rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Healthy Activities Improve Lives (HAIL)
Status: Not yet recruiting

The investigators have developed an online platform to support the 8-week, F&S! exercise program called the Healthy Activity Improves Lives (HAIL) online platform. The aim of this study is to perform a cluster randomization of four racially diverse churches or senior centers to either the standard F&S! program, or the combined HAIL Online Platform + F&S! program to examine the efficacy of the HAIL online platform + F&S! program for older adults in black communities.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals over the age of 60 years Participants are able to travel to one of the churches for the in-person F&S! exercise sessions Participants cannot be currently participating in a regular PA program (i.e., at least 100 min per week of moderate to vigorous physical activities)  Exclusion Criteria:  Participants do not understand study procedures or are unable to participate in the verbal consent process Participants must have a physician responsible for their medical care Participants endorse an item on the Revised Physical Activity Readiness Questionnaire (rPAR-Q) as confirmed by their treating physician Participants who report any contraindication to exercising (e.g., recent ECG changes or myocardial infarction, unstable angina, uncontrolled arrhythmias, third degree heart block, congestive heart failure) Participants who receive a score of 28 or higher on the Telephone Interview for Cognitive Status (TICS) during pre-screening - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 60 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult
Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
Status: Not yet recruiting

This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Voluntary and informed consent of the mother for her own study participation (if applicable); Voluntary and informed consent of the legal guardian of the child for participation of the child in the study; Mothers/legal guardians ≥18 years of age; Documented maternal HIV infection; Willingness to consent to HIV testing for the child and herself (or just her child); and  Willingness to consent to active tracing including home tracing.  Exclusion Criteria:  Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her. Having delivered more than 72h (3 days) ago; Prisoners; Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion; Stillbirths; Infant requiring emergency care (e.g. immediate or rapid occurring life threatening conditions, resuscitation, prolonged obstetric related intensive care, severe jaundice) or born with severe malformation; If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g); or Unlikely to comply with protocol as judged by the principal investigator or his designate - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Mothers living with HIV presenting for delivery at included health facilities - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Pregnant women living with HIV and their exposed infants recruited at maternity clinics in Mozambique and Tanzania. The investigators expect to recruit 4000-6000 mother-child pairs in 12 months, or 56-71 mother-child pairs per cluster-randomization period (7 weeks) into Cohort A.  Assuming 12-week VHT rates of 2.5% and 1% VHT rates in Mozambique and Tanzania respectively, the investigators expect to roll-over approximately 105 HIV positive infants (75 in Mozambique and 30 in Tanzania) from both countries into Cohort B. - SamplingMethod: Probability Sample
Using ROSA for Challenging The TKA Standard of Care
Status: Not yet recruiting

This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.

Standard of care medial parapetallar approach (Control)
ROSA PSA medial parapetallar approach
ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty Varus knee deformity of 0 to 10 degrees Sufficient ligamentous function to warrant retention of the posterior cruciate ligament Between the ages of 21 and 80 inclusive Patients willing and able to comply with follow-up requirements and self-evaluations Ability to give informed consent  Exclusion Criteria:  Active or prior infection Medical condition precluding major surgery Predominantly inflammatory arthropathy Patellectomy PCL deficiency Major coronal plane deformity Prior trauma to the tibia or femur resulting in malalignment, canal occlusion, or open reduction and internal fixation Valgus alignment Neurologic condition limiting mobility Bone defects requiring augments, cones and/or stemmed implants - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
Status: Not yet recruiting

The goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. It is planned to include about 60 people in the study (30 people each in the group with thermoplastic orthoses and 30 participants with factory-made orthoses)

The main questions it aims to answer are:

1. How much improvement in dexterity will the patient wearing the orthosis get? 2. By how much will the grip strength of the whole hand and pincer grip strength improve with the orthosis? 3. How will wearing the orthosis affect the pain associated with the disease? Participants will

measurement of grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the appointed times.
measurement of pincer grip strength with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the designated times.

4. completion of the DASH questionnaire 6. assessment of the NRS pain scale in relation to the period of 6 months before the start of the study 7. Likert scale - evaluation of satisfaction with the use of the orthosis 8. the Kapandji scale Researchers will compare patients with thermoplastic orthosis and patients with fabric orthosis to see which is more functional.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  diagnosed with RA diagnosed thumb deformity: butonier finger, type I or II female age 18 - 65 years patient's consent to the study  Exclusion Criteria:  other deformity of the thumb less than 1 year since surgical intervention in the hand less than 6 months since delivery injections within the thumb change in treatment during the study and 3 months before the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Erector Spina Block or Parasternal Block Plus Chest Tube Wound Infiltration for Cardiac Surgeries
Status: Not yet recruiting

Pain management is important after coronary artery bypass graft (CABG) surgery. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. Analgesia with regional methods after surgery provides effective analgesia by reducing morphine consumption. In this study we have planned to compare the erector spina plane block with parasternal block +local infiltration to chest tube areas.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who will undergo open heart surgery Patients who agreed to participate in the study-  Exclusion Criteria:  Patients who do not agree to participate in the study Patients with chronic lung disease Patients with D. Mellitus - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD
Status: Not yet recruiting

Advances in prenatal and neonatal care have improved outcomes in children with severe congenital heart disease (CHD). With the increase in survival, neurocognitive problems such as executive functioning (EF) impairments have become more apparent in these children. EF problems have cascading negative effects on a child's development. New insights in EF development suggest that in otherwise physically healthy young children, EF can be improved by training. In a pilot study funded by Stichting Hartekind, the investigators studied the feasibility of a personalized EF training program called 'Kleuter Extra' and the results were promising. Therefore, the current study will investigate the effectiveness of this program in 4-6-year-old children with severe CHD. The researchers will also explore interactions between the parent-child relationship and EF development of the child as psychosocial difficulties in these children and their parent(s) and/or caretaker(s) may impact EF-development. If found effective, EF training for children with severe CHD will improve their developmental outcome.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children aged 4.0 - 6.0 years upon inclusion with severe CHD according to the criteria of Marino (Marino, 2012) IQ estimated > 55 (no moderate to severe intellectual disability) Diminished EF based on a below average score on any of the subtests of the 'KleuterExtra' test battery (≤ 25 percentile) at t = 0 Sufficient comprehension of the Dutch language by parents to understand the study information and to be able to fill out the Dutch questionnaires. Sufficient comprehension of the Dutch language by the child to be able to participate in the EF test battery and the EF training program.  Exclusion Criteria:  Children receiving targeted EF support at school upon inclusion. Children with severe brain damage (estimated IQ < 55) Genetic syndromes known to directly affect cognitive performance (e.g. Down syndrome) Children with severe psychiatric disorders upon inclusion that require treatment first, such as a posttraumatic stress disorder, separation anxiety disorder, or reactive attachment disorder. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 6 Years - StdAgeList: Child
Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies
Status: Recruiting

Introduction:

Among the most drastic complications of chemotherapy is oral mucositis(OM). It is a painful inflammatory, often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol. Many treatment modalities have been introduced for the prevention and treatment of oral mucositis , of which low level laser therapy(LLLT) is gaining popularity. The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence. Also, the parameters used have not been optimized and no standard method has yet been established. Based on this point, this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 children's cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM.

Aim:

To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers.

Methods:

This study is a randomized, prospective, double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized into two groups: group 1 will receive low level laser therapy and group 2 will receive mock treatment. Patient will be followed to asses the development of oral mucositis on prespecified time points.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  pediatric patients diagnosed with Acute Myeloid Leukemia. Children with a minimum age of 3 years and a maximum 18 years. Children with sufficient cooperation to accept the treatment and evaluation periods  Exclusion Criteria:  Patients with limited mouth openings less than 1 cm, due to difficulty of laser radiation. Patients with dysplastic oral lesions. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain.
Status: Recruiting

Recommended treatment for chronic non-specific LBP is exercise therapy, behavioral therapy including pain management, or a combination of these; There is not enough evidence to establish recommendations for which one is the most appropriate.

The primary objective of this study is to explore the effects of Ilio-psoas Release on Sub-acute back pain, ROM & functional disability

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Sub-acute (pain for > 1.5 month) Age 18-40 years Willing to participate Both gender will be recruited.  Exclusion Criteria:  Any history related to spinal surgery Previous administration of epidural injections LBP due to specific pathology Neurological deficits (like stroke) Clinical disorder contraindicated to exercise - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery
Status: Recruiting

The study team will look at 3 new tests that will make it easier to measure frailty in patients awaiting surgery for cancer and compare them against standard clinical measures of frailty in a pilot study. The expected outcome is that evidence will be collated in order to apply for a major grant to look at improving the care of frail patients with cancer in the future.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female. Aged 70 years and over. Patients with a diagnosis of primary operable colorectal cancer where treatment includes a planned curative surgical procedure. About to undergo elective surgery for cancer. Mental capacity to consent.  Exclusion Criteria:  Patients with unresectable cancer. Patients presenting as an emergency. Patients who are having chemotherapy or radiotherapy before their surgery. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Gastrointestinal cancer patients - SamplingMethod: Probability Sample
Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
Status: Recruiting

This is an observational prospective study to develop predictive biomarkers for pain response in participants with chronic pancreatitis scheduled for endoscopic therapy. Participants will undergo baseline assessments including electroencephalography (EEG), quantitative sensory testing (QST), and psychosocial questionnaires. Response to endoscopic therapy will be assessed at approximately 3, 6, 12 and 18 months post-procedure using questionnaires.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  adults older than 18 years; Cambridge III or IV criteria for CP; or M-ANNHEIM criteria for definitive chronic pancreatitis; scheduled for endoscopic therapy for ductal obstruction (may include lithotripsy, pancreatic duct dilation, or stone extraction to facilitate successful stenting) as part of routine clinical care based on multidisciplinary review; pain present for ≥ 3 days per week for ≥ 3 months; average pain over the last week ≥ 4 on a 11-point numeric rating scale (NRS).  Exclusion Criteria:  chronic pain syndrome other than CP; episode of acute pancreatitis within 2 months of enrollment; endoscopic therapy including ERCP, EUS Guided Celiac Plexus Block or pancreatic surgery < 6 months prior to enrollment; active illicit drug use (excludes marijuana use); American Society of Anesthesiologists classification > 3; immune-mediated pancreatitis or associated pancreatic neoplasms Major neurological disease such as stroke, uncontrolled epilepsy, dementia Diagnosis of schizophrenia Chronic benzodiazepine use. Use of short acting benzodiazepine on as needed basis is acceptable if participant is able to hold benzodiazepine prior to EEG recording. Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults older than 18 years with painful chronic pancreatitis scheduled for endoscopic therapy. - SamplingMethod: Non-Probability Sample
Epidemiology and Genomic Surveillance of Staphylococcus Aureus in ICU Neonatology
Status: Not yet recruiting

Newborns hospitalized in Neonatology are particularly vulnerable to infections, in particular healthcare associated infection (HAI). Staphylococcus aureus represents the 2nd microorganism responsible for sepsis, this infection is particularly serious and like any HAI, it increases the length of hospitalization of newborns and neonatal morbidity.

In September 2020, the CDC published recommendations for the prevention and control of Staphylococcus aureus infections in neonatal intensive care unit/ICU. They specify the indications for implementing a MSSA surveillance strategy as well as the screening and management methods.

Despite the absence of a defined strategy at the national level, our establishment chose to initiate management measures several years ago following serious infections and MSSA epidemics in neonatal intensive care unit/ICU.

With the aim of improving the efficiency of care and evaluating the strategy chosen at the establishment, it is necessary to describing

the epidemiology of MSSA carriage and infections
cross-transmission of MSSA strains between patients
the success rate of decolonization
the sensitivity of detection of digestive carriage by stool swabbing in order to limit the number of samples from newborns.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  newborns hospitalized in neonatal ICU MSSA carrier  Exclusion Criteria:  none - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: MSSA carrier among newborns hospitalized in neonatal ICU - SamplingMethod: Non-Probability Sample
Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents
Status: Not yet recruiting

The goal of this study is to compare motor learning rates on two different tasks, when combined with non-invasive brain stimulation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 10-17 years Ability to follow two-step instructions Provides informed consent  Exclusion Criteria:  Presence of illness, disease - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 10 Years - MaximumAge: 17 Years - StdAgeList: Child
Attention Training for COVID-19 Related Distress
Status: Not yet recruiting

The study aims to test whether attention training (attention bias modification or attention control training) reduces distress or COVID-19 related anxiety compared to a neutral condition.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  COVID-19 Anxiety Syndrome Scale > 7 and/or COVID-19 related loss  Exclusion Criteria:  Does not speak English Fluently - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial
Status: Not yet recruiting

The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action.

The main questions it aims to answer are:

What is the clinical relevance of improvements of symptoms and quality of life after treatment with HBOT for post-COVID?
What are the changes in absence from work after treatment with HBOT?
What is the cost-effectiveness of treatment with HBOT?
What are possible mechanisms of action of HBOT?

Participants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Cognitive and/or physical symptoms ≥ 12 months after acute COVID-19 infection Symptoms include post-exertional malaise (PEM) and/or dysautonomia as assessed by questionnaires and/or NASA LEAN test Symptoms affect day-to-day life (based on SF-36 'role limitations due to physical functioning' score of ≤ 50 at baseline). Current treatment regimen is stable for at least 1 months before inclusion  Exclusion Criteria:  Unfit for hyperbaric treatment Previous diagnosis of ME/CFS Unable to provide informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety
Status: Recruiting

The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged 18 and above. Patients with cesarean category 3 and 4.  Exclusion Criteria:  Patients under the age of 18 Patients undergoing emergency cesarean section Patients with bleeding disorders Individuals with psychological disorders - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Our study will be conducted in pregnant patients. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult