cyrilzakka/clinical-trials huggingface dataset:
PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy

The trial compares Laxabon® 4L versus Pursennid® Ex-Lax 36mg and 2L Laxabon® for large bowel cleansing prior to colonoscopy allocating patients planned for colonoscopy to one of the two cleansing regimens.

Effective large bowel cleansing prior to colonoscopy is still not achieved in all cases that undergo the procedure. The use of balanced electrolyte-polyethylene glycol (PEG) solution have improved the cleansing results and shortened the time needed for preparing the bowel. The problem with using PEG solution alone is the relatively large volume of the solution that the patients need to drink. The recommendation is to drink the solution until diarrhea fluid is clear and often 4 L or more is needed. Many patients refuse to drink the sufficient volume needed to get a clean colon. The large volume load can be a risk to patients suffering from renal and/or heart insufficiency.

Good results of bowel cleansing have also been reported with sodium phosphate solution or tablets. The fluid volume needed to drink along with sodium phosphate is generally no problem but this regimen causes electrolyte disturbances that usually are subclinical and of no significance but in patients with renal or heart insufficiency the sodium phosphate is contraindicated due to the risk of serious electrolyte disturbances.

Several combinations of stimulant laxatives with PEG solution have been tested before and the actual combination has been compared in one randomized study(1). Low-volume PEG plus sennosides preparation was better tolerated but it was not as effective as standard large-volume PEG.

PEG solution (Laxabon®) 4L is used for large bowel cleansing in many centers in Sweden and is the standard regimen used in our colonoscopy unit. In this study we compare this standard regimen with senna glycoside (Pursennid® Ex-Lax) 36mg (tablets) taken orally in the night before the colonoscopy and 2L Laxabon® solution orally starting to drink the solution four hours prior to the colonoscopy.

The result of large bowel cleansing is evaluated during the colonoscopy according to two separate validated scoring methods (Aronchick and Ottawa scores). Abdominal symptoms, discomfort, subjective grading of how hard/easy it was to complete the cleansing program and extra costs are evaluated with questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled to undergo elective complete colonoscopy as an outpatient
* Age 18 or older
* The patient gives written informed consent and can understand the information given
* The patient can participate only once in the study

Exclusion Criteria:

* Earlier resection of the large bowel or rectum
* Active known colitis
* Ileus or gastro-intestinal obstruction
Electromyographic (EMG) and Mechanomyographic (MMG) Comparison

The purpose of this study is to assess the delay between the detection (by mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough effort.


Eligibility Criteria:
Inclusion Criteria:

* More or equal than 18 years old
* Patient affiliated to social security or similarly regime
* Healthy volunteer
* BMI less than 30

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent or person under legal protection
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
Effect of a Plant-based Ingredient on Glucose Response

The study is designed to determine the extent to which a plant-based ingredient is able to modulate blood glucose response when administered with a meal.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, age at start of the study ≥ 18 and ≤ 50 years;
* Apparently healthy: no medical conditions which might affect the study measurements, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
* Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
* Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm/dL; both inclusive) as judged by the research physician;
* Body mass index (BMI) ≥ 18,0 and ≤ 25,0 kg/m2;
* Agreeing to be informed about medically relevant personal test-results by study physician;
* Willing to comply to study protocol during study;
* Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
* Accessible veins on arms as determined by examination at screening;
* Being literate;
* HbA1C ≤ 6.5 % (48 mmol/mol).

Exclusion Criteria:

* Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
* Any history of gastro-intestinal disorders (including frequent diarrhoea for example);
* Blood donation in the past 2 months;
* Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
* Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between 23.00 PM and 6.00 AM;
* Reported intense sporting activities \> 10h/w;
* Consumption of ≥120 ml of alcoholic drinks for males and females in a typical week;
* Drug abuse as indicated by urine analysis;
* Chronic smokers, tobacco chewers and drinkers;
* Use of any medication, including supplements and traditional medicine;
* Reported dietary habits, such as a medically prescribed/slimming diet;
* Not being used to eat breakfast;
* Reported weight loss/gain (\>10%) in the last six month before the study;
* Being an employee of Unilever or CRO;
* Allergy or intolerance to food products and aversion to food products provided during the study;
* If female: pregnant or will be planning pregnancy during the study period;
* If female: lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period.
Vitamin D in Healthy Adults After Strenuous Endurance Exercise

The purpose of this study was to investigate the effects of vitamin D supplementation on biochemical response and aerobic capacity after strenuous endurance exercise (SEE).

All participants conducted a graded exercise test on an ergometric bicycle to determine the maximal oxygen consumption (VO2max) before and after supplementation, and the speed equivalent to 65% VO2max was conducted for a SEE test by ergometric bicycle for 2 hours, followed by increasing 100 RPM until exhaustion. Venous blood samples were drawn before, immediately after, 2-hour after, 4-hour after, 8-hour after, and 24-hour after the SEE test to determine the concentrations of biomarkers. Data was analyzed by Two-way mixed design ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* The volunteers included have conditions as stated below :

  1. no history of cardiovascular, liver, kidney and diabetes disease
  2. no acute sport injury
  3. male adult whose concentration of 25(OH)D is under 30 ng/mL, and maximal oxygen consumption is over 40 ml/kg/min
  4. did not participated in any clinical trials or research in the last 3 months before our experiment
  5. no supplements were taken during the experimental period
  6. were requested to maintain their regular daily life style and avoid alcohol intake

Exclusion Criteria:

* The volunteers were excluded if they have the situation stated below:

  1. history of cardiovascular, liver, kidney and diabetes disease
  2. acute sport injury
  3. their concentration of 25(OH)D is over 30 ng/mL, or maximal oxygen consumption is under 40 ml/kg/min
  4. participated in any clinical trials or experimental research in the last 3 months before our experiment
  5. taking supplement during the experimental period
  6. did not maintain their regular eating habit or drink alcohol
Dietary Nitrate Supplementation and Crossfit Athletes

In the past, dietary nitrate supplementation has been shown to have clinical benefits in the treatment of cardiovascular issues. More recently, however, the focus of nitrate supplementation has shifted to focus of human performance, and has shown to increase the time to exhaustion during maximal intensity exercise and lower the cost of oxygen consumption during submaximal intensity exercise. Acutely, nitrate supplementation in the form of beetroot juice has been shown to increase strength measurements, as well as increase the time to complete a 2000 meter rowing ergometer test. However, to the author's knowledge, there are no studies that link the relationship between multi-day nitrate supplementation and the rowing test or the nitrate's effect on strength when in the salt form. Additionally, to the author's knowledge, no evidence has been published which relates dietary nitrate supplementation and its effects on a CrossFit circuit workout.

Our central hypothesis is that six days of dietary nitrate supplementation will improve strength, endurance, a power more than a placebo in male CrossFit athletes.

The purpose of this randomized, double-blind, crossover study is to identify if dietary nitrate supplementation improves strength , endurance, and power measurements in male CrossFit athletes. Specifically, the strength measurements will be taken using isometric and isokinetic tests on the Biodex dynamometer. Endurance will be measured using time trials for a 2000 meter rowing test and the "Fran" CrossFit workout. Finally, power will be analyzed using the Wingate cycle test.

The treatment group will receive 1 serving of f potassium nitrate KNO3- (N) (8 mmols NO3-). The placebo group will receive 1 serving of the nitrate-free placebo (PL) potassium chloride (8 mmol KCl).

The participants will complete two three-day baseline testing, with a six-day supplementation period following each round of baseline testing. Following the first six-day supplementation period, there will be a 10 day washout period before the second baseline testing begins.

Eligibility Criteria:
Inclusion Criteria:

* College-aged male CrossFit between the ages of 20 and 35 years (yr), a peak maximum oxygen uptake (VO2peak) of at least 50 ml/kg/min will be recruited to participate in this study.

Exclusion Criteria:

* Having any thyroid and/or kidney diseases that could affect NO synthesis and/or metabolism, any illness, smoking, taking other medications, injured, not well-trained (as noted by the VO2peak), consuming any other supplements at the time of the study except protein or multivitamin, allergic to any component of the supplement, including tree nuts, in case of potential packaging mixing and contamination. Women and children as well are excluded.
Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage

The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.

Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to assess for cure. Patients were contacted 1 month later to determine if they had developed another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).

Eligibility Criteria:
Inclusion Criteria:

* patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter)
* minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient

Exclusion Criteria:

* patients requiring immediate hospitalization
* patients who have received 2 or more doses of antibiotics in the previous 36 hours
* patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices
* patients with a concurrent, non-abscess infection
* patients with an allergy to Trimethoprim-sulfamethoxazole
Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health

The primary goal of this research is to evaluate the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on gut health, including microbiome-metabolome arrays and gut epithelial/barrier function, in healthy young adults.

Secondary Objectives include:

* To examine the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on the measures of metabolic health and inflammation in healthy young adults.
* To determine the feasibility of healthy young adults to successfully incorporate and sustain the recommended daily intake of pulses into their diets for eight consecutive weeks

Research Interventions:

Participants will be asked to consume a normal diet supplemented daily with either A) whole-cooked canned lentils, or B) whole-cooked canned chickpeas. The control condition will be instructed to consume a normal diet while restricting all pulse intake throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 30 years old
* Ability to speak and read in English

Exclusion Criteria:

* Intake of antibiotics in the last 3 months
* Intake of pre/pro/postbiotics in the last 3 months
* Current or past (within the last 6 months) user of tobacco, marijuana, or E-cigarette products
* Cardiovascular disease (heart failure, hypertension, hyper/dyslipidemia, past myocardial infarction)
* Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, fistulas, suspected or known gastric strictures, gastritis, radiation enteritis, GI bleeding, gastric bezoar, recent GI surgery in the last 3 months, etc..),
* Neurological disorders (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled or insulin dependent diabetes - A1C \> 9%).
* Food allergy to study foods (pulses or soy, milk, peanuts, tree nuts)
* Regular consumption of pulses (\>1 cup/wk for males; \>0.5 cup/wk for females)
* Current heavy alcohol use (≥ 15 drinks / week for men, ≥ 8 drinks / week for women)
* Class 3 Obesity (BMI \> 40 kg/m2)
* Known to be currently pregnant (self-disclosed).
Redetachment Under Densiron for RD Multiple Breaks

Densiron is used as a tamponading agent for inferior retinal detachment with inferior retinal breaks However, data about the use of Densiron -68 for RRD with multiple retinal breaks; especially if involving both superior and inferior quadrants; are not sufficient.

Inferior retinal detachment (IRD) (retinal detachment with inferior retinal breaks ± proliferative vitreoretinopathy) poses a challenge to primary pars plana vitrectomy because of the insufficient tamponade effect. Lighter than water tamponading agents - including gas and silicone oil (SO)- provide no contact with inferior retina, which may open up inferior retinal breaks and may develop proliferative vitreoretinopathy (PVR) as well.

Heavier than water tamponading agents are used for IRD with a favorable outcome. They include: fluorosilicone oil (FSO) 1 2, perfluorocarbon liquids 3 4 , semifluorinated alkanes namely perfluorhexyloctane (F6H8) 5, and fluorinated alkanes which include: HeavySil 6, Oxane HD 7 8 9 10, HWS 46-3000 11, and Densiron-68. 12-22

Densiron-68 (Fluoron, Neu Ulm, Germany) consists of a mixture of polydimethylsiloxane 5000 (PDMS) (69.5%) and perfluorhexyloctane (H6F8) (30.5%). It has a viscosity of 1387 mPas, specific gravity of 1.06 g/cm3, and interfacial tension of 35 mN/m. it has been successfully employed for IRD with a favorable outcome. 15,17,19,20,22,16,12-14,23,18 The final retinal reattachment rate reached up to 95%. 15 There are several reports about the use of Densiron-68 for IRD associated with PVR which reveal a favorable secondary reattachment rate; ranging between 70% and 95%. 17,21,24,25

However, data about the use of Densiron -68 for RRD with multiple retinal breaks; especially if involving both superior and inferior quadrants; are not sufficient.

Eligibility Criteria:
Inclusion Criteria:

* - RRD with multiple retinal breaks (MRBs), using Densiron-68 tamponade.
* Age= 16 and older

Exclusion Criteria:

* - RRD using conventional silicone oil (SO) or Gas tamponade.
* RRD with single RBs
* Age \< 16 years
Epilepsy Impact Scale

The investigators are developing a questionnaire that can quickly measure the impact that epilepsy has on a person's life. This questionnaire will be useful in following whether the impact of epilepsy increases, decreases or stays the same over time. The results also may point out areas that would benefit from discussion or attention in visits with your doctor.

The investigators have used a set of broad open-ended questions about the impact of epilepsy on a person's life to formulate a long list of questions to characterize the impact the seizures, medications, and comorbidities that you are having. In the future, this will be boiled down to a short list of questions.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or more.
2. Patient has had at least 1 seizure in the past 365 days.
3. Patient can speak and understand English.

Exclusion Criteria:

1. Patients suspected of having one of the imitators of epilepsy, for example, syncope, sleep disorder, psychogenic nonepileptic seizures, will be excluded, even if they also have epileptic seizures.
2. Patients unwilling to spend the time doing the questionnaire.
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Only patients successfully completing study CLAF237A2311 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from CLAF237A2311
* Other protocol-defined exclusion criteria may apply
Combining Bioimpedance and Blood Volume Measurements in Haemodialysis

Around 60,000 patients in the UK are being treated for severe kidney failure. The most common treatment is haemodialysis (HD). An important part of HD is removing extra fluid from the body which the kidneys normally remove in urine. Deciding how much fluid to remove is not easy. It is normally based on clinical signs, such as blood pressure or tissue swollen with fluid, but there is a need for better tests to help guide these decisions.

Bioimpedance tests are one way of measuring fluid status. They involve passing a small electric current through tissue using stickers on the skin. The test is portable, cheap, simple, painless and harmless. One bioimpedance device, the Body Composition Monitor (BCM), has been designed particularly for kidney patients. However the BCM measures fluid in the whole body and cannot tell us how much fluid is in the blood (the blood volume), which has the biggest effect on patients' health.

The aim of this study is to see whether blood volume measurements can help to make fluid management more individualised. This could reduce the impact of dialysis on patients' health and improve patients' experience of the treatment.

Objective 1: To demonstrate whether the addition of blood volume measurements can help to tailor fluid management to HD patients' individual needs. In particular we will look at how body size, nutritional state, age and localised fluid can affect patients' blood volume.

Objective 2: To see if there is a simple way of making blood volume measurements with no need for expertise or extra equipment.

It is planned to recruit 40 patients into 4 clinically different groups and compare results between them.

The results will be compared between groups to help us understand how decisions about fluid management can be tailored to keep blood volume at the optimal level.


Eligibility Criteria:
Cohort 1 - Reference group: This group is intended to represent HD patients who have normal fluid status and normal compartmental fluid volumes.

Inclusion criteria:

* Ultrafiltration volumes in the preceding two weeks of less than 0.5 litres;
* pre-HD BCM-measured OH \<1.1 litres; pre-HD blood pressure \<140/90.

Cohort 2 - High BMI group: This group is intended to represent patients with high BMI who routinely finish dialysis with significant fluid depletion, as defined by BCM, without intradialytic symptoms.

Inclusion criteria:

* BMI\>30 with target weight \> 1.1 kg below normally hydrated weight;
* no recorded symptoms related to fluid removal in the preceding 2 weeks.

Cohort 3 - Low LTI group: This group is intended to represent patients who have a low LTI and who routinely finish dialysis with a degree of excess fluid as defined by BCM.

Inclusion criteria:

* LTI \< 10kg/m2 with target weight \> 1.1 kg above normally hydrated weight.

Cohort 4 - Localised oedema group: This group is intended to represent patients who have localised lower limb oedema.

Inclusion criteria:

* Oedema as defined by pitting