cyrilzakka/clinical-trials huggingface dataset:
Comparison of Pulsed-field Gel Electrophoresis and Whole Genome Sequencing to Determine Transmission Rate of ESBL-producing E.Coli

The aim of this quality control study is to compare two different techniques to determine ESBL-producing E.coli transmission.

Pulse-field gel electrophoresis (PFGE) was considered the reference standard to determine transmission events of extended-spectrum Beta-Lactamase (ESBL) producing E.coli . However, this technique lacks the resolution to differentiate closely related strains, which is needed to identify ESBL-transmission. Furthermore, PFGE is not able to distinguish mobile genetic elements. In contrast, whole genome sequencing (WGS) allows the identification of single-nucleotide polymorphisms (SNPs) that differentiate bacterial strains and mobile genetic elements, such as plasmids at the highest possible resolution, therefore enabling investigation of their relatedness by phylogenetic analyses and ultimately detailed exploration of transmission pathways. As WGS is now readily available and affordable, the investigators aim to reinvestigate transmission events in the 24 index-contact patient-pairs identified after cessation of contact precautions by reassessing the genetic relatedness of both strains and mobile genetic elements by sequencing all 48 recovered ESBL- E.coli strains.

The investigators hypothesize that the number of transmission events as defined by transmission of ESBL-producing E. coli strains may have been overestimated by PFGE as compared to WGS, as PFGE lacks the resolution to differentiate closely related strains. However, transmission of mobile genetic elements may have been missed by PFGE as this technology is not able to identify the genetic relatedness of plasmids, genes and other mobile genetic elements. Thus WGS may reveal additional transmission events defined as the transmission of mobile genetic elements.

Different sequencing approaches may yield different results in terms of detection of transmission events.

The investigators hypothesize that short-read sequencing may suffice to reliably detect relatedness of strains but that additional long-read sequencing approaches are needed to detect transmission of mobile genetic elements.

Eligibility Criteria:
Inclusion Criteria:

* The patient population is defined as the 24 contact-index patient pairs identified during screening of contact patients after cessation of contact precautions as part of a quality control, performed from June 2012 to December 2013 at the University Hospital Basel and from January 2012 to December 2013 at the FELIX PLATTER-Hospital.

Exclusion Criteria:

* Patients not meeting the above mentioned inclusion criteria.
Metabolic Effects of Sleep Extension in People With Obesity

This study is designed to determine the impact of extending sleep duration on glucose metabolism in people with obesity. Half of the participants will be instructed to increase their time-in-bed by one hour (sleep extension; n=15) while the other half will be be instructed to maintain their current sleep habits (n=15).

Restricting sleep is known to be detrimental to glucose metabolism in healthy adults. Obesity is a condition associated with both lower sleep duration and poor glucose tolerance. Therefore, increasing sleep duration is a potentially novel therapeutic strategy for improving glucose metabolism in this population. The investigators will assess this by determining insulin sensitivity during a hyperinsulinemic-euglycemic clamp before and after a sleep intervention in both the control and sleep extension groups.

Eligibility Criteria:
Inclusion Criteria:

* Sleep \<7h/night
* Body mass index 25-50 kg/m2
* Altered glucose metabolism (any of the following) Fasting glucose 100-125 mg/dL or, 2-h plasma glucose 140-199 mg/dL during an oral glucose tolerance test (OGTT) or, HbA1c 5.7-6.4% or, homeostatic model assessment of insulin resistance (HOMA-IR) ≥2.0

Exclusion Criteria:

* Sleep disorders

  1. moderate to severe sleep apnea (apnea-hypopnea index ≥15 events/hour)
  2. had ≥15 periodic limb movements per hour sleep \[PLMS\]
  3. narcolepsy or insomnia
* Perform shift work
* Excessive caffeine or alcohol consumption
* Significant organ dysfunction/disease (e.g. diabetes mellitus, kidney disease)
* Liver disease other than metabolic dysfunction associated steatotic liver disease (MASLD)
* Prior bariatric surgery
* Pregnancy or breastfeeding
* Taking medications that can affect study outcomes (alter sleep duration or glucose metabolism)
* Tobacco or illicit drug use
* Perform intense exercise \>70 min/wk or moderate exercise \>150 min/week
* Excessive alcohol consumption (\>21 units of alcohol per week for men and \>14 units of alcohol per week for women)
A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)


Eligibility Criteria:
Inclusion Criteria:

* Post-bronchodilator FEV1/FVC ratio \<0.7 and a post-bronchodilator FEV1 of 50-80%.
* Diagnosis of moderate COPD for a minimum of 6 months.
* Stable disease for at least 1 month prior to screening

Exclusion Criteria:

* More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
* History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.
Exploratory Cognition Study of Sertindole in Patients With Schizophrenia

The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on neurocognitive functioning in patients with schizophrenia.

Cognitive deficits, including impairments in areas such as memory, attention, and executive function, are major determinants and predictors of long-term disability in schizophrenia. At present, available antipsychotic medications are relatively ineffective in improving cognition. However, scientific discoveries during the past decade suggest that it may be possible to develop medications that are effective in improving cognition in schizophrenia.

One of the important reasons to focus on cognitive deficits as a target for pharmacological treatment, is the association found between cognitive impairment and social dysfunction observed in patients with schizophrenia. Pervasive cognitive deficits have a limiting effect on the quality of life of patients with schizophrenia including social interaction and problem solving, community living, and employment prospects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia
* Participation in 11286 study
* Capable of completing all study-related psychometric activities for the duration of the study
Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions.

The progression of brain lesions after severe head trauma or subarachnoid hemorrhage results from extra cranial aggression which is well controlled in intensive care and intracranial aggression which is less well known and therefore less well managed. The detection of events that can generate new lesions from intracranial monitoring is limited and late once the lesions are irreversible. Invasive cortical depolarizations (SD) can be observed using cortical electrodes and an acquisition system having access to the usually filtered DC signal (0 to 1 Hz). SD are observed at the onset of a new attack of the cortex and spread widely away from the site of aggression. During their propagation, SD generate a significant metabolic demand, and can cause ischemic injury, particularly after meningeal or post-traumatic hemorrhage. SDs are therefore both a marker of new lesion and a mechanism of progression of primary lesions. Yet this type of monitoring is only performed in some expert centers around the world. The analysis of the feasibility and safety of the placement of cortical electrodes in this indication is therefore an essential step to study the clinical benefit of individualized management on the basis of this monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 year old
* Patients admitted in neurological reanimation unit for brain lesions after severe head trauma or subarachnoid hemorrhage and requesting a intracranial monitoring or a surgery (evacuation of a hematoma, treatment of an aneurysm, external ventricular bypass).
* Patients affiliated to a social security system
* Patient having been informed and having signed the Consent form OR Close to the patient who has been informed and signed the Consent form OR third party certificate then close consent for further study.

Exclusion Criteria:

* Patient with scalp acute infection
* Pregnant or nursing women
* Contre-indication to intracranial surgery
* Patient with not corrected coagulation disorder
* Patient treated with NSAIDS
* Patient treated with under platelet antiaggregants
* Patient under legal protection, guardianship, curators
* patients under legal protection
* Patient participating in a study who may interfere with this study.
* people under duress psychiatric care,
Histiocytosis and Inflammatory Manifestations in Patients with H Syndrome

H syndrome is a rare genetic disorder predisposing to histiocytosis. Our knowledge of the clinical spectrum of these patients is based on case reports and small patient series. Patients with H syndrome have been treated with a range of immunomodulatory and chemotherapeutic agents, with limited success. We aim to comprehensively assess the clinical manifestations and patterns of treatment response in a multinational cohort of patients with H syndrome.

H syndrome is a rare inflammatory genetic disorder predisposing to histiocytosis, caused by germline biallelic loss-of-function mutations in SLC29A3, encoding the protein equilibrative nucleoside transporter 3 (ENT3). ENT3 transports nucleosides from lysosomes to the cytoplasm following lysosomal degradation of nucleic acids. Results from our previous study (under review) suggest a model in which impaired nucleoside trafficking aberrantly activates nucleoside-sensing Toll-like receptors, leading to persistent activation of ERK, driving histiocytosis. This constitutes a novel signaling pathway leading to activation of ERK and histiocytosis, in the absence of somatic mutations in MAPK cascade genes. Our knowledge of the heterogenous clinical spectrum of these patients is based on case reports and small patient series. Patients with H syndrome have been treated with a range of immunomodulatory and chemotherapeutic agents, with limited success. Improvement following therapy with tocilizumab, an IL6-receptor antibody, has recently been reported in isolated case reports. There is a lack of data on MEK inhibitor therapy in these patients. We aim to comprehensively assess the clinical manifestations and patterns of treatment response in a multinational cohort of patients with H syndrome.

Eligibility Criteria:
Inclusion Criteria: Any patient with a genetically confirmed diagnosis of H syndrome -

Exclusion Criteria:

-
Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain

Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with vertebral fracture.

Secondary objectives were:

* to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral fracture pain;
* to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in this population.

The duration of the study period for each participant was up to 13 weeks, including a screening period up to 5 days, and 12-week follow-up after the injection.

Eligibility Criteria:
Inclusion criteria:

- Moderate to severe pain due to non-traumatic vertebral fracture associated with osteoporosis.

Exclusion criteria:

* Mild pain score on the Pain Intensity-Numeric Rating Scale \[PI-NRS\] at screening and randomization visits;
* Narcotic addiction;
* Post-fracture vertebral instability;
* Unwillingness to use study-defined rescue analgesia exclusively.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma

Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a subject with mild asthma inhaling an allergen.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* generally healthy, men and women with mild allergic asthma, aged 18 to 60 years
* only asthma med is short-acting bronchodilator used not more than twice weekly
* FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction

Exclusion Criteria:
Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata

Methodology: The 70 patients of age 20 to 50 years presented to the out-patient department of CMH Abbottabad suffering from alopecia areata were enrolled. The non-probability consecutive sampling technique was used. Patient in group-A applied clobetasol propionate 0.05% twice daily, whereas Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. The Patients were assessed at baseline, 4th weeks, 8th week and 12th week after treatment of each session. Hair loss was calculated from SALT score at presentation and on follow-up after 3 months. The degree of response was assessed on the basis of hair re-growth as excellent (\>75% re-growth), Marked (51-75% re-growth), moderate (26-50% re-growth), or slight (≤25% re-growth). To determine statistical significance χ2-square test, taking p-value \<0.05 as significant, was used.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 20 to 50 years
* Both male and female
* Duration of illness less than 2 months
* those who never received any treatment before

Exclusion Criteria:

* Patients having duration of alopecia greater than 2 months
* Atypical alopecia areata i.e., Alopecia universalis etc
* Hypersensitivity history to topical corticosteroids or tacrolimus
* patients taking any systemic immune suppression
* pregnancy/lactation
A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

The primary aim of this study is to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga and those not receiving yoga. Secondary endpoints will include other measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and adherence to yoga and to chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* History of stage I-III breast cancer
* Patient scheduled to receive or within 2 weeks of receiving intravenous chemotherapy for their breast cancers
* Eastern Cooperative Oncology Group Performance status of \<3
* Ability to understand English

5.2 Exclusion Criteria:

* Planning to start yoga on their own within the next 12 weeks
* Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study
* Severe chronic obstructive pulmonary disease
* Class III or IV heart failure
* Child C cirrhosis
* End-Stage renal disease

Exclusion Criteria:

* Planning to start yoga on their own within the next 12 weeks
* Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study
* Severe chronic obstructive pulmonary disease
* Class III or IV heart failure
* Child C cirrhosis
* End-Stage renal disease
Iron Supplementation and Side Effects

The objective of this study is to examine patient-reported gastrointestinal side effects, as well as iron status indicators, inflammatory markers and oxidative stress following administration of ferrous sulfate and iron-enriched Aspergillus oryzae supplementation.

Iron deficiency anemia (IDA) afflicts more than 2 billion people globally, making it the most prevalent nutrient disorder, today. Inadequate dietary intake of iron results in consequences like cognitive decline, fatigue, abnormal growth and adverse pregnancy outcomes. These ramifications have associated burdens on economical progression due to decreased market productivity. Inorganic iron supplements like ferrous sulfate (FeSO4) are most commonly used to treat IDA, however known associated side effects occur, decreasing compliancy in individuals. Moreover, inorganic iron salts present a large bolus of iron to the intestinal lumen, resulting in non-transferrin bound iron which leads to systemic inflammation and further exacerbation of chronic diseases. Organic iron compounds have strong potential to be utilized for supplementation, however only under circumstances in which contain high absorbance. Seventeen subjects were randomized in a three-armed, double-blinded crossover design to examine the differences among three treatments (FeSO4, ASP-s and placebo). Outcomes will be to assess acute inflammatory proteins, oxidative stress, iron status indicators, non-transferrin bound iron and gastrointestinal-related side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40
* Female
* BMI \< 30 kg/m2
* Nonsmoker
* Non pregnant
* Non lactating
* No food allergies to wheat or dairy
* No history of gastrointestinal diseases/disorders
* Willing to discontinue use of vitamin/mineral supplements
* No medications that interfere with iron absorption
* No blood or plasma donations during study period

Exclusion Criteria:

* History of gastrointestinal diseases or disorders
* Donating blood or plasma two weeks prior to study period
* On medications interfering with iron absorption
* Food allergies to wheat or dairy
* Pregnant or lactating
* Smoker
* Anemic (\< 120 g/L)
* Ferritin \> 40 ug/L
Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients

The goal of this clinical research is to learn if an ultrasound contrast agent called OPTISON (perflutren protein type A) is effective in finding sentinel lymph nodes before surgery. Contrast agents can help make ultrasound images more accurate. The sentinel lymph node is the first node that may be the target of cancer cells that spread from the tumor.

Study Procedures:

If you agree and are eligible to take part, you will receive perflutren protein type A by injection under the skin near the nipple. After you receive the injection, the radiologist will take more ultrasound images and videos of the tumor and lymph nodes in the underarm area.

You will have a biopsy of the sentinel lymph node that was identified in the ultrasound and a titanium clip marker will be inserted into the node. The clip helps distinguish the biopsied node from other nodes. You will be told the results of biopsy. After the biopsy, a radioactive seed may be inserted into the node to allow the surgeon to find and remove it during your surgery, an extra node may be removed at that time.

You will still have standard of care sentinel lymph node biopsy during your already scheduled surgery. You will sign a separate surgical consent form that explains this procedure and its risks.

You will be called by phone 30 days after the seed is removed to check for any side effects. This phone call should take about 10 minutes.

Length of Study:

Your active participation in this study will be over the follow up phone call.

This is an investigational study. Perflutren protein type A is FDA approved and commercially available for use in contrast-enhanced echocardiograms. Its use in this study is investigational.

Up to 21 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older.
2. Ipsilateral biopsy-proven invasive breast cancer \<5 cm in maximal dimension by Ultrasound or Mammography.
3. No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign subsequent FNA biopsy.

Exclusion Criteria:

1. Pregnant or nursing women
2. Prior SLN dissection
3. Neoadjuvant chemotherapy.
4. Prior axillary lymph node surgery.
5. Prior history of ipsilateral breast cancer.
6. Known or suspected: Cardiac shunts
7. Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin
8. Known or suspected: hypersensitivity to a prior OPTISON administration
Ventricular Matrix Remodeling: Correlates and Prognosis

To assess the diagnostic and prognostic usefulness of serum markers of left ventricular remodeling for predicting congestive heart failure.

BACKGROUND:

Recent studies have established that cardiac extracellular matrix (ECM) remodeling is a major determinant of pathologic left ventricular hypertrophy (LVH) and progressive left ventricular dilatation, and as a result, contributes to the development of left ventricular dysfunction and overt congestive heart failure (CHF). The recent development of reliable serologic assays for procollagen peptides, metalloproteinases (MMP) and their tissue inhibitors (TIMP), and cytokines permits the in vivo assessment of LV ECM remodeling, and raises the possibility of expanding the utility of these markers 'from the bench to the bedside.' Prior studies of ECM biomarkers in congestive heart failure have been limited to cross-sectional investigations of small samples of highly selected patients with advanced disease. The fundamental question whether serum markers of ECM remodeling are important correlates of left ventricular dilatation or left ventricular hypertrophy, or are independent predictors of incident congestive heart failure in the community remains unanswered.

DESIGN NARRATIVE:

The aims of the study are to: determine the relationships between serum markers of ECM remodeling and traditional congestive heart failure risk factors; analyze the cross-sectional relations between markers of ECM remodeling and echocardiographic left ventricular hypertrophy and left ventricular dilatation, Doppler indices of left ventricular filling and serum natriuretic peptides; investigate prospectively the relationships between ECM remodeling markers and progressive left ventricular dilatation and left ventricular hypertrophy and congestive heart failure incidence, adjusting for standard risk factors. Stored samples from the Framingham Offspring and Omni cohorts will be used. Participants at the extremes of the joint distributions of left ventricular wall thickness and left ventricular internal dimension from echocardiograms performed at earlier Framingham exams will be sampled.

Eligibility Criteria:
No eligibility criteria
Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage

To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.

Objective :

To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks'.

Method :

Double blinded Randomized controlled trial in two centers over 30 months.

Treatment :

Patients will be randomly allocated into one of the two following group :

Group A : 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp.

Group B: 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp.

Number of patients:

1550 patients per group (one third reduction of occurrence with alpha and beta set at 0.05 and 0.20 respectively). Patients were included in the study during 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Women\>18 years,
* during first stage of normal labor,
* at 36 to 42 weeks,
* with epidural analgesia and informed signed consent

Exclusion Criteria:

* Cesarean section delivery,
* clotting disorders,
* prostaglandin allergy,
* absent consent.