cyrilzakka/clinical-trials huggingface dataset:
Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

This study is aimed to evaluate the efficacy and safety of short-course radiotherapy combined with sintilimab in neoadjuvant treatment of stage III, locally advanced esophageal squamous cell carcinoma.

This study was designed as a single arm, phase II trial. Subjects will receive short-course radiotherapy combined with sintilimab as neoadjuvant therapy of stage III, locally advanced esophageal squamous cell carcinoma. The primary endpoint is pathologic complete response(pCR).

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and ≤75 years old

  * Esophageal squamous cell carcinoma diagnosed biopsy histopathology
  * Patients with resectable esophageal squamous cell carcinoma confirmed by pathology (including histology or cytology) , with pathological stage T3-4 or N+
  * At least one measurable lesion
  * Eastern cooperative oncology group (ECOG) performance status of 0 to 1
  * With adequate organs function

Exclusion Criteria:

* Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
* Patients who have a higher risk of bleeding or perforation due to the tumor\&amp;#39;s obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
* Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy
Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections

Diabetic foot ulcers are frequent with average lifetime risk of 15%, and can lead to bone and joint infections. Current protocols for their management include evaluation of ischemia, assessment of underlying bone infection, sharp debridement, off-loading and use of dressings that promote moist wound healing. Extensive debridement is optimal for wound healing and decreases the risk of recurrence. However, extension of surgical debridement is left at the clinician judgement and thus lacks standardised protocols. Plus, there is currently no known risk factors or specific biomarkers that can help guide the clinician for the extent of debridement or that can predict a recurrence in case of non-extensive debridement. The main objectives of the study are to either unravel a new biomarker, and/or identify risk factors associated with poor prognosis following surgical debridement in diabetic foot ulcers. Histones, more specifically H3.1 subtype, have been associated with sepsis.

The main hypothesis is that higher blood levels of H3.1 will be present in participants showing poor prognosis (i.e., having additional surgeries, amputation, death) and that a rise in H3.1 blood levels compared to baseline (before the 1st surgical intervention) would provide an early warning of relapse or treatment failure.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥ 18 years old) suffering from diabetes mellitus (type 1 or 2)
* Diabetic foot ulcer with severe infection (grade 3 and 4 according to IWGDF 2019 classification)
* Scheduled surgical debridement

Exclusion Criteria:

* Spondylodiscitis
* Pregnant or lactating women
* Previous enrolment in a clinical trial
* Consent declined by participant or tutor in case of incapacitation
* Tutor cannot be reached for consent in case of incapacitation
OCT-guided DSAEK Graft Shaping and Smoothing

The primary goal of this study is to determine if excimer laser smoothing of the cornea before Descemet's stripping automated endothelial keratoplasty (DSAEK)improves postoperative Best Spectacle Corrected Visual Acuity (BSCVA).

Many surgeons are moving away from full thickness corneal transplantation (because of risks involving rejection, irregular astigmatism, and wound dehiscence) to partial thickness transplantations of either the anterior or posterior (endothelial) layers. However this technique is not without its drawbacks. DSAEK uses a mechanical microkeratome to cut the graft, but vision is limited by the roughness of the cut surface.

DSAEK can lead to significant refractive error due to the non-uniform shape of the microkeratome cut graft, and the roughness of the microkeratome cut surface limits vision to an average of 20/31. Optical coherence tomography (OCT)-guided laser shaping and smoothing may improve the refractive and visual outcome.

Eligibility Criteria:
Inclusion Criteria:

* Adults with visual complaint and objective evidence of decreased vision due to corneal edema related to Fuchs' corneal endothelial dystrophy

Exclusion Criteria:

* Inability to give informed consent
* Inability to maintain stable fixation for OCT imaging
* Inability to commit to required visits to complete the study
* Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery
Aminoterminal Propeptide of Type III Procollagen and Severity of Coronary Artery Disease in Patients Without Myocardial Infarction

Background: Myocardial fibrosis is a major component in cardiac remodeling in patients with myocardial infarction or hibernation. However, the association of cardiac fibrosis and coronary artery disease (CAD) in patients without infarction or hibernation is still unclear. In the present study, we analyzed the relationship between serum concentrations of procollagen propeptides and severity of CAD in such patients. Patients and methods: Forty-six patients (32 men and 14 woman; mean age 64 years) with chest pain and normal left ventricular contractility were enrolled into this study. Myocardial infarction was excluded by history and electrocardiograms. All patients received stress thallium-201 single photon emission computed tomography (SPECT) and analysis of the serum levels of the aminoterminal propeptide of type I and III procollagen (PINP and PIIINP).


Eligibility Criteria:
Inclusion Criteria:

* We prospectively studied 46 consecutive patients aged 50 to 75 years (32 men and 14 women; mean age was 64 years) who were referred for chest pain evaluation.

Exclusion Criteria:

* MI was excluded by history and electrocardiograms. Regional wall motion abnormalities and impaired left ventricular contractility (left ventricular ejection fraction \< 50%) were excluded by routine echocardiography.
A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.

Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.

This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.

Eligibility Criteria:
- Number of sites/patients: Approximately 18 sites and 125 patients.

Inclusion Criteria:

1. Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures.
2. Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) of 1996 authorization after receiving a full explanation of the extent and nature of the study.
3. Patient must be at least 18 years of age and undergoing one of the specified minor surgical procedures at the time of screening.
4. If female, patient must be surgically sterile, postmenopausal, or not pregnant or lactating and must have been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and predose.
5. Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.

Exclusion Criteria:

1. Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid.
2. Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.
3. Patient has a Mallampati Classification Score of 4; or a Mallampati Classification Score of 3 and a thyromental distance \<4 cm, or for any other reason has a difficult airway, in the opinion of the Principal Investigator.
4. Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period.
5. Patient has participated in an investigational drug study within 1 month prior to study start.
6. Patient is unwilling to adhere to pre- and postprocedural instructions.
7. Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.
Quality of Perioperative Invasive Ventilation in PICU

This is purely observational study in which quality of invasive ventilation is observed with electrical impedance tomography (EIT) during perioperative intensive care. EIT parameters will be used to assess if protective ventilation strategies are successfully followed during routine care.

20 neonates and infants undergoing elective surgery and requiring postoperative treatment and follow up in PICU or in pediatric anestesiology clinic, will be included in this prospective observational study. Swisstom BB2-monitor and NeoSensorBelts will be used to monitor their ventilatory care from arrival to the operation room (prior intubation) to postoperative intensive care (until 2 hours after extubation). EIT parameters assessing lung aeration and ventilation distribution will be used to assess the quality of invasive ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from a parent of legal guardian
* Infant undergoing elective or semi-elective surgery
* Postoperative admission to PICU expected
* Spontaneous breathing prior to study inclusion

Exclusion Criteria:

* Need for respiratory support prior to surgery
* Thoracic surgery
* Body weight \< 1500g or \> 10 kg
Effect of Intravenous Lidocaine and Dexamethasone Combination on Postoperative Sore Throat, Cough and Hoarseness.

Post operative sore throat (POST) following tracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and dexamethasone has been used independently for this purpose. However, there is no study assessing the synergistic analgesic effects of lidocaine and dexamethasone for POST. The purpose of this study is to compare the effect of lidocaine, dexamethasone and lidocaine dexamethasone combination on the incidence and severity of POST.

Sore throat and hoarseness following tracheal intubation are common postoperative problems causing dissatisfaction and discomfort to the patients. Their incidence varies from 30%-70%.

Both non pharmacological and pharmacological measures have been tried to minimize the incidence and severity of POST with variable success rate. Prophylactic use lidocaine and steroids have been used independently for this purpose. Dexamethasone as an adjuvant to lidocaine has shown to improve the quality of analgesia. However, there is no study assessing the combine effects of lidocaine and dexamethasone for POST.

Eligibility Criteria:
Inclusion Criteria:

* Patients of American Society of Anesthesiologist(ASA) physical status 1 \& 2 requiring general anesthesia with endotracheal intubation.
* Duration of surgery more than 90 min

Exclusion Criteria:

* Those with preexisting hoarseness or sorethroat
* Smoker
* Vocal performer by occupation
* Recent or recurrent respiratory tract infection
* Risk factors for postoperative aspiration
* Obesity
* Pregnancy
* Receiving analgesics, corticosteroids and calcium channel blockers
* Contraindication to corticosteroid medications
* Anticipated difficult intubation
* Mallampati grade \> 2
* Difficult mask ventilation requiring oral or nasal airway
* Cormack and Lehman grade III and IV on laryngoscopy
* More than one intubation attempt
* Those requiring orogastric or nasogastric tubes
Hepatitis B Virus Mutants and the Therapeutic Effect of Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B

In order to clarify the association between HBV mutations appearing before and during interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive CHB patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the mutations of preS/S gene and BCP-preC/C region, particularly for the deletion mutations. Furthermore, Real-Time PCR will be performed to measure the ratios of wild-type HBV and deletion mutant HBV before and at the end of peginterferon alfa-2a therapy. Finally, statistical analysis will be done to elucidate whether the mutations of preS/S gene and BCP-preC/C region have any relation with the therapeutic effect of peginterferon alfa-2a.

Hepatitis B virus (HBV) infection is a serious worldwide health issue. Approximately 400 million people worldwide are chronic hepatitis B (CHB) patients. Currently, two therapeutic methods can be used to treat CHB. One is the nucleos(t)ide analogues, the other is the interferon alfa. Interferon alfa acts mainly by enhancing the immune system and directly inhibits the virus to a limited extent. It is known that mutations at preS, S, basal core promoter, precore and core gene are associated with an increased risk of HCC. However, it remains to be clarified as to the relation between HBV mutations and the therapeutic responses to interferon treatment. In order to clarify the association between HBV mutations appearing before and during interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive CHB patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the mutations of preS/S gene and BCP-preC/C region, particularly for the deletion mutations. Furthermore, Real-Time PCR will be performed to measure the ratios of wild-type HBV and deletion mutant HBV before and at the end of peginterferon alfa-2a therapy. Finally, statistical analysis will be done to elucidate whether the mutations of preS/S gene and BCP-preC/C region have any relation with the therapeutic effect of peginterferon alfa-2a.

Eligibility Criteria:
Inclusion Criteria:

HBeAg-positive chronic hepatitis B patients on Peginterferon therapy

Exclusion Criteria:

HBeAg-negative chronic hepatitis B patients HBeAg-positive chronic hepatitis B patients on other kinds of therapy
Use of Facebook as a Motivating Factor in a Weight-reduction Program for Obese and Overweight Adolescents

The purpose of this study is to determine if Facebook can be used as a motivating factor for obese or overweight adolescents in a weight-reduction program.

This study is a randomized controlled trial. There will be two randomly assigned groups of obese or overweight adolescents (WHO definition). Both groups will be enrolled in a 12 week weight reduction program which includes personal nutritional evaluation and food plan and exercise routine. Follow-up appointments will be held every 3 weeks. One group will be encouraged to update their Facebook status at least once a day, regarding their healthy lifestyle changes (exercise routine, healthy food choice, "checking-in" at the wellness center, kilograms lost, etc). The control group will be asked not to share information about their program on Facebook for 12 weeks. Facebook follow-up will be held by the investigators on the study's Facebook account. Teenagers will be thoroughly explained on how to set the account to a limited profile if they want to. At the end of the program both groups will be compared regarding weight loss and mean BMI.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between 13 and 19 years old.
* Obese or overweight according to the IOTF.
* No physical or medical impediment for performing physical activity.
* No risk for eating disorders (SCOFF questionnaire).
* Report less than 20 minutes of physical activity per day.
* Have an active Facebook account and use it more than 20 minutes per day.
* Low-risk in the Gatehouse Bullying Scale.

Exclusion Criteria:

* Physical or medical impediment for performing physical activity.
* Answer "yes" at least twice on the SCOFF questionnaire.
* Report more than 20 minutes of exercise per day.
* Not having an active Facebook account or using it less than 20 minutes per day.
* "High Risk" on the Gatehouse Bullying Scale.
Rurality Adapted Physical Activity Sport Health

Physical activity (PA) has been an integral part of non-drug therapy since the early 2010s. This supportive care is likely to reduce fatigue and improve the quality of life of patients during and after the cancer treatment phase.

Physical activity also has a protective effect in terms of tertiary prevention by reducing the risk of recurrence of certain cancers (breast, colon, prostate) by around 40 to 50% and by reducing overall mortality.

Adapted physical activity (APA) is offered at the Institut de Cancérologie de l'Ouest (ICO) in Angers, but there are obstacles particularly linked to the geographical distance of the establishment where this activity is offered.

The RAPASS project is a prospective study which will be proposed to patients followed at the ICO, living in rural areas and far from Angers. Its main objective is to describe the fatigue and quality of life of patients before, during and after a 13-session home-based APA programme. The data collected will also be used to describe changes in physical condition and level, compliance with the programme, continuation of physical activity beyond the duration of the programme, and satisfaction.

The oncologist first assesses the patient's need for APA. The patient is then seen by the ICO's APA coach (EAPA) who presents the APA programme. If the patient agrees to participate, the coach assesses the patient's physical capacity in order to adapt the programme to their needs.

The programme is then carried out with the departmental sports for all committee 49.

The frequency of practice will ideally be one session per week at the patient's home, supervised by a coach from Departmental Committee for Sport for All in 49. A total of 13 sessions will be carried out.

The sessions will aim to develop all the components of physical fitness (endurance, strength, balance, flexibility, coordination, etc.).

The patient receives a walking logbook to record the number of daily steps taken, an exercise booklet to work independently and a pedometer.

In the presence of the coach, the patients perform different exercises and complete different questionnaires.

The programme is evaluated by the ICO EAPA 3 months after the 13th and final session.

Eligibility Criteria:
Inclusion Criteria:

* Performans Status ≤ 2
* Patient living in a rural area
* Patient with a brain tumour and/or metastatic cancer
* Patient with a medical prescription for APA practice
* Patient with a certificate of no contraindication to physical activity

Exclusion Criteria:

* Persons deprived of their liberty, under court protection, under guardianship or under the authority of a guardian
* Patient unable to undergo the trial procedures for social or psychological reasons
* Patient who does not understand French
Investigation of a New Diet for the Treatment of Obesity in the NHS

Over one in four adults living in the UK is living with obesity. Obesity is associated with health complications including type 2 diabetes, heart disease and depression. The current NHS treatment for obesity includes attending a specialist hospital weight management service called 'Tier 3' where patients receive help from healthcare professionals such as doctors, dieticians and psychologists. It is known that health conditions associated with obesity improve or reverse if a person with obesity loses five per cent or more of their body weight. On average, currently available Tier 3 programmes achieve less weight loss than this. In our specialist obesity clinic at the Imperial Weight Centre, we (the study research team) have designed a new weight loss programme called Imperial Satiety Protocol (or I-SatPro for short). I-SatPro comprises dietary advice including eating a low carbohydrate (low glycaemic index) diet, eating protein for the satiating effects, eating healthy fats and abstaining from high sugar and/or processed foods which can drive over-eating. Participants will be advised to eat according to subjective feelings of hunger and fullness, rather than eating according to a defined calorie restriction. Similar to other Tier 3 Programmes, I-SatPro also contains locally devised content related to healthy eating, for example fibre intake, the timing of eating, lifestyle change such as exercise, self-care such as advice on sleep and behavioural change strategies.

The purpose of this feasibility/pilot study is to check whether:

1. Our patients like I-SatPro
2. Whether our patients want to follow I-SatPro
3. Check whether our patients following I-SatPro achieve improvements in their health including: weight loss, changes in blood pressure, changes in diabetes control, changes in blood lipids 'cholesterol', changes in their eating patterns and relationship with food, changes in their wellbeing

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Male or female
* Body mass index ≥35kg/m2 with at least one obesity related co-morbidity
* Body mass index ≥40kg/m2 with or without an obesity related co-morbidity
* Eligible for treatment under the NHS

Exclusion Criteria:

* History of any medical, psychological or other condition, or use of any medications, which would either compromise the validity of the study or the safety of the participant
* English language fluency and comprehension insufficient to be able to participate in educational and group components of the programme
* Usual residence/place of work is sufficiently far from the study site or logistical/lifestyle factors mean that it is likely that the patient would be unable to attend for all sessions/components of the study
* Pregnancy or breast feeding
* Previous bariatric surgery
* Concurrent participation in another research study which would either compromise the validity of the study or the safety of the participant
* Previous participation in a study if the investigators judge that this would either compromise the validity of the study or the safety of the participant
* Unable to give informed consent