cyrilzakka/clinical-trials huggingface dataset:
Pseudomonas Aeruginosa Infections Among COVID-19 Patients in Intensive Care Units at CHRU of Nancy (Pyo-COVID-3)

P. aeruginosa is an opportunistic bacterium known to be responsible for numerous healthcare-associated infections, particularly in intensive care units (ICU). The frequency of these infections seems to have increased during the first waves of the COVID-19 pandemic. Identifying cases of co-infection and secondary infections with P. aeruginosa in patients with COVID-19 would provide a better understanding of the epidemiological evolution and characteristics of infected patients.

Treatment of P. aeruginosa infections requires the use of antibiotics. Antibiotic resistance is a growing problem, with an increase in resistance among P. aeruginosa strains. The misuse of antibiotics to treat patients can accentuate the phenomenon of antibiotic resistance, and failure to take account of resistance revealed by antibiograms can compromise patient recovery. Analysis of bacteriological results and patient medical records would enable a posteriori evaluation of the proper use of antibiotics (choice and adaptation of molecules, doses and duration of prescriptions), and identify any areas for improvement.

The main objective is to describe the evolution of P. aeruginosa infections in ICU patients with COVID-19 during the first 3 waves of COVID-19 (01/03/2020 to 31/05/2021). Secondary objectives are to describe the typology of P. aeruginosa strains identified among included patients (sampling sites and resistance profiles), to assess antibiotic prescriptions for these patients and to describe the relapse rate of included patients with a first P. aeruginosa infection.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients hospitalized for at least 48 h in an intensive care unit (ICU) at CHRU-Nancy for acute respiratory distress syndrome due to COVID-19.
* Patients hospitalized from 1st March 2020 to 31st May 2021.
* Patient developed an hospital-acquired infection caused by P. aeruginosa during their ICU stay.

Exclusion Criteria:

* Patients \<18 years old.
* Patient without COVID-19 at the ICU admission.
* Patients with P. aeruginosa isolated \<48 hours following ICU admission.
* Patients who did not want to be included in the study.
The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

The aim is to investigate the accuracy of manual diagnostics of benign paroxysmal positional vertigo (BPPV) by comparing it to BPPV diagnostics in mechanical rotational chair (TRV chair). VNG (videonystagmography) goggles will be used in both scenarios.

Furthermore, the investigators will examine the importance of angulation and velocity in relation to the diagnostic outcome.

Open-label, randomized controlled trial with cross over comparing manual bedside BPPV diagnostics with diagnostics in a mechanical rotational chair (TRV chair) when using VNG goggles in both scenarios.

Patients with a history of positional vertigo will be considered for enrollment and randomized to which diagnostic modality they begin with. Each subject will wait for minimum 30 minutes between the two diagnostics.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Classic BPPV-patient history (short lasting (\<1 minute) positional rotatory vertigo, no accompanying tinnitus or hearing loss, and no focal neurological findings.
* Understand written and spoken Danish

Exclusion Criteria:

* Pregnancy
* Weight ≥ 150 kg and or Height ≥ 2m
* Neck and spine immobility to a degree where MD on examination bed is impossible
* Insufficient cooperation during diagnostic testing
* Sedative antihistamines taken within the past seven days
* Comorbidities: Heart failure (EF \< 40), known cerebral aneurysm, cerebrovascular events (\<3 months) or dissection disease
* Spontaneous or gaze evoked nystagmus
Effects of Diaphragmatic Breathing on Pain, Function, Balance and Quality of Life in Pregnant Women With Low Back Pain

The aim of the study was to investigate the effects of diaphragmatic breathing on pain, function, balance and quality of life in pregnant women with low back pain.

Individuals with pregnancy-related low back pain who present to the Obstetrics and Gynecology Clinic of İzmir Menemen State Hospital are identified as the study population. Patients meeting the eligibility criteria will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Pregnancy between 19-29 weeks
* Low back pain that started with pregnancy (at least 1 week; no previous history of low back pain)
* No treatment for the lumbar region or spine in the last 3 months

Exclusion Criteria:

* History of cardiovascular disease
* Multiple pregnancy
* Medical complications (e.g., bleeding, pre-eclampsia, placenta previa, etc.)
* Diagnosed cognitive disorders
* High-risk pregnancy
* History of abdominal and/or thoracic surgery
Sleep and Pain Interventions in Women With Fibromyalgia

Insomnia affects 67-88% of chronic pain patients. SPIN II is a randomized controlled clinical trial that will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia.

This mechanistic trial will assess sleep, pain, arousal, and neural imagining outcomes at baseline, post-8 week behavioral treatment (CBT-I or SHE), as well as at 6 and 12 month followups. This information will provide novel information about the neural structures and functional networks associated with chronic pain, and their manipulation through a cognitive behavioral intervention to improve insomnia. Demonstration that a relatively brief intervention can reverse or resolve pain related maladaptive neural plasticity, and improve or resolve clinical pain symptoms would have immediate and far-reaching implications for millions of chronic pain sufferers as well as for the US healthcare system and economy.

Eligibility Criteria:
Inclusion Criteria:

* female
* 18+ years of age
* willing to be randomized
* can read and understand English
* diagnosed with Fibromyalgia and insomnia
* no prescript or over the counter pain or sleep medicaments for 1+ month

Exclusion Criteria:

* unable to provide informed consent
* cognitive impairment
* sleep disorder other than insomnia (i.e., sleep apnea, periodic limb movement disorder
* bipolar or seizure disorder
* other major psychopathology (other than depression or anxiety)
* psychotropic or other medications that alter pain or sleep
* participation in non-pharmacological treatment (including CBT) for pain, sleep, or mood outside current trial
* internal metal objects or electrical devices
* pregnancy
Pelvic Microbiomes of Benign and Malignant Ovarian Diseases

This case-control study aims to compare the pelvic microbiomes of benign ovarian diseases and ovarian malignancies by 16s RNA techniques and culture. Discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube are collected from age and menopausal status matched patient before and during procedures of laparoscopies. The discharges/flushing fluid would be sent for 16s RNA analysis and microculture respectively, and the results would get self-contrasted comparison and case-control comparison.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopy procedures
* Specific pathological diagnosis

Exclusion Criteria:

* Previous history of pelvic surgeries
* Evidences of pelvic inflammation diseases
Impact of Enzyme Replacement Therapy on Cardiac Function in Patients With Fabry's Cardiomyopathy (RECAFTURE Trial)

The purpose of this study is to evaluate the impact of ERT on LV diastolic function and flow in patients with Fabry's cardiomyopathy using diastolic stress echocardiography, LV vortex flow and CMR.

1. Objectives -The purpose of this study is to evaluate the impact of ERT on LV diastolic function and flow in patients with Fabry's cardiomyopathy using diastolic stress echocardiography, LV vortex flow and CMR.
2. Primary / Secondary Endpoint 1) Primary endpoint

   * Changes of peak exercise E/E' by diastolic stress echocardiography (RECAP-F STRESS trial) and LV vortex flow parameters (RECAP-F FLOW trial) at 1 year follow up.

     2) Secondary endpoint
   * Changes of extracellular volume by CMR(T1 mapping) at 1 year follow up (RECAP-F trial) ② Evaluation of the degree of the resting LV diastolic function ③ Other echo-parameters; LV mass index at baseline, 1 year follow up, reduction of peak exercise E/E prime at 1 year follow up

     * Changes of quality of life using questionnaire ⑤ Change of peak VO2, exercise time, AT by diastolic stress echocardiography at 1 year follow up ⑥ Change in T1 baseline(myo, ms) \& T1 baseline(blood, ms) T1 postcontrast(myo, ms) \& T1 baseline(blood, ms) by CMR
3. Study Methods 1) Study Design : 28 patients with newly diagnosed genetically confirmed Anderson-Fabry's disease will undergo diastolic stress echocardiography, LV vortex flow analysis, and cardiac MRI before enzyme replacement therapy(ERT) (baseline study) and after 1 year of treatment with agalsidese beta at the dose of 1mg/kg (follow-up study).

2) Study procedures : Examinations as described below will be done before ERT and 1 year later

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16\~75 years with Fabry's disease who were confirmed by enzyme assay and gene study
* All patients should have LV hypertrophy in 2D echocardiography (end diastolic septum and posterior wall thickness ≥12mm)
* Patients provided with the written, informed consent to participate in this study

Exclusion Criteria:

* Contraindication for agalsidase beta enzyme replacement treatment
* Patients who cannot perform supine bicycle stress echocardiography, contrast echocardiography or cardiac MRI
* Hemodynamically significant valvular heart disease or arrythmias
* History of acute myocardial infarction or congestive heart failure with reduced LV ejection fraction of less than 35%
* CVA in the prior 6 months
* Scheduled or planned surgery in the next 6 months
* Chronic liver cirrhosis
* Allergy to contrast agent (Definity®, Lantheus Medical Imaging, North Billerica, MA, USA)
EMONO for the Treatment of Peripheral Neuropathic Pain

To assess the effect of 3 consecutive days of one-hour administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical air), in add-on therapy to chronic analgesic treatments, on average pain intensity in patients with chronic peripheral neuropathic pain. A total of 250 randomised patients to be included in all the participating centres, i.e., 125 randomised patients in each of the 2 study groups treatments


Eligibility Criteria:
Inclusion Criteria:

* Patients with a mean pain intensity from 4 to 9 as assessed daily with a Numerating Rating Scale during the 7 day period preceding inclusion in spite of administration of usual pain treatments.
* Neuropathic pain lasting for more than 3 months but less than 10 years
* Definite or probable peripheral neuropathy

Exclusion Criteria:

* legal incapacity
* patient with another concomitant chronic pain
* ongoing major depression
* Chemotherapy-induced peripheral neuropathic pain
Effect of Spiriva® on Health-related Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Stopped Smoking During Treatment.

Post marketing Surveillance to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) on health-related quality of life in COPD patients who stopped smoking during treatment and to obtain safety data regarding adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD
* Smoker at start

Exclusion Criteria:

* Patients presenting with any general and specific contraindications listed in the Patient Information Leaflet ('Gebrauchsinformation') and the Basic Product Information('Fachinformation')
Use of Curcumin to Treat Unfavorable Bleeding Patterns in Contraceptive Implant Users

The investigators plan to study the effects of curcumin, the active ingredient in the spice turmeric, on the irregular bleeding experienced by women who use the contraceptive implant.

The investigators are proposing a randomized, double blind placebo-controlled clinical trial over a 30-day reference period for treatment of women experiencing bothersome bleeding while using the etonogestrel (ENG) contraceptive implant. The primary outcome of the study will be the total number of amenorrhea days in a 30-day reference period. The study has a number of secondary outcomes (see study objectives) focused around the efficacy of oral curcumin to stop bleeding/spotting and for how long.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Women 15-45 years of age
* Currently using the ENG implant for at least 30 days and use proven on exam (palpation of implant at screening visit)
* Willing to continue using the implant for at least 30 days from study enrollment
* \>7 days of continuous bleeding/spotting in the last 30 days, OR 2 or more episodes of bleeding/spotting in the last 30 days.
* Access to a reliable cell phone and must be willing to receive and respond to a daily text or email message to assess bleeding and use of study drug
* Negative gonorrhea/chlamydia screening performed at screening visit

Exclusion Criteria:

* Postpartum within six months
* Post-abortion within six weeks
* Currently pregnant
* Currently breast-feeding (to be eligible, must be 4-6 weeks from cessation of breastfeeding)
* Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
* Bleeding dyscrasia
* Anticoagulation use
* Active cervicitis
* Allergy to curcumin or turmeric
* History of venous thromboembolism
* Current or past breast or uterine malignancy
* Use of P450 pathway inducing drug
* Implant is due to be switched out in 2 months or less from enrollment
* Currently using oral contraceptives in addition to implant (to be eligible, needs to have a 4-6 week washout period)
* Prior pregnancy occurred while Nexplanon/Implanon was in place
Prescription Pattern and Awareness About Antibiotic Prophylaxis and Resistance

To assess the knowledge of Pediatric dentists regarding the prescription of antibiotics, antibiotic prophylaxis and antibiotic resistance

Antibiotics commonly are prescribed by dentists, and the uses and abuses of these drugs should be familiar to all practicing clinicians. Antibiotics are used in dentistry for two major reasons: to control oral infection, and to prevent a bacteremia precipitated by dental manipulations from causing severe systemic sequelae.

In recent years, there has been an increasing tendency to reduce the widespread use of antibiotics for prophylactic and therapeutic purposes. This is based, both on increasing scientific evidence and enhanced professional experience. The development of resistant strains of microorganisms, doubt on the efficacy of the proposed prophylactic regimens, possible toxic and adverse reactions to antibiotics and poor compliance by patients and dentists raised questions about risks and benefits.

The American Academy of Pediatric Dentistry (AAPD) has published guidelines for antibiotic use, recognizing the increasing prevalence of antibiotic-resistant microorganisms. The guidelines are intended to provide guidance for the proper and judicious use of antibiotic therapy in the treatment of oral conditions in children.

Good knowledge about the indications of antibiotics is the need of the hour in prescribing antibiotics for dental conditions. Dental practitioners should know the protocol to be applied in their patients and should apply the most recent guidelines regarding antibiotic regimen.

Eligibility Criteria:
* Inclusion criteria:

  * Dental practitioner
  * Deal with children
* Exclusion criteria:

  * Undergraduate student
Study of SyntheCelTM Dura Replacement to Other Dura Replacements

Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 18 and 75 years of age
* Patient is scheduled for an elective cranial procedure requiring a dural incision
* Patient has an MRI no earlier than two months prior to the date of enrollment
* Surgical wound is expected to be Class I/clean
* Patient is available and willing to participate in the investigation for the duration of the study
* Patient has signed a written Informed Consent to participate in the study prior to any study mandated determinations or procedures. This does not include MRIs that may be performed prior to obtaining informed consent.

Exclusion Criteria:

* Patient has a cranial metallic implant(s) that would interfere with evaluation of the device or recovery
* Patient is somnolent or comatose (Glasgow score\< 8)
* Patient has had a prior intracranial neurosurgical procedure in the same anatomical location
* Patient will require use of a dural adhesive or sealant
* Patient has known hydrocephalus
* Patient's life expectancy is less than 6 months
* Patient has a systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever \> 101°F, positive blood culture and/or a positive chest x-ray for acute infectious process
* Patient has known allergy to device component (cellulose)
* Patient is an acute cranial trauma surgical case
* Patient has a local cranial infection
* Patient has had chemotherapy and/or radiation treatment within 12 weeks prior to surgery, or has chemotherapy and/or radiation treatment planned 10 weeks post surgery
* Patient has been clinically diagnosed with malignancy (other than basal cell carcinoma or low grade glioma), uncontrolled diabetes, sepsis, systemic collagen disease
* Patient has creatinine levels \> 2.0 mg/dL
* Patient has total bilirubin level \> 2.5 mg/dL
* Patent has clinically significant coagulopathy with a partial thromboplastin time (PTT) ≥ 35, international normalized ratio (INR) ≥ 1.2, or is receiving Warfarin or Coumadin
* Patient has a compromised immune system or autoimmune disease (white blood cell (WBC) count \<4000/uL or \>20,000/uL)
* Patient is participating in another clinical trial using investigational devices/drugs
* Patient is pregnant or breastfeeding or wishes to become pregnant during the course of the study
* Patient is unable or unwilling to sign a consent form
Analysis of Breast-Conserving Surgery Plus Whole-Breast Irradiation Versus Mastectomy

This is a retrospective propensity score-matched analysis of a large institutional cohort of patients in order to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery or mastectomy for breast cancer.

The aim of the study is to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery + whole breast irradiation or mastectomy for breast cancer.

Recent observations regarding long-term outcomes among patients with early-stage breast cancer who underwent breast-conserving surgery plus whole-breast irradiation or mastectomy are from a small number of registry-based studies.

Therefore, these findings may overestimate differences in survival between the two groups, compared with randomized controlled trials conducted in the 1980s.

This study performed a propensity score-matched analysis in a cohort of 9710 patients aged \<70 years who underwent breast conserving surgery + whole breast irradiation or mastectomy without external radiotherapy for a first primary breast cancer (pT1-2, N0-3a) at the European Institute of Oncology between 2000 and 2008.

Patients were matched by propensity score.

Eligibility Criteria:
Inclusion Criteria:

* First primary breast cancer
* pT1-2
* pN0-3a
* Surgery performed at European Institute of Oncology between 2000 and 2008

Exclusion Criteria:

* pT\>=3
* Neoadjuvant treatment
* Presence of metastatic breast disease at the time of admission or within 3 months
Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels

The purpose of the study is to compare the effect of two surgical techniques (open vs robotic assisted) on plasma levels of NGAL (neutrophil gelatinase-associated lipocalin) after radical prostatectomy.

Patients undergoing radical prostatectomy are at increased risk of acute kidney injury (AKI) because of intraoperative bleeding, obstructive uropathy and older age. In particular robot-assisted laparoscopic radical prostatectomy (RALP) which is in increasing demand as an alternative surgical option for retropubic radical prostatectomy (RRP) is associated with postoperative renal dysfunction because pneumoperitoneum during RALP can decrease cardiac output and renal perfusion. NGAL may become important for diagnosis of postoperative AKI after urogenital oncosurgery.

Eligibility Criteria:
Inclusion Criteria:

* patients who undergo prostatectomy
* American Society of Anesthesiology (ASA) I-III

Exclusion Criteria:

* preexisting renal disease
* emergency surgery
* heart failure
* peripheral vascular disease
Gum Health Gel in Post Extraction Sockets

This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars

This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars which includes pain , swelling and trismus

Eligibility Criteria:
Inclusion Criteria: Horizontal and mesioangular impaction in healthy patients older than 18 years old -

Exclusion Criteria:any medically compromised patient and the presence of any infection

-
Rapamycine vs Placebo for the Treatment of Inclusion Body Myositis

Sporadic Inclusion Body Myositis (IBM) is the most frequent inflammatory myopathy in patients over 50. It is a slowly progressive, but today untreatable (notably by classical immunosuppressants) disease.

Rapamycin used in organ transplantation blocks the activity of T effector cells, preserves T regulatory cells and induces autophagy (protein degradation), all parameters impaired during IBM.

RAPAMI is a prospective, randomised, controlled, double blind, monocentric, phase IIb trial evaluating rapamycine against placebo.


Eligibility Criteria:
Inclusion Criteria:

* IBM defined by the Benveniste \& Hilton-Jones ( Neuromuscul Disord. 2010;20: 414-21) or Llyod criteria (Neurology 2014; 83: 426-433)

Exclusion Criteria:

* Impossiblility to walk 10 meters
* Hypersensitivity to rapamycin or one compound of the oral solution
* Severe respiratory insufficiency (FVC \< 50% and/or FEV1 \< 50%)
* Severe chronic kidney disease (Estimated Glomerular Filtration Rate \< 15 ml/min and/or proteinuria \> 0.3 g/24h)
* Chronic liver disease (cirrhosis and/or ALT/AST \> 2.5 normal values)
* Cancer non in remission (necessitating specific treatment) during the past 12 months
* Connective Tissue Disease non in remission (necessitating specific treatment) during the past 12 months
* Pregnancy
* Seropositivity for HIV, HCV or HBV
* Total cholesterolemia \> 8 mmol/l
* Triglyceridemia \> 5 mmol/l
* Hemoglobinemia \< 11 g/dL
* Thrombopenia \< 100 000/mm3
* Neutropenia \< 1500/ mm3
* Lymphopenia \< 1000/ mm3