bioihbjkbjnl/mcl2 huggingface dataset:
Differences in Cannabis Impairment and Its Measurement Due to Route of Administration
Condition: Behavioral Pharmacology of Cannabis
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      This research is being done to measure the effects of both oral and vaporized cannabis
      (marijuana), at different doses, on the ability to perform certain tasks such as balancing,
      eye tracking, and computerized measures of memory and attention, as well as performance on a
      novel app (DRUID) that is being developed for field sobriety testing. The investigators will
      collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to
      see if there are markers in those fluids that can predict performance on the behavioral tasks
      and the DRUID App. The results of this study will help us better understand the effects of
      using cannabis, and to help identify behaviors and/or substances in the body that relate to
      cannabis impairment.
    


Intervention name(s): cannabis
Intervention type(s): Drug
Intervention description(s): Cannabis will be self-administered by study participants
Other intervention name(s): marijuana
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Neuromuscular Warm-up on Injuries in Female Athletes
Condition: Knee Injuries; Anterior Cruciate Ligament Injuries; Ankle Injuries; Lower Extremity Injuries
MeSH terms: Wounds and Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Ankle Injuries
Study type: Interventional

Summary: 
      The goal of the study is to determine effect of coach-led neuromuscular warm-up on
      non-contact, lower extremity (LE) injury rates among female athletes in a predominantly
      non-white public high school system. The investigators hypothesized the warm-up would reduce
      non-contact LE injuries.
    

Detailed description: 
      We will recruit basketball and soccer coaches and their athletes from Chicago public high
      schools. We will randomize teams to intervention and control groups. We will train
      intervention coaches to implement a 20-minute neuromuscular warm-up and tracked training
      costs. Control coaches will use their usual warm-up. All coaches will report weekly athlete
      exposures (AEs) and injuries resulting in a missed practice/game. Research assistants will
      interview injured athletes. We will compare injury rates between control and intervention
      groups.
    

Intervention name(s): neuromuscular warm-up
Intervention type(s): Other
Intervention description(s): neuromuscular warm-up exercises that take 20 minutes to perform
Other intervention name(s): Knee Injury Prevention Program (KIPP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Knee injury; ankle sprain; anterior cruciate ligament; adolescent; soccer; basketball; prevention
Effect of CoQ10 Plus Selenium Supplementation on Clinical Outcomes and Biochemical Markers in ME/CFS (CoSeME Study)
Condition: Myalgic Encephalomyelitis
MeSH terms: Encephalomyelitis; Fatigue Syndrome, Chronic; Myalgia
Study type: Interventional

Summary: 
      In recent years, it has been suggested that nutritional deficiencies may be of causal
      relevance in individuals with ME/CFS. These include deficiencies of vitamins and trace
      elements. It is likely that the observed nutritional deficiencies contribute to the core
      symptoms of the disease. Coenzyme Q10 (CoQ10) has been studied as an alternative and
      complementary therapy in ME/CFS for fatigue, pain, tiredness, neurocognitive impairment, and
      sleep problems. This demonstrates how alterations in energy metabolism, mitochondrial
      dysfunction, oxidative stress, imbalance of the immune-inflammatory response, and activation
      of the NLRP3 inflammasome are likely consequences of low levels of CoQ10 and selenium, which
      are related to the main symptoms in ME/CFS. Hypothesis: CoQ10 and selenium levels are
      decreased in ME/CFS patients. A natural therapeutic alternative in the treatment of common
      symptoms in ME/CFS could be the oral CoQ10 (Ubiquinone) plus selenium supplementation to
      module redox status and inflammation response in ME/CFS. Aims: To evaluate the efficacy of
      oral Ubiquinone + selenium supplementation on clinical outcome and circulating biomarkers in
      ME/CFS. We enrolled 42 ME/CFS patients diagnosed according to the 1994 CDC/Fukuda criteria
      who have received oral treatment of 400 mg Ubiquinone + 200 microgram selenium daily for 8
      weeks. Demographic, clinical characteristics and laboratory variables, and validated outcome
      measures to perceived fatigue, sleep disturbances, and quality of life will be also
      evaluated. In addition, plasma biomarkers related to oxidative stress status (total
      antioxidant capacity and lipoperoxide levels), inflammatory response (pro-and
      anti-inflammatory cytokines), and cardiovascular dysfunction (FGF-21 and NT-proBNP) will be
      assayed.
    


Intervention name(s): CoQ10 plus Selenium
Intervention type(s): Dietary Supplement
Intervention description(s): 400 mg/day CoQ10 soft gel capsula (Bio-Quinone active 100 mg b.i.d) plus 200 microgram organic selenium yeast tablet (SelenoPrecise 100 microgram b.i.d.) over 8 weeks
Intervention MeSH terms: Selenium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fatigue; Coenzyme Q10; selenium; sleep disturbances; biomarkers; myalgic encephalomyelitis; chronic fatigue syndrome
Multiple Dose, Double-Blind, Placebo and Active Controlled Study of Pharmacokinetics of Diractin® as Well as Safety and Efficacy for the Treatment of Muscle Soreness
Condition: Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 2

Summary: 
      Multiple-dose, double-blind, double-dummy, parallel, randomized, placebo and active
      controlled study of pharmacokinetics of Diractin® as well as safety and efficacy for muscle
      soreness from exercise.
    


Intervention name(s): Diractin; Diractin
Intervention type(s): Drug; Drug
Primary purpose: Treatment
Keywords: pharmacokinetics; of Diractin®; safety; efficacy; exercise
Iodine Supplementation During Pregnancy and Neuropsychological Development
Condition: Healthy; Iodine Deficiency; Pregnancy
Study type: Interventional

Summary: 
      The investigators have shown that Nice area, like most of France, remains an area of mild
      iodine deficiency. The investigators want to assess the potential benefit of early iodine
      supplementation during pregnancy in women with normal thyroid function on the
      neuropsychological development of their children assessed at the age of two with the Bayley
      test.
    

Detailed description: 
      Iodine is required for the synthesis of thyroid hormones. During pregnancy, iodine needs are
      increased to cover maternal and fetal thyroid hormones synthesis and the increased renal
      iodine clearance. Maternal hypothyroidism and/or severe iodine deficiency are associated to
      mental retardation in their offspring. Indeed, thyroid hormones and iodine are necessary for
      fetal brain development.

      Iodine deficiency remains the first cause of preventable mental retardation. In France,
      preventive programs with salt iodine fortification are insufficient to eradicate iodine
      deficiency. In previous studies, we have shown that iodine deficiency is the rule for
      pregnant women in our area: 66 to 85% of women tested depending on the stage of pregnancy
      (Brucker-Davis 2004, Hieronimus et al 2009, abstract at the 2008 ETA and SFE meetings,
      article in preparation reporting results from our 2006 PHRC: Study of thyroid function during
      pregnancy with or without iodine supplementation).We will study the impact of early iodine
      supplementation in normal pregnant women on the neuropsychological development of their
      offspring assessed at 2 years of age. This is the follow-up of a cohort of children born to
      women enrolled in our 2006 PHRC. 110 healthy women have been included in this prospective
      study: they were seen early (median 8 weeks of gestation) and had strictly normal thyroid
      function tests, as well as no personal thyroid history. They were randomized into two groups:
      group A taking pregnancy vitamins without iodine supplementation (Oligobs GrossesseR 2
      tablets/day) our group B taking the same vitamins but iodine fortified (Oligobs MaxiodeR 2
      tablets per day, i.e. 150 mcg of iodine/day).
    

Intervention name(s): Neuropsychological test
Intervention type(s): Behavioral
Intervention description(s): Bayley test (version III) which provides several scales of development. Children are assessed just one time at two year old
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy; iodine deficiency; neuropsychological development
Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of two doses of LP08
      compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly
      different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis
      design will be employed, i.e. the measured outcomes will be subjects' improvements in
      quantitative and qualitative measures of the disease condition being assessed prior to and
      after LP-08 instillations at four and eight weeks follow-up visits
    

Detailed description: 
      This is a single-center, dose-ranging, placebo-controlled, double-blind, randomized study
      including male and female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS)
      as determined by a physician using the current diagnostic criteria for IC/BPS. A total of 36
      subjects will be enrolled at up to five (5) study sites in the U.S. Enrollment is expected to
      be completed within one year of initiating the study. The study is comprised of two parts.
      The first part of the study is a dose-ranging, randomized, double-blind, placebo-controlled
      study evaluating the safety, tolerability and efficacy of LP-08 at 20 mg and 80 mg doses as
      compared with placebo. The second part of the study is an Open Label Extension study of the
      safety, tolerability and efficacy of LP-08 80 mg. Subjects randomized to the placebo control
      group must have completed the randomized portion study, including the eight week follow-up
      period, to be eligible for the Open Label Extension.
    

Intervention name(s): LP-08 80mg; Normal saline; LP-08 20mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravesical instillation of 80mg LP08; Intravesical instillation of normal saline; Intravesical instillation of 20mg LP08
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Interstitial Cystitis; Painful Bladder Syndrome; Bladder Pain Syndrome; Liposome; LP-08
Physical Activity, Sedentary Behaviour and Physical Fitness Profile of Primary School Children in Lagos, Nigeria.
Condition: Physical Activity
Study type: Observational

Summary: 
      This research study intends to use a mixed method approach(both qualitative and quantitative)
      to describe and analyse the levels, patterns, and correlates of physical activity((PA),
      sedentary behaviour(SB), and physical fitness(PF) profiles of primary school children in
      Lagos state, Nigeria. The study is in four phases.
    

Detailed description: 
      Phase1 is a scoping review of literature of the level of compliance of all the countries in
      sub-saharan Africa to the Global observatory on physical activity(GOPA) recommendation on the
      minimum level of daily physical activity to reduce incidence of non communicable chronic
      diseases e.g. hypertension, diabetes, obesity etc.

      Phase2 is a concurrent mixed method which will explore parents and other stakeholders
      awareness, understanding and perspectives on PA,SB, and PF among primary school children in
      Lagos, Nigeria.

      Phase 3 is a cross sectional study which will investigate levels, patterns and correlates
      among physical activity, sedentary behaviour and physical fitness profile of primary school
      children in Lagos, Nigeria.

      Phase 4 is development of physical activity guideline for primary school children in Lagos,
      Nigeria.
    

Intervention name(s): Interviews
Intervention type(s): Other
Intervention description(s): Interviews for stakeholders
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population are primary school children(6-12 yrs) in public and private schools in
        Lagos state, Nigeria..
Phase 1 Dosing Study of BAX 513 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate whether orally administered BAX 513 (different
      doses administered for 5 days) affects hemostatic parameters in healthy volunteers.
    


Intervention name(s): Fucoidan (extract of Laminaria japonica); Placebo
Intervention type(s): Other; Other
Intervention description(s): Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID; Cellulose filled capsule - oral administration - 5 different dose levels - BID
Other intervention name(s): BAX 513
Intervention MeSH terms: Fucoidan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Nonalcoholic Fatty Liver Disease is Associated With Increased Atrial Fibrillation Risk in an Elderly Chinese Population
Condition: Nonalcoholic Fatty Liver Disease; Atrial Fibrillation; Cross-sectional Study
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Atrial Fibrillation
Study type: Observational

Summary: 
      Atrial fibrillation and nonalcoholic fatty liver disease are two pathological conditions that
      are highly prevalent worldwide and share multiple CVD risk factors. There is rare research
      performed among elderly adults. The investigators are conducting a cross-sectional analysis
      of elderly adults (≥65 years) to investigate the association between atrial fibrillation and
      nonalcoholic fatty liver disease in an elderly Chinese population.
    

Detailed description: 
      Because of the aging population and improvements in cardiovascular treatments, its prevalence
      is expected to increase substantially over the next few decades. AF has been reported to be
      associated with high rates of hospitalization and death. Along with older age, there are many
      independent risk factors for AF like obesity, hypertension, diabetes, ischemic heart disease,
      heart failure and valvular heart disease.

      Non-alcoholic fatty liver disease is one of the most prevalent liver diseases in the world
      whose prevalence ranges from 6% to 35%, with a median of 20% in the general population. In
      recent years, an increasing body of evidence have indicated that NAFLD is linked to
      cardiovascular disease, myocardial abnormalities, left ventricular diastolic dysfunction,
      heart failure, aortic valve sclerosis and so on.

      NAFLD has also been observed to be significantly associated with AF in patients with type 2
      diabetes. Furthermore, a cohort study showed that NAFLD was associated with an increased risk
      of prevalent AF in a middle-aged population. However, whether the association between NAFLD
      and AF also holds true in the elderly population remains uncertain. Therefore, the
      investigators conducted this cross-sectional study to explore the association between NAFLD
      and AF in an elderly Chinese population.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The elderly adults (≥65 years old) who had undergone an annual physical examination at
        Zhenhai Lianhua Hospital, Ningbo, China in 2014
Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index During Cryopreservation of Abnormal Human Semen Samples
Condition: Spermatogenesis and Semen Disorders; DNA Double Strand Break
Study type: Interventional

Summary: 
      Cryopreservation is the storage of biological material at subzero temperatures at which
      biochemical processes of cell metabolism and the biochemical reactions that lead to cell
      death are slowed, interrupted or stopped.Many investigators have focused on the use of
      antioxidants in the freezing media to reduce the negative effects of reactive oxygen
      species(ROS) on spermatozoa and in this context addition of vitamin E to cryoprotective
      medium enhanced the post-thaw sperm motility and preserved sperm DNA integrity , superoxide
      dismutase (SOD) and catalase (CAT) were added to boar spermatozoa freezing media and they not
      only increased sperm motility and viability but also decreased post-thaw ROS generation which
      led to improvement in results of in vitro fertilizing with thawed spermatozoa.However, the
      impact of in vitro addition of proanthocyanidins to human semen before cryopreservation on
      post-thawing semen parameters, DFI has not been studied yet. The research question evaluated
      in the current study was whether semen samples of infertile men supplemented or not with
      procyanidine before cryopreservation, differ in post-thawing semen parameters and sperm DNA
      fragmentation index (DFI).
    


Intervention name(s): procyanidine
Intervention type(s): Dietary Supplement
Intervention description(s): Natural antioxidant
Intervention MeSH terms: Procyanidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Nitrate Supplementation; Source
Condition: Blood Pressure; Nutritional Physiological Phenomena
Study type: Interventional
Phase: Phase 4

Summary: 
      The main aim of the current study will be to compare the effects of ingesting different
      nitrate-rich sources on plasma nitrite concentrations.
    

Detailed description: 
      Oral ingestion of nitrate (NO3-) has been shown to increase plasma nitrate and nitrite
      levels. Significant lowering of pulmonary oxygen uptake during exercise, as well as
      significantly lower blood pressure values at rest have been observed after supplementation
      with nitrate. However, no study has yet described a direct comparison between different
      nitrate-rich beverages with respect to the bioavailability of nitrate/nitrite and the
      possible hemodynamic effects. Based on the gaps in current literature, our main goal will
      therefore be to gain further insight into the effects of nitrate supplementation with
      different sources on plasma nitrite levels.
    

Intervention name(s): Sodium nitrate; Beetroot juice; Spinach; Rocket salad
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Nitrate; Bioavailability; Sports
The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic Patients
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids
      to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel
      randomized controlled trial the investigators recruited 70 diabetic patients and randomly
      allocated to control and treatment groups. Participants in treatment group consumed 30 gr
      flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily.
      Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood
      pressure, weight, waist circumference and body mass index were measured at the first and end
      of the trial.
    

Detailed description: 
      Nutritionists have concern about consumption of full fat dairy in diabetic patients due to
      their content of saturated fatty acids. The investigators aimed to add flaxseed with high
      content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without
      adverse effects of it. In this parallel randomized controlled trial the investigators
      recruited 70 diabetic patients and randomly allocated to control and treatment groups.
      Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while
      controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar,
      glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference
      and body mass index were measured at the first and end of the trial.
    

Intervention name(s): low fat yogurt enriched with flaxseed; low fat yogurt
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): daily intake of low fat yogurt enriched with flaxseed for 8 weeks; daily intake of low fat yogurt for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diabetic patients; flaxseed; lipid profile; cardiovascular risc factors
The Effect of Laser Photocoagulation on the Soft Tissue Healing During Socket Preservation
Condition: Soft Tissue Healing
Study type: Interventional

Summary: 
      The main aim of this study was to evaluate clinically the effect of laser photocoagulation in
      comparison to the non-resorbable dense polytetrafluroethylene (dPTFE) membrane on the soft
      tissue healing during socket preservation with bovine bone xenograft.
    

Detailed description: 
      The study was designed as randomized, controlled, clinical trial. patients who were
      undergoing tooth extraction and socket preservation were divided into two groups: Group I:980
      nm Diode laser was used to seal the socket by photocoagulation .Group II : a non-resorbable
      dPTFE was used to seal the socket and stabilized by suturing to the soft tissue margins of
      the socket

      All patients were clinically and radiographically evaluated at the baseline and on the second
      , third and fourth weeks postoperatively.Then recalled after 4 months for the final
      radiographic examination.
    

Intervention name(s): Socket sealing by diode laser photocoagulation; socket sealing with dense polytetrafluroethylene membrane
Intervention type(s): Procedure; Procedure
Intervention description(s): tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed using 980 nm diode laser photocoagulation applied in a non-contact mode with a poer output of 1 watt in a continuous wave mode for 3-5 minutes; tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed by a non-resorbable dPTFE membrane that is stabilized by suturing to the soft tissue margins of the socket
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment