophylactic antibiotics after surgery.; Randomization to receive prophylactic antibiotics after surgery
Intervention type(s): Other; Other
Intervention description(s): No antibiotics were ordered after surgery.; In general, the antibiotic given is a combination sulfamethoxazole/ trimethoprim oral suspension (2-3 mg trimethoprim/kg by mouth once a day); or if indicated, nitrofurantoin (1mg/kg by mouth once daily). All subjects did not receive intraoperative antibiotics.
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Using the block randomization procedures, a subject was assigned to a study group by computer using the REDCap randomization module. Subjects were randomized to receive post operative antibiotics or to not receive any antibiotics postoperative.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distal hypospadias repair; urinary tract infection; prophylactic antibiotic use
Comparative Pharmacokinetics of YH14659 in Healthy Male Subjects
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare pharmacokinetics after single oral administration
      of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by
      Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in
      healthy male volunteers.
    


Intervention name(s): YH14659; clopidogrel & aspirin
Intervention type(s): Drug; Drug
Intervention description(s): YH14659 capsule by oral; clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tinnitus Treatment by Structured Cognitive Behavioral Therapy
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral
      therapy intervention procedures that are manualized and structured within the disease
      management program TCP are effective.
    

Detailed description: 
      Intervention:

      Individual application of structured and tinnitus specific cognitive behavioral therapy
      intervention procedures in the clinical setting of the structured therapy program "tinnitus
      care program (TCP)"

      Duration of intervention per patient: 1-15 treatment sessions plus self treatment up to 16
      weeks

      Control intervention: Waiting group (16 weeks)
    

Intervention name(s): Cognitive behavioral therapy; Waiting group
Intervention type(s): Behavioral; Other
Intervention description(s): 1-15 individual sessions of 50-60 min. to apply 1-15 manualized tinnitus specific cognitive behavioral therapy interventions structured by the tinnitus care disease management program; No intervention
Other intervention name(s): tinnitus care program; tinnitus care program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tinnitus, cognitive behavioral therapy, CBT
Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps
Condition: Artificial Intelligence; Colonoscopy; Quality Control
Study type: Interventional

Summary: 
      To investigate the degree of the real-time detection and classification system for increasing
      the adenoma detection rate during colonoscopy.
    


Intervention name(s): DeFrame; Classified DeFrame; conventional colonoscopy
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): The DeFrame system is applicated during colonoscopy. The DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, notifying the endoscopists of the presence of the lesion.; The Classified DeFrame system is applicated during colonoscopy. The Classified DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, the color of the rectangle box will turn blue when the polyp is considered as an adenoma, notifying the endoscopists of the presence of the lesion.; conventional colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Constipation Associated With Irritable Bowel Syndrome (IBS-C)
Condition: Constipation
MeSH terms: Irritable Bowel Syndrome; Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.
    

Detailed description: 
      Patients will be treated for 28 days, with clinical assessments carried out over 2 visits.
      Follow-up will be performed via telephone at a specific interval during the study to
      determine the outcome of unresolved AEs, any new drug-related AEs or any pregnancies. During
      the run-in period and the treatment phase, patients are prohibited from taking prescription
      or over the counter (OTC) laxative medication or constipating medications. Prescription and
      OTC medications not related to constipation are permitted and must be fully documented, but
      any changes (e.g., dosage, regimen) are to be limited as much as possible.
    

Intervention name(s): MOVICOL; Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): sealed laminated sachet, 1 - 3 sachets daily for 4 weeks; sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
Other intervention name(s): Macrogol (PEG) 3350; sodium chloride; sodium bicarbonate; potassium chloride; acesulfame potassium; lemon-lime flavouring; Sucrose; lemon and lime flavour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Constipation; Irritable Bowel Syndrome
Tricaprilin In Age-Associated Memory Impairment
Condition: Age-Associated Memory Impairment
MeSH terms: Memory Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether tricaprilin, a compound that increases
      energy availability in the brain, improves memory in older adults with "normal" loss of
      memory abilities since early adult life.
    

Detailed description: 
      One physiological hallmark of aging in mammals is a decreased uptake and metabolism of
      glucose within the brain. The impaired glucose metabolism in the brain may contribute or
      exacerbate the cognitive deficits observed during normal aging. Facilitation of memory in
      elderly individuals occurs when glucose levels are elevated by the administration of
      carbohydrate. However, such a treatment poses challenges since elevated blood glucose levels
      are difficult to maintain and must be within a relatively narrow window, as excessive
      hyperglycemia is associated with cognitive impairments. The purpose of this study is to
      explore whether increasing levels of other substrates for the brain improves cognitive
      functioning in normal aged individuals with memory disorders.

      Study participants will be 120 men and women aged 50-85 who have been diagnosed as having
      Age-Associated Memory Impairment (AAMI). During the double-blind period of the protocol, 60
      participants will receive tricaprilin and 60 participants will receive a matching placebo.
      Tricaprilin or the matching placebo will be administered once a day for ninety days by mixing
      powder in 8 ounces of a liquid. Each participant will be seen six (6) times: at Screening;
      Baseline; treatment days Days 30, 60, 90; and 14 days after the conclusion of treatment (Day
      104).
    

Intervention name(s): Tricaprilin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Powder formulation will be mixed in a liquid (approximately 8 oz).; Powder formulation will be mixed in a liquid (approximately 8 oz).
Other intervention name(s): AC-1202; Matching placebo to AC-1202
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mild Cognitive Impairment; Cognition disorders; nutritional supplement; dietary supplement