cyrilzakka/clinical-trials huggingface dataset:
A Feasibility Randomised Controlled Trial of Early Vitrectomy for Post-operative Exogenous Endophthalmitis

This randomised clinical trial will explore the feasibility and acceptability of carrying out early vitrectomy surgical treatment compared to standard treatment in acute endophthalmitis. We will investigate the effectiveness of early vitrectomy plus intravitreal antibiotics compared to standard care intravitreal antibiotic injections in the management of postoperative exogenous endophthalmitis. This is a feasibility trial that will evaluate the expected effect size with which to inform the design of a definitive randomized trial of this question.

The EVIAN Study is a multicentre, feasibility, randomised controlled trial to evaluate the effect of early vitrectomy surgery on acute endophthalmitis.

Patients with postoperative exogenous endophthalmitis following any ocular surgery/procedure/injection intervention will be recruited at 48 hours following initial presentation.

Patients with vision of 35 ETDRS letters or better are ineligible for the trial, and would continue on standard of care management. Patients with vision of worse than 35 ETDRS letters will be eligible for the study. At the 48-hour time-point, eligible patients will be randomised in a 1:1 ratio.

The treatment group will undergo vitrectomy within 48 hours of randomisation. The control group will have continued intravitreal antibiotic eye injections according to local protocols. If the vision reaches perception of light, then a vitrectomy surgery would be considered as part of standard of care at 12-15 days. Follow up will be for 6 months in both groups.

Visual acuity, funds photography, B-scan ultrasound, and optical coherence tomography (OCT) scanning will be performed from baseline until the final follow-up at 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The patient over 18 years of age
* Patient has capacity to give informed consent
* Patient has not previously been enrolled in this study in regards to their other eye
* Diagnosis of postoperative endophthalmitis at any time-point following an ocular surgery/procedure/injection
* Patient is healthy to undergo vitrectomy surgery
* Symptomatic Visual loss attributable to POE
* Best corrected visual acuity worse than 35 ETDRS letters, including CF, HM and POL vision

Exclusion Criteria:

* Patient suffered a major thromboembolic event within the past 3 months as (defined as TIA, Stroke, or MI)
* Known adverse reaction to intravitreal antibiotics (amikacin/vancomyin/cephalosporins)
* Blood pressure greater than 200 systolic or 100 diastolic
* Any other condition that in the opinion of the investigator would preclude participation in the study (such as unstable medical status or severe disease that would make it difficult for the patient to be able to complete the study)
* The patient will use an investigational drug during the study
* History of optic atrophy in the study eye
* Corneal oedema/haze that would prevent visualisation of fundus to perform vitrectomy surgery
* Patient over the age of 95 who present with POE should immediately be placed on the pre-screening log as ineligible
Effects of Pioglitazone in Hypertensive Patients

Insulin resistance is often complicated with hypertension. AGE and inflammation play important roles in insulin resistance. Some studies reported that pioglitazone, insulin sensitizer, is effective for patients with insulin resistance, however, the mechanisms are still unclear. The aim of this study to evaluate the effect of pioglitazone compared with glimepiride on AGE, inflammatory cytokines and cardiac markers (BNP and echo) in hypertensive patients during oral glucose tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension with insulin resistance

Exclusion Criteria:

* Chronic systolic heart failure, ACS
NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations

This prospective, multicenter, non-interventional study (NIS) in Germany aims to collect real-life data of patients with non-squamous (NSQ) metastatic non-small cell lung cancer (mNSCLC) (incl. large cell neuroendocrine carcinoma (LCNEC) if considered NSCLC-like by the treating physician) for whom 1st line treatment initiation with tremelimumab and durvalumab in combination with a platinum-based chemotherapy (TDC) according to marketing authorization was scheduled. The study aims to describe the effectiveness with respect to mutations in Kirsten rat sarcoma viral oncogene homolog (KRAS), Serine/threonine kinase 11 (STK11), Kelch-like ECH-associated protein 1 (KEAP1), and Tumor protein p53 (TP53) as well as expression of Thyroid transcription factor 1 (TTF-1) and Programmed death-ligand 1 (PD-L1) in routine clinical practice. The generated data aims to deepen the understanding of optimal, biomarker-guided treatment strategies for NSQ mNSCLC in distinct subgroups with a high medical need.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Decision to start first-line (1L) treatment with TDC according to the current SmPCs
* Histologically or cytologically confirmed diagnosis of NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician)
* Treatment-naïve for metastatic disease
* No sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) alterations
* Molecular Next Generation Sequencing (NGS) panel as per institutional standard has been initiated (including the following genes: KRAS, STK11, KEAP1, and TP53)
* TTF-1 expression analysis has been initiated
* PD-L1 expression analysis has been initiated
* Women of childbearing potential must use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab
* Ability to understand the study concept
* Provision of signed informed consent form in accordance with applicable local provisions

Exclusion Criteria:

* Current participation in interventional clinical trials
* Contraindications according to current SmPCs
Pericapsular Nerve Group Block: An Imaging Study for Determination of the Spread of the Injectate Using 3-D CT Scan

Over the last 20 years, different interventional regional analgesia techniques have been proposed to treat pain after hip surgeries.

The most commonly used techniques are the fascia iliaca and femoral nerve blocks, resulting in reduced pain scores, opioid-sparing effects, and opioid-related adverse effects. However, these interventional analgesia techniques result in a motor block and muscle weakness of the quadriceps muscle, impeding early ambulation and rehabilitation.

Recently, the pericapsular nerve group (PENG) block has been proposed as an effective choice for analgesia after hip surgeries while sparing the motor function of the lower extremities. The aim of this technique is to inject local anesthetic to target the more distal sensory branches innervating the anterior aspect of the hip joint.

Ten patients scheduled for hip surgery were included after Ethical Committee approval and informed consent were obtained.

Preoperatively, patients received an ultrasound-guided pericapsular nerve group block. The injections were performed preoperatively using a Canon US Applio 700 with a linear transducer (14 to 6 MHz), and a 21-gauge, 80 mm stimulating needle (SonoPlex Stim, Pajunk ® ️ GmbH, Germany). After confirmation of the correct needle tip position with 2 mL of sodium chloride 0.9%, 20 mL of injectate containing 18 mL ropivacaine 0.5% with 2 mL of radiopaque contrast (Iomeron 300: 61.24% w/v of Iomeprol equivalent to 30% iodine or 300 mg iodine/mL (Bracco UK Limited)) was injected.

After surgery, high-definition CT scans (Siemens) were obtained to determine the distribution patterns of the injectates.

Eligibility Criteria:
Inclusion Criteria:

1. an indication for PENG blocks for postoperative pain management
2. American Society of Anesthesiologists (ASA) physical status I or II
3. at least 18 years old, and able to understand the purpose and risks of the study

Exclusion Criteria:

1. pregnancy
2. body mass index above 35 kg/m2
3. hepatic or renal insufficiency
4. history of allergic or adverse reactions to local anesthetics or contrast agents.
Evaluating Effectiveness of Elevated Intra-abdominal Pressure (IAP) by PressureDOT.

To test the diagnostic efficacy of using the PressureDOT, an in-body real-time pressure-sensing smart capsule, in monitoring elevated intra-abdominal pressure in subjects.

This study aims to evaluate the PressureDOT (abbreviated as PDT, serial number: PD01), a state-of- the-art continuous pressure sensing system that is among the most advanced in the world. Unlike traditional methods of monitoring intra-abdominal pressure, such as indirectly measuring abdominal pressure by infusing saline into the bladder, PDT offers a minimally invasive, wireless solution intended to reduce the common risk of urinary tract infections associated with traditional methods and significantly decrease the need for manual operations.

The PDT capsule utilizes high-density circuit board technology and is protected by a unibody encapsulation that shields its internal components. This design enables the capsule to precisely and continuously monitor intra-abdominal pressure and temperature while transmitting data to an external receiving device wirelessly. Additionally, the external receiver is equipped with a special algorithm that can instantly track the capsule's speed of movement through the gastrointestinal tract, providing richer data support for clinical diagnosis.

Considering that elevated intra-abdominal pressure is a potential early high-risk factor for various diseases and closely related to the user's health status, this project plans to conduct a Phase I clinical trial across a broad spectrum of groups, including athletes, astronauts, vocalists, individuals undergoing rehabilitation, and any participants at risk of increased intra-abdominal pressure. These groups may face a risk of elevated intra-abdominal pressure due to their unique circumstances. Through this clinical trial, we hope to validate the effectiveness of PDT in the early diagnosis of elevated intra-abdominal pressure, reduce the long-term risk of exposure to high intra-abdominal pressure for participants, and further alleviate the burden on medical practitioners, thereby reducing medical costs.


Eligibility Criteria:
Inclusion Criteria:

* healthy participants without previous surgical history

Exclusion Criteria:

* previous abdominal surgical history
* GI obstruction history
* no need of magnetic resonance imaging in two weeks after capsule ingestion.
* history of swallowing difficulty, dysphagia, odynophagia.
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196

This is a phase 1 study in which healthy adult volunteers will receive BRII-196 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 to 49 years of age inclusive;
* Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-24.0kg/m2 (inclusive);
* Male or female;

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
* A history of significant hypersensitivity, intolerance, or allergy to any drug compound;
* History of alcohol or other substance abuse;
Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis

This is a multicenter, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on ICU patients at risk of sepsis as an aid in identifying sepsis.


Eligibility Criteria:
Inclusion Criteria:

* 1. Provision and understanding of signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis.
* 2. Male or female, aged ≥ 18 years.
* 3. Admitted to ICU on the day of screening, with expectation that patient will require ICU management for a minimum of 24 hours.

Exclusion Criteria:

* 1. Expected to die within 24 hours no matter what therapy is given, from the time of screening.
* 2. Suffering on ICU admission or study entry from or known acute or chronic pancreatitis or pancreatic cancer).
* 3. Admitted to ICU due to elective cardiac surgery with an uncomplicated stay anticipated.
* 4. Patients having a valid Do Not Resuscitate order.
* 5. Previous ICU admission during this hospital stay
* 6. Confirmed COVID-19 as reason for ICU admission
Study on Surgical Treatment Strategies for Moderate Ischemic Mitral Regurgitation

This study aimed to compare the efficacy of isolated coronary artery bypass grafting and coronary artery bypass grafting + mitral valve repair in moderate ischemic mitral regurgitation patients through a cohort and explore the potential risk factors of the clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Adult coronary artery disease patients complicated with moderate ischemic mitral regurgitation.
2. undergoing coronary artery bypass grafting with or without mitral valve repair.

Exclusion Criteria:

1. patients under the age of 18 years,
2. patients complicated with more than moderate ischemic mitral regurgitation or undergoing mitral valve replacement,
3. patients complicated with primary mitral valve disease other than ischemic mitral regurgitation, such as rheumatic mitral regurgitation or mitral valve leaflet prolapse,
4. patients undergoing concomitant aortic valve procedure.
GRC 27864 First in Man, Single Ascending Dose Study in Healthy Volunteers

A Single Dose Study of GRC 27864 in Healthy Volunteers.

This is a phase I study of GRC 27864 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Participants will remain in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female healthy subjects, age ≥18 to ≤55 years (≥65 years for elderly subjects study) at the time of informed consent
2. Body mass index between 18.5 and 32.0 kilograms per square meter (kg/m2), inclusive
3. Female subjects who are of child-bearing potential or had tubal ligation must agree to use highly effective methods of contraception
4. Male subjects whose partners are of child-bearing potential or had tubal ligation must also agree to use two highly effective method of contraception

Exclusion Criteria:

1. Subjects with inherited or acquired disorders in platelet function, bleeding or coagulation.
2. Presence of any clinically relevant acute or chronic disease which could interfere with the subject safety during the clinical study, expose the subject to undue risk.
3. Veins unsuitable for repeat venepuncture.
4. Presence of clinical laboratory test values judged clinically significant by the investigator.
5. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV)-1 and/or -2 antibodies at screening.
6. History or presence of drug abuse at screening or upon admission to the CRU.
7. Participation in another clinical study with an experimental drug within 3 months before the first administration of the IMP.
8. Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the subject to comply with the Clinical Study Protocol requirements.
Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes

More than 300,000 total knee joint replacement surgeries are performed per year in the United States and safe, effective management of post-operative pain in these patients, often elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be challenging and often require a multidisciplinary, multimodal approach. Opiates have been a mainstay of treatment in the post-operative period with varying degrees of success and complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled pain inhibits early mobilization and hinders post-operative physical therapy.

A new paradigm for treating post-operative pain following total knee replacement may be the use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the anterior capsule and thereby decrease post-operative pain. There are several publications that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis however the use of RFA in the preoperative management of pain in patients undergoing total knee joint replacement has not been investigated.

The aim of this study is to determine if patients undergoing unilateral total knee replacement obtain any post-operative pain relieving benefits from C-RFA of the articular sensory nerve supply when performed prior to surgery, as compared to sham controls who receive only local anesthetic injections of these same nerves without the benefit of ablation treatment.


Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the knee scheduled to undergo their first unilateral knee joint replacement
* willingness to undergo fluoroscopy-guided C-RFA or sham treatment

Exclusion Criteria:

* pregnancy,
* severe cardiac/pulmonary compromise,
* acute illness/infection,
* coagulopathy
* bleeding disorder,
* allergic reactions,
* contraindications to a local anesthetic
Ethnic Variations in Antidepressant Response

This 11-week study aims to determine how genetic factors affect the way African Americans and Caucasians with major depression respond to antidepressant medication \[citalopram (Celexa®)\].

Depressed patients vary substantially in their responses to antidepressants. Genetic factors may account for a large part of these differences in response. This study will include both African Americans and Caucasians to examine the role of genetic factors in treatment response.

Participants receive citalopram (Celexa) for 8 weeks and a placebo for 1 week. Visits occur once a week for 11 weeks. A variety of interviews, scales, tests, and questionnaires are used to assess participants.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for Major Depression
* African-American or Caucasian ethnic background (both parents and 3 out of 4 grandparents)

Exclusion Criteria:

* Schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression, or bipolar disorder
* Current drug abuse or history of drug abuse within the past 6 months
* Unstable medical or neurological conditions that interfere with the treatment of depression
* Allergy to citalopram
* Failure to respond to adequate citalopram drug trial (40 mg for at least 6 weeks)
* Seizure disorder
* Pregnancy
* Psychotropic medications, including antidepressants and neuroleptics
* Suicidal ideation or other safety issues
* Fluoxetine (Prozac) or MAOIs (Nardil, Parnate) in the last 2 months
* Ongoing cognitive behavioral therapy or intensive psychotherapy. General talk therapy is acceptable
Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer

Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study

Patients will be recruited among patient refered to our department for a breast cancer and needing an axillary dissection. Enrolled patients will have an injection of Lanreotide or placebo the day before surgery when they arrive in their room. The quantity of lymph in axillary drain will by daily noted until day 4. The patient will be evaluated at D15, D30 and M6 for pain, lymphocele and adverse events.

Data will be compared in the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 18 years),
* Patient undergoing an axillary lymphadenectomy for breast cancer
* Patient giving her agreement after being informed

Exclusion Criteria:

* Patients that don't understand the trial
* Type 2 diabetic patients
* Cyclosporine treatment
* Biliary lithiasis
* Pregnancy or breast feeding
* Allergic reaction to Lanréotide or same class treatments
* Patient included in another trial within the last 30 days
Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital

Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor.

The aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme.

Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor.

The aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme. Previous studies have shown a possible implication of drugs or medical history or intraoperative complications. The investigators aim to describe the other possible risk factors (such as portal vein clampage) and the type of surgery done after the diagnosis and its impact on survival as well.

Eligibility Criteria:
Inclusion Criteria:

* Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019
* for the group Perforation: patients having during the follow-up a complication such as intestinal perforation. The complete list uses the ICD-10 codes for intestinal perforation, esophageal perforation, duodenal perforation etc.

Exclusion Criteria:

* No exclusion criteria
Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal Intubation

Videolaryngoscopy provides a better laryngeal view and do not need airway alignment for tracheal intubation.

The C-MAC-VS can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. This device is great for cases with limited mouth opening, airway obstruction and difficult intubation. C-MAC-VS has no lumens so it's very easy to clean and it can accommodates a size ETT 6.0 and greater.

Eligibility Criteria:
Inclusion Criteria:

* patients with BMI ≥ 30 kg/m2,
* presence of any predictors of difficult intubation;
* Mallampati score \> =3;
* inter-incisor distance \< 3 cm;
* thyromental distance \< 6 cm;
* neck extension \< 80°from neck flexion;
* cervical spine instability; history of difficult endotracheal intubation or difficult mask ventilation

Exclusion Criteria:

* patients have increased risk of pulmonary aspiration;
* have significant medical diseases in term of cardiac, respiratory, hepatic, renal
An Extension Trial for Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.

The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM

A Retrospective, nonrandomized, open-label study to evaluate the long term safety and IOP-lowering effectiveness of STREAMLINE® SURGICAL SYSTEM in patients with open-angle glaucoma who participated in the DF6-CL-20-01 protocol.

Eligibility Criteria:
Inclusion Criteria:

participated in the DF6-CL-20-01 trial.

Exclusion Criteria:

lost to follow up in the DF6-CL-20-01 trial