cyrilzakka/clinical-trials huggingface dataset:
Bacterial Lysates on Respiratory Tract Microecology and Evaluation of the Efficacy of Prevention and Treatment of VAP

The purpose of this study is to assess the effect of bacterial lysates on respiratory tract microecology in patients with mechanical ventilation and the efficacy of prevention and treatment of ventilator associated pneumonia.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a one-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to Bacterial Lysates( 14mg, once a day) or placebo(once a day).

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU for mechanical ventilation
* The expected mechanical ventilation time is more than 72h
* Sign the informed consent form when conscious and voluntary, and complete the questionnaire survey and follow-up as required; If it is unable to sign the informed consent form and complete the questionnaire survey and follow-up, the legal representative or guardian can act on behalf of it.

Exclusion Criteria:

* Ventilator associated pneumonia is known and confirmed
* Pregnant or lactating female
* Allergic to the active ingredients of bacterial lysates or any excipients listed in the ingredients
* Patients with autoimmune diseases
* Patients with acute intestinal infection
* Patients participating in other clinical studies at the same time
* Patients considered unsuitable by other researchers to participate in this study
Comparison of Postoperative QoR-15 Scores Between Sevoflurane and Remimazolam

The purpose of the study is to compare the quality of recovery (QoR)-15 scores according to the use of maintenance anesthetics in the cervical spine surgery. Total intravenous anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and malignant hyperthermia. However, it is still not enough to explain which is better between TIVA or inhalation anesthesia. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA with remimazolam. The hypothesis of the investigators study is that, in patients with cervical spine surgery, total intravenous anesthesia based on remimazolam can improve the the quality of recovery compared to inhalation anesthesia based on sevoflurane.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who aged 20-70 years
* ASA-PS: 1-3
* BMI \< 30
* Anterior cervical discectomy and fusion surgery

Exclusion Criteria:

* Tolerance or hypersensitivity to benzodiazepine
* Dependence or addiction to psychotropic drugs or alcohol
* Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions
Comparison of Iodine + Isopropyl Alcohol Versus Iodine + Antimicrobial Sealant for Skin Preparation

The purpose if this study is to determine whether a microbial sealant (iodine + cyanoacrylate) \[InteguSEAL®, Kimberly-Clark\] reduces surgical site infections when compared to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) \[Duraprep®\] in oncologic surgery.

Patient's skin flora is a major source of pathogens, and microbial contamination of the surgical site is a likely precursor of SSI. A variety of skin products may be used, including iodophors, alcohol-containing products, and clorhexidine gluconate. Despite these perioperative tactics, bacteria continue to survive at the skin level and migrate to contaminate the wound.

A microbial sealant (InteguSEAL®, Kimberly-Clark) that uses cyanoacrylate to seal endogenous skin flora has demonstrated to reduce wound contamination. The efficacy of the microbial sealant in preventing SSI has been tested in cardiovascular surgery and open inguinal hernia repair, with a reduction on SSI rate when compared to standard skin preparations. This cyanoacrylate has not been tested in oncologic surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years undergoing elective clean or clean-contaminated breast, gynecologic or digestive tract surgery
* Accepts to participate and signs the informed consent form
* Have a telephone number to be contacted after surgery

Exclusion Criteria:

* Previous allergy to one of the study products
* Two or more procedures in different anatomical sites at the same time / surgery (v.g. hysterectomy and mastectomy)
* Pregnancy
* Breast feeding
* Contaminated or infected surgeries
Descriptive Study of the Incidence and Outcome of PAS in Two Large Referral Hospitals in Egypt

placenta accreta spectrum incidence and outcome

placenta accreta spectrum ( PAS ) one of the most serious condition in obstetrics nowadays so the investigators measure the incidence by this study

Eligibility Criteria:
Inclusion Criteria:

* gestational age above 28 weeks

Exclusion Criteria:

* age less than 18
Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)

Brief Summary:

The FREEDOM study aims to develop a scalable intervention to improve type 2 diabetes mellitus control in low-income Black adults in the Deep South. The intervention targets social determinants of health (SDoH) such as reduced healthcare access, poverty, transportation barriers, and food insecurity.

Detailed Description:

1. FREEDOM Study (Type 2 Diabetes Mellitus):

   The FREEDOM study is a 12-month clinical trial enrolling 304 Black adults with Type 2 Diabetes Mellitus across three healthcare systems in Alabama and Mississippi. Participants are randomly assigned to one of eight combinations of three intervention components:
   * Digital Health Coaching: Participants receive one-on-one phone-based coaching for optimized diabetes management.
   * Food Box Delivery: Food boxes are delivered every two weeks to participants' homes,
   * Remote Patient Monitoring (RPM): Participants receive essential supplies, including glucometers, for remote blood glucose measurement. Data is monitored remotely for timely interventions.

   The study involves three in-person visits at baseline, month 6, and month 12, as well as two telephone study check-ins at month 3 and 9. Survey packets are administered at each time point.
2. FREEDOM-HIV Study (Type 2 Diabetes Mellitus and HIV Cohort):

Additionally, a cohort within the study, known as the FREEDOM-HIV study, will enroll additional 80 adults who have both Type 2 Diabetes Mellitus and HIV. This cohort will be observed over a 6-month period and will also consist of the same three intervention components.

Eligibility Criteria:
Inclusion criteria:

1. Self-identified as Black/African American
2. ICD diagnosis of T2DM
3. ≥18 years of age
4. Ongoing insulin treatment
5. HbA1c ≥8% within 6 weeks of study screening
6. has the ability to converse in and read English
7. must provide written informed consent prior to enrollment

Exclusion criteria:

1. Current enrollment in any diabetes-related interventional study
2. Cognitive impairment
3. End-stage kidney disease (CKD-5)
4. Pregnant or plans to become pregnant within 12 months
5. Currently enrolled in a structured lifestyle change program
6. Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention

HIV Cohort Criteria

Inclusion Criteria

1. ≥ 18 years of age
2. ICD diagnosis of T2DM
3. HbA1c ≥ 7%
4. Confirmed HIV+ diagnosis
5. Prescribed HIV ART therapy as part of care

Exclusion Criteria

1. Current enrollment in any diabetes-related interventional study or structured lifestyle change program
2. Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention
3. Cognitive impairment
4. End-stage kidney disease (CKD-5)
5. Pregnant or plans to become pregnant within 12 months
Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA

Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA


Eligibility Criteria:
Inclusion Criteria:

* Patients with localized rectal CA
Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

osteolateral thoracotomy is a painful surgical procedure.Thoracic epidural analgesia (TEA) is usually considered as the "gold standard" for postoperative thoracic analgesia. Unfortunately, it's not always possible to realize it because of contraindications or because of technical failures.Analgesia using a paravertebral block is an alternative to the TEA : it provides an unilateral sensitive and sympathetic block using a catheter.In our study, the catheter will be placed by the thoracic surgeon at the end of the surgical procedure, under direct vision, to insure maximal security also on patients on antiplatelets agents, anticoagulants or with haemostasis disorders (the placement of the catheter by the anaesthetist with the loss of resistance technique is contraindicated in these cases).Patients will be randomized to receive either a continuous 48-hours infusion of ropivacaine 0,5% or saline serum in the control group.All patients are connected to a PCA pump with intravenous morphine and will receive paracetamol and nefopam.The visual analogic scale (VAS) at rest and on movement, total morphine consumption and side effects will be recorded during the first 48 hours after surgery. The aim of this study is to prove a decrease of pain at rest and on movement, a decrease of the cumulated total morphine dose consumption and a decrease of the side effects (nausea, vomiting, pruritus, sedation, bradypnea, urinary retention).


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for thoracotomy who presented with contraindications to TEA.Contraindications to TEA are :
* Patient's refusal after informations about advantages and risks of the technique
* Anti platelets treatment that can't be discontinued
* Anticoagulants at a curative dosage- haemostasis and/or coagulation disorders: thrombopenia \< 100.000/mm3, ACT \> 1,5 / control, PTT \< 75%- Systemic or local infection of the puncture point
* 2 and 3 grade atrio-ventricular heart block without pacing
* Severe aortic valve stenosis
* Kyphoscoliosis
* certain neurological disorders

Exclusion Criteria:

* Patient's refusal to participate in the study
* Psychiatric disorder (impossibility to collect the informed consent)
* Patient under juridical protection
* On going an other study
* Pregnancy, breastfeeding
* Non balanced epilepsy
* 3 grade auriculae-ventricular heart block without pacing
* Severe hepatocellular insufficiency
* Anti arrhythmic treatment : class III of the Vaughan William's classification- Skin infection of the puncture point
* Allergy to aminoamides local anaesthetic
* Surgical difficulties to insert paravertebral catheter
Clinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients

The objective of this study is to examine the short and long-term effect of myofascial trigger point injections with either a local anesthetic or saline in patients with chronic low back pain presenting with myofasical pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

* CLBP of non-malignant origin, with or without accompanying leg pain, including patients with history of previous back surgery or trauma
* MPS as evident by at least one active MTP, located medial or lateral to the posterior iliac crest involving the gluteus maximus or medius, quadratus lumborum and erector spinae muscles
* While not precluding the participation in the study, MTP in other areas will not make patients eligible
* Pain lasting for at least six months

Exclusion Criteria:

* Any current motor weakness, but not sensory loss or abnormal reflexes in the lower limbs
* Any injection or nerve block in the low back in the last 6 months
* Local or systemic infection
* Bleeding disorder or the use of anticoagulation medications
* Known allergy to local anesthetics
* Poor understanding of written and spoken English or French
Data Collection of Arterial Line Waveform and BP Values

Collect continuous systolic and diastolic blood pressure values and waveforms as recorded by an arterial line catheter and by non-invasive blood pressure (NIBP) and to collect Photoplethysmogram Pulse Oximetry (PPG) waveform in order to optimize the Sensifree algorithm.

Sensifree is developing a continuous non-invasive blood pressure measurement system, that uses a fingertip PPG sensor as a signal source. The system provides systolic, diastolic and mean arterial pressure values, for use in hospitals and other clinical settings. The PPG waveform is analyzed by a proprietary software algorithm, calculating BP values.

The current best method to obtain similar information is by using an Arterial line catheter which will serve as a reference device. In this study, the sponsor aims to prospectively collect continuous radial arterial line \& PPG waveforms, as well as NIBP data over the period of the surgery in order to test and refine the algorithm.

Eligibility Criteria:
Inclusion Criteria:

1. Signed inform consent
2. Age 18 or greater
3. Elective surgery that requires invasive BP monitoring (A-line)

Exclusion Criteria:

1. Emergency surgery
2. A-line not inserted
3. Informed consent not signed
Evaluation of Free Aminoacids in Saliva as A Diagnostic Biomarker of Periodontal Disease

Amino acids (AAs) are organic molecules that are associated with inflammation and innate immunity diseases with critical roles in the cell repair and protection process. Our aim was to identify the free amino acids in saliva of a group of periodontitis patients and healthy individuals and additionally to assess their levels in different periodontal disease types and compare it to the healthy individuals.

The study consisted of three groups: healthy individuals (control(C); n=20), Stage III Grade B generalized periodontitis (GP-B; n=20), and Stage III Grade C generalized periodontitis (GP-C; n=20). Clinical periodontal parameters (plaque index (PI), gingival index (GI), probing depth (PPD), gingival recession (GR), clinical attachment level (CAL) and bleeding on probing (BOP)) were measured. The amino acid analysis in saliva was accomplished by liquid chromatography-mass spectrometry (LC MS/MS) as mean concentration.

Eligibility Criteria:
Inclusion Criteria:

systemically healthy, clinical diagnosis of periodontitis, clinical diagnosis of periodontal health

Exclusion Criteria:

history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 3 months); nonsurgical periodontal treatment (previous 6 months); surgical periodontal treatment (previous 12 months); presence of \<10 teeth; current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy); diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, smoking, or excessive alcohol consumption.
Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer

The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.

The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.

Eligibility Criteria:
Inclusion Criteria:

* Has given written consent prior to any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
* Has successfully completed the main study.

Exclusion Criterion:

- Has been withdrawn from the main study.
Feasibility Study of the Use of the gekoTM Device for Faecal Incontinence in Older People Living at Home or in Care Homes

This research aims to investigate the feasibility for the treatment of OnPulse(TM) for the treatment of faecal incontinence (FI) (including mixed faecal and urinary incontinence) in older people living at home or in a Care Home. It will determine patient acceptability, tolerability and usability of the T-2 gekoTM device for FI by assessing:

1. device user factors: acceptability of use, ease of device placement, ease of device interface control and understanding of device instructions;
2. tolerability of device: skin tolerability.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Aged 60 and over?
3. Reporting faecal incontinence of any severity
4. Living in own home or a Care Home
5. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
6. Able and willing to follow the protocol requirements.

Exclusion Criteria:

1. Patients or Carers unable to speak, read or understand English
2. Patients or Carers unable to give informed consent because of lack of capacity
3. Patients with leg conditions (such as a venous ulcer) that would preclude placement of the gekoTM device.
4. Have implantable electronic devices
5. Has sore, infected or inflamed areas, broken skin or skin eruptions for example phlebitis, thrombophlebitis, venous leg ulcers, varicose veins etc. in the region where the device would be fitted.
6. Any cancerous lesions in the lower limb
7. Is pregnant
Comparison of Lower-risk MDS Patients With and Without Improvements in Fatigue Following Blood Transfusion Therapy

At present, it is unclear why some myelodysplastic patients (MDS) receiving blood transfusion therapy exhibit an increase in Hemoglobin (Hb) without a concurrent improvement in fatigue. Research is thus required to elucidate on why fatigue persists in some MDS patients in order to devise strategies to alleviate fatigue in "non-responders" to blood transfusion.

One hypothesis is that patients who exhibited persistent fatigue following a blood- transfusion- induced increase in Hb have an impaired ability to utilize oxygen at the peripheral level. This could be the consequence of impairments in vascular function, mediated by endothelial dysfunction as a result of transfusion-induced iron-overload and oxidative stress associated with the disease. Taking the current gaps in knowledge pertaining to MDS-related fatigue into account, the objective of this study is to improve understanding on the aetiology fatigue in MDS patients. To achieve this aim, the study will measure a comprehensive group of patient-reported and disease-related outcomes: i) prior to blood transfusion therapy when Hb levels are low and; ii) following blood transfusion therapy, when Hb levels have been increased. Results from the post-transfusion tests will be analyzed to determine which participants remain fatigued despite an increase in Hb, and which participants shown an improvement in fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated to a social security regimen or beneficiary of the same
* Signed written informed consent form
* Patient, ≥ 18 years-old, with established diagnosis of myelodysplastic syndrome with low or intermediate-1 risk cytogenetic profile
* FACIT-F score ≤ 34,
* Indication of blood transfusion.

Exclusion Criteria:

* Contra-indication to experimental procedures and/or physical exercise,
* Concomitant cancer diagnosis,
* Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
* Refusing participation.
A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration

Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor \[VA\]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥50 years, at time of signing Informed Consent Form
* Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit
* Previous treatment with at least three anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
* Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
* Best-corrected visual acuity (BCVA) of 34 letters or better

Exclusion Criteria:

* Subfoveal fibrosis or subfoveal atrophy in study eye
* Subretinal hemorrhage that involves the center of the fovea in study eye
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
* Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
* Previous intraocular device implantation in study eye
* Previous laser (any type) used for AMD treatment in study eye
* Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
* Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye
* CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye
* Uncontrolled blood pressure
* History of stroke within the last 3 months prior to informed consent
* Uncontrolled atrial fibrillation within 3 months of informed consent
* History of myocardial infarction within the last 3 months prior to informed consent
* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications in the opinion of the investigator
* Current systemic treatment for a confirmed active systemic infection
* Chronic use of oral corticosteroids
* Active cancer within 12 months of randomization
* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)