cyrilzakka/clinical-trials huggingface dataset:
Candidemia in Critically Ill Patients

Candidal sepsis (candidemia) is a criticals problem in patients hospitalized in the intensive care unit, with a significant impact on morbidity and mortality. Risk factors for candidemia in intensive care patients included age, presence of a central venous catheter, inpatient surgery, and administration of parenteral nutrition (TPN). Mortality in patients with candidemia is estimated at 50-60%. Early identification and treatment, including control of the source of infection, are essential to improve morbidity and mortality in these patients.

In this study, we would like to identify risk factors for the development of candidemia in intensive care patients, including those who have not undergone abdominal surgery, and to examine what percentage of patients who developed candidemia were given empirical antifungal therapy and what factors influenced the decision to give or not to give such empirical therapy.

Study design: A retrospective study based on data collection from computerized systems will include patients who were hospitalized in the intensive care unit from January 2014 to December 2024 and were diagnosed with Candida in at least one blood culture.


Eligibility Criteria:
Inclusion Criteria: Patients admitted to the ICU from January 2014 to December 2024 and had at least one positive blood culture for candidemia -

Exclusion Criteria: Missing data

-
Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye

The study aims to further understand glaucoma pathogenesis and progression by utilizing enhanced depth imaging optical coherence tomography to visualize and measure lamina cribrosa in vivo and segmentation technology to accurately delineate and measure boundaries of the retinal layers. Investigators will elaborate further on key concepts of lamina cribrosa thickness and trans-synaptic degeneration.

Two important areas of the eye that need investigation in order to further understanding of glaucoma. First is the retina (part of the eye that converts images from the eye's optical system into electrical impulses sent along the optic nerve to the brain). Newer technology, Spectral Domain Optical Coherence Tomography (SD-OCT), allows us to look at different layers of the retina and carefully measure thickness of each layer. Second area is lamina cribrosa (a portion of the white part of the eye which has nerve fibers passing through it connecting the eye to the brain). If lamina cribrosa is thin, it is possible it may bend easily and disrupt nerve fibers. SD-OCT allows measurement of lamina cribrosa thickness.

Findings will help monitor changes that occur in the eye as a result of glaucoma.

Individuals with primary open-angle glaucoma and unilateral visual field defects were chosen as the main patient population (in addition to normal controls). By approximating each participants baseline anatomy using the fellow, "internal control" eye, investigators will be able to better determine if any changes occur in the macula or the lamina cribrosa as a result of glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Best-corrected visual acuity of 20/40 or better
* No media opacities
* Spherical equivalent refractive errors in a range of -6 to +6 diopters
* Cylinder correction within 3.0 diopters.

Exclusion Criteria:

* Age \< 18 years old
* Visual Acuity \< 20/40
* Nuclear sclerosis \> +2
* Corneal diseases
* Contact lens use
* History of posterior segment intraocular surgery
* Systemic or ocular diseases that can cause visual field loss.
Hemodynamic Monitoring Carotid Surgery

patients scheduled for carotid endoarterectomy will be randomly assigned to a group in which arterial hypotension will be avoided by a predictive haemodynamic approach or to a group in which arterial hypotension will be treated in a standard manner


Eligibility Criteria:
Inclusion Criteria:

- \>18 years old patients

Exclusion Criteria:

* Body MassIndex \> 35 Kg /m2;
* Atrial Fibrillation
* Urgent surgery
* Pregnancy
Impact of Geriatrician Interventions on Chemotherapy Delivery in Vulnerable Elderly Oncology Patients

This is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (RDI).

This randomized parallel group trial is designed to evaluate the impact of implementing geriatrician-prescribed interventions, on the ability to deliver adequate chemotherapy treatment, as measured by RDI of at least 85%, in a cohort of vulnerable \[≥1 deficit identified at CGA and/or ≥1 comorbidity Grade 3-4 as defined by Cumulative Illness Rating Scale for Geriatrics (CIRS-G)\] elderly cancer patients with early stage or advanced solid organ malignancies.

Patients will be randomized using a 2:1 allocation to Arm A: routine oncological care plus geriatric intervention or Arm B: routine oncological care

Eligibility Criteria:
Inclusion Criteria:

1. Any solid tumors
2. Either early stage disease planned for treatment with neo/adjuvant chemotherapy, or metastatic disease planned for treatment with chemotherapy and ≤ 1 previous chemotherapy treatment in the metastatic setting
3. Absence of symptomatic central nervous system (CNS) metastases
4. Eastern Cooperative Oncology group (ECOG) performance status 0-2
5. Estimated life expectancy of ≥ 12 weeks
6. At least 1 deficit identified on CGA at screening/baseline, and/or at least one comorbidity of grade 3 or 4 severity, as defined by CIRS-G
7. Written informed consent in according to International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use/Good Clinical Practice (ICH/GCP), and national/local ethics regulations
8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule

Exclusion Criteria:

1. Age ≤ 69 years
2. Any patients who did not meet the inclusion criteria
First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum - International Study

First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic cancer of colon or rectum
SynCardia CardioWest TAH-t Postmarket Surveillance Study

The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.


Eligibility Criteria:
Inclusion Criteria:

* The TAH-t is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

Exclusion Criteria:

* Patients who are not cardiac transplant eligible.
* Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas \<1.7m², or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) \< 10 cm.
* Patients who cannot be adequately anticoagulated on the TAH-t.
Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia

To evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic GTN.

This is a randomized, multicenter clinical trial including patients seen at one of 13 gestational trophoblastic disease reference centers in Brazil. Subjects are eligible if they have low-risk gestational trophoblastic neoplasia according to FIGO 2000 criteria and the FIGO/WHO prognostic risk score. The study includes two treatment arms: immediate treatment with single-agent chemotherapy (center choice of agent) or second uterine curettage. The primary outcome is the rate of primary remission. Secondary outcomes are the number of chemotherapy cycles required to achieve remission, rate of primary chemotherapy resistance, rate of relapse, and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological diagnosis of molar pegnancy according to the morphological criteria described by Sebire et al., who meet the diagnostic criteria for low-risk non-metastatic GTN according to FIGO 2000 criteria

Exclusion Criteria:

1. High risk GTN (FIGO risk score ≥ 7) or metastatic disease at diagnosis of GTN (stage II, III or IV);
2. Histopathological diagnosis of choriocarcinoma, placental site trophoblastic or epithelioid trophoblastic tumor at the second curettage;
3. Previous chemotherapy treatment;
4. Level of hCG at the time of GTN diagnosis less than 20 IU/L (to minimize the risk of inclusion of patients with false positive hCG, either by cross-reaction with pituitary hormones or by the presence of circulating heterophilic antibodies);
5. Relapsed GTN;
6. Incomplete medical records.
7. Loss to follow-up;
8. Voluntary desire to stop participating in the study.
Prevalence of Metabolic Syndrome in Patients With Schizophrenia in Korea

The aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean patients with schizophrenia.

Primary objective:

• To investigate the prevalence of the MetS in Korean patients with schizophrenia

Secondary objectives:

• To compare the prevalence of the MetS among 3 groups according to antipsychotics: typical antipsychotic monotherapy group, atypical antipsychotic monotherapy group, 2 or more antipsychotics group (polypharmacy)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV-TR
* Age between 18-65 years
Study to Evaluate the Safety, Tolerability, Efficacy and PK of IdeS in Kidney Transplantation

This study will assess the safety and efficacy of IdeS in the transplantation setting. Each patient will receive one dose of IdeS. If the crossmatch test is negative at the time of transplantation, the patient will be transplanted with a kidney from a deceased or living donor. The starting dose will be 0.25 mg/kg BW, given as a single intravenous infusion prior to surgery.

This study will assess the safety and efficacy of the IgG degrading cysteine protease IdeS in the transplantation setting. Patients with DSAs will be treated with IdeS prior to transplantation. Each patient will receive one dose of IdeS. If the crossmatch test is negative after IdeS treatment, the patient will be transplanted with a kidney from a deceased or living donor. Two to four dose groups are planned. Each group will contain 2 patients with the possibility to extend the group to up to 4 patients per group if required for safety and/or efficacy evaluation. The starting dose will be 0.25 mg/kg BW, given as a single intravenous infusion prior to surgery with the possibility to increase the dose in higher dose groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CKD and in dialysis with preformed anti-HLA antibodies (non-DSA, DSA or both), negative T-CDC CXM and at least one antibody MFI \> 3000

Exclusion Criteria:

* Prior malignancy within 2 years excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and prostate cancer Gleason \<6 and prostate-specific antigen (PSA) \<10 ng/mL.
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV
* Clinical signs of ongoing infectious disease.
* Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure \> New York Heart Association (NYHA) grade 3, unstable coronary disease or oxygen dependent chronic obstructive pulmonary disease (COPD)
* History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study
* Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to IdeS (e. g streptokinase and/or staphylokinase)
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 4 months of the first administration of investigational product in this study.
* Patients consented and screened but not dosed in previous studies are not excluded
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).


Eligibility Criteria:
Key Inclusion Criteria:

* Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
* Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
* A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
* Moderately to severely active UC
* Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab

Key Exclusion Criteria:

* Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
* Active tuberculosis (TB) or history of latent TB that has not been treated
* Use of any concomitant prohibited medications as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance Status (PS) ≤1
* Histologically or cytologically confirmed, unresectable metastatic colorectal cancer
* Measurable disease by RECIST guidelines
* Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
* Available paraffin embedded tumor tissue
* Willing to give a whole blood sample for the study of proteins and genetic polymorphisms

Exclusion Criteria:

* Less than 28 days elapsed since major surgery at time of randomization
* Known CNS metastases
* Excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
* Uncontrolled hypertension
* Clinically significant cardiovascular disease
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
* Known HIV Positive
Hematological Response in Patients With Paroxysmal Nocturnal Hemoglobinuria Treated With Anti-C5 Antibody: an External Control Arm Study for Iptacopan Use in Anti-C5 naïve Patients

The aim of this non-interventional secondary use of data study is to evaluate hematological response in patients with paroxysmal nocturnal hemoglobinuria and anemia in the 6-month period after initiation of anti-C5 antibody treatment using real-world data obtained from multiple datasets. The results will be used to contextualize results from the APPOINT-PNH (NCT04820530) trial with iptacopan.


Eligibility Criteria:
Inclusion Criteria:

1. Incident users of anti-C5 antibody treatment (i.e., first use of anti-C5 antibody with no evidence of use prior to that)
2. Confirmed clinical diagnosis of PNH (including PNH clone size \>10% in RBC percent/white blood cell (WBC) percent)
3. Adult patients ≥18 years of age
4. Baseline Hb \<10 g/dL.

Exclusion Criteria:

Patients who met any of the following criteria were not eligible for inclusion.

1. Bone marrow transplantation within one year prior to initiating anti-C5 treatment
2. Hereditary complement deficiency
3. Reticulocyte count \<60x10\^9/L.
4. Pregnancy
Cytology Study of Cells From Patients With Low Back Pain

The investigators are doing this study to learn more about the cause of back pain with or without pain shooting down one or both legs. The investigators specifically want to know if cells that move into injured areas of the body are present in a space in the spine (epidural space) of patients with back pain and with or without shooting pain. The investigators will collect cells when patients are being treated, then examine the cells using a microscope. The investigators also will shine different colors of light into the epidural space to see if there is a correlation between how different colors of light are reflected and the types of cells present.

The objective of this study is to examine the cell population in the epidural space of patients with low back pain +/- radiculopathy to determine if the cell population reveals pathological processes sustaining the pain. Cells will be collected for microscopic inspection and will be examined in situ during exposure to white and UV light. The overall goal is to advance our knowledge about the etiology of low back pain +/- radiculopathy to guide mechanistic based therapy.

The primary information sought is to determine if description of pathological processes based upon direct observation with percutaneously placed epiduroscopes can be confirmed by cytological analysis. the observations described include: 1) increased fibrosis from slight to complete replacement of other tissue, or obliteration of the epidural space; 2) alteration of color and/or appearance of epidural fat; 3) increased or decreased vascularity. The overall description range from acute inflammatory changes to advanced fibrosis (scarring).

Specimens for cytological analysis will be obtained from different sites in the epidural space by using commercially available cytology specimen collecting brushes and/or catheters. These are inserted through the working channel of an epiduroscope into the lumbar epidural space to aid treatment.

Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign an informed consent form
* Age \>18 years at the time of signing the informed consent form
* A diagnosis of low back pain with or without radiculopathy and scheduled for epiduroscopy assisted epidural neurolysis

Exclusion Criteria:

* Patients not scheduled for epiduroscopy assisted epidural neurolysis
* Are female who is pregnant
* Are a female of childbearing age and are not using an acceptable form of contraception
* Have a medical history or condition that would not make the patient a good candidate for epiduroscopy procedure
* Are unwilling or unable to provide written informed consent and/or to obey the study procedures
CAP Pilot Study for Obstructive Sleep Apnea (OSA)

This is a pilot to review the feasibility of a program that assists patients towards therapy compliance by scheduled intervention through the first month of therapy. The hypothesis of this study is that the trial program will function as intended and average patient adherence will be over 4 hours per night.


Eligibility Criteria:
Inclusion Criteria

* 21 to 75 years of age
* Diagnosed with OSA (AHI \>5 events/hour) and eligible for Continuous Positive Airway Pressure (CPAP) treatment under local requirements
* Must be initiated on program (i.e. received their device) within 12 weeks of CPAP titration study
* Naïve to CPAP therapy, i.e have not been prescribed CPAP in the past
* Access to a cellphone

Exclusion Criteria:

* Contraindicated for CPAP therapy
* Medically unstable condition/diagnosis that is not yet under control
* Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
* Periodic Leg MOvement Arousal Index greater than 15/hr
* Home titration of longer than 5 days
PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration

The investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation.

Currently kidney transplantation is the only viable option for patients with kidney failure to regain quality of life and health. The number of organs available for transplantation is insufficient with a widening gap between supply and demand. Nowadays, centers accept older and higher risk donor organs with co-morbidity, often leading to non-function, complications and with half of the patients back on dialysis within 15 years. Furthermore, many donor kidneys have to be discarded as too damaged and beyond repair. Increasing the quality and therefore transplantability of these high-risk donor organs could significantly increase the donor kidney pool.

Using prolonged normothermic perfusion of marginal donor organs, the investigators aim to kick start regeneration in the kidney before transplantation, improving function and survival long-term. Furthermore, the choice to accept or decline a donor kidney organ is currently based on subjective criteria and causes great uncertainty amongst clinicians. There is a dire need for tools to aid in decision making and reduce this uncertainty. Biomarkers predictive of graft regeneration are lacking. Samples from perfused kidneys and donor recipients will be collected and analysed to allow the formulation of a kidney fitness index.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing 1st or 2nd kidney transplant
* Patients undergoing a kidney transplantation from DCD Maastricht III \& V
* Transplant recipients aged ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Patients undergoing 3rd or subsequent kidney transplant
* Patients undergoing a kidney transplantation from DCD Maastricht I, II \& IV
* Transplant recipients aged \< 18 years
* Patients receiving multi-organ transplants
* ABO/HLA incompatible transplants
* Highly sensitized patients with a panel-reactive antibody (PRA) ≥85%
* Kidneys with CIT \> 12 hrs at the point of arrival at transplant centre
* Kidneys with complex vascular anatomy (≥3 arteries, artery which cannot be can-nulated or attached to the patch holder)
* Kidneys explanted from a donor on normothermic regional perfusion
Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201

Compare the long-term safety of pradefovir to adefovir dipivoxyl

* Compare the long-term safety of pradefovir to adefovir dipivoxyl
* Monitor development of resistance
* Evaluate virologic and biochemical response

Eligibility Criteria:
Inclusion Criteria:

* Patients who completed 48 weeks of treatment in study RNA200103-201

Exclusion Criteria:

* Patients who were determined to be treatment failures in study RNA200103-201
* Patients who experienced a serious adverse event judged to be related to study drug in study RNA200103-201
* Patients with a serum creatinine greater than 2.0 mg/dl on two consecutive determinations in study RNA200103-201