bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Reality Experiences for Anxiety and Pain Control
Condition: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      This trial studies the impact of virtual reality experiences on anxiety before surgery and
      pain after surgery. The goal of this study is to examine how different virtual reality
      experiences may help reduce anxiety and improve pain control, which may help reduce the need
      for medications such as opioids.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To measure the impact of a gaming virtual reality (VR) experience compared to a
      mindfulness VR experience on preoperative anxiety and postoperative pain.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients participate in a VR intervention (Angry Birds) over 15 minutes before
      standard of care surgery and then participate in a VR intervention (TRIPP) over 15 minutes
      after surgery.

      ARM II: Patients participate in a VR intervention (TRIPP) over 15 minutes before standard of
      care surgery and then participate in a VR intervention (Angry Birds) over 15 minutes after
      surgery.
    

Intervention name(s): Survey Administration; Virtual Reality Game; Virtual Reality Meditation
Intervention type(s): Other; Procedure; Procedure
Intervention description(s): Ancillary studies; Participate in VR Game "Angry Birds"; Participate in VR Meditation "TRIPP"
Other intervention name(s): VR Game; VR Meditation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to determine the safety, pharmacokinetics,
      immunogenicity in humans, the recovery time required from the biologic effects and the
      optimal biologic dose range of BMS188667 (CTLA4Ig)
    


Intervention name(s): Abatacept
Intervention type(s): Drug
Intervention MeSH terms: Abatacept
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long Term Safety of Naldemedine
Condition: Opioid-induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety of naldemedine for the
      treatment of constipation due to opioid therapy.
    


Intervention name(s): Naldemedine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Naldemedine 0.2 mg tablet taken orally once a day; Placebo tablet taken orally once a day
Other intervention name(s): S-297995; Symproic®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid Induced Constipation
Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      Initial study in children with epilepsy to evaluate the pharmacokinetics, safety,
      tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to
      develop dosing adaptations for future studies.
    


Intervention name(s): Brivaracetam
Intervention type(s): Drug
Intervention description(s): Oral solution
Evaluation period (3 weeks up-titration):
For subjects ≥8 years:
~0.4 mg/kg bid for Week 1
~0.8 mg/kg bid for Week 2
~1.6 mg/kg bid for Week 3
For subjects <8 years:
~0.5 mg/kg bid for Week 1
~1.0 mg/kg bid for Week 2
~2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
~0.8 mg/kg bid for Week 4
~0.4 mg/kg bid for Week 5
For subjects <8 years:
~1.0 mg/kg bid for Week 4
~0.5 mg/kg bid for Week 5
Intervention MeSH terms: Brivaracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brivaracetam; Epilepsy; Child; Pharmacokinetics; Adolescents
Effects of Cocoa Flavanols on Human Cognitive Function
Condition: Neural Degeneration
MeSH terms: Nerve Degeneration
Study type: Interventional

Summary: 
      To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function
      in healthy older adults.
    

Detailed description: 
      This is a randomised controlled double blind cross over study investigating the acute effects
      of high flavanol (495mg) compared to low flavanol (23mg)cocoa drink on cognitive function in
      a healthy older adult population (n=60). The primary outcome measure of this study is to
      determine the effects of the flavanol intervention on cognitive measures of executive
      function and attention and the secondary measures of blood pressure and to determine whether
      any observed effects are paralleled by plasma flavanol levels.
    

Intervention name(s): Cocoa Drink
Intervention type(s): Dietary Supplement
Intervention description(s): High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cranberry-lingonberry Juice Started During Acute Infection in Prevention of Urinary Tract Infections in Children
Condition: Urinary Tract Infection; Pyelonephritis; Cystitis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Cystitis; Pyelonephritis
Study type: Interventional

Summary: 
      Cranberry and cranberry-lingonberry juice prevented urinary tract infections in children and
      in adults in our earlier clinical trials. The preventive effect was, however, observed late
      in the follow-up and the next recurrence was not prevented in children. The investigators
      hypothesize that cranberry-lingonberry juice should be started already during the
      antimicrobial treatment of acute urinary tract infection in order to maximize the preventive
      efficacy of the juice. In addition, the investigators aim to find the explanation for the
      efficacy of cranberry-lingonberry juice by analyzing the concomitant changes in the chemical
      composition of urine and feces as well as the changes of gut microbiota.
    


Intervention name(s): Cranberry-lingonberry juice; Placebo juice
Intervention type(s): Other; Other
Intervention description(s): Juice iwth similar sugar concentration as cranberry-lingonberry juice but without berry extracts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of LY3532226 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of the study drug
      known as LY3532226 in healthy participants. Blood tests will be performed to check how much
      LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This
      study will last approximately 8 weeks including screening period.
    


Intervention name(s): LY3532226; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to examine the safety, tolerability, and pharmacokinetics of single- and
      multiple-ascending doses of ACT-1014-6470 in healthy subjects
    


Intervention name(s): ACT-1014-6470 (SAD); ACT-1014-6470 (MAD); Placebo (SAD); Placebo (MAD); 14C-ACT-1014-6470 microtracer; 14C-ACT-1014-6470 microtracer placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of ACT-1014-6470; soft capsules for oral use.; Multiple doses of ACT-1014-6470; soft capsules for oral use.; Single dose of matching placebo; soft capsules for oral use.; Multiple doses of matching placebo; soft capsules for oral use.; Single dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use.; Single dose of matching placebo; soft capsules for oral use.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single-center, double-blind, randomized, placebo-controlled Phase 1 study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Prospective Ultrafast MRI Radiomics for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      The goal of this prospective study is to investigate the performance of ultrafast MRI
      radiomics in classifying histological factors and subtypes of breast cancer compared with
      standard MRI among radiologists with varying experience. The written informed consent was
      obtained from all participant. We extracted 1618 radiomic features from ultrafast and
      standard contrast-enhanced MRI before treatment. Classification of hormonal receptors, human
      epidermal growth factor receptor 2, and Ki67 status and subtypes was evaluated using the area
      under the receiver-operating characteristic curve (AUC) with the DeLong test.
    


Intervention name(s): MRI
Intervention type(s): Diagnostic Test
Intervention description(s): MRI based classification of breast cancer histological factors and subtypes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population should fulfill the following criteria as follows:(a) histologically
        confirmed invasive breast cancer, (b) participant consent, and (c) MRI performed before
        treatment.
Tolerance and Practicality of Module AOX
Condition: Gastrointestinal Diseases; Nutrition
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary objective of this clinical trial is to test the tolerance and practicality of the
      new device Module AOX.

      The secondary objective is to determine the changes in oxidative, antioxidative status,
      plasma free amino acids, and various immune parameters in critically ill patients receiving
      the enteral nutrition with and without using Module AOX.
    

Detailed description: 
      Surgery and trauma induce hypercatabolism accompanied by a systemic immunoinflammtory
      response and massive production of reactive oxygen species at the site of injury. In these
      situations, requirements for certain amino acids (glutamine, cysteine) and antioxidant
      micronutrients (zinc, vitamin E, vitamin C, beta-caroteen, selenium) are markedly increased
      and may not be covered by the levels normally present in standard enteral diets, especially
      in the early phase when enteral nutrition is introduced gradually. Thus, supplementation with
      amino acids and antioxidant micronutrients may be appropiate in order to optimize nutritional
      support in such patients.

      The administration of selected nutrients via modular devices added to a standard enteral
      formulation is an attractive means of providing optimized nutrition support for specific
      disease states. Module AOX is intended for supplementation of patients requiring nutritional
      support for a condition in which oxidative stress is expected. The module contains:

        -  Glutamine: to support gut mucosal and immune function, to minimize early depletion of
           glutamine stores and preserve body protein

        -  Cysteine: to support synthesis of glutathione, an important cellular antioxidant, and to
           support the synthesis of acute phase proteins

        -  Vitamin E, vitamin C and beta-caroteen: water- and lipid-soluble antioxidant
           micronutrients to boost antioxidant defenses

        -  Zinc: to compensate for increased losses and to support protein synthesis, immune
           function and wound healing

        -  Selenium: to compensate for increased losses, support antioxidant defenses and immune
           function
    

Intervention name(s): Module AOX (attached to Sondalis ISO)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Comparison of Subjective Balance Tests
Condition: Balance; Posture
Study type: Interventional

Summary: 
      There is many subjective balance tests to evaluate static and dynamic balance. But, there is
      no sufficient information about which balance test is the most sensitive test to evaluate
      balance. Therefore, the aim of this study is to compare of sensitivity of the subjective
      balance tests with an objective system.
    

Detailed description: 
      In the clinical setting, many balance tests are used for evaluating balance in individuals.
      These tests are utilized to assess both static and dynamic balance. However, sufficient
      research has not been conducted to decide which subjective balance test is more sensitive
      than the other tests. Therefore, the aim of this study is to compare of sensitivity of the
      subjective balance tests with an objective system.
    

Intervention name(s): Limits of Stability
Intervention type(s): Other
Intervention description(s): Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
Other intervention name(s): Postural Sway test; Berg Balance Scale; Y Balance Test; Romberg Balance Test; One-Leg Stance Test; Tinetti Balance Test; Timed up an go test; Functional Reach Test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Balance; Limits of Stability; Postural Sway
Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Proton pump inhibitors (PPIs) are treatment of choice for different gastrointestinal
      disorders common in type 2 diabetes. Sulfonylureas (SUs) are anti-diabetes agents
      particularly widely used in developing countries. Gliclazide, a recommended SU drug, is
      metabolised in part by CYP2C19, the main enzyme responsible for the PPI metabolism.

      A randomised, placebo-controlled, two-sequence, two-period crossover study will be performed
      to explore whether gliclazide pharmacokinetics (PK) and pharmacodynamics (PD) are altered
      upon co-administration with omeprazole. Sixteen healthy volunteers, CYP2C19
      extensive/ultrarapid metabolisers (EM/UM), will receive placebo or omeprazole alone for 4
      days, and concomitantly with single dose of gliclazide on day 5. Plasma concentration of
      gliclazide will be measured for 24 hours, and plasma glucose and insulin levels up to 12
      hours after gliclazide administration.
    


Intervention name(s): Omeprazole; Placebo oral tablet; Gliclazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.; Placebo will be administered orally once daily for 5 days in one of the two treatment periods.; Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
Intervention MeSH terms: Gliclazide; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
Condition: Severe Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones
      (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after
      Roux-en-Y gastric bypass surgery.
    

Detailed description: 
      To do this the effect of combined GLP-1 receptor blockade by Exendin 9-39 and
      DPP-4-inhibition will be evaluated.
    

Intervention name(s): exendin 9-39; sitagliptin; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Exendin 9-39 is a specific GLP-1 receptor antagonist; DPP-4 Inhibition; Saline
Other intervention name(s): GLP-1 antagonist; Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effects of Supplementation With Linseed Oil on Blood Lipids in Vegetarians
Condition: Inter-conversion n-3 PUFA, Vegetarians
Study type: Interventional

Summary: 
      The study was performed to investigate the effects of a daily consumption of linseed oil on
      fatty acid distribution in plasma and red blood cell lipids and blood lipids in vegetarians.
    

Detailed description: 
      Recent studies suggest that the daily intake of n-3 LC-PUFA (EPA and DHA) can modulate
      cardiovascular risk factors and prevent lifestyle diseases.

      The major dietary source of EPA and DHA is seafood (seaweeds and fatty cold water fishes),
      but they can also be found in lean red meat, in organ meats such as liver and brain.
      Vegetarians who do not eat meat or fish, have very low or negligible intakes of EPA (< 5 mg
      EPA/d) and DHA.

      The purpose of the present study is to explore the tissue distribution and inter-conversion
      of ALA to n-3 LC-PUFA as consequence of linseed oil supplementation in vegetarians.

      Eight vegetarians (3 m; 5 f) who do not eat meat, fish or seaweeds such as algae foods since
      least two years ago and two subjects (1 m; 1w) who consume the normal western style diet
      living in Jena (Germany) entered the study. The participants consumed 10 mL linseed oil per
      day for 10 weeks. The resulting daily dose of ALA was approx. 5.7 g/d.
    

Intervention name(s): Linseed oil
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary supplement: 10 mL linseed oil per day
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: n-3 LC-PUFA, vegetarians, fatty acids, blood lipids
A Study of Absorption, Metabolism, Excretion, and Absolute Bioavailability of Carbon-14-Labelled [14C] Selpercatinib (LY3527723) in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare the amount of selpercatinib that gets into the
      blood stream and how long it takes the body to get rid of it and also to assess the
      pharmacokinetics (PK), metabolism, and routes and extent of elimination of selpercatinib in
      healthy male participants. The study will last up to 59 days (Part 1) or 46 days (Part 2)
      including screening and 7-day safety follow-up.
    


Intervention name(s): [14C] Selpercatinib; Selpercatinib; [14C] Selpercatinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as an oral solution; Administered orally; Administered intravenously
Other intervention name(s): LY3527723; LOXO-292; LY3527723; LOXO-292; LY3527723; LOXO-292
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the antihypertensive efficacy and safety of
      Fimasartan (BR-A-657•K) 60 mg~120 mg in patients with mild to moderate essential
      hypertension.
    

Detailed description: 
      Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and
      potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan
      (BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the
      Fimasartan(BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan
      (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was
      safe and tolerable though one temporal adverse event was observed in high dose.

      A Randomized, Double-blind, Losartan-controlled, Parallel Group Comparison Dose Titration
      Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan
      (BR-A-657•K) 60mg~120mg in Patients with Mild to Moderate Essential Hypertension.

      Approximately 480 patients will be enrolled over 12 months in 24 centers nationwide.

      After 2 weeks of placebo run-in period, all subjects will be randomized into one of the
      following 2 groups. Subjects will take test/control drug for 12 weeks of treatment period.
      And Extensin study have 12 weeks in treatment period.

      If subjects take any antihypertensive medications before screening, the subjects will have 1
      week of wash-out period.

      If the hypertension is not controlled well, there is a possibility of dose titration.

      Group I : Fimasartan group. Group II : Losartan group
    

Intervention name(s): Fimasartan; Losartan (Control)
Intervention type(s): Drug; Drug
Intervention description(s): Fimasartan 60 ~ 120mg/po take one tablets once a day; Losartan 50 mg ~ 100 mg/po, take one tablets once a day
Other intervention name(s): A657-BR-CT; Cozar
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Losartan
CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The aim of the study is to compare the acute procedure and safety outcomes as well as long
      term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically
      Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated
      Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D
      Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).
    


Intervention name(s): Ablation catheter
Intervention type(s): Device
Intervention description(s): Ablation of paroxysmal atrial fibrillation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment