cyrilzakka/clinical-trials huggingface dataset:
Macrophage Programing in Acute Lung Injury

The histologic hallmarks of lung inflammation and in the extreme, acute respiratory distress syndrome (ARDS), include intense accumulation of inflammatory cells in the airspaces and interstitium, injury to alveolar epithelial and endothelial cells, loss of epithelial-capillary integrity and accumulation of edema fluid in the interstitium and airspaces. Accordingly, for alveolar repair to occur inflammation must be halted, debris and inflammatory cells removed, injured tissue cells replaced, and capillary barrier function re-established. Macrophages are key players in all of these. Here the investigators hypothesize that resident alveolar macrophages and recruited macrophages serve completely different functions, acting independently (i.e. division of labor) yet cooperatively (synergism).


Eligibility Criteria:
Inclusion Criteria:

1. Written, informed consent (by surrogate if unconscious or if altered mental status)
2. Admission to a Medical Intensive care unit
3. Orally/nasally intubated, evaluable within 24 h of intubation or onset of ARDS
4. Expected to remain mechanically ventilated for at least 48 h after the first study procedure.

Exclusion Criteria:

1. Treatment with immunosuppressants in the prior 3 months (antineoplastic agents, tumor necrosis factor alpha antagonists, cyclosporine, methotrexate, azathioprine, or mycophenolate. Treatment with glucocorticoids for septic shock is acceptable).
2. History of solid organ or bone marrow transplantation
3. History of chronic lung disease (e.g. COPD, pulmonary fibrosis, cystic fibrosis)
4. Human immunodeficiency virus positivity
5. Severe or massive hemoptysis
6. At significant risk for bleeding (INR \> 3 or PTT \> 3x normal)
7. Presence of an advanced directive to withhold life-sustaining treatment
8. Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition;
9. Pregnancy
2D Versus 3D Laparoscopic Training on a Virtual Reality Simulator

Laparoscopy training programs with virtual reality simulators are widely used before new surgeons are allowed to operate on patients. Laparoscopic surgery results in shorter time to recover, less surgical trauma and thereby a shorter stay at the hospital compared with open surgery. However, it is more difficult to learn laparoscopic surgery, than open surgery, in part because surgeons have to work in a 3-dimensional space, through a 2-dimensional interface on a screen. This results in loss of depth perception and therefore a higher visual and cognitive load. This trial examines if using 3D vision instead of 2D vision on the laparoscopic virtual reality simulator reduces the time to reach proficiency, by decreasing the cognitive and visual load during practice on a Virtual Reality Simulator.


Eligibility Criteria:
Inclusion Criteria:

* Residents working in Denmark. Participants are required to have a medical license and provide informed consent before inclusion

Exclusion Criteria:

1. Participation in prior studies involving laparoscopic training.
2. Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
3. Performing more than 3 supervised laparoscopy surgeries during the intervention.
4. Performing laparoscopy surgery between the intervention and the retention test 3-6 weeks after.
5. No informed consent.
6. Does not speak Danish on a conversational level.
Cardiovascular Response in Implant Surgery

The aim of this study was to observe the level of anxiety and its relationship with cardiovascular changes in each implant.


Eligibility Criteria:
Inclusion Criteria:

* Over 30
* 4 years and older implant in the same session

Exclusion Criteria:

* patients with syndrome,
* having systemic disease,
* having heart problems,
* undergo another oral or maxillofacial procedure in the last 6 months,
* using medications that may cause changes in medical conditions and heart rate,
Cytokine-guided Robotic Cystectomy

There is a recognised complication of surgery known as a 'Paralytic Ileus', where bowel function is reduced after an operation, causing an obstruction and resulting in nausea and vomiting. This complication is more common in patients that have robotic surgery due to the positioning required and the gas pressures required for keyhole/robotic surgery. While some of the factors involved in a paralytic ileus are known, the full mechanism and the chemicals involved are not yet fully understood.

This study is looking at the level of specific chemicals called 'cytokines', and the changes in the level of these cytokines in the blood before and after robotic surgery, specifically during bladder removal (cystectomy). Cytokine levels will be compared against post-operative recovery and whether a paralytic ileus is developed.

Cytokines are signalling proteins that are release by immune cells in response to stress on the body. In this study the aim is to evaluate the concordance between cytokine rise (specifically monitoring the following cytokines: Interferon (IFN)-gamma, tumour necrosis factor (TNF)-alpha, Interleukin (IL) -1beta, IL-2, IL-4, IL-6, IL-12 and IL-17) and postoperative ileus (a condition where bowel function slows causing build up of faecal matter) following robotic radical cystectomy and the pneumoperitoneum (gas insufflation of the abdomen) pressures that were required intra-operatively.

This study includes patients undergoing radical cystectomy. The study will measure pre-anaesthetic, post-anaesthetic, immediately post-operatively and two further post-operative serum cytokines levels and compare them with the pneumoperitoneal pressures required intra-operatively and the outcome of whether a clinical diagnosis of paralytic ileus was made.

Serum cytokine levels will be taken on five occasions:

1. st Sample (Baseline)-Before induction of anaesthetic
2. nd Sample-Immediately after induction of anaesthetic
3. rd Sample-Immediately post-operative
4. th Sample - 2 hours post-operative
5. th Sample - 1 day post-operative

No alterations will be made to the care of the patient, this is purely an observational study.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 40 and 75 years of age
* Patients undergoing a Robotic radical cystectomy
* Patient consenting to enter the study
* Patients consenting for blood samples for cytokine analysis

Exclusion Criteria:

* Patients \<40 years of age and patients \>75 years of age
* Patients unwilling or unable to consent
EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors

The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs

The management of nonfunctional pancreatic neuroendocrine tumors (NF-pNETs) remains controversial. In general, surgical resection is the standard treatment for NF-pNETs. However, the incidence of postoperative adverse events of surgical resection is relatively high. Recently, several studies have revealed that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may offer an effective treatment for pNETs. Therefore, a multicenter prospective study is being conducted to further identify the efficacy and safety of EUS-FNI for NF-pNETs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with NF-pNETs are evaluated by cytology or immunohistochemistry.
2. Patients who refuse surgery or observation.
3. Patients who have given their fully informed consent.

Exclusion Criteria:

1. Patients who are not suitable for EUS-FNI.
2. Patients who have poor conditions including blood coagulation dysfunction, mental disorders, and mild or severe cardiorespiratory.
Choice of Diction's Effect

The purpose of the research is to determine how the language used when discussing preferences about cardiopulmonary resuscitation (CPR) affects decisions regarding this (code status)

Most Americans express a preference for dying at home naturally and surrounded by loved ones. However, many also believe that cardiopulmonary resuscitation (CPR) is more effective than it is, and want to have CPR even when the chances for a good outcome is poor. Among other reasons, the alternative term (Do Not Resuscitate, or DNR) has been shown in the literature to be associated by patients with passive, sub-optimal, and low quality care.

This study will attempt to determine patient preference for the "no CPR" term on patients admitted to the hospital using alternate phrasing. During admission to the Medical Teaching Service, patients over the age of 65 who are able to consent and who are not critically ill/unstable will be approached. After checking brief background questions (such as if they ever had discussions like these before), they will be randomized into two groups and asked code status using one of the two phrases. This question will determine the patient's "code status;" asking for this is a routine part of hospitalized care that is required by law (the exact terminology is left to the care team). After determining the patient's code status, they will be asked how satisfied they were with the decision; the investigator will be asked if they agree with the decision separately. Demographic and clinical information will be collected. Six months later, the patient will be contacted again; at this time, they will be asked about recent life and health changes. Finally, they will be asked their code status one more time. This will conclude the participant's involvement in the study

Eligibility Criteria:
Inclusion Criteria:

* 65 or older
* English-fluency in reading and speaking
* Capacity to consent

Exclusion Criteria:

* Unstable psychiatric illness
* Unstable/critically ill patients requiring ICU-level care
* Active substance abuse
Bioequivalence Study of Different Aprocitentan Tablet Formulations

The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
* Healthy male or female participant aged between 18 and 55 years (inclusive) at Screening.
* Body Mass Index of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
* Systolic blood pressure (SBP) 100-140 mmHg, Diastolic blood pressure (DBP) 60-90 mmHg, and pulse rate 60-100 bpm (inclusive), measured on the dominant arm, after 5 min in the supine position at Screening and on Day 1 pre-dose of the first period.
* Woman of Childbearing Potential who has a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 of the first period. She must agree to consistently and correctly use (from Screening, during the entire study, and for at least 30 days after the last study treatment administration) a highly effective method of contraception with a failure rate of less than 1% per year.
* Woman of non-childbearing potential, i.e., postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause; in addition, an FSH test must be performed at Screening to further support postmenopausal status), with previous bilateral salpingectomy, bilateral salpingo oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, uterine agenesis.

Exclusion Criteria:

* Pregnant or lactating woman.
* Previous administration of aprocitentan.
* Known hypersensitivity to endothelin receptor antagonists or to excipients used in any of the formulations.
* History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed).
* Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study results.
* Clinically relevant findings on the physical examination at Screening and on Day -1 of the first period.
* Clinically relevant findings in clinical laboratory tests (hematology and clinical chemistry) at Screening and on Day -1 of the first period.
* Previous treatment with any prescribed medications (including vaccines) or over-the-counter medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks or 5 terminal elimination half-lives (t½; whichever is longer) prior to first study treatment administration.
* Legal incapacity or limited legal capacity at Screening.
* Positive COVID-19 test, if performed (subject to current epidemiological regulations in the Czech Republic) during the screening period.
Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related Macular Degeneration (AMD)

Monocentric and prospective study, evaluating the benefit of self-monitoring optimized by therapeutic education either by the environmental Amsler or the Amsler grid according to the patient's choice and to determine the patient's ability to determine the reality itself recidivism and therefore the need for treatment.


Eligibility Criteria:
Inclusion Criteria:

* Affiliation to a social security scheme
* Patient agreeing to participate in the process of therapeutic education.
* Centrofoveal fixation with visual acuity\> 2/10
* Antecedent of at least one recurrence so that the patient is aware of the notion of recurrent chronic disease
* Intravitreal injection antecedent less than 6 months ago

Exclusion Criteria:

* Vulnerable people
* Majors subject to legal protection or unable to express their consent
* Arterial emboli disorders of less than three months such as myocardial infarction, stroke
Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

This is a prospective randomized controlled parallel trial. The aim of this study is to evaluate bone formation and soft tissue healing after 4 and 8 months in patients with ridge deficiencies in simultaneous implantation approach. The trial will compare a (sugar cross linked) - SCL pericardium membrane OSSIX® Breeze vs native pericardium membrane (Jason®).


Eligibility Criteria:
Inclusion Criteria:

1. Males and females, age 18 and above.
2. General good health (ASA 1 and ASA 2).
3. Adults with buccal bone defect, who are in need of implant placement, and going through a guided bone regeneration treatment.
4. Patient needs 1-3 implants.
5. Good oral hygiene (full mouth plaque index \<25%).
6. Adequate control of inflammation (full mouth bleeding on probing \<25%).
7. Patient is willing to sign an informed consent and participate in the clinical study.

10 8. Patient is able to understand and comply with the study related procedures, such as exercising good oral hygiene and attending all follow-up examinations.

Exclusion Criteria:

1. Physical status ASA III or ASA IV.
2. General contraindications for dental and/or surgical treatments.
3. Inflammatory and autoimmune disease of the oral cavity.
4. Patients with known collagen hypersensitivity.
5. Patients with sensitivity to porcine-derived materials.
6. Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.
7. Acute infection in the oral cavity or acute inflammation at the implantation site.
8. General diseases, where measures of stomatology, maxillo-facial surgery, implantology, periodontology, endodontology or other measures of oral surgery are contraindicated.
9. Disease of oral mucosa.
10. Uncontrolled periodontal disease
11. Concurrent or previous radiotherapy of head area.
12. Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
13. Smoking (over 10 cigarettes a day).
14. Pregnant or lactating women.
15. Women of childbearing potential, who are not using a highly effective method of birth control.
16. Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to study entry.
Acute Effects of LBBP Versus BVP for CRT

The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) \<=35% with left bundle branch block (LBBB).

The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart failure and LBBB.

Eligibility Criteria:
Inclusion Criteria:

* NYHA class II-IV;
* LVEF \<=35%;
* LBBB with QRS duration \>=130ms.

Exclusion Criteria:

* moderate-to-severe aortic stenosis;
* frequent premature ventricular complexes;
* signiﬁcant peripheral vascular disease.
Development of a Telephone-based Continuation Treatment for Patients With Chronic Depression.

There is a high risk for relapse in people suffering from depression. Studies indicate that the continuation of an acute psychotherapeutic treatment can reduce the likelihood of relapse. Therefore, this pilot study is aimed to investigate the feasibility of a continuation psychotherapy over 6 months, to support people suffering from chronic forms of depression in their daily life. The investigated continuation therapy itself includes about one telephone call per month (therapist - patient), focussing on the integration of strategies into the patient's daily routine. The patients receive either 30 minutes or 50 minutes phone calls. On the one hand, these phone calls are supported by a workbook for patients containing psychoeducative elements, strategies and exercises. On the other hand, the therapist's work is based on a manual containing several modules and strategies. Both tools (workbook, manual) are understood as a framework, using the appropriate sections according to the patient's needs. As a result, the patients receive a continuation treatment which is appropriate and adapted to their individual situation.

The main purpose of this pilot study is to evaluate the feasibility of a telephone based psychotherapeutic continuation treatment with a small sample of 20 patients suffering from chronic depression. In case of promising results the effectiveness of this kind of treatment is going to be investigated within a comparative trial (including face-to-face intervention, no intervention).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Diagnosis of chronic (300.4) or recurrent (296.31-3) depression (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
* Currently in partial or full remission
* Previous psychotherapy (acute treatment; some kind of cognitive-behavioral therapy)
* adequate knowledge of German language
* in case of taking antidepressants: long-term and stable dosage (with unchanged taking since 3 months at least)

Exclusion Criteria:

* acute suicidality
* psychotic symptoms
* severe cognitive impairments
* in case of taking antidepressants: anticipated stopping medication within treatment period (6 months)
Surgeon Core-strengthening Program as a Modifier for Exertion Associated With Vaginal Surgery

Work-related musculoskeletal pain and injury is a growing concern in surgery. Vaginal surgery has unique ergonomic risks, but no studies have addressed the potential for an exercise regimen to reduce physical strain by vaginal surgeons

Surgical ergonomics is a burgeoning field, spurred by the recognition of the high prevalence of work-related musculoskeletal pain and injury in practicing surgeons including obstetrician/gynecologists. Surgery is often a demanding physical task, and the muscles and joints that are stressed vary by the surgical approach. Vaginal surgery has unique ergonomic challenges, particularly for assistants who may need to laterally bend their torsos to visualize the surgical field while still holding retractors. This is often a compromising physical position for the back, the shoulders, and sometimes the neck which increases the risk of acute or chronic musculoskeletal injury. The risk of injury can be thought of as a discrepancy between the demands of the task and the individual's physical capabilities. Surgeons' injury risk may be decreased if their physical capabilities can be improved through exercise. Most existing publications on surgical ergonomics have focused on raising awareness and on environmental changes such as optimizing surgeon posture during the case or introducing micro-breaks and stretching. Few publications have assessed a structured exercise program with the goal of decreasing surgeon pain or fatigue during and after surgery. To our knowledge, no studies have addressed this in vaginal surgery.

Eligibility Criteria:
Inclusion Criteria:

Participant: ob/gyn resident or urology resident or urogyn fellow or urogyn attending Case: vaginal prolapse surgery \>2 hours in length

Exclusion Criteria:

Participant:

1. Actively in physical therapy
2. Joint surgery or joint injury within last 12 weeks
3. Pregnant
4. Less than 6 weeks postpartum

Case:

1. Vaginal surgery \<2 hours in length
2. Non-prolapse vaginal surgery
Pivotal Study of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema (DIAMOND-1)

The primary objective is to evaluate the efficacy and safety of OCS 01 as compared to Vehicle in subjects with Diabetic Macular Edema (DME).

A Phase 2/3 Pivotal Double-masked, Randomized, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema

Stage 1: To select a dosing regimen for OCS-01 in subjects with DME, and evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 12 in subjects with DME.

Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in subjects with DME.

Eligibility Criteria:
Inclusion Criteria (selection) - Stage 1:

1. Have a signed informed consent form before any study-specific procedures are performed.
2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus at Visit 1 (Screening).

Inclusion Criteria (selection) - Stage 2:

1. Have a signed informed consent form before any study-specific procedures are performed.
2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus prior to Visit 1 (Screening).

Exclusion criteria (selection) - Stage 1 and Stage 2:

1. Have macular edema considered to be because of a cause other than DME.
2. Have a decrease in BCVA because of causes other than DME.
3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.