cyrilzakka/clinical-trials huggingface dataset:
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea

Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
* Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
* Baseline serum potassium \> 3.0 mmol (meq)/L
* Patient considered sufficiently stable clinically to likely complete a 6 week study period
Association of Multiple Medications With the Severity of Dyspepsia

Dyspepsia is a very common gastrointestinal disease. Some medications, were associated with higher frequent incidences of dyspepsia, including non-steroid anti-inflammatory drugs (NSAIDs), Bisphosphonates, Tetracyclines, et al. Multiple medications were suggested to be strongly relate to adverse drug events (ADEs), adverse drug reactions (ADRs), drug-drug interactions, and drug-disease interactions, which may cause gastrointestinal(GI) dysfunction or injury to the GI mucosa. However, it was unclear whether multiple medications was associated with more severe symptoms of dyspepsia and dyspepsia-based score systems.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥18 years old
2. Patients who met broad criteria of dyspepsia

Exclusion Criteria:

1. organ failure defined by Marshall standard
2. severe psychiatric illnesses
3. suspected or identified bowel obstruction
4. known malignancy
5. pregnancy or lactation
6. unable to provide consent
Effect of Body Weight Change to Surgical ICU Outcomes

Aims of study

1. Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in 28 days
2. Determination cut point of maximum weight change to outcome treatment

Study type : Prospective observational study Location : General surgical intensive care unit Inclusion criteria : All admission patient with expected survive more than 24 hours Exclusion criteria : Patient died within 24 hours or who could not be weighed.

Eligibility Criteria:
Inclusion Criteria:

* All admitted ICU patients expected survive more than 24 hours

Exclusion Criteria:

* All expected ICU patients survive less than 24 hours
* All patient cannot be weighed.
MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

The study had a 4 week single blind placebo period followed by 12 weeks of double blind treatment. Patients were randomized to one of four treatment arms to evaluate the antihypertensive efficacy of Losartan.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with mild to moderate hypertension
* Patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure

Exclusion Criteria:

* Pregnant of lactating female patients
* Secondary hypertension or history of malignant hypertension
* Sitting systolic blood pressure \> 210 mmHg
* History of stroke
* History of myocardial infarction with in the past year
* Current of prior history of heart failure
* Known hypersensitivity to losartan
* Obesity
* Patients known to be HIV positive or known to be positive for Hepatitis B
* Absence of one kidney
* Patient is abusing or previously abused alcohol or drugs with in past two years
Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

The aim of the study is to assess the safety and efficacy of Curcumin supplementation in combination to the conventional therapy in improving the clinical outcomes, oxidative stress and inflammation in diabetic patients with risk of ASCVD.

Atherosclerotic cardiovascular disease (ASCVD) is one of the most devastating consequences of Diabetes Mellitus (DM), especially when combined with other comorbid conditions such as dyslipidemia and hypertension. To lessen the probability of ASCVD, modifying an individual's lifestyle and regulating one's lipid profile, blood pressure, and glucose levels are all beneficial approaches that decrease the risk of ASCVD occurrence. Numerous diseases, including hypertension, dyslipidemia, and diabetes mellitus, have been shown to be significantly influenced by both oxidative stress and inflammation. Curcumin is thought to regulate blood pressure, lipid profile, blood glucose levels. Moreover, It is claimed that curcumin can alleviate inflammation and oxidative stress. Curcumin is therefore suggested to have a beneficial role in lowering the risk of atherosclerotic cardiovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Adult Male or female patients aged 40 years or older
2. A calculated 10 year ASCVD risk score of 5 % or more
3. Patient previously or newly diagnosed with hypertension
4. Patient previously or newly diagnosed with dyslipidaemia
5. Patients diagnosed as Type 2 diabetes mellitus taking insulin or oral hypoglycemic agent with controlled HbA1c \< 10%
6. Willingness and ability to give informed consent.

Exclusion Criteria:

1. Congenital or acquired bleeding disorders.
2. Cholelithiasis, gall bladder or biliary tract disease or other active liver diseases.
3. Pregnant or breastfeeding women.
4. Oral hypoglycemic drugs that affect cardiovascular diseases risk.
5. Patients with clinical ASCVD (myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease).
Predicting the Response to Montelukast by Genetic Variation in Asthmatics

The purpose of this study is to examine a specific variation in the genetic code for an enzyme (LTC4 synthase) which plays an important role in the airway inflammation associated with asthma. We hypothesize that asthmatic patients with this variant gene will have a better response to montelukast than patients with the wild type gene, as measured by the ability of montelukast to protect against a hypertonic saline challenge.

Multiple genetic polymorphisms in the leukotriene pathway have been described but their clinical relevance is unclear. A single nucleotide polymorphism in the LTC4 synthase promoter region has been associated with increased LTC4 synthase mRNA and a trend toward improved bronchodilatory response to leukotriene modifiers in severe asthmatics. This study will examine mild to moderate asthmatics with the variant gene and evaluate the bronchoprotective response of montelukast in a double-blind, placebo-controlled cross-over fashion.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, age 18-55
* Clinical history consistent with asthma
* Mild to moderate asthma as determined by pulmonary function tests--60% or higher of predicted FEV1 for age, sex and race.
* Response to hypertonic saline, which will be the main outcome variable measured.

Exclusion Criteria:

* Smokers (total lifetime smoking history\>10 pack-years, any in the past year)
* Pregnant woman-if of childbearing age, not using an acceptable form of birth control.
* Use of a leukotriene modifier within the past month
* Use of inhaled or oral steroids within the past month.
* Emergency room visit for asthma exacerbation within the past 6 weeks.
* Intubation for asthma exacerbation in the past 10 years.
* Adverse reaction to inhaled beta-agonists in the past.
* No recent (past 48 hours) use of anticholinergics, theophylline, antihistamines, pseudoephedrine.
* Patients will also be asked not to use any short acting beta-agonists for 6 hours and long-acting beta-agonists for 48 hours before their initial visit (when pulmonary function evaluation will be performed).
* Lung disease other than asthma
* Significant medical illness other than asthma
Bone Microarchitecture in the Transplant Patient

The optimal management of calcium and phosphate metabolism regulation in chronic kidney disease (CKD) is important in preventing fracture risk and vascular calcification and thus morbidity and mortality, global and vascular.

Kidney transplant in a CKD context, usually with a pre-existing underlying renal osteodystrophy, malnutrition, chronic inflammation, hypogonadism and immunosuppression protocols still often made up of high-dose corticosteroid therapy, are all theoretical factors of post-transplantation bone disease. For other solid organ transplants, even though there is generally no underlying renal osteodystrophy before the transplant, the proportion of osteoporotic patients at the time of transplant is substantial. The bone risk in the immediate post-transplant period is notable.

Patients' follow-up is based on biological, radiological and histological tools. Bone densitometry (DXA) is used to measure bone mass. However, recent international recommendations do not consider DXA as a valid tool to assess bone health in CKD patients. Moreover, it is less informative than peripheral quantitative tomography resolution (HR-pQCT). This latest technique, available in Lyon and Saint-Etienne, is more precise, allowing a three-dimensional study of the trabecular microarchitecture and compartmental volumetric bone density (total, cortical, trabecular), while similar to DXA in terms of radiation (less than 5 μSv). The prevention of cardiovascular risk factors is also part of the daily care of patients with a regular cardiac monitoring (heart ultrasound) and vascular (blood pressure, Doppler of the supra-aortic trunks).

TRANSOS study aims to evaluate in a prospective cohort (longitudinal follow-up of 6 months), the bone status in patients receiving solid organ transplantation in the University Hospitals of Lyon and Saint-Etienne, using DXA and HR-pQCT (at baseline and month 6), in combination with classical biological and cardiovascular monitoring. Transplantation is an important activity in these two hospitals and this protocol provides the same bone follow-up for all solid organ transplants, with a reliable, efficient, non-invasive and low-dose radiation tool.

The primary objective of TRANSOS study is to evaluate changes in tibial cortical density between the baseline and the 6th month post-transplant measured by HR-pQCT.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 10 year-old
* Patient receiving a first solid organ transplant within involved hospitals (Lyon, Saint Etienne): kidney, heart, kidney-pancreas, lung
* Informed consent signed by the patients or their parents (minors)

Exclusion Criteria:

* No health cover
* Ongoing pregnancy
Home Tele-Monitoring of Non-Invasive Ventilation in COPD Patients in France

Tele-monitoring emerged and unfolded differently among various healthcare organisations and countries. Evidence regarding its impact on the management of COPD patients is still insufficient to draw firm conclusions. Assumption has been made that remote monitoring of home NIV treatment could help to identify novel predictors of the early detection of NIV failure and deteriorations in patients with COPD.

The incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data in France needs evaluation.

In addition, predictors of unplanned all-cause and COPD-caused hospitalisations as well as of compliance and persistence to NIV therapy should be assessed in this patient population with special respect to continuous tele-monitoring.

The study will determine in France the incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data. Clinical and telemetric predictors of unplanned all-cause and COPD-caused hospitalisations and of NIV therapy compliance and persistence will be assessed in those patients


Eligibility Criteria:
Inclusion criteria:

* Age ≥18 years
* COPD eligible for NIV treatment
* Prescription of an adequate ResMed NIV device with tele-monitoring option as part of routine clinical care
* Acceptance of tele-monitoring and corresponding data handling
* Naive to long-term NIV treatment with initiation of NIV either ≤7 days before or after enrolment into study
* Able to fully understand information on data protection and provide written informed consent for use of corresponding medical and telemetric data.

Exclusion criteria:

* Invasive ventilation therapy
* Another life-threatening disease with estimated survival \< 12 months (other than COPD, e.g. cancer)
* Further exclusion criteria according to manua of the device intended and prescribed
Sublingual Misoprostol in Reduction of Caesarean Blood Loss

Caesarean delivery is inevitably associated with a higher amount of blood loss vis-à-vis primary postpartum haemorrhage, when compared to vaginal delivery. Oxytocin use in tropical developing countries for the reduction blood loss at caesarean section have been met with challenges of ineffectiveness due to poor transportation, inadequate storage and drug adulteration. Therefore, there is a need for an effective, temperature stable uterotonic with a lesser risk of adulteration. The study is aimed at evaluating the effectiveness and safety of adjunctive sublingual misoprostol in reducing intraoperative blood loss at caesarean section.

It would be a double blind randomized controlled trial. One hundred and fifty-two pregnant women at term who have indications for caesarean section and have risk factors for primary postpartum haemorrhage, as well as meet the eligibility criteria would be randomized equally into two study arms (Misoprostol study arm and Placebo study arm) after informed consent. The Misoprostol study arm will receive 400 mcg of sublingual misoprostol as two 200 mcg misoprostol tablets. The Placebo study arm would receive two sublingual placebo tablets similar to the misoprostol tablets. The Misoprostol and the Placebo tablets will be given in each study arm at the point of starting the uterine incision at caesarean section. Both study arms would receive routine intravenous oxytocin at the time of clamping of the umbilical cord. The outcome measures will be estimated intraoperative blood loss, the need for additional intraoperative oxytocic, blood transfusion, the occurrence of side effects, and incidence of primary postpartum haemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at term (37+0 weeks to 41+6 weeks gestational age) for elective or non-elective caesarean sections
* Pregnant women who have risk factor for primary postpartum haemorrhage
* Pregnant women who consent to participate in the study

Exclusion Criteria:

* Pregnant women who withhold consent to participate in the study
* Caesarean sections for dire emergencies (umbilical cord prolapse, suspected fetal distress and active antepartum haemorrhage)
* Previous caesarean sections or other uterine surgeries
* Pregnant women with no risk factor for primary postpartum haemorrhage
* Allergy to misoprostol use
* Known history of hepatic, renal and haematological disorders
* Caesarean section to be done under general anaesthesia
* Fever (temperature ≥ 37.5 degrees centigrade)
* Pre-operative anaemia (pre-operative haematocrit level \< 30 %)
* Pregnant women who are unconscious or have eclampsia
Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries

To analyze outcomes between patients with Z2FT injuries following repair, randomized to two groups. The first group will be the negative control, with no tendon wrap. The second group will have a VersaWrap Tendon Protector applied over the site of the tendon repair. VersaWrap is current SOC at UF.

VersaWrap Tendon Protector is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue. It functions by separating the healing tendon from surrounding tissues to facilitate tendon gliding and tendon healing. VersaWrap can be placed on, over, or around flexor tendons and remains in place until healing is complete and then is bioresorbed. VersaWrap is FDA cleared for the use in procedures where there is no significant loss of tendon tissue and is currently one of the standard of care treatments used for this injury at UF Health.

VersaWrap Tendon Protector includes a bioresorbable hydrogel sheet and a wetting solution. The sheet is transparent, flexible, ultrathin, non-sided, and can be cut to the desired size. It is made of polysaccharides alginate and hyaluronic acid.

Tendon adhesions are a major problem following repair, particularly for zone 2 flexor tendon (Z2FT) lacerations. The purpose of this study is to prospectively analyze outcomes between patients with Z2FT injuries following repair, randomized to two groups. The first group will be the negative control, with no tendon wrap. The second group will have a VersaWrap Tendon Protector applied over the site of the tendon repair. Outcomes will be evaluated during standard of care post-operative clinic visits at 2 (+/-10 days) weeks, 6 weeks (+/-2 weeks) and 3 months (+/- 1 month) following surgery. Data will be collected from standard of care measurements that include the following outcome measures that will be performed at each follow up visit: range of motion of the affected finger at different joints; total active motion (TAM) of the finger; Strickland modification of TAM (only including proximal interphalangeal (PIP); and distal interphalangeal (DIP) joints), as well as, DASH score and Michigan Hand Outcomes questionnaire. A measurement of grip strength will be obtained at the 3 month follow up visit. This is an important study as adhesions are a particularly serious problem following repair of Z2FT injuries, which can result in persistent finger stiffness and decreased range of motion reducing the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients presenting to the plastic surgery service with a zone 2 flexor tendon injury requiring surgical repair

Exclusion Criteria:

* Patients with a sensitivity or allergy to polysaccharides alginate, hyaluronic acid, or citrate

  * Patients with psychiatric or medical problems that preclude them from having surgery
  * Female patients that are pregnant or breastfeeding
  * Prisoners
  * Patients who are unwilling or unable to follow-up
Analgesic Properties of Oral Sucrose During Immunizations

The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.

The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.

Acute pain during early life may alter infant pain responses, cognitive development and behavioral outcomes. Infants respond to immunizations with significant pain and distress. This study will examine the analgesic properties of oral sucrose and maternal holding in postnatal infants.

Comparison: Administration of oral sucrose, sterile water and maternal contact 2 minutes before routine immunizations.

Eligibility Criteria:
Inclusion Criteria:

1. Currently between 4 and 11 months of age;
2. Between 37 and 42 weeks' completed gestation at birth;
3. Birth weight greater than 2.5 kg; and
4. No evidence of acute or chronic disease

Exclusion Criteria:

1. Fed 30 minutes prior to immunization;
2. Received analgesic/sedative the day of the immunizations;
3. Parent wishes to feed the infant during the immunizations;
4. Infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered; or
5. Language barriers preclude the process of obtaining parental consent.
Balance Impairment and Falls Risk in People With Lower Limb Arthritis, and Can These be Improved With Exercise?

Arthritis has been reported as a risk factor for falls. Few studies have investigated the effect of balance training on balance performance in women with lower limb arthritis. The aim of this study was to evaluate the effectiveness of a four-month individualised home exercise programme in improving gait stability and balance for women with arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Lower limb osteoarthritis or lower limb rheumatoid arthritis

Exclusion Criteria:

Participants were excluded if they:

* Did not have lower limb arthritis,
* Were bed bound,
* Had additional co-morbidities that confer risk of falls (such as Parkinson's disease, stroke, multiple sclerosis, history of cardiac syncope, epilepsy),
* Had undergone lower limb surgery within the previous twelve months, and/or
* Had synvisc or a corticosteroid injection within the last six months.
Facial Expression Recognition of Emotion and Categorization of Emotional Words in Gilles de la Tourette's Syndrome

Gilles de la Tourette's syndrome is a childhood onset inherited neuropsychiatric disorder characterised by the presence of both multiple motor tics and one or more vocal tics (noises), with psychiatric and/or behaviour disorders (such as obsessive compulsive behaviour...).

This disease is associated with an dopamine system imbalance which could be responsible of a specific trouble in the recognition in some facial expression. This has been already shown in Gilles de la Tourette patients with obsessive compulsive behaviour.

We hypothesise that patients with Gilles de la Tourette's syndrome present a dysfunction of voluntary and automatic treatment of emotional information.

The main purpose of this study is to show if patients with Gilles de la Tourette's syndrome present a lack of specific facial expression recognition of emotion and determinate more precisely if this alteration involves the cortical way (high frequency way) or the under cortical way (low frequency way).

20 patients with Gilles de la Tourette's syndrome compared to 20 healthy paired volunteers.

Study progress (patients):

Inclusion visit :

Psychiatric evaluation Psychological evaluation

Ophthalmic visit

Protocol :

Facial expression recognition test Lexical decision test

Study progress (healthy volunteers):

Psychiatric evaluation Ophthalmic visit Facial expression recognition test Lexical decision test

Eligibility Criteria:
Inclusion Criteria:

* Age : \>18 years
* Patient with a Gilles de la Tourette 's syndrome such as defined in the DSMIV
* Stability of treatment \>1 month
* Mini Mental State \> 26
* Affiliation to social security
* Agreement of patients

Exclusion Criteria:

* Patients with cognitive disorders, dementia, mental retardation...
* Patients with serious neurological pathologies
* Patients with a vision contrast altered.
* Patients who do not understand the words associated with an emotion
* Pregnant women
* Person who participate to an other study