bioihbjkbjnl/mcl2 huggingface dataset:
French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      Single arm, multi-center prospective clinical trial to determine the safety and effectiveness
      of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80
      years of age.
    


Intervention name(s): AQUABEAM System
Intervention type(s): Device
Intervention description(s): Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lower Urinary Tract Symptoms (LUTS); Benign Prostatic Hyperplasia (BPH); AQUABEAM; Aquablation
Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation
Condition: Exercise-induced Asthma
MeSH terms: Asthma; Asthma, Exercise-Induced; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the bronchial inflammation and
      hyperresponsiveness after oil supplementation. Before and after oil supplementation the
      investigators measure decrease in lung function after exercise-challenge in a cold chamber
      and increase of inflammatory markers in the blood.
    

Detailed description: 
      Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung
      function testing at rest and show a decrease in lung function when they do sports or an
      exercise-challenge. In a previous study the investigators could show, that the combination of
      exercise test and inhalation of cold air ist more sensitive and specific than
      exercise-challenge in ambient temperature.

      It is known that omega - 3 -fatty acids could reduce the production of inflammatory
      mediators.

      In this study the investigators will investigate the protective effect of oil supplementation
      with middle-chain and polyunsaturated fatty acids in an exercise-induced asthma provocation
      model.

      Therefore the investigators will measure the decrease in lung function and a increase of
      inflammatory markers in the blood before and after oil supplementation.

      Before and after the exercise-challenge the investigators will measure spirometry and body
      plethysmography. The investigators want to examine if the body plethysmography is more
      sensitive in the measurement of exercise induced bronchoconstriction than spirometry.

      The investigators hypothesize that the oil supplementation can reduce bronchial inflammation
      and hyperresponsiveness.
    

Intervention name(s): Exercise challenge in a cold chamber; Methacholine challenge; Oil supplementation verum; Oil supplementation placebo
Intervention type(s): Other; Other; Dietary Supplement; Dietary Supplement
Intervention description(s): Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.; Nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg; Patients and subjects will take double blind an oil supplementation with middle-chain and polyunsaturated fatty acids for four weeks; Patients and subjects will take double blind sunflower oil for four weeks
Intervention MeSH terms: Methacholine Chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: exercise-induced asthma; cold chamber; exercise challenge; cold air challenge; oil supplementation; middle-chain and Polyunsaturated Fatty Acids
Neutrophil Function During Therapy With Protease Inhibitors in Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The aim of this study is to characterize neutrophil function in patients undergoing chronic
      hepatitis C triple therapy with protease inhibitors in comparison to dual therapy with
      peginterferon and ribavirin and with interferon free treatment regimen to thereby elucidate
      the possible mechanisms of protease-inhibitor associated infections.
    

Detailed description: 
      Chronic hepatitis C infection (CHC) is a major health problem, potentially leading to liver
      related mortality via complications of liver cirrhosis or hepatocellular carcinoma, and
      affects more than 185 million persons worldwide. Antiviral therapy evolved during the past 25
      years from standard interferon, the combination with ribavirin and pegylated interferon (P/R)
      to the addition of protease inhibitors and is currently on the edge to an interferon-free era
      with the first such substances being approved in 2014. However, current standard therapy for
      CHC genotype 1 patients without cirrhosis consists of ribavirin and pegylated interferon
      (P/R) in combination with boceprevir (BOC) or telaprevir (TPV), which are direct acting
      antivirals and represent the first-generation protease inhibitors.

      Triple therapy for CHC has been reported to be associated with a quantitative and qualitative
      increase in treatment-related (serious) adverse events compared to the former standard
      therapy without protease-inhibitors. Moreover, reports of serious infectious complications
      during triple therapy - especially in patients with acquired immune deficiencies like liver
      cirrhosis - that lead to considerable morbidity and mortality, have accumulated recently. The
      mechanisms of this increased susceptibility to infections remain unclear. However, BOC is
      known to inhibit neutrophil elastase activity.

      Aims of this study were therefore to analyse infections that occurred in CHC outpatients
      during therapy in the study centre, to prospectively characterize neutrophil function in
      patients undergoing CHC triple therapy in comparison to dual therapy with peginterferon and
      ribavirin and to thereby elucidate the possible mechanisms of protease-inhibitor associated
      infections.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with chronic hepatitis C undergoing antiviral therapy
      
Biospecimen description: 
      Serum Plasma
To Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib, and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours
Condition: Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-part study in patients with advanced solid tumours: Part A will assess the effect
      of itraconazole on the PK parameters of olaparib and will determine the effect of olaparib on
      the QT interval following single oral dosing; Part B will determine the effect of olaparib on
      the QT Interval following multiple oral dosing; Part C will allow patients continued access
      to olaparib after the PK and QT phases and will provide for additional safety data
      collection. A total of 48 patients are planned to be enrolled; at least 42 evaluable patients
      will be required to complete the study. Patients will participate as a single cohort in all
      parts of the study.
    


Intervention name(s): Pharmacokinetic sampling; Olaparib tablet dosing; Itraconazole
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Blood samples taken pre and post dosing with olaparib+/- itraconazole; Olaparib tablets: Part A 100mg od, days 1 and 9 only. Part B 10x300mg doses over 5 days (300mg bd).; Itraconazole 200mg od Part A days 5 to 11 only
Intervention MeSH terms: Itraconazole; Olaparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: oncology,; cancer,; tumour,; anticancer drug,; pharmacokinetics,; olaparib,itraconazole,; neoplasm,; QT interval
Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
Condition: Breast Cancer; Melanoma
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      Generally, French studies concerned with the quality of life of cancer patients focus on the
      period of treatment (up to 2 years post diagnosis). However, studies about quality of life
      "after" cancer are relatively rare (= long-term quality of life, or from 5 years post
      diagnosis). These studies mainly concern the most common cancers (breast and prostate).

      Or changes in quality of life after treatment could be different depending on the type of
      cancer. In addition, there is a significant influence of sociodemographic variables on the
      quality of life in remission.

      Similarly using remote diagnostics, quality of life questionnaires related to health, must be
      reassessed because too often developed for situations in process.

      Based on these findings, "ELCCA II" study proposes to study for five years, the evolution of
      the impacts of two types of cancer (breast and melanoma) on quality of life (overall and
      related to the subjective health), socioeconomic status, and behavioral and emotional
      dimensions (post-traumatic development, coping, anxiety-depression) of those treated.
    


Intervention name(s): quality of life assessment
Intervention type(s): Other
Intervention description(s): All patients with breath cancer or melanoma will have quality of life assessment 1, 6, 12, 24, 48 and 60 months after the initial cancer diagnosis.
Those assessment will use standardized quality of life questionnaire :
QLQ-C30
SWLS (Satisfaction with Life Scale)
PTGI (Post-Traumatic Growth Inventory)
HADS (Hospital Anxiety and Depression Scale)
Brief COPE
MHLCS (Multidimensional Health Locus of Control Scale)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Mechanisms of Desensitization During Peanut Oral Immunotherapy
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to attempt to understand how desensitization works in peanut
      allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify
      the early changes in the desensitization process the immune cells undergo to become
      desensitized to the peanut protein.
    

Detailed description: 
      Peanut allergic children will undergo an oral food challenge (OFC) to 1 gm peanut protein in
      order to accomplish two objectives: (1)to confirm the diagnosis of peanut allergy, and (2) to
      measure the amount of peanut protein it takes to cause an allergic reaction. Each subject
      will then undergo a modified rush phase in which the subject receives 6 doses of peanut
      protein in one day. The build-up phase begins afterward in which the subject's dose of peanut
      protein is increased every 2 weeks for 36 weeks. After the final build-up dose, the subject
      consumes that dose for 2 weeks after which he or she returns to the food allergy center for
      the second food challenge. If the subject successfully consumes this food challenge without
      symptoms, the daily dosing of peanut protein will be stopped and the subject will then
      undergo a third food challenge. If the subject successfully consumes the peanut protein
      during that challenge, he or she will return for a fourth food challenge to peanut.
    

Intervention name(s): Open label peanut OIT
Intervention type(s): Drug
Intervention description(s): Subject will take increasing amounts of peanut protein up to a maximum maintenace dose of 1450mg.
Other intervention name(s): Peanut flour
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Peanut allergy
Axial Length Variability
Condition: Cataract Senile
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The accuracy of IOL calculation relies on the one hand on axial length measurements and on
      the other hand on corneal and lens thickness measurements.

      AL difference in pre and postoperative measurements may be caused by changes of lens
      parameters.

      Aim of this study is to evaluate the magnitude of changes in pre and postoperative
      measurements of AL.
    

Detailed description: 
      This is a prospective observational, controlled and unmasked study that would include
      patients which undergo cataract presurgical examination, after patient signed written
      informed consent. For each patient only one eye will be included.

      In total 50 eyes of 50 patients will be include. Due to missing previous data, the sample
      size is an approximation.

      Prior to surgery, slit lamp examination and cataract grading (LOCS) is performed. Routine
      biometry is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and
      Heidelberg Anterion (Heidelberg Engineering, Germany) for AL and lens measurement.

      Additionally, evaluation of tilt and decentration will be performed using Purkinje meter
      device.

      Follow-up examination will be performed three months after surgery and will contain: AL and
      lens measurement using the two ss-OCT biometery devices, lens evaluation (tilt and
      decentration of the IOL) using the Purkinje meter. Refractive outcome will be evaluated by
      determining best-corrected visual acuity and subjective refraction.

      In women of childbearing age, a pregnancy test will be performed before inclusion into the
      study.

      Main outcome variable:

      • Extend of AL difference between pre- and postoperative measurements in both devices

      Additional outcome variables:

        -  Agreement between the two ss-OCT devices in AL measurement

        -  Evaluation of lens parameter in AL differences between pre- and postoperative
           measurements

        -  Limit of agreement in lens tilt and decentration using two ss-OCT devices and Purkinje
           meter
    

Intervention name(s): Axial length variability
Intervention type(s): Other
Intervention description(s): Biometry (axial length measurement)is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) pre and postoperatively.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
School Nurse-directed Secondary Obesity Prevention for Elementary School Children
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Primary Aim: To test the efficacy of an elementary school-based, school nurse-led weight
      management program to reduce excess weight gain among children, 8 to 12 years old who are
      overweight and at risk of overweight by increasing healthy dietary practices and physical
      activity levels and decreasing sedentary practices.

      Primary Hypothesis: Relative to the control condition, the children receiving the
      intervention will have a significantly lower body mass index (BMI), following implementation
      of the 9-month intervention, controlling for baseline values.
    

Detailed description: 
      Primary Hypothesis: Relative to the control condition, the children receiving the
      intervention will have a significantly lower body mass index (BMI), following implementation
      of the 9-month intervention, controlling for baseline values.
    

Intervention name(s): SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together); Mailed monthly newsletters
Intervention type(s): Behavioral; Behavioral
Intervention description(s): attention control condition after school weight management program; Newsletters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Bread Gluten Content on Gastrointestinal Volumes
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators will apply non invasive Magnetic Resonance Imaging (MRI) techniques
      developed in Nottingham to evaluate the gastric emptying, small bowel water content, colonic
      gas and volumes in healthy volunteers eating three breads with different amount of gluten
      (none, normal, or high gluten) in three consecutive weeks.
    


Intervention name(s): MRI scanners; VAS Symptom scores
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Stomach; Small bowel; Colon; MRI; Function; Gastrointestinal volumes
Effects of Milk Proteins on Protein Synthesis in Healthy Male Subjects Fed a Hypercaloric, High Sucrose Diet
Condition: Obesity
Study type: Interventional

Summary: 
      This study aims at assessing the hypothesis that dietary protein content is a major factor
      regulating lean body mass gain and energy expenditure during overfeeding, and thus long term
      body weight gain

      To test this hypothesis, healthy normal weight male and female subjects will before and after
      a 7-day hypercaloric, high-sucrose diet (+40% excess energy as sucrose) and either a low (5%
      total energy) or a high (20% total energy) protein intake. Each subject will be studied with
      both low- and high protein diets according to a randomized, crossover study. On each occasion
      the following measurements will be done in basal conditions (after 2-day isoenergetic,
      controled diet) and at the end of the 7-day overfeeding:

        -  whole-body protein turnover, oxidation and synthesis in fasting conditions and fed
           conditions (13C-labelled leucine)

        -  intrahepatic and intramuscular fat concentration (1H-Magnetic Resonance Spectroscopy)

        -  Energy metabolism in fasted and fed conditions (indirect calorimetry)

        -  plasma concentration of glucose, non-esterified fatty acids, total triglyceride,
           very-low density lipoprotein (VLDL)-triglyceride, insulin, glucagon, growth hormone
           (GH), insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein
           (IGFBP) 1,2 and 3 in fasting and fed conditions The effects of high-protein and
           low-protein sucrose overfeeding on whole body protein synthesis will be compared using
           two-way ANOVA; relationships between changes in whole body protein synthesis on one
           hand, and intrahepatic/intramuscular fat concentrations, total energy expenditure, and
           plasma concentration of metabolic variables on the other hand, will be evaluated by
           linear regression analysis
    


Intervention name(s): 7-day overfeeding
Intervention type(s): Other
Intervention description(s): 7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: protein synthesis; intrahepatic fat; lean body mass; IGF1; energy metabolism
Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
Condition: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients
      being treated with chemotherapy.

      PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs
      work in preventing delayed nausea after chemotherapy in patients who have cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effectiveness of a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist
           antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in
           patients with chemotherapy-naive cancer.

        -  Compare the effectiveness of prochlorperazine administered on a preventive vs as needed
           basis in controlling delayed nausea after chemotherapy in these patients.

        -  Compare the quality of life of patients treated with a 5-HT3 receptor antagonist
           antiemetic vs prochlorperazine.

        -  Compare the quality of life of patients treated with prochlorperazine administered on a
           preventive vs as needed basis.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      center.

      Patients receive their scheduled chemotherapy regimen containing doxorubicin and their
      scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic (ondansetron,
      granisetron, tropisetron, or dolasetron mesylate) combined with dexamethasone on day 1.

      Patients are then randomized to 1 of 3 antiemetic arms.

        -  Arm I: Patients receive oral prochlorperazine every 8 hours on days 2 and 3.

        -  Arm II: Patients receive oral ondansetron every 12 hours, oral granisetron every 12
           hours, or oral dolasetron mesylate either once a day or every 12 hours on days 2 and 3.

        -  Arm III: Patients receive oral prochlorperazine as needed, up to 4 times per day, on
           days 2 and 3.

      Quality of life is assessed at baseline and on day 4.

      PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study within 3 years.
    

Intervention name(s): dolasetron mesylate; granisetron hydrochloride; ondansetron; prochlorperazine; quality-of-life assessment
Intervention type(s): Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Ondansetron; Granisetron; Prochlorperazine; Dolasetron
Allocation: Randomized
Primary purpose: Supportive Care
Keywords: nausea and vomiting; unspecified adult solid tumor, protocol specific
Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
Condition: Tibial Fracture
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used
      in conjunction with standard-of-care treatment compared to standard-of-care treatment alone
      in the care of subjects with open fractures of the tibial diaphysis.
    

Detailed description: 
      CERAMENT™|G is a resorbable, gentamicin containing ceramic bone graft indicated to fill bony
      voids or gaps which are not intrinsic to the stability of the bony structure and where there
      is risk of bacterial contamination.
    

Intervention name(s): CERAMENT|G; SOC treatment
Intervention type(s): Device; Procedure
Intervention description(s): Surgical repair of tibia fracture, CERAMENT™|G applied to bony voids.; surgical repair of tibial fracture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: wound; open fracture; fracture; tibial