cyrilzakka/clinical-trials huggingface dataset:
Postoperative Delirium at Heidelberg's Intensive Care Unit -New Diagnostic Markers

Summary:

Postoperative delirium is a highly prevalent disease (10-30% prevalence) after surgery in intensive care unit, however, it is often misdiagnosed and mistreated. The aim of the present project is to investigate risk factors for postoperative delirium in more detail, to evaluate respective cognitive test systems and to measure EEG activity parallel to patients' serum anticholinergic activity. The pathophysiology of delirium is unknown up to now: a possible dysbalance between cerebral acetylcholine and dopamine concentrations is a likely hypothesis. Therefore, the measurement of peripheral serum anticholinergic activity could be a new prognostic factor for evaluation of delirium. Because delirium is also associated with higher postoperative mortality and morbidity, with delayed functional recovery, and postoperative delirium makes patient management much more difficult, increases costs, and, above all, causes severe discomfort to the patient new interdisciplinary diagnostic strategies are necessary to resolve this problem.


Eligibility Criteria:
Inclusion Criteria:

* All patients at Intensive Care Unit over a defined time period
* Over 18 years old

Exclusion Criteria:

* Elective heart and vascular patients
Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib

The overall goal of this real-world data collection is to assess demographic, clinical characteristics and real-world effectiveness of pediatric neuroblastoma patients treated with lorlatinib through the expanded access program.


Eligibility Criteria:
Inclusion Criteria:

* Patient receives lorlatinib through Pfizer's expanded access program for treatment of ALK+ neuroblastoma.
* HCP documentation of at least one tumor assessment of response after patient has had at least one dose of lorlatinib
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Any patient who does not meet any of the inclusion criteria defined in the previous section.
Validation and Standardisation of a Pool of Simplified Evaluation Aimed to the Diagnoses of Aphasic Disorders and Adapted to the Patients Suffering an Acute Phase of Stroke

Every year in France, from 100 000 to 145 000 people are affected by a stroke. 75% patients survived with aftereffects, in particular aphasic disorders.

A sketch of a new tool called BESTA aiming to a rapid handover to the acute phase post stroke had been worked out. After a meeting, 13 multidisciplinary experts have discussed, adjusted and a new complete tool (BESTA) had been created in order to evaluate the different states of aphasia.

The goal of this study is the validation and the standardization of this new BESTA tool.


Eligibility Criteria:
Inclusion Criteria:

Patients with stroke:

* Every patient over 18,
* admitted among neuro-vascular unit,
* native french speaker,
* the level of vigilance is satisfactory in order to allow a speech therapy test.

Healthy Volunteers:

* Every volunteers over 18,
* without any medical history of a stroke or any speech disorders,
* native french speaker.

Exclusion Criteria:

Patients with stroke and Healthy Volunteers :

* dementia disease
* psychiatric condition
* non-equipped deafness
* pregnant woman
* patient with medical histories of stroke
Factors Affecting Mortality and Morbidity in Trauma Patients Followed in Intensive Care Unit

In this study, the demographic and clinical characteristics of trauma patients followed up in the Intensive Care Unit of the Anesthesiology and Reanimation Clinic of the Health Sciences University Okmeydanı Training and Research Hospital for a 2-year period were evaluated prospectively to determine the morbidity and mortality rates and to determine the factors affecting these rates. data.

Trauma is an important health problem that causes increased morbidity and mortality. Most of the patients are taken into intensive care and followed up in intensive care with severe and multitrauma and constitute an important part of the critical diseases followed in the intensive care unit. At the same time, these fatal injuries cause a serious public health problem both economically and socially.

According to World Health Organization data, 5.8 million people die each year due to trauma. Trauma is seen more frequently at a young age and the most common cause is motor vehicle accidents and it is the first cause of death between 1-44 years. There is a strong relationship between deaths caused by trauma and factors such as age, gender, cause of trauma, and trauma area. In addition, the duration of ICU and mechanical ventilator stay, supportive treatments, trauma scores, and scores such as APACHE 2 and SOFA routinely used in intensive care have been shown to be strongly associated with mortality.

Therefore, the demographic data, trauma scores, mechanical ventilator requirement, renal failure, inotropic need, intensive care scores such as APACHE 2, SOFA, re-operation, re-operation, intensive care stay, blood replacement need, wound infection and morbidity and mortality in trauma patients will be effective.

Eligibility Criteria:
Inclusion Criteria:

* Trauma Patients Followed up in the Intensive Care Unit between 14 October 2019 and 15 October 2021
* All trauma patients over the age of 18 who signed the informed consent form and agreed to participate in the trial

Exclusion Criteria:

* Patients under the age of 18
* Patients who refused to participate in the study
* Non-traumatic patients
3D or 2D Upper Extremity Exergaming for Persons With Parkinson's Disease

A pilot study with the "10cubes" for small and precise movements and training in the virtual environment will be carried out. We will recruit at least 20 persons with Parkinson's disease to participate in the study. Such activities can increase participation, slow down the progress of the disease and contribute to the functional improvements of the hand that lead to the increased quality of life. The movement of the hand will be assessed with a small 3D camera, also suitable for the estimation of kinematic parameters. Participants will be randomized into 2 groups; one group using an LCD screen and the other using 3D goggles (Oculus Rift CV1) enabling them to carry out the task in virtual environment. Both groups will take 10 training sessions within 2 weeks. Their task will be collecting 10 virtual cubes one-by-one and putting them in the virtual treasure box. Clinical tests (Box and Blocks Test and motor part of the UPDRS) will be carried out in the clinical settings prior and after the training sessions. We hypothesise that the different feedback equipment may provide different results.

The participants will practise grab and grasp in virtual environment (VE), either on a laptop computer or using 3D goggles. They will sit in a comfortable chair, with a small camera tracking the hand and finger movements of their affected (dominant, in case of both hands affected) hand. The participant will grab any of the virtual cubes lying around the VE and put it in the treasure box. When the cube falls into the treasure box it disappears and the participant scores, one by one until the 10th cube or 120s of time elapse. The cubes will be randomly spread in the VE and will all have the same virtual size, weight and bouncing factor, but different colour. If the participant is left-handed, the treasure box will be mirrored to the right side. If the cube is pushed into the floor, it disappears without a score and is lost. Each participant will take 10 consecutive training sessions in 2 weeks, each session lasting for 30min. Within a session, the participant will take 5 trials, with breaks of 1-2 min between them.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease diagnosis
* minor problems with daily activities and upper extremities
* Hoehn and Yahr Scale level 2-3

Exclusion Criteria:

* insufficient cognitive and motor abilities to carry out the exergaming task
Experience With a Pediatric Summer Intensive Therapy Program

The purpose of this study is to explore the lived experiences of children with neurodevelopmental diagnoses and their caregivers with an intensive model of therapy. Children will receive usual care during the summer intensive program and the investigators will access medical records to assess effectiveness. Children and caregivers will also be asked to participate in semi-structured interviews upon the completion of the episode of care.

The purpose of this study is to explore the lived experiences of children with neurodevelopmental diagnoses and their caregivers with an intensive model of therapy. Research questions include: 1.) What are the perceptions of children and caregivers about intensive therapy after participating in multiple intensive therapy episodes over time? 2.) Why do caregivers choose to continue with an intensive model of therapy periodically for their child with neurodevelopmental diagnoses? 3.) What were the outcomes for children with neurodevelopmental disabilities participating in an episode of intensive therapy? Children will receive usual care during the summer intensive program and the investigators will access medical records to assess effectiveness. Children and caregivers will also be asked to participate in semi-structured interviews upon the completion of the episode of care.

Eligibility Criteria:
Inclusion Criteria:

* Children receiving therapy through the Children's Therapy Center's Tiger Intensive Program and their caregivers from May 24 to August 13 2021.

Exclusion Criteria:

* n/a
An Artificial Intelligence Assisted Telehealth Intervention to Promote Self-Management in Patients With Type 2 Diabetes Mellitus (Qualitative Interview)

This protocol involves a qualitative study of the needs/preferences of people with diabetes and health coaches regarding a telehealth coaching platform for glycemic control in people with diabetes.


Eligibility Criteria:
Inclusion Criteria:

Health Coaches Group:

(i) age between 18 and 80 years (ii) fluent in English (iii) work in or carry expertise in physical activity, nutrition/diet or health behavior.

People with Diabetes Group (Patient/Caregiver Dyads):

(i) age between 18 and 80 years (ii) fluent in English (iii) have Type-II diabetes.

Exclusion Criteria:

None
Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase.

Patients with squamous cell carcinoma of the head \& neck, anal canal, cervix, esophagus or lung will be assessed before start of radiotherapy and 1-2 weeks after start. Multi-parametric MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) will be performed in parallel to metabolomic analyses of tumour tissue. The investigators will correlate changes in imaging bio-markers to corresponding changes in tissue or blood bio-markers by repeated imaging and biopsies for better understanding of the image parameters.

The data from the two assessments will be used for identifying imaging bio-markers, predictive for outcome. The patient data will be divided into one set of data for hypothesis generation and another set for validation.

Eligibility Criteria:
Inclusion Criteria:

1. Morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (SCC) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung.
2. The patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy
3. The tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions
4. The patient must be at least 18 years of age, able to understand the given information and, leave a written informed consent to participate

Exclusion Criteria:

1. The patient is unwilling to participate in the study
2. Patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour)
3. Pregnancy or lactation
4. Contraindications to investigations with MRI, gadolinium contrast or PET-tracers
5. Patients with an estimated glomerular filtration rate (GFR) \<60 ml/min/1.73m2.
6. Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective.
A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers

The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.

This is a Phase 1, open-label, assessor-blind, parallel-group study to evaluate the PK and tolerability of a single subcutaneous dose of 300 milligram (mg) tralokinumab when delivered as a 2 milliliters (mL) injection at different flow rates to healthy adult volunteers.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy males and females ages 19-65 years
* Body mass index of 19.0-30.0 kilogram per meter square (kg/m\^2)
* No clinically significant abnormality
* Vital signs, electrocardiogram (ECG), and laboratory parameters within normal range
* Negative alcohol and drug screens
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception
* Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective contraception.

Key Exclusion Criteria:

* Concurrent enrollment in another clinical study where the subject is receiving an investigational product
* Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer
* Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
* Current use of regular pain-modifying, anti-depressant, anxiolytic, or hypnotic medication
* History of thrombocytopenia or bleeding disorder or use of anticoagulants
* History of any immunodeficiency disorder or use of immunosuppressive medication.
* History of a clinically significant infection
* History of cancer
* Positive Hepatitis B or C
* Positive HIV
Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism

The purpose of this study is to evaluate the serum dehydroepiandrosterone sulfate in subclinical hypercortisolism

In the past few years, with the widespread use of chest and abdominal imaging, the prevalence of adrenal incidentaloma (AIs) has been increasing and now approaches the 8.7% incidence reported in autopsy series. subclinical hypercortisolism (SH) is noted in up to 30% of patients with adrenal incidentalomas. Several groups have reported adverse clinical sequelae in individuals with SH, with recent studies highlighting an increase in cardiovascular morbidity and mortality compared to the general population. Accurate exclusion or confirmation of a diagnosis of SH is therefore a key step in the investigation and management of patients with AIs. Suppressed adrenocorticotropic hormone (ACTH) and low dehydroepiandrosterone sulfate (DHEAS) levels are frequently found in SH patients. Present study added new evidence for the limitations of ACTH and confirmed the usefulness of DHEAS for the detection of SH especially with unsuppressed ACTH in AI patients. On one hand, in the cross-sectional study, biometric measurements and sex hormones (including DHEAS, 24h-UFC, ACTH and cortisol) are analysed to explore the differences among SH patients, and nonfunctional adrenal adenoma patients. One the other hand, in the longitudinal study, changes in DHEAS, ACTH and cortisol in SH with surgical management and SH with conservative management both at baseline and different follow-up months after their different treatment management are collected to explore the changes of DHEAS and ACTH of SH patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with adrenal accidental tumor (diameter \> 1cm) found by physical examination or imaging examination due to non-adrenal diseases

Exclusion Criteria:

* concomitant use of drugs influencing glucocorticoid metabolism or secretion
* major psychiatric illness or history of excess alcohol intake
* overt clinical features of hypercortisolism
* clinical and endocrine function evaluation (surgery patients at the same time reference to postoperative pathology) revealed primary aldosteronism, pheochromocytoma, adrenocortical carcinoma, adrenal metastasis of cancer, myelolipoma; oncocytoma, congenital adrenal cortex hyperplasia and ganglion cells neuroma/paraganglioma, schwannoma, adrenal hematoma and uncertain diagnosis)
* non-adenoma lesions such as cysts and hemorrhage
* The pregnancy
* Patients with severe underlying diseases (such as liver and kidney failure, acute severe infection, etc.) that may affect the function of the hypothalamus-pituitary-adrenal axis (HPA axis)
A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease.

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg (FSC) BID on arterial stiffness in COPD subjects. Following a 1 to 14 day run-in period, approximately 250 subjects will be randomly assigned to double-blind treatment for 12 weeks. After the 12 week treatment period, subjects in both treatment arms will receive open label Tiotropium bromide Handihaler18mcg (Tio)QD for 4 weeks in addition to their continued study drug (either FSC250/50 or placebo). The primary measure of efficacy is Pulse Wave Velocity (PWV) at Endpoint. Secondary efficacy measures include Augmentation Index (AIx), Biomarkers of cardiovascular disease, measures of lung function. (e.g. FEV1). Safety will be assessed through the collection of adverse events and COPD exacerbations. Exploratory endpoints include the effect of Tiotropium on PWV and AIx when added to placebo or FSC. Treatment groups will be stratified based on current smoking status. There will be a total of 6 study visits (screening, randomization, and after 4, 8, 12 and 16 weeks of treatment). A follow-up phone contact for collection of adverse event and pregnancy information (if applicable) will be conducted approximately 14 days following the last study visit.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
* Males or females greater then or equal to 50 years of age.
* A post-albuterol FEV1/FVC ratio of \< or equal to 0.70
* A post-albuterol FEV1 \< 80% of predicted normal.
* Patients can be current or fomer smoker and must have a cigarette smoking history of \> greater then or equal to 10 pack-years .

Exclusion Criteria:

* A current diagnosis of asthma
* A body mass index (BMI) of \> or equal to 35kg/m2
* A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis).
Transdisciplinary Intervention Integrating Geriatric And Palliative Care With Oncology Care For Older Adults With Cancer

The purpose of this research study is to pilot test a transdisciplinary intervention that integrates both geriatrics and palliative care with routine oncology care for older adults with incurable cancer. The investigators will explore their perceptions of the supportive care needs of older patients with cancer. Using these data, the investigators will finalize the transdisciplinary intervention and perform a pilot, randomized trial of the transdisciplinary intervention versus usual care in patients age ≥65 with newly diagnosed, incurable cancer.

While evidence suggests that older adults with incurable cancer have unique geriatric and palliative care needs, models of care that are focused on these needs are lacking. The investigators propose to pilot test an intervention targeting the geriatric and palliative care needs of older adults with incurable cancer, referred to as a "transdisciplinary intervention."

The goals of the proposed study are: (1) conduct focus groups with clinicians (from oncology, geriatrics and palliative care) and interviews with patients to explore their perceptions of older patients' supportive care needs and finalize the transdisciplinary intervention; (2) to demonstrate the feasibility and acceptability of delivering the transdisciplinary intervention to older patients with incurable GI and lung cancers; and (3) to estimate the effect size of the transdisciplinary intervention for patient-reported outcomes (e.g., between-group differences from baseline to week 12 in quality of life, physical function, physical and psychological symptoms).

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* Diagnosed with incurable (defined as metastatic or receiving chemotherapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, or lung cancer within the prior 8 weeks (including patients with prior diagnosis of cancer who developed incurable disease)
* Verbal fluency in English
* Planning to receive care at Massachusetts General Hospital (MGH)

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study
* No medical problems for geriatric clinician to address (e.g. comorbidities, polypharmacy, etc.)