cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain

The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed of cancer-related pain of more than 3 months duration
* Pain relief during the last week rated unsatisfactory by the patient
* Pain severity during the last week rated moderate (between 4 and 7/10)
* Analgesic therapy must have been stable for 7 days
* Able to understand English or French
* Willing and able to give written informed consent

Exclusion Criteria:

* Patients who are currently receiving or have received methadone as analgesic in the last 6 months
* Contraindication to receive methadone (allergy, QTc segment on the ECG\>450msec, concurrent treatment with medication that could increase methadone's effects)
* Patients presenting with changes in their cancer status/treatment with potential effects on their pain severity, during the duration of the trial (eg: new metastasis, indication for radiotherapy)
* Patients whose life expectancy is shorter than 2 months
* Patients with cognitive impairment presenting with difficulties understanding the trial and completing the research questionnaires
* Pregnant or lactating women (women of childbearing potential must have negative pregnancy test)
Measurement of Jugular Venous Pulse in Critically Ill Patients.

To assess the utility of clinical bedside examination for the measurement of jugular venous pulse in critically ill patients.

Procedures: All patients with central venous catheters (CVP) will undergo physical examination of the jugular veins, while blinded to the actual CVP measured from the catheter. Clinicians with various experience levels (attending physician, fellow, resident physician, 4th year medical student) will participate.

The following clinical data will be obtained: Demographic data such as age, sex, weight and diagnosis will be collected. Each clinician's bedside CVP will be recorded from the bedside monitor. Clinicians will be blinded to bedside monitor.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the ICU who have existing central venous catheters.

Exclusion Criteria:

* Patients admitted to the ICU who do not have existing central venous catheters
Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses

Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. The aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.


Eligibility Criteria:
Inclusion Criteria:

Patients:

1. The subject has given their written consent to participate in the trial.
2. Are referred to Department of Clinical Physiology, Skåne University Hospital, for suspected or known CCS or heart failure
3. Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to \>80 years old)
4. Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c)
5. No caffein intake \<24h prior to the examination

Healthy volunteers:

1. The subject has given their written consent to participate in the trial.
2. Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to \>80 years old)
3. No caffein intake \<24h prior to the examination

Exclusion Criteria:

Patients:

1. Acute referral (in-house patients)
2. Clinically unstable
3. Acute chest pain
4. Severe or decompensated heart failure
5. Non sinus rhythm (e.g. atrial fibrillation)
6. Asthma or severe chronic obstructive pulmonary disease
7. Known chronic renal failure (eGFR \<45mL/min/1.73m2)
8. AV-block II or III
9. Left Bundle Branch Block
10. Systolic blood pressure \<90 mmHg or \>230 mmHg at rest
11. Increased intracranial pressure
12. Known allergy or adverse reaction to adenosine or mannitol
13. Known allergy or adverse reaction to gadolinium contrast agents
14. Treatment with medication containing dipyradimol or teofyllamin/teofyllin
15. Claustrophobia
16. Devices contraindicated to CMR imaging (pacemaker, implants, intracranial clips etc)
17. Pregnancy or breast feeding (screened by question only)
18. Inability to give informed consent due to mental state, language difficulties etc

Healthy volunteers:

1. Any of the exclusion criteria for patients
2. Blood pressure \> 140/90 measured according to clinical routine
3. Known systemic disease
4. Known cardiac disease
5. Cardiovascular medication
6. Medication that might influence cardiovascular health
7. Smoking
Ultrasound Measure of Gastric Volume in Diabetic and Non Diabetic Patients Before General Anesthesia

The main objective is to compare the frequency of a " full stomach " in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18
* American Society of Anesthesiologists (ASA) classification 1 to 3
* Needed a general anesthesia for a programmed surgical intervention
* Respect of instructions of the pre-operative fasting;
* Affiliation to the social security;
* Consent form signed

Non inclusion Criteria:

* Pregnant or breastfeeding women
* Patients already operated or to be operated from the upper digestive tract (esophagus, stomach, duodenum)
* Patients treated with a prokinetic treatment and / or a level 3 analgesic

Exclusion criteria

* Unfeasibility to ultrasound measurement of antral area
* Failure to observe fasting instructions
Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis

The aim of this study is to determine whether antibiotic treatment could reduce mechanical ventilation duration in patients with nosocomial tracheobronchitis acquired under mechanical ventilation.

Rationale:

Ventilator-associated tracheobronchitis (VAT) is common in intensive care unit (ICU) patients, rates of 2.7%-10.6% are reported in the literature. This nosocomial infection is associated with weaning difficulties resulting in prolonged duration of mechanical ventilation (MV) and ICU stay. A case-control study performed in chronic obstructive pulmonary disease (COPD) patients with VAT found antibiotic treatment to be significantly associated with reduced duration of MV. Another case control-study, performed in VAT patients without chronic respiratory failure, found no significant difference in duration of MV between patients who received adequate antibiotic treatment and those who received inadequate antibiotic treatment. In addition, antibiotic use is known to be associated with subsequent multidrug-resistant bacteria (MRB), longer duration of MV, and mortality rates. Therefore, a randomized controlled study is necessary to determine the impact of antibiotic treatment on outcome in VAT patients.

Patients and methods:

390 patients will be included in this prospective randomized open multicenter study. Inclusion of 390 patients is required to demonstrate a significant reduction of MV duration of 5 days (α = 0.025, β = 0.10). An intermediate analysis will be performed. All patients intubated and ventilated \> 48h who developed a first episode of VAT are eligible. Primary endpoint is the duration of MV. Secondary end points are ICU length of stay, mortality, ventilator-associated pneumonia, ICU-acquired infection, MRB, and yeast rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients with tracheobronchitis diagnosed after 48h of invasive mechanical ventilation

Exclusion Criteria:

* Immunodepressed patients
* Patients with tracheostomy at ICU admission
* Patients who developed ventilator-associated pneumonia before ventilator-associated tracheobronchitis
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect.
* Patients must be taking an ACE inhibitor prior to their operation

Exclusion Criteria:

* Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist
* Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study.
* Pregnancy as ruled out by standard of care screening procedures.
* Individuals whose weight is less than 3.5 kg at the time of enrollment.
* Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.
The Five-repetition Sit-to-stand Test for Lower Back Pain or Radiculopathy

The five-repetition sit-to-stand test (5R-STS) has been used in many medical disciplines, but has never been correlated with or validated in regard to degenerative spinal diseases. The investigators aim to assess the possibility of using the standardized 5R-STS as an objective measure of functional impairment and pain severity in patients with degenerative lumbar spinal diseases.


Eligibility Criteria:
This study will include 100 Patients:

Inclusion Criteria:

* Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)
* Symptoms of lower back pain, neurogenic claudication, or radiculopathy

Exclusion Criteria:

* Hip or Knee prosthetics
* Walking aides

This study will also include 25 healthy volunteers:

Inclusion Criteria:

- No degenerative spinal or lower extremity complaints

Exclusion Criteria:

* Back pain, leg pain, other lower extremity-related complaints
* Knee or hip prosthetics
* Walking aides
Distinct Metastatic Phenotypes Between Early-onset and Late-onset Colorectal Cancer

The clinical and pathological features of early-onset colorectal cancer (EOCRC) differ from those of late-onset colorectal cancer (LOCRC). Our research aims to thoroughly elucidate the distinctions between them by analyzing clinical prognosis, metastatic patterns, gene expression, and genomic mutation profiles. Our deliberation will uncover latent strategies for personalized therapeutic of both EOCRC and LOCRC.


Eligibility Criteria:
Inclusion Criteria:

* The initial diagnosis of colonoscopy and pathology belongs to colorectal cancer;
* Patients should sign an informed consent form after fully understanding the purpose, procedures and potential risks of the study, indicating their voluntary participation in the research.

Exclusion Criteria:

* Patients with obvious local or systemic severe infection;
* Acute abdomen: intestinal obstruction, peritonitis, intestinal perforation;
* Have a systemic underlying disease that has not been controlled, or is unstable;
* Patients with poor physical fitness or serious other organic diseases who cannot tolerate anesthesia and surgery;
* Women during pregnancy, perinatal and lactation;
* Patients with severe mental disorders (such as schizophrenia, bipolar disorder, etc.) or patients who are mentally incapable or unable to understand the requirements for participation in the study.
Phase 1 Study of Anti-glycation Agent GLY-230 in Healthy Subjects

To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by mouth.


Eligibility Criteria:
Inclusion Criteria:

* Men age 18-55
* Negative drug screen
* Normal EKG, clinical chemistries, CBC, urinalysis, and
* Give written informed consent

Exclusion Criteria:

* Active concomitant serious medical or surgical disease,
* Hepatic or renal laboratory values above reference range, ise of other experimental drug within previous 30 days
Acne Treatment With Active Oplon's Patches

The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.

Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.

Eligibility Criteria:
Inclusion Criteria:

* Acne Vulgaris
* Over 18 years
* Signing informed consent

Exclusion Criteria:

* Active treatment of acne
* Change in hormonal therapy
* Antibiotic treatment in a week prior to the experiment
* Sensitive skin
* Pregnancy
Identification of the Lumbar Interspinous Spaces; Palpation Versus Ultrasound Versus Fluoroscopy

The of epidurals and spinals, relies primarily on palpation of anatomic landmarks that are not always easy to find, More so, even after correct identification of palpable landmarks, Variability exists leading to performing neuraxial injection in undetermined intralaminar level. The most accurate method for identifying the interspace is the using of the fluoroscopy or CT technique, but exposure to radiation and availability make it unpractical in majority of cases. As ultrasound technology becomes more accessible to the clinician, it holds great potential to facilitate performing neuraxial anesthesia by the anesthesiologist in routine cases.

The aim of this study to compare the accuracy of identifying the intervertebral space, between manual palpation, versus ultrasound versus fluoroscopy.

Neuraxial anesthesia relies upon a sound knowledge of anatomy to accurately direct needle placement both to achieve consistent success, and to avoid damage to other nearby structures. This prospective randomized study, will be performed in the pain management unit. We will assess patients who are scheduled to receive an epidural steroid injection. The investigator will request permission fro the ethics committee of Hadassah Medical Hospital.

Three anesthesiologist will perform this study, every one of the anesthesiologist will be asked to identify intralaminar space by one technique and we will compare the accuracy of the identifying of the intralaminar space.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for epidural steroid injection under fluoroscopy technique.
* Age above 18 years

Exclusion Criteria:

* Inability to understand consent form.
* refusing to sign the consent form.
* contraindication for neuraxial injection.
* local or systemic infection.
* pregnant women.
* previous spine surgery.
A Clinical Trial of Chazhu Xiaozhi Decoction Against Non-alcoholic Fatty Liver Disease

The goal of this clinical trial is to learn if drug Chazhu Xiaozhi decoction works to treat non-alcoholic fatty liver disease in adults. It will also learn about the safety of drug Chazhu Xiaozhi decoction. The main questions it aims to answer are:

Does drug Chazhu Xiaozhi decoction improve the degree of hepatic steatosis in patients with non-alcoholic fatty liver disease? What medical problems do participants have when taking drug Chazhu Xiaozhi decoction? Researchers will compare drug Chazhu Xiaozhi decoction to a placebo (a look-alike substance that contains no drug) to see if drug Chazhu Xiaozhi decoction works to treat non-alcoholic fatty liver disease.

Participants will:

Take drug Chazhu Xiaozhi decoction or a placebo every day for eight weeks Keep a record of their symptoms and the degree of hepatic steatosis before and after the treatment


Eligibility Criteria:
Inclusion Criteria:

According to the diagnostic criteria, patients with NAFLD and Spleen Deficiency and Damp-Heat Syndrome are selected. The specific criteria are as follows:

1. Age 18-50 years, both genders eligible;
2. Meets the diagnostic criteria for NAFLD;
3. Meets the diagnostic criteria for Traditional Chinese Medicine Spleen Deficiency and Damp-Heat Syndrome;
4. Has significant risk factors: CAP≥238dB/m, Body Mass Index (BMI) ≥23 kg/m²;
5. Has not received any anti-NAFLD medication treatment in the past month;
6. Normal major organ function, including heart, kidney, and liver functions, specifically: no significant abnormalities on electrocardiogram; normal serum creatinine and urea nitrogen; normal serum bilirubin and albumin levels;
7. Has sufficient cognitive and understanding abilities to comprehend the study content and its potential risks and benefits;
8. Voluntarily participates in the study and signs an informed consent form.

Exclusion Criteria:

1. Has liver steatosis due to other definitive causes, such as alcoholic liver disease, drug-induced liver injury, viral hepatitis infections (e.g., hepatitis B, hepatitis C, etc.);
2. Has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, Wilson's disease, etc.;
3. Has severe dysfunction of major organs such as the heart, kidneys, lungs, etc., such as severe heart failure (NYHA functional classification III or above), renal failure (glomerular filtration rate eGFR \< 30 mL/min/1.73m²), acute exacerbation of chronic obstructive pulmonary disease, etc.;
4. Has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.;
5. Known allergy or intolerance to any component of the study medication;
6. Has participated in another clinical trial within the last three months;
7. Pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial;
8. Has severe mental illness or behavioral disorders that may affect adherence to the study protocol;
9. Other conditions that the researcher considers unsuitable for participation in this study.
Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis

To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.

In this study, we aim to include patients implated with leadless pacemakers, collect key variables and other clinical data during implantation of leadless pacemakers, and observe the final implantation site, intraoperative complications and prognosis information of patients. This study aims to clarify the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis, and provide data support for the standardization of leadless pacemaker implantation process in China.

Eligibility Criteria:
Inclusion Criteria:

* Patient received implantation of leadless pacemaker
* Patient agreed to join into this study and signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Ventricular septal defect
* History of mechanical tricuspid valve replacement
* History of inferior vena cava filter placement
* Pregnant or plan to be pregnant within 2 years
* Life expectancy \< 1 year
* Patient was included in other studies that could introduce bias into this study
A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer

The purpose of this study is to assess two treatment strategies (leuprorelin treatment and active surveillance without androgen deprivation) for indolent prostate cancer and to compare their therapeutic benefit for management of patients with low-risk, localized prostate cancer.

The drug being tested in this study is called leuprorelin. Leuprorelin is being tested to treat people who have prostate cancer. Study assessments will include adverse events, prostatic-specific antigen (PSA) levels, and prostate biopsies.

The study will enroll approximately 120 patients. Participants will be randomly assigned (by chance, like flipping a coin) to a treatment group that will receive leuprorelin 11.25 mg (as one injection) or to an untreated observation group. Patients in the leuprorelin group will also receive bicalutamide 50 mg, a non-steroidal antiandrogen, once daily for 15 days to prevent a flare-up.

This multi-center trial will be conducted in France. The overall time to participate in this study is 12 months. After the screening visit, participants will make 6 visits to the clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Is an out-patient 50 to 80 years old.
2. Has read, understood, signed and dated the informed consent.
3. Has indolent prostate cancer defined by:

   * Clinical Stage T1c or T2a.
   * Biopsy cores of which at least 12 reveal the presence of positive cores and the absence of cores with tumor length \> 3 mm.
   * Absence of Grade 4 cells (Gleason \<7).
   * Prostate specific antigen (PSA) levels \<10 ng/ml.
4. Has a life expectancy \> 5 years.
5. Has accepted the principle of active surveillance.
6. Is willing to participate in the study for a minimum of fifteen months.

Exclusion Criteria:

1. Has prior androgen deprivation including a 5-alpha reductase inhibitor (finasteride or dutasteride) within the last 6 months.
2. Has psychological failure related to prostate cancer therapy.
3. Has any active disorder likely to affect the conduct of the study or the patient's prognosis during the study.
4. Has a mental deficiency or any other reason that may hinder the understanding or strict application of the protocol.
5. Is under judicial protection, tutorship or curatorship.
6. Is unlikely to attend control visits.
7. Is currently enrolled in an investigational study or has participated in another investigational study within the last 3 months.
8. Has an allergy or hypersensitivity to any components of leuprorelin (Enantone LP) 11.25 mg or Casodex® 50 mg.
9. Has a medical history of severely impaired hepatic function linked to bicalutamide or a pathological cause.
10. Has testosterone level \< 0.5 ng/ml.