bioihbjkbjnl/mcl2 huggingface dataset:
Subjective Image Quality in Stereoscopic Image Modifications
Condition: Stereoscopic Vision
Study type: Observational

Summary: 
      Humans attain binocular vision from the two retinal images of both eyes through a series of
      sensory and motor processes that culminate in the perception of stereoscopic depth. Looking
      at a scene creates two slightly different images on the retinas which is due to the eyes'
      different positions on the head. This so called binocular disparity provides information to
      calculate depth and therefore enables stereopsis. Physiologically the two retinal images are
      superimposed and merge into one stereoscopic image.

      If one image is presented to one eye in an experimental setting, and a completely different
      image is presented to the other eye, the investigators visual system, analogous to diplopic
      vision, is not able to fuse these image stimuli. Instead, a phenomenon called binocular
      rivalry occurs. Here, both images are seen alternating and the brain can switch back and
      forth between these images.

      The aim of the present study is to investigate the effects of objective changes to image
      quality on the investigators subjective stereoscopic perception. This psychophysiological
      testing is done by looking at different images and thereafter by subjective grading of the
      image quality.

      The investigators hypothesize that overlapping image modifications occurring in both eyes are
      detected immediately, but changes, that are rotated by 90 degrees against each other, should
      be suppressed and result in one stereoscopic image, reduced in image quality. Whether this
      also accounts for more detailed images, such as reading cards, is questionable.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants will be selected by the Department of Clinical Pharmacology healthy
        subjects, male and female, 18-35 years
Relative Bioavailability of Tipranavir (TPV)/Ritonavir (RTV) at Steady State Administered as Oral Solutions vs. Capsules in the Fed and Fasted State in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to establish the relative bioavailability of the TPV oral solution formulation (500 mg
      coadministered with RTV oral solution 200 mg) to the TPV capsule formulation (500 mg
      coadministered with RTV capsules 200 mg), with both treatments at steady-state under fasted
      and fed conditions in healthy male and female volunteers.
    


Intervention name(s): TPV capsule; TPV solution; RTV capsule; RTV solution; standard meal
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open Non-Comparative Study To Evaluate Administration Of a New Nutraceutical
Condition: Sleep Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Interventional

Summary: 
      The Research Hypothesis for the present pilot study in a special care setting is that in a
      population suffering of mild and recent sleep disorders the pre-sleep arousal measured by the
      Pre-Sleep Arousal Scale (PSAS) after 30 days of oral administration with a nutraceutical
      composed of hawthorn, lavender and hop (Sonidor®) shall significantly improve in comparison
      with the baseline condition.
    

Detailed description: 
      Sonidor® was developed as a nutraceutical composed of hawthorn, lavender and hop inducing
      sleep and relaxation in subjects with mild sleep disturbances. In addition, the Sonidor®
      innovative three-layer-tablet formulation should allow the active components to be released
      with different speeds into the gastrointestinal tract exerting a synergistic action to induce
      sleep-promoting effects.

      Primary objective is to have a preliminary evaluation of the efficacy of Sonidor® in subjects
      affected by persistent mild sleep disorders (difficulty in initiating sleep for at least 1
      month and reduced quality of sleeping) to whom in special care setting have been suggested
      sleep hygiene guidelines and administered the tested nutraceutical for one month.
    

Intervention name(s): Sonidor®
Intervention type(s): Dietary Supplement
Intervention description(s): Sonidor® triple layer release tablets are developed with a specialized process to improve stability and bioavailability of the formulation based on hawthorn, lavender and hop extracts. The hawthorn, lavender and hop extracts used to product Sonidor® have an elevated content of vitexin (3%), monoterpens (4% as linalool) and flavonoids (4%), respectively.
Intervention model: Single Group Assignment
Intervention model description: Pilot, open, non-comparative, multicenter study
Masking: None (Open Label)
Primary purpose: Treatment
Lifestyle Intervention After Colonoscopy (LIFE-SCREEN Pilot)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The study aims to evaluate the impact of promoting advice on the latest evidence-based diet
      and lifestyle recommendations for cancer prevention at colorectal cancer (CRC) screening
      among individuals who may be at higher risk for developing CRC. The overall aim of this
      LIFE-SCREEN pilot study is to test the trial methods and procedures to be used in the
      LIFE-SCREEN cluster randomized RCT, in order to discover obstacles and problems prior to the
      main RCT so that corrective actions can be taken to improve the research process.

      The patients (n=40) will be recruited at the Centre Léon Bérard and at the Hôpital Edouard
      Herriot at the time of CRC screening.

      After inclusion, the intervention material (documents explaining the strategies to achieve
      and maintain recommended behaviours as part of a healthier lifestyle) may be given to the
      patient during the pre-colonoscopy consultation and/or at the post-colonoscopy visit. Weight,
      height and blood pressure will be measured during the pre-colonoscopy consultation. Patients
      will be invited to complete a baseline questionnaire to collect information on their
      lifestyle, state of health and socio-demographic status. Approximately four to six weeks
      after, patients will also be asked to complete an evaluation questionnaire asking for their
      opinion on this material and the procedures. Focus groups with available and willing
      participants and hospital staff will be organized at the end of the pilot phase recruitment,
      to gather additional information on the intervention procedures. In addition, all hospital
      staff will be asked to complete an assessment questionnaire.

      Biological samples will then also be collected to test the objective baseline measure of
      nutritional changes used in the RCT. In order to assess the feasibility and the acceptability
      of urine, faecal and blood sample collection in this population, the first ten participants
      recruited (n=10) will be given the option to refuse one or more of the biological sample
      collections (phase I). Participants will also be asked to complete a questionnaire to provide
      information on their opinion and willingness to donate biological samples. This assessment
      questionnaire will allow us to refine the strategies for the other 30 participants (phase
      II). In this phase II, biological samples will be compulsory (phase IIa) or optional (phase
      IIb) for all 30 participants.
    


Intervention name(s): Lifestyle intervention
Intervention type(s): Other
Intervention description(s): Documents explaining the strategies to achieve and maintain recommended behaviours as part of a healthier lifestyle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Colorectal cancer; Higher risk; Lifestyle intervention
Identifying Genes That May Increase the Risk for Heart Disease in African Americans
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      Heart disease and stroke disproportionately affect African Americans in the United States.
      These conditions are likely caused by both environmental and genetic factors. This study will
      attempt to identify specific genes of African and European ancestral origins that may
      influence the development of heart disease in African Americans.
    

Detailed description: 
      African Americans have a high risk of developing heart disease and stroke, and are more
      likely to die from heart-related illnesses than other racial and ethnic groups. A large
      majority of African Americans are descendants of both African and European ancestors who
      mixed five to six generations ago. Because only a few generations have passed since that
      time, it is still possible to identify specific genes, the basic units of heredity, as being
      either African or European in origin. This is a sub study of the Jackson Heart Study, which
      is examining the environmental and genetic factors that influence the development of heart
      disease in African Americans. In this study, researchers will examine genes from participants
      in the Jackson Heart Study to identify specific African and European genes that influence the
      development of heart disease in African American men and women.

      This study will use genetic samples from individuals participating in the Jackson Heart
      Study. There will be no study visits for participants. Study researchers will examine the
      genetic samples and identify specific African and European genes that may influence the
      development of heart disease, high blood pressure, lipid disorders, left ventricular
      hypertrophy, and low birth weight.
    

Time perspective: Prospective
Keywords: Blood Pressure, High; Stroke; Hypertension; Diabetes Mellitus; Obesity; Cerebrovascular Accident; Atherosclerosis
A Study of Selumetinib in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)
Condition: Neurofibromatosis 1; Neurofibroma Plexiform
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Neurofibroma, Plexiform
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical
      Efficacy of Selumetinib, a Selective Mitogen Activated Protein Kinase Kinase (MEK) 1
      Inhibitor, in Chinese Paediatric and Adult Subjects with Neurofibromatosis Type 1 (NF1) and
      Inoperable Plexiform Neurofibromas (PN).
    

Detailed description: 
      Paediatric and adult patients with Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform
      Neurofibromas (PN) will be evaluated in the screening visit to confirm eligibility.
      Approximately 16 paediatric and 16 adult qualified patients will receive oral selumetinib 25
      mg/m^2 twice a day (approximately every 12 hours) continuously until disease progression or
      unacceptable drug-related toxicity, whichever occurs first. Once a patient has discontinued
      the study treatment then the patient will be followed for specified period for safety
      assessment
    

Intervention name(s): Selumetinib
Intervention type(s): Drug
Intervention description(s): All eligible subjects will first receive a single oral dose of selumetinib 25 mg/m^2. After a washout period of 2 days, oral selumetinib 25 mg/m^2 twice daily will be administered continuously. Subjects will continue to receive selumetinib until disease progression or unacceptable drug-related toxicity, whichever occurs first.
10 mg and 25 mg capsules strengths available.
Other intervention name(s): Koselugo
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurofibromatosis Type 1; Plexiform Neurofibromas; Phase 1; Selumetinib; Chinese; Paediatric; Adult
Ventricular-Vascular Coupling in Heart Failure
Condition: Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      This study will test the hypothesis that increases in ventricular-vascular stiffness can be
      demonstrated by arterial tonometry and echocardiography in subjects with heart failure with
      preserved ejection fraction (HF-nlEF)(i.e. normal left ventricular function.) We will also
      track changes in pulsatile hemodynamics over time in subjects hospitalized with HF-nlEF.
    

Detailed description: 
      The pathophysiologic mechanisms responsible for the development of heart failure in people
      with preserved ejection fraction (i.e. normal left ventricular function) remain poorly
      understood. One possible mechanism may be the contribution of increased arterial stiffness to
      changes in pulsatile hemodynamic load during ventricular systole, implicating abnormal
      ventricular-vascular interactions throughout the cardiac cycle in the pathogenesis of heart
      failure with normal ejection fraction.

      To investigate changes in ventricular-vascular stiffness in subjects with heart failure and
      normal left ventricular function, comparisons will be made between 3 distinct
      sub-populations:

        -  subjects with heart failure and normal ejection fraction

        -  non-diabetic hypertensive controls

        -  normotensive controls
    

Intervention name(s): arterial tonometry; echocardiography
Intervention type(s): Procedure; Procedure
Intervention description(s): used to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger.; ultrasound test using sound waves to create a moving picture of the heart
Other intervention name(s): PAT; cardiac echo
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adults with heart failure and preserved left ventricular function
      
Keywords: heart failure; preserved ejection fraction; vascular stiffness
Assessment of Left Ventricular Torsion by Echocardiography Study
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Observational

Summary: 
      The purpose of this study is to learn about the twisting or wringing motion of the heartbeat
      called Left Ventricular Torsion (LV Torsion) which can be seen on ultrasound.
    

Detailed description: 
      This study is designed to characterize the myocardial torsional behavior in patients with a
      variety of cardiac pathologies.

      Simple and inexpensive methods for measurement of LV torsion could facilitate more widespread
      investigation of LV torsion, which might reveal significant relationships between torsional
      alterations and clinical outcomes and eventually lead to routine clinical application.
      Recently, Doppler tissue imaging (DTI) has been shown to accurately reflect myocardial
      velocity24,25 with better temporal resolution than MRI.26 Investigators hypothesize therefore
      that DTI might be used for quantification of LV rotation and torsion of the human heart. The
      purpose of the present study was to examine the accuracy of a novel method with DTI for
      quantifying the LV torsion in humans and tagged MRI as the reference standard.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing cardiac echocardiography testing in the outpatient department
      
Keywords: HCM; HOCM; hypertrophic cardiomyopathy; tissue doppler echocardiography; myocardial torsion
Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair
Condition: PAD; Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine if high-dose PUFA supplementation in patients
      undergoing EVAR for infra-renal AAA reduces the peri-operative inflammation.
    

Detailed description: 
      In this 2:1 double-blind, randomized, placebo controlled trial, subjects will be given an
      active drug of n-3 polyunsaturated fatty acids (PUFAs) or a placebo soybean oil for about two
      weeks prior to an endovascular abdominal aortic repair (EVAR) and subsequently six months
      after the procedure.

      An EVAR is known to produce a systemic inflammatory response with an increased risk of
      prolonged hospitalization and complicated post-operative recovery with cardiac events, renal
      and pulmonary dysfunction, and multiple organ failure. The study proposed here has the
      potential to provide valuable insight on the role of nutritional intervention to improve
      outcomes related to surgical revascularization.
    

Intervention name(s): Pro-Omega; ProOmega Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each Pro-Omega capsule is 550 mg. Must take 4400 mg/day x 6 months.; Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA). Each soybean capsule is 550 mg. Must take 4400 mg/day x 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this study is to determine if bread containing fenugreek reduces blood sugar
      and insulin compared to identical bread without fenugreek.
    

Detailed description: 
      Trigonella foenum-graecum (fenugreek) has been used in traditional medicine for the treatment
      of diabetes. Fenugreek has been demonstrated to lower blood glucose in response to a glucose
      load while leaving the levels of serum insulin unaffected in rodents. This effect of lowering
      blood sugar without changing insulin levels demonstrates improved insulin action. Fenugreek
      has also been shown to decrease glucose absorption by inhibiting intestinal disaccharidases.
      Fenugreek decreases glycohemoglobin in diabetic rodents. An amino acid extracted from
      fenugreek seeds, 4-hydroxyisoleucine, decreases glucose and insulin in diabetic rodents,
      improves glucose tolerance and stimulates insulin secretion from isolated pancreatic rodent
      islets.

      Fenugreek imparts a bitter taste to products into which it is placed, and this property has
      limited its use in treating diabetes. Dr. Losso and his associates developed a process that
      allows incorporation of fenugreek into bread and other bakery goods without imparting a
      bitter taste, and the success of this process was confirmed in taste testing. This study is
      designed to evaluate the effect of fenugreek bread made by Dr. Losso's proprietary process on
      glucose and insulin.
    

Intervention name(s): Trigonella foenum-graecum (fenugreek)
Intervention type(s): Dietary Supplement
Intervention description(s): 2 slices of bread containing 5 grams of the natural herb fenugreek 2 times, 1 week apart
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      Whole blood drawn for glucose and insulin levels.
    
Keywords: Fenugreek; Trigonella foenum-graecum; Diabetes mellitus; Blood sugar; Insulin; Glucose
Effects of Video Game on Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To investigate the effects of video game play therapy in patients with knee osteoarthritis
    

Detailed description: 
      A total of 80 patients with knee osteoarthritis were randomized into two groups, including
      video game group and exercise group.

      Physical activity, quality of life, emotion, and balance were assessed at before treatment
      and follow-up assessments, including at after 2 week of treatment; after 4 weeks of
      treatment; and 1 and 3 months after treatment is terminated, respectively.
    

Intervention name(s): video game; exercise
Intervention type(s): Other; Other
Intervention description(s): 20-min per session for 3 times per week for a 4-week duration; 20-min per session for 3 times per week for a 4-week duration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: knee osteoarthritis; video game; therapeutic effects
A Dose-escalation Study to Investigate Safety and Toleration of OZ439
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration
      of OZ439 OD for 3 days to healthy male and female volunteers. The study aims:

        -  To determine the safety and tolerability of ascending doses of OZ439 OD for three days.

        -  To assess pharmacokinetic parameters of ascending doses of OZ439 given OD.

        -  To identify the maximum tolerated dose of OZ439 administered.
    

Detailed description: 
      This study will be conducted in a randomised, placebo-controlled dose-escalation design with
      OZ439 OD administered with full fat milk for three days to healthy male and female subjects
      between 18 to 55 years of age, using features of an adaptive study design. The study is
      expected to have three cohorts with a total of 36 healthy male and female subjects. An
      additional two cohorts may be used if required. The results of this study will inform the
      maximum tolerated exposure of OZ439 following OD dosing for three days in subjects who are
      not fasted.
    

Intervention name(s): OZ439
Intervention type(s): Drug
Intervention description(s): OZ439 x mg once daily for 3 days with milk
Intervention MeSH terms: Artefenomel
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: malaria; dose escalation; safety; tolerability; maximum tolerated dose
A Multiple Dose Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Participants (MK-5172-010)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study was to compare hepatic pharmacokinetics (PK) derived from liver tissue
      to plasma PK after administration of grazoprevir (MK-5172) to participants with chronic
      hepatitis C virus (HCV) infection. Participants will be randomized to one of four different
      liver ultrasound-guided Fine Needle Aspirate (FNA) schedules (at 4-, 8-, 24-, or 72-hours
      after the Day 7 dose).
    


Intervention name(s): Grazoprevir
Intervention type(s): Drug
Intervention description(s): GZR 100 mg tablet by mouth q.d. for 7 days.
Other intervention name(s): MK-5172
Intervention MeSH terms: Grazoprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment