cyrilzakka/clinical-trials huggingface dataset:
Augmented Reality BCI Longitudinal Study for Persons with Late Stage ALS

The goal of this study is refine the usability of a BCI based communication platform.

The study will take place in the greater Los Angeles area and will enroll up to 10 participants with late stage ALS. Each subject will receive a Cognixion Axon-R augmented reality brain computer interface and associated communication software. The study duration is 3 months for each participant.

The key questions that will be addressed in this study are:

1. How quickly can participants learn and gain confidence with a pure BCI interface.
2. How effective are alternate input modalities including eye tracking for this use case.
3. Identify the extent to which generative AI based personalization impacts the communication quality.

Key measures include:

ITR - information transfer rate SUS - system usability scale


Eligibility Criteria:
Inclusion criteria:

* Must have someone (LAR) who can consent to their participation and who will be present in the study alongside the participant
* Must have a designated individual who can be trained on the Cognixion system
* Fluent in understanding English
* 18 years or older
* Must have ALS and need an assistive communication device
* Must be able to engage in volitional eye opening and sustain eye opening independently for x duration
* Must have a way to communicate apart from using the Cognixion device such as vocalizations, head nod, eye blinks, eyebrow raises, etc. At a minimum, reliable way of communicating "Yes" and "No"

Exclusion criteria:

* Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)
* Severely hearing impaired or deaf
* Sensitivity to flashing lights
* History of epilepsy and/or seizures
* Vision disorders restricting the visual field such as glaucoma, diplopia (double vision), nystagmus (involuntary eye movements)
* History of vertigo or other vestibular disorders
* Scalp that is prone to irritation, inflammation, injury, or infectious process
Localized Osteosarcoma in Upper Egypt: A Clinical Prediction Model

To assess survival outcome of pediatric patients with localized osteosarcoma of the extremities in Upper Egypt, identify factors of prognostic significance for survival, and to determine factors predictive of surgical methods employed in these patients, and developing a clinical model for risk prediction.

Background Osteosarcoma is the most common of all primary malignant bone tumors. Accounting for about 2.6% of all pediatric neoplasms, it predominantly occurs in the extremities, with a peak incidence in the second decade of life.

In Upper Egypt, we have a higher proportion of the population in underdeveloped communities with limited access to medical care so the patients usually seek medical advice at advanced stage leading to a higher prevalence of metastatic disease at initial presentation, as well as a greater proportion of larger tumor size that more likely to be associated with potential adverse risk criteria prior to surgery.

A previous study from Upper Egypt showed that a metastatic disease at diagnosis was independently correlated to a dismal outcome. Since the effect of many other factors of prognostic significance, such as, gender, age, tumor location and response to chemotherapy may have been mitigated by the large effect of the metastatic disease on the prognosis; So, here, we will analyze the data of 30 patients with non-metastatic osteosarcoma of the extremities, to determine prognostic factors associated with survival, and also to develop a model for a better prediction of factors correlated to that a certain surgical approach was employed in these patients based on their baseline clinical data and the tumor response to chemotherapy.

Patients \& Methods We will carry out a retrospective analysis of data assembled from medical records of 30 pediatric patients with a histologically-verified non-metastatic osteosarcoma of the extremities treated at South Egypt Cancer Institute with a unified chemotherapy protocol between January 2001 and December 2015. These data will be categorized according to demographic data, clinical characteristics, tumor response to chemotherapy, and surgical methods employed in these patients. Prognostic factors will be determined using univariable and multivariable methods. A predictive model for surgical outcomes in these patients based on the baseline clinical factors, and their tumor response to chemotherapy will be developed.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose age less than 19 years.
* Patients diagnosed with verified osteosarcoma involving the extremities.

Exclusion Criteria:

* Patients whose age more than 19 years.
* Non-extremities Osteosarcoma .
Genetic and Functional Analysis of Cherubism

The goal of this research study is to identify genes and regulatory elements on chromosomes that cause cherubism. Together with the investigators collaborators the investigators also study blood samples and tissue samples from patients to learn about the processes that lead to this disorder. The long-term goal of researchers involved in this study is to find mechanisms to slow down bone resorption in cherubism patients.

Cherubism is a very rare bone disorder where bone gets excessively resorbed only in the jaw bones (mandible and maxilla). The resulting cavities in bone fill up with soft fibrous (fibro-osseous) tissues that can expand and push the bony shells apart. Thus the characteristic facial appearance in patients with progressed cherubism. Bone resorption (cherubism lesions) in this disorder occurs always symmetrically in the mandible, the maxilla or in both. This distinguishes cherubism from similar disorders. As cherubism progresses, the lesions can invade the eye sockets (inferior and/or lateral orbital walls) and displace the eye balls and push down the eyelids. As a result the sclera (white of the eye) below the iris becomes visible and patients have an upward gazing appearance (cherubic look) which gave the name to this fibro-proliferative bone disorder.

Cherubism typically appears between ages of 2-7 years. It is often diagnosed during dental evaluations. At early stages cherubism is accompanied by lymph node swelling. Proliferation of the fibro-osseous tissue typically stops after puberty and in many the soft tissue in the cherubic bone cavities are replaced by new bone.

For this study we will:

* Send out study participation kits and consent by phone
* Collect a saliva sample from eligible individuals
* Obtain information regarding cherubism
* Document disorder with photos and doctor's letters
* If patients undergo surgery for cherubism we ask to obtain some bone tissue that would otherwise be discarded
* Isolate DNA from the saliva sample
* Perform genetic analyses of the DNA with the most up-to-date methods available to identify genetic variations
* Study in the laboratory why the genetic variations cause the disorder

Eligibility Criteria:
Inclusion Criteria:

* cherubism; unaffected individuals only if part of a participating cherubism family

Exclusion Criteria:

* no cherubism unaffected individuals only as part of a participating cherubism family
Fluid Responsiveness Evaluation by AbdomiNal Compression in Kids Based on the STARLING Concept

Purpose:

Fluid responsiveness in a context of circulatory failure can be predicted by different way. Dynamic criteria such as pulse pressure variation, stroke volume variation during an end-expiratory occlusion maneuver or a passive leg raising have been reported to predict fluid responsiveness. Only aortic velocity peak variation measured with transthoracic echocardiography during mechanical ventilation has been reported to predict fluid responsiveness in children. Besides some physician use a maneuver of abdominal compression to predict fluid responsiveness in children with circulatory failure. This strategy has never been formally evaluated.

The investigators will study the diagnosis accuracy of the stroke volume variation induced by an abdominal compression to predict stroke volume variation after 10 ml/kg fluid load in children with circulatory failure.

Thirty-eight pediatric patients under eight years old in circulatory failure, for whom the attending physician has decided a fluid load will be included. Hemodynamic parameters: arterial pressure, heart rate, stroke volume measured with echocardiography; will be recorded. This data collection will be performed before, after abdominal compression and after a fluid load of 10 ml/kg.

Patients will be aposteriori sorted in two groups: Fluid responders and Fluid non-responders. Fluid responders are defined as patients that show an increase greater than 15 % in stroke volume. The diagnosis ability of the Stroke volume variation after an abdominal compression to predict fluid responsiveness will be investigate and receiving operative characteristic (ROC) curve will be built. The correlation between the variation of stroke volume during abdominal compression and during the fluid load will be studied. Other parameters such as arterial pressure and heart rate will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 8 years old
* Patient with a circulatory failure defined as follow :

Treatment including vasopressor or inotrope

OR macrocirculatory failure

* Heart rate \> 2 Standard Deviation (SD)
* Systolic arterial pressure \< 2 SD
* Mean arterial pressure \< 2 SD
* Diastolic arterial pressure \< 2 SD

WITH signs of microcirculatory failure

* Capillary refill time \> 2 secondes
* Blotch
* Organ dysfunction due to the circulatory failure (Oliguria \< 0,5 ml/kg/h, acute lung injury, encephalopathy)

Exclusion Criteria:

* Opposition from the parents or the one who holds the parental authority
* Cardiogenic acute pulmonary edema,
* Extreme hemodynamic instability,
* Intra-abdominal hypertension,
* Recent abdominal surgery that does not permit an abdominal compression without causing pain.
* Patient with mechanical circulatory support, such as Extra Corporal Life Support or Berlin-Heart
* Patient with congenital cardiopathy with a palliative correction or an incomplete correction
* Open thorax
* Prone position
* Investigators not available
* No security number registration.
* Moribund patient
POCUS VS CT in Diagnosis of Acute Dyspnea in Chronic Hemodialysis Patients

Estimate the predictive value of POCUS in diagnosis of different causes of acute dyspnea in hemodialysis patients and compare between POCUS and CT in differentiation the causes of acute dyspnea in those population.

Dyspnea is "a subjective experience of breathing discomfort that consists of qualitatively dis-tinct sensations that vary in intensity.Dyspnea is a common symptom both in general practice and in hospital emergency rooms. It has been reported that 7.4% of patients presenting to emergency rooms complain of dyspnea;among patients in general practice, 10% complain of dyspnea when walking on flat ground and 25% complain of dyspnea on more intense exertion, e.g., climbing stairs.Dyspnea is considered acute when it develops over hours to days.Acute breathlessness in haemodialysis patients can be caused by various conditions such as acute coronary syndrome, catheter-related infection, pneumonia and pericardial effusion, as well as a reaction to the dialyser or medication given during dialysis Hence, clinical acumen remains integral in evaluation of acute breathlessness in this group of patients. Point of Care Ultrasound is complementary to a medical examination performed by primary care physicians in conjunction to physical examination to investigate unclear findings. As such it is used to find and identify either the presence or absence of specific pathological results seen in your patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients maintained on regular hemodialysis equal to / more than 6 months admitted to emergency department and ICU of Internal Medicine Department from September 2021 to August 2022 presented by acute dyspnea.

Exclusion Criteria:

* • Age less than 18

  * Diagnosed chronic pulmonary disease.
  * Severe heart failure (NYHA class IV).
  * Active malignancy.
  * Pregnancy.
  * Hepatic Failure (Child B,C).
  * Comatosed Patients.
A Comparative Study Between Radius and Capitate Shortening in Ulna Minus Variance Kienbock's Disease

1. Kienböck's disease refers to avascular necrosis of the lunate carpal bone, known as lunatomalacia. It was first recognized and described by Austrian radiologist Robert Kienböck's in 1910
2. The lunate is the central bone in the proximal row, and it articulates with the scaphoid, capitate, triquetrum, and occasionally the hamate. More proximally, the lunate is a component of the radiocarpal joint, and it also articulates with the ulna via the triangular fibrocartilage complex (TFCC)
3. The exact cause of Kienböck's is not known, though there are thought to be a number of factors predisposing a person to Kienböck's. Although there is no evidence that Kienböck's disease is inherited, it is possible that unidentified genetic factors could contribute to the development of the condition, It is multifactorial, related to the following variables:Ulnar negative variance (or ulna minus),Vascular supply to the lunate bone,Lunatemorphology,Radial inclination angle,multiple wrist trauma
4. Kienböck's disease is the second most common type of avascular necrosis of the carpal bones, preceded only by avascular necrosis of the scaphoid. The typically affected population is males aged 20-40 years
5. Patients usually present with unilateral pain over the dorsal aspect of the wrist, limited wrist motion, weakness, or a combination of the three. Wrist extension and axial loading exacerbate pain. Symptoms range from mild to debilitating. It is rarely bilateral, and trauma is often absent. Physical examination commonly reveals wrist swelling, tenderness over the expected location of the lunate, synovitis, and loss of grip strength
6. Kienböck's disease is a clinical and imaging diagnosis. Both radiography/computed tomography and magnetic resonance imaging (MRI) are highly specific. However, MRI is the most sensitive and detects radiographically occult cases


Eligibility Criteria:
Inclusion Criteria:

* Age : 18-65 Years.
* Stages II \& III.
* Ulna minus.

Exclusion Criteria:

* Teens.
* Serious medical condition.
* Stage I\& IV.
* Sever osteoporosis.
Single Ascending Dose Study of AMG 570 in Healthy Subjects

The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by the investigator
* Normal or clinically acceptable electrocardiogram (ECG)
* Female subjects must be of documented non-reproductive potential
* Subjects must be current for all vaccinations
* Other inclusion criteria may apply

Exclusion Criteria:

* Current or chronic history of liver disease
* History of active infections
* History of significant respiratory disorder
* Evidence of renal disease
* Other exclusion criteria may apply
Lung Transplant HCV, Pilot Study

In this study HCV negative recipients will be transplanted with HCV positive lungs. Investigators will attempt to decrease infectivity rates by performing Normothermic Ex vivo Lung Perfusion (EVLP), which is an approved method of donor lung preservation, assessment and treatment, and could be an excellent platform to reduce/eliminate hepatitis C virus. Patients will be treated by the standard approved direct-acting antivirals (DAAs) if infection occurs. It is planned to enroll 20 patients from the Lung transplant wait list in this study. Patients will be actively followed for 6 months including HCV PCR tests and then for up for 5 years to look for evidence of HCV infection and any liver or extra-hepatic complications, as well as standard post-transplant complications. This will be a single center pilot study.

The success of lung transplantation (LTx) is significantly hindered by the lack of sufficient number of available donors. Many potential donor lungs cannot be utilized in clinical transplantation because donors have chronic viral infections such as hepatitis C (HCV) infection. This study will test the possibility of safely transplanting lungs from HCV positive donors. Donor lungs will be subjected to Normothermic Ex vivo Lung Perfusion (EVLP) for 6 hours for organ assessment and reduction of viral load prior to transplantation. After transplantation, recipients will be carefully monitored for HCV infection and if infection occurs, they will be promptly treated with highly effective antiviral therapy using newly approved DAAs. The aim of the study is to show that transplantation of lungs from HCV positive donors is safe in the era of DAAs. The hypothesis is that the rate of HCV transmission to recipients will be lower than previously described due to EVLP pre-treatment and any HCV transmission that does occur will be readily treatable and curable. If successful, the knowledge from this study can have a large impact to patients with end stage organ diseases by providing a large novel source of donors for lung and potentially other organ transplantations.

Eligibility Criteria:
Inclusion Criteria:

* Recipients listed for single or bilateral lung transplant
* HCV Nucleic Acid Amplification Testing (NAT) negative
* Ability to provide written informed consent

Exclusion Criteria:

* Participation in another interventional clinical trial
Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy

Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.

Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.

Patients will be randomly assigned to be submitted to evaluate safety, complication rates, easy to perform , clinical outcomes and effectivity.

Eligibility Criteria:
Inclusion Criteria:

* All intubated and mechanically ventilated patients indicated for a tracheostomy

Exclusion Criteria:

* Patients with tracheal or neck abnormalities, soft tissue infection in the neck, neck surgery history, oxygenation problems , coagulation disorders or coagulation parameter changes and those requiring urgent or surgery patients unable to provide informed consent.
Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair

Inguinal hernia repair is one of the most commonly performed surgeries around the world. It accounts for approximately 75% of all abdominal wall hernias and presents a lifetime risk of 27% in males and 3% in females. Since the modern concept of surgical hernia repair described by Bassini in 1887, with the technique that bears his name, several techniques have been developed in the last century in order to improve surgical outcomes after inguinal hernia repair.

Different open repairs, such as anterior (Shouldice, McVay) or posterior (Stoppa) approach were described and developed, until Lichtenstein described the tension-free hernioplasty concept supported by the use of a prosthetic mesh to repair the hernia defect. Notable Improvements were observed with this technique in terms of recurrence, pain, and discomfort in comparison with previous tension repairs. Considerable advantages over open repair have been obtained with the introduction of minimally invasive surgery to inguinal hernia repair, in terms of patient comfort and recurrence rates.

Regarding prosthetic material, meshes have evolved since the first Dacron mesh used by Lichtenstein. First generation meshes were manufactured using more material and for this reason they have been described as heavyweight meshes. New generation meshes have been designed with less material in order to diminish the inflammatory response and foreign body reaction, providing less chronic pain with similar recurrence rates than heavyweight meshes. The density (or weight) of the mesh, measured in g/m2, is inversely proportional to the size of the pore and lately it has been reported that one of the main aspects related to prosthetic materials is pore size. Large pore meshes use less material, consequently they have been associated with a better tissue ingrowth. The large pore of lightweight meshes is conditioned by the less amount of material used.

All previous studies compare both light and heavyweight polypropylene meshes But in order to get a proper comparison of the behavior of meshes in the inguinal region it is important to include the material and the pore size. The aim of our study is to compare patient-reported outcomes with the use of either a Polytetrafluoroethylene (PTFE) large pore mesh (LP-PTFE) vs a small pore polypropylene mesh (SP-PPL).

Patients fitted for laparoscopic bilateral inguinal hernia repair will be randomized to recieve one of both meshes on study in both inguinal sides.

Eligibility Criteria:
Inclusion Criteria:

* male patients
* 20-80 years old
* Primary Bilateral Hernia

Exclusion Criteria:

* Women
* BMI \>35
* Recurrent hernias
* Previous infraumbilical laparotomy
* Inguinoscrotal hernias
A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. Despite the range of treatment options for RA steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. This study will assess the treatment patterns, achievement of treatment targets and maintenance of response.

Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 1660 participants will be enrolled this study, worldwide.

Participants will not receive Upadacitinib as part of this study, but will be followed for response to treatment for up to 24 months.

There may be higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits, every 3 months, during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of moderate to severe active Rheumatoid Arthritis (RA).
* Physician decision on patient treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
* Upadacitinib prescribed in accordance to the applicable approved label and local regulatory and reimbursement policies.
* French Participants Only: Taking oral glucocorticoids ≥5 mg/day of prednisone or equivalent for at least 3 months prior to study start.

Exclusion Criteria:

- Prior treatment with Upadacitinib.
MK2461 Phase I/II Study in Patients With Advanced Solid Tumors (MK-2461-002 AM1)(COMPLETED)

The purposes of this phase I portion are; 1) to evaluate the safety and tolerability of MK2461 and 2) to determine the recommended phase 2 dose or doses of MK2461.

The purpose of the phase II portion is to evaluate the anti-tumor efficacy of MK2461.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age, with adequate organ function, and an ecog performance of \<2

Exclusion Criteria:

* No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation
* Patients must not have primary central nervous system tumor