bioihbjkbjnl/mcl2 huggingface dataset:
Ability to Awaken in Nonmonosymptomatic Enuresis
Condition: Enuresis, Nocturnal, 2 (Disorder)
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Observational

Summary: 
      To evaluate the effect of controlling lower urinary tract symptoms (LUTS) with
      anticholinergics on improving the ability to awaken (AA) in children with nonmonosymptomatic
      enuresis and evaluate the potential implication of improved AA for treatment response
      prediction.
    

Detailed description: 
      Nocturnal enuresis is associated with three main etiologies, including nocturnal polyuria
      secondary to abnormal anti-diuretic hormone levels, low bladder capacity related to lower
      urinary tract dysfunction, and sleep disorders causing problems in arousal. Among them, the
      association between enuresis and lower urinary tract symptoms (LUTS) has gained importance.
      If these two conditions coexist, the diagnosis is nonmonosymptomatic enuresis (NME). The
      reported prevalence of LUTS among enuretic patients ranges widely from 21% to 99%. Moreover,
      it was reported that spontaneous resolution can be prolonged, and some cases of NME are
      likely to become refractory if treated like monosymptomatic enuresis (ME) cases. A possible
      explanation for this may be the presence of bladder dysfunction that is not addressed
      properly by the standard treatment of ME. However, this explanation is only speculative.

      By showing a paradoxical increase in light sleep and higher cortical arousal index in
      enuretic children with reduced bladder capacity, one of the reason for impaired ability to
      awaken (AA) in enuretic patients may lie in the chronic stimulation of the bladder. This kind
      of bladder dysfunction leading to an abnormal bladder-brain dialogue has been further
      elaborated by an experiment showing brain dysfunction in the ventrolateral periaqueductal
      gray matter as a result of the experimental reduction of the bladder capacity. If this is
      true for enuretic children, we may be able to improve arousal (improved AA) by increasing
      their bladder capacity.

      Based on this hypothesis, the present study aimed to evaluate to the effects of
      anticholinergic therapy with standard urotherapy on improvement of AA and show the effect of
      improved AA on treatment response in children with NME.
    

Intervention name(s): anticholinergic
Intervention type(s): Drug
Intervention description(s): Initial anticholinergic therapy to all patients
Other intervention name(s): Vesicare; BUP-4
Intervention MeSH terms: Cholinergic Antagonists
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children with primary nonmonosymptomatic enuresis who received initial anticholinergic
        therapy
      
Keywords: anticholinergics; awakener
Perforator Artery Changes During Suprafascial Pre-expansion of the Perforator Flaps
Condition: Scar; Contracture; Flap Disorder
MeSH terms: Contracture
Study type: Interventional

Summary: 
      Tissue expansion methods have been recommended as a means of improving the clinical results
      with perforator flaps but in plastic surgery literature there are few clinical trials
      supporting this opinion. The purposes of this clinical study are to address the ''preexpanded
      perforator flap concept'' by demonstrating a case series of relevant reconstructive
      procedures and to evaluate the perforator vessel changes that happen during the expansion
      periods of various perforator flap donor sites.
    


Intervention name(s): preexpanded perforator flap surgery
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: scar; contracture; perforator flap; preexpanded perforator flap; perforator vessel; artery diameter
Evaluation of a Family-based Pediatric Obesity Program: TEENS+
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Investigators propose to pilot an adolescent obesity intervention, TEENS+, to examine the
      feasibility of this dietary intervention strategy and preliminary effectiveness of two models
      of parental involvement within adolescent obesity treatment.
    

Detailed description: 
      Investigators will recruit overweight or obese adolescents (BMI >85th percentile) and
      parent(s) (BMI >25 kg/m2). Families will participate in one of two 6-month treatments: 1)
      TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child's weight
      management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight
      management. All adolescents will participate in TEENS+, which includes behavioral support,
      nutrition education, and supervised physical activity.

      For the adolescents, intervention will consist of weekly 1 hour exercise sessions and
      alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend
      the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent
      behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL).
      Assessments will consist of anthropometric measures, lab work, psychological surveys, and
      nutritional evaluations. Assessments will be completed at baseline, 3 months, 6 months
      (post-intervention), and 9 months.
    

Intervention name(s): Parents as Coaches; Parent Weight Loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Adolescents will receive lifestyle intervention (TEENS) and parents will receive parents as coaches (PAC) intervention.; Adolescents will receive lifestyle intervention (TEENS) and parents will receive parent weight loss (PWL) intervention.
Other intervention name(s): TEENS+PAC; TEENS+PWL
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Obesity; Lifestyle Intervention; Family-based Intervention; Motivational Interviewing
A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a
      placebo and to haloperidol in patients with schizophrenia.
    


Intervention name(s): Lurasidone 20 mg; Lurasidone 40mg; Lurasidone 80 mg; Haloperidol 10mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Lurasidone 20mg/day tablets; Lurasidone 40mg/day tablets; Lurasidone 80mg/day - 2 40mg tablets; Haloperidol 10mg/day tablets; Matching Placebo to Lurasdione and Haloperidol
Intervention MeSH terms: Haloperidol; Haloperidol decanoate; Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Latuda; Lurasidone
Evaluation of Nephure™, and the Reduction of Dietary Oxalate, in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this double-blind study is to determine the effect of reducing oxalates in the
      diet of healthy volunteers by using Nephure, an oxalate-reducing enzyme, as compared to
      placebo.
    

Detailed description: 
      This study aims at evaluating the effect from Nephure in reducing dietary oxalate in healthy
      volunteers on a controlled diet as compared to placebo. Subjects are on a normal diet with
      controlled oxalate (750mg/day) and calcium (550mg/day) levels for 8 consecutive days. The
      study is a cross-over design with two four-day treatment periods. The study intends to
      determine level of reduction in urinary oxalate output as a measure of the effect of Nephure
      on dietary oxalate when ingested with a meal.
    

Intervention name(s): Nephure Oxalate-reducing Enzyme; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 3g of Nephure is mixed with 8oz of water and ingested with breakfast, lunch and dinner.; 3g of non-GMO maltodextrin is mixed with 8oz of water and ingested with breakfast, lunch and dinner.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, randomized, placebo-controlled, cross-over study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Self Directed Positive Parenting Program (Triple P) for Psychosis: A Clinical Case Series
Condition: Schizophrenia; Spectrum; Disorders
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The aim of the case series study is to explore if a self directed version of the Positive
      Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with
      psychosis who are parents.
    

Detailed description: 
      As above.
    

Intervention name(s): Self Directed Positive Parenting Program
Intervention type(s): Other
Intervention description(s): Individuals with psychosis who are parents will receive a copy of the "Every Parent's Self Help Workbook" (Markie-Dadds, Sanders & Turner, 1999) and up to ten sessions of support. This is a case series study.
Other intervention name(s): "Every Parent's Self Help Workbook"
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Parenting; Psychosis; Schizophrenia; Delusions; Hallucinations
Brown Rice Intervention on Metabolic Syndrome (BRIMS)
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The specific aim of this study is to determine the effects of substituting brown for white
      rice on the treatment of metabolic syndrome (MetS).
    

Detailed description: 
      Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central
      obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the
      development of type 2 diabetes and CVD. It has become one of the major public health
      challenges in China due to rapidly nutrition transition and the nature of obesity epidemic.
      Treatment of MetS in China is very important for the prevention of the epidemic of its
      consequences (such as CVD and type 2 diabetes).

      Compelling evidence from recent human studies has demonstrated that diet modifications are
      effective means in MetS management. Consumption of carbohydrate-rich foods such as rice
      affects blood glucose and influences diabetes risk. Specifically, eating polished white rice
      may increase diabetes risk, whereas eating brown rice, a whole grain product, may decrease
      risk. This is likely related to the different ability of white and brown rice to raise blood
      glucose levels, as measured by their glycemic index (GI) and glycemic load (GL), and to the
      higher levels of dietary fiber, vitamin B complex, magnesium and other micronutrients in
      brown rice.

      A total of 200 participants with MetS (defined by ATP-III criteria) will be randomly assigned
      to a brown rice diet or an isocaloric white rice diet for 16 weeks. Effects of substituting
      brown for white rice will be evaluated by measuring metabolic profile (BMI, blood pressure,
      total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and insulin, HbA1C).
    

Intervention name(s): Brown rice/White rice
Intervention type(s): Dietary Supplement
Intervention description(s): ad libitum intake of brown rice/white rice at every lunch and dinner for 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: brown rice; white rice; diabetes risk
Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia
Condition: Healthy
Study type: Interventional

Summary: 
      Sugar-sweetened beverages are the main source of added sugars in most Westernized countries,
      and for this reason constitute a primary target for sugar reduction by many companies,
      including Nestlé. Instead of using high-intensity sweeteners which are non-caloric in nature,
      an alternative would be to reduce sugars without altering sweetness.

      In this protocol, the general goal is to investigate the relative contribution of sweet taste
      perception and sugar intake on post-prandial glucose response. 4 different nutritional
      products will be tested by 16 healthy subjects in a crossover design.
    

Detailed description: 
      After enrollment, participants will be asked to come to the investigational site 6 times for:

        -  two sensory tests dedicated to assess the sensory capacity of the participants from the
           same sensory test repeated twice, for better consistency.

        -  4 testing visits for a 3-h blood kinetics after each product intake. These visits will
           be scheduled on different days separated by a washout period of at least one week.
           Outcomes will be glycemia and insulinemia.
    

Intervention name(s): Product 1; Product 2; Product 3; Product 4
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Comparison with products 2, 3, and 4; Comparison with products 1, 3, and 4; Comparison with products 1, 2, and 4; Comparison with products 1, 2, and 3
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a monocentric, controlled, randomized, open, complete crossover study design
Masking: None (Open Label)
Primary purpose: Other
Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is conducted to evaluate and compare the relative bioavailability for
      Esomeprazole in two different products containing 40 mg Esomeprazole after a single oral dose
      administration under fasting conditions.
    

Detailed description: 
      A randomized, single-dose, two-treatment, partial replicate, three-phase, three-sequence,
      bioequivalence study of the two study products. Blood samples were collected at different
      time intervals and stored at -70⁰C freezer. Esomeprazole plasma concentrations were analyzed
      using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were
      performed on the concentrations obtained using Phoenix WinNonlin® software.
    

Intervention name(s): Test product (T) 40 mg Hard Gelatin Capsules; Reference product (R) 40 mg Hard Gelatin Capsules
Intervention type(s): Drug; Drug
Intervention description(s): Hard Gelatin Capsules products containing 40 mg Esomeprazole; Reference product (R) 40 mg Hard Gelatin Capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, single-dose, partial replicate crossover, three-phase, three-sequence, two treatments bioequivalence study.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Esomeprazole; Bioequivalence; Randomized; Replicate
Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
Condition: Nasopharyngeal Carriage of Streptococcus Pneumoniae
MeSH terms: Pneumonia, Pneumococcal
Study type: Observational

Summary: 
      The purpose of this study is to assess the direct effects of the ten-valent pneumococcal
      conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.

      These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive
      pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov
      Identifier:NCT00861380) during 2009 to 2011.

      Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder
      non-vaccinated siblings aged 5 to 9 years.
    

Detailed description: 
      This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in
      2013 from vaccinated and unvaccinated children.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal
        Disease (FinIP) Trial (ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011 and
        their unvaccinated older siblings.
      
Biospecimen description: 
      Nasopharyngeal and oropharyngeal swabs
Brain Function in Children With Congenital Heart Disease (CHD)
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      The purpose of the study is to determine whether the neurodevelopmental outcome and in
      particular executive functions in 9 to 14 year old school children with congenital heart
      disease who underwent cardiopulmonary bypass surgery during their first three months of life
      is impaired in comparison to healthy children at same age. Executive functions are higher
      order cognitive functions and critical for school success.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage
Condition: Subarachnoid Hemorrhage; Cerebral Vasospasm; Hydrocephalus
MeSH terms: Subarachnoid Hemorrhage; Hydrocephalus; Vasospasm, Intracranial; Hemorrhage
Study type: Observational

Summary: 
      The purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral
      Vasospasm following Subarachnoid Hemorrhage
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to University Hospital.
      
Biospecimen description: 
      Cerebrospinal Fluid (CSF)
    
Keywords: Xanthine Oxidase; Cerebrospinal fluid
Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis
Condition: Pancreatitis, Chronic
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy of 2 different doses of intramuscular
      (IM) vitamin D3 as compared to an oral replacement dose in normalizing vitamin D levels in
      the blood of patients with tropical calcific pancreatitis.
    

Detailed description: 
      Tropical calcific pancreatitis (TCP) is a form of chronic pancreatitis unique to developing
      countries. Patients with TCP often have malabsorption leading to nutritional deficiencies. We
      have noted that vitamin D deficiency is common in patients with TCP. The ideal regimen for
      supplementing vitamin D3 in chronic pancreatitis remains unclear and there are no previous
      studies available. High dose oral vitamin D2 has been shown to be ineffective in normalizing
      vitamin D levels in patients with pancreatic insufficiency due to cystic fibrosis.

      Intramuscular (IM) vitamin D3 supplementation in chronic pancreatitis has certain advantages.
      Firstly, decreased and inconsistent absorption from the intestine is avoided. Secondly, IM
      vitamin D3 has a long duration of action (6-12 months). The safety of high-dose IM vitamin D3
      has been proven in previous studies in healthy individuals. Finally, the injection form is
      considerably less expensive as compared to oral vitamin D3.

      The aim of the current prospective double blind study is to compare 2 regimens of high dose
      IM vitamin D3 replenishment with oral vitamin D3 in standard recommended doses in normalizing
      serum vitamin D3 levels in patients with TCP.
    

Intervention name(s): Vitamin D3 (Cholecalciferol)
Intervention type(s): Drug
Intervention description(s): Arm 1 - Intramuscular vitamin D3 3,00,000 Units single dose
Arm 2 - Intramuscular vitamin D3 6,00,000 Units single dose
Arm 3 - Oral vitamin D3 500 Units/day for 6 months
Other intervention name(s): IM vitamin D3 - Inj Arachitol (Solvay, India); Oral vitamin D3 - Tab Cipcal (Cipla, India)
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tropical calcific pancreatitis; Tropical chronic pancreatitis; Chronic pancreatitis; Vitamin D; Vitamin D deficiency; Cholecalciferol; Intramuscular vitamin D3
Sex Hormones and Orthostatic Tolerance
Condition: Orthostatic Intolerance
MeSH terms: Orthostatic Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine the causes of "orthostatic intolerance" which occurs more
      commonly in women than in men. Orthostatic tolerance is the ability to remain standing up
      right for long periods of time, or to avoid dizziness when moving to standing from a seated
      or lying position.
    

Detailed description: 
      In this study we are interested in determining the impact of female reproductive hormones
      (estrogen and progesterone) on orthostatic tolerance (described above) so we administer these
      hormones to participants. We also test participants' orthostatic tolerance in our laboratory
      and use this information to place subjects into groups.
    

Intervention name(s): Ganirelix acetate; 17β-Oestradiol; Progesterone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ganirelix acetate: .25 ml/day by subcutaneous injection; 17 beta estradiol: 0.2 mg/day (patches); progesterone, 200 mg day-1 oral
Other intervention name(s): Antagon; 17 beta estradiol; estradiol; P4; Prometrium
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone; Ganirelix
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether increased dose of local anesthetic (lidocaine) increases duration of
      peripheral nerve block (adductor canal block) and to develop a model for assessing duration
      of peripheral nerve blockades. The investigators hypothesize that increasing the dose of
      lidocaine (by increased concentration) will increase the duration of an adductor canal block.

      The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 )
      made earlier with different concentrations of lidocaine and a placebo group. For further
      information see trial registration at European Union Drug Regulatory Authorities Clinical
      Trial System.
    


Intervention name(s): Adductor canal block with 20 ml lidocaine, single bolus
Intervention type(s): Drug
Intervention description(s): Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adductor canal block; healthy volunteers; US-guided peripheral nerve block; lower limb; duration; Muscle Strength; Anesthetics, Local; Sensation