cyrilzakka/clinical-trials huggingface dataset:
Post-Surgical Mediastinitis Within the CHU Brugmann Hospital

Mediastinitis is an infectious complication that can occur after cardiac surgery. The incidence varies between 1 and 3% depending on the type of procedure and the patient's condition. The mortality of this severe postoperative complication rises from 10 to 35%, which makes it dreadful.

The major risk factors reported are obesity, diabetes, and immunosuppressive therapy. There are other less important ones: age, coronary bypass grafting (especially if using the two internal mammary arteries), nosocomial pneumonia, dialysis, prolonged mechanical ventilation, long operative asepsis, undrained retro-sternally hematoma, prolonged pre-operative hospitalization...).

Prevention is very important. The principle of asepsis must absolutely be respected. The use of prophylactic antibiotic therapy is recommended.

The most commonly encountered organisms are Staphylococcus aureus, coagulase-negative Staphylococci and gram-negative bacilli.

There are several treatment modalities that vary between centers and may be different depending on the surgical team's experience and the depth or extent of the infection. The common principles of these treatments are: antibiotic therapy and surgical debridement (the timing of which may vary). The timing and modalities of wound closure are subject to variations: immediate sternal closure with placement of multiple or delayed drains. Muscle flaps or large omentum transplant may be necessary if tissue loss is too important.

The investigators propose to review their experience in the treatment of cardiac post-surgery mediastinitis at Brugmann University Hospital in the last 20 years in both adult and pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* post-cardiac surgery mediastinitis
* patients of the CHU Brugmann (adults) and HUDERF (pediatric) Hospitals

Exclusion Criteria:

- none
A Dose Escalation Study of NanO2 in Patients with Mild Respiratory Distress

EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study.


Eligibility Criteria:
Inclusion Criteria:

* Requiring supplemental oxygen but ≤ 6L oxygen by nasal cannula to maintain an oxygen saturation \>92% or PaO2 \>60mmHg
* Admitted to a hospital with symptoms of mild RD
* Signed informed consent obtained from the subject or subject's legally authorized representative
* Agrees to not participate in another clinical trial for the treatment of mild RD through Day 28

Exclusion Criteria:

* Presence of extracorporeal membrane oxygenation
* Unstable hypertension
* History of significantly impaired renal function defined as an eGFR ≤ 30mL/min/1.73m2 (MDRD equation or similar) or impaired hepatic function defined as the presence of decompensated cirrhosis (acute deterioration in liver function characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage)
* Presence of pulmonary embolism at baseline
* Evidence of right ventricular heart failure
* Unstable hemodynamically as defined by receiving 0.5μg/kg/min or greater norepinephrine
* Inability to comply with the study procedures
* Currently pregnant or breastfeeding
* Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 48 hours
* History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion
Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

Infantile hypertrophic pyloric stenosis (IHPS) is the most common condition for surgical treatment in infant. Traditionally, laparoscopic or open pyloromyotomy are the standard treatments. However, because of severe dehydration, electrolyte disturbance, and malnutrition, these patients have lower tolerance about surgery and recover more slowly than usual. We are going to study the per-oral pyloromyotomy (POP), also named as gastric per-oral endoscopic myotomy (G-POEM), which showed promising results for adult gastroparesis, for a novel application of treating IHPS.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pyloric stenosis with or without sonographic confirmation.

Exclusion Criteria:

* Comorbid conditions that could affect postoperative recovery.
* Needed an additional procedure during the same anaesthetic.
Tracking Service Use and Outcomes II:First Episode Psychosis and Psychotic Disorders Clinic

Main Research questions:

1. Who are the patients referred for treatment at the Psychotic Disorders Clinic?
2. What are the outcomes from treatment for first episode psychosis in multiple outcome domains?
3. What hospital resources are used over the early course of the illness?
4. How satisfied are patients and family with the treatment and services they received? This is an important study that will help us evaluate the service and treatment offered by the Psychotic Disorders Clinic's specialized early intervention program,which helps young people experiencing early stages of psychotic illness.A growing body of evidence suggests that intervening earlier in the course of the illness with specialized and complimentary pharmacological and psychosocial treatment may be associated with improved outcomes.

The project is primarily a descriptive study of individuals experiencing their first episode of psychosis presenting at the Psychotic Disorders Clinic/Early Intervention Program.

The objectives of the study are:

1. Track multi-dimensional outcomes within the program
2. Track service use
3. Compare outcomes for this early intervention program with outcomes noted in published follow up studies
4. Evaluate effectiveness of the Psychotic Disorders Clinic in improving outcomes for persons experiencing their first episode of psychosis

Eligibility Criteria:
Inclusion Criteria:

* male or female between ages of 16 to 50 years of age
* capable of providing informed consent
* receiving treatment voluntarily
* experiencing a "first episode of psychosis" defined as the first episode of illness and where the subject,at presentation,meets DSM-IV criteria for one of the following diagnoses:schizophrenia,schizophreniform disorder,schizoaffective disorder,brief psychotic disorder,delusional disorder,and psychosis NOS

Exclusion Criteria:

* primary diagnosis of mood disorder
* diagnosis of substance-induced psychosis
* diagnosis of psychosis due to a general medical condition
* diagnosis of mental retardation
* diagnosis of developmental disorder
* has received antipsychotic treatment for greater than 1 month
* has received treatment for an earlier episode of psychosis from which there has been a remission of symptoms for greater than 3 months
Comparison of Image Based Robotic Total Knee Arthroplasty Vs Imageless Augmented Reality Assisted Total Knee Arthroplasty

This study compares the accuracy of two different techniques in placing a total knee replacement. In one technique, accurate instrument placement is facilitated by a robot, and in the other technique, augmented reality is used for correct instrument placement. Both surgical techniques are already commonly used. During both the robotic technique and the augmented reality technique, the additional information (angles - axes) obtained during the operation is used to optimize the placement of the various prosthesis components.

Patients that were recently diagnosed with advanced osteoarthritis of the knee can participate in this study. This means that the cartilage of the knee is affected by wear and tear. This causes pain, stiffness and swelling resulting in reduced mobility. When non-operative treatments are insufficient in treating the osteoarthritis, surgery is proposed wherein a knee arthroplasty is performed.

The goal of this study is to further optimize and personalize patient care. Additionally, the aim of the study is to investigate whether both techniques are equivalent in optimally placing the prosthesis and whether both techniques lead to comparable results.


Eligibility Criteria:
Inclusion Criteria:

* Subjects from 18 years up to 85 years old
* Patients eligible and planned for a primary Total Knee Arthroplasty
* Patients willing to sign the informed consent form (ICF) for participating in this study
* Indication of surgery is primary osteoarthritis

Exclusion Criteria:

* Revision knee surgery
* Other medical conditions contributing to the rehabilitation process of the TKA according to the surgeon, such as Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident
* The patient received a TKA within the last three months or has a TKA planned in the next three months, for the contralateral knee
* Patient is participating in another clinical trial
* Patient is not able to understand Dutch, French or English
* Patients who did not meet all of the inclusion criteria
SGLT2 Inhibitors in Treating Patients with PCOS

Chronic inflammation is the core of Polycystic ovary syndrome (PCOS), and obesity and overweight further exacerbate the level of inflammation in the peripheral circulation and ovarian tissue in PCOS patients. Metformin is a classic endocrine drug for the treatment of PCOS, but its clinical response rate is only about 40%. Our previous published study (Diabetes Obes Metab, 2022) observed that the new hypoglycemic drug SGLT-2 inhibitor can significantly improve the clinical symptoms of patients with insulin resistance PCOS, and the clinical efficacy is not inferior to metformin, but its specific mechanism of action is not clear. Recent studies have shown that SGLT-2 significantly attenuates the activation of the Nod-like receptor protein 3 (NLRP3) inflammasomes and the secretion of IL-1β in patients with type 2 diabetes mellitus at high risk of cardiovascular disease. Based on the above research background, this project will combine clinical research and mechanism exploration to solve the following two problems:

1. whether SGLT2 inhibitor can further improve the clinical efficacy of PCOS patients compared to metformin;
2. mechanistic studies further clarify whether SGLT2 inhibitors improve inflammatory symptoms by modulating NLRP3 inflammosomes in the treatment of polycystic ovary syndrome;

This clinical study is a prospective, single-center, randomized (1:1) controlled clinical study. The enrollment population is overweight or obese PCOS patients. After signing the informed consent form, patients who meet the inclusion/exclusion criteria will be randomly assigned to the experimental and control groups for treatment in a 1:1 ratio, for a total of 108 patients enrolled.

Subjects randomized to the trial group will receive SGLT-2 inhibitors for 24 weeks.

Participants randomised to control will receive metformin for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 18-45
* Meet Rotterdam criteria
* BMI≥20kg/m2

Exclusion Criteria:

* Treatment with any additional medications that might impede the trial, including GLP-1 RAs, metformin, pioglitazone, contraceptives, or traditional Chinese medicine within the past 3 months
* Pregnancy or lactation
* Mental illness
* Malignant tumors
* Chronic kidney disease or severe liver dysfunction
* Inflammatory bowel disease
* Involvement in other research programs within the past 3 months
Arthroscopic Midcarpal Wrist Arthrodesis: Clinical and Functional Outcomes

All cases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist fusion with cannulated screws from January 2015 to December 2017 will be reviewed.

The union rate and time to union will be recorded following the standard radiological postoperative control. Wrist assessments performed pre- and postoperative regarding strength, range of motion and pain will be analysed. Complications will be recorded as well.

Participants will be recruited for wrist assessment. They will be asked to fill out questionnaires about the functional result related to their quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. All the patients suffered from traumatic or degenerative mid-carpal wrist arthritis or instability and treated surgically with arthroscopic midcarpal wrist arthrodesis in the Division of Plastic Surgery and Hand Surgery University Hospital Zürich from January 2015 to October 2017 will be included.
2. Signed informed consent for participation in the study and for further use of collected data.

Exclusion Criteria:

1. Missing Informed consent
Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)

The SPERA trial is designed to 1. provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited cytotoxic chemotherapy regimens for metastatic disease and 2. to evaluate the safety of oral satraplatin in this patient population.

\*\*\*\*\*UPDATE\*\*\*\*\* On October 30th, 2007 GPC Biotech announced topline overall survival results for the Phase III trial in hormone refractory prostate cancer-Satraplatin and Prednisone Against Refractory Cancer (SPARC) trial.

The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The companies reported that the trial did not achieve the endpoint of overall survival (p=0.80, stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The companies are currently conducting pre-specified subset analyses.

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic(Stage D2)prostate cancer
* Progression after unlimited prior cytotoxic chemotherapy regimens
* ECOG Performance status equal/less than 2
* Surgical or medical castration
* Adequate bone marrow, liver, and renal function
* Informed consent
* Patients treated with bisphosphonates prior to entry are eligible and should continue bisphosphonates therapy while on this trial

Exclusion Criteria:

* Serious concurrent uncontrolled medical disorder
* Malignant disease requiring on-going therapy
* Prior significant RT/radionuclide therapy
* Major GI surgery or GI disease affecting absorption
* Disease where corticosteroids are contraindicated
* Brain metastases
* Poorly-controlled or uncontrolled insulin-dependent diabetes
The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus

This study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of OLP (Presence of painful and atrophic-erosive oral Lesions, bilateral, mostly symmetrical lesions, presence of lace-like network of slightly raised white lines).
2. Age between 30-60 years
3. Ability to complete the present clinical trial.

Exclusion Criteria:

1. Pregnant or breast feeding women (pregnancy test for women of child bearing age).
2. Lichenoid reactions caused by certain drugs or dental amalgam.
3. Therapy for oral lichen planus (OLP) in the 6 months prior to the study.
4. Patient doesn't have hepatitis C \[after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2
5. Presence of candidiasis before treatment.
6. Patients with pre-existing diabetes or an initial random glucose level exceeding 200 mg/dL before initiating steroid therapy were excluded.
7. Hypertensive patients
8. Contraindications for corticosteroid use (immunodeficiency or severe heamatological alterations).
Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.


Eligibility Criteria:
Inclusion Criteria:

18 to 75 years old Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, silent ischemia or myocardial infarction（≥1month） .

Reference vessel diameter ≥3.0 mm, and \<4.5mm. Lesion length of ≤20 mm Written informed consent

Exclusion Criteria:

Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction Cardiogenic shock (systolic arterial pressure \<90mmHg), congestive heart failure (NYHA=4，EF≤35%) Severe valvular heart disease Life expectancy no more than 1 year or factors causing difficulties in clinical follow up Intolerance to aspirin and/or clopidogrel, ticagrelor Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy Leukopenia or thrombopenia A history of peptic ulcer or GI bleeding in the previously Stroke within 6 months prior to the operation A history of severe hepatic or renal failure Stents covering a major side branch (≥2.5 mm need to intervention) Left main lesion Graft lesion Aortic-coronary ostial lesion In-stent restenotic lesion Chronic total occlusion Severe calcified lesions. Visible angiographic thrombus
The Effect Of Pulsed Electromagnetic Field And Progressive Resistance Exercise On Knee Osteoarthritis

The purpose of this study is to investigate the effect of pulsed electromagnetic field and progressive resistance exercise on Knee Osteoarthritis. It is experimental research study that look at the additive effect of pulsed electromagnetic field and progressive resistive exercise on pain level, patient-reported and performance-based physical function and Quality of life for patients with knee osteoarthritis

Background: osteoarthritis is the main cause of disability in elderly population.\[1,2\] It affects almost one third of individuals aged 65 and older and approximately 25% of osteoarthritis patients 60 years and older cannot perform activities of daily living.\[3\] The clinical symptoms that lead to disability in Knee osteoarthritis are more frequent than all other joint complaint.

A large body of evidence exists proving the beneficial effects of progressive resistance exercise (PRE) in patients with knee osteoarthritis (OA).\[4,5,6\] Pulse electromagnetic field(PEMF) is a physical therapy modality that could be used for treating knee osteoarthritis (OA) and there emerging evidence suggesting its beneficial effect in reducing pain and improving function for knee osteoarthritis (OA)\[7\] The purpose of the study is to examine the effectiveness of using pulsed electromagnetic field (PEMF) with progressive resistance exercise (PRE) training in decreasing pain level ,improving physical function, and improving quality of life in patients with Knee osteoarthritis (OA) A small randomized control trial conducted to recruit 32 patients with knee osteoarthritis (OA). Participants with knee osteoarthritis (OA) as defined by American College of Rheumatology recruited from Prince Basma Educational Hospital. Eligible patients were randomly assigned to receive 24 sessions (3 sessions/week for 8 weeks) of either the combined (PRE and PEMF) treatment or PRE only. Participants will be evaluated at baseline, after the end of treatment protocol (8 weeks), and at 3 and 6 months follow up. Mixed ANOVA and repeated measure ANOVA will be used to evaluate the differences between groups in pain, and physical function, and quality of life

Eligibility Criteria:
Inclusion Criteria:

* 40 year-old and above
* Diagnosed with unilateral or bilateral knee OA

Exclusion Criteria:

* Patients with current or previous knee surgeries
* Inflammatory arthritis's (rheumatoid arthritis, gout, etc.)
* Alzheimer disease
* Parkinson disease
* Unable to walk unaided for 6 months

To maximize the efficiency of our experiments we excluded patients if they:

* Have participated in progressive resistance training or received pulsed electromagnetic field treatment in the prior year
* Exercise regularly more than once a week.
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function

The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis
2. Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg
3. Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications

Exclusion Criteria:

1. Women who are pregnant, nursing or women of childbearing potential
2. Subjects with acute renal disease.