cyrilzakka/clinical-trials huggingface dataset:
Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients pathologically diagnosed with non-metastatic head and neck malignant tumors
* Aged 18-80 years
* Eastern Cooperative Oncology Group performance status of ≤2
* Planning to receive definitive RT or postoperative adjuvant RT
* Normal liver, kidney and bone marrow function
* Sign informed consent

Exclusion Criteria:

* Those who are known to be allergic to 4-aminoquinoline compounds or have more serious allergic constitution
* Had a history of head and neck radiotherapy
* Patients with non head and neck parts in the radiotherapy area
* Poor oral hygiene or severe periodontitis
* Suffering from severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy
* Recently taking or taking diuretics or other drugs known to interact with hydroxychloroquine sulfate tablets
* Retinopathy
* Other patients (combined with any serious other diseases) who the investigator believes are not suitable for participation in this study
Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain

Ankle sprain is very common. In France, its daily incidence is estimated at 6000. It often causes pain, a temporary period of disability and can results in recurrence and chronic ankle instability. Therefore, an early management and follow up treatment is necessary. Now, functional treatment is clinically the treatment strategy of choice for ankle sprain. It is based on rest, ice, compression, elevation and can use a functional support (like an ankle brace). To evaluate gravity and improve management, a clinical assessment delayed between 4 and 5 days post injury is necessary.


Eligibility Criteria:
Inclusion Criteria:

Consulted for ankle trauma as primary reason Agreeing to participate in the telephone survey 6 weeks after trauma Affiliation in a social security scheme

Exclusion Criteria:

Patients deprived of liberty Patients with an unbalanced psychiatric disease If consultation delayed 48 hours due to trauma Patients with fracture Patients with Chopart or Lisfranc injury Pregnant women People who do not speak French
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery

The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative opioid consumption and pain scores in CPPs.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain \> 6 months, opiate-using patients scheduled for thoracic or lumbar spinal surgery

Exclusion Criteria:

* Pregnant or breastfeeding women, significant hepatic, renal or cardiac disease, allergy to any of the study drugs, inability to consent, respond to pain assessments or use the patient controlled analgesia device
Reduced Dose Radiotherapy Following High Dose Chemotherapy in Intracranial Non-germinomatous Germ Cell Tumor

The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT).

Treatment outcome of intracranial NGGCT is around 50% with conventional chemo- and radiotherapy. Also, late sequelae such as endocrinopathy or cognitive problem are unavoidable especially with craniospinal irradiation. In this study, high dose chemotherapy and reduced dose of radiotherapy will be used to improve survival and minimize the late sequelae in the patients with intracranial NGGCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically proven intracranial non-germinomatous germ cell tumor or
* Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein.

Exclusion Criteria:

* Patients with organ dysfunction (ejection fraction \<40%, creatinine \> 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase \> 5 x ULN).
* Pregnant or nursing women
Emergency Department Longitudinal Integrated Care

The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. This study will provide important feasibility information for future studies of ED-LINC. The collaborative care intervention (ED-LINC) will be supported by a novel Emergency Departement (ED) health information exchange platform.

The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. According to the 2015 national survey on drug use and health, an estimated 3.8 million individuals over 12 years of age were currently misusing opioid pain relievers. An additional 329,000 people use heroin. The Emergency Department (ED) is currently at the forefront of this public health emergency and often a place where patients come for treatment of overdose and for treatment of medical problems related to illicit opioid use.

Overall, the goal is to establish the feasibility of a multi-component intervention called 'Emergency Department Longitudinal Integrated Care (ED-LINC)' which is guided by principles of collaborative care and is comprised of components that are evidence-based. ED-LINC is initiated from the ED and continues longitudinally for patients at-risk for opioid use disorder.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65
* Patients with at least one risk factor for opioid use disorder via the EMR pre-screen
* Patients with score of ≥ 4 on the NIDA modified ASSIST for illicit opioids (e.g. heroin) OR a score of ≥ 4 on the NIDA modified ASSIST for prescription opioids
* Currently have a phone
* Able to provide a phone number and one additional piece of contact information

Exclusion Criteria:

* They are incarcerated or under arrest
* Non-English speaking
* Live beyond a 50 mile radius of HMC
* Require active resuscitation in the ED or other clinical area at the time of RA approach
* Are receiving palliative care services or hospice care for a chronic illness such as metastatic cancer
* Are in the ED or hospital for a primary psychiatric emergency such as suicidal ideation or attempt
* Receiving chronic opioid therapy (COT) defined as prescription opioids for most days out of the last 90 days for a chronic pain condition
* In the ED for sexual assault
Gene Sequencing as a Strategy for Identifying Genetic Factors Associated With Serious Adverse Events After Covid-19 Vaccines in Use in Brazil

This protocol proposes to investigate genetic factors that may be involved in the pathogenesis of adverse events of interest with selected covid-19 vaccines: vaccine-induced immune thrombotic thrombocytopenia, and neurological adverse events, such as Guillain-Barré syndrome, acute disseminated encephalomyelitis and transverse myelitis, with the intention of identifying useful biomarkers in identifying people at higher risk, thus reducing the occurrence of these serious adverse events (SAE).

Participants higher than 5 years old with no maximum age limit and both sexes, who had a serious adverse event after vaccination against Covid-19, such as Guillain-Barré syndrome, vaccine-induced immune thrombotic thrombocytopenia, transverse myelitis and Acute disseminated encephalomyelitis. Parents, siblings and/or sons of cases with SAE will have biological samples collected and stored; depending on the result of the study, they may have their samples analyzed later.

Eligibility Criteria:
Inclusion Criteria:

* Sign the ICF by the subject or the subject's legally acceptable representative;
* Sign the ICF by the participant's family member;
* Proven vaccination with one of the vaccines for COVID-19 available by the PNI, containing information on the date of application, type (manufacturer) of vaccine received and batch (desirable);
* Meet the minimum criteria for a level of certainty 3, 2 or 1 in Brighton Collaboration for vaccine-induced immune thrombotic thrombocytopenia as described in 3.2.1.1 OR,
* Meet the minimum criteria for a level of certainty 3, 2 or 1 in Brighton Collaboration for Guillain-Barré syndrome as described in 3.2.1.3 OR,
* Meet the minimum criteria for a level of certainty 3, 2 or 1 in Brighton Collaboration for Acute Disseminated Encephalomyelitis as described in 3.2.1.4 OR,
* Meet the minimum criteria for a level of certainty 3, 2 or 1 in Brighton Collaboration for Transverse Myelitis as described in 3.2.1.5 OR,
* Be classified in the causality categories adopted by the PNI/MS, namely: A1, B1 or B2.

Exclusion Criteria:

* Reports in which it is not possible to retrieve the clinical/laboratory data necessary for evaluation, due to inadequate filling of the notification or unavailability of data;
* Cases of death in which there are no samples available and/or suitable for carrying out the analyzes defined in the protocol;
* Cases in which another diagnosis is made for the adverse event of interest, being discarded as a SAE;
* Cases classified in causality categories (PNI/MS) as A2, A3, A4, C or D;
* Refusal to sign the informed consent form;
Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

This is a non-randomized, non-interventional pilot observational study designed to follow high-risk patients through their surgical and hospital stay. The investigators will collect 2 4ml vial's of blood (total of 8ml) prior to surgery to assess CV biomarkers - inflammatory, metabolic, hypercoagulable and platelet.

This study is primarily an observational pilot study. After identifying patients as high-risk according to the following criteria: CAD and/or CVD and/or PAD and/or \>=60 years old and at least 2 of the following - renal insufficiency, diabetes, COPD, hypertension, active smoker (or active within 6 months of consent), cancer, congestive heart failure, or any blood clot - they will be asked to sign a consent form. Patients surgical and hospital course will continue as per standard of care. Prior to surgery, 8ml of blood will be collected for to assess cardiovascular biomarkers including inflammatory, metabolic, hypercoagulable and platelet biomarkers to be tested independently in Dr. Berger's lab in Smilow. Study staff will perform electrocardiograms on POD 2. Results of these ECGs will not be placed in the patients' charts. No other procedures will be done for research purposes only.

Eligibility Criteria:
Inclusion Criteria:

* • ≥ 21 years of age

  * Subjects undergoing open orthopedic surgery of the hip, knee or spine
  * High-risk subject cohort:
  * Coronary artery disease (CAD), or
  * Cerebrovascular disease (CVD) (prior stroke, TIA or carotid artery disease (\>70% stenosis), or
  * Peripheral artery disease (PAD), or
  * Age ≥ 60 years and any 2 of the following:

    * Renal insufficiency (creatinine clearance \< 60ml/min)
    * Diabetes
    * Chronic Obstructive Pulmonary Disease (COPD)
    * Hypertension
    * Active smoker or stopped less than 30 days prior to consent
    * Cancer
    * Congestive heart failure
    * Prior blood clot

Exclusion Criteria:

* • Severe co-morbid condition with life expectancy \< 6 months

  * Inability to give informed consent or adhere to follow-up as per protocol
Comparison of Temperature Using Tracheal Thermometer and Pulmonary Artery Catheter in Adult Patients Undergoing CABG

In anesthesia, monitoring of core body temperature is one of important factors. Measurement of temperature using a pulmonary artery catheter is representative one of core temperature measurements. The core temperature by a pulmonary artery catheter is compared with the tracheal temperature by an endotracheal tube with thermometer. This study was designed to confirm the accuracy of the endotracheal tube thermometer.

All patients undergoing general anesthesia are monitored core body temperature. Coronary artery bypass graft surgery needs general anesthesia with endotracheal intubation and insertion of pulmonary artery catheter. Using endotracheal tube with thermometer and pulmonary artery catheter, the investigators will measure tracheal temperature and pulmonary artery temperature every 5 minutes for 1 hour after induction of general anesthesia.

Standard monitoring devices (non-invasive BP, electrocardiogram, pulse oxygen saturation) are applied to participants in an operation room, and 1% propofol 1-2 mg/kg and rocuronium 0.8 mg/kg are administered intravenously for induction of general anesthesia. An endotracheal tube with thermometer (Human Endotracheal Tube, Insung Medical Co., Korea) is inserted. After inserting a 9Fr central venous catheter with a pulmonary artery catheter insertion port, core body temperature is measured by a pulmonary artery catheter (Swan-Ganz CCOmbo V, Edwards Lifesciences, Irvine, California, USA).

Tracheal temperature will be compared with pulmonary artery temperature by using Bland-Altman method.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18-year-old undergoing coronary artery bypass surgery

Exclusion Criteria:

* Emergency surgery
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media

The aim of this study is to assess in France the impact of Prevenar on the possible evolution of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of children with AOM.


Eligibility Criteria:
Inclusion Criteria:

* Infants aged from 6 to 24 months
* Presenting with AOM (ear infection)
* Patients must not have received any antibiotic therapy within the past 7 days.

Other inclusion applies.

Exclusion Criteria:
T Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus Fumigatus Infections After Allogeneic Stem Cell Transplantation

The purpose of the study is to determine the feasibility, safety and efficacy of administering rapidly-generated donor-derived pentavalent-specific T cells (Penta-STs) to mediate antiviral and antifungal activity in hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus (AF) infection/ reactivation or with active disease.

Reconstitution of anti-viral and antifungal immunity by donor-derived antigen-specific T cells has shown promise in preventing and treating infections with CMV, or/and EBV, or/and AdV or/and BKV, HHV6 or/and AF post-transplant. However, the broader implementation of T cell immunotherapy using conventional protocols is limited and until today it was practically impossible for Greece by the cost, the complexity and the time required for virus-specific T cells (VSTs) production and by the antigenic competition between different antigens, which limits the spectrum of viruses that can be targeted in a single T cell product.

In this trial, the investigators will evaluate the feasibility, safety and efficacy of donor-derived Penta-STs infusion to allogeneic HSCT recipients with confirmed AdV, EBV, CMV, BKV and AF infection.

Eligibility Criteria:
Inclusion Criteria:

1. Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant.
2. Cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: AdV, CMV, EBV, ΒΚV and AF.
3. Karnofsky/Lansky score of ≥ 50.
4. ANC \> 500/μl.
5. Bilirubin ≤ 2x\*, AST \< 3x\*, Serum creatinine ≤ 2x\*, Hemoglobin \> 8.0 g/dl.
6. Pulse oximetry of \> 90% on room air.
7. Available pentavalent-specific T cells.
8. Negative pregnancy test (if female of childbearing potential)
9. Patient capable of providing informed consent.

Exclusion Criteria:

1. Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days.
2. Steroids \> 0.5 mg/kg/day prednisone.
3. Received donor lymphocyte infusion in last 28 days.
4. GVHD ≥ grade 2.
5. Active and uncontrolled relapse of malignancy.
6. Patients with other uncontrolled infections
Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair

This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair.

Patients will be randomised to injection of Marcaine© og a needle prick per-operatively.

Pain will be estimated using the VAS score in:

1. the wound 2 the abdomen 3 the shoulder

Scoring will be performed:

1. pre-operatively
2. 1 hour postoperatively
3. at discharge from the hospital d day 1,2 and 3 post OP

e. 1 year post OP

as above

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 year
2. Informed consent
3. a diagnosis of an inguinal hernia
4. ASA group ≤ 3
5. BMI ≤ 35

Exclusion Criteria:

1. Communication problems
2. No consent
3. Open procedure (not laparoscopic)
4. ASA-group 4
5. Use of Steroid or immunosuppressive tretament
6. Regular morphine use.
Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions in Nature or at Sea

The aim of this study was to examine the effectiveness of a video-based multicomponent program: the Fibrowalk Virtual plus face-to-face sessions for patients with fibromyalgia (FM) in nature or at sea (FM) compared to Fibrowalk Virtual only.

This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as- usual (TAU) in comparation of the Fibrowalk virtual plus face-to-face sessions in the nature or at sea.

VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

FACE-TO-FACE SESSIONS ADDED TO VIRTUAL FIBROWALK combines de same components than Fibrowalk Virtual and added 4 face-to-face sessions (1 per mounth) to resolve doubts and reinforce the main concepts of therapy in the nature or at sea.

The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance

Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 75 years-old. 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified - - - ACR diagnostic criteria for fibromyalgia
* Able to understand Spanish and accept to participate in the study.

Exclusion Criteria:

* Participating in concurrent or past RCTs (previous year).
* Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.
Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

This is a prospect, multi-center, random study to investigate whether early offering PCSK9 inhibitor to acute myocardium infarction(AMI) can alleviate ventricular remodeling after primary percutaneous intervention(PPCI). Totally,twenty acute myocardium infarction subjects will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy for AMI including PPCI. The experiment group will receive first PCSK9 inhibitor before PPCI, then twice a month until 3 months later. Six month after AMI, Myocardial salvage index will be used to evaluate ventricular remodeling. TnI peaking time and LDL control rates also will be recorded and compared.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be at least 18 years of age and less than 80 years old
2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for AMI and LAD should be the only culprit vessel.
3. Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure

Exclusion Criteria:

1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
2. Known hypersensitivity or contraindication to study medications
3. Plan to receive revascularization in next six month.
4. Have received revascularization before.
5. Subjects with life expectation less than one year.
6. Subjects with active malignant tumor
7. subjects with severe liver or renal dysfunction（ALT \>5倍ULA，eGFR\<15ml/min/1.73mm2）
8. Other conditions which the investigators think not applicable to the study.
Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline

The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline. The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
2. Age range from 20 to 90 years
3. MMSE score ≥ 19
4. MoCA\<26
5. Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
6. Able to follow the study instruction
7. Adequate cardiopulmonary function to perform aerobic exercise
8. Able to walk with or without assistive devices

Exclusion Criteria:

1. Unstable medical history (e.g., recent myocardial infarction) that might limit participation
2. Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
3. Current participation in another interventional trial
Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index

This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.

The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system can be built using BIS as the control variable, two proportional-integral-differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. Preliminary results show that this system can be used during surgery. We propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system during the postoperative period. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain BIS between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop system group to do similar or better.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1-3
* Abdominal aorta surgery

Exclusion Criteria:

* Pregnant women
* Neurological or muscular disorder