bioihbjkbjnl/mcl2 huggingface dataset:
Study of Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Metabolic Markers
Condition: Healthy
Study type: Interventional

Summary: 
      To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and
      inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic
      responses in healthy adult subjects.

      Study hypothesis: The degree of fat saturation does not affect postprandial lipemia,
      haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety
      responses in health adult subjects.
    

Detailed description: 
      The experimental are comprise of 50g fat, 14g protein and 84g carbohydrate. Each of the test
      fat [palm mid fraction (PMF), shea butter (SB) and high oleic sunflower oil (HOSF)] will be
      compared which will be in a form of experimental meals (muffin).

      33 volunteers receives 3 experimental meals (muffins) in a random order, 2 week apart, over a
      6-week period. They will be randomized, blinded and will undergo a 3x3 arms crossover. The
      first 15-ml ("0" min) fasting venous blood samples is obtained. Immediately thereafter, the
      subject consumes the test meal plus a glass of water within 15 minutes. The time sequence is
      started mid-way of consuming the test meal.

      At 30 min, 60 min, 90, 120 min (2 hr), 150 min and 180 min (3 hr), 210 min, and 240 min (4
      hr), 15-ml each of blood is collected (via a vascular catheter inserted earlier in the
      subjects hand/arm).
    

Intervention name(s): Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil
Intervention type(s): Dietary Supplement
Intervention description(s): Acute effect of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety, and insulinemic response in human volunteers ; 6 wk each with 2 week wash out in between
Other intervention name(s): POP vs SOS vs OOO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Palm mid fraction; Shea butter; sn-1, sn-3 fatty acids; Cholesterol; Postprandial lipemia,; Inflammatory markers; Satiety; Gut hormone; Insulin
Pharmacokinetics and Bioequivalence of Molnupiravir, 200 mg Capsules and Lagevrio, 200 mg Capsules in Healthy Volunteers
Condition: Viral Infection; COVID-19
MeSH terms: Virus Diseases
Study type: Interventional

Summary: 
      The study aimed for:

        1. Comparative evaluation of the safety of the drug Molnupiravir, capsules, 200 mg (JSC
           "Valenta Pharm", Russia), and Lagevrio, capsules, 200 mg (Merck Sharp & Dohme (UK)
           Limited, UK), based on the analysis of adverse events (AEs);

        2. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug
           Molnupiravir, capsules, 200 mg (Valenta Pharm JSC, Russia), and Lagevrio, capsules, 200
           mg (Merck Sharp & Dohme (UK) Limited, UK), in healthy volunteers in fasted conditions.
    


Intervention name(s): Molnupiravir
Intervention type(s): Drug
Intervention description(s): A single dose of R or T drug in each of 2 periods of the study in fasted conditions
Intervention MeSH terms: Molnupiravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.
Condition: Automobile Driving
Study type: Interventional

Summary: 
      The purpose of the validation study is to develop a valid test battery for assessing driving
      ability in a driving simulator when influenced by drugs. Ethanol has known, well-documented
      and well-characterized effects on driving behaviour and accident risk, and will be used to
      assess the simulator test scenarios' sensitivity to drug effects. Once the test scenarios
      have been refined and their ability to predict driving accident risk have been validated, we
      plan to use the simulator to assess driving ability under the influence of different drugs
      suspected to produce driving impairment.
    


Intervention name(s): ethanol; Ethanol; Placebo drink
Intervention type(s): Drug; Drug; Other
Intervention description(s): BAC level 0.5 g/dL (drink + placebo pill). Drink with 2,4 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill.; BAC level 1.0 g/dL (drink + placebo pill). Drink with 3,6 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill.; Placebo drink containing no alcohol + placebo pill
Intervention MeSH terms: Ethanol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Driving; DUI; Driving simulation; Drugs; Ethanol
An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject
Condition: Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032
      for 24 weeks treatment.
    


Intervention name(s): BMS-790052; BMS-650032
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 60 mg, daily, 24 weeks; Tablets, Oral, 1200 mg, daily, 24 weeks
Intervention MeSH terms: Asunaprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Studies of the Use of Self Hypnosis, Acupuncture and Osteopathic Manipulation on Muscle Tension in Children With Spastic Cerebral Palsy
Condition: Spastic Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      We propose to identify patients and families for inclusion in pilot studies of the three
      modalities. Patients and their families will be asked to participate in these studies.

      Our research group has done some preliminary work with the modality of hypnotherapy, but has
      no experience to date with the other two modalities. The idea to try relaxation techniques
      was generated by the observation that there is great variation in the degree to spasticity at
      different times in the same patient with CP. When queried, mothers responded that they were
      able to get their child to relax and decrease the tension in their muscles by stroking,
      talking softly, and/or by playing certain types of music. The availability of hypnosis and
      training in self-hypnosis was presented to several families of our patients. Their
      understanding and acceptance of this alternate therapy was gratifying. The results of this
      therapy have been promising and have encouraged us to proceed with this modality and to
      consider making other nonconventional modalities available to our patients.

      We hypothesize that at least one of the two modalities will be accepted readily by patients
      with CP and their families, and with their acceptance compliance with the method chosen will
      be at levels of 80 percent or more.
    

Detailed description: 
      The primary objective of this project is to develop and evaluate two different alternative or
      complementary medical modalities that have been used in children with cerebral palsy by
      practitioners in an attempt to decelerate the complications from the neurologic insult and
      resultant muscle imbalance. The specific aims are: 1) The development and incorporation of
      two alternative modalities (osteopathic manipulation and acupuncture) into available services
      in southern Arizona for individuals with cerebral palsy. 2) The evaluation of the uptake of
      and compliance with the two modalities in the clinical services for cerebral palsy. 3)
      Conduct pilot studies of each of the two modalities to determine their efficacy in decreasing
      the degree of muscle tension in children with spastic cerebral palsy.
    

Intervention name(s): Self Hypnosis; Acupuncture; Osteopathic Manipulation
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Primary purpose: Treatment
PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if the calcitriol absorption in pediatric subjects
      is comparable to that in adults and adolescents, with no significant impact on
      calcium/phosphorus metabolism.
    


Intervention name(s): Calcitriol 3 mcg/g ointment
Intervention type(s): Drug
Intervention description(s): Topical ointment; twice daily application
Intervention MeSH terms: Calcitriol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
Condition: Hypercholesterolemia With Type2DM
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, open label, dose titration study to evaluate the efficacy and safety of
      Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
    

Detailed description: 
      To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid
      profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .
    

Intervention name(s): Pitavastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks; Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
Other intervention name(s): Livalo; Lipitor
Intervention MeSH terms: Atorvastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pitavastatin; PWV; ESPRIT; Pitavastatin and Atorvastatin; Adiponectin; fasting insulin; hs-CRP; baPWV
Train the Brain With Music: Brain Plasticity and Cognitive Benefits Induced by Musical Practice in Elderly People
Condition: Age-related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This longitudinal study aims to countervail age-related cognitive and cerebral decline in
      healthy retired people through intensive piano / keyboard music practice in Switzerland and
      Germany.
    

Detailed description: 
      Recent data suggest that music making might prevent cognitive decline in the elderly.
      However, experimental evidence remains sparse and no information on the neurophysiological
      basis has been provided, although cognitive decline is a major impediment to healthy aging.
      This study combines for the first time protocolled music practice in elderly with
      cutting-edge neuroimaging. The investigators propose a multi-site Hannover-Geneva
      longitudinal randomized intervention study in altogether 100 retired healthy elderly (64-76)
      years, 70 Geneva, 100 Hannover), offering either piano instruction or instruction on musical
      culture for one year. Participants will be tested at 3 time points on cognitive, perceptual
      and motor abilities as well as via wide-ranging functional and structural neuroimaging data
      (Magnetic Resonance Imaging, MRI). The research team expects positive transfer effects from
      intensive piano training not only on subjective well-being, but also on executive functions,
      working memory, hearing in noise and relationships of these behavioral features with
      morphological and functional brain plasticity. This study may therefore for the first time be
      demonstrate, that music making can provoke important societal impacts by diminishing
      cognitive and perceptual-motor decline underpinned by functional and structural brain
      plasticity.
    

Intervention name(s): musical practice; music education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intensive weekly musical keyboard training over 12 months; Recreative weekly musical courses without practice over 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Longitudinal RCT (clinical trial) with an experimental group and an active control group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: countervail age-related cognitive and cerebral decline; healthy elderly; musical training; neuroimagery and brain plasticity; psychometrics; executive function; mental health; well-being; sensorimotor function
Effectiveness of a Community - Based Cross-sector Network for the Management of Mental Health Problems and Disorders Associated With Forced Displacement Due to Armed Conflict in the Municipality of Soacha - Cundinamarca
Condition: Mental Disorder; Mental Disorder in Adolescence; Mental Problems; Mental Disorder in Infancy
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      It is of great importance to generate interventions that help ensure greater inclusion and
      social participation of the population that was and is a victim of the armed conflict,
      especially in the post-conflict transition in Colombia, and to influence development in the
      post-accord period through relationships between groups and society. Therefore, the question
      for this investigation is, what is the effectiveness of a community-based cross-sector
      network for the management of mental problems and disorders associated with forced
      displacement due to armed conflict in the commune of Soacha - Cundinamarca, in order to
      contribute to inclusion and social participation in the post-accord period?

      Objective: To design a community-based cross-sector network for the management of mental
      problems and disorders associated with forced displacement due to armed conflict in the
      commune of Soacha - Cundinamarca, in order to contribute to inclusion and social
      participation in the post-accord period in Colombia.
    


Intervention name(s): Community intervention
Intervention type(s): Other
Intervention description(s): Community intervention will be built depending on contextual factors and will contain the following elements:
Cross-sector intervention, including sectors to define the intervention as "primary health care services, education services" (language, knowledge to prevent health problems and resilience strategies), family welfare units, "Integral Care and Reparation Unit for Victims" (UARIV), Ministry of Labour, national and international social support network, among others.
The leader will be chosen by the community, with the capabilities to coordinate the community-based network.
Mental health providers at the local level, who must develop psychosocial and mental diagnoses and interventions, based on experience and evidence, respectively. This team will include psychiatry, psychologists (one an expert in clinical psychology) and a community team involved in the implementation of mental interventions.
Intervention model: Single Group Assignment
Intervention model description: A mixed study of before and after using quantitative and qualitative research techniques
Masking: None (Open Label)
Primary purpose: Screening
A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of both single and multiple dose drug
      levels of MYK-224 in healthy adult Japanese participants.
    


Intervention name(s): MYK-224; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Other intervention name(s): BMS-986435
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MYK-224; Healthy Participants of Japanese Ethnicity
PK & PD Study of Pegylated rhEPO, and Evaluated Its Safety and Tolerability in Male Healthy Individual
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The object of this randomized, parallel, positive controlled study is to explore the
      pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous
      administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous
      administration, by assessing plasma concentration of the drug and the reticulocyte count,
      hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the
      security and tolerability of the test drug in healthy subjects, and provide sufficient
      information for dose selection in the future phase II and III study.
    


Intervention name(s): Pegylated rhEPO; EPIAO®
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: PK & PD study; rhEPO; Pegylated rhEPO; male healthy subject
Zinc Status and Growth in Cystic Fibrosis
Condition: Cystic; Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study is to improve the understanding of the relationship of zinc status
      and growth in infants and young children who were diagnosed with cystic fibrosis via newborn
      screening.
    

Detailed description: 
      The objective of this study is to improve the understanding of the relationship of zinc (Zn)
      status and growth in infant and young people with cystic fibrosis (PWCF). The investigators
      hypothesize that Zn deficiency in infant and young PWCF is associated with poor growth.

      Aim #2: To study the association between Zn levels in red blood cells and nutritional status
      in PWCF at 3 months to 3 years of age and compare it to the association between serum Zn and
      nutritional status in the same population. Hypothesis: Lower Zn levels in red blood cells is
      associated with poorer nutritional status in infant and young PWCF and is a better measure of
      Zn status compared to serum Zn.
    

Intervention name(s): Serum Zn; Red Blood Cell Zn
Intervention type(s): Biological; Biological
Intervention description(s): The investigators will obtain an additional 2 mL of blood in an extra tube. This will be collected at the same time blood is collected for the participant's yearly CF screening labs so as to minimize additional needle sticks.; If the participant is greater or equal than 5 kg, an additional 2 mL of blood will be obtained in an extra tube. This will be collected at the same time blood is collected for the participant's yearly CF screening labs so as to minimize additional needle sticks.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients ages 3 months to 3 years with CF identified via new born screening
      
Keywords: Zinc; Growth; Nutrition; Cystic; Fibrosis
How Shoes With Rocker Soles Affect Walking
Condition: Diabetic Feet
MeSH terms: Diabetic Foot
Study type: Interventional

Summary: 
      The purpose of this study is to compare how 3 special types of shoes with rocker-shaped soles
      help people with foot deformities to walk better. This study will use modern gait lab
      techniques to measure the forces on the bottom of the feet and to examine whether there is
      any effect higher on the leg from the rocker soles.
    

Detailed description: 
      The rocker sole is the most commonly prescribed external shoe modification. Use of rocker
      soles has been based on theoretical considerations and empirical observations with minimal
      scientific study and validation. With the passage of the therapeutic shoe bill (PL-100-203,
      section 4072) authorizing Medicare coverage of shoes and shoe modifications for diabetics, it
      is important to have objective data regarding the effect of rocker soles. This cross-over
      study will randomize 46 subjects (40 sensate and 6 insensate) to a combination of 3 rocker
      soles. Patients will be evaluated at baseline and after 20 minutes wearing each rocker sole
      shoe design to determine the effect of the type of rocker sole on plantar pressure and gait.
    

Intervention name(s): Shoes with Rocker Soles
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rocker sole; Plantar pressure; Diabetic feet; Insensate feet; gait analysis; Pedorthics; Gait abnormalities
A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.
Condition: Bacterial Infections.
MeSH terms: Infections; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients
      aged 3 months to 11 years (inclusive) following the intravenous administration of a single
      dose of dalbavancin.
    

Detailed description: 
      This is a open label, multi center study to investigate the pharmacokinetics, safety and
      tolerability of a single dose of intravenous dalbavancin in hospitalized pediatric patients
      with known or suspected bacterial infection. Patients will be enrolled and results will be
      evaluated in 3 age cohorts as follows:

      Cohort 1: Patients 6 years to 11 years of age, inclusive; Cohort 2: Patients 2 years to <6
      years of age; Cohort 3: Patients 3 months to <2 years of age.

      All patients in each cohort will be administered a single dose of dalbavancin in addition to
      background anti infective treatment to be chosen by the investigator according to standard of
      care. Pharmacokinetic samples will be obtained at various timepoints. Dalbavancin can be
      administered at any time (before, during or after) the standard of care therapy.
    

Intervention name(s): Dalbavancin
Intervention type(s): Drug
Intervention description(s): Intravenous dalbavancin given at 15 mg/kg (not to exceed 1000 mg) for patients ≥5 years of age, and 25 mg/kg for patients <5 years of age.
Intervention MeSH terms: Dalbavancin
Intervention model: Single Group Assignment
Masking: None (Open Label)