cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Inhaled Saline in Acute Lung Injury

To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ARDS).

Hypertonic Saline (HS) aerosols have proven efficacious mucolytics in patient with cystic fibrosis and are well tolerated in that population. Safety concerns in mechanically ventilated patients with ARDS center primarily on HS's effects on lung water distribution (intra vs. extra alveolar) and on airway reactivity. For that reason we plan a small feasibility trial with narrowly focused physiologic endpoints, namely to measure the effects of a single 5ml dose of 7% Saline aerosol on blood gas tensions, hemodynamics and the static and dynamic properties of the relaxed respiratory system. This narrowly scoped study is to lay the foundation for a larger multicenter intervention trial.

Eligibility Criteria:
Inclusion Criteria:

* Study participants will include consenting adult patients (age \> 18), who had been intubated and mechanically ventilated for \<72 hours and meet international consensus criteria for ARDS.
The Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Tuberculosis Infection

The purposes of this study

1. to compare the positivity of tuberculin skin test(TST) and QuantiFERON-TB Gold (QFT-G), and determine the level of agreement between two tests in patients with rheumatic diseases
2. to evaluate the difference in the occurrence of active TB in patients who receive both QFT-G and TST compared with those who receive only TST for detecting of Latent tuberculosis infection(LTBI) who are candidates of TNF inhibitors.

Study Assessment

1. The positive rates of QFT-G and TST as a screening test for LTBI

   * The positive rates of QFT-G and TST will be analyzed
   * Additional analysis will be performed according to the type of disease
2. The agreement between QFT-G and TST as a screening test for LTBI

   * The agreement between QFT-G and TST will be analyzed for patients with rheumatic diseases who examined both QFT-G and TST
   * Additional analysis will be performed according to the type of disease
3. The correlation of the occurrence of active TB and two tests (QFT-G and TST)

   * The analysis of the correlation of the occurrence of active TB and two tests will be conducted for patients who have experienced anti-TNF agents

3-1. The occurrence of active TB in accordance with results of TST

3-2. The occurrence of active TB in accordance with results of QFT-G

3-3. The difference in the occurrence of active TB in patients performed both QFT-G and TST compared with those performed only TST for detecting of LTBI who are candidates of TNF inhibitors (pilot study).

Eligibility Criteria:
Inclusion Criteria:

* patients with rheumatic diseases who examined TST or QFT-G in Hanyang university hospital from 2004 to 2010

Exclusion Criteria:

* N/A
Quality of Recovery Using QoR-15 in Enhanced Recovery After Colorectal Surgery.

This observational study will evaluate the patient reported outcomes and postoperative patient-related quality of recovery in 150 patients undergoing colorectal surgery within an enhanced recovery program at CHU Liège. The QoR15 survey will be performed preoperatively and repeated postoperatively at hospital or via telephone calls on Day + 1, Day +2; Day + 3, Day 7 and Day + 14. The total score and the score at the subsections will be correlated with the medical and surgical characteristics of the patients.

For several years, we have been applying the concept of Enhanced Recovery Program (ERP) for colorectal surgery at CHU Liége (Belgium). Since October 2015, the University Hospital of Liège has been labelled as reference center for ERP after colorectal surgery by a French-speaking organization GRACE (French-speaking group for Enhanced Recovery after Surgery; www.grace-asso.fr). Despite the benefits for the patient and the economic benefits of such programs, few studies have investigated postoperative patient-related quality of recovery of patients who have had ERP.

This observational study will evaluate the patient reported outcomes and postoperative patient-related quality of recovery in 150 patients undergoing colorectal surgery according to an ERP at CHU Liège.The QoR15 survey will be performed preoperatively and repeated postoperatively at hospital or via telephone calls on Day + 1, Day +2; Day + 3, Day 7 and Day + 14. The total score and the answers at the subsections will be correlated with the medical and surgical characteristics of the patients.

Eligibility Criteria:
Inclusion Criteria:

* •any patient scheduled for colorectal surgery within an ERP at CHU Liège
* Correct comprehension of french

Exclusion Criteria:

* •unable to answer the survey (cognitive disorders, bad knowledge of the French language)
* •closure of loop ileostomy
Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent,
2. Men or women aged 18 to 75 years,
3. Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
4. Established disease (presence of blood or mucus in the stools) or new diagnosis (bloody stools occurring at least during 14 days prior to baseline visit),
5. Clinical Activity Index (CAI) \>= 6 and Endoscopical Index (EI) \>= 4,
6. Women of child-bearing potential, if heterosexually active, have to apply a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptive method, some intrauterine devices (IUDs), sexual abstinence, or vasectomised partner. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

Exclusion Criteria:

1. Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
2. Toxic megacolon,
3. Baseline stool positive for germs causing bowel disease,
4. Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract,
5. Active peptic ulcer disease,
6. Haemorrhagic diathesis,
7. Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured,
8. Severe co-morbidity substantially reducing life expectancy,
9. Active colorectal cancer or a history of colorectal cancer,
10. Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer other than colorectal cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible,
11. Immunosuppressants within 3 months and/or corticosteroids (oral, intravenous \[IV\] or topical rectal) within 4 weeks prior to baseline,
12. Current relapse occurred under maintenance treatment with \> 2.4 g mesalazine per day,
13. Abnormal renal function (Serum Cystatin C \> upper limit of normal \[ULN\]),
14. Abnormal hepatic function (ALT, AST or AP \>= 2 x ULN) or liver cirrhosis,
15. Known intolerance/hypersensitivity/resistance to study drugs or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the study drugs,
16. Doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs,
17. Existing or intended pregnancy or breast-feeding,
18. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
Respiratory Impact of LA Volume After IS Block

The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.

The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.

Our prospective randomized controlled trial will include two parallel groups: a group will receive a volume of 20 mls of ropivacaine 0.75%, while the other group will receive a volume of 10 mls.

All participants will have a preoperative ultrasound-guided interscalene brachial plexus with an extrafascial injection of 10 or 20 mls of ropivacaine 0.75%. In both groups, participants will have an examination of the hemidiaphgragm with the ultrasound, before and 30 min after the block. The respiratory function will also be assessed with a bedside spirometer before and after the block, and at 12 and 24 postoperative hours. During surgery all participants will receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 milligram kg\^2, iv ketorolac 30 milligrams, and iv acetaminophen 1000 milligrams, according to the current practice in our institution. In the postoperative period, Participants will be prescribed an IV pca of morphine.

Assignment to one of these two groups will be done according to a computer-generated list of random numbers, and the sealed envelopes method will be used.

Eligibility Criteria:
Inclusion Criteria:

* arthroscopic surgery of the shoulder
* ASA class 1 to 3
* age more than 18 years old

Exclusion Criteria:

* patient refusal or inability to understand and/or sign the inform consent
* contraindication for perineural block (allergy to local anesthetics, infection of puncture site, major coagulopathy, sensitive or motor deficiency on the operative side arm
* chronic alcool abuse
* opioid drug abuse or under substitution treatment
* patients known for allergies to paracetamol, non steroidal anti inflammatory drugs, dexamethasone, sulfate magnesium, ondansetron, droperidol, and omeprazole;
* patients under chronic corticotherapy
* patients known for malignant hyperthermia;
* patients with chronic kidney failure (Glomerular Filtration Rate \< 20 ml/min)
* patients with severe pulmonary disease
* patients with history of neck surgery or radiotherapy on the operative side;
* pregnancy
MMRF CureCloud Research Initiative

The MMRF CureCloud Research Initiative, a Direct-to-Patient Research effort aimed at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses will be generated from blood specimens and the resulting data aggregated with the correlating clinical information. Blood will be collected from all participants after electronic online consenting via a mailed blood kit designed for a mobile phlebotomy appointment. Through the consenting process, participants will also be authorizing collection of their electronic medical records information.

More than ever, there is an urgent need for a deeper understanding of the clinical, molecular and immune parameters involved in multiple myeloma disease initiation, progression and response to treatment. Such rich information, collected at the population level, is crucial to generate the evidence needed to ultimately make Precision Medicine a reality for all multiple myeloma patients. To this end the Multiple Myeloma Research Foundation (MMRF) is launching the MMRF CureCloud Research Initiative, a Direct-to-Patient Research effort aimed at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses will be generated from blood specimens and the resulting data aggregated with the correlating clinical information. Blood will be collected from all participants after electronic online consenting via a mailed blood kit designed for a mobile phlebotomy appointment. Through the consenting process, participants will also allow the MMRF to collect their electronic medical records information. An important deliverable of the MMRF CureCloud Research Initiative is a curated dataset of integrated genomic, immune and correlating clinical data that will be made available to support scientific investigations through the MMRF CureCloud, a cloud-based platform with tools and capabilities for the seamless aggregation, integration and analysis of large collections of myeloma datasets.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with active Multiple Myeloma
2. Patients have signed an online consent form

Exclusion Criteria:

1. Patients who live outside the United States
2. Patients with a diagnosis other than Multiple Myeloma or a known or suspected precursor to Multiple Myeloma
Reproducibility Study of OABSS and Its Response to Treatment

The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms.


Eligibility Criteria:
Inclusion Criteria:

* At screening visit (Week -2):

  * Symptoms of OAB ≥ 3 months
  * Number of urgency episodes in last 3 days ≥ 3
* Based on the 3-day micturition diary prior to Visit 1 (Week 0):

  * Number of micturition per day ≥ 8
  * Number of urgency episodes in 3 days ≥ 3

Exclusion Criteria:

* At screening visit (Week -2):

  * Stress is the predominant factor as determined by the investigator
  * Indwelling catheters or practicing intermittent self-catheterization
  * Symptomatic urinary tract infection, chronic inflammation
  * Treatment for OAB was started, quitted or changed in 4 weeks
  * Diabetic neuropathy
* At Visit 1 (Week 0):

  * Patient who did not complete the 3-day micturition diary according to the instruction
Procedural Sedation Using Propofol Versus Midazolam/Ketamine in the Adult Emergency Department

The use of procedural sedation and analgesia (PSA) to accomplish painful procedures in the emergency department (ED) has become a standard of practice over the last decade. Substantial variance exists regarding usage of medication for PSA, and many anesthetic agents have been proposed for this use.

To our knowledge no head to head study compared the clinical effectiveness, safety profile and amnestic properties of midazolam/ketamine vs. propofol regimens for PSA in the adult ED setting.

This prospective randomized trail can will help to evaluate the effectiveness and safety profile of Midazolam/katamine regimen for ED PSA in adults and will contribute to the discussion regarding propofol roll in the ED.


Eligibility Criteria:
Inclusion Criteria:

* Patients with orthopedic injuries requiring painful manipulation (i.e. reduction of fracture or dislocation, drainage of abscess, suture of extensive laceration)
* Age between18-65 years
* American Society of Anesthesiologists (ASA) score of 1 or 2
* Systolic blood pressure higher than 90 mmHg and lower than 160 mmHg before initiating sedation
* Willingness and ability to provide an informed consent
* No known hypersensitivity to either medication
* No evidence of intoxication
* No recent heavy meal.

Exclusion Criteria:

* Pregnant women and patients who do not meet the above criteria will be excluded.
Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome

The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in subjects with Restless Legs Syndrome (RLS).

This was a multicenter, randomized, double blind, placebo controlled, parallel group study, comparing 4 doses of GEn (XP13512) with placebo given once daily to subjects with RLS. Eligible subjects were randomized in equal numbers into 1 of 5 treatment groups (GEn 600 mg, 1200 mg, 1800 mg, or 2400 mg or placebo) for 12 weeks of treatment. Data from this study will be utilized as part of a larger pharmacokinetic (PK) pharmacodynamic (PD) analysis of data from several studies (XP084/RXP111495) that are part of the GEn RLS clinical development program. Safety and tolerability were also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men or women at least 18 years of age
* RLS, based on the IRLSSG Diagnostic Criteria
* History of RLS symptoms occurring at least 15 nights in the month prior to Screening or, if on RLS treatment, this frequency of symptoms must have been applicable prior to start of treatment
* Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights
* Total RLS severity score of 15 or greater on the IRLS Rating Scale
* If taking dopamine agonists, gabapentin, or other treatments for RLS (e.g., opioids, benzodiazepines) medications must have been discontinued at least 2 weeks prior to Screening;
* If taking any prescription medication, therapy must have been stabilized for at least 3 months prior to Screening with no anticipated changes for the duration of the study;
* Body Mass Index (BMI) of 34 or below
* estimated creatinine clearance of at least 60 mL/min

Exclusion Criteria:

* a sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
* history of RLS symptom augmentation or end of dose rebound with previous dopamine agonist treatment
* neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesias, and dystonias);
* other clinically significant or unstable medical condition or conditions which could affect RLS treatment efficacy assessments
* serum ferritin level below 20 ng/mL
* currently suffering from moderate or severe depression using the Diagnostic and Statistical Manual of Mental Disorders and Treatment IV (DSM IV TR)
Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease

This project involves the use of oral Lactobacillus reuteri as an adjunct therapy for 8 weeks. Endoscopic observation of intestinal inflammation will be conducted at 1 month, 3 months, 6 months, and 12 months after the administration of the drug. Intestinal fluid will be collected endoscopically for 16S RNA analysis to assess changes in the gut microbiota. Inflammatory changes in the patients will be detected through peripheral blood tests, and fecal calprotectin levels will be measured to evaluate the progression of the disease.


Eligibility Criteria:
Inclusion Criteria:

1. Be over 18 years old
2. Agree to sign informed consent; Have been diagnosed with IBD for at least 3 months but not more than 3 years -

Exclusion Criteria:

1. Does not meet the diagnostic criteria of CD
2. Patients with other autoimmune diseases, infectious diseases and malignant tumors Patients with CD during pregnancy and lactation; Patients with serious diseases of the liver, kidney, heart and lung, etc
3. Patients with allergic diseases such as asthma and allergic rhinitis; alcoholic Patients with mental illness
4. Patients with suspected cancer in their intestines
5. Antibiotics, probiotics and prebiotics have been used in the past three months Had intestinal surgery (except appendicitis surgery)
6. There is currently an infection
7. He has had cancer in the last 5 years -
The Role of Natural Killer, Complement and T-lymphocytes in COVID-19 Disease, a Prospective Monocentric Study

The current study is an open, non-randomized, monocentric, and interventional study. CoViD-19 patients will be recruited at UZ Brussel after informed consent is obtained. Whole blood and serum samples will be collected during acute disease (inclusion and 7 days after inclusion) and during patient follow-up at 2 months after infection.

Sample storage and subsequent use in fundamental research will be performed at VUB Neuro-Aging and Viro-Immunotherapy.

Additionally, medical records of UZ Brussel will be searched and epidemiological, clinical, radiological, and biological data of the selected patients will be obtained at the diagnosis time point and during follow-up.

Healthy volunteers will be recruited as well in the current study, as a comparison arm, after informed consent is obtained.


Eligibility Criteria:
Covid-19 patients

Inclusion Criteria:

* Positive nasopharyngeal reverse transcriptase-polymerase chain reaction for SARS-Coronavirus-02
* Signed inform consent

Healthy Volunteers

Inclusion Criteria:

* Signed inform consent
Evaluation of the "Intranasal Fentanyl" Protocol in Pediatric Surgical Emergencies at Strasbourg University Hospital

Emergency trauma departments receive thousands of patients each year whose main symptom is pain. In recent years, intranasal fentanyl (FIN) has entered the therapeutic arsenal to treat pain in the emergency department. Various studies have validated its effectiveness for musculoskeletal pain as well as its tolerance and safety of use. Since then, new protocols have been implemented including this treatment. In This study, the investigators propose to retrospectively study the quality of prescription of intranasal fentanyl in the treatment of pain in the emergency department and the quality of monitoring of this treatment in current practice.


Eligibility Criteria:
Inclusion Criteria:

* Child \< 18 years old
* Child treated in the pediatric emergency department of Strasbourg University Hospital
* Child who has benefited from intranasal fentanyl between 08/01/2022 and 09/31/2024.
* Child (and/or his/her parental authority) who has not expressed, after information, his/her (their) opposition to the reuse of his/her health data for the purposes of this research.

Exclusion Criteria:

* Refusal of the child (and/or his/her parent) to participate in the study
* Patient's medical file not incomplete
* Child not domiciled in France.
Endoscopy Needs of People in Suichang County, Lishui City, Zhejiang Province, China

With the improvement of people's health awareness, more and more people realize the importance of endoscopy. Compared with other imaging methods (such as gastrointestinal contrast, abdominal ultrasound, CT, MR, nuclear medicine, etc.), in addition to the diagnosis of diseases, endoscopy also has obvious advantages in obtaining specimens for further pathological examination. However, the pain and discomfort caused by endoscopy have discouraged many people and even missed the opportunity for early diagnosis. At present, painless endoscopy can improve this kind of situation, but everyone has various doubts about it. In order to accurately understand and grasp the needs of people in Suichang County for gastrointestinal endoscopy, so as to better carry out gastrointestinal endoscopy/screening/diagnosis and treatment work in the future, we designed this demand survey.


Eligibility Criteria:
Inclusion Criteria:

* All people who come to the endoscopy center for gastrointestinal endoscopy, as well as those who may have gastrointestinal endoscopy in outpatient clinics, ward patients and other social groups, and are willing to participate in the questionnaire survey.

Exclusion Criteria:

* People who cannot cooperate, are unconscious, or who are unwilling to participate in questionnaire surveys.