cyrilzakka/clinical-trials huggingface dataset:
Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia

To investigate use of aerosol combined with intravenous antibiotics for the treat of multi-drug resistance gram negative bacterias diagnosed ventilator-associated pneumonia in intensive care unit in a hospital.

Ventilator-associated pneumonia (VAP) refers to the endotracheal tube or tracheostomy patients pneumonia after 48h of mechanical ventilation, mechanical ventilation is one of the most common and most serious complications, hospital acquired is An important cause of pneumonia. According to the onset time of VAP, VAP can be divided into early-onset VAP and late-onset VAP. The time limit is mechanical ventilation for 4 days, in which early-onset VAP (mechanical ventilation ≤ 4d) is mainly caused by pathogens sensitive to most antibacterial drugs (such as methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae, etc.); late-onset VAP ≥ 5D occur during mechanical ventilation, mainly caused by multi-drug resistant (multi-drug resistance, MDR) (such as P. aeruginosa, Acinetobacter baumannii, methicillin-resistant Staphylococcus aureus). Some early-onset VAPs can also be caused by MDR. Therefore, MDR has become the main pathogen of VAP, especially Gram-negative bacilli. Studies have shown that VDR caused by MDR has a mortality rate of 76% and an attributable mortality rate of 20-30%. Such bacteria are not sensitive to commonly used antibacterial drugs in the clinic, and sensitive antibiotics, such as aminoglycosides, have a large systemic side effect, thereby limiting clinical use. Therefore, in theory, nebulized inhaled sensitive antibiotics can achieve high drug concentrations in lung tissue, and lower blood concentrations can avoid or reduce systemic side effects.

Eligibility Criteria:
Inclusion Criteria:

・After 48 hours of mechanical ventilation diagnosed VAP.

Exclusion Criteria:

* Maternal
* who not meet the age limits,
* used amikacin within 15 days,
* allergic to amikacin,
* APACHE II score \> 35,
* severe neutropenia unrelated to sepsis or meningitis,
* unable to retain specimens
Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor

The endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.

Primary objective:

Obtain a tissular characterization of a biliary or pancreatic stenosis with a confocal microscope which is in direct contact of the stenosis during the Endoscopic Retrograde Cholangio-Pancreatography (ERCP).

Secondary objectives:

* Compare the result of this "optical biopsy" to a conventional biopsy.
* Tolerance

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to older
* Patient with an inflammatory or tumoral stenosis of bile duct or a solid or cystic tumor in the pancreas with a dilatation of the principal pancreatic canal.
* Signed consent

Non inclusion Criteria:

* Patient who have no indication for an ERCP
* Allergy to fluorescein
* Allergic rhinitis, asthma, eczema
* Pregnancy, breast feeding
* Patients with dialysis
* Patient with severe heart failure
* Patient with cirrhosis
* Hemostasis failure which can induce difficulties or contraindication for the biopsy during the conventional endoscopy
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope

The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.


Eligibility Criteria:
Inclusion Criteria:

Patients affected by clinical diagnosis of reflex syncope who meet all the following criteria:

* age \>=40 years
* significant limitation of social and working life due to unpredictable or frequent syncope recurrences, ≥2 within the last year.
* type 2B cardio-inhibitory response to TT (according to the VASIS classification).
* Alternative therapies have failed or were not feasible.
* exclusion of other possible competitive causes of syncope.

Exclusion Criteria:

- Any other indication to IPG, implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines

Any cardiac dysfunctions possibly leading to loss of consciousness:

* overt heart failure;
* ejection fraction (LVEF) \<40% (Echo-assessed within 3-month prior to study participation);
* myocardial infarction;
* diagnosis of hypertrophic or dilated cardiomyopathy;
* clinically significant valvular disease;
* sinus bradycardia \<50 bpm or sinoatrial block;
* Mobitz I second-degree atrioventricular block;
* Mobitz II second or third-degree atrioventricular block;
* bundle-branch block;
* rapid paroxysmal supraventricular tachycardia or ventricular tachycardia;
* preexcited QRS complexes;
* prolonged QT interval;
* Brugada syndrome;
* arrhythmogenic right ventricular cardiomyopathy
* Symptomatic orthostatic hypotension diagnosed by standing BP measurement;
* Nonsyncopal loss of consciousness (eg, epilepsy, psychiatric, metabolic, drop-attack, cerebral transient ischemic attack, intoxication, cataplexy).
* Symptomatic cardioinhibitory carotid sinus hypersensitivity.
Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography

This study examines the effect of vitamin D on Retinal changes in patient with optic Neuritis.


Eligibility Criteria:
Inclusion Criteria:

* age 15-50 years
* no history of demyelinative events
* level of vitamin d below 20 ng/ml
* no pass 10-32 day from starting symptom

Exclusion Criteria:

* using vitamin D supplement
A Prospective Study to Collect Images in Patients Treated With Iodine-131 as Part of a European Research Project in Radiation Protection.

This trial is a prospective, non-interventional, monocentric study aiming to collect standard of care imaging of patients treated with Iodine-131 for the determination of dosimetric studies.

Data from this study will be collected as part of an European research project called MEDIRAD.

The overall objectives of this project are to enhance the scientific bases and clinical practice of radiation protection in the medical field, and more specifically to develop and implement the tools necessary to establish the range of absorbed doses delivered to healthy organs in patients undergoing thyroid ablation and the threshold absorbed dose required for thyroid ablation. This will enable patient specific treatment planning that will minimize risk to the patient while ensuring a successful outcome and will facilitate development of a large scale epidemiological study of the effect of low absorbed doses from irradiation of normal organs with internal sources of radionuclides.

Patients will be followed as part of their standard of care. Imaging (SPECT/CT (Single Photon Emission Computed Tomography-Computerized Tomography) and Whole Body scintigraphy) performed at 48 hours post Iodine-131 treatment will be collected. Measures of external gamma radiation will also be collected in the European database.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with differentiated thyroid cancer (papillary or follicular) stage T1b, T2, T3A, Nx-N0-N1, M0 (according to AJCC 8th edition, 2017) of intermediate risk of recurrence (according to 2015 ATA Risk Stratification System)
2. Patient is eligible to receive a therapeutic activity of 3.7 GBq of I-131 after total thyroidectomy or completion thyroidectomy
3. Age ≥ 18 years old
4. Patient affiliated to the French social security system
5. Patient who has received an informed consent for the study

Exclusion Criteria:

1. Patient who has received an external radiotherapy within 6 weeks prior to I-131 treatment
2. Patient who has received a systemic chemotherapy within 6 weeks prior to I-131 treatment
3. History of treatment with I-131
4. Pregnant or breastfeeding women
5. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
6. Patient protected by law
Nxstan: A Culturally Tailored Intervention to Prevent Diabetes in American Indian Men

To reduce modifiable diabetes risk factors' in overweight and obese AI men residing on the Colville reservation through a community-based, culturally informed intervention, the study specifically aims to: 1. conduct focus groups and interviews with adult members of Colville tribe to inform the adaptation, manualization and implementation of a culturally informed diabetes prevention program among overweight and obese AI men; 2. evaluate the effectiveness of a community-based, culturally informed diabetes prevention intervention by assessing between group changes.

To reduce modifiable diabetes risk factors' in overweight and obese AI men residing on the Colville reservation through a community-based, culturally informed intervention, the study specifically aims to: 1. conduct focus groups and interviews with adult members of Colville tribe to inform the adaptation, manualization and implementation of a culturally informed diabetes prevention program among overweight and obese AI men; 2. evaluate the effectiveness of a community-based, culturally informed diabetes prevention intervention by assessing between group changes in: Primary Outcomes: weight, dietary fat and caloric intake, vegetable consumption, and physical activity; Secondary Outcomes: physical fitness, blood pressure, lipids, self-reported quality of life; and, 3. evaluate the sustainability of the diabetes prevention intervention by assessing participant perceptions of program component fit through focus group discussions with participants in the intervention and telephone interviews with those who left the program.

Eligibility Criteria:
Inclusion Criteria:

* Must be male and self-reported American Indian; Reside in or near Colville tribe; ages 21-65, A BMI ≥25 kg/m2 and/or a waist circumference \>90 cm for men; no prior diabetes diagnosis; No history of heart disease, serious illness, cancer diagnosis in the last five years, or other conditions that may impede or prohibit participation; and, willingness to consent to randomization

Exclusion Criteria:

* Females, under 18 years old or older than 65 years
Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery

It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus.

Patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care.

The primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes).

The trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent

Exclusion Criteria:

* Emergency colorectal surgery, unable to consent
Oral Hygiene Among Portuguese Older Adults

The goal of this clinical trial was to compare two different oral hygiene instruction methods on oral hygiene behavior in older adults. We also wanted to evaluate the self-perception of oral health changes with each instruction method. The main questions we aim to answer were:

* Which method has better results in changing oral hygiene habits?
* Which method has better results in reducing bacterial plaque?

Participants:

* Completed a questionnaire about socioeconomic aspects and oral hygiene habits;
* Were examined to assess their oral hygiene status;
* Completed a questionnaire about self-perception of oral health;
* Received oral hygiene instruction (depending on the group: Generalised Approach or Personalised Technique).

Two months later, they were assessed again on oral hygiene habits, oral hygiene status, and self-perception of oral health.

This study aimed to evaluate the effectiveness of two different oral hygiene instruction methods on oral hygiene behavior in older adults. Secondly, we intended to assess the self-perception of oral health changes with each instruction method.

This study was a clinical trial that included a convenience sample of 60 participants attending a university dental hospital (Egas Moniz Dental Clinic, Almada, Portugal).

Data were collected in two phases: The first phase (baseline) consisted of three parts: a questionnaire focusing on the participant's socioeconomic data and oral hygiene behaviors, clinical records obtained through an intraoral examination, using the Oral Hygiene Index-Simplified (OHI-S), and oral hygiene instruction.

For the oral hygiene instruction, the sample was divided into two groups of 30 participants (n=30) each group, exposed to different methods of professional education. The first one, identified as "General Approach" (GA), focuses more broadly on the different topics of oral diseases and oral hygiene care. The second group, identified as "Personalised Technique" (PT), was based on the specific needs of each participant.

After two months, to establish a follow-up session, the self-reported questionnaire on oral hygiene behavior and self-perceived oral health was administered again and the same clinical records on OHI-S were collected.

Eligibility Criteria:
Inclusion Criteria:

* Being able to speak and understand Portuguese;
* Being able to understand and sign an informed consent form;
* Being literate and able to comply with the study protocol.

Exclusion Criteria:

* Being edentulous;
* Being institutionalized;
* Having disabilities such as blindness, deafness, or dementia.
Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?

Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)?


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 55 years old
* Clinically suspected optic neuritis defined as a sudden decrease of the visual acuity and/or a damage to the field of vision and/or a defect of the colour vision and/or retro-orbital pain with a relative afferent pupillary defect (except if the optic neuropathy is bilateral or symmetrical), in the absence of a severe retinal macular pathology, and in the absence of a toxic or iatrogenic intake (ethambutol, vfend)
* Clinical optic neuritis duration \< 15 days
* First episode of an inflammatory ON
* No corticosteroids in the month before
* Indication to a corticosteroid therapy at high dose to cure the felt symptomatology
* Retinal nerve fibre layer (RNFL) thickness upper 75 µm at initial stage
* Isolated ON, multiple sclerosis or NMO (Neuro Myelitis Optica) - SD (Spectrum Disorder) context
* Having signed informed consent for participating in the study

Exclusion Criteria:

* Contra-indication to MRI

  * Cardiac pacemaker or defibrillator implant
  * Neurosurgical clips
  * Cochlear implants
  * Intra-orbital or encephalic foreign bodies
  * Stents implanted since less than 4 weeks and osteosynthesis equipment implanted since less than 6 weeks
  * Claustrophobia
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
* Eye examination suggests a pre-existing eye abnormality that could affect the visual function (amblyopia, strong myopia...)
* Pregnant or breastfeeding women
Bacteriotherapy to Improve Underarm Odor

The goal is to improve the underarm odor by changing the microbiome. The autochthonous bacterial community is replaced by a non-smelling microbiome, by daily application of bacteria in a spray.

Participants are recruited and selected based on their initial underarm odor and underarm microbiome. The participants use two sprays: one spray containing the bacteria, and the other nothing (placebo). Participants do not know which spray they have. They use one spray during one month, and meanwhile take samples of their underarm microbiome (for sequencing), volatome (for GC/MS analysis) and odor (for odor panel analysis). Samples are stored in the freezer and brought to the university after one month, when they receive the second spray. The bacterial spray contains bacteria that are correlated with good underarm odor.

Eligibility Criteria:
Inclusion Criteria:

* above average underarm malodor
* microbiome dominated with malodorous bacteria

Exclusion Criteria:

* not healthy
* microbiome with too high levels of Staphylococcus
Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery

This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.

Dermabond and the Prevena Incision Management System are both FDA approved wound care products. Prevena is a negative pressure system which holds the wound together and removes exudate and debris from the site to prevent infection. Dermabond is a surgical glue which holds the wound together to prevents infection. Prevena is more expensive to apply. However, the hypothesis is that the Prevena System will decrease infection rates and therefore, decrease the ultimate cost of the health care needed after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. In need of elective vascular procedure requiring ≥8 cm groin incision.
2. Able to provide consent
3. Able to care for wound or have support person to complete wound care
4. Willing to comply with follow-up

Exclusion Criteria:

None
Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women

The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced cervical cancer in elderly women.

Concurrent radiotherapy is the standard treatment of inoperable cervical cancer .Due to the physical conditions, elderly patients usually associated with medical complications, so generally just receive radiotherapy alone. Recently, some retrospective studies have shown that the impact of chemotherapy did not cause an increase in the complication rate among elderly patients as compared to younger patients with cervical cancer, and may improve the survival when concurrent with radiotherapy. Cisplatin and paclitaxel are two effective drug in treating cervical cancer, but whether they are safe enough for elderly when concurrent with radiotherapy, there are no clearly reports. In this study ,we replace the conventional dose chemotherapy with weekly cisplatin or lipsome paclitaxel , to compare the efficiency and safety of weekly cisplatin / liposome paclitaxel concurrent chemoradiotherapy and radiotherapy alone in the treatment of cervical cancer in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven squamous carcinoma of cervix
2. FIGO stageⅡB and ⅢB
3. Over 65 years
4. Do not receive other treatment
5. Performance index ECOG grade 0 to 2
6. Normal ECG
7. Normal hematological parameters
8. Normal renal and liver function tests

Exclusion Criteria:

1. Concomitant disease which may adversely affect the outcome
2. Poor nutritional status
3. Medical or psychological condition precluding treatment
4. Previous treatment
5. Concurrent treatment for any cancer
Evaluation of Ganovo （Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.

Given no specific antiviral therapies for new coronavirus pneumonia approved yet and Ganovo, an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open, controlled trial will evaluate the efficacy and safety of Ganovo in hospitalized patients infected with SARS-CoV-2.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years old;
* Pneumonia patients with new coronavirus infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the diagnosis and treatment plan for pneumonia with new coronavirus infection (Current Trial Version);
* Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days);
* Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration;
* Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration;
* Patients who voluntarily sign informed consent.

Exclusion Criteria:

* The pneumonia patients with severe new coronavirus infection met one of the following conditions: respiratory distress, RR \>= 30 times / min; or SaO2 / SpO2 \<93% in resting state; or arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) \<300MMHG (1mmhg = 0.133kpa);
* Pneumonia patients with severe new coronavirus infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with ICU monitoring treatment;
* Severe liver disease (such as child Pugh score \>=C, AST \> 5 times upper limit);
* Patients with contraindications specified in the instructions of ritonavir tablets;
* The pregnancy test of female subjects in the screening period was positive;
* The researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.).
Pilot Study on the Effectiveness of a TAP-block for Inguinal Hernia Repair

An prospective double blinded randomised trial,whether the use of an perioperative echoguided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic.

Hernia inguinal repair is the most common operation performed by general surgeons in the Netherlands. On of the most common complications after hernia repair is postoperative and chronic pain. Postoperative pain is an expected but undesirable effect after an operation, which can result in an prolonged hospital stay or longer time to return to full normal daily activities. There are indications that an insufficient treatment of postoperative pain is a risk factor for persistent or chronic pain after open inguinal hernia repair. Chronic pain is not uncommon after hernia repair, with an incidence of 11%.

The objective of this study is to determine, whether the use of an perioperative echo guided unilateral TAP block has an superior effect on postoperative pain after open hernia inguinal repair compared to wound infiltration with a long acting local anesthetic. There will be no further analysis in this study regarding the incidence of open hernia inguinal repair and chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 year, competent, elective surgical treatment, Body Mass Index (BMI) between 20-35.

Exclusion Criteria:

* fever, a coagulation disorder, patients with kidney and liverfaillure, an infection at the place where the puncture place, preoperative use of narcotic and nonsteroidal antiinflammatory drugs.