cyrilzakka/clinical-trials huggingface dataset:
Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers

Differentiation between major depressive disorder (MDD) and bipolar disorder (BD) as soon as possible in the patient journey represents a major clinical issue. When the patient is in a depressive phase, the symptoms are similar between the two pathologies and the current clinical scales fail in distinguishing them. Physicians often report this difficulty and as a consequence, the mean time from onset to bipolar disorder diagnosis is currently 7.5 years. These diagnostic delays and misdiagnosis lead to damaging consequences for patients and their loved ones: worsening of symptoms, comorbidities, suicide risk and inadequate care resulting in severe impairment in social and occupational functioning. Faced with these high expectations for accurate diagnostic methods for an earlier management of psychiatric patients, the combination of relevant clinical features and biomarkers could stand for a solution, leading to a personalised approach in patients with mood disorders.

In a first clinical discovery study, a panel of RNA biomarkers in the blood of patients with a major depressive episode (MDE) has been identified, allowing to differentiate bipolar disorder from MDD (unipolar depression). These biomarkers are based on RNA modifications, namely RNA editing, that could be identified using molecular biology, NGS and artificial intelligence. This panel constitutes EDIT-B test, which is based on Alcediag's proprietary and patented biomarkers and algorithms.

The present study aims to validate the biomarker signatures proposed by Alcediag by measuring the association between the modifications of the RNA editing and major depressive disorder/ bipolar disorder diagnosis, in patients with a MDE in real-life setting pilot centres.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Male or female ≥ 18 and ≤ 80 years of age at inclusion.
3. MADRS ≥ 20
4. In- and out-patients can be recruited.
5. Diagnosed with MDE with the MINI for DSM-5
6. Currently treated for the MDE
7. Diagnosed with MDD or BD with the MINI for DSM-5.
8. For patients with BD: at least one manic or hypomanic episode
9. For patients with MDD: at least one MDE

Exclusion Criteria:

1. MDD patients with first degree family history of bipolar disorder
2. YMRS \> 12
3. Pregnant women
4. Unipolar or bipolar depression secondary to major central nervous system affections, including infections in the brain, tumours of the brain, stroke, Alzheimer's disease, Parkinson's disease, Multiple sclerosis, other major brain affections
5. Schizo-affective patients

Abbrevations:

BD Bipolar Disorder DSM-5 Diagnostic and Statistical Manual of Mental disorders 5 MADRS Montgomery-Asberg Depression Rating Scale MDD Major Depressive Disorder MDE Major Depressive Episode MINI Mini-International Neuropsychiatric Interview YMRS Young Mania Rating Scale
TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

PRINCIPAL ENDPOINT To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.

SECONDARY ENDPOINT To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.

The security will be valued by the % of patients that:

Will have negative CMV Neutropenia \<1000 neutrophils/mm3 or \<500 neutrophils/mm3 in the first 35 days of treatment - follow-up Renal toxicity in the first 35 days of treatment - follow-up (defined by elevated creatinine \>1mg/dL or twice the basal value) CMV illness during the treatment or in the next 2 months Blood Antigenemia / PCR positive in the next 2months of treatment

This dates Hill be compared with a patients control group treated with intravenous valganciclovir

Clinical trial with a drug in new conditions of use

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Any patients with allogenic TPH
* Following in post-TPH with antigenemia or PCR-CMV
* CMV in blood test detected by antigenemia or PCR before the day 180 post-TPH
* The beginning of treatment must be Duch early as possible. Maximum in the 72 hours from the antigenemia or PCR-CMV detection
* Be the first or second time of a CMV infection
* Sign the informed consent
* Pregnancy negative test in fertile age patients

Exclusion Criteria:

* Patients received auto or syngenic TPH
* Patients \<50 kg weight
* Known allergy or hypersensibility patients to valganciclovir, ganciclovir or aciclovir
* Digestive intolerant: nauseous, vomit and or diarrhea that could difficult oral administration of valganciclovir
* Patients that presents CMV infection or that is being evaluated for suspected CMV
* Patients that have presented \>2 CMV infection episode, before the current one
* Severe liver disease defined by bilirubin ≥ 10mg/dL
* Treated with: foscarnet, ganciclovir, cidofovir or another antiviral drug active to CMV, in the previous 30 days at the current episode
* Neutrophils \< 500 /µL at the beginning of valganciclovir treatment. Patients with \>500 PMN/µL and \< 1000/µL must start a G-CSF treatment to get neutrophils value \> 1000/µL
* Platelets \< 25/mm3 even receiving transfusion
* Clearance Creatinine \< 10mL/min or dialysed patients
* Pregnancy or lactant women
* Other contraindication detailed in the "filling card"
* Previous inclusión in this study at the treated group. Is allowed that a patient participate as a control case and after that receive valganciclovir treatment in after CMV episode
AI-Based LOS Prediction in Hip Fracture Patients

With increasing life expectancy, the elderly population is growing. Hip fractures significantly increase morbidity and mortality, particularly within the first year, among elderly patients. Managing anesthesia in these elderly patients, who often have multiple comorbidities, is challenging. Identifying perioperative factors that can reduce mortality will benefit the perioperative management of these patients.

The aim of this study is to develop and validate a machine learning based model to predict the length of hospital stay for hip fracture patients after PACU. Different machine learning algorithms such as R language Gradient Boosting, Random Forest, Artificial Neural Networks and Logistic Regression will be used in the study and the best performing model will be determined. In addition, the prediction mechanism of the model will be examined with SHAP analysis and its applicability in clinical decision processes will be evaluated. Thus, by predicting the length of hospital stay, clinicians will be enabled to manage patient care processes more effectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent hip fracture surgery at our institution between 2017 and 2024
* Patients aged 65 years or older
* Patients with hip fractures resulting from a low-energy trauma (simple fall from standing height)

Exclusion Criteria:

* Patients with pathological hip fractures due to malignancy
* Cancer patients with multiple organ metastases
* Patients who underwent revision hip fracture surgery
Age and Gender in TMJ Sounds

The temporomandibular joint (TMJ) plays a crucial role in masticatory function, and its proper lubrication is essential for smooth, frictionless movement. Disruptions to the lubricating system, often due to age-related changes or parafunctional activities such as teeth clenching or bruxism, can increase joint friction, leading to vibrations or intra-articular sounds. These sounds have become an essential diagnostic tool for assessing internal derangements of the TMJ. While magnetic resonance imaging (MRI) is considered the gold standard for diagnosing TMJ disorders, its limitations in evaluating intra-articular structures have led to the development of alternative methods, such as Joint Vibration Analysis (JVA). This study explores the relationship between age, gender, and TMJ vibration frequencies using JVA in a cohort of 367 participants. We analyzed four key vibration parameters: Range of Motion (ROM), Total Integral Left (TIL), Total Integral Right (TIR), and frequency distributions in the \<300 Hz and \>300 Hz segments.


Eligibility Criteria:
Inclusion Criteria:

* Participants capable of achieving an inter-incisal opening of 30 to 50 mm without restrictions.
* Free from symptoms indicative of temporomandibular disorder (TMD).
* Possessing fully and/or prosthetically restored dentition.
* Demonstrating adequate mouth opening to facilitate the rotation of the condylar process.

Exclusion Criteria:

* Individuals using psychotropic or narcotic medications, regardless of medical oversight.
* Regular consumption of painkillers or anti-inflammatory agents.
* Long-term treatment with cortisone or its derivatives. Individuals who have sustained traumatic injuries to the maxillofacial region.
* Participants who have suffered the loss of organs and/or tissue in the maxillofacial area due to medical or traumatic causes.
Pilot Study of Wearable Artificial Kidney

This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.

This is a pilot study to evaluate the clearances, tolerability and safety of a wearable artificial kidney device for treating patients with chronic kidney failure.

Eligibility Criteria:
Inclusion Criteria:

* End stage renal failure
* Regular haemodialysis
* Cardiovascular stability
* Stable vascular access

Exclusion Criteria:

* Allergy to heparin or ethylene oxide
* Recent cardiovascular or neurological event
* Unable to provide informed consent
* Age \< 18
Role of Blood Lactate Level in Prediction of Outcome of Cirrhotic Patients at The Intensive Care Unit

1. Determine in-hospital and 28-days mortality rates of critically-ill cirrhotic patients admitted to ICU
2. Evaluate the role of (blood lactate level, lactate/albumin ratio, lactate/bilirubin index and MELD-lactate score) in prediction of mortality compared to other non- lactate containing scores.
3. Study predictors of in-hospital and 28-mortality in these patients.

Liver cirrhosis is a major health problem, which causes high mortality and economic burden worldwide. A large number of liver cirrhosis patients are prone to acute decompensation with organ failure, thus leading them to be admitted to intensive care unit (ICU).

Though liver cirrhosis patients have improved outcomes in ICU over the past decade, the prognosis for those patients remains poor, with in-hospital mortality. Assessment of prognosis, especially in patients with cirrhosis at the ICU, is of importance in order to guide therapeutic measures and improve their outcome.

Many prognostic scores are used to help predicting complications, expected survival and estimate the risk of various medical interventions in these patients as CTP, MELD, CLIF-C OF, CLIF-C AD and CLIF-C ACLF scores. Although these models are non-invasive, they have certain deficiencies as they don't consider other conditions that are associated with poor prognosis as poor tissue perfusion in critically-ill cirrhotic patients.

Lactate is a marker of metabolic changes resulting from tissue hypoxia or stress caused by the release of adrenaline. It was used to improve the prediction of short-term mortality of critically ill patients at ICU. Little is known about role of blood lactate in prediction of prognosis of critically ill Egyptian cirrhotic patients at ICU. Therefore, the investigators will conduct their study to shed some light on this topic.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients who are at least 18 years old at their first ICU admission in Al-Rajhy University Hospital (according to the established admission policy) and stay more than 24 h will be included.

Exclusion Criteria:

* 1) Patients admitted for liver transplantation.
* 2) Patients whose blood lactate data is lost at 24 hours from ICU admission.
* 3) Patients taking drugs that increase level of serum lactate as metformin , acetaminophen, linezolid, epinephrine, beta2 agonists, propofol, nucleoside reverse transcriptase inhibitors (NRTIs) as lamivudine and abacavir , and theophylline
Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)

This study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy.

The study was terminated on January 12, 2009 due to the overall low rate of enrollment. The decision to terminate the trial was not based on any safety concerns. Patients who were enrolled in the study prior to January 12, 2009 were allowed to remain in the study until completing their participation as specified in the protocol.

Eligibility Criteria:
Inclusion Criteria:

Proven or probable invasive aspergillosis. Patient is intolerant to polyene therapy.

Exclusion Criteria:

Patients with invasive aspergillosis for more than 30 days at the time of study entry. Patients with uncontrolled bacterial or viral infection at the time of study entry. Patients with significant liver dysfunction or who are taking certain medications which interact with voriconazole.
Evaluation of the Effects of Different Ventilation Modes Used During Anesthesia Awakening on the Frequency of Postoperative Atelectasis

In our study, we aimed to detect atelectasis developing in patients undergoing surgery under general anesthesia using transthoracic lung ultrasonography and to investigate the effect of ventilation methods used during recovery from anesthesia on the formation of postoperative atelectasis.

Postoperative atelectasis is one of the most common pulmonary complications seen in surgical patients. Postoperative pulmonary complications and possible respiratory side effects have long been associated with anesthesia. Pulmonary complications are an important cause of morbidity and mortality in the postoperative period. The incidence of postoperative pulmonary complications due to long-term anesthesia varies between 5% and 80%, depending on the patient population, the surgery performed, and the criteria used to define the complication. It is known that the recovery period makes a significant contribution to the total amount of postoperative atelectasis. Spontaneously breathing patients are under the influence of anesthetic agents and neuromuscular blockers and cannot regain their functional residual capacity. For this reason, it is emphasized that atelectasis may develop in the postoperative period in cases whose anesthesia application is terminated by applying a spontaneous breathing period. Pressure support ventilation (PSV) is widely used for ventilator weaning in the intensive care unit (ICU) and has recently been available on anesthesia machines.

It is expected that the use of lung ultrasonography in operating rooms can reduce the complications that may develop in the postoperative period with evidence-based detection and early postoperative detection of atelectasis in the early postoperative period.

In this study, it was aimed to compare the effect of pre-extubation ventilation mode applied by anesthesia practitioners with ultrasound in the postoperative period on the frequency of atelectasis in adult patients who underwent surgery and whose lungs were evaluated as normal by ultrasound in the preoperative observation room. Modified LUS scores were used as lung ultrasonography evaluation criteria in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia with supine position
* Endotracheal intubations and mechanical ventilation during general anesthesia
* Operation time is more than 2 hours

Exclusion Criteria:

* Patients who will undergo surgical intervention under emergency conditions
* Pregnancy
* Upper respiratory tract disease in the last 3 weeks
* Previous lung surgery
* Advanced cardiac and/or pleural lung disease and chest wall deformity, and primary or metastatic lung cancer
A Study of PEG-rhG-CSF and rhG-CSF Used for Aplastic Anemia Granulocyte Deficiency

This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.

This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.Research objectives: To explore the reasonable injection frequency of long-acting PEG-rhG-CSF in the adjuvant treatment of aplastic anemia patients with granulocytosis through a single center prospective clinical study.Disease classification of aplastic anemia: a total of 45 cases of SAA/VSAA with ANC\<0.5×109/L were stratified and randomized into three groups according to the radio of 1:1:1(15 cases in each group).PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected;PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected;RhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.Dose/protocol adjustment: after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the original group of drugs.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old, male or female, or weight≥50kg.
2. Patients with severe or very severe aplastic anemia of absolute neutrophil value\< 0.5×109/L
3. ECOG score ≤ 2 points.
4. Normal renal function.

Exclusion Criteria:

1. Patients with clonal chromosomal abnormalities.
2. Patients with previous malignant tumors.
3. Patients with severe or uncontrolled infectious diseases and /or bleeding.
4. Patients with AIDS or syphilis positive.
5. Severe organ dysfunction.
6. Patients used GM/G-CSF,PEG-rhG-CSF,interleukin-11 within 2 weeks before admission.
7. Allergic to G-CSF or PEG-rhG-CSF related components.
8. Participated in other clinical trials within 6 months.
A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants

The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of S-217622 in participants with mild and moderate hepatic impairment compared with control participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥50 kilograms (kg) and body mass index (BMI) within the range of ≥18.5 to \<38.0 kilogram-meter squared (kg/m\^2) at the Screening visit.

Participants With Hepatic Impairment

* A diagnosis of clinically stable hepatic disease for at least 1 month prior to the Screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique (including laparoscopy, computerized tomography \[CT\] scan, magnetic resonance imaging \[MRI\], or ultrasonography).
* Mild or moderate hepatic impairment based on the Child-Pugh classification score at the Screening visit to determine eligibility:

  1. Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6)
  2. Moderate (Class B) hepatic impairment (Child-Pugh classification score 7 to 9)
* A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the Follow-up/Early Termination visit.

Healthy Participants

* Matched to each participant with moderate (and mild when possible) hepatic impairment with respect to sex, age (± 5 years), and BMI (± 10%).

Exclusion Criteria:

* History or presence of/significant history of or current cardiovascular, respiratory, renal, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
* History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function.
* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Breast cancer within the past 10 years.
* Participant with poor venous access.

Other inclusion and exclusion criteria may apply.
The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery

Study objective:

This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots.

Eligible patients:

Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.

Study intervention:

Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules.

Any serious postoperative complication needing intervention, specifically re-bleeding, wound infection, wound rupture, or the occurrence of blood clots for the first 30 days after surgery will be registered through the following interventions:

* Screening of patient medical records
* Distribution of an electronic self-report form (eForsk®) to participating patients at postoperative day 30
* Follow-up phone call to verify data after day 30.

The study is terminated after the final phone call. All study data will be registered in an electronic, pseudonymous web-based registration form (eCRF/Viedoc®).

Number of participants: To assess the effect of TXA on the defined surgical complications compared to placebo, 1500 patients are needed in each group.

Data monitoring committee:

A data monitoring committee consisting of a group of independent scientists will be appointed for this study to monitor the safety and scientific integrity of this human research intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible to be included in the study only if all of the following criteria apply:

  1. They are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center.
  2. They are over 18 years of age and capable of independently providing informed consent
  3. They have received adequate oral and written information about the study and signed the informed-consent form

Exclusion Criteria:

* Patients with known allergy to tranexamic acid. Insufficient knowledge of national language or English.