bioihbjkbjnl/mcl2 huggingface dataset:
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin B
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the
      highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors
      such as the fragile membrane, etc. Cytochalasin B serves to facilitate spindle or pronuclear
      transfer procedures helping to reduce the damage rate with no harm reported. Using
      Cytochalasin B during ICSI could serve to rescue some oocytes from the degeneration allowing
      for more chances of viable zygotes,
    


Intervention name(s): Cytochalasin B use in ICSI handling medium
Intervention type(s): Other
Intervention description(s): A medium with in-house supplementation of Cytochalasin B to decrease oocyte degeneration after ICSI and improve survival rate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study of Current Practice Which Compare the Rate of Prostate Cancer by Using 2 Kind of Transrectal Biopsies: 3 by IRM-echography Image Fusion and 12 Systematized Guided Echographies.
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected
      by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get
      no lower rate of cancer detection than those obtained by 12 systematic transrectal
      ultrasound-guided biopsies of the prostate.
    

Detailed description: 
      The act of current practice evaluated by this research is the act of prostate biopsies : the
      patient will have to undergo 12 systematized transrectal echography guided biopsies of the
      prostate and 3 additional biopsies targeted on the suspicious lesion detected with MRI, which
      are both done in current practice.

        -  A first operator is not informed of the location of the target. He will perform a series
           of 12 systematic transrectal ultrasound-guided biopsies of the prostate.

        -  Immediately after the second operator will perform 3 additional targeted biopsies on the
           suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with
           the Koelis ® system

      Act added by the research: Using a fusion of MRI - ultrasound images software system (Koelis
      ®).
    

Intervention name(s): systematic biopsies; Targeted biopsies guided by a fusion of MRI and ultrasound- images
Intervention type(s): Procedure; Procedure
Intervention description(s): 90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate; Immediately after the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system
Other intervention name(s): Ultrasound-guided biopsies of the prostate; Biopsies of the prostate by fusion of MRI and ultrasound- images with the Koelis ® system
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: cancer; prostate; PSA; biopsies; ultrasound; MRI; fusion of images
Bioavailability Study of Colcrys® in Apple Juice
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and compare the relative bioavailability of a single
      0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice
      relative to the same dose given as an intact tablet to healthy subjects following an
      overnight fast.
    

Detailed description: 
      The purpose of this study is to evaluate and compare the relative bioavailability of a single
      0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice
      relative to the same dose given as an intact tablet to healthy subjects following an
      overnight fast. Sixteen healthy, non-smoking, non-obese, male and female volunteers between
      18-55 years of age will be randomly assigned in a crossover fashion to receive each of two
      dosing regimens in sequence with a 14 day washout period between dosing periods. In each of
      the dosing periods, after an overnight fast, subjects will receive one intact Colcrys® 0.6 mg
      tablet (followed by 240 mL of water) or one Colcrys® 0.6 mg tablet crushed and dissolved in
      20 mL of apple juice (followed by 220 mL of water) according to the randomization schedule.
      Blood samples will be drawn from all participants before dosing and for 48 hours post-dose at
      times sufficient to adequately define the pharmacokinetics of colchicine. Vital signs (blood
      pressure, heart rate, respiratory rate, and temperature) will be measured prior to dosing and
      at 1 hour ± 30 minutes post dose. Subjects will be monitored throughout their participation
      in the study for adverse reactions.
    

Intervention name(s): colchicine 0.6 mg tablet; colchicine 0.6 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): One Colcrys® 0.6 mg intact tablet taken by mouth; One Colcrys® 0.6 mg tablet dissolved in apple juice
Other intervention name(s): Colcrys®; Colcrys®
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability
Opioid Use and Predicting Factors at the Emergency Department
Condition: Pain; Pain, Acute
MeSH terms: Emergencies; Acute Pain
Study type: Observational

Summary: 
      Background: Increasing opioid misuse is a worldwide problem. About 10% of opioid misusers are
      primarily exposed to opioids at the Emergency Department (ED). This study was conducted to
      determine the feasibility for a clinical trial investigating the effect of Virtual Reality
      therapy on opioid consumption at the ED.

      Methods: Adult patients were included when primarily seen by the Emergency Physician and
      presenting with a NRS pain score ≥4. Main objective was to identify the target population and
      evaluate outcome measures to sustain a trial incorporating the Oral Morphine Equivalent (OME)
      at the ED as the primary endpoint. Primary outcome was mean OME administered at the ED.
      Secondary outcomes included NRS pain scores, main symptoms and type of analgesics
      administered at the ED.
    


Intervention name(s): Usual care
Intervention type(s): Other
Intervention description(s): Patients received usual care
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We aim to include all patients ≥16 years, who are admitted to the ED of the Radboudumc and
        primarily seen by an ED physician.
      
Keywords: Emergency Department; Pain at rest; Opioid use
Study of Paliperidone ER in Adolescents and Young Adults With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This 8-week, prospective open-label study will investigate the effectiveness and tolerability
      of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er
      will be well tolerated and efficacious for reducing aggression, self-injury, and irritability
      in adolescents and young adults.
    


Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention description(s): Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.
Other intervention name(s): Invega
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autistic Disorder
Pilot Study of How Children With Asthma Exacerbations Metabolize Prednisone
Condition: Asthma Exacerbation
MeSH terms: Asthma
Study type: Observational

Summary: 
      The objective of the investigators pilot study is to assess the pharmacokinetic profile of
      two corticosteroid drugs, prednisone and prednisolone, in children who present to the
      pediatric emergency department with an asthma exacerbation. The investigators hypothesis is
      that the pharmacokinetic profile in this population will be similar to healthy children and
      adults.
    

Detailed description: 
      The standard of practice in treating children with asthma exacerbations is to give
      corticosteroid drugs early in the course of the exacerbation. These drugs decrease symptoms,
      provide faster time to recovery and improve of quality of life. However, there is 100%
      variability in a child's response to corticosteroids at a standard dose which is based on
      primarily on adult studies. The pharmacokinetic analysis or the process by which a drug is
      metabolized by the body is the first step to determine the proper dose.

      Patients between the ages of 2 and 16 years with asthma exacerbations will be recruited from
      the pediatric emergency department. After the patients get the drugs, blood samples will be
      drawn over 8 hours to get the following parameters: maximum concentration reached in the
      body, the time for the drug to be eliminated from the body, how long the drug stays in the
      body, how much of the drug is found in the urine after it is given, and concentration of
      metabolites or breakdown products in urine and blood. These are the parameters needed to make
      the pharmacokinetic profile and is the first step towards appropriate dosing of these two
      medications for asthma exacerbations in children.
    

Intervention name(s): Prednisolone and prednisone
Intervention type(s): Drug
Intervention description(s): oral, or intravenous prednisone, prednisolone, given the first time for asthma exacerbation
Intervention MeSH terms: Prednisone; Prednisolone
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children between the ages of 2 and 16 years who present to the tertiary care pediatric
        emergency department in London, Ontario with an asthma exacerbation
      
Keywords: asthma; pharmacokinetics; prednisone; prednisolone; asthma exacerbation; pharmacokinetic profile
A Clinical Study to Evaluate MW33 Injection
Condition: Covid19
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, single-dose escalation trial will be
      conducted to evaluate the safety, tolerability, immunogenicity, pharmacokinetic and
      pharmacodynamic characteristics of a single dose of MW33 injection at different doses given
      to healthy subjects to provide a basis for exploration of the therapeutic and preventive
      effects of MW33 against neocoronavirus in human.
    


Intervention name(s): MW33 injection; MW33 injection placebo
Intervention type(s): Combination Product; Combination Product
Intervention description(s): a recombinant fully human antibody to coronavirus; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea
Condition: Insomnia; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The prevalence of sleep disorders has achieved epidemic proportions in Western countries.
      Despite this, assessment and treatment of sleep disorders remains infrequent, unattainable,
      and often costly. Dayzz is aware of the need for easily accessible, user-friendly, and
      affordable treatment strategies for known sleep conditions. This research proposes a
      randomized controlled outcome study aimed to validate a, digitized, cost-effective mobile app
      which assesses and manages insomnia and CPAP adherence in persons with sleep apnea. The app's
      sleep training protocols recommend life-style and behavioral changes and tracks these changes
      with the aim of improving sleep and well-being. In this study, the dayzz app digital
      treatment protocol will be compared to the standard treatment for these sleep conditions by a
      sleep professional.
    


Intervention name(s): Dayzz mobile sleep training; Treatment as usual
Intervention type(s): Behavioral; Other
Intervention description(s): The dayzz digital sleep program provides each user with relevant educational materials (depending on their sleep condition), sleep tracking, and sleep or health-related tasks or challenges pertaining to their sleep or sleep difficulties.
Each app user is matched with a "sleep trainer" who will communicate with them via a "chat" option within the dayzz app and who will support the participants with any sleep training issues or technical aspects of all app for the duration of the treatment program.
Participants receive a wrist-worn device for monitoring sleep and activity patterns, a Fitbit fitness tracker (www.fitbit.com), to be worn for the duration of the study.; Standard medical care for specific sleep condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sleep disorders; cognitive and behavioral treatment; digital treatment; insomnia; sleep apnea; sleep
Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention
Condition: Cardiometabolic Risk; Abdominal Obesity
MeSH terms: Obesity, Abdominal; Inflammation
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the synergistic effects of daily consumption of food
      products fortified with bioactive components (fibres, polyphenols, omega-3, Slow Digestible
      Starch) for 9 weeks, compared to the daily intake of standard food products on low-grade
      inflammation in cardiometabolic risk subject.

      The inflammatory parameters will be assessed in fasting and in postprandial period after the
      consumption of a hyper-carbohydrate and hyper-lipidic test meal called Flexmeal. A metabolic
      stress will be induced by a fructose ingestion challenge during the last 6 days of
      interventional period.
    


Intervention name(s): bioactive components fortified food products intake (biscuits and cookies); control food products intake (biscuits and cookies)
Intervention type(s): Other; Other
Intervention description(s): Volunteers will have to consume daily 100 g of fortified biscuits and cookies instead of those usually consumed during nine weeks. The last week, volunteers will have to consume daily a fructose solution (3g/kg fat free mass); Volunteers will have to consume daily 100 g of standard biscuits and cookies instead of those usually consumed during nine weeks. The last week, volunteers will have to consume daily a fructose solution (3g/kg fat free mass)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: inflammation; cardiometabolic risk; endotoxemia; polyphenols; oxidative stress; slow digestible starch; fibers; gut microbiota; nutritional challenge test
Lifestyle Modification and Potato Consumption
Condition: Obesity
Study type: Interventional

Summary: 
      The investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle
      intervention in overweight and obese glucose intolerant adults. We will evaluate the effects
      of the consumption of potatoes (high or low resistant starch) vs. commonly consumed
      carbohydrate sources on glucose tolerance; and ( the extent to which potato consumption
      alters markers of lipid metabolism and inflammation in the context of a lifestyle
      intervention program.
    

Detailed description: 
      Our primary objective is to compare the effects of potato consumption to those of commonly
      consumed carbohydrate sources on glucose tolerance and other cardiometabolic risk factors in
      overweight and obese, glucose intolerant men and women participating in a lifestyle
      intervention program. We hypothesize that consumption of potatoes is a healthy adjunct to
      lifestyle intervention in overweight and obese glucose intolerant adults. Our specific aims
      include: (1) to evaluate of the effects of the consumption of potatoes (high or low resistant
      starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and (2) to determine
      the extent to which potato consumption alters markers of lipid metabolism and inflammation in
      the context of a lifestyle intervention program.
    

Intervention name(s): potatoes; other carbohydrate
Intervention type(s): Other; Other
Intervention description(s): Daily intake of assigned treatment for 8 weeks; Daily intake of assigned treatment for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: resistant starch; lifestyle intervention
Evaluation of a Digital Childhood Obesity Treatment
Condition: Childhood Obesity; Treatment Adherence
MeSH terms: Obesity; Pediatric Obesity
Study type: Observational

Summary: 
      This study aims to evaluate if a web-based digital support system aiming to replacing or
      complement standardized pediatric behavioural obesity treatment. The hypothesis is that a
      digital system of communication between the family and the clinic can generate improved
      treatment results (change in BMI SDS) and reduce the number of missed visits.
    

Detailed description: 
      Childhood obesity treatment is time consuming for both the health care system, and for the
      involved families. There is an association between the intensity and the outcome of
      treatment.

      In this study all children who start treatment for childhood obesity will use a digital
      support system as a complement to behavioral treatment. The digital support system includes
      daily weighing on scales that do not show any digits, linked to a mobile app where weight
      development is shown as a moving average in the form of BMI standard deviation score (SDS).
      The app also provides an individual target curve visualizing the expected weight journey.
      Weight in growing children is complex to interpret why BMI SDS is used. Objective data from
      scale are automatically transferred to the database and the clinic and the family have direct
      contact with the clinic via the app.

      The evaluation will be carried out when approximately 120 children have had the opportunity
      to be treated with the support system for one year. The results will be compared with a
      matched control group from the BORIS childhood obesity treatment register.
    

Intervention name(s): Support system
Intervention type(s): Device
Intervention description(s): A support system named Provement will be used to provide behavioral treatment.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children who start treatment for childhood obesity at Martina children Hospital will
        use a digital support system as a complement to behavioral treatment. Approximately 120
        children 3-18 years will be included in this first evaluation.
      
Keywords: Mobile Health; Support System; Behavioral treatment; Self-Monitoring
MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)
Condition: Neutropenia; Fever
MeSH terms: Neutropenia; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in
      the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute
      neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic
      coverage. Such patients would be candidates for empirical therapy with an intravenous
      anti-fungal agent.
    


Intervention name(s): caspofungin acetate; Comparator: AmBisome
Intervention type(s): Drug; Drug
Intervention description(s): Duration of Treatment: 28-90 days; Duration of Treatment: 28-90 days
Other intervention name(s): MK0991
Intervention MeSH terms: Caspofungin; Liposomal amphotericin B
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes
Condition: Vaginal Dryness; Vaginal Atrophy; Vulvar Dryness; Vulvar Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen.
      Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of
      intimate area. The objective of this study is to investigate the effects of a non-hormonal
      moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.
    


Intervention name(s): Moisturizing vaginal and vulvar sea buckthorn oil cream; Moisturizing vaginal and vulvar cream
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment