bioihbjkbjnl/mcl2 huggingface dataset:
French Linguistic and Metric Validations of Parent-proxy QOL Chronic Cough Specific Questionnaire (PC-QOL)
Condition: Chronic Cough
MeSH terms: Cough
Study type: Interventional

Summary: 
      Cough is one of the most common reasons for consultation. Even if cough is a non-specific
      symptom, it can be the first sign of a chronic pathology. Several studies have demonstrated
      that chronic cough causes quality-of-life (QoL) impairment. Physicians' incapability to
      evaluate cough impact and patients' QoL has been documented. Therefore, a parent-proxy QoL
      chronic cough specific questionnaire (PC-QOL) has been developed and validated by Chang A. B.

      Objective : The aim of the study is to validate the French version of the PC-QoL, a
      parent-proxy QoL chronic cough specific questionnaire.

      Methods : Linguistic validation will be performed using backward/forward translation
      guidelines, and cognitive debriefing by 10 parents. Psychometric validation will be tested in
      150 patients. Inclusion criteria are: patients with a diagnosis of chronic cough (> 4 weeks);
      18 years of age or younger; all etiologies excepting cystic fibrosis. Informed consent from
      parents will be obtained. At enrollement, each parent will fulfill the PC-QOL questionnaire
      and two cough-related measures (visual analogue score, verbal category descriptive). Clinical
      data (medical history, physical examination) will be collected. Children QoL will be assessed
      using VSPA, Kidscreen and Qualin questionnaires. For assessing reproductibility and
      sensitivity to change, parents will be retested 7 and 21 days later. Content validity,
      construct's validity, external validity and instrument's reliability will be explored.
    


Intervention name(s): parent-proxy QoL chronic cough specific questionnaire (PC-QOL)
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effects of a New Combination of Nutraceuticals (AkP06) Without Monacolin K on Plasma Lipids and Glucose
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      The study is designed evaluate the effects of a new combination of nutraceuticals (AkP 06)
      without Monacolin K on lipid and glucose metabolism.

      The study will analyze the impact of 4 weeks treatment with Akp06 or placebo, according to a
      randomized scheme, on metabolic parameters in dyslipidemic subjects that do not require or
      not tolerate a statin therapy. In particular, it will assess the ability of AkP 06 to reduce
      the plasma levels of LDL cholesterol, HbA1C, glicaemia and fasting insulin and to increase
      those of HDL cholesterol.

      In addition, effects on serum transaminase and creatine phosphokinase (CPK) concentration
      will be evaluated.
    

Detailed description: 
      The experimental design involves the construction of a placebo-controlled, randomized,
      single-blind, parallel-groups.

      Patients with mild hypercholesterolemia, of both sexes and aged between 18 and 75 years, will
      be recruited, from the beginning of the study and for the next 2 weeks at the outpatients
      Hypertension Clinic.

      The subjects will be enrolled in the 50/50% male/female ratio ± 10% comparable for age, in
      order to obtain a proper comparison between groups with similar demographic characteristics
      or not statistically different.

      The subjects, selected on the basis of inclusion and exclusion criteria, will be divided into
      two groups, to a computer based randomization scheme to receive one of two different
      treatments, two tablet/day before meals of the new nutraceutical AkP06 (Akademy Pharma)
      containing Morus Alba and without Monacolin K, vs. two tablet/day of placebo, always before
      meals. During the first two weeks both groups will follow the prescribed diet and assume
      placebo tablets. At the end, blood tests (traditional metabolic parameters, blood glucose,
      HbA1C, fasting insulin, transaminase levels, CPK) will be performed. During the next 4 weeks
      a group will assume AkP06 (Akademy Pharma) containing Morus Alba and without Monakolin K, the
      other will assume placebo and everyone will continue to follow the prescribed diet. At the
      end of this period blood tests will be repeated. Tablets of AkP06 and placebo will be
      provided by Akademy Pharma free of charge
    

Intervention name(s): AkP06; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet; first 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Dose-Ranging Study of SKF7® for Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study has been designed as a randomized, double blinded, multi-centric, placebo
      controlled and phase II dose-ranging study. One group will receive placebo alone and the
      other three groups will receive IP twice daily (different dosages) for four months.
    

Detailed description: 
      Labisia pumila or Kacip Fatimah, a native Malaysian plant, has been used as traditional
      medicine for over 400 years by both men and women for multiple treatments. Studies in animal
      models showed that Labisia pumila extract could regulate body weight gain and visceral fat
      reduction. SKF7® is a standardized extract of Labisia pumila (Kacip Fatimah) from the
      Myrsinaceae family.
    

Intervention name(s): SKF7® Labisia pumila standardized extract
Intervention type(s): Other
Intervention description(s): Botanical extract of Labisia pumila (Kacip Fatimah)
Other intervention name(s): SKF7®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Diabetes and Social Issues: Evaluation of a Diabetes Education Module
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly
      developed treatment and education module will be tested compared to a waiting-list control
      group. The module covers the topic "diabetes and social issues". Primary outcome variable is
      diabetes-specific empowerment regarding diabetes and social issues. Secondary outcome
      variables are: diabetes-related distress, health-related quality of life, depressive
      symptoms, self-care behavior, and glycemic control.
    

Detailed description: 
      The module consists of one lesson (duration: 90 minutes). The module is derived from the
      empowerment approach and is based on the previously evaluated education and treatment program
      for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by
      a trained diabetes educator. Patients are randomized either to the immediate participation in
      the module or to the control group. Control group is a waiting-list control group. Patients
      in this waiting-list control group get the education after the completion of the 6-month
      follow-up.
    

Intervention name(s): Education - Diabetes and Social Issues
Intervention type(s): Behavioral
Intervention description(s): Based on the treatment and education programme PRIMAS a problem-specific education module regarding "Diabetes and Social Issues" was created. The module covers specific and detailed aspects of the topic "social issues" such as driver licence, hypoglycemia when driving, and the pass for severly handicapped persons. With this module, a more comprehensive education of patients with specific interest is possible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; education; randomized; prospective
Evaluation of Inpatient Sleep and Activity Following Childbirth
Condition: Sleep
Study type: Observational

Summary: 
      Sleep is critical to mental and physical health following childbirth. However, patients who
      are hospitalized for labor and delivery may be admitted for days with significant impacts on
      sleep levels. Little is known about sleep and activity levels in inpatients during nighttime
      and daytime following childbirth and how this may affect their mental and physical health and
      wellbeing. If abnormalities are identified, targeted interventions may be possible to
      optimize recovery following delivery.
    


Intervention name(s): planned or unplanned Cesarean, operative, or non operative delivery
Intervention type(s): Procedure
Intervention description(s): All types of delivery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant women booked to deliver their child(ren) at Lucile Packard Children's
        Hospital. Eligible and consenting patients enrolled will wear an Actigraph watch during
        their inpatient stay (from preoperative period if undergoing cesarean delivery or during
        labor if undergoing a planned vaginal delivery).
      
Keywords: Postpartum sleep
Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants
Condition: Diphtheria; Hepatitis B; Poliomyelitis; Tetanus; Acellular Pertussis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study, infants will be randomly allocated into three groups:

        -  one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)

        -  the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)

        -  the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be
           double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current
           formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV
           vaccine.
    

Detailed description: 
      A study to compare the immunogenicity & safety of 2 formulations of GlaxoSmithKline (GSK)
      Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 & 5 months age. The
      immunogenicity & safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of
      subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current
      formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib
      vaccine (new formulation)
    

Intervention name(s): DTPa-HBV-IPV/Hib vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients
Condition: Cirrhosis; Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Hepatic encephalopathy (HE) is an important complication of liver cirrhosis. Lactulose is a
      first line treatment for HE, but the adherence to this treatment is relatively low, due to
      side effects such as diarrhea, distention, etc.
    

Detailed description: 
      Lactulose is a first line treatment for HE, but the adherence to this treatment is relatively
      low due to side effects. Lactulose-paraffin recently available in the market can be used for
      the treatment of HE, and possibly have fewer side effects.

      The aim of this study was to compare the adherence of the treatment of lactulose and
      lactulose-paraffin.
    

Intervention name(s): Comparison between Lactulose and Lactulose-Paraffin
Intervention type(s): Drug
Intervention MeSH terms: Lactulose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy
Condition: Chagas Disease
MeSH terms: Chagas Disease; Chagas Cardiomyopathy; Cardiomyopathies
Study type: Observational

Summary: 
      The purpose of this study is to analyze the influence of polymorphisms of the genes CLDN-1
      (Claudina-1), LGALS3 (Lectin galactoside-binding soluble 3), SOCS3 (Suppressor of cytokine
      signaling 3), IL-28B (interleukin-28B), CCL5 (Chemokine C-C ligand 5) in the determination of
      clinical forms and in the percentage of cardiac fibrosis in patients with Chagas disease.
    

Detailed description: 
      The Chagas disease, in its chronic phase, can lead to the development of cardiac arrhythmias
      and dilated cardiomyopathy, which can evolve to heart failure, causing great morbidity and
      reduction on patient's quality of life. Some patients stay asymptomatic while others develop
      the cardiac form of the disease (chronic chagasic cardiomyopathy), or other forms, like the
      digestive (megacolon and megaesophagus) and the mixed form (cardiac and digestive).

      The objective of this study is to analyze the association between single nucleotide
      polymorphisms with the clinical forms and the amount of cardiac fibrosis in patients with
      Chagas disease.

      The polymorphisms will be analyzed by real time PCR (Polymerase Chain Reaction). The genes
      whose polymorphisms will be analyzed are: galectin-3, SOCS-3, IL-28B, CLDN-1 and CCL5.

      The patients shall be accompanied in the specialized outpatient clinics for Chagas disease -
      Center of Biotechnology and Cell Therapy. They will be submitted to collection of blood
      samples for biochemical analysis and cardiac magnetic resonance imaging.
    

Intervention name(s): Gathering of samples of genetic material
Intervention type(s): Genetic
Intervention description(s): The samples will be obtained from peripheral blood mononuclear cells and the genotyping of the polymorphisms will be done by real time PCR.
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Tertiary Hospital
      
Biospecimen description: 
      Plasma, Serum, Whole Blood
    
Keywords: Chagas disease; Polymorphisms; Biomarkers
Oxytocin Antagonist in Patients With Repeated Failure of Implantation
Condition: Implantation Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the investigators compare the usual way of embryo transfer (without medication)
      with an embryo transfer while administering oxytocine antagonist. This to improve
      implantation and increase the pregnancy rate.
    


Intervention name(s): Atosiban; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bolus atosiban 6.75mg + infusion atosiban 18mg/u during 3 hours. once administered starting 1 hour before embryotransfer.
Intervention MeSH terms: Atosiban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: repeated implantation failure (RIF); atosiban; pregnancy
Effect of Tadalafil (Cialis) on the Cardiovascular System of Spinal Cord Injury (SCI) Males
Condition: Hypotension; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Hypotension; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      To address the effect of tadalafil (Cialis) on the cardiovascular system of men with complete
      spinal cord injury at T-6 and above. The hypothesis is that tadalafil will cause significant
      hypotension in people with tetraplegia.
    

Detailed description: 
      Tadalafil is a long-acting PDE-5 inhibitor, used to treat erectile dysfunction (ED). ED is a
      common issue for males with spinal cord injury (SCI).Patients with SCI are at risk of
      developing orthostatic hypotension, especially those with an injury at or above the T-6
      level.An earlier study of the shorter-acting PDE-5 inhibitor sildenafil (Viagra) revealed
      that it can cause orthostatic hypotension, tachycardia and dizziness after administration in
      the SCI population, and suggested that caution should be used in prescribing sildenafil in
      this population, as blood pressure can drop significantly. There is potential for the
      significant hypotension seen with the short-acting medications to be much more problematic
      with the longer-acting tadalafil.

      The study will be a prospective, randomized, double-blind, placebo-controlled cross-over
      design. This will be done by comparing the effects of administering tadalafil 20 mg and
      placebo on blood pressure (lying and sitting), and heart rate (lying and sitting). These
      measurements will be taken in the clinic setting prior to dosing, then repeated hourly for
      the first two hours post-dose, and again at four hours post-dose. The patient will repeat the
      measurements at home using an automated blood pressure apparatus at 12, 22,29 and 36 hours
      post-dose.In addition, the patient will record perceived dizziness on a visual analog scale
      ecah time the BP and HR are recorded.
    

Intervention name(s): tadalafil; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg tablet, administered once per study protocol; placebo tablet administered once per study protocol
Other intervention name(s): Cialis
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypotension in SCI males; Erectile Dysfunction
Enhanced Vascular Function Following Intake of Feruloyl Esterase-processed High Fibre Bread.
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      This study evaluates the impact of a high phenolic acid intake from wholegrain wheat bread on
      human vascular function and plasma phenolic acid concentrations in healthy adults. All
      participants received a high fibre flatbread with enzymatically released free FA (14.22 mg),
      an equivalent standard high fibre bread (2.34 mg), or a white bread control (0.48 mg).
    

Detailed description: 
      Clinical trial data have indicated an association between wholegrain consumption and a
      reduction in surrogate markers of cardiovascular disease. A number of components of wheat
      have been suggested to contribute to the cardiovascular health benefits associated with
      wholegrain consumption, most notably the fiber component. However, phenolic compounds that
      are bound to arabinoxylan fibre, particularly the hydroxycinnamate ferulic acid, may also
      contribute, in part, to vascular health effects. These phenolics may be more active when
      released enzymatically from the fiber prior to ingestion.

      The aim of the present study was therefore to determine whether the intake of high fibre
      bread containing higher free ferulic acid levels (enzymatically released during processing)
      enhances human endothelium-dependent vascular function to a greater extent than that of
      traditional wholegrain bread and/or a white bread control.
    

Intervention name(s): White Bread; Wholegrain bread; Wholegrain Enzyme
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): White bread made with commercial white flour with bran/fibre removed; Wholegrain bread made with commercial wholegrain flour.; Wholegrain bread made with enzyme-treated commercial wholegrain flour.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal
Condition: Whooping Cough; Malaria; Malnutrition
MeSH terms: Malaria; Whooping Cough; Malnutrition
Study type: Observational

Summary: 
      Longitudinal survey in Northern Senegal to investigate the environmental factors modulating
      the immune response to childhood vaccines and to malaria.

      A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor
      District) was followed-up for 18 months. During that period, 5 visits have been made to the
      villages to assess the immunological and nutritional status of the children.
    

Detailed description: 
      Longitudinal survey in Northern Senegal to investigate the environmental factors modulating
      the immune response to childhood vaccines and to malaria.

      A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor
      District) was followed-up for 18 months. During that period, 5 visits have been made to the
      villages to assess the immunological and nutritional status of the children (T1 (October
      2008), T2 (January 2009), T3 (June 2009), T4 (October 2009) and T5 (January 2010)).

      The project was approved by the National Ethics Committee of Senegal. Written individual
      informed consent was obtained from each participant's parent or legal guardian at the
      beginning of the survey, and at each visit child's and parent's approval was sought orally.

      Capillary blood was collected from the finger tip of each child, using sterile single-use
      material.

      Body temperature was measured by means of auricular thermometer at all visits.
      Anthropomorphic data were collected at visits T2, T3, T4 and T5.

      A Hemocue photometer (HemoCue AB, Ängelholm, Sweden) was used to determine haemoglobin
      concentration on a blood drop at visits T3, T4 and T5.

      At each visit, a questionnaire was filled in for every child. Information was collected on
      the date of birth family membership to asses if siblings or children living in the same house
      were in the cohort.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Residents of 5 villages from the Senegal Valley River, belonging to the Podor District in
        Saint-Louis Region in Northern Senegal.

        Agniam (16°32'N-14°48'W; total population (TP): 989; several temporary ponds, traditional
        housing, irrigated crops) Fanaye Diery (16°32'N-15°13'W; TP: 6781; animal husbandry,
        irrigated crops, some urbanized habitat) Niandane (16°35'N-14°59'W; TP: 5100; Rice and
        banana farming, irrigated crops, some urbanized habitat) Ndiayène Pendao (16°30'N- 15°03'W;
        TP: 2734; animal husbandry, Savannah surroundings) Guédé Village (16°33'N-14°48'W; TP:3005;
        Traditional housing, irrigated crops)
      
Biospecimen description: 
      Sera, culture supernatants
    
Keywords: Children; Immunity; Sub-Saharan; Pertussis; Malaria; Nutrition; antibodies