cyrilzakka/clinical-trials huggingface dataset:
Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Emergency Wards

CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention.

OBJECTIVES: To show using a randomized trial that patients hospitalized in emergency wards with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice.

METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients admitted in emergency wards:

Control group: antibiotic prescriptions will be initiated and managed by the attending physicians Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice.

STUDY PROCESS: The study will took place in the emergency wards of 4 university hospitals. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults Hospitalized in emergency wards Receiving antimicrobial therapy for active infection or prolonged surgical prophylaxis Therapy prescribed by the attending ward physician

Exclusion Criteria:

* Patients receiving antimicrobial therapy not prescribed by the attending ward physician
Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

This four-year, prospective, longitudinal study will evaluate and validate a patient-reported outcome measure, clinician-reported outcome measures, and imaging techniques in assessing characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity and oropharyngeal cancer patients.

This clinical trial studies patient-and-clinician-reported measures as well as standard imaging methods to see how accurate they are in identifying and evaluating lymphedema (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer. Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and chewing, as well as psychological and emotional symptoms, such as negative body image and avoiding social interactions. Finding an accurate test to identify and evaluate LEF may allow doctors to treat LEF more quickly and control symptoms more effectively, and thus provide patients with a better quality of life.

The goal of this proposed study is to establish a valid, clinically useful measurement battery for head and neck LEF by achieving these specific aims:

Aim 1: To determine the reliability and validity of the patient-reported outcome measure (LSIDS-H\&N) for assessing LEF-related symptoms in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.

Aim 2: To determine the reliability and validity of the clinician-reported outcome measures (HN-LEF Grading Criteria and Modified Patterson Scale) for assessing external and internal LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.

Aim 3: To determine the reliability and validity of imaging techniques (CT scan and ultrasonography) in identifying site-specific LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.

Eligibility Criteria:
Inclusion Criteria:

* a newly diagnosed, histologically proven cancer arising from the oral cavity and oropharynx
* tumor stage II or greater
* age ≥ 21 years old
* willing and able to undergo study assessment
* able to speak and read English and understand Informed Consent.

Exclusion Criteria:

* have medical record documentation of cognitive impairment that would preclude the ability to provide informed consent
* are unwilling to undergo routine follow-up
* have recurrent cancer
* have any other active cancer.
Taper-shaped Cuff Endotracheal Tube Against Respiratory Infections

The incidence of postoperative pneumonia after aortic surgery reaches 60%. In experimental lung model, endotracheal tube with taper-shaped cuff has been shown to decrease microaspiration. This effect has never been demonstrated in patients. The investigators hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of postoperative pneumonia in patients after aortic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 ans
* Elective aortic surgery
* Admission in ICU after aortic surgery

Exclusion Criteria:

* Tracheostomized patients
Effect of the Angiotensin II Receptor Antagonist Irbesartan on Biochemical and Functional Markers of Endothelial Dysfunction in Patients With Hypertension

Primary:

* To evaluate the impact of irbesartan on endothelial function in hypertensive patients with metabolic syndrome.

Secondary:

* To evaluate the oxidative stress status in patients with hypertension with metabolic syndrome.
* To correlate the oxidative stress status with endothelial function in these patients.
* To evaluate the effect of irbesartan on the oxidative stress stage in patients with metabolic syndrome and to correlate it with the effect on endothelial function .
* To correlate the change in endothelial function and oxidative stress stage with the change of arterial pressure levels.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension grade 1 or 2
* With at least two of the following criteria for the diagnosis of metabolic syndrome:

  * Body mass index \> or = 25 kg/m2 AND waist circumference \> or = 100 cm.
  * Dyslipidemia (triglycerides fasting serum levels \> or = 200 mg/dL OR HDL serum levels \< or = 40 mg/dL)
  * Fasting serum glucose \> or = 110 mg/dL but \< 126 mg/dL

Exclusion Criteria:

* Known hypersensitivity to Irbesartan
* Hypertension grade 3
* History of clinical vascular events such as TIAs, stroke, peripheral arterial disease
* Coronary artery disease
* Renal insufficiency (creatinine serum levels \> or = 1.2 mg/dL)
* Presence of clinical heart failure
* Asthma and COPD
* Valvular cardiopathy clinically relevant
* Current therapy with antioxidant drugs, statins
* Therapy with AIIRA for at least 3 months during the last semester
* Presence of any acute illness or major trauma in the last 8 weeks
* History of a chronic inflammatory disease such as rheumatoid arthritis, immune disorders or connective tissue disease.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Ketamine Analgesia in Third Molar Surgery

BACKGROUND AND PURPOSE Outpatient surgery (day case surgery) is increasing. When the patients go home on the same day, this demands safe pain relief. A reduction of morphine (opioid) use is sought because of side effects and the dependency risk. An effective alternative to opioids is ketamine, which lacks the side effects of opioids but provides powerful analgesic effects.

METHOD At the start of surgery, Ketamine or placebo will be given in a vein to evaluate if the acute pain decreases significantly. Inflammation is known to cause pain. By measuring different proteins in the blood, the investigators want to understand how inflammation links to the pain. Wisdom tooth surgery provides significant post-operative pain and is a widely accepted pain model in drug studies. Patients referred for wisdom tooth surgery are asked to participate in the study. For statistical certainty, in total 165 persons will be enrolled to three groups. Two with active drug (different dose) and one placebo. Everyone gets local anesthesia. The completion of the study will be done in four years. The Ethics Review Board has approved the study.

CLINICAL RELEVANCE Effective pain relief after daily surgical procedures is important for patient´s safety and reducing the risk of long-term pain. It is also ethically necessary for the continued expansion of day case surgery. New knowledge of the mechanisms of pain increases the opportunities for individual and safe pain relief. Day case surgery is performed in all operating specialties, this might affects many patients nationally and internationally.


Eligibility Criteria:
Inclusion Criteria:

* Healthy or mild well-compensated systemic disease (ASA I \& II)
* 18- \<45 years
* 50-100 kg body weight

Exclusion Criteria:

* Medication drugs: analgesics, hypnotics (the last week before surgery), thyroid hormones, psychoactive drugs or monoamine oxidase inhibitors (MAO inhibitors).
* Hypertension \[\> 150/95 mmHg in screening study\]
* Heart failure
* Psychosis
* Epilepsy
* Hyperthyreosis
* Myasthenia gravis
* Glaucoma
* Verified sleep apnea
* Diabetes (insulin treated)
* Porphyria
* Pregnancy
* Breast-feeding
* Blood transmitted infections, such as HIV and hepatitis B and C
* Known hypersensitivity to midazolam, ketamine, ibuprofen, or local anesthetics
* Inability to obtain the requisite written or oral information
Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy

Randomized controlled trial on laparoscopic cholecystectomy. Interventional group: preincisional infiltration with levobupivacaine. Control group: no local infiltration.

Postoperative pain with numeric rating scale is registered, besides other parameters like heart rate, blood pressure, rescue analgesia requirements, nausea and vomiting, etc.


Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic cholecystectomy

Exclusion Criteria:

* Patient refusal
* Open surgery
* Reintervention surgery
* Drain tube placement
* Cognitive impairment
* Allergic reactions to local anesthetics
Omentopexy After Sleeve Gastrectomy in Children and Adolescences.

Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric operation, has become one of the most commonly performed bariatric surgeries. Postoperative gastrointestinal complications are agonizing in patients underwent this procedure. Most of these complications can be prevented by omentopexy in association with sleeve gastrectomy. The Primary aim of this study to assess the effectiveness of omentopexy during laparoscopic sleeve gastrectomy in reducing post-operative complication.

This study was a carried out as a prospective study of 48 patients with obesity between January 2015 and October 2024. The patients were divided into 2 groups; group 1: included 24 patients managed with LSG with omentopexy and group 2: included 24 patients managed with LSG without omentopexy. Pre- operation data and post operation outcomes were taken for all patients in each group.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) of 40 kg/m2 or
* BMI of 35 kg/m2 due to at least 1 comorbid condition

Exclusion Criteria:

* secondary obesity
* more than 18 years
* previous operation
Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients with stage II bladder cancer.

OBJECTIVES: I. Determine the efficacy of combination chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) following aggressive transurethral resection of bladder tumors in patients with stage II transitional cell carcinoma of the bladder without nuclear overexpression of mutant p53. II. Determine the proportion of patients treated with this regimen in whom bladder preservation rather than radical cystectomy is possible.

OUTLINE: All patients undergo complete or near complete transurethral resection of the bladder tumor at entry or within 6 weeks prior to entry. Upon confirmation of staging and histology, patients receive combination chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) every 21 days for 4 courses. Subcutaneous G-CSF is given with each course. Patients with a complete response after chemotherapy proceed to intravesical therapy or observation; those with a partial response, stable disease, or progression proceed to definitive surgery.

PROJECTED ACCRUAL: 30 patients will be entered over approximately 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Invasive transitional cell carcinoma of the bladder that is clinical stage T2-3a N0 M0 by cystoscopy Cystoscopy performed at Memorial Sloan-Kettering Cancer Center (MSKCC) No multifocal carcinoma in situ No obstructive uropathy or palpable mass Pathologic confirmation of histology and no more than 20% positive expression of nuclear p53, as follows: On study following transurethral resection of the bladder (TURB) OR At TURB performed within 6 weeks of entry as part of initial staging

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 3,500 Platelets greater than 150,000 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min per 1.73 square meters Cardiovascular: No NYHA class III/IV status Other: No concomitant malignancy other than basal cell skin carcinoma Negative pregnancy test required of fertile women Adequate contraception required of fertile women

PRIOR CONCURRENT THERAPY: No prior systemic chemotherapy No prior bladder irradiation
A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788

The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of R788 compared with placebo, and to investigate the safety and efficacy of long term dosing of R788 in patients with chronic idiopathic thrombocytopenic purpura.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients
* Patients diagnosed with idiopathic thrombocytopenic purpura at least 6 months before acquisition of consent
* Patients with a platelet count averages \<30000/μL during screening period. Each platelet count should not exceed 35000/μL.
* Patients who have used and failed or who were intolerant at least 1 typical regimen for the treatment of ITP before informed consent (with or without splenectomy)

Exclusion Criteria:

* Patients with thrombocytopenia associated with other disease
* Patients with autoimmune hemolytic anemia
* Patients with poorly controlled hypertension
* Patients with a history or active coagulopathy
Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori

Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of eradication therapy against Helicobacter pylori.


Eligibility Criteria:
Inclusion Criteria:

Male or Female with 18 years or more of age without history of H. pylori eradication AND

1. Patients with H. pylori associated peptic ulcer in scar stage, OR
2. Non-ulcer dyspepsia patients with H. pylori infection

Exclusion Criteria:

1. Under 18 years, OR
2. Patients with a history of previous treatment of H. pylori infection, OR
3. Pregnant or Breast feeding women, OR
4. Patients with severe renal, liver, or heart disease, OR
5. Patients with gastric malignancy, OR
6. Patients with a history of drug allergy or hypersensitivity, OR
7. Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy
Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery

Two hundred children aged 1-12 years undergoing short surgery will be randomized into two groups. Ketofol will be used for induction and maintenance of anesthesia in group l. .Ketofol with lidocaine will be prepared for group ll. A reducted McFarlan infusion dose will be used. Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU) will be recorded.

Aim of the research: In this study investigators want to examine the effectiveness of the use of ketofol and a mixture of ketofol and lidocaine on the total consumption of opioids and on the postoperative recovery of pediatric patients. Investigators will evaluate the safety, efficacy, and outcomes of the anesthesia procedure with respect to the administration of different anesthetics, specific pharmakocinetic profiles and compare the length of recovery between patients in two groups.

Including criteria: children aged 1 to 12 years who underwent short surgery (up to 60 min).

Primary and secondary outcome measures: The primary outcome of this study will be extubation time and the secondary outcome will be time spend in PACU.

Description of the study: Each subject included in the study will be given general anesthesia with ketofol or ketofol and lidocaine, with the addition of fentanyl. After 20 s the LMA will be placed. Maintenance of anesthesia will be performed using an air / oxygen mixture (50% / 50%) and an infusion of ketofol or ketofol and lidocaine. Ketofol will be prepare in a ratio of 1: 4 for induction and 1: 7 for maintenance. The same mixtures of ketofol will be added 1 ml of 2% lidocaine for the second group of patients. After extubation, patients will be transferred to the PACU.

Eligibility Criteria:
Inclusion Criteria:

* surgical procedures max 60 min ASA I and II

Exclusion Criteria:

* ASA \> II surgical procedures longer than 60 min
Lausanne Trialogue Paradigm - Brief: A Family Model for Child Mental Health in a Community Setting

The current study is a feasibility pilot of the Lausanne Trialogue Play paradigm Intervention - Brief (LTP-Brief), a family systems therapy implemented in a community mental health setting. We will study the ultrabrief, virtual therapy to assess the feasibility of a future pilot RCT. Feasibility metrics include resource, scientific, and management considerations, as well as an examination of pre-post change in future child and family outcomes of interest.

COVID-19 represents an acute crisis to children's mental health, with potential for long-term consequences. There is evidence for elevated mental health symptomatology in children since the start of the pandemic, with the emergence of stress-related disorders and the exacerbation of pre-existing disorders. Indeed, the pandemic has had detrimental effects on family life due to widespread job loss and financial insecurity, and increases to parental psychological distress, mental illness, and substance use. Social consequences of COVID-19 are expected to have cascading negative effects on child mental health symptoms. Thus, a COVID-19 family recovery program is critically needed, both during and after the pandemic, to manage the current mental health crisis in children and create cascading and sustainable effects for lifelong physical and mental health. The main goal of the the current study is to investigate feasibility of a future pilot and/or main RCT of a brief, virtual mental health treatment program for children and families designed to optimize reach of services. Specifically, the Lausanne Trialogue Play paradigm assessment is a semi-structured assessment of whole family interactions, with emphasis on the co-parenting relationship, which has been used extensively in research settings for assessment and consultative purposes. The current study will assess the feasibility of using the LTP in an assessment-as-treatment model. This brief treatment program, called the LTP-Brief intervention (LTP-B) will consist of a family play assessment (including an LTP assessment) with video feedback to caregivers as a method for promoting change in family interaction patterns. By targeting change across the family system, rather than focusing on specific child mental health symptoms directly, the model addresses upheaval of family life during COVID-19 and has potential to create sustainable improvements in family well-being within a short period of time.

Eligibility Criteria:
Inclusion Criteria:

* The sample will comprise of families referred to the outpatient mental health services at Sick Kids Center for Community Mental Health (SKCCMH), a non-profit children's mental health treatment centre in Toronto, ON, Canada.
* Participants will include children ages 0 months to 15.11 years old, and their caregivers, though the majority will fall in the range of 3- to 14-years-old.
* The first 25 families to be referred to the LTP-B service and who agree to participate in research will be included.

Exclusion Criteria:

* No exclusion criteria beyond what is standard for the clinical service at SKCCMH.
Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block

Regional anesthesia is an essential component of anesthesia and analgesia. It has many advantages, it decreases pain post operatively, improves patient outcome and allow early recovery and ambulation Post-operative pain following breast surgery results from injured muscles and nerves, management of acute post operative pain is a consistent factor for better outcome and patient satisfaction

All patients will be monitored by standard intraoperative monitoring that includes continuous electrocardiography (ECG), capnography, pulse oximetry, and non invasive blood pressure.

Induction of general anesthesia will be done by propofol 1.5-2 mg/kg and fentanyl 3µg/kg.

Tracheal intubation will be facilitated by administration of rocuronium 0.8 mg/kg. Anesthesia will be maintained with isoflurane 1MAC (Pecs block):the block will be performed with the patients in the supine position.The infraclavicular and axillary regions will be cleaned with antiseptic solution. the in plane technique will be used from proximal and medial to distal and lateral in an oblique manner at dermatome level T2 and T3.The puncture site was infiltrated with 2%lidocaine and once the structures is identified with Ultrasound

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* aged 18-60years old
* ASA class 1 to 3
* scheduled for elective modified radical mastectomy

Exclusion Criteria:

* patients refusal,
* coagulopathies
* concurrent anticoagulant therapy
* allergy to local anaesthetics
* infection at puncture site