cyrilzakka/clinical-trials huggingface dataset:
Biomarkers for Gynecologic Cancer

A novel blood metabolic biomarker, AminoIndexTM (gynecological), was developed for gynecological cancers from over 400 Japanese patient's plasma free amino acid profiles (PFAAs) by a rapid and sensitive LC-MS (Liquid Chromatography - Mass Spectrometry), followed by multivariate statistical analyses. However, further studies to assess whether this biomarker demonstrates the same performance characteristics in non-Japanese populations for cancer is yet to be determined.

"AminoIndex Technology" was developed based on high-throughput and absolute quantitative analysis method of amino acids and amines using UFLC-MS, and creating a clinical database to search for amino acid patterns across different diseases including cancer. "AminoIndex Technology" can evaluate certain health conditions and the possibility of diseases by analyzing the balance of plasma amino acids. Multicenter studies in Japan were conducted to develop an blood based biomarker panel for cancer.

This study wil be conducted to evaluate the performance of AminoIndexTM (gynecological) biomarker based on "AminoIndex Technology" for gynecological cancers in US populations. This will be done by analyzing plasma metabolites including amino acids, from endometrial and ovarian cancer patients, from patients with benign gynecological disease, and healthy subjects using Liquid Chromatography and Mass Spectrometry (LC-MS) and Liquid Chromatography - Tandem Mass Spectrometry (LC-MSMS).

Eligibility Criteria:
Inclusion Criteria:

Participants in this study will be patients with Primary endometrial and ovarian cancer, benign gynecological diseases (such as uterine fibroids, endometriosis, dysplasia, and benign ovarian tumors), and healthy subjects that meet the following criteria:

* Age \> 20 years (no data is currently available on use of AminoIndexTM in patients under 20 years of age or over 80 years of age)
* Willing to follow fasting and clinic visit requirements
* Ability to understand and consent to participate in study.

Women of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

Women will be excluded from study participation for the following reasons:

* An inability to fast (no food or drink other than water) for 8 hours prior to the pre-surgery sample collection.
* Are known to be positive for HIV/HCV/HBV
* Pregnancy or breastfeeding (Pregnant and breastfeeding women are excluded from this study because amino acid levels are known to differ in pregnancy).
* Currently receiving investigational agents.
* History of any drug therapy or surgery for treatment of gynecological cancer
* Unable to come for the blood sample collection between 6:00 AM and 12:00 Noon
* Currently undergoing dialysis
* Congenital metabolic disease
* The investigator considers individual to be ineligible based on prior medical history, histology or other findings
Effect of Specifically Developed Exercise Intervention on Falls Among Older Adults in Nursing Homes

The aim of the study is to examine the effect of multicomponent exercises recommendations on falls, physical functioning, physical activity, and general physical and psychological well-being among Hungarian older adults dwelling in nursing homes.

Methods: Randomized controlled trial of an individually exercise guideline recommended by IAGG-GARN for older males and females living in a nursing home. A stratified randomization will be performed after the baseline assessment. The assessment of primary and secondary outcomes takes place in all subjects upon entry to the study (pre-test) by blinded assessors and at 12 weeks (post-test). After baseline assessments is completed, participants will be randomly allocated to one of the two groups using stratified randomization based on equal distribution of age and gender ratio.

Expected results:

* Reduce the incidence of falls among the nursing homes residents of the intervention group (IG)
* Increase of lower extremity physical functional ability (balance, gait speed, and strength) of the IG
* Improvement of level of physical activity independency of the IG
* Improvement of functional independency of the IG
* Improvement of physical and psychological well-being among IG.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate
* Males and females aged ≥65 years living in nursing homes
* Physically mobile (capable of ambulating/rising from chair with or without assistance)
* Not under simultaneous physical activity/exercise investigation in other experimental studies or under other exercise rehabilitation programme
* To be able to read and understand the self-reported assessments as well as follow the verbal instructions.

Exclusion Criteria:

* Physically unable or medically unfit to participate in physical exercise after consultation of the responsible medical team
* Score of \< 18 on mini-mental state examination (MMSE).
Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage

The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
* At least 18 years of age.
* Total antral follicle count of at least 12 as measured by ultrasound prior to stimulation.
* Basal FSH \< 10 IU.
* At least 8 normally fertilized eggs (2PN.)
* Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
* Willing to comply with study protocol and procedures and able to speak English.

Exclusion Criteria:

* Planned preimplantation genetic diagnosis or preimplantation genetic screening.
* Gestational carriers.
* Use of reinseminated eggs.
* Concurrent participation in another clinical study.
* Previous enrollment in this clinical study.
* History of cancer.
Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation

Weaning is an important process to gradually separate mechanically ventilated patients from ventilators. A good weaning strategy aims to early identify mechanically ventilated patients who are ready for extubation but not to prematurely extubate them. Spontaneous breathing trial (SBT) is a test to assess the patient's ability to breathe spontaneously when extubated. Several methods have been used to conduct an SBT, including T-piece breathing, low-level pressure support ventilation (PSV) of 5-7 cm H2O, continuous positive airway pressure and automatic tube compensation (ATC).

The investigators hypothesized that an SBT with inspiratory pressure augmentation increases initial SBT success, reduces the length of invasive mechanical ventilation (iMV) support and does not increase reintubation risk as compared with T-piece, which result in a higher proportion of patients successfully liberated from iMV in the inspiratory pressure augmentation group. However, inspiratory pressure augmentation significantly reduces work of breathing on an SBT as compared with T-piece. Patients extubated following an SBT with inspiratory pressure augmentation may experience increased respiratory effort after extubation and this may increase the use of noninvasive ventilation after extubation. An SBT with inspiratory pressure augmentation increases iMV free days but not MV free days as compared with T-piece. Longer iMV free days may be associated with a lower mortality due to fewer iMV related complication.

This study is a pragmatic, cluster-randomized, multiple crossover, multicenter trial to compare SBTs with T-piece versus inspiratory pressure augmentation in weaning outcomes. Mechanically ventilated patients who meet the criteria for readiness to SBT will be included. The patients will use either T-piece or inspiratory pressure augmentation as SBT for weaning according to an ICU-based cluster randomization and crossover sequence.


Eligibility Criteria:
Inclusion Criteria:

1. Admitted to the adult intensive care unit (ICU)
2. Receiving invasive mechanical ventilation via an endotracheal tube
3. Ready to start an SBT\* \*The criteria of readiness to an SBT include FiO2 ≤ 0.4, PEEP ≤ 8 cmH2O, minute ventilation ≤ 0.15 L/min/predicted body weight, inspiratory pressure or driving pressure ≤ 14 cm H2O, stable cardiovascular status and no worsening of non-pulmonary organ function.

Exclusion Criteria:

1. Age \< 20 years
2. Receiving mechanical ventilation via tracheostomy
3. Mechanical ventilation \< 12 hours
4. Invasive ventilation started before the index hospitalization
5. On do-not-intubate order
Register of Therapeutical Patients Over 60 Years

Register for the study of the prevalence and burden of diseases, risk factors and outcomes of hospitalizations in older age groups in the countries of Eurasia.

An open, multicenter registry to track all major noncommunicable diseases and risk factors in older age groups, prescribed drugs, and disease outcomes.

Eligibility Criteria:
Inclusion Criteria:

* over 60 years
* Appointment to a doctor of a therapeutic profile

Exclusion Criteria:

* Reluctance of the Patient to participate in the Register;
* Age under 60 at the time of inclusion in the Register.
Effect of Renal Impairment on the Pharmacokinetics of NN9535

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
* Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft \& Gault formula) for any of the renal function groups
* Body Mass Index (BMI) equal to or less than 40kg/m2

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Renal transplanted patients
* Certain cardiac problems (heart failure, unstable angina, MI (myocardial infarction) within the last 3 months)
* Known current hepatic dysfunction or severe hepatic disease during the last 12 months
* Female of childbearing potential/breast feeding
* History of alcoholism or drug abuse
* Blood donation during the last 8 weeks prior to the study
* Past or current history of pancreatitis
Place of Jugular Ultrasound in the Evaluation of the Volemia by a Clinician Doctor in Routine Care

Interventional study with minimal risks and constraints, prospective, monocentric.

To appreciate the volemia of a patient is a frequent problem in hospital in various situations: renal insufficiency, dyspnea, dysnatremia, etc. The aging of the population, the chronicity of pathologies, overweight among other causes can make it difficult to assess the volume of the disease by the clinic alone. The consequences of a poor evaluation are delayed management and possible iatrogeny.

New discrimination markers have emerged to help the clinician such as "brain natriuretic peptide (BNP)" in dyspnea, and especially transthoracic echocardiography (TTE) assessing filling pressures with a high potency. discrimination. In current practice the TTE has unequal accessibility, and requires trained practitioners. It is difficult to have an TTE performed for all patients where the question arises.

Just as an assessment of the initial volemia is often necessary, there are few objective monitoring criteria. One can quote the variation of the weight or the evolution of certain biological parameters but none is completely specific.

A new marker has been described for a few years: jugular ultrasound. Better accessibility (requires only a probe of 7-9Hz, possibly 5Hz), it can indeed be performed by any practitioner in less than a minute. The jugular distension is a reflection of cardiac pre-load and can be correctly estimated by ultrasound. It has been shown that cardiac decompensated patients have dilated jugular veins compared to a reference population. A low cohort also demonstrated the presence of jugular ultrasound distension in the absence of clinical distension.

In a US study, 119 patients admitted to the emergency department for dyspnea had a sensitivity of 99% for a specificity of 59% for trans-jugular ultrasound in cardiogenic edema.

However, many applications remain to be explored, and the repeated use of jugular ultrasound in the same patient has never been studied. The accessibility of the measure could make it an excellent monitoring tool.

As a clinical situation, the investigators chose a well standardized and studied situation such as blood transfusion that can bridge the preload measured by invasive measures and measured by jugular ultrasound. This situation is complicated in patients in 1 to 5.7% of the situations of secondary pulmonary overload.

Eligibility Criteria:
Inclusion Criteria:

* Major patient;
* Requiring a transfusion of 2 or more red blood cells in a routine care situation (transfusion programmed in the context of a day hospital or a traditional hospitalization, except in cases of massive bleeding);
* Affiliate or beneficiary of a social protection scheme;
* Having given his written consent.

Exclusion Criteria:

* Patient with clinical or biological criteria for admission to intensive care as defined in the 1999 US ICU Practice Guidelines;
* Major persons subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty;
* Pregnant or lactating woman
Efficiency of Botulinum Toxin Type-a in the Management of the Myofascial Pain

\*\*Study Title:\*\* Investigation of the Relationship Between Clinical Outcomes and Pain Mediators in the Treatment of Masticatory Muscle Disorders Associated with Myospasm Using Onabotulinum Toxin A

\*\*Study Importance:\*\* Temporomandibular disorders (TMD) are a major cause of chronic orofacial pain, affecting 5-12% of the population. Masticatory muscle disorders (MMD) are a common subgroup of TMD, ranging from localized myalgia to fibromyalgia. Myospasm is characterized by sudden pain, malocclusion, and limited jaw movement, while myalgia includes localized, myofascial, and referred pain patterns. The etiology of MMD is complex, involving neuromuscular dysfunction, inflammation, and increased acetylcholine activity at the neuromuscular junction. Various mediators, including CGRP, substance P, and inflammatory cytokines, play a role in sensitization and pain perception.

\*\*Objective:\*\* This study aims to evaluate the effectiveness of onabotulinum toxin A (BTX-A) in patients with MMD who have not responded to conventional non-invasive treatments. It hypothesizes that BTX-A reduces pain by decreasing inflammatory cytokines and neuropeptides associated with pain.

\*\*Methodology:\*\*

* \*\*Study Design:\*\* Prospective observational clinical study.
* \*\*Participants:\*\* Patients diagnosed with MMD based on RDC/TMD criteria, who have not improved with conventional treatments.
* \*\*Exclusion Criteria:\*\* Conditions such as pregnancy, metabolic disorders, trauma, systemic diseases, and medication use that could interfere with results.
* \*\*Intervention:\*\* BTX-A will be injected into the masseter and temporalis muscles (30 and 15 units per side, respectively) following a standardized protocol.
* \*\*Data Collection:\*\*
* Before (T0) and one month after (T1) treatment.
* Clinical assessments include maximum mouth opening (MMO), pain levels (VAS), and oral health impact profile (OHIP-14).
* Blood and saliva samples will be analyzed for IL-1, IL-6, TNF-α, CGRP, and NGF using ELISA.
* \*\*Statistical Analysis:\*\* Dependent t-test or Wilcoxon signed-rank test will be used to compare pre- and post-treatment values. Correlations between biomarker levels and pain reduction will be analyzed using Spearman correlation.

\*\*Expected Outcomes:\*\*

* Significant reduction in pain and improvement in MMO.
* Decreased levels of inflammatory and neuropeptide biomarkers.
* Evaluation of saliva as a non-invasive medium for biomarker analysis, potentially guiding future diagnostic and monitoring strategies.

\*\*Significance:\*\* This study provides insights into the pathophysiology of MMD and the efficacy of BTX-A in pain management, potentially offering an alternative therapeutic approach for patients resistant to conventional treatments.


Eligibility Criteria:
Inclusion Criteria: Patients diagnosed with MMD based on RDC/TMD criteria, who have not improved with conventional treatments.

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Exclusion Criteria:Conditions such as pregnancy, metabolic disorders, trauma, systemic diseases, and medication use that could interfere with results

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Genetic Load and Phenotype in Aggressive AMD

Patients with AMD will provide cheek cell samples to determine if their is a correlation between genotype (DNA markers) and phenotype (the type of AMD the patient has).

This study seeks to test individuals who have already progressed to various forms of AMD to evaluate correlations between genetic markers and particular features of AMD including geographic atrophy and pigment epithelial detachments. We hypothesize that patients with more aggressive forms of AMD will have a higher genetic burden contributed by markers in ARMS 2, Complement Factor H (CFH), Complement component 3 (C3), Complement component 2 (C2) , Factor B (FB), or other genetic polymorphisms associated with CNV.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female 50 years of age and older
* Subject provides a signed and dated informed consent
* Subject agrees to provide two buccal swabs in accordance with this protocol
* Diagnosis of CNV secondary to AMD in at least one eye

Exclusion Criteria:

* Previous sample donation under this protocol
* Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases which have been present prior to the age of 50.
* Opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate imaging of the posterior segment.
Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients

With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs of omitting prophylactic FFP transfusion compared to current practice of prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.

Rationale: Fresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients.

Objective: With the aim to restrict inappropriate FFP transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of ICU patients with a coagulopathy undergoing an invasive procedure. The objective is to assess the effectiveness and costs of prophylactic FFP transfusion (current practice) compared to no prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy, prior to undergoing an invasive procedure (e.g. placement of central venous catheter, tracheostomy, chest tube).

Study design: Prospective, multicentre, randomized, open-label, blinded end point evaluation (PROBE) design.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* INR \>1.5 and \<3.0
* undergoing invasive procedure (insertion of a central venous catheter, a chest drain, percutaneous tracheostomy)

Exclusion Criteria:

* clinically overt bleeding at the time of the procedure (excludes minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, or normal menses)
* thrombocytopenia of \< 30 x 109/L.
* use of abciximab, tirofiban, ticlopidine or activated protein C
* use of heparin \< 1 hour prior to the procedure, or low molecular weight heparin in therapeutic doses \< 12 hours prior to procedure
* history of congenital or acquired coagulation factor deficiency or bleeding diathesis
* no informed consent
Probiotics for Gallstones in Post-bariatric Surgery Patients

Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving bariatric surgery for morbid obesity
* Patiets at ages between 20 to 60 y/o
* Patients willing to follow up regulary after bariatric surgery

Exclusion Criteria:

* Patients having gallstones before bariatric surgery
* Patients refusing taking probiotics or refusing regular follow up after bariatric surgery