cyrilzakka/clinical-trials huggingface dataset:
Transfusion and Skeletal Muscle Tissue Oxygenation

The aim of the present study was to re-challenge the current data that anaemia in chronically anaemic haematology patients is not associated with low skeletal muscle StO2, and that the age of RBCs does not influence tissue responses. The investigators investigated these aspects using improved technology NIRS devices, for deeper tissue penetration and removal of the superficial signal from the skin.

Anaemia is state of decreased blood oxygen carrying capacity . Acute anaemia is associated with increased tissue oxygen extraction . On the other hand, with chronic anaemia human body has time to at least partially adapt to decreased blood oxygen carrying capacity , .

Near-infrared spectroscopy (NIRS) is non-invasive method to assess tissue oxygenation (StO2) and estimate tissue haemoglobin (THb) levels . The investigators have studied skeletal muscle StO2 in critically ill patients with preserved oxygen (i.e., cardiogenic shock) and with impaired oxygen extraction (i.e., septic shock) , , . In addition to measuring resting StO2, the investigators performed vascular occlusion tests to stop arterial blood flow, to estimate oxygen consumption, and at the end of the occlusion, it was also possible to estimate vascular reactivity and maximal reperfusion capability .

Under acute blood loss in trauma patients, the skeletal muscle StO2 measured by NIRS correlates with blood haemoglobin (Hb) and delivery of oxygen, and can easily detect latent stage of haemorrhagic shock . Unexpectedly, chronically anaemic haematology patients with preserved oxygen extraction capability did not show low skeletal StO2 and THb index despite their severe anaemia, which is what would be predicted from normal physiological responses .

It is known that there are structural and functional changes to RBCs during storage. Recent study detected deleterious effects of RBC storage on microvascular responses to transfusion in stable anaemic trauma patients .

The aim of the present study was to re-challenge the current data that anaemia in chronically anaemic haematology patients is not associated with low skeletal muscle StO2, and that the age of RBCs does not influence tissue responses. The investigators investigated these aspects using improved technology NIRS devices, for deeper tissue penetration and removal of the superficial signal from the skin.

Eligibility Criteria:
Inclusion Criteria:

* chronic haematologic patients

Exclusion Criteria:

* pregnancy
* rejection to participate
Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery

The primary purpose of this study is to evaluate the safety and efficacy of preoperative intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* Patients scheduled to undergo hip or knee replacement
* 8 g/dl \< Hb \< 13 g/dl for men and 8 g/dl \< Hb \< 12 g/dl for women at screening (3-4 weeks prior to surgery)
* anemia
* signed written informed consent

Exclusion Criteria:

* immunosuppressive or myelosuppressive therapy
* history of thromboembolic events
* a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
* hypersensitivity to any component of the formulation
* transfusion within 1 month prior to study inclusion
* liver values 3 times higher than normal
* active severe infection/inflammation
* renal insufficiency
Medical Illustration Design Characteristic Evaluation

The goal of this study is to understand what people understand from medical illustrations, and what meaning and emotions (such as anxiety) they derive from different design elements.

The investigators will conduct cognitive interviews to understand the meaning laypersons obtain from different illustrations, their opinions on illustration styles, and their level of anxiety after viewing illustrations.

The investigators will also study the effect of systematically varying medical illustration designs on layperson understanding and anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Speaks English or Spanish ﬂuently
* Is able to independently consent
* Has adequate corrected vision to read patient education documents

Exclusion Criteria:

\* None
Advance Care Planning in Primary Care: a Cluster Randomized Clinical Trial

The study on the effectiveness of a training program in Advance Care Planning (ACP) with primary care professionals has been designed as a cluster-randomized clinical trial.

Aim: To measure the effectiveness of a training program on ACP in Primary healthcare professionals in a population area of Catalonia. Design: Cluster Randomized clinical trial with a measure of pre-post effectiveness between groups of intervention based on the measurement of self-efficacy in advance care planning. Scope: Barcelona Nord and Maresme (BNM). Population: Primary care doctors and nurses. Sample: doctors and nurses from the Primary Care Service (SAP) of the BNM. The study is divided into 3 phases: 1) Planning: training design, randomization and parallel assignment in 2 arms, online training versus online and face-to-face training; 2) Implementation: data collection pre-intervention and training; 3) Evaluation: post data collection (1 follow-up 4 months after recruitment/ after training) and data analysis. Intervention: both arms (A and B) will carry out the online training which consists of a 10 hours course. Arm B will also do the 6-hour face-to-face workshop, divided into two sessions of 3 hours. Primary outcome: ACP Self-efficacy (using a validated scale Advance Care Planning-Self Efficacy Spanish (ACP_SEs). Secondary outcomes: Socio-demographic: age, gender, years of professional experience and in the professional field, previous knowledge in ACP, previous training in ACP; training Satisfaction; ACP Registration Variables in the medical records of patients identified as chronic advanced patients:% clinical records with ACP processes registration, identification of the surrogate decision-maker, values, preferences, and specific decisions records, identification of the place of care and of death preferred, adequacy of the place of death in case of death. Analysis: calculation of the sample applying correction values for the cluster effect; mean, median, range, confidence interval, and standard deviation of quantitative variables and absolute and relative frequency of qualitative variables. Pre- and post-comparison for the measurement of variance (ANOVA) resulting between the intervention groups from the chi-square test; multivariate logistic regression model and 5% significance level


Eligibility Criteria:
Inclusion Criteria:

* Cluster inclusion criteria:

  • Being a primary care team belonging to SAP BNM.
* Individuals inclusion criteria:

  * Being a doctor or a nurse working at the primary care teams recruited.
  * 280 will take part in the study, belonging to the 10 primary care teams recruited.

Exclusion Criteria:

* Cluster inclusion criteria:

  • Being teams that share Primary Care Center, in order to avoid contamination between clusters as long as they share patient assignment.
* Individuals inclusion criteria:

  * Professionals who refuse to be part of the study.
Assessment in Patients After Thoracic Surgery

Lung cancer is the leading cause of death in men and the second in women with a 5 year survival in Europe of less than 15%. One of the methods most used for its treatment is pulmonary resection. The objective of this study is to analyze the clinical profile presented to patients after pulmonary resection.

One of the most widely used methods for the treatment of lung cancer is pulmonary resection. The morbidity and mortality of pulmonary resection surgery is conditioned by both the type of intervention and the patient's condition. Functional deterioration is a risk associated with hospitalization in the elderly, with a high prevalence (35-70%) and serious consequences, since in the majority it can lead to the appearance of complications not related to the reason for admission or the specific treatment. It is very important to evaluate the clinical profile of patients after pulmonary resection in order to stablish a more specific repercussion.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted for lung resection and who sign the informed consent

Exclusion Criteria:

* Patients who did not agree to sign informed consent and those who presented other types of problems to be able to adequately carry out the assessment, such as not handling the language.
The Relationship of the Intestinal Microbiome and the Menstrual Cycle

In the present study the dynamic changes of the intestinal microbiome are observed over a 4-week period in the different stages of the menstrual cycle in women at childbearing age. The focus is on how the dynamic changes of sex hormones during a menstrual cycle of women at childbearing age (with or without contraception) are related to microbiological colonization of the gut. In Addition the Expression of the β-glucuronidase by the bacteria will be investigated.

Our gut has a complex and diverse bacterial population which is called the microbiome. The number of bacteria in the intestine is estimated to exceed 10\^14. The composition of the microbiome is individual and changes over the lifetime of the host.

The composition of a healthy microbiome consists more than 90% of bacteria from the Bacteroidetes and Firmicutes phyla types. Nevertheless the microbiome varies even between healthy individuals and evolves over the lifetime.

Most of the microorganisms are not pathogen, thus they have been shown to interact with several physiological processes in our body. In Addition it has been shown that the bacterial population has an impact on building our gut epithelial cells, our immunology and the defence against pathogens.

Interestingly estrogen and the microbiome seem to be under reciprocal influence. In our body estrogen is only active in the deconjugated form. Therefore, after it was conjugated in the liver, the bacteria in the gut can perform a deconjugation through the secretion of the enzyme ß-glucuronidase. Ultimately, the activated estrogen is going back into blood circulation, otherwise it would leave the body through bile excretion. The composition of the microbiome is fundamental, because the presence and abundance of different gene expressions varies between the different types of bacteria. The bacterial genes which are responsible for metabolizing estrogens are called the estrobolome. However, data whether there is a relationship of the changes of the sex hormones during the menstrual cycle and the intestinal microbiome in women is sparse.

Parts of the estrogens circulating in the body are metabolised in the liver and are then secreted to the intestine conjugated with glucuronide. The intestinal microbiota could potentially affect estrogen metabolism via Beta-glucuronidase activity. Beta-glucuronidase is an enzyme that catalyses the deconjugation of estrogen. As a consequence, it may bind to estrogen receptors and unfold its downstream effects.

Eligibility Criteria:
Inclusion Criteria:

* women at childbearing age
* age 18-40 years
* BMI 18.5-24.9 kg/m²
* taking oral contraceptives
* not having any contraceptives

Exclusion Criteria:

* chronic and acute infectious diseases
* history of taking antibiotics or probiotics in the last 3 months
* gastrointestinal disorders in the last 3 months
* Polycystic Ovary Syndrome
* disorders of the menstrual cycle (e.g. oligomenorrhea, anovulation)
* other than mediterranean diet
Immunisation Simulation Using the Real-size Infant Manikin in Medical Education

This was a quasi-experimental study that comprised medical students in pediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta. The investigators determined students' knowledge and practice improvement through simulation by using the real-size infant's arm and leg manikins; and evaluate the confidence in immunization after the simulation.


Eligibility Criteria:
Inclusion Criteria:

* Medical students in paediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta
* Medical students who attended immunisation workshops

Exclusion Criteria:

* Students who refused to participate
* Students who did not attend the immunisation workshops
Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

This a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by the physician and by the patient in a dairy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute Pharyngitis according to instruction for use
* Female or male individuals ≥ 18 years
* Agreement to abide by the routinely provided doctor's appointment for follow- up (reflected in the planned visits of observation plan resist)

Exclusion Criteria:

* Contraindications according to instructions for use
* Male or female person under 18 years
* Sore throat for more than 5 days
* Any disease that can, in the opinion of the treating physician to affect the outcome of the study.
* Patients with known intolerance to one of the substances used
* Surgical procedures to the mouth and throat in the last 6 weeks before inclusion in the NIS
* Bacterial Pharyngitis
* Pregnancy
Prospectively Predict the Efficacy and Explore the Mechanism of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy

Dynamic multiomics detection of plasma derived exosomes to explore the efficacy and mechanism of anti-HER2, immunotherapy and anti-CLDN18.2 of gastrointestinal cancer.

The investigators will recruit 500 advancer/late-stage gastrointestinal cancer patients.Blood and tumor tissue will be collected at treatment baseline, every time point response till disease progression. All samples will be processed by exosomes proteome detection to explore the efficacy and mechanism of anti-HER2, immunotherapy and anti-CLDN18.2 of gastrointestinal cancer.

Eligibility Criteria:
Inclusion Criteria:

* • Having signed informed consent

  * Age:18-80 years old
  * Histologically confirmed GI cancer
  * Unresectable recurrent or metastatic GI cancer
  * Previous neo-adjuvant or adjuvant treatment for GI cancer, if applicable, more than 6 months
  * Measurable disease according to the RECIST criteria
  * Karnofsky performance status ≥70
  * Life expectancy of ≥3 month
  * No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
  * ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
  * Serum albumin level ≥3.0g/dL
  * Serum AKP \< 2.5 times ULN
  * Serum creatinine \<ULN, and CCr \< 60ml/min
  * Bilirubin level \< 1.5 ULN
  * WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Previous systemic therapy for metastatic GI cancer

  * Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
  * Allergic constitution or allergic history to protium biologic product or any investigating agents.
  * Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
  * Pregnancy or lactation period
  * Other previous malignancy within 5 year, except non-melanoma skin cancer
  * Legal incapacity
Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)

The purpose of this research study is to evaluate a decision support tool for patients diagnosed with ductal carcinoma in situ (DCIS).

Today, guideline concordant care options for patients diagnosed with ductal carcinoma in situ (DCIS) are lumpectomy (with or without radiation treatment) and mastectomy, with optional endocrine therapy. Several ongoing trials are evaluating the safety of active monitoring (AM) as an alternative to immediate surgery for select patient groups. Little is known about women's acceptability of AM after a diagnosis with DCIS.

Here the study team seeks to answer the question: if AM is found to be a safe alternative to immediate surgery, how likely are women to choose it as their first course of treatment?

In this study, women are asked to imagine having recently been diagnosed with DCIS. For some in the intervention arm, in-depth information about surgical options and AM are presented with a web-based decision support tool. After exploring the decision support tool, participants are asked to make a hypothetical treatment choice and to answer a series of additional questions about their decision-making process and personal preferences. Women in the control arm receive a reduced version of the decision support tool that only provides in-depth information about the surgical options (AM is mentioned as an experimental approach).

The overarching hypothesis of this study is that patients who are offered AM as a guideline-concordant care option (a potential future scenario if ongoing trials confirm the safety of AM) are more likely to choose it compared to women in current clinical practice (who receive information about surgical options only).

Primary research question: Compared to presenting active monitoring (AM) as an experimental option, does presenting AM as a guideline-concordant care option increase its uptake as treatment choice?

Secondary research questions: Compared to presenting active monitoring (AM) as an experimental option, does presenting active monitoring as a guideline-concordant care option increase AM acceptability, decrease perceived AM riskiness, and decrease uptake of mastectomy as treatment choice?

Eligibility Criteria:
Inclusion Criteria:

* Sex: Female
* Age: 50-79 years
* Has had a negative mammographic screen in the past 12 months

Exclusion Criteria:

* Personal history of breast cancer
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig in adult participants with MM.

Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide

In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Eastern cooperative oncology group (ECOG) performance of \<= 1.
* Confirmed diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria with either newly diagnosed or relapsed or refractory (RR) MM, depending on the substudy.

Exclusion Criteria:

* Participant who has known active central nervous system involvement of MM.
* Participant who has known active infection as outlined in the protocol.
A Pharmacokinetic Study of Sugammadex in Dialysis Patients

The primary objective of this prospective study is to assess the trend of sugammadex (and its complex with rocuronium) concentration in surgical patients with routine outpatient hemodialysis. Patients with end stage renal disease who are to receive general anesthesia and muscle paralysis will have their paralysis by rocuronium reversed with sugammadex. Patients will then have blood drawn during their next three routine hemodialysis sessions to assess for the plasma concentration of sugammadex or the sugammadex-rocuronium complex over time.

Patients with end-stage renal disease often have several additional comorbidities and stand to benefit immensely from this established superior drug. Prior studies have not been able to correlate negative adverse events with sugammadex in patients with end-stage renal disease. More work needs to be done, however, to assess the fate of this renally excreted molecule. It has been shown that there is potential to clear sugammadex with high flux dialysis. We hypothesize that post-surgical patients with end-stage renal disease will see a significant decrease in plasma sugammadex concentration after routine outpatient dialysis.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Currently on hemodialysis renal replacement therapy
* To be undergoing a surgical procedure with the intent of starting hemodialysis postoperatively
* To be undergoing a surgical procedure requiring general anesthesia
* To have neuromuscular blockade for the surgical procedure

Exclusion Criteria:

* Diagnosed with a blood-borne infection (Hepatitis B or C, HIV)
* Allergy to rocuronium or sugammadex
* Planned renal transplant procedure
* Peritoneal dialysis patient
* Starting hemoglobin value of less than 8.0 g/dl
* Women who are currently pregnant