cyrilzakka/clinical-trials huggingface dataset:
Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study

Patients with severe and above degree burns are often complicated with inhalation injury and systemic infection. During debridement and dressing change in such patients, doctors will be more cautious in using analgesics. Patients often moan, shiver and limb movement due to insufficient sedation and analgesia, resulting in unpleasant feelings and experiences, which increases the anxiety of patients during hospitalization. Previous studies have shown that the use of ketamine in burn patients during dressing change can produce good analgesia and maintain stable vital signs.

Esketamine, the dextral monomer of ketamine, has hypnotic, sedative and analgesic effects and could be safely used in clinical anesthesia. Compared with ketamine, esketamine has stronger analgesic efficacy and less circulatory influence, which is more consistent with the characteristics of ideal analgesic drugs in burn dressing. As an FDA-approved drug for the treatment of refractory depression, esketamine has potential social benefits in burn patients due to its rapid antidepressant pharmacological properties. This study hypothesized that esketamine could reduce the pain of dressing change in patients with severe burns and reduce the occurrence of early depression in such patients.

This study adopted a prospective, double-blind, randomized, controlled, single-center design. A total of 52 severe burn patients aged 18-60 years who need debridement and dressing change under sedation and analgesia were included and randomly divided into the experiment group: esketamine would be used in the induction phase; the control group: esketamine would not be used in the induction phase. Both groups were given dexmedetomidine and butofinol before induction, and fentanyl as a remedy during the dressing change phase. The dosage of fentanyl in the dressing change phase, the pain score (SF-MPQ) after recovery, the incidence of sedation-related complication were compared between the two groups.

This study explores the advantages of esketamine in reducing the use of opioids and the pain score of patients.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Grades II to IV
* Patients with severe degree burns Ages 18 to 60
* Patients who signed informed consent forms

Exclusion Criteria:

* Hepatic and renal insufficiency
* Allergy to intended medication
* History of antidepressant or antipsychotic drug use
* Atrioventricular block of second degree or higher
* Patients who can't cooperate
A Dose Escalation Trial of Five Fraction Stereotactic Radiation Therapy for Brain Metastases

This study looks at dose escalation for five fraction stereotactic radiotherapy for patients diagnosed with brain metastases with tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter.

This study looks at dose escalation treatment in patients diagnosed with brain metastases. Treatment involve five fraction stereotactic radiotherapy for patients with brain tumors 2.1-4.0 cm in diameter or 4.1-6.0 cm in diameter and dose escalation treatment is delivered only to the single largest tumor while all other tumors are treated with standard of care practices if they are present. A dose escalation schedule is proposed based on the monitoring of CNS toxicity and tumor size of the largest tumor, given it falls into the parameters set on diameter.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have histologically confirmed malignancy.
* All patients must have imaging suggestive of one or more brain metastases.
* Karnofsky performance status (KPS) ≥ 60
* Age \> 18 years
* Patients must provide written informed consent to participate in the study.
* Patients must have less than or equal to 10 brain metastases as identified on brain MRI.

Exclusion Criteria:

* History of surgical resection to the tumor of interest
* History of radiation to the tumor of interest
* History of previous whole brain irradiation
* Receipt of systemic therapy within one week of planned radiation treatment except for hormonal agents.
* Patient is unable to have MRI or MRI contrast.
* Inability to meet the appropriate normal tissue dose constraints secondary to tumor location should result in exclusion of the patient / tumor.
* Patients with a non-index tumor (second tumor) greater than 3 cm in diameter will be excluded.
Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma

The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of COPD and diagnosis of asthma before the age of 30
* Current or ex-smokers with a cigarette smoking history of at least 10 pack-years
* Treatment with inhaled steroids at least 1 year before study entry
* FEV1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years
* FEV1 increase of more than 200 mL 30 min. after 400 mcg salbutamol or documented increase of 200 mL after reversibility test within the last 5 years
* Post bronchodilator FEV1 less than 80% predicted normal (ECCS) at visit 1
* Post bronchodilator FEV1 less than 70% of FVC at visit 1

Exclusion criteria:

* Respiratory infection or exacerbation 6 weeks prior to Visit 1 or during run-in period.
* Significant diseases other than COPD or asthma
* Myocardial infarction within the last 6 months
* Unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year
* Hospitalisation for heart failure (NYHA Class III or IV) within the last year
* History of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
* Known active tuberculosis
* History of thoracotomy with pulmonary resection
* History of cancer within the last 5 years (excluding treated basal cell carcinoma)
* Patients requiring oxygen therapy for more than 1 hour per day
* Patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before Visit 1
* Known hypersensitivity to anticholinergic drugs or lactose
Optimized Heart Failure Therapy Through Continuous Monitoring

Patients with heart failure have a high incidence of atrial fibrillation (AF)and re-admission for heart failure. New methods have been developed to continuously monitor arrhythmia's and heart failure parameters. One such method is implantation of an implantable loop recorder. Also home-monitoring is available for continuous monitoring and information sending to the treating physicians, with improving detection of atrial fibrillation (AF) and/or other sever arrhythmia's we hope to improve patient care.

Objective of the study:

To investigate the clinical efficacy in detecting clinically relevant arrhythmia's (especially AF) of the Reveal XT in patients with mild to moderate heart failure and elevated risk factor for stroke and transient ischemic attack (TIA)(CHADS-score \>2), currently not treated with oral anticoagulation (OAC).

Study design:

In 50 stable sinus rhythm (no known AF)patients with New York health Association (NYHA class) 2-3, a CHADS2-score\>2 and no indication for a implantable cardioverter-defibrillator (ICD) or pacemaker (PM) or OAC. Patients are put on home-monitoring (CareLink) and regular outward clinic visits. The number of relevant arrhythmia's detected will count for the primary endpoint. Also the number of medication changes and institution of OAC.

Study population:

50 stable patients, recruited from the outward clinic. NYHA class 2-3. Reveal XT implantation. CHADS2-score 2 or more. No indication for ICD/PM or OAC. No AF known.

Primary study parameters/outcome of the study:

Primary endpoints

* AF burden and AF episodes detected
* Detected other relevant arrhythmia's like SVT's (not AF) or ventricular tachycardias (VT's) or bradycardias
* % patients on OAC after 1 year follow-up
* Number of clinically relevant patient activated events
* Number of treatment policy changes based on the Reveal XT

Secondary study parameters/outcome of the study

* specificity of AF detection algorithm by the Reveal
* Predictive value of the cardiac Compass data to predict worsening heart failure episodes.

no additional description needed

Eligibility Criteria:
Inclusion Criteria:

* EF \> 35%
* NYHA 2-3
* No AF documented
* Not on OAC

Exclusion Criteria:

* use of OAC
* documented AF \> 30 sec
* planned or actual PM/ICD
* life-expectancy \< 1 year
* no informed consent
CALS Patient Activated Learning System (PALS)

The overall goal in this line of inquiry is to test whether the Patient Activated Learning System (PALS) is effective in reducing disparities in access to reliable, easily understood health information, and whether this increased understanding has downstream consequences such as increases in trust in the medical system and self-management behaviors.

Participants will view, in randomized order, PALS or WebMD content on hypertension and on high cholesterol. This study will test knowledge uptake across topics as well as attitudes toward and trust in the information and information providers.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age.
* Self-reported hypertension diagnosis.
* English speaking
* Passing the cognition screener
* Able to read in English
* Patient at designated recruitment clinics

Exclusion Criteria:

* Non-English speakers
* Not having self-identified as having hypertension
* Inability to read in English
* Being younger than 18
* Not passing the screener
* Not being a patient on the participating clinics
Computerized Adaptative Testing of Self-perceived Quality of Care in Psychiatry

Objectives

1. to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived quality of care in Psychiatry.
2. to analyze the implementation of this new measure in clinical practice : qualitative analysis of the relationship patient/professional.

Prospective and multicentric study

1. Development and validation of the CAT. 4 steps :

   * Elaboration of a pool of items, based on literature review and interview with patients.
   * Selection of the most relevant items based on a qualitative approach using cognitive interview with patients.
   * Calibration of the item bank : the psychometric properties of the item bank will be based on classical test and item response theories and approaches, including the evaluation of unidimensionality, item response theory model fitting, and analyses of differential item functioning.
   * Metrological validation of the CAT.
2. Analysis of the implementation of the CAT in clinical practice using interview with professionals and patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia, bipolar disorder or depression according DSM V
* criteria
* age over 18 years
* informed consent to participate
* French as the native language

Exclusion Criteria:

* diagnosis other than schizophrenia, bipolar disorder or depression according DSM V criteria
* decompensated organic disease, and mental retardation
Gut Microbiota and Proteins Intake

Gut microbiota are involved in the regulation of mammalian metabolic pathways through host-microbiota metabolic, signaling, and immune-inflammatory interactions that physiologically connect the gut, liver, brain, and other organs. Correlation of these metabotypes with gut microbial profiles facilitates deciphering inherent host-microbe relationships.

Microbiome sequencing have generated novel insights into the role of gut microbial composition in health and disease, but are limited in addressing the microbial contribution to host metabolism and the gut microbial dysbiosis in disease.

This is an exploratory trial, aiming to examine how gut microbial conditions determine response to dietary challenge by measuring urine, plasma and stool metabolites resulting from metabolism of protein, polyamines and bile acids in combination with stool bacterial composition. The focus of this trial is to evaluate impact of protein based food challenges, based on cross-over design of two diet challenges of animal and vegan protein sources.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* Regular bowl movement (at least once every 1-2 days)
* Between 18 and 55 years old
* BMI between 18.5 and 27 kg/m2 (inclusive)
* Willing and able to sign written informed consent prior to trial entry

Exclusion Criteria:

* Clinically relevant digestive, renal or metabolic disease, as determined by the medical (screening) visit and a standard blood chemistry analysis (glucose, total cholesterol, LDL, HDL, triglycerides, Aspartate aminotransferase (ASAT), Alanine aminotransferase (ALAT), gamma glutamyl transferase (Gamma-GT), C reactive protein (CRP), creatinine)
* Undergoing regular medical treatment, pain-killers accepted, based on the medical questionnaire
* Special diets: vegetarian, high protein or weight loss program (anamnesis)
* Pregnancy (anamnesis)
* Food allergy
* Participation in a cholesterol management program with functional foods like food supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols (margarines, yoghurts), evaluated during the medical visit
* Practicing more than 5 moderated physical activity per week
* Smoker (anamnesis)
* Have a high alcohol consumption (more than 2 drinks/day) (anamnesis)
* Consumption of illicit drugs, (anamnesis)
* Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
* Subject who cannot be expected to comply with the study procedures, including consuming the test products.
* Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.
Ultrasound-guided Subclavian Venous Catheterization in Children

The subclavian vein (SCV) is often the preferred site for central venous access. Ultrasound-guided SCV catheterizations with supraclavicular (SC) or infraclavicular (IC) approach have been proved to be useful in children. The investigators compared the success rate, number of attempts, time tocatheterization, and complication.


Eligibility Criteria:
Inclusion Criteria:

* central venous lines required patients
* children \< 10 yr of age

Exclusion Criteria:

* inadequate ultrasound visualization of the subclavian vein
A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease

A long-term extension study to evaluate the safety, tolerability, and efficacy of AL002 in participants with Early Alzheimer's Disease.

This is a Phase 2, parallel-group, long-term extension (LTE), dose-blind study to evaluate the long-term safety and efficacy of AL002 in participants with Early Alzheimer's Disease. The study is a multicenter, global trial that will enroll participants who completed the planned treatment period in AL002-2 (parent study).

Eligibility Criteria:
Inclusion Criteria:

* Completion of the Planned Treatment Period in the AL002-2 study.
* The participant is willing and able to give informed consent.
* Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week

Exclusion Criteria:

* Participants deemed not able to provide consent or assent by the Investigator or by local regulations.
* Participants who were prematurely and permanently discontinued from treatment in the parent study for safety reasons.
* Participation deemed inappropriate per Investigator discretion.
Continuous Pectoral Nerve Block in Breast Cancer Surgery

The purpose of the study is to evaluate the effect of continuous pectoral nerve block on postoperative analgesia consumption in breast cancer surgery.

Pectoral nerve block has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for postoperative analgesia in breast cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) I-II
* 18-65 years
* Body mass index (BMI) ≤40 kg/m2
* Elective breast cancer surgery

Exclusion Criteria:

* ASA ≥4
* under 18 years of age or over 65 years of age
* declining to give written informed consent
* history of allergy to the local anesthetics
* contraendications of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc)
* history of breast surgery
* treatment due to psychiatric disorder
* history of treatment for chronic pain
* history of nerve blocks in order to treat postoperative pain
Multicenter Infection Surveillance Study Following Open Heart Surgery

The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between hospital-acquired pneumonia and surgical infection and patient outcomes, including length of hospital stay.

Nosocomial infections are recognized as an important cause of increased patient morbidity and mortality. The reported prevalence for nosocomial infections most commonly ranges from 5 to 20%, but can be significantly greater among patients requiring intensive care. The most common sites of hospital acquired infection include the lung, urinary tract, surgical wounds, and the bloodstream. Patients undergoing cardiac surgery appear to be at increased risk for the development of nosocomial infections due to the presence of multiple surgical wounds (chest and lower extremity incisions), frequent postoperative utilization of invasive devices (i.e. central venous catheters, chest drains, intra-aortic balloon counter pulsation, pulmonary artery catheter), and the common use of prophylactic or empiric antibiotics in the perioperative period. In the cardiac surgical postoperative period, nosocomial infections have been found to be associated with prolonged length of stay (LOS) in the ICU and total hospitalization, development of multiorgan dysfunction, and increased hospital mortality. Nosocomial Pneumonia (NP) is in fact the leading cause of mortality due to hospital-acquired infections. Patients with Ventilator Associated Pneumonia (VAP) have been found in various studies to have significantly higher mortality rates than those without VAP, with ranges of 20.2-45.5% and 8.5-32.2%, respectively. Strategies that both reduce postoperative pain and sedation have the potential to reduce postoperative pneumonia by allowing earlier extubation and more effective pulmonary toilet post-extubation. Non-opioid pain management has the potential to reduce NP rates because of superior pain management, as well as the reduction in opioids required, and the concomitant avoidance of opioid side effects. The clinical and financial consequences of NP justify aggressively pursuing strategies aimed at prevention. Specifically, these strategies are targeted at reducing the incidence of NP by addressing the modifiable risk factors including prolonged endotracheal intubation and ventilator support, sedation, and long hospital LOS.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, \>18 years of age;
* Scheduled for elective cardiac surgical procedure, including coronary revasculari-zation or valve surgery;
* Provision of informed consent

Exclusion Criteria:

* Patients with a prior allergic reaction or dependency to morphine, Demerol, Di-laudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);
* Cardiac transplant patients
* Inability to perform follow-up assessments;
* Pre-existing infection (pneumonia or surgical site)
* Repeat of primary surgery
Use of Acetyl Salicylic Acid and Terbutalin in Assisted Reproductive Techniques (ART)

This study aims to determine the possible effects of Acetyl Salicylic Acid (ASA) and Terbutalin on ART treatment.

This study aims to determine the possible effects of ASA and Terbutalin on ART treatment.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women below 39 years of age

Exclusion Criteria:

* Women who may react allergically to the drugs administered
* Women with hyperthyroid or IDDM
* Women who do not want to participate in the study
* Women who are unable to give informed, written consent.
Emerging Physical Therapy Practice in Palliative Care: A Survey of Perceptions of Physical Therapists

The purpose of this study is to explore emerging physical therapy practice in palliative care, and the perceptions of physical therapists regarding their care of the functionally dependent elderly, including: (1) the role and utilization of palliative care intervention in current practice, (2) current and potential goal-setting practices which may relate to palliative care, and (3) therapists' awareness of cultural and psychosocial issues in patient care.

Palliative Care is a growing medical practice specialty, however the level of physical therapist involvement and the particular roles for physical therapy in this evolving discipline are relatively unknown.

The purpose of this study was to explore emerging physical therapy practice in palliative care, and the perceptions of physical therapists regarding their care of the functionally dependent elderly, including the role and utilization of palliative care intervention in current practice, goal-setting practices which may relate to palliative care, and therapists' awareness of cultural and psychosocial issues in patient care.

Eligibility Criteria:
Inclusion Criteria:

* Physical Therapists who are members of the APTA and live in the United States
* Reported practice in an inpatient or home health setting

Exclusion Criteria:

None
Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis

It aims to demonstrate the superiority of a 6-week supplementation with Lactibiane Buccodental compared to placebo, as adjunctive therapy in chronic periodontitis in patients with generalized chronic periodontitis


Eligibility Criteria:
Inclusion criterion:

* Age ≥ 18;
* Patient with moderate to severe chronic periodontitis (mean attachment loss ≥ 3 mm), generalized (more than 30% of sites with loss of attachment), with presence of at least one of three bacterial species the red complex (either Pg, Tf or Td), which, according to the practitioner, may be the result of mechanical treatment (ultrasonic debridement);
* Patient able and willing to participate in the research by complying with the procedures of the protocol especially concerning the consumption of the product under study and having served it by signing a dated informed consent form;

Criteria of non-inclusion:

* Patient with acute oral lesions or necrotizing ulcerative periodontitis;
* Patient who has taken antibiotics in the last 3 months, or who has received treatment affecting periodontal tissue in the past month, or on immunosuppressive therapy (ciclosporin), antihypertensive (nyfedipine), antiepileptic (phenytoin), under biotherapy, or under treatment of hyposialie;
* Patient with a medical history or current pathology that, in the opinion of the investigator, is likely to interfere with the results of the study or to expose him / her to additional risk: unbalanced diabetes, rheumatic fever, disease affecting renal or hepatic function, neurological deficiency, immunological disease;
* Patient smoking more than 10 cigarettes a day;
* Patient with known allergy to at least one of Lactibiane Buccodental® ingredients;
* Pregnant or breastfeeding woman or intending to start a pregnancy within 3 months;
* a woman who is in a state of childbearing not covered by an active method of contraception;
* Patient with a psychological or linguistic disability to understand and sign informed consent, or to understand and implement the constraints of the study;
* Patient participating in another clinical trial, or at the time of exclusion from another clinical trial;
* Patient under legal protection (tutorship, guardianship) or deprived of his rights following the administrative or judicial decision.
* Patient not affiliated to a social security scheme