cyrilzakka/clinical-trials huggingface dataset:
Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)

This is a monocentric, non-randomized, prospective, in silico feasibility study conducted by Strasbourg Europe Cancerology Institute. The purpose of this study is to evaluate the optimisation of potential dental implant sites protection, without degrading tumor volume coverage, through designation of potential dental implant sites before volume delineation and dosimetry calculations in patients with oropharyngeal or oral cavity squamous cell carcinoma treated by radiotherapy.

35 patients will be included in this study and will benefit from a dental consultation for dental rehabilitation plan elaboration and radiological guide confection. Two dosimetric computer-tomography scans, with or without radiological guide, will be conducted. Virtual dental implants will be visualised by the dental surgeon on scanner images (with or without radiologic guide). After volume delineation and dosimetry calculations, the optimal treatment plan will be validated. Patients will be followed throughout radiotherapy and during 18 months following the end of radiotherapy for evaluation of toxicity, quality of life and dental implant survival rate.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 18 years old
* Performance Status 0 to 2
* Histologically-confirmed diagnosis of : infiltrating squamous cell carcinoma of the oral cavity or oropharynx
* Indication for an exclusive radiotherapy or post-surgery radiotherapy, with or without chemotherapy
* Indication for a radiotherapy of lymph node areas
* Partial or complete toothlessness requiring rehabilitation
* Signed informed consent from the patient

Exclusion Criteria:

* History of head and neck radiotherapy
* Partial mandibulectomy
* Retarded wound healing or trismus impairing radiological guide preparation
* Patient refusing the study
* Pregnant women
The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry

The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach.). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.

By recording the results of all of your biopsies over many years, it may be possible to find out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and which patients with Barrett's esophagus develop precancer and cancer. The data from your biopsies will be used to determine the best way to diagnose esophageal disease.

You are being asked to participate in the study because you are receiving an upper endoscopy (a procedure where a tube with a light and camera are inserted in your mouth and down your throat) with forceps and brush biopsies of your esophagus as part of your standard clinical care, and you are between the ages of 18 and 80.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Able to read, comprehend, and complete the consent form
* Aged 18 to 80, and,
* Meet one of the following:
* Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or
* Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or
* Patients who have undergone endoscopic eradication therapy(including, but not limited to endoscopic mucosal resection, endoscopic submucosal dissection, radiofrequency ablation and/orcryoablation/spray cryotherapy)who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM) with accompanying WATS3D sampling and forceps biopsies.

Exclusion Criteria:

* Patients meeting any of the following criteria will be excluded from this study:
* Patients who on their enrollment endoscopy have a visible highly suspicious lesion, such as a nodule or ulcer, (noted while undergoing endoscopy) that requires targeted biopsy will be excluded from the study.Patients requiring a targeted biopsy on follow-up endoscopies will be allowed to remain in the study.
* Patients who do not undergo both biopsy forceps and WATS3D biopsy of the esophagus on their initial evaluationfor routine care will be excluded from this study. Subsequent endoscopicevaluation may include forceps biopsies alone, WATS3D biopsies alone, or both forceps and WATS3D biopsies.
Difference in the Frequency of Use of Lachrymal Substitutes in Patients With Moderate to Severe Dry Eye Syndrome

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population.

Topically administered lubricants are the basis for treatment of this disease. Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged over 18 years
2. Signed and dated written informed consent.
3. History of dry eye syndrome for at least 3 months
4. Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
5. OSDI ≥ 22
6. Normal ophthalmic findings except dry eye syndrome
7. No administration of topical lubricants 24 hours before the screening examination

Exclusion Criteria:

1. Presence of an ocular pathology judged by the investigator as incompatible with the study.
2. Any other clinical relevant ocular abnormality except DES.
3. History of allergy, known hypersensitivity to one of the components: the administered medical device product, fluorescein or lissamine green
4. History of known clinically relevant allergy
5. Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplasic, hematological disease; severe psychiatric illness, etc.).
6. History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
7. Pregnancy, lactation.
8. Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilized.
9. Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
10. Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
11. Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.
Preemptive Low-dose Epidural Ketamine for Preventing Chronic Post-thoracotomy Pain

Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. While thoracic epidural analgesia has become the mainstay for managing acute post-thoracotomy pain, its effect on the chronic post-thoracotomy pain seems questionable. The objective of this prospective, double-blinded, randomized, controlled trial was to assess the effect of preemptive low-dose epidural ketamine in addition to preemptive thoracic epidural analgesia on the incidence of chronic post-thoracotomy pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery with a thoracotomy incision

Exclusion Criteria:

* history of previous thoracic surgery, chronic pain, psychiatric disease, cardiac or vascular disease, neurologic deficits, or contraindications to epidural catheterization such as coagulopathy, or localized or systemic infection
Validation of Cognitive Screenings for the Hearing Impaired

There are currently no cognitive tests that have been validated as screening tools for people with dementia and comorbid hearing loss. This is particularly important given the high prevalence of hearing impairment in older adults presenting to memory services and the risk of misdiagnosis of dementia in this population as outlined above.

Cognitive tests validated in hearing impaired populations will also be important as outcome tools for interventional research aiming to find out if treating hearing loss may reduce dementia risk in the longer term.

Hearing loss is very prevalent in older population. This leads to further problems such as communication problem, isolation from the community and depression. Moreover, hearing impairment may potentially affect the patients' cognitive function as demonstrated in the above mentioned published papers.

Communication problems that arise from a hearing loss alone can also interfere with administration of cognitive test battery, as a previous study showed that re-administered of MMSE test with assistive listening device can immediately improve the test score among elderly (1).

Therefore, special adaptation of the cognitive test battery to address the needs of hearing impaired older adult is necessary. This is to ensure that the test result reflects the exact cognitive state of the older adult with hearing impairment, not effected by hearing loss.

Moreover, appropriate cut-off point scores for hearing impaired population should be identified for these new cognitive screening tools. This is to ensure appropriate referral for further diagnosis and prompt management for cognitive impairment/dementia among older adults with hearing loss.

In addition, since hearing loss can potentially lead to deterioration in patients' cognitive function over time (2). Follow up assessments of cognitive function among older adults with hearing impairment can determine the rate of deterioration in retrospective trial(2). This prospective trial follow up of cognitive function among hearing loss participants may uncover additional risk factors associated with the deterioration. Better understanding of these risk factors can potentially lead to further intervention in order to delay decline in patients' cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Age over 65 years
* Documented Hearing loss (currently wearing hearing aids and/or hearing testing with a hearing average of \>/= 30dB HL in D-HI,MCI-HI group)

Exclusion criteria

* Uncorrected visual impairment; cognitive and/or physical disability(s) which prevent the performance of the written/drawing elements of the tests, in the opinion of the researcher.
* Severe to profound hearing loss (PTA \>70dBHL)
CO2 Clearance During Noninvasive Ventilation (NIV)

In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask or the same mask with the addition of a new CO2 clearance device

In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask (FM) or the same mask with the addition of a new CO2 clearance device (FM+d) In the interval between NIV sessions, arterial blood gases will be monitored and if PaCO2 will return to a baseline value with a tolerance of 10%, the patients will undergo another 1 h trial using the other mask.

The subjects will be studied in the sitting position and asked to relax throughout the period of the study.

The patients will be ventilated using pressure support ventilation (PSV) The order of use of the two interfaces will be determined for each patient by a previously generated randomized sequence.

FIO2 will be adjusted to obtain oxygen saturation around 92% at baseline and never modified throughout the study.

End-expiratory pressure will always fixed at 2 cm H2O, and trigger sensitivity will set at -0.5 cm H2O.

Inspiratory assistance during either PSV will be titrated to achieve a tidal volume between 6-8 mL/kg while avoiding occurrence of discomfort or visually assessed "wasted efforts".

The ventilatory settings will determined at the beginning of the first trial, and maintained unmodified throughout all the 3 runs.

Patient tolerance to NIMV, defined as the level of comfort using the different mask, will be assessed by means of a scale used and validated in previous studies that is defined as follows: 1, bad; 2, poor; 3, sufficient; 4, good; 5, very good. The patients were asked by the respiratory therapist to answer the following question: "How do the patient feel your breathing is using this mask?" The patient will give the score to the therapist at the end of each run, just before ABG measurements.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis
* sign inform consent
* able to tolerate the application of NIV

Exclusion Criteria:

* inability to tolerate the mask
* contraindication to NIV
* cancer, neurological diseases, and need of another life support besides the ventilator
A Study to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128(A New Xanthine Oxidase Inhibitor)

A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 50 years at screening;
2. Subjects with a Body Mass Index (BMI) between 18.0 (inclusive) and 28.0 kg/m2 (inclusive); and a total body weight ≥55kg (male） and 45kg (female)
3. Participants who are overtly healthy as determined by medical evaluation including medical history, laboratory tests, vital signs and standard 12 lead ECGs.
4. Subject is willing to participate and to Sign written informed consent form.

Exclusion Criteria:

1. Subjects with a history of hypersensitivities to investigational products, including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities
2. Subjects with evidence or a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (except simple appendectomy or repair of hernia) that may influence drug absorption
3. Subjects with evidence or a history of clinically significant hepatic (including carrier of viral hepatitis), renal, neurologic, immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric (mood disorder, obsessive-compulsive disorder, etc.) diseases.
4. Subjects with a history or current have mental disease.
5. Subjects who have taken any medicine that may affect outcomes within 30 days before the first administration of the investigational product.
6. Subject who have taken IBI128 in other studies.
7. Subjects who have a history of acute arthiritis.
8. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy.
9. Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator
A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

This study will determine the safety, tolerability and activity of CDX-527.

Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-527. The dose-escalation part of the study will determine the safety profile of CDX-527 and determine which dose(s) of CDX-527 will be studied in the expansion part of the study.

The expansion part of the study will enroll eligible patients with certain solid tumors to be treated at dose(s) identified during dose-escalation

Up to 40 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

Eligibility Criteria:
Key Inclusion Criteria:

1. Recurrent, locally advanced or metastatic solid tumor cancer excluding the following: MSI-low colorectal cancer, glioblastoma multiforme, prostate cancer, pancreatic cancer, mucosal and ocular melanoma.
2. Receipt of all standard therapies for the tumor type
3. Measurable (target) disease by iRECIST
4. If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment
5. Willingness to undergo a pre-treatment and on-treatment biopsy, if required

Key Exclusion Criteria:

1. History of severe hypersensitivity reactions to other monoclonal antibodies.
2. Previous treatment with any anti-CD27 antibody.
3. Inadequate washout period from prior therapy as defined in the Protocol.
4. Patients who have received more than 0 or 1 prior PD-1/PD-L1 inhibitor depending on their tumor type
5. Major surgery within 4 weeks prior to study treatment.
6. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment.
7. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least 3 years to be allowed to enroll.
8. Thrombotic events within the last 6 months prior to study treatment
9. Active, untreated central nervous system metastases.
10. Active autoimmune disease or documented history of autoimmune disease.
11. History of (non-infectious) pneumonitis or has current pneumonitis.
12. Active diverticulitis
13. Known infection of HIV, Hepatitis B, or Hepatitis C.

There are additional criteria your study doctor will review with you to confirm your eligibility for the study.
Influence of Preoperative Fear on Pain and Postoperative Outcomes

Fear of anesthesia plays a crucial role in the perioperative setting and can negatively affect recovery. The main objective is to assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery, as well as to relate preoperative anxiety to postoperative analgesic assessment in this population.

This is a prospective observational study including all patients scheduled for surger between January 20 and May 30, 2025

Fear is a response that arises in the face of immediate threats, such as medical procedures, while anxiety is related to uncertainty about treatment and prognosis. These factors can negatively affect recovery. Assessing anxiety levels using specific tools may be essential to predict clinical outcomes and facilitate patient recovery after surgery.

This prospective observational study will assess the relationship between fear of anesthesia, surgeries, and hospitals and poorer postoperative pain control in patients undergoing scheduled surgery. It will also relate preoperative anxiety to postoperative analgesic assessment in this population.

Disease or disorder under study: Fear of anesthesia and postoperative pain control using two preoperative questionnaires. Patients will be followed up until discharge to assess postoperative pain and postoperative outcomes. 103 patients scheduled for surgery between January 20 and May 30, 2025 will be included.

Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years old scheduled for surgery with admission during the study period will be included.
* Verbal and written informed consent.

Exclusion Criteria:

* Minors
* Cognitive impairment
* Patients not being able to understand and respond to preoperative questionnaires
* Patients not being able to respond to postoperative pain assessment
* Patients not giving informed consent.
Clinical Trial for a Outpatient Clinical Management for Complicated Acute Appendicitis

The aim of this study is to evaluate the safety and efficacy of outpatient management of complicated acute appendicitis. For this purpose, a randomized clinical trial was designed. Selected patients who have undergone surgery for acute appendicitis are randomized into two groups. One group with hospitalization and another group without admission.

The aim of this study is to evaluate the efficacy and safety of outpatient management of laparoscopic appendicectomy in complicated acute appendicitis.

This was a single center randomized controlled clinical trial consisting in 2 treatment groups. Patients were recruited in University Hospital of Tarragona Joan XXIII of Spain.

All patients admitted in the emergency department at University Hospital of Tarragona Joan XXIII with acute appendicitis diagnosis were likely to enter in the study.

All patients who met the inclusion criteria and none of the exclusion criteria were admitted to the study for emergency surgery.

In order to avoid the biases a unique anesthetic and surgical protocol were established for both groups.

Once Laparoscopic appendicectomy was performed the patients were randomly assigned to the hospitalization group or outpatient group.

Patients in the hospitalization group were admitted in the hospitalization ward. Patients in the outpatient group were referred to the day-surgery unit where they were discharged according to ALDRETE criteria.

The primary endpoint was the length of hospital stay (LHS). The length of hospital stay was calculated from the day and hour of admission in the surgical area to the day and hour of discharge, based on the hours of hospital stay. Secondary endpoints included the failures of the outpatient management, readmissions and the hospitals cost

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* ASA classification (American Society of Anesthesiologists) less than or equal to 3
* patients who live accompanied in a home at a maximum distance of 30 minutes from the hospital and an adequate cognitive capacity.

Exclusion Criteria:

* pregnancy or breastfeeding
* complicated Acute Appendicitis
* surgical management performed in more 90 minutes