cyrilzakka/clinical-trials huggingface dataset:
Length of the Femoral Stem in Arthroplasty Done for Patients With Proximal Femoral Metastatic Lesion

Proximal femoral metastatic disease is a common cause of morbidity and mortality in cancer patients.protecting the entire femur using long nail or long femoral stem was hypothesized to prevent future fracture.However we believe that long stem isn't always necessary and won't decrease the complication rate.noting it's increased complication rate in this high risk patient category .

Skeletal metastasis is the third most common site of cancer metastasis after the lungs and liver, almost all patients with metastatic prostate cancer will have bone metastasis. And about 90% of patients dying from breast cancer has skeletal metastasis.

The most common site to which cancer metastasize to long bones is the proximal femur, especially to the intertrochanteric region and femoral neck, contributing to increasing incidence of impending and pathologic fractures of this site.(8) Recent advances in cancer treatment increased the longevity of patients, with subsequent increase in morbidity of metastatic disease and increased number of patients living longer with this condition .

To date, long femoral stem is most frequently used in cases of pathological and impending proximal femoral fractures. Its use is believed to add more stability and prophylactically protect the entire femur from newly developed distal lesions. However, long stems has more operative time, more cardiopulmonary complications and are more technically demanding compared to standard femoral stems arthroplasty.(5) Recent retrospective study by Xing et al reported comparable outcomes between standard, medium and long stems and concluded that the routine use of long stems is unjustified.Another recent report by Joel et al investigated the use of long femoral stem in 22 limbs, they reported no hardware failure with no cases of intraoperative cardiopulmonary complications, however they recommended larger comparative trials with rigorous methods to investigate the functional outcomes and complications of long femoral stems in proximal femoral metastatic lesions.

In face of the potential advantages in this patient population, the goal of this study is to investigate the use of standard length femoral stems and its results compared to long femoral stems in proximal femoral metastasis .

Eligibility Criteria:
Inclusion Criteria:

* pathological or impending pathological pertrochanteric or neck femur fracture, regardless of the presence of distal femoral metastasis.

Exclusion Criteria:

* Previous arthroplasty in the same side. fractures or lesions involving the subtrochanteric region Pathological fracture due to metabolic disease
Inflammatory Markers and Resistant Depression

This study focuses on blood inflammatory markers (pro-inflammatory cytokines, anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant unipolar depression in comparison with non-resistant unipolar depressed patients.


Eligibility Criteria:
Inclusion Criteria:

* group 1: Patients with resistant MDD (at least 2 failed treatments for the current episode) ,current treatment with IRS or IRSNA,
* group 2: patients with MDD remission after response to an antidepressant treatment.

Exclusion Criteria:

* comorbid somatic or psychiatric disorders: chronic or acute inflammatory diseases, previous treatment with brain stimulation for the current episode, legal protection
Speech Treatment for Minimally Verbal Children With ASD and CAS

Comorbid Childhood Apraxia of Speech (CAS) may be one factor that limits speech development in some minimally verbal children with autism. CAS is a disorder affecting speech movement planning. This study tests whether CAS-specific treatment, appropriately modified for minimally verbal children with autism, improves their speech.

Although one in four children with autism remain minimally verbal past age five, not all the factors that limit spoken language in these minimally verbal children are known. One powerful contributor may be a motor speech disorder, Childhood Apraxia of Speech (CAS). CAS is an impairment in the ability to plan and sequence for speech, which makes speech inconsistent and imprecise. This project proposes to investigate whether CAS makes the speech of minimally verbal children with autism unintelligible, and then to test whether treating the CAS improves children's speech.

First, a cohort of 20 minimally verbal children with both autism and CAS is identified. The prediction is that the more severe the CAS, the more inconsistent and imprecise a child's speech, and therefore the lower their intelligibility will be. Then, a set of mono- and bisyllabic words is selected that contain the disordered movements that each child shows and use those in treatment.

Treatment will take the form of 15 one-hour sessions where speech practice is embedded in a naturalistic, play-based milieu that is centered on each child's own developmental level. It will involve principles of motor learning (intensive practice of a few words, sometimes all in a row and sometimes mixed up). Different types of cues (touch cues, simultaneous production, etc.) will also be employed to help children say their words correctly, fading back these supports as the child's speech improves. Both of these techniques have been shown to be effective for treating CAS.

Our outcome measures will include both (1) "by-ear" assessments of intelligibility and (2) acoustic and kinematic measurements of children's speech after 15 treatment sessions. The findings will inform clinical practice for minimally verbal children with autism and may lead to the development of novel interventions for this severely affected population.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for Autism Spectrum Disorder
* Able to correctly repeat at least 2 syllables
* Meets criteria for Childhood Apraxia of Speech
* Lives in an environment where child is exposed to English at least 50% of the time

Exclusion Criteria:

* Poorly controlled seizures
* Factors such as blindness or deafness that contribute to minimally verbal status
* Lives in an environment where English is not spoken at least 50% of the time
* Child experiences behavioral challenges that preclude participation in the study
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function

The effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects. The results are compared to the data gained from subjects with normal liver function.

The effect of moderate hepatic impairment on the pharmacokinetics (PK), safety and tolerability of a single dose of FG-4592 in male and female subjects is investigated. Data obtained from these subjects are compared to data from BMI-, age- and sex-matched subjects with normal hepatic function. Both groups consist of 8 subjects.

Screening takes place from Days -22 to -2 before admission to the clinical unit on Day -1. Administration of the trial medication takes place on Day 1 under fasted conditions. Healthy subjects are discharged on Day 5 and subjects with moderate hepatic impairment on Day 7, if there is no reason to extend the stay. An end-of-study visit (ESV) takes place 5 to 9 days after (early) discharge.

Safety assessments are performed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

Both healthy subjects and subjects with moderate hepatic impairment:

* Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
* Male subjects and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study period and for 90 days after the study drug administration.

In addition, subjects with moderate hepatic impairment must also meet the following inclusion criteria:

* Subject has Child-Pugh classification Class B (moderate, 7 to 9 points) liver function impairment \[screening\].

Exclusion Criteria:

Both healthy subjects and subjects with moderate hepatic impairment:

* Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months before screening.
* Subject has a known or suspected hypersensitivity to FG-4592, or any components of the formulation used.

In addition, healthy subjects must also NOT meet the following exclusion criteria:

* Subject has any of the liver function tests (LFT) (Aspartate Aminotransferase \[AST\], Alanine Aminotransferase \[ALT\], Alkaline Phosphatase \[ALP\], Gamma Glutamyl Transferase \[GGT\], Total Bilirubin \[TBL\] above the upper limit of normal (ULN). In such a case the assessment may be repeated once \[Day-1\].

In addition, subjects with moderate hepatic impairment must also NOT meet the following exclusion criteria:

* Subject had a previous liver transplantation.
Comparison of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method

Our study first aims to develope a realistic cadaver model of hemoptysis based on Thiel's embalmed cadavers. Secondly, participants will intubate the hemoptysis cadaver model with (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath XBlade and a suction advance before the optic of the camera. We hypothesis that, in simulated hemoptysis on the Thiel's embalmed cadaver, the rate of failed intubation at first try will be different depending on the laryngoscope used.

For the simulation of hemoptysis, we will need to use the Thiel's embalmed cadaver, who's realism is established, create a synthetic form of blood resembling real blood by its viscosity and color for the simulation and elaborate the dynamic interface of the simulation of hemoptysis. The quantity and way of administration of the blood through the trachea will be tested to obtain a realistic hemoptysis as seen in supraglottic.

For the simulation, we will compare the efficiency of intubation, judged by the failure rate of intubation on first try, for (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath XBlade with the suction advanced before the camera. We will also measure the time to intubation, the failure rate of intubation, the suction use and the difficulty of intubation as reported by the participants.

Eligibility Criteria:
Inclusion Criteria:

* all wiling doctors and medical residents in the departments of anesthesiology, emergency medicine and intensive care
* experience with the technique of intubation using videolaryngoscopy and direct laryngoscopy.

Exclusion Criteria:

* refusal to participate
Knee Care @Home Programme Feasibility Trial

The main goal of this trial is to determine the feasibility of a randomized controlled trial for the Knee Care at Home Programme, rather than the effectiveness, for patients recovering from anterior cruciate ligament reconstruction. Specifically, the trial aims to: (1) assess the feasibility of studying the effectiveness of the Knee Care at Home programme, including patient engagement and satisfaction; and (2) conduct a qualitative assessment to identify barriers and facilitators in the implementation and delivery of the programme.

Participants will be asked to take part in a 22-week intervention within a 24-week postoperative rehabilitation period following anterior cruciate ligament reconstruction. Internet-based remote sessions (3 times a week, 40 minutes per session) will supplement conventional clinic-based rehabilitation (face-to-face sessions). After the anterior cruciate ligament reconstruction, outcome measures are assessed during consultations with the orthopedic surgeon. These consultations occur after 4 weeks of intervention interval, except for the second postoperative consultation which occurs after a 2-week intervention period interval. Additional evaluations will occur during each remote session.

The team of researchers will evaluate the enrollment (screening, informed consent, eligibility, and allocation), data collection (response rates, missing data, and implementation and technical issues), intervention fidelity (adherence, adherence rate at remote sessions, adherence at conventional rehabilitation, quality of delivery, participant responsiveness, and safety), and acceptability (patient satisfaction and motivation).

Eligibility Criteria:
Inclusion Criteria

* Undergone primary ACLR regardless of surgical method and choice of autograft.
* Have a healthy contralateral (opposite) knee.
* The time between ACL injury and ACLR should not exceed 12 months.

Exclusion Criteria

* Declined to participate.
* Concomitant osteochondral injuries.
* Undergone multiple reconstructions of the lateral collateral ligament or posterior cruciate ligament.
* Significant lower limb injuries within the 12 months before the ACL injury.
* Medical conditions that may affect recovery.
* Using medication for mental disorders.
* Severe impairments in communication or balance.
REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients

The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.


Eligibility Criteria:
ACTIVE RP PATIENTS

Select Inclusion Criteria:

* Physician-confirmed (or confirmation in medical records) diagnosis of RP defined as an initial, acute, episode and at least one pericarditis recurrence after the initial acute episode
* Experienced at least one pericarditis episode in the 3 years prior to inclusion
* Under the care of a physician for the treatment and management of RP
* Currently prescribed medication for RP

Select Exclusion Criteria:

* Diagnosis of pericarditis secondary to tuberculosis (TB), cancer if not in full remission, post thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis, systemic autoimmune diseases, except SJIA and adult Still's disease, HIV
* Appears to have an impairment (e.g., cognitive, hearing, visual) or insufficient English or Spanish proficiency that could interfere with ability to complete patient-completed assessments
* Currently enrolled in a therapeutic investigational drug or device study

INACTIVE RP PATIENTS

Select Inclusion Criteria:

* Physician-confirmed (or confirmation in medical records) diagnosis of RP defined as an initial, acute, episode and at least one pericarditis recurrence after the initial, acute episode
* Patient had a last episode occurring at least 3 years and up to 5 years before registry inclusion
* Resolution of RP symptoms confirmed with no further RP treatment for 3 years prior to registry enrollment

Select Exclusion Criteria:

* Experienced a pericarditis episode within 3 years from enrolling in the registry
* Currently receiving RP treatment prescribed by a treating physician (e.g., CS, colchicine)
* Diagnosis of pericarditis secondary to tuberculosis (TB), cancer if not in full remission, post thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis, systemic autoimmune diseases except SJIA and adult Still's disease, HIV
* Enrolled in a therapeutic investigational clinical trial during the observation period
Depression and Immune Function in Multiple Sclerosis (MS)

Depression is one of the most common symptoms of multiple sclerosis (MS) with a life-time prevalence of major depressive disorder (MDD) of up to 50%. Depression occurs more frequently in MS than in other chronic diseases including other neurological and inflammatory disorders and may contribute to lower quality of life, cognitive problems, difficulties at work, and poorer long term health outcomes. Despite its clinical relevance, the biological mechanisms which may be responsible for the high risk for MS patients to develop depression are unknown.

In this observational study, investigators explore the molecular mechanisms responsible for the impaired regulation of immune cells in relapsing-remitting (RR) MS patients with depression. Investigators will compare the molecular and phenotypical profile of immune cells obtained from RRMS patients with clinical depression (n=50), matched MS patients who do not suffer from depression (n=50) as well as matched healthy controls (n=50) and matched patients with depression but without a comorbid neurological disorder (n=50).


Eligibility Criteria:
Inclusion Criteria:

* Relapsing remitting MS by McDonald Criteria (for RRMS and RRMS+MDD groups).
* Currently meeting diagnostic criteria for Major Depressive Disorder (for MDD and RRMS+MDD groups)
* Age 18-55.
* On stable treatment regime, either untreated or on disease modifying therapy (DMT) for \> 6 months

Exclusion Criteria:

* Secondary-progressive or primary progressive MS.
* Substance abuse for more than 6 months.
* Pregnancy
* Use of steroids or vaccination or infections in the previous 3 months.
* Signs of serious psychiatric pathology other than depression including schizophrenia, bipolar disorder or developmental and learning disorders including disorders on the autism spectrum
* Antidepressant medication.
Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection

A single-center prospective study. Patients undergoing surgery for acute type A aortic dissection with femoral arterial cannulation between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.


Eligibility Criteria:
Inclusion Criteria:

* Operated for acute type A aortic dissection between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden.

Exclusion Criteria:

* Non-femoral arterial cannulation
* Concomitant femoro-femoral bypass
* Conversion to ECMO with arterial inflow in the previously cannulated femoral artery
* Death within 30 days from procedure
* Loss to follow-up
Exploring the Relationship Between Caring Experience, Perceived Behavioral Control, and Caring Intention Among Students

This research project conducts a relevant investigation into the past background and learning experiences of university students during the process of caring. Additionally, it aims to understand the correlations between different scales.


Eligibility Criteria:
Inclusion Criteria:

* University students aged 18 and above.

Exclusion Criteria:

* University students who refuse or are unwilling to participate.
Routine Preoperative Evaluation in Surgical Patient

The "routine" pre-operative tests in healthy orthopaedic patients undergoing intermediate/ major surgery are not justified. In this study of 670 healthy orthopedic patients with 7610 preoperative tests, investigators found that surgical plan was influenced in \<1% of patients. Surgeons should be sensitized to reconsider this practice particularly with limited resources.

Background: Routine preoperative tests in healthy patients not only cause extra anxiety, but may delay treatment without influencing surgical plan. This has worse impact in resource-constrained settings where fee for service rather than health insurance is the usual norm. Investigators aim to determine if "routine" pre-operative tests are justified in healthy orthopedic patients.

Methods: Investigators conducted a non-commercialized, non-funded matched case control study in tertiary care university hospital and a level-1 trauma centre for healthy patients (ASA-1\&2) admitted from January 2014-December 2016 for elective orthopedic intermediate and major procedures. Cases (patient who had a change in his/her surgical plan after admission) and controls were selected independently of the exposure of interest then matched randomly to cases on age, gender and procedure type. Primary exposure was the routine preoperative lab tests, as defined by the American Society of Anesthesiologist, which included 13 blood tests. Analysis was done using Principle Component Analysis and Conditional logistic regression at univariate and multivariable levels reporting matched adjusted Odds Ratios. The data will bereported in line with STROBE criteria.

.

Eligibility Criteria:
Inclusion Criteria:

* Participants irrespective of age and gender.
* ASA-1 and ASA-2 status.
* Primary elective orthopedic procedures.
* Blood lab tests done at the institution only.

Exclusion Criteria:

* Ambulatory care procedures
* Revision surgery.
* Participants admitted to other services, high care or intensive care units.
Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients

This is a dose escalation study involving stage IV breast cancer patients not progressing after 6 months of first line systemic treatment. Potential advantages of stereotactic body radiotherapy (SBRT) in treating breast primary tumor in metastatic breast cancer are:

* radio-biological advantage of a short highly effective treatment schedule
* possibility of preventing lesions to become symptomatic
* possibility of continuing systemic treatment without interruption


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older
* Histologically confirmed diagnosis of invasive breast carcinoma (biological immunohistochemical profile: luminal and/or human epidermal growth factor receptor 2 positive)
* Distant metastatic disease not progressing after 6 months of systemic therapy
* Zubrod Performance status of 0-1
* Unifocal tumour \< 5 cm tumor size
* Tumor CT or 18-labeled fluorodeoxyglucose positron emission tomography (5FDG-PET) detectable
* No surgery being recommended at time of enrollment.

Exclusion Criteria:

* prior radiotherapy
* active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash
* Women who are pregnant or lactating.
* Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol