cyrilzakka/clinical-trials huggingface dataset:
Gut and Vaginal Microbiota Profile Study for HIV Women

Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually contributes to variable cervical lesions. we hypothesize that vaginal microbiota imbalance may make WLHIV prone to HPV infection，thereafter results in severe cervical lesion.

Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually contributes to variable cervical lesions. Besides the HPV co-infection, microbiota study recently reveals that the changes of vaginal bacteria spectrum might also be related with cervical disease in WLHIV. However, data on HPV prevalence in WLHIV and its associated cervical lesion incidence is still limited in China. Moreover, the causal relationship between vaginal microbiota and cervical lesion in WLHIV is not clear. Here, we hypothesize that vaginal microbiota imbalance may make WLHIV prone to HPV infection，thereafter results in severe cervical lesion.

Eligibility Criteria:
Inclusion Criteria:

* HIV women （including pregnant）;
* sign consent paper

Exclusion Criteria:

* virgin or maiden
The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease

The study is to further exploring the optimal switching strategy by evaluating the pharmacodynamic responses as well as adverse events in patients with complexity of coronary artery disease managed by percutaneous coronary intervention (PCI). All participants will be divided into three groups and recieving ticagrelor 90mg plus aspirin 100mg at 12 hours after the last dose of clopidogrel; recieving ticagrelor 90mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel; recieving ticagrelor 180mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-75
2. Patients with complexity of CAD determined by coronary angiography and implanted stent successfully
3. Taking clopidogrel 75mg daily over 5 days or paients never took clopidogrel previously should receive 300-600mg drugs at least 12 hours before coronary angiography
4. Agreeing to participate in this trial and signed the written informed consent.

Exclusion Criteria:

1. They contraindicated with ticagrelor (including: allergying to ticagrelor or its active metabolite
2. Concomitanting therapy with a strong cytochrome P-450 3A inhibitor or inducer
3. Previous intracranial haemorrhage or ongoing bleeds
4. Moderate or severe hepatic impairment)
5. Having a previous medication with ticagrelor or long term anticoagulation
6. Having a history of asthma or chronic obstructive pulmonary disease (COPD) and recurrent attacked
7. Having an uncontrolled hypertension\>180/110mmHg
8. Having a hemoglobin\<100g/L 9.Having a platelet counts\<100×10\^9/L
9. Having severe renal impairment (clearance\<30mL/min)
10. Having a history of hepaein-induced thrombocytopenia (HIT)
11. Having a pregnancy or were during lactation.
Delirium in Mechanically Ventilated Patients

The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.

This is a single center, observational, cross-over design study assessing the impact of daily awakening from sedation on delirium in the ICU. Enrolled patients will receive a daily baseline delirium assessment using the CAM-ICU tool before the awakening from sedation and an assessment during the awakening from sedation. Each patient will thus serve as their own controls for these interventions.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* intubated and mechanically ventilated
* receiving sedative and/or analgesic medication
* candidate for daily awakening from sedative and/or analgesic medication

Exclusion Criteria:

* primary neurologic disease (stroke, seizure, elevated ICP)
* post cardiac arrest
* do not speak English (assessment only English language validated)
Magnetic Resonance Imaging in Subjects With Gouty Tophi

The purpose of this study is to determine the reproducibility of Magnetic Resonance Imaging (MRI) in the quantitative assessment of tophus volume.

This is a multi-center, validation study of MRI in the quantitative assessment of gouty tophi. Subjects with palpable gouty tophi (confirmed by aspiration of the tophus) in select anatomical sites (foot, hand or elbow) will undergo pre- and post contrast MRI on two occasions separated by 5 to 10 days. This study will consist of up to 4 study visits.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with gout and at least one tophi.

Exclusion Criteria:

* Unable to undergo MRI.
Study of Energy Expenditure in Infants With Ventricular Septal Defects

OBJECTIVES:

I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.

PROTOCOL OUTLINE:

Height, weight, and vital signs (including oxygen saturation by pulse oximetry) are measured on Day 1. Resting energy expenditure, oxygen consumption (VO2), carbon dioxide production (VCO2), and resting respiratory exchange quotient (RQ) are measured using open circuit respiratory calorimetry on Day 1. Patients undergo assessment of total daily energy expenditure using the doubly labeled water method comprised of oral deuterium and oral oxygen O 18 with the next scheduled feeding on Day 1. Urine samples are collected prior to isotope administration, then serially for approximately 12 hours after isotope administration on Day 1, and then daily on Days 2-7. These samples are analyzed by mass spectrometry. On Day 1, patients also undergo echocardiogram to confirm size of defect and measure the degree of pulmonary/systemic blood flow ratio and pulmonary artery pressures.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Infants with moderate to large ventricular septal defect (VSD) by most recent echocardiogram who meet the following conditions: no other concurrent heart or lung disease; no chromosomal defects or congenital anomalies

OR

Healthy control infants without VSD who meet the following conditions: clinically well; no heart disease; no chromosomal defects or congenital anomalies

--Prior/Concurrent Therapy--

Surgery: VSD infants -- No prior cardiac surgery or palliative procedures; VSD and control infants -- Greater than 6 weeks since other prior surgery

Other: VSD and control infants: Greater than 6 weeks since prior hospitalization
Inpatient Endoscopy Procedure Planning Delays and Impact on Length of Stay and 30-day Readmission

Single center retrospective cohort study of all inpatient endoscopy procedures to asses factors associated with inpatient endoscopy delays and impact on length of stay and 30-day readmission

Background: Delays in inpatient endoscopy planning negatively influence the quality and accessibility of care. This may result in higher healthcare costs, negative health outcomes, and unnecessary readmissions and use of hospital beds. Additionally, prolonged hospital stay is associated with poorer health outcomes and risk of nosocomial infections, amongst others.

Objective: To asses factors associated with inpatient endoscopy delays and impact on length of stay and 30-day readmission

Study design: Single center retrospective cohort study of all inpatient endoscopy procedures (gastroscopy, colonoscopy, ERCP, sigmoidoscopy) during 2016-2022. Data will be identified and extracted using CTCue. Only pseudonymized data will be used. Inpatient endoscopy delay will be defined as the number of days between the planned date versus the actual date. Multivariable logistic regression models will be performed to assess factors associated with inpatient endoscopy delay.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years)
* Clinical admission in any hospital department of at least two days during 1 January 2016 and 1 December 2022
* Endoscopic procedure during clinical admission, including gastroscopy, endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), flexible sigmoidoscopy, colonoscopy

Exclusion Criteria:

* Elective admission
* Procedure only for insertion of nasogastric or nasojejunal (feeding) tube without any other diagnostic or therapeutic aims
Incidence and Risk Factors of Peri-operative Stroke in Non-cardiac,Non-neurosurgical Surgeries

Stroke is an important cause of perioperative morbidity and mortality, particularly in patients \> 60 years. In cardiac, neurological and carotid surgery the incidence is known to be high (2.2-5.2%). However, little is known regarding perioperative stroke following other types of surgery including general, urological, orthopedic, thoracic and gynecological procedures. We therefore propose to undertake a multicenter, observational cohort study, to determine the current incidence of, the risk factors for, and outcome associated with perioperative stroke in patients undergoing non-cardiac and non-neurological surgery.

Patient population: Prospective cohort study of 10,000 adults undergoing non-cardiac, non-neurological surgery.

Screening and enrollment: Consecutive patients undergoing (elective or emergency) non-cardiac, non-neurosurgical surgeries will be recruited.

Monitoring, follow-up, and data collection: Usual treatment will be provided. Demographic details will be recorded. Patients will be visited regularly in hospital. Patient will be reviewed for neurologic deficit using the mNIHSS. Brain imaging will be performed to confirm stroke event. Follow-up at 30 days after discharge will be done to ascertain if there is any adverse outcome.

Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 60 Years and older
* Genders Eligible for Study: Both
* Accepts Healthy Volunteers: No
* Sampling Method: Probability Sample

Exclusion Criteria:

* hospital stay after surgery less than 3 days
* not consent of the assessment
* surgery canceled
ClearSight Baby Cuff

A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients.

A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients under 2 years old

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Age \< 2 years
3. Availability of a standard blood pressure measurement as part of standard of care

Exclusion Criteria:

1. Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the prototype finger cuff
2. Inability to place finger cuffs appropriately due to subject anatomy, condition, or obstructive paraphernalia
3. Known sensitivities to system materials
4. Broken or open skin located at the site of the finger cuff
5. Proven left-right difference in blood pressure
6. Cardiac problems that can cause a difference in blood pressure between the two arms, including aortic coarctation
7. Extreme contraction of the smooth muscles in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

The purpose of the study is to assess the functional outcome, quality of life and late sequelae in a representative sample of 600 long-term survivors of Ewing sarcoma and to build a unique clinical and functional data pool of the underlying cohort of 3000 Ewing sarcoma patients with a follow-up of 3 decades.

Trial objective: As survival rates of bone sarcoma patients have been raised owing to improved treatment strategies the focus of investigations is now on the medical, social, and economic sequelae of intensive multimodal treatment. This study aims to assess the functional outcome, quality of life and late sequelae in a representative sample of long-term survivors of Ewing sarcoma. The data recorded combined with standardized treatment data covering a 30-year period will produce a data pool that is unique for its magnitude and will be used for the development of guidelines for further improvements of future bone sarcoma treatment.

Working plan: The working plan provides for the assessment of functional outcome and quality of life by means of validated tools (TESS, SF36, PEDQOL) and objectively measuring daily activity patterns by using the Step Activity Monitor (SAM) in 600 long-term Ewing sarcoma survivors and a control group of 300 matched healthy subjects. Information on sarcoma treatment and follow-up is obtained by re-structuring and complementing the database of the relevant patient cohort (n=3000) from four consecutive nationwide and international clinical trials between 1980 and 2008. Procedures of local treatment will be evaluated regarding functional outcome, quality of life, and survival probability and prognostic factors predicting long-term outcome will be identified.

Exploitation of results: The results will be presented at scientific meetings and will be published in international journals. Guidelines will be developed regarding improvements in the treatment, rehabilitation, and social integration of bone sarcoma patients to be utilized in guiding patients and in the decision process of medical professionals regarding their treatment. In the long run, the evidence based guidelines on treatment and follow-up are to be transferred into the health system.

Eligibility Criteria:
Inclusion Criteria:

* CESS81/CESS86/EICESS92/EURO-E.W.I.N.G.99 trials participants of the German Society of Pediatric Hematology and Oncology (GPOH)

Exclusion Criteria:

* no complete remission (CR)
* any kind of paralysis
* \<3y after diagnosis
Thiol/Disulphide Homeostasis and Vascular Endothelial Growth Factor Levels in Diabetic Children

The aim of this study to evaluate the vascular endothelial growth factor level and thiol/disulphide homeostasis in saliva of diabetic children with gingivitis.

Eighty children (44 with type 1 diabetes mellitus and 44 systemically healthy) will be recruited for the study. The children will be divided into four subgroups based on their periodontal and systemic condition: 1) systemically and periodontally healthy children, 2) systemically healthy children with gingivitis, 3) periodontally healthy children with T1DM, and 4) children with T1DM and gingivitis. The plaque index, gingival index, probing pocket depth, will recorded. The vascular endothelial growth factor level determined by ELISA. Native thiol, total thiol and disulphide levels will be measured in saliva.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed as type 1 diabetes mellitus
* Age between 7-14 years

Exclusion Criteria:

* Having another systemic problem except type 1 diabetes mellitus
* Children carrying orthodontic appliances
Improving Surgeon Performance Measures for Robot-Assisted Surgery

The purpose of this study is to develop new tools to understand surgeon performance to improve surgical training and participant outcomes after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Surgeons who perform robotic surgery for candidate procedures
* Surgeons who perform candidate procedures that are frequently performed by at least three surgeons (to ensure the ability to make adequate comparisons)
* Surgeons who agree to participate in the study

Exclusion Criteria:

* Surgeons who decline to participate in the study
Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients

Study of adult patients with severe all-cause trauma having a body temperature less than 36°Celsius (C) that is managed by a Mobile Emergency Service team and oriented towards a Vital Emergency Room.

Currently two devices are used to warm patients during their care at the scene of an accident: a survival blanket and heating in the emergency vehicle. Despite these two devices many patients arrive in hypothermia (body temperature less than 36°C) in emergency departments. The objective of this study is to evaluate the effectiveness of a body warmer associated with standard warming devices on the correction of hypothermia compared to the standard procedure in severely traumatized patients with hypothermia .

It is a national multicentric study with 14 participating Mobile Emergency Service centers and hopefully will include 612 patients.

The study will be carried out according to a pattern of 28 successive periods of one week each during the winter period (October to April), for a total duration of 7 months. 14 action periods ON (warming standard procedure + body warmer) and 14 control periods OFF (warming standard procedure) will be run in random order for each center.


Eligibility Criteria:
Inclusion Criteria:

* Major patient with all-cause trauma Grade A or B
* Patient with a trans-tympanic body temperature of less than 36°Celsius (C) at primary management by terrestrial or heliport Mobile Emergency Service team.

Exclusion Criteria:

* Patient initially supported by a pre-hospital medical team who does not participate in the study,
* Patient with cardiopulmonary arrest at initial pre-hospital medical team management,
* Patient with bilateral otorrhagia (due to the non-feasibility of trans tympanic temperature),
* Patient with inguinal crease or subclavicular fossa injury,
* Patient with severe burn (Burnt Body Surface\> 20%),
* Patient deprived of liberty including patients with an electronic bracelet.
Acute Gastrointestinal Injury in Pediatrics

Critically Ill children may develop acute gastrointestinal injury secondary to severe inflammation.

Data collection from enrolled subjects including profile, laboratory examinations, inflammatory markers on day 1 and day 3, nutritional support and daily calorie intake, and finally outcome of the patient

Eligibility Criteria:
Inclusion Criteria:

* critically ill pediatric patients receiving care at the PICU
* presence of AGI (any degree)

Exclusion Criteria:

* patients who's body weight cannot be measured
Improving the Diagnosis of Meningitis in Emergency Rooms

A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of meningitis caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of meningitis after POC test.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted at hospital for meningitis requiring, for the emergency physician, a microbiological examination with a "POC meningitis kit."
* Patient who has freely signed the informed written consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant woman, parturient or nursing
* Adult patient under guardianship
* Patient deprived of liberty under court order
* Patient refusing or unable to sign the informed consent form.
Effects of Dexmedetomidine on Intraocular Pressure During Scheduled Spine Surgeries

The aim of this study is to examine the effects of intraoperative systemic use of dexmedetomidine on the intraocular pressure (IOP) in patients undergoing spine surgeries in a prone position under general anesthesia.

The study is a Prospective, Randomized, Placebo -controlled, Double-Blinded clinical trial Adult patients with an ASA physical status of class I, II or III who are scheduled for an elective spine surgery in prone position under general anesthesia will be included in the study.

The patients will be randomized with closed envelope manner into two groups: the group of dexmedetomidine and the group of normal saline.

In the dexmedetomidine group (DEX group), bolus dose 1,0 μg/kg of dexmedetomidine will be administered in 10min before induction to anesthesia and 0,4-0,8 μg/kg/h of dexmedetomidine will be infused continuously until the end of the surgery.

In the saline group (placebo group), the same volume of saline will be administered in an identical way.

All study medication will be prepared by an independent anesthesiologist who is not associated in the study (who will hold the randomization codes until the end of the study).

All patients will receive the same type of anaesthesia (TIVA with propofol) and postoperative analgesia including paracetamol 1gr iv (4 times/day) and continuous wound infiltration with ropivacaine 0.2% 5ml/h for 48 postoperative hours.

Basic monitoring for the study includes:

ECG, Invasive and noninvasive blood pressure, Heart Rate, EtCO2, SpO2, Cardiac Output (CO), Stroke Volume (SV), Stroke Volume Variation (SVV), Patient State index (PSi), IOP, Urine output.

Measurements

The measurement of IOP will be conducted in both eyes with Icare PRO tonometer by an ophthalmologist who will not know in which group the patient is in the below predefined time points:

* T1: before administration of the study drug
* T2: after administration of the bolus dose of the study drug
* T3: after tracheal intubation
* T4: just before prone position
* T5: just after prone position
* T6: 30min after T5
* T7: 60min after T6
* T8: 120min after T7
* T9: 180min after T8
* T10: at the end of the surgery and the patient in supine position At the time of each tonometer reading the following data set is collected: MAP, heart rate, EtCO2, SpO2, CO, SV, SVV, urine output, Psi, IOP. Moreover OPP will be calculated as MAP minus IOP.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia

Exclusion Criteria:

* Patients who refuse to be a part of the study
* Patients with previous eye surgery
* Preexisting eye disease (e.g glaucoma)
* Allergy to the study drug or any drug which is in the trial
* Preoperative unstable hemodynamics
Accuracy and Predictive Values for Colorectal Cancer of Quantitative FIT in Symptomatic Patients in Primary Care

The aim of this study is to determine accuracy and predictive values for colorectal cancer of a faecal quantitative immunochemical test (FIT) in unselected symptomatic patients presenting in primary care. Main reference test will be linkage to a nationwide colorectal cancer registry.

This is a nationwide multi-centre study in primary care, Sweden. Patients from the age of 40 years and above presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible.

Consenting patients will fill out a short form on symptoms during last 4 weeks. They will provide 2 faecal samples from 2 different days. Samples will be analysed at any of three laboratories within 5 days using QuikRead go® (Aidian Oy). The analytical working range is 10-200 µg Hb/g faeces. The outcome will be reported as the concentration of first test (FIT 1) and highest concentration of two tests (FIT max). The outcome of the study FIT will remain within the study and GPs must request a separate FOBT for clinical purposes.

Reference test will be linkage to the Swedish Colorectal Cancer Registry (with in practice complete coverage) after at most 2 years for all patients. Accuracy and predictive values will be determined and ROC-curves analysed.

Some patients included in the study will be referred for colonoscopy for clinical reasons, and the outcome of FIT in relation to colonoscopy findings will be reported for this group as well.

Eligibility Criteria:
Inclusion Criteria:

Patients presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible.

Exclusion Criteria:

Referral for bowel examination for other reasons than symptoms. Not able to understand the instructions for participation.