cyrilzakka/clinical-trials huggingface dataset:
Sleep in Pediatric HSCT

Through an aggregated N=1 randomized controlled design (each patient will serve as their own control, with the 5-day intervention period determined by randomization), the current study will test the acceptability, feasibility, and impact on sleep and supportive care engagement of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during Hematopoietic Stem Cell Transplant (HSCT) recovery.

Context: Patients undergoing treatment for cancer face disease, treatment, and environmental obstacles to sufficient, sound sleep. Hospitalizations can further worsen sleep quality and quantity due to overnight vitals checks, medication administration, blood draws, and environmental noise and light. For patients undergoing hematopoietic stem cell transplant (HSCT), the risk for poor sleep is especially high due to protracted hospitalization, frequent vitals checks resulting in multiple night awakenings, and high symptom burden peaking approximately 10 days post-transplant.

Objectives:

Primary: Test the acceptability and feasibility of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during HSCT recovery.

Secondary: Assess the effect of one 6-hour window for nighttime sleep on subject sleep and engagement in supportive care on the oncology unit.

Study Design:

Aggregated N=1 randomized controlled design. All participants will undergo a 5 day observation and then be randomized to receive the 5 day intervention (extended vitals checks) during either nights of days +5-+9 or days +10-+14.

Setting/Participants:

Inpatients on the HSCT Unit at the Children's Hospital of Philadelphia (CHOP)

Study Interventions and Measures:

Intervention-increasing time between vitals checks from every 4 hours to one 6-hour period at night.

Subjects will wear an actigraph for the duration of the study, complete a daily sleep diary, and complete self- and parent-proxy psychosocial measures (symptom burden, health related quality of life, sleep) and acceptability. Medical record review will also be conducted to assess vitals check frequency.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 8 to 21 years.
2. Undergoing HSCT at The Children's Hospital of Philadelphia
3. Parent/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. History of developmental delays given the relationship to sleep/wake patterns
2. Sleep disorder diagnosis as documented in the medical record
3. Cognitive delays that impact the ability to complete study measures
4. Not proficient in English
Extended Support for Persons With Pituitary Tumours After Surgery

Patients with pituitary tumours often live with life-long consequences of their disease. Treatment options include surgery, radiotherapy and medical therapy. Symptoms associated with the tumour and/or its treatment affects several areas of life. The year after pituitary surgery constitutes an important time-period with medical evaluations of surgery and decisions on hormonal substitution. The development and evaluation of extended patient support during this time-point is limited. Care based on person-centredness has exclusively been promoted which comprises a care where care providers inquire how patients view their health situation and what their needs, resources, and preferences are. Person-centredness focuses on preserving patient autonomy, function, and well-being and strives to emphasize patient involvement through equalizing power between health care professionals and the patient with the main goal of an enhanced health situation. The aim of the study is to evaluate if a support within a person-centered care practice one year after surgery increases wellbeing for patients with pituitary tumours.


Eligibility Criteria:
Inclusion Criteria:

1. Pituitary tumour; adenoma or craniopharyngioma
2. Planned neurosurgery due to pituitary tumour

Exclusion Criteria:

1. Pituitary carcinomas
2. Health conditions which may restrain the understanding of the study and/or the ability to adhere to the protocol for example decreased cognitive functions or drug addiction.
A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)

This study will test whether a plant-based diet is practical (feasible) for overweight people with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The researchers will decide how practical the diet is by looking at how much weight participants lose and how well they are able to stick to the diet. The researchers will also determine whether the diet is effective in preventing multiple myeloma in participants. In addition, they will look at how safe the plant-based diet is for participants, and see if the diet affects participants' quality of life.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥25
* Confirmed diagnosis of MGUS or SMM
* M spike (immunoglobulin) ≥0.2 g/dL or abnormal free light chain ratio with increased level of the appropriate involved light chain
* Secretory disease
* Age ≥18 years
* Willingness to comply with all study-related procedures
* ECOG performance status of 0-3
* Interest to learn to cook plant based recipes

Exclusion Criteria:

* Patients that already follow a whole foods plant based or vegan diet (ovo-lactovegetarian diets are not excluded)
* Legume allergy
* Severe allergies, such as anaphylactic shock to peanuts
* Concurrent participation in weight loss/dietary/exercise programs
* Mental impairment leading to inability to cooperate
* Enrollment onto any other therapeutic investigational study
* Concurrent pregnancy
* Patients with a known diagnosis of diabetes mellitus will not be excluded but will need to be followed regularly with an endocrinologist/primary care physician during the trial period.
* Positive HBV, HCV, HIV PCR testing
* Non English speaking
* ≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)
* If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania

The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures
* Patient has a documented clinical diagnosis of Bipolar I mania
* Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit

Exclusion Criteria:

* Patients (female) must not be pregnant or lactating
* Patients with a known intolerance or lack of response to previous treatment with quetiapine
* Patients who have previously participated in this study
The Lived Experience of Pediatric Nurse-caregiver Relationship in the PICU: a Descriptive Phenomenological Study

The goal of this qualitative study is to make exploration in the lived experience of pediatric nurse-caregiver relationship in the PICU. The main question it aims to answer is:

• What is the meaning of nurse-caregiver relationship among pediatric intensive care nurses in Hong Kong

Participants will be invited to undergo individual, in-depth, semi-structured interviews.

Pediatric intensive care nurses care not only for critically ill children but also for their caregivers. Under unfamiliar and critical situations, caregivers demand nursing care to ease their negative emotions and to cope. Pediatric intensive care nurse is the bridge to connect the healthcare team to the caregivers in the pediatric intensive care units (PICU). Previous literature discussed the relationship between nurses and family caregivers as therapeutic and meaningful, which consisted of elements like mutual respect, empathy, support, and more. Nurses' and family caregivers' roles shifted and changed in different times and settings. However, the relationship between the two had not been acknowledged in the PICU context. A review of the literature showed that the interaction between the pediatric intensive care nurse and the family caregivers involved six elements. Consequently, a conceptual framework was developed which may help represent the essence of the nurse-caregiver relationship.

This study aims to explore the lived experience as to the meaning of nurse-caregiver relationship among pediatric intensive care nurses in Hong Kong. Descriptive phenomenological approach will be adopted to gain an accurate and unbiased description of the lived experience. An estimated ten pediatric intensive care nurses in Hong Kong will be invited to undergo individual, in-depth, semi-structured interviews. Hence to obtain pediatric intensive care nurses' detailed information so as to reveal the essence of Nurse-Caregiver Relationship in PICU.

Data will be analyzed using Colaizzi's seven-step strategy as it aligns with the study aim and is able to obtain the meaning of experience. This qualitative study may disclose the nurse-caregiver relationship and the complex nursing relationship role in the context of PICU in Hong Kong and allow clinical reasoning to improve FCC via understanding pediatric intensive care nurses' experience.

Eligibility Criteria:
Inclusion Criteria:

* any full-time registered nurse in any hospital in Hong Kong
* interacted with the caregivers of NICU/PICU patients in the last 12 months
* with at least 12 months' experience in NICU/PICU
* able to speak in Cantonese and read Chinese
* being willing to articulate their feelings and experiences

Exclusion Criteria:

* Part-time registered nurses
* student nurses
* enrolled nurses
Outcomes of Complicated CL in Ethiopia Treated With Miltefosine

Cutaneous Leishmaniasis in Ethiopia causes severe dermatological mutilations. Forms that require systemic treatment are cLCL, MCL, and DCL. National guidelines recommend equally all drugs that are also used for VL treatment. Miltefosine is one of these recommended medications but remains underused due to scarcity of drugs.

Outcomes of patients receiving miltefosine have never been documented systematically in Ethiopia until today. This is needed to provide evidence to advocate for increased access to miltefosine in Ethiopia, and to establish baseline data for future research on CL treatment options. The aim of this study is to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using miltefosine within a routine care setting located in an endemic area in Ethiopia.


Eligibility Criteria:
Inclusion Criteria:

* Parasitologically or clinically confirmed diagnosis of Leishmaniasis
* Clinical routine care decision to initiate miltefosine

Exclusion Criteria:

* Medical emergencies, underlying chronic conditions, or other circumstances that make participation in this study medically or otherwise inadvisable
Effects of Laser Therapy on Muscle Function in COPD Patients

Light-emitting diodes (LEDs) have been used to minimize muscle fatigue in athletes and healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible to early muscle fatigue. The objective of this study is to assess the acute effects of LEDs on muscle function, exercise capacity, and cardiorespiratory responses during isometric and dynamic exercise in patients with COPD. This study will assess 30 patients with moderate to severe obstruction (FEV1 ≤ 70% predicted). Isometric and dynamic protocols will be conducted in two visits each, for a total of four visits a week a part. First, a venous blood sample will be taken from the patients. The isometric protocol will start with the determination of the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC) for the isometric endurance test (IET). Patients will be randomized to receive either the placebo or LED application. Immediately after finishing this procedure, the patients will carry out the IET until the limit of tolerance or until a 20% fall of strength is observed. After the test, another blood sample will be taken. In the other visit (one week later), the same order of procedures will be performed, except with the opposite (LED or placebo). For the dynamic protocol, the same procedures described above will be followed except with the maximal incremental cycle ergometer test used instead of the IET. The electromyography will be recorded during the isometric and dynamic protocols. Differences in muscle function, exercise capacity, and cardiorespiratory responses between the LED and placebo applications will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients with COPD by increasing exercise tolerance.


Eligibility Criteria:
Inclusion Criteria:

* 35 patients will be selected (see sample calculation in Section 6) who have moderate to severe obstruction (FEV1 ≤ 70% predicted) and stable disease, as suggested by the absence of changes in medication in the last 4 weeks.

Exclusion Criteria:

* Ischemic heart disease, recent surgery, neuro-muscular or orthopedic that limit the performance of the protocol.
* Patients will only be included in the study after signing the consent form.
User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)

Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. Thereafter, a healthcare professional will perform an additional reading with the reference method (YSI 2300 STAT plus). In addition, blood will be drawn for determination of hematocrit. In the study, a minimum of 10 test strip vials that cover a minimum of 3 strip lots will be used. In addition multiple devices will be employed. After completion of the study the study participants will be given a questionnaire to fill out.


Eligibility Criteria:
Inclusion Criteria:

* patients with type 1 or type 2 diabetes or healthy
* Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
* 18 years old and above;

Exclusion Criteria:

* Does not meet inclusion criteria;
* Subjects with any other severe disease in the discretion of the investigator
* Not capable to read English user instructions at the discretion of the patient
* Pregnancy or Nursing mothers
* Any condition that may prevent participants from successful participation in the trial (in discretion of the investigator)
* Illiteracy
Hong Kong Cohort of Abnormal Sleep in Ageing Population (HK-ASAP): Focusing on Brain Health and Sleep Quality

Poor sleep quality can significantly jeopardize the brain health, cognitive functions, daily activities, quality of life, and even be implicated as a key potential contributing factor in the development of accelerated cognitive decline and prodromal dementia. Consequently, research efforts to understand, and therefore potentially model, the effects of sleep quality on cognition and brain health are of great pragmatic values.

Objectives: This study aims to investigate the cognitive changes in older adults with sleep disturbances, examine the neuroimaging contributors to poor sleep quality and cognitive deficits.

Eligibility Criteria:
Inclusion Criteria:

* Chinese old adults are the ones who are over 60 years of chronological age.
* Sleep disturbance: individual's subjective sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI) with a total score \>5.

Exclusion Criteria:

* History of bipolar disorders or psychosis.
* History of major neurological deﬁcits, including stroke, transient ischemic attack or brain tumor.
* Unable to participant magnetic resonance imaging (MRI) scanning.
Realistic in Generation of HEp-2 Cell Images Using Latent Diffusion Models: a Multi-center Visual Turing Test

The objective of this prospective observational study is to rigorously examine the feasibility and efficacy of utilizing latent diffusion models for data augmentation in anti-nuclear antibody (ANA) Hep-2 cell immunofluorescence images. The main question it aims to answer is:

Can the application of such models potentially enhance the data quality, increase sample diversity, or improve the accuracy and efficiency of subsequent analytical processes (like disease diagnosis and classification) when utilized with ANA-related images?

A fundamental problem in biomedical research is the low number of observations available, mostly due to a lack of available biosamples, prohibitive costs, or ethical reasons. Augmenting few real observations with generated in silico samples could lead to more robust analysis results and a higher reproducibility rate. Here, The investigators propose to use unsupervised learning with latent diffusion models for the realistic generation of ANA-IIF image data.

The investigators hypothesize that the the generation of ANA-IIF image will be realistic if it is hard to differentiate them (fake) from real (true) . To test this hypothesis, the investigators present a Multi-center Visual Turing tests (https://turing.rednoble.net/) in order to evaluate the quality of the generated (fake) images.

This experimental setup allows the investigators to validate the overall quality of the generated ANA-IIF images, which can then be used to (1) train cytopathologists for educational purposes, and (2) generate realistic samples to train deep networks with big data.

Eligibility Criteria:
Inclusion Criteria:

* Originating from reputable medical institutions
* Possessing relevant certification and qualifications
* Having over one year of experience in interpreting anti-nuclear antibody (ANA) patterns within a laboratory setting

Exclusion Criteria:

* Lacking relevant professional certification and qualifications
* Without experience in interpreting ANA patterns
* Unwilling to accept the rules and informed consent of the visual Turing test
Fascial Distortion Model With And Without Neck Isometrics In Patients With Cervical Spine Overload

Cervical spine pain is the one the most common musculoskeletal disorder and spinal overload is one of the major causes. Forward tilting of every inch of head increases load on the cervical spine and is referred as cervical spine overload. Persistent overloading and overburdening results in radiation of pain, weakness of muscles and limitation in joint range.

Psychological factors are also play role in acute, sub-acute or chronic neck pain. Treatment commonly used for this pain is NSAID, physiotherapy interventions (mobilisation, manipulation, TENS, ultrasound, stretching, isometrics and FDM) and awareness about posture. FDM was established in 1991 by Stephan Typaldos and it recommends that musculoskeletal ailments are due to disruption in fascia. There are 6 diverse proposed facial distortions and diagnosis in this model i.e., trigger band, herniated trigger band, folding distortion, continuum distortion, tectonic fixation and cylinder distortion. Main purpose of this randomised clinical trial will be to find out the effects of fascial distortion model with and without neck isometrics in patients with cervical spine overload.

Patients will be recruited into study by consecutive sampling technique and after that patients will be allocated to the groups by random sampling assignment. NPRS, NDI and goniometer will be used as data measuring tool. Treatment will be given to 2 groups. One group will get treatment of only FDM and other group will get treatment of FDM and neck isometrics as well. Treatment will be given two times a week for 4weeks and duration of the session will be of 30 minutes. After collecting data from defined study setting, data will be entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria:

   * Trigger band pain pattern
   * Age limit 20 to 30 years.
   * Male and female
   * Pain in the cervical spine
   * Limited cervical ROM
   * Uneasiness while working in a sitting posture for 4 hours but no abnormal neurological findings

Exclusion Criteria:

* Progressive degeneration of spine (spondylosis)
* Previous cervical spine injuries
* Congenital and developed spine deformities (scoliosis)
Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

A small percentage of patients with retinal degeneration accumulate fluid in the center of their retina.

Previous studies using an oral form of treatment has been successful in decreasing this fluid which improves vision.

This study will test the use of a topically applied form of this treatment to the eye to reduce the amount of fluid and improve or preserve vision.

Patients with certain retinal degenerations will be asked to take part in a research study about the use of a topically applied eye drop for treating fluid in the central part of the retina (macular edema).

In the current study, investigators propose to use topical Trusopt in a group of patients with retinal degeneration (RD) to determine its effectiveness in reducing the amount of retinal fluid in patients with RD and macular edema. The methods will involve an initial one month treatment with topical Trusopt three times a day in each eye. After a period of one month, patients will return for a follow-up examination. At baseline, they will have had a measurement of their center vision and a measurement of their macular fluid with a photographic-like procedure termed optical coherence tomography (OCT). After the one month period of treatment, they will again have a measurement of their vision and re-evaluation with OCT. An improvement at least of one line (7 letters) or more of vision will be considered as a clinically significant improvement.

Eligibility Criteria:
Inclusion Criteria:

* Presence of cystic macular fluid on OCT testing

Exclusion Criteria:

* Allergic reaction to sulpha containing compounds
* Intolerance to dorzolamide (Trusopt)
Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis

The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 50 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed participation in the TR03 study

Exclusion Criteria:

* Medical condition or other factors that in the opinion of the Investigator may interfere with the conduct of the study.
* Subject is a pregnant or lactating female
Ursodeoxycholic Acid (Udca) as a Local Drug Delivery Agent in the Treatment of Intra-bony Defects

The aim of this study is to evaluate the efficacy of ursodeoxycholic acid as local drug delivery agent in intra- bony defect to achieve bone regeneration.

Experimental: Main treatment group the prepared UDCA gel will be injected using a syringe with blunt cannula into the defect site.

Comparator: In patients allocated to control group, placebo gel will be injected in to the defect site using a syringe with blunt cannula.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy male and female patients of age\>18 years with intrabony defects - two wall or three wall defects and probing pocket depths (PPD) of \>3mm will be included

Exclusion Criteria:

* Medically compromised patients, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy will be excluded.