cyrilzakka/clinical-trials huggingface dataset:
Effects of Traumeel®S Tablets on Recovery and Inflammatory Immune Response After Repeated Bouts of Exercise

To investigate and compare the effects of Traumeel®S tablets versus placebo on recovery and inflammatory immune response over a period of 72 hours after a second bout of strenuous concentric exercise on bicycle (exercise #2).


Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age ≥ 18 and ≤ 40 years
* BMI ≥ 18.5 and \< 27,5 kg/m2 (WHO standard for normal range BMI)
* Maximum relative oxygen uptake (VO2max) \< 53 ml/kg x min
* General state of good health
* Non-smoker
* Medically approved unrestricted participation in sports as shown by diagnostic performance test conducted on treadmill no longer than 3 months prior to study entry
* Willingness to provide signed informed consent

Exclusion Criteria:

* Weekly training volume ≥ 6 hours
* Use of dietary supplements (incl. high-dosed vitamins and minerals)
* Chronic immune deficiency
* Current infection
* Heart and/or circulation disorders
* Abnormal findings on exercise ECG
* Musculoskeletal disorders
* Any current clinical condition that requires systemic treatment or might have an impact on study objectives
* Hypersensitivity to botanicals of the Compositae family (e.g. Echinacea)
* Lactose intolerance
* Illicit drug or alcohol abuse
* Participation in another clinical trial within 4 weeks prior to study entry
Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix

The purpose of this study is to evaluate the soft tissue clinical results in patients that received, or not, a soft tissue augmentation around dental implant inserted immediately after the extraction.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determinate eligibility for study entry. Patients who meet eligibility requirements will be randomized in this single blinded(investigator) study.

Group (Test) will receive immediate implant after extraction and a soft tissue augmentation with a collagen matrix.

Group (Control) will receive only immediate implant after extraction without soft tissue augmentation.

Eligibility Criteria:
Inclusion Criteria:

- Presence of a single failing tooth in the esthetic region (second premolar to contralateral second premolar), the adjacent teeth should be present and without any dental pathologies.

Exclusion Criteria:

* Patients who are heavy smokers (more than 10 cigarettes/day);
* Patients who suffer from any systemic diseases that could negatively influence wound healing;
* Patients who received head and neck radiation treatment;
* Patients who have a full contraindication to implant surgery;
* Patients who have uncontrolled periodontal disease;
* Patients who show a full mouth plaque and bleeding score higher than 25%;
* Patients who have deficient extraction sockets according to the classification of Juodzbalys et al. 2008.
* Patients with known allergy, sensitivity or intolerance to collagen
* Patients who are pregnant or who are breastfeeding
EPO for Postop Delirium in Elderly Patients

Postoperative delirium is a common complication after surgery. The underlying pathophysiology of this complication is unclear, however neuroinflammation and oxidative stress secondary to surgery had shown to be the cause of postoperative cognitive dysfunction and delirium. Erythropoietin represents non-erythropoietic effects of anti-inflammatory properties. The aims of this study were to determine the role of erythropoietin toward the development of postoperative delirium, in terms of changes in inflammatory reaction by affecting the innate immunity in elderly patients undergoing total joint arthroplasty surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and older
* Patients scheduled for elective total knee arthroplasty, total hip arthroplasty

Exclusion Criteria:

* Unable to communicate
* Cognitive impairment
* Unable to pre-screen delirium due to underlying central nervous system disease
* History of hypersensitivity related to erythropoietin and other anesthesia-related drugs
* History of myocardial infarction, pulmonary infarction, cerebral infarction, ischemic vascular disease, epilpesy, chronic liver disease, chronic kidney disease
* Uncontrolled high blood pressure
* Within one month of starting anti-hypertensive medication
Feasibility Study of Take-Home LAAM Medication - 3

The purpose of this study is to test therapeutic benefits of take-home LAAM. (1) Do subjects with take-home LAAM availability show increased clinical responsibility over subjects without; (2) Do subjects with take-home LAAM attempt diversion when random recall and other diversion safeguards are used; (3) Does treatment response correlate with background or drug use variables at intake, discharge, or during treatment?

1-Year study, participant will be randomly assigned to one of two groups: One will have the opportunity to earn take-home doses by turning in a designated number of clean urines. Two will not have the opportunity to earn take-home doses. Clinic visits three times per week. Urine sample given at each visit.

Eligibility Criteria:
Inclusion Criteria:

meets DSM-IV criteria for opiate dependence. M/F, 18 years or older. Certified for LAAm treatment by a physician. Able to understand english. Willing to provide names, addresses, and numbers of 3 relatives who can aid in patient location for follow-up visits.

Exclusion Criteria:

Hypertensive to LAAM. Pregnant or nursing women. Female of childbearing potential who refuses to use an acceptable form of birth control. Clinically significant abnormality in hematology, blood work, or UA, ETOH and/or sedative/hypnotic dependence according to DSM-IV criteria. Medical or psychiatric illness which would jeopardize safe study participation.
A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.

The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.


Eligibility Criteria:
Inclusion Criteria:

1. The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；
2. Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
3. Documentation of CD19/CD22 tumor expression

3. Liver, kidney, lung and heart function meet requirements; 4. Expected survival \>3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion.

-

Exclusion Criteria:

1. Active CNS involvement by malignancy；
2. Isolated extramedullary leukemia recurrence；
3. Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
4. Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.

4. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab.

7. Other situations deemed inappropriate for participation in this study by the investigator.

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Comparison With Observational Methods and Performance Assessment From Real-life Experience of Closed-Loop Insulin Delivery Systems

This study aims to compare glycemic control obtained under closed loop depending on the system : Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1.

Since 2021, several closed-loop insulin delivery systems have been reimbursed in France for patients living with type 1 diabetes. The "real-life" efficacy and safety of these systems have already been the subject of several publications, confirming the results of clinical trials.

To date, there are no clinical trial comparing closed-loop systems. There are, however, a few observational studies that have attempted such a comparison, but with few patients included or a poorly adapted methodology.

Given the size of the cohort of patients with type 1 diabetes fitted with a closed-loop system in the diabetology department of the Centre Hospitalier Sud-Francilien since 2021 (\> 400), we propose a single-center analysis to compare real-life performance of Smartguard (Medtronic 780) versus Control IQ (Tandem) in patients with diabetes type 1 during a follow-up of 12 months and using a propensity score

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 16 years
* Patient with diabetes type 1.
* Patient treated with a CONTROL-IQ or SMARTGUARD closed-loop insulin delivery system between 01/2021 and 05/2022.
* Follow-up patient in Centre Hospitalier Sud Francilien

Exclusion Criteria:

* Women who had pregnancy within 12 months of system initiation.
* Patient who have been treated with both systems within 12 months.
* Patient or parental authority objecting the use of data
A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers

This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger
* Female subject is postmenopausal
* Subject is within 20% of ideal body weight
* Subject is a nonsmoker

Exclusion Criteria:

* Subject has multiple or severe allergies to food or medications
* Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates
* Subject has any infections, including HIV
* Subject consumes excessive amounts of caffeine or alcohol
* Subject has donated blood or taken another investigational drug in the last month
* Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug
Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer

The incidence of rectal cancers is at 15,000 new cases per year in France of which 10 to 15% are locally advanced (T4bNxM0) at the moment of diagnosis. The rate of invaded resection margins (R1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. The invasion of the resection margins triples the risk of local recurrence. In the absence of surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative resection. The care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a difficult therapeutic problem with great variability in the methods of care and management around the world. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. With regards to the organization of its healthcare system, Australia is shown to be a leader as regards the care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer.

This research project rests on the comparison between two contrasting countries with regards to the care management of PRC-bTME (Primary rectal cancer beyond total mesorectum excision planes) and LRRC (Locally recurrent rectal cancer), France and Australia. Regarding its healthcare system for patients with PRC-bTME and LRRC, Australia equipped itself with a veritable policy of centralisation and clinical pathway, appearing as an international referent country in this surgical field.

The main hypotheses of research are that these differences rest on individual and collective representation of disease, organisations, structures, clinical pathway and care management.

Benchmarking of clinical practices is a process that consists of a structured comparison and the sharing of good practices of clinical care; it is based on a quality of care assessment and allows to fit into an approach of continuous improvement of this quality of care.

Eligibility Criteria:
Inclusion Criteria:

* Patients operable and/or capable of receiving a radiotherapy and/or a chemotherapy
* Patients in care in the French and Australian centres participating in the study

Exclusion Criteria:

* Patients suffering from primitive rectal cancer at a stage inferior to T4b
* Patients suffering from primitive locally-advanced metastatic rectal cancer (T4NxM1)
* Patients suffering from recurrence of metastatic rectal cancer
* Patients having been refused a surgical procedure because of one or multiple comorbidities
Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry

The INSIGHT ('Insight into Real-world Practice of Management of HCC in Asia-Pacific') registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with HCC between 1st January 2013 and 31st December 2019 in nine countries (i.e., South Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore). Approximately 30% of the sample size will be identified retrospectively and 70% will be identified prospectively from the start date of the registry (October 2016), with an even distribution of consecutively diagnosed patients within the different years.


Eligibility Criteria:
Inclusion Criteria:

* Female or male aged 21 or above.
* Patient with confirmed diagnosis of HCC between 1st January 2013 and 31st December 2019 based on one or more of the following criteria:

  * American Association for the Study of Liver Diseases (AASLD) criteria
  * Asian Pacific Association for the Study of the Liver (APASL) criteria
  * Histology/cytology
  * Space occupying lesion in the liver and an serum alpha-feto protein of \> 400 ng/mL in a patient with chronic viral hepatitis or cirrhosis from any cause
* Informed consent form (ICF) to be presented and signed by patients who are still alive at the point of study enrolment, per local regulations. For the collection of data for deceased subjects, appropriate waiver of consent as per local regulations and guidelines will have to be in place.
* Patient who is being followed-up at the participating site.

Exclusion Criteria:

- Patients participating in any HCC-related therapeutic/interventional clinical trial.
Effects of Carotid Stent Design on Cerebral Embolization

The goal of the proposed study is to contrast the relative efficacy of closed-cell stents versus open-cell stents in preventing periprocedural cerebral embolization in high-risk patients with symptomatic and asymptomatic extracranial carotid stenosis undergoing carotid artery stenting (CAS).

Stroke is responsible for more than 10% of all deaths and much severe disability in developed countries. In the United States, approximately 600,000 new strokes are reported annually, of which 150,000 are fatal, and more than 4,000,000 surviving stroke victims are affected by significant disability. Seventy-five percent of strokes occur in the distribution of the carotid arteries and are considered of a thromboembolic etiology, most of which originate in carotid lesions. Carotid artery stenting (CAS) with cerebral embolic protection is currently the preferred treatment of carotid stenosis in high risk surgical patients, i.e., those with significant comorbidities or a hostile neck from previous surgical procedures or radiation. Although several predictors of adverse outcomes after CAS have been identified, the effects of device characteristics, including stent design, on neurologic adverse events have not been established.

The proposed study will be a randomized prospective controlled trial designed to test the hypothesis that the implantation of closed-cell stents for carotid lesions in high-risk patients will be associated with a reduced perioperative cerebral microembolization, as detected by transcranial Doppler and diffusion-weighted magnetic resonance imaging of the brain, and reduced 30-day stroke, myocardial infarction, and death rates when compared with the implantation of open-cell stents.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at high risk for carotid endarterectomy due to either anatomic or co-morbid conditions; AND
* Symptomatic patients (TIA or non-disabling stroke within 6 months of the procedure), with carotid stenosis ≥ 50% as diagnosed by angiography, using NASCET methodology (50); OR
* Asymptomatic patients with carotid stenosis ≥ 80% as diagnosed by angiography, using NASCET methodology

Exclusion Criteria:

* Conditions that interfere with the evaluation of endpoints
* Subject has anticipated or potential sources of cardiac emboli
* Subject plans to have a major surgical procedure within 30 days after the index procedure.
* Subject has intracranial pathology that makes the subject inappropriate for study participation.
* Subject has a total occlusion of the ipsilateral carotid artery (i.e., CCA).
* Severe circumferential lesion calcification that may restrict the full deployment of the carotid stent.
* Carotid stenosis located distal to the target stenosis that is more severe than the target stenosis.
Latiglutenase as a Treatment for Celiac Disease

Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in Patients with Well-Controlled Celiac Disease

This is a phase 2, single-center, prospective, randomized, double-blind, placebo-controlled, study in patients with well-controlled celiac disease. Patients with confirmed CD diagnosis (biopsy) will be recruited to participate in the study. Informed consent must be obtained prior to performing any screening procedures. Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the screening period. Patients that fail to meet screening period eligibility will be discontinued from study participation at Visit 2. At Visit 2, eligibility will be confirmed, adverse events will be documented at Visit 2. Patients who continue to meet eligibility requirements at Visit 3 will begin the next treatment phase. During the treatment phase patients will self-administer treatment and gluten daily with their evening meal. At the end of the treatment period, Visit 4, patient eligibility will be confirmed and adverse events will be documented. The final visit, Visit 5, will be a safety follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed CD diagnosis
* Self-reported adherence to a gluten-free diet for ≥ 12 months
* Agree to maintain dosing of approved prescribed and OTC medications
* Willing to take study treatment with evening meal during any single day
* Willing to take gluten foodstuff with evening meal during any single day
* Willing to maintain GFD for entire study duration
* Willing to agree to minimal ingestion outside of three main daily meals
* Willing and able to comply with all study procedures
* Access to the internet via smartphone, tablet, computer or equivalent to facilitate daily symptom reporting
* Must sign informed consent

Exclusion Criteria:

* Active dermatitis herpetiformis at the time of screening
* IBS (Irritable Bowel Syndrome)
* History of any form of colitis
* Received any systemic biologics (such as monoclonal antibodies or other protein therapeutics where the half-life overlaps with the study start) within 6 months prior to study start
* Taking any oral probiotic supplements (not including probiotics contained in commercially available food preparations) 6 months prior to entry
* Use of any immunosuppressive medications (i.e., for chronic treatment of autoimmune disease or transplant-rejection prophylaxis) 6 months prior to entry
* History of alcohol abuse, illegal drug use
* Unwilling to practice highly effective birth control (unless surgically sterilized or post-menopausal)
* Received any experimental drug within 30 days of randomization, in the case of experimental biologics at least 6 months prior to randomization
* Uncontrolled complications of celiac disease, which, in the opinion of the investigator, could affect immune response or pose an increased risk to the patient
* Inability to give informed consent
* Any medical condition, other than celiac disease, which, in the opinion of the investigator, could adversely affect the patient's participation in the trial.
A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223

The aim of this non interventional study is to describe the proportion of Belgian mCRPC patients which were treated with 1 to 4 and 5 to 6 Radium-223 injections and the patient characteristics which are potentially associated with this proportion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases
* All consecutive patients who started Radium-223 treatment between 22 December 2014 and 01 June 2017
* Availability of medical records during the observation period (22DEC2013 - 01JUN2018)

Exclusion Criteria:

* Patients treated with Radium-223 for any reason before 22 December 2014 (for example an interventional trial)
* Patients participated in an investigational program with interventions outside of routine clinical practice during the radium-223 treatment period
* Patients received other radiopharmaceuticals for the systemic concomitant use for treatment of prostate cancer or for other use during the Radium-223 treatment period
Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium

Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia. Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients. Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. The investigators hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard.

Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. We hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard

Eligibility Criteria:
Inclusion Criteria:

* age \> or = 18 years
* hospitalised in ICU
* tracheal intubation using a polyvinyl chloride tube and mechanical ventilation
* predictable mechanical ventilation \> or = 6 hours after inclusion
* enteral nutrition by a nasogastric tube

Exclusion Criteria:

* refuse to participate to the study
* no informed consent
* pregnant
* contra-indication for enteral nutrition
* tracheotomy
* intubation or re-intubation done in 6 hours preceding the inclusion