cyrilzakka/clinical-trials huggingface dataset:
Family Participation in Ghana Hospital Care

This mixed methods study aims to understand family care participation in the adult medicine wards of Korle Bu Teaching Hospital, Ghana. The main questions it aims to answer, from the perspective of the patient, family caregiver, nurse, doctor, ward assistant, and hospital administrator, are:

1. What is the role of the family caregiver in hospital care?
2. What is the perceived effect of family participation in hospital care?
3. What are the barriers and facilitators experienced in family participation?
4. What are suggestions for family participation interventions?

These questions will be answered with three study arms:

1. A prospective observational cohort (population: patients and family caregivers)
2. A time and motion study (population: nurses and doctors)
3. Interviews and focus group discussions (population: patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators)


Eligibility Criteria:
Prospective Observational Cohort

* Inclusion Criteria

  * Population
  * Patient: Admitted to the ward (in-patient)
  * Family caregiver: caregiver providing care at the bedside of the patient on the ward
  * Environment: Admitted to a medicine ward of KBTH
  * Admission time: Admitted in the last 48 hours
  * Adult: ≥18 years
* Exclusion criteria

  * Admission time: Planned discharge or transfer within the first 24 hours of admission
  * Child: \<18 years
  * Previously enrolled in this study arm
  * No consent given

Time and Motion

* Inclusion Criteria

  * Population: Nurses and doctors
  * Environment: Working in a medicine wards of KBTH
* Exclusion Criteria

  * Population: \<6 months of work experience on a medicine ward of KBTH
  * Previously enrolled in this study arm
  * No consent given

Qualitative (interviews and focus group discussions)

* Inclusion Criteria

  * Population
  * Patient: Admitted to the ward (in-patient)
  * Family caregiver: Caregiver providing care at the bedside of the patient on the ward
  * Health workers: Nurses, doctors and ward assistants
  * Hospital administrator: Managers and professors
  * Environment
  * Patient: Admitted to a medicine ward of KBTH
  * Family caregiver: Caring for their relative on a medicine ward of KBTH
  * Health worker: Working on a ward medicine of KBTH
  * Hospital administrator: Responsible for care delivery of a medicine ward of KBTH
* Exclusion Criteria

  * Population
  * Patient: Unconscious or unable to participate in a conversation
  * Family caregiver: Unable to leave the patient for reasons of safety
  * Health worker: \<6 months of work experience on a medicine ward of KBTH
  * Hospital administrator: \<6 months in a management role of a medicine ward of KBTH
  * Admission time
  * Patient: Admitted \<48 hours
  * Child: \<18 years
  * Previously enrolled in this study arm
  * No consent given
Mobile Mindfulness Meditation Intervention to Improve the Well-Being of Cancer Survivors

Evaluate the impact and satisfaction of Mobile Mindfulness Meditation on anxiety, pain, fatigue, trauma, and sleep in cancer survivors.

Through previous research, mindfulness meditation has been linked to decreases in anxiety, increased pain tolerance, better mood, and improved quality of life, in both healthy and medical populations. Although mindfulness meditation is well promoted both clinically and in the media, finding ways to promote engagement in and fidelity to the intervention, in a format that is accessible for cancer survivors is crucial, as the availability of resources and appreciation of the benefits does not necessarily lead to behavior change.

With many more people surviving cancer than in previous decades, there is an opportunity to act on the residual effects of cancer diagnosis and treatment, and with the prevalence of technology ever increasing, online and mobile interventions have become more frequently delivered and have a particular utility for this population. Physical and geographic limitations could prevent cancer survivors from accessing psychosocial interventions. Whether the repeated beneficial findings of face-to-face training in mindfulness meditation will be found in a mobile environment is an open and timely question. This intervention will include two arms: the impact of the use of the mobile app for anxiety and for cancer related neuropathy.

Eligibility Criteria:
Inclusion Criteria

Anxiety Arm:

1. previous diagnosis of cancer, other than non-melanoma skin cancer
2. over 21 years of age
3. routine access to the Internet
4. comfortable reading and writing in English
5. have completed primary treatment for cancer
6. indicate the presence of cancer related anxiety as indicated by the PROMIS measure
7. not currently practicing meditation regularly (more than one hour per week), and
8. diagnosed with any stage of cancer
9. own a smartphone or tablet

Cancer Related Neuropathy Arm

1. diagnosis of cancer
2. use of a taxane or platinum agent
3. experiencing CIPN, per self-report
4. over 21 years of age
5. routine access to a smart device
6. comfortable reading and writing in English, and
7. not currently practicing meditation regularly (more than one hour per week).

Exclusion Criteria:

None
Internal Jugular Ultrasound Measures During Respiration in Children

Project Aims: The purpose of this study is to determine the size of the right internal jugular vein (RIJV) in children with normal respiratory physiology during the respiratory cycle and evaluate the reliability of those measurements.

Hypothesis: Ultrasound measurements of internal jugular vein collapse of children can be reliably measured in the respiratory cycle.

Intervention: We will ensure that the patient is not having any respiratory symptoms or signs of dehydration. A clinical asthma score will be assigned using the Modified Woods pulmonary index scoring system. The Gorelick Dehydration Scale with also be calculated.

Using bedside ultrasonography with the Sonosite Titan ultrasound machine, each measurement will be taken with the subject lying in bed with the head of the bed elevated at 45 degrees with the subject's head in the neutral position and then turned 45 degrees leftward. Measurements of the internal jugular vein at maximal inhalation and exhalation will be recorded. Reliability calculations will be assessed.


Eligibility Criteria:
Inclusion Criteria:

Subjects ages 6-17 years old presenting to the emergency department (ED) will be enrolled into the normal respiratory function group.

Exclusion Criteria:

Children will be excluded from participation if they have: a baseline chronic lung disorder (including asthma), current respiratory illness, fever, Emergency Services Index (ESI) triage category of less than or equal to 2 (emergent acuity), chronic cough, dyspnea with exercise, wheezing, or a history of smoking by self and/or parent report.

Subjects will be excluded if they had prior cardiac/pulmonary disease or surgeries (other than asthma for the acute exacerbation group), significant musculoskeletal abnormalities (such as scoliosis) that might compromise baseline pulmonary function testing, a history of smoking tobacco or marijuana, and prematurity (birth at less than 37 weeks gestation. In addition, those with an allergy to ultrasound gel will be excluded from participation.
CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define methods to identify those patients at higher risk for certain side effects, as well as those who are at higher risk for relapse of their leukemia.

Outline of Therapy:

Combinations of chemotherapy drugs will be given orally, intravenously and intrathecally (directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a half years.

Therapy will be divided into five phases:

Induction (4 weeks): chemotherapy given to produce a clinical remission (defined by normal blood counts, with the absence of leukemia cells in the blood and fewer than 5% leukemia cells in the bone marrow).

Consolidation (11 weeks): chemotherapy given to consolidate the remission. Delayed Intensification (7 weeks) Intensive chemotherapy aimed at killing any resistant leukemia cells will be given only for patients at high risk of relapse.

Intensive Continuation (approximately 1 year): Eight week cycles of chemotherapy, given eight times.

Continuation (final year of therapy): Eight week cycles of largely oral chemotherapy, with one clinic visit for a lumbar puncture every eight weeks.

Irradiation: radiation will be given in the middle of intensive continuation to the head and spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time of diagnosis.

Follow-up: After the conclusion of therapy, there will be periodic office visits, initially monthly, then gradually spaced out to annual visits. The purpose of these visits is to evaluate for late side-effects of therapy.

Eligibility Criteria:
Inclusion:

* Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive)
* Patients with overt CNS (central nervous system) or testicular disease are eligible
* Informed consent according to institutional and FDA guidelines.
* Adequate organ function is required.
* HIV seropositive patients will not be excluded from this study.
* Patients greater than 1 year of age and less than 29.99 years of age are eligible.

Exclusion Criteria

* Patients with medical, psychological, or psychiatric problems that are likely to compromise their ability to tolerate intensive therapy will be ineligible.
* All patients with evidence of significant organ dysfunction not thought to be attributable to ALL (patients with clinically significant congestive heart failure, cardiac ejection fraction \<40%, total bilirubin \>2, serum creatinine \>2) will be ineligible. Note: echocardiogram or MUGA are required prior to therapy ONLY for those patients with history or physical findings suggestive of cardiac dysfunction not directly attributable to anemia or ALL. Note: Patients with total bilirubin \>2 but direct (conjugated) bilirubin less than the upper limit of normal will still be eligible. These patients should be evaluated for deficiency of the enzyme glucuronyl transferase.
Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.


Eligibility Criteria:
INCLUSION:

* Children 5 years old and younger
* require treatment for glaucoma or ocular hypertension
* vision is 20/80 or better
* cup-to-disc ratio of 0.8 or less

EXCLUSION:

* do not have abnormal fixation
* IOP greater than 36 mm Hg
* significant retinal disease
* penetrating keratoplasty
* severe ocular pathology
* optic atrophy
* eye surgery in the past 30 days
* cardiovascular abnormalities
* hypersensitivity to beta blockers, carbonic anhydrase inhibitors or sulfa drugs
Study of Oglemilast for the Prevention of Asthma.

The purpose of this study is to determine whether it is effective in the treatment of exercise-induced asthma and investigate the safety of oglemilast.


Eligibility Criteria:
Inclusion Criteria:

* stable mild asthma patients who exhibit at least a 20% decrease in FEV1 following exercise.

Exclusion Criteria:

* pulmonary disease other than asthma, psychiatric illness, active cardiac disease, high blood pressure, history of substance abuse, current smokers.
PEACE: Pediatric Antifungal Comparative Effectiveness

The overarching objective is to develop new evidence-based treatment guidelines for invasive fungal diseases in children. To accomplish that, this protocol will focus on two specific aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and for the subset of patients with invasive candidemia; 2) Characterize the incidence rate of inpatient pediatric invasive candidiasis per hospital admissions.

This study is a multicenter, national and international, prospective observational comparative effectiveness study.

The primary aim of this study is to compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and for invasive candidemia. The primary effectiveness endpoint for study aim 1 is the comparison of global response at 14 days of antifungal therapy between antifungal therapeutic classes. The secondary effectiveness endpoints for study aim 1 are comparative effectiveness of the 1) global response to antifungal therapy after 30 days and 2) all-cause mortality at 30 days.

The secondary aim is to characterize the frequency of pediatric candidiasis by describing the incidence of pediatric candidiasis relative to all pediatric admissions. For this aim, the investigators will use descriptive statistics to establish the frequency of hospital admissions involving an invasive candidiasis per total hospital admissions and total hospital days during the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age \> 120 days and \<18 years
2. Documented proven or probable case of invasive candidiasis
3. Parental/guardian permission (informed consent, if required) and if appropriate, child assent (if required).

Exclusion Criteria:

1) Any history of prior Candida infection within the previous 35 days (These patients will not be eligible for analysis in aim 1 but will be eligible for inclusion of aim 2)
Local Infiltration Analgesia for Foot Surgery

Prospective cohort assessing the effects of ankle block (local infiltration analgesia) on duration of analgesia, pain, opioid consumption, and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Surgery of the foot/ankle
* Intraoperative local infiltration analgesia of the ankle
* Age \>= 18 years

Exclusion Criteria:

* Inability to read and understand Danish
* Uncooperativeness (judged by investigators)
REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities

The goal of the Rehabotics project is the development of a comprehensive rehabilitation system to provide highly individualized treatment of upper limb function in patients with motor disorders due to acquired brain damage (eg stroke) or neurodegenerative disease (eg sclerosis), having as central pillar the integration of robotic systems and support functions. A key part of the proposed system is the development and evaluation of an innovative robotic extraskeletal device that will be applied in the form of a glove to the diseased limb of the neurological patient.

The proposed robotic system:

1. will measure various motor and kinematic parameters of the extremity in order to assess the patient's condition and progress, and
2. will offer a specialized rehabilitation program (therapeutic exercises, retraining of functional movements and support of daily activities) through an interactive virtual environment provided by the Rehabotics platform.

The aim is to provide an environment for the provision of a high level of treatment and support services to patients with hand mobility disorders which will take place both in the clinical environment and in the patient's home through telemedicine applications.

To demonstrate the efficiency of the proposed system, Rehabotics will be applied on post-stoke patients for rehabilitation while also using a control group receiving traditional physiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* stroke pathology,
* Ashworth Scale ≤ 3,
* 6 months maximum time since the incident

Exclusion Criteria:

* Presence of neurological pathologies that affect hand motion (Parkinson's disease)
* Musculoskeletal deficits that affect normal finger range of motion (e.g. finger fractures, joint stiffness/pain, arthritis that affect joint motion)
* Ashworth Scale \> 3,
* Over 6 months since the incident
Impact Of Sacral Neuromodulation On Urine Markers For Interstitial Cystitis (IC)

Urine will be collected and sent to the University of Maryland. Urines will be analyzed for urine markers.

Urine will be collected and flash frozen in liquid nitrogen then placed in a -70 C freezer. All urine will be collected and stored until the final follow-up is complete. The urine samples will then be sent as a single batch to the Department of Infectious Disease, University of Maryland. Urines will be assayed in a blinded fashion and a written report of the levels of each of the 3 urine markers will be sent to Beaumont Hospital. Change in urine marker levels will be analyzed and correlated with change in symptom scores.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be drawn from Dr. Peters patient base that covers Southeast Michigan.

Exclusion Criteria:

* Male
Relapse Markers for Colorectal Cancer

This is an observational case-control study which enroll metastatic and non-metastatic colorectal cancer (CRC) patients. The objective of this study is to evaluate a novel blood multi-marker test for the detection of relapse in colorectal cancer patients. This test is based on whole-blood transcriptomic signatures and circulating tumor methylated DNA markers. The patients will be enrolled into 4 study groups, two cross-sectional and two longitudinal groups, to follow up patients up to 36 months from primary tumor resection.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age at time of informed consent.
* Subject has signed the informed consent form (ICF) and is able to understand the information provided in it.
* At least a blood sample is collected per subject according to the sample collection protocol.
* Patients enrolled in local prospective protocols, in which samples have been collected according the study procedures may be included.
* Group 1: patients with a radiologically and, whenever is possible, histologically confirmed relapse (local or distant) of colorectal cancer within 5 years from primary surgery. Metachronous primary tumors are not considered as relapse and should be excluded.
* Group 2: Patients declared disease-free for at least 36 months but less than 5 years, as confirmed by radiological examination.
* Group 3: Patients with a stage III-IV colorectal cancer with a curative treatment and disease-free for at least 3 months but less than 18 months.
* Group 4: Histologically and radiologically confirmed diagnosis of stage I, II, III or IV colorectal adenocarcinoma, eligible for a treatment with curative intent.

Exclusion Criteria:

* Personal history of cancer (non-hematologic) other than CRC in complete remission for less than 5 years.
* Personal history of hematologic cancer.
* A blood transfusion within 6 weeks prior to inclusion into the study.
* Transplant with regular intake of immunosuppressants.
* Pregnant woman (self-declaration).
* Conditions or comorbidities that would preclude the compliance with the planned surveillance program or with the protocol as judged by the Investigator.
* Previous inclusion in the RELMA-C study and/or re-inclusion in a different study group.
* Group 1: Any treatment for CRC relapse prior to blood collection.
* Group 2: Patient is disease-free for less than 36 months or more than 5 years.
* Group 3: Patient is disease-free for less than 3 months or more than 18 months
* Group 3: Stage IV patients with detectable residual disease after primary treatment.
* Group 4: Any cancer treatment prior to blood collection.
Psychological Impairment Due to Covid-19

Hospital staff and emergency personnel are expected to suffer impaired psychological outcomes during a pandemic in terms of Quality of Life, anxiety, depression or other outcomes. The Covid-19 pandemic is a threat for both somatic and psychological health, therefore the impact of the impairment of this event on psychological parameters has to be assessed.

Hospital staff and emergency personell are confronted with severe and life-threatening situations, therefore this group is considered to be at risk for impaired psychological health. A pandemic such as the Covid-19 endemic is suggested to severely impair the psychological state of this profession, amongst others Quality of life, anxiety, depression and other parameters. Therefore, it is crucial to assess the impact of impairment due to this global threat on the psychological health of health care providers. We therefore designed this study to evaluate baseline psychological characteristics and to re-assess those values in an interval of 60 days.

Eligibility Criteria:
Inclusion Criteria:

Hospital staff (doctors and nurses)

Exclusion Criteria:

None
The Emotional Impact of Surveillance for Pancreatic Cancer

Due to its rarity a population screening program for pancreatic cancer is not possible. For this reason, considering background data on genetic predisposition and familiarity for this lethal tumor, efforts have been pushed to build up surveillance programs for subjects at high-risk of pancreatic cancer, due to familiarity and/or genetic predisposition. These programs are based on radiological examinations (such as MRI or endoultrasonography) and laboratory tests. However, little is known about the psychological burden of these programs. Only a handful of studies investigated, in various ways, how the participation in surveillance programs for pancreatic cancer may burden the psychological status, with a consequent possible impairment of the psychological wellbeing, and a higher risk of withdraw from the surveillance program itself. The aim of this study was to assess the psychological and emotional impact in high-risk individuals participating in a surveillance program for pancreatic cancer due to familiarity and/or to genetic predisposition, using specific psychological tools, such as multiple psychological questionnaires, investigating different functioning areas, administered by a clinical psychologist.


Eligibility Criteria:
Inclusion Criteria:

* Being enrolled in the Institutional surveillance program for pancreatic cancer
* Ability to understand the details and implications of a study protocol.

Exclusion Criteria:

* None