bioihbjkbjnl/mcl2 huggingface dataset:
How Exercise Signals Health Responses
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this research is to determine the blood signals that promote health and
      well-being in response to exercise at different intensities.
    

Detailed description: 
      Most studies find a dose-response relationship between exercise participation and all-cause
      mortality. In contrast, physical inactivity and consequent overweight or obese status is
      associated with a cadre of health consequences. Frequently, comorbidities of obesity are
      mechanistically linked via chronic low grade inflammation stemming from increases in
      adiposity. Although exercise is known to combat obesity and obesity related disease states,
      the mechanisms of action are not fully understood. Therefore, the investigators propose the
      following study in an attempt to elucidate anti- and pro-inflammatory endocrine responses to
      exercise. Initial studies in animal models have provided evidence that exercise induces
      long-term anti-inflammatory effects, potentially via myokine signaling following skeletal
      muscle activation. Humans are an ideal study population as the investigators can prescribe
      multiple exercise protocols that mimic human behavior, and control exercise intensity to meet
      recommendations. Also, humans allow the investigators to collect larger plasma samples and
      therefore measure more circulating proteins of interest over multiple time-points. Finally,
      the investigators can select individuals that exercise at different frequencies, allowing the
      investigators to analyze the differences in endocrine responses to exercise over differing
      levels of fitness. In summary, a human model will allow for a much better understanding of
      the human condition.
    

Intervention name(s): 50% heart rate reserve (HRR) low intensity exercise; 75% HRR moderate intensity exercise; Control no exercise
Intervention type(s): Other; Other; Other
Intervention description(s): Trained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity); Trained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity); Trained and untrained participants will have a no exercise control day
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: A 3-way factorial design will be employed with training status as a between-subjects variable, and exercise intensity and time as within-subjects variables. The order of exercise intensity will be counterbalanced across subjects.
Masking: None (Open Label)
Primary purpose: Other
Evaluation of the Efficacy and Safety of Nano-S1
Condition: COVID-19 Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to assess the efficacy of the efficacy and safety of investigational drug
      (NanoS) in patients with mild to moderate COVID-19 at high risk for progression to severe
      COVID-19, including death.
    

Detailed description: 
      We conducted a prospective randomized double-blind clinical trial over five months to
      determine the efficacy of NanoS compared to placebo. The effectiveness of treatment was
      measured by the significant decline in the number of cases of covid-19 infection and/or a
      decrease in the viral load determined by SARS-CoV-2 cycle threshold (Ct) value using RT-PCRs
      test.
    

Intervention name(s): NANOS1 , argent colloïdal ,
Intervention type(s): Drug
Intervention description(s): orally, during 5 day
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ARGENT COLLOIDAL
Risk Factors for Human Corneal Graft Failure : a Monocentric Retrospective Observational Cohort
Condition: Corneal Transplant Rejection
Study type: Observational

Summary: 
      Keratoplasty is one of the most common grafts and penetrating keratoplasty is still the
      technique most used in the world, ahead of lamellar grafts, and is estimated to represent 70%
      of the total.

      Graft rejection is still the main cause of failure of this type of surgery, to the extent
      that nearly a third of all patients will in some way be affected by rejection in due course.

      Numerous risk factors for rejection have been identified, whether related to the donor, the
      recipient, or the surgical procedure itself.

      In addition, many of the studies performed have used univariate analysis only, and yet there
      is a strong case for multivariate analysis, given the wide range of factors that need to be
      examined.

      This study seeks to analyze the rejection rates and the survival of penetrating keratoplasty
      for a group of patients from Montpellier Hospital (France).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutives keratoplasty performed in the ophthalmology department of the CHRU (Centre
        Hospitalier Régional Universitaire) of Montpellier between 15/06/2005 and 18/09/2018, a
        period of just over 13 years.
      
Keywords: Cornea / surgery; Corneal Transplantation* / adverse effects; Corneal Transplantation* / methods; Graft Rejection / prevention & control; Humans
A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The effects of Lacosamide, an antiepileptic drug, on sleep have not been formally evaluated.
      The present study is being conducted to assess the effects of Lacosamide on sleep quality in
      healthy subjects.
    

Detailed description: 
      In some patients with Epilepsy, seizure activity is associated with specific phases of
      sleep/wake cycle, and sleep deprivation is known to precipitate seizure activity. Inadequate
      or disturbed sleep and excessive daytime drowsiness is often reported by patients with
      Epilepsy due to the effects of seizures as well as antiepileptic drugs. Thus, the use of
      healthy subjects improves the certainty that any changes in sleep are related to the study
      drug and not other factors.
    

Intervention name(s): Lacosamide
Intervention type(s): Drug
Intervention description(s): Lacosamide will be given orally in 50 mg tablets twice a day for 7 days. The dose will increase weekly by 100 mg per day to a target dose of 300 mg per day. Once the target dose of 300 mg per day has been achieved for 9 days, a 2-day tapering of Lacosamide will occur by 100 mg per day.
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Lacosamide; Vimpat
Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The central hypothesis is that acupuncture break the vicious circle of androgen excess and
      reverse insulin resistance and improve health related quality of life and affective symptoms
      in overweight and obese women with and without Polycystic Ovary Syndrome.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorder in
      women. The main metabolic phenotype is hyperinsulinemia and insulin resistance, which are
      independent of body weight and worsen hyperandrogenism and ovulatory dysfunction.
      Pharmacological treatments are symptom oriented and usually effective but have metabolic and
      gastrointestinal side effects. Therefore, it is important to evaluate new nonpharmacological
      treatment strategies, as most women with PCOS require long-term treatment.

      Hypothesis and Aims Our central hypothesis is that acupuncture break the vicious circle of
      androgen excess and reverse insulin resistance and improve health related quality of life and
      affective symptoms in overweight and obese women with and without PCOS.

      The specific aim are designed to test the hypotheses that

        1. Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) improves
           insulin sensitivity in overweight and obese women with and without PCOS

        2. Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) regulate key
           signaling molecules and mitochondrial oxidation/biogenesis in skeletal muscle and
           adipose tissue in overweight and obese women with and without PCOS

        3. Acupuncture (chronic i.e. 5 weeks treatment, 3 times per week) improve health related
           quality of life and symptoms of anxiety and depression in overweight and obese women
           with and without PCOS

      Time frame of the study is 5-6 weeks. No long term follow up.
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Needle placement in abdominal muscles, in m. vastus lateralis, lower leg and hands.
Stimulation: Manual rotation of the needles and electrical stimulation of the needles in the abdominal muscles and m. vastus lateralis will be stimulated electrically with low burst frequency Duration: 30 min Treatment: 3 times/wk during 5 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; Insulin resistance; Acupuncture
Wine Consumption and Glycemic Control
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Many studies have reported that alcoholic beverage consumption, especially in the form of
      wine, reduces the risk of developing type 2 diabetes by as much as 40%. This association
      suggests that wine consumption may somehow improve the body's ability to control its blood
      glucose concentration. Indeed, it has been reported that when wine is consumed immediately
      prior to ingestion of glucose, the release of insulin is enhanced and blood glucose
      concentration is lowered. The mechanism of wine's effects on blood glucose concentration is
      unknown, but is likely related to its ethanol or antioxidant content. In this study, the
      investigators plan to test whether wine or plain ethanol (vodka) ingestion alters the control
      of blood glucose in subjects who have diabetes or pre-diabetes.
    

Detailed description: 
      Our central hypothesis is that improvement in glycemic control by acute consumption of wine
      is mediated by ethanol. Subjects will have type 2 diabetes, pre-diabetes, and be sedentary
      and obese (BMI >30). Subjects' glycemic control will be assessed by an oral glucose tolerance
      test (OGTT) at three different time points. One OGTT will occur shortly after consumption of
      red wine, the second after consumption of vodka containing the identical amount of ethanol as
      the wine treatment, and the third OGTT will occur shortly after consumption of an equal
      volume of water. The three OGTTs will be administered in random order.
    

Intervention name(s): Alcohol consumption
Intervention type(s): Other
Intervention description(s): 28 grams (2 drinks) of ethanol will be consumed either in the form of wine or vodka.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: type two diabetes; glycemic control
Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to
      17-day washout period between doses. The study will consist of a screening visit, study
      center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each),
      1 washout period (14 to 17 days separating periods 1, 2 and 3), and exit procedures.
    


Intervention name(s): 35 mg risedronate DR tablet; 35 mg risedronate DR tablet; 35 mg risedronate DR tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet; 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner; 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eustachian Tube Growth and Development
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Observational

Summary: 
      This study is to measure over time (from 3 years until 13 years of age) Eustachian tube
      function (the way the Eustachian tube works) and facial growth in groups of children with two
      types of middle-ear disease and with little past middle-ear disease. These measures will be
      used to determine if facial growth is related to improved Eustachian tube function, to see if
      the better function explains why young children who have middle-ear disease outgrow it as
      they get older, and to determine if these measures are different for the children in the
      three groups defined by disease history.
    

Detailed description: 
      The existing literature documents an important role for the Eustachian tube (ET) in the
      pathogenesis and/or persistence of otitis media (OM). Cross-sectional studies report a lower
      prevalence of OM in older children, a better ET pressure-regulating function in older
      children and age-related differences in ET form, length and width, and the vector orientation
      of the paratubal musculature. These growth-related changes in ET structural relationships are
      demonstrably predictive of increasingly more efficient ET function (ETF) and, because the ET
      and paratubal musculature are intimately related to the cranial base, the vector orientation
      of the ET system can be reconstructed from osteological or radiographic data. Together, these
      observations suggest that measurable, age-related changes in ET-paratubal muscle vector
      relationships are reflected in more efficient ETF and, by consequence, a decreased OM risk.
      The overall goal of the proposed longitudinal study is to evaluate the validity of this
      hypothesis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric otolaryngology clinic
      
Biospecimen description: 
      cells obtained from buccal brushing
    
Keywords: otitis media; ear; acute otitis; middle ear; Eustachian tube; recurrent acute otitis media; chronic otitis media with effusion; no significant history of otitis media
Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS
Condition: Functional Endoscopic Sinus Surgery; Premedication; Analgesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous
      dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes,
      there is lack in studies that had compared the efficacy of intravenous and Intranasal
      Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus
      surgery.

      Therefore, we established this randomized study to compare intranasal dexmedetomidine with
      intravenous dexmedetomidine improving quality of the operative field in functional endoscopic
      sinus surgery.
    


Intervention name(s): Intranasal dexmedetomidine; Intravenous dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): 45 -60 min before the operation, patients will receive dose of dexmedetomidine 1microgram/kg diluted in 10ml 0.9% saline administered to each naris as drops + infusion saline; patients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of (0.4 µ g/kg/h) + intranasal saline.
Other intervention name(s): Propofol 2 mg/kg; fentanyl 1 µg/kg; Cis-atracurium 0.15mg / kg; Isoflurane 1-1.5% in 50% oxygen; Propofol 2 mg/kg,, fentanyl 1 µg/kg , Cis-atracurium 0.15mg / kg and Isoflurane 1-1.5% in 50% oxygen
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Propofol; Isoflurane; Atracurium; Cisatracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dexmedetomidine; Intranasal; Intravenous
Effect of Core Stability Exercises and Treadmill Training on Balance in Children With Down Syndrome
Condition: Physical Therapy
Study type: Interventional

Summary: 
      Introduction: Core stability exercises and treadmill training play a crucial role in physical
      therapy interventions and have an effect on balance in children with Down syndromes (DS),
      whether core stability exercises or treadmill training has more effect on improve balance has
      not been investigated yet. The aim of the study was to investigate the effect of core
      stability training versus treadmill exercises on balance in children with Down syndrome.
      Methods: Forty-five children with Down syndrome included in the study. The children aged 4-6
      years, and they were equally divided randomly into three groups (A), (B) and (C). Group A
      received traditional physical therapy intervention strategies to facilitate the balance of
      participated children. Group (B) received same as the group (A), with additional core
      stability exercises training. Group (C) received same intervention strategies as group (A) in
      conjunction with a treadmill exercise program. The children's balance was evaluated using the
      Berg Balance Scale and the Biodex Balance System. Treatment sessions were for 60 min, thrice
      a week, for eight consecutive weeks.
    


Intervention name(s): core stability exercises and treadmill training exercises
Intervention type(s): Device
Intervention description(s): Forty-five children with Down syndrome included in the study. The children aged 4-6 years, and they were equally divided randomly into three groups (A), (B) and (C). Group A received traditional physical therapy intervention strategies to facilitate the balance of participated children. Group (B) received same as the group (A), with additional core stability exercises training. Group (C) received same intervention strategies as group (A) in conjunction with a treadmill exercise program. The children's balance was evaluated using the Berg Balance Scale and the Biodex Balance System. Treatment sessions were for 60 min, thrice a week, for eight consecutive weeks.
Other intervention name(s): traditional physical therapy program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Calorie Anticipation and Food Intake
Condition: Eating Behaviour; Obesity
Study type: Interventional

Summary: 
      The regulation of our food intake is on the short-term guided by appetite and satiety signals
      generated by the sight and consumption of food. Food intake is not only regulated by appetite
      and satiety signals - external cues also play an important role.

      It has been observed that food intake and the pleasure derived from consumption is affected
      by manipulation of the external cues.

      The investigators will assess the contribution of food anticipation (calorie information) and
      actual consumption of a test food (calorie intake) on in satiety responses (such as ghrelin
      responses, appetite and subsequent food intake). The investigators expect the information on
      the amount of calories, rather than the actual amount of calories in the food, to predict the
      ghrelin responses and the subsequent intake of a second meal.
    

Detailed description: 
      In a randomized cross-over design with 4 conditions, all participants will consume twice the
      low-caloric food (once with the low-calorie information and once with the high-calorie
      information) and twice the high-caloric food (again, once with the low-calorie information
      and once with the high-calorie information) in a randomized order.
    

Intervention name(s): low calorie yogurt; high calorie yogurt
Intervention type(s): Behavioral; Behavioral
Intervention description(s): all participants consumed twice the low-caloric food (once with the low-calorie information and once with the high-calorie information); all participants consumed twice the high-caloric food (once with the low-calorie information and once with the high-calorie information)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Satiety,; satiation,; anticipation,; food intake
Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Papilloma
Study type: Interventional
Phase: Phase 3

Summary: 
      A research project is currently being undertaken looking at Human Papilloma Virus (HPV)
      vaccination in special risk groups. It aims to see if young women with a chronic illness
      respond well to the HPV vaccine or whether they may require additional doses to ensure
      protective immunity. The four valent HPV vaccine protects against HPV types 16 & 18, cervical
      cancer and HPV types 6 & 11, anogenital warts.

      The six special risk groups include:

      Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia
      Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow
      Transplants This immunity is measured by antibody levels of the HPV types, which requires a
      single blood test one month after the final dose of HPV vaccine.

      This is compared to healthy controls using antibody response to HPV vaccine. This will assess
      directly whether these special risk groups respond as well to the HPV vaccine.
    


Intervention name(s): Licensed quadrivalent HPV vaccine, Gardasil
Intervention type(s): Drug
Intervention description(s): The dose of the four valent (4v) HPV vaccine is 0.5ml administered by intramuscular (IM)injection. The recommended schedule is 0, 2 and 6 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Juvenile Idiopathic Arthritis; Inflammatory Bowel Disease; Acute Lymphoblastic Leukemia; Chronic Renal Disease; Solid Organ Transplant