cyrilzakka/clinical-trials huggingface dataset:
Comparation of Ultrasonic Imaging of Enthesopathy in Patients With Psoriatic Arthritis and Psoriasis

Psoriatic arthritis(PsA) and psoriasis(Ps) are two systemic inflammatory diseases linked with rash of psoriasis, but there's still great controversy regarding the exact relationship between them. Our study is to investigate the characteristics and differences of the ultrasonic imaging of enthesopathy in the lower extremity in patients with PsA and Ps, to explore the risk factors of Ps developing into PsA in the long term course.

As one of the most common chronic inflammatory skin diseases, psoriasis(Ps) can be intimately associated to psoriatic arthritis (PsA), affecting approximately 1% to 2% of the world's population. About 30% of them will develop into PsA with serious impact on their health-related quality of life.

PsA, characterised by different subsets with varying degree of severity, is a chronic, complicated inflammatory disease.Enthesitis is the prevalent and distinctive feature of PsA.

Musculoskeletal Ultrasound (MSUS) is a valid noninvasive modality, essential to evaluate entheses thickness, enthesophytes, bursitis and bone erosions as well as to disclose vascularisation on tendons through power doppler (PD) assessment. In recent years, more and more attention has been paid to the diagnosis and management of Ps and PsA, owing to its discrimination of identifying subclinical entheses and joint changes.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis or osteoarthritis.
* Body Mass Index (BMI)\<30 kg/m2.
* Absence of local glucocorticoid or other drugs injection or surgical treatment for entheses scanned in the previous 6 weeks prior to clinical and musculoskeletal ultrasound (MSUS) evaluation.

Exclusion Criteria:

* Other systemic rheumatic diseases or malignant neoplasms.
* Peripheral neuropathy of lower extremity.
Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease

The objective of this long term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1- patients with moderate chronic kidney disease eGFR 30-59 and Cohort 2- patients with severe chronic kidney disease or kidney failure eGFR \<30).


Eligibility Criteria:
Inclusion Criteria:

COHORT 1

* Is going to receive or has received PROHANCE injection during an MRI examination;
* Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
* Provides written informed consent and is willing to comply with protocol requirements.

OR

COHORT 2

* Is going to receive or has received PROHANCE injection during an MRI examination;
* Has CKD with eGFR below 30 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
* Provides written informed consent and is willing to comply with protocol requirements.

Exclusion Criteria:

COHORT 1

* Has received a GBCA within the past 12 months prior to inclusion in this study;
* Has unstable kidney function;
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
* Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
* Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.

OR

COHORT 2

* Has received a GBCA within the past 12 months prior to inclusion in this study;
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
* Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
* Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.
Evaluating the Carter Institute Caregiver Education Program at the VA

This project implemented and evaluated the Rosalyn Carter Institute's (RCI's) educational and support program for caregivers, "Caring for You, Caring for Me." Specifically, it examined effects of the program upon family caregivers to older adults in the Atlanta area and elderly Veterans receiving outpatient primary care at the Atlanta Veterans Affairs Medical Center (VAMC).

Primary objectives of the research were:

1. to evaluate user satisfaction with and perceived utility of the "Caring for You, Caring for Me" caregiver educational program among formal (VHA staff) and informal (family) caregivers who undergo the program;
2. to assess effects of the program upon psychosocial and physical well-being of informal caregivers over a 1-year period .

Eligibility Criteria:
Inclusion Criteria:

* Family members of Veterans aged 65+ years and receiving care through the Atlanta VAMC's Clinic and Atlanta area.
* Must be the primary caregiver to someone 55 and over.
* Must have been assisting with at least one activity of daily living (ADL) for at least 6 months prior to beginning the intervention.

Exclusion Criteria:

* Caregivers are automatically excluded if veteran has a terminal illness with six months or less to live.
Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure

Aim: To evaluate the efficacy of iron supplements given at intervals corresponding to the mean life of red blood cells compared to weekly supplementation, in reducing the prevalence of preschool anemia.

Method: Ninety-nine children from public day care centers with ages from 24 to 59 months old were randomly divided into two groups. All the children received 40 doses of 30 mg of ferrous sulfate during a 10-month intervention period. Group 1 received once weekly supplementation and Group 2 received supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.

The prevalence of anemia after the supplementation regimens reduced from 20.20% to 5.05% (P \< 0.0005); the reduction was not significantly different between the two groups (P = 0.35). The mean hemoglobin concentration increased in both groups (Group 1: 0.27 g/dL; P \< 0.016 and Group 2: 0.47 g/dL; P \< 0.0005) without significant differences between the groups (P = 0.17).

Eligibility Criteria:
Inclusion Criteria:

* The participants of the study were children with ages ranging from 24 to 59 months old that attended four local public day care centers

Exclusion Criteria:

* Presence of infection or reported infections within two weeks prior to the intervention
* Anemia lower than 7.0 g/dL and children taking medications containing ferrous sulfate
Study of Fampridine-SR Tablets in Multiple Sclerosis Patients

The purpose of the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets.

Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients

Eligibility Criteria:
Inclusion Criteria:

* Patient with clinically defined multiple sclerosis
* All patients must be able to complete two trials of a timed 25 foot walk

Exclusion Criteria:

* Female patients who are either pregnant or breastfeeding.
Carvedilol in HF With Preserved EF

Beta-blockers improve clinical outcomes in heart failure and reduced ejection fraction (HFrEF); but not in those with preserved EF. Global longitudinal strain (GLS) is a prognostic factor independent of left ventricular ejection fraction (LVEF). In a retrospective with 1969 patients with HF and LVEF of ≥40%, beta-blocker was associated with improved survival in those with low GLS (GLS \<14%), but not in those with GLS ≥14%. In this prospective, randomized clinical study, the investigators will assess the effect of slow-release carvedilol in patients with HFpEF and hypertension. The primary endpoint is the time-averaged proportional changes in NT-proBNP level and GLS change from baseline to month 6.


Eligibility Criteria:
Inclusion Criteria:

* age ≥20 yrs
* symptomatic HFpEF with LVEF≥50%
* NT-proBNP ≥220 pg/ml (sinus rhythm) or ≥660 pg/ml(AF) (BNP ≥80 pg/ml (sinus rhythm) or ≥240 pg/ml(AF) )
* SBP≥140mmHg and/or DBP ≥90mmHg, or if taking anti-hypertensive medication, SBP ≥110mmHg.
* LAVI≥29(sinus rhythm)/34ml/m2 (AF) or LVMI≥115(male)/95(female) g/m2
* meet one the following

  1. Average E/e'≥ 9
  2. Septal e' \< 7 cm/s
  3. Lateral e' \<10 cm/s
  4. TR velocity \> 2.8 m/s
  5. PASP \> 35 mmHg
  6. GLS \< 16%

Exclusion Criteria:

* systolic blood pressure \< 110 mmHg, or heart rate \< 60 beats/min
* contra-indication to beta-blockers
* creatinine\> 2.4mg/dL
* amyloidosis, hypertrophic cardiomyopathy with obstruction, severe aortic or mitral valve disease, acute coronary syndrome, Cerebrovascular event within 6 months, PCI within 3 months before
* AST/ALT \>3 x normal upper range
Natural History Study of Patients With Leber Congenital Amaurosis Associated With Mutations in RPE65

MGT005 is a natural history study to collect longitudinal prospective data from patients with Leber Congenital Amaurosis associated with defects in RPE65.

Leber Congenital Amaurosis (LCA) is a diagnosis for a group of severe, autosomal recessively inherited rod - cone dystrophies that typically result in complete visual loss in the third or fourth decade of life. One form, LCA2, is caused by a mutation in the gene encoding RPE56, an RPE-specific 65-kDa isomerase. Non-functional RPE65 results in photoreceptor cells that are unable to respond to light resulting in these patients being visually impaired.

In preparation for human clinical trials, a detailed prospective phenotypic study will be undertaken to investigate the natural history of RPE65-LCA. Such a study will help identify suitable patients for therapeutic intervention. Furthermore through greater phenotyping an optimal window for intervention and specific parameters to help quantify effect and identify clinical end points may have been ascertained .

Eligibility Criteria:
Inclusion Criteria:

* Patients with RPE65 associated retinal dystrophy
* Minimum subject age of 3 years
* Able to give consent/parent or guardian able to give consent

Exclusion Criteria:

* Patients unable or unwilling to undertake consent or clinical testing
* Have received a gene therapy treatment in both eyes
Tecemotide (L-BLP25) in Rectal Cancer

The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagnosed rectal cancer who are eligible for neoadjuvant therapy.

Tecemotide (L-BLP25) is designed to induce an immune response that may lead to immune rejection of tumor tissues that aberrantly express MUC1 antigen. MUC1 is highly expressed in all colorectal cancers and since the adaptive immune system plays a role in the prognosis of rectal cancer, it is reasonable to speculate that tecemotide (L-BLP25) administration might boost the tumor-specific immune response and increase the number of tumor-infiltrating lymphocytes (TILs).


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects with histologically documented resectable rectal adenocarcinoma in Stage 2-4
2. Availability of tumor biopsy sufficient for immunological analysis
3. Indication to receive neoadjuvant concomitant chemoradiotherapy consisting of a radiation dose of 45-52 Gy and capecitabine 825 mg/m\^2 orally twice daily. The use of an equivalent schedule based on 5-FU is acceptable
4. Magnetic resonance imaging small pelvis / computed tomography thorax/abdomen (or X-ray thorax) to document absence of metastatic disease. Imaging must not be older than 6 weeks prior to randomization
5. Eastern Cooperative Oncology Group performance status of 0 or 1
6. Written informed consent
7. Greater than or equal to (\>=) 18 years of age

Exclusion Criteria:

1. Previous chemotherapy and/or previous radiotherapy of the pelvic region
2. Relapsing disease
3. Previous vaccination with any MUC1 vaccine and other therapeutic cancer vaccines
4. Previous organ transplantation (bone marrow or solid organs)
5. Subjects with metastatic disease (except for solitary, resectable liver or lung metastases)
6. Inadequate hematological function (that is, platelet count less than 140\*10\^9 per liter \[/L\], or white blood cell less than 2.5\*10\^9/L, or hemoglobin less than 90 gram per liter). Clinically significant hepatic dysfunction (that is alanine aminotransferase greater than 2.5\*upper limit of normal \[ULN\], or aspartate aminotransferase greater than 2.5\*ULN, or bilirubin greater than 1.5\*ULN). Inadequate renal function (that is serum creatinine greater than 1.5\*ULN)
7. Autoimmune diseases
8. Recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies
9. Clinically significant cardiac disease, for example, New York Heart Association Classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by medical history and an electrocardiogram
10. Other protocol defined exclusion criteria could apply
Echo Acquisition Despite Geographic Separation by Replication of Human Movements (EAGER)

Echocardiography is a cornerstone of modern cardiology management, but access in rural and remote areas is limited. We have developed a robot ("Edler" named after the originator of echocardiography) which enables a sonographer to complete an examination at a distance. This study seeks to compare the images obtained by both methods, the completeness of the exam over a feasible time, and to identify particular components of the exam that are difficult to obtain using the robot.

The EAGER study is an effectiveness and feasibility trial of robot -assisted echo.

Patients who have undergone a standard echo will be asked to have a repeat study with a different sonographer, working remotely, obtaining images using the robot. This study is limited to 1 hour and as many views as possible will be obtained. During the study, the remote sonographer and patient are in direct contact over a video link. Another person will be in the room with the patient and the patient will be instructed on the use of a stop switch which will disengage the robot if they feel uncomfortable.

The acquired images will be saved to the imaging cloud and interpreted by an imaging specialist blinded to the original echocardiogram. A side-by-side comparison will be undertaken for each view, and image quality and study completeness will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Having a conventional echocardiogram

Exclusion Criteria:

* Declined consent to undergo both examinations
Self-Help Parent Training for Conduct Problems in Children

This project will introduce a self-help parent training programme for families on National Health Service (NHS) waiting lists for child mental health services. It will examine whether access to treatment can be increased by providing an intervention that requires fewer resources and by releasing clinician time for more serious cases. This intervention will be tested in a randomised, controlled trial in which 35 subjects will receive treatment immediately and 35 will receive treatment after waiting for 10 weeks. All families will also complete questionnaires before and after the 10 week study period in order to measure changes in child behaviour, parenting, and parental mental health. Cost-effectiveness of this programme will also be analysed. Intention-to-treat analyses will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Families on waiting lists and child and adolescent mental health services clinics with children aged 2-5.
* Scores in the clinical range on a standardised measure of child behaviour problems.
* At least one parent in each family must be literate, fluent English speakers to participate because the self-administered intervention will primarily consist of written instructions and information in English.

Exclusion Criteria:

* Clients whose children score below a clinical cut-off score on a standardised measure of child behaviour problems. This is to ensure that participants are appropriate for an intervention aiming to reduce behaviour problems.
* Non-English speakers or those who are unable to read cannot be included because reading English is required to complete the self-administered intervention.
* Children or parents with severe disabilities and children with a developmental disorder (e.g., autism) will be excluded because the version of the parent training programme that will be implemented is not designed for families with these types of problems.
* Children who live with a temporary caregiver will be excluded because the intervention is designed for full-time parents and follow-up will be after one year.
* Children or parents who are currently receiving treatment for psychological problems will be excluded because outcomes may be influenced by interventions not affiliated with this project.
Is Anesthetic Loss of Consciousness a Top Down or Bottom up Phenomenon. What Does the Neurologic Examination Say?.

Using very slow or fast propofol intravenous injection, monitored using standard American Society of Anesthesiology (ASA) standard and SEDLine EEG (Med Tech), the patient was evaluate by a neurologist every 30 sec using the FOUR coma scale.

Clinical experimental randomized study, approved by the Ethic Committee, with informed consent, included ASA I- II adults, without neurological illness and normal physical exam.

The patient randomized in two groups, rapid induction (GR) with propofol in target controlled infusion (TCI) effect site mode using the phamacokinetic (PK) model from Marsh ke0 1,21 min-1 using a calculated target of 5.4 ug/ml (loss of counsciousness EC95) and slow induction (GL) 10 mg/kg/h with calculated effect site concentrations (CeCALC) same PK model.

The same neurologist, blind to the correspondent group, evaluated all the patients every 30 sec using the coma FOUR scale until loss of counsciousness (LOC), defined as a FOUR (E0 no eyes opening response and /or M0 no motor response). At LOC the existance of brainstem reflex was evaluated (B no pupil and corneal reflex), respiratory pattern (R apnoea), CeCALC and patient state index (PSI) SEDline™ was recorded during all the examination.

After LOC in both groups we maintain in GR the initial target (5.3 ug/ml) and the LOC CeCALC during 10 min without intervention, except respiratory support if it was required.

Frontal EEG 4 channel and spectrogram from SEDline monitor was extracted for each case and posterior analysis.

Fisher exact test was used to describe primary outcome and difference between B and R for each group. The difference in time to reach LOC LOC, Ce and PSI was analysed with T- Student.

Eligibility Criteria:
Inclusion Criteria: ASA 1-2 patients programmed for elective surgery, normal neurologic examination -

Exclusion Criteria: neurologic illness, receiving drugs that affect Central Nervous System during the last 48 hours

-
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients

Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to de-creases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to CBT-I in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.

Subjects will be randomized into one of four groups, four, eight, ten or twelve sessions. Sessions will be con-ducted weekly by Telehealth and will be modified based on the duration of treatment but all will include the following, evaluation and orientation; data acquisition and delivery of sleep restriction therapy \& stimulus control instructions; review of sleep hygiene; cognitive therapy \[decatastrophization\]; managing non-adherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration. Treatment will be conducted by a master therapist via a HIPAA compliant video link.

All CBT-I related data will be obtained via dedicated internet websites built with RedCap, where subjects will be asked to complete weekly and monthly questionnaires. One website will be for use by subjects. One website will be for use by the therapist. The patient and therapist website will have a landing page (password entry), a login page, and an activities page (what questionnaires are due when). For an example of such a website, please see our pilot study, https://redcap.med.upenn.edu/surveys/?s=RXLLA7C4KJ (access using password "sleepstudy"). The patient website will contain daily sleep diaries, weekly severity measures of insomnia (ISI), sleepiness (ESS), fatigue (PROMIS 7a, Brief Fatigue Inventory, and FACIT-F), depression (PHQ-9), anxiety (GAD-7), a medical symptoms checklist.

Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of organ-confined BC;
2. Treatment with RT;
3. Willingness and ability to provide informed consent;
4. They endorse problems with both insomnia and CRF, as determined by a score within the significant ranges on the ISI, PROMIS 7a, BFI, and FACIT-F;
5. and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD).

Exclusion Criteria:

1. History of untreated obstructive sleep apnea (OSA \[defined as an apnea-hypopnea index ≥ 10\]) or above threshold scores on the STOP-BANG;
2. History of narcolepsy;
3. Night shift work;
4. Distant metastatic disease at presentation;
5. Active alcohol and/or drug dependence;
6. They do not have a diagnosis of BC;
7. They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT;
8. They have a current diagnosis of significant medical and/or psychiatric disorders;
9. And/or they are not between the ages of 25-85 years.