cyrilzakka/clinical-trials huggingface dataset:
Improving the Quality of Care for Children With Acute Malnutrition in Uganda

This is a cluster RCT in 6 health centres in Uganda, testing supportive supervision to improve health outcomes and quality of care of children with malnutrition

Introduction Malnutrition in children is highly prevalent in West Nile Region. According to a recent analysis of data available from the health management information system (HMIS) and official registers, the health outcomes of children suffering from malnutrition and treated at health center (HC) level in Arua Region are not reaching the international standards (75% cured rate as for the international SPHERE standards). This despite the availability of clear national guidelines for treatment, thus suggesting possible deficiencies in the quality of care provided. Lack of supportive supervision may be one of the reason explaining substandard outcomes.

Methods This is a cluster randomised controlled trail (RCT) with health centers (HC) as unit of randomisation. The six largest HC in Arua district will be randomised in two groups, intervention (quality improvement group) and control. The intervention will aim at improving the quality of care provided at HC level, and as a consequence, the health outcomes of children. The main intervention will consist of enhances nutritional supervision (high frequency supervision, specific to nutritional services), while the control will be standard care (no intervention). Complementary intervention will include training and networking activities for HC staff. Outcomes of the study will include: health outcomes (recovered, non recovered, defaulters, transferred, died); process outcomes (satisfaction and knowledge of staff); cost outcomes (cost for the health system and for the families) and equity outcomes (access to care and health outcomes by wealth quintile).

Relevance of the study The study will inform, with a robust design, about the efficacy and cost-efficacy of a quality improvement intervention for ameliorating the health of children suffering from malnutrition in Uganda.

Currently no other study with RCT design explored the efficacy of supportive supervision as a quality improvement intervention. This study will therefore fill an important knowledge gap.

Eligibility Criteria:
For the primary outcomes, the study sample will consists of children with malnutrition treated at in health center (HC) in Arua district

Inclusion Criteria:

1. Children 6 months-5 years
2. Diagnosis of SAM or MAM according to National criteria (10) SAM: weight-for-height \<- 3 standard deviation (SD) from the mean based on the WHO 2006 standards (11).

MAM: weight-for-height \<- 2 and \> -3 standard deviation (SD) from the mean based on the WHO 2006 growth reference standards .

Exclusion Criteria:

1. Not matching the above criteria for SAM and MAM
2. Refusal to participate/ consent
3. Unable to adhere to study follow up procedures
Trial of Comprehensive Migraine Intervention

Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.


Eligibility Criteria:
Inclusion Criteria:

* Migraine,
* Baseline migraine related disability of mild or worse,
* No current or past triptan use,
* Not satisfied with current headache care.

Exclusion Criteria:

* Allergy or contraindication to study medications,
* Daily or near daily analgesic medication use.
Psychometric Properties Mobility Measures MS

Current study will investigate the quality (psychometric properties) and clinical utility of several mobility measures, according to disability level. Therefore, several aspects will be inquired:

* Was there an effect of rehabilitation
* Is the measure able to detect change over time? And thus the change exceed measurement error and is it clinically important (responsiveness)
* Does the measure assess what it claims to measure (validity)
* Is the measure able to differentiate all performances of the patients, inclusively the very good and very bad performances (floor and ceiling effects)
* Does the measure gives similar results under consistent test conditions on another testing day (reliability) Worldwide, theoretical approaches to physical therapy and rehabilitation in Multiple Sclerosis often appear significantly different. Since the present research protocol will be performed at different centers across European countries (and US sites), this multi-center study can additionally be applied for mapping the volume and content of rehabilitation, as well as the differential impact of diverse rehabilitation approaches and training volume on mobility, for several disability levels.

Some health-economic analyses will be performed to examine what the approximate cost of rehabilitation compared to effects is and what drivers of costs are (setting, equipment, staff).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS according to McDonald criteria24,
* Expanded Disability Status Scale25 (EDSS) ≥ 2 and ≤ 6.5 as determined by neurologists or trained clinician
* no relapse within the last month
* no changes in disease modifying treatment and no corticoid-therapy within the last month
* receive at least 10 sessions of physical therapy (in- or outpatient rehabilitation), with a maximum duration of 3 months

Exclusion Criteria:

* other medical conditions interfering with mobility (e.g. stroke, pregnancy, fractures, ...)
* other neurological impairments with permanent damage (stroke, Parkinson, ...)
* MS-like syndromes such as neuromyelitis optica
* not able to understand and execute simple instructions
The Effect of Releasing the Tourniquet in Total Knee Replacement Before Closure on the Blood Loss , Joint Effusion , Hematoma Formation and Wound Complication

The study , observe the effect of releasing the Tourniquet in total knee replacement surgery before closure in comparison with releasing it after wound closure

The effect was assessed by Hb drop post operative and Hematoma formation ( measured by ultrasound ) as well as the wound complication

The study is conducted in tertiary university hospital as a referral hospital for joint arthroplasty , the patients was informed about the study and consent was taken , the same operator , same theater and the same prosthesis company as well as the same radiologist during the study period.

the patient randomly assigned to either group A (Tourniquet release before closure of the wound and hemostasis ensured ) , or a group B ( Tourniquet release after wound closure )

post operative Hb drop was studied between the groups , and each patient underwent ultrasound measurement of the intraarticular hematoma . The wound complication between the groups was also studied .

Eligibility Criteria:
Inclusion Criteria:

* primary knee osteoarthrosis

Exclusion Criteria:

* Rheumatoid arthritis
* post traumatic arthritis
* revision knee replacement
* patients on anticoagulant/antiplatelet except acetylsalicylic acid 80-100 mg
UNC Childhood, Adolescent, and Young Adult Cancer Cohort

Purpose: This study aims to create a registry of childhood, adolescent, and young adult patients with cancer (\<40 years-old at cancer diagnosis), entitled the 'UNC Childhood, Adolescent, and Young Adult Cancer Cohort' (UNC-CAYACC). This resource will serve to support cancer outcomes research among pediatric and young adult cancer patients with a primary focus on enrolling patients treated as adolescents or young adults (AYAs, 15-39 years).

Procedures: As appropriate for age, participants will complete physical and cognitive functional assessments; questionnaires to assess health-related quality of life and other patient-reported outcomes; will undergo body composition and anthropometric measurements; and will be asked to provide biospecimens for biobanking. Assessments will be collected (as possible) at diagnosis, during active treatment, following treatment completion, and annually in survivorship to assess outcomes throughout the treatment and survivorship trajectory. Sociodemographic and clinical information such as cancer treatment modalities and cumulative doses will be collected by medical record abstraction. Participants will be eligible to enroll at any time from diagnosis through survivorship. This registry will provide data to better understand the manifestations of accelerated aging and key contributing factors among children, adolescents, and young adults with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient ages 0-39 years at the time of cancer diagnosis (ages 1-39 years at enrollment) who are at any point in treatment and survivorship trajectory
* English or Spanish speaking

Exclusion Criteria:

* Unwilling to sign informed consent
* Speak a language other than English or Spanish.
Critical Care Ultrasound Guided Weaning

Weaning patients from the ventilator in the intensive care unit is sometimes difficult because of three main interrelated etiologies: impaired lung, heart or diaphragm function. In this context, ultrasonography performed during tests for extubation of patients may enable the diagnosis of cardiac dysfunction, loss of pulmonary aeration, diaphragm dysfunction, and venous congestion, thereby reducing the number of failures in extubation.

The combination of TTE (Trans Thoracic Echocardiography), LUS (Lung Ultrasound), DUS (Diaphragmatic ultrasound) and VEXUS (Venous excess Ultrasound) may enable the identification of the etiology of weaning failure and reduce the number of extubation failures by enabling the development of an appropriate treatment strategy. With this study, it is aimed to contribute to the literature in this sense.

The aim of this study is to reduce the number of extubation failures by defining the etiology of weaning failure and developing appropriate treatment strategies by using intensive care ultrasonography applications in combination (defining cardiac, pulmonary, diaphragmatic and venous congestion).

Most patients can be extubated after the first SBT (spontaneous Breathing Trial). A patient who fails extubation is automatically classified as difficult weaning, and intensive care professionals frequently encounter patients who are difficult to wean from mechanical ventilation.

Before performing a new SBT following a failed SBT, the cause of the failure should be determined and an appropriate treatment strategy developed.

Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation \> 24 hours Eligibility to weaning from mechanical ventilation

Exclusion Criteria:

* Age \< 18 years old
* Severe skin lesions or infections that cannot perform ultrasound
* Severe subcutaneous emphysema that cannot perform ultrasound
* Patients with a known neuromuscular disease
* Patients with a duration of mechanical ventilation \<24 hours,
* Patients with severe mitral stenosis, severe mitral regurgitation, or prosthetic mitral valve
Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses

The aim of the present study is to evaluate the postoperative visual acuity for distance, intermediate and near vision as well as the cylinder correction and the patient satisfaction after bilateral implantation of AT LISA tri toric 939MP IOLs.


Eligibility Criteria:
Inclusion Criteria:

* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
* Man or woman, over 50 years of age
* Healthy eyes with bilateral cataract requiring surgical treatment for both eyes
* Bilateral regular corneal astigmatism (confirmed by topography measurement)
* Only patients requiring intraocular lenses of a power comprised between sphere +0.0 and +28.0 dioptres and between a cylindrical range of +1.0 to +4.0D in both eyes will be able to participate in the trial.
* Biometry measurement/cataract density compatible with the IOLMaster evaluation
* Bilateral uncomplicated cataract surgery and implantation into capsular bag by injector
* Assured follow-up examinations

Exclusion Criteria:

* Patients unable to meet the limitations of the protocol or likely of non cooperation during the trial,
* Patients whose freedom is impaired by administrative or legal order,
* Monophtalmic patient.
* Previous ocular surgery, including corneal/refractive surgery,
* Chronic or recurrent uveitis,
* Acute ocular disease or external/internal infection,
* Any kind of macular degeneration and impairment of retina (clinical diagnosis/OCT examination)
* Diabetes with retinal changes,
* Pseudoexfoliation syndrome
* Pathologic myosis
* Irregular astigmatism, especially keratoconus,
* Endothelial corneal dystrophy
* Glaucoma or IOP higher than 21mmHg under ocular hypertension treatment
* Aniridia
* Pseudophakia
* Cornea guttata; keratoplasty
* Amotio operation; anamnesis with vitreous surgery
* Amblyopia
* Intraocular tumours; endotamponade
* Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to \> 0.3 logMAR
* Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
* Pupil diameter over 6 mm in mesopic condition
* Corneal opacity
Effect of Perioperative Sleep Quality on Chronic Post-Surgical Pain

The goal of this prospective observational cohort study is to assess the impact of perioperative sleep quality on the development of chronic post-surgical pain (CPSP) in adult patients (aged 18-80 years, ASA I-III) undergoing elective video-assisted thoracic surgery (VATS), modified radical mastectomy (MRM), or coronary artery bypass grafting (CABG). The main questions it aims to answer are:

Does poor perioperative sleep quality increase the risk of CPSP at 3 months post-surgery? How do subjective and objective sleep parameters (e.g., total sleep duration, deep sleep time) correlate with CPSP and recovery outcomes? Researchers will compare patients with varying perioperative sleep quality levels (assessed via the Richards-Campbell Sleep Questionnaire \[RCSQ\] and wearable device data) to evaluate differences in CPSP incidence, pain and quality of life.

Participants will:

Wear a Huawei wearable device to collect objective sleep data (e.g., sleep duration, deep sleep time) during hospitalization.

Complete questionnaires preoperatively and postoperatively, including RCSQ, Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and Brief Pain Inventory (BPI).

Undergo follow-up assessments at 1, 3, and 6 months post-surgery to evaluate pain scores , CPSP status, and quality of life (SF-36).


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 years.
2. Scheduled for elective video-assisted thoracic surgery (VATS).
3. Scheduled for elective modified radical mastectomy (MRM).
4. Scheduled for elective coronary artery bypass grafting (CABG).
5. American Society of Anesthesiologists (ASA) physical status classification I-III.
6. Willing to sign the informed consent form, participate in the study, and complete all follow-up assessments.

Exclusion Criteria:

1. History of surgery within the past 3 months.
2. Chronic use of opioids or sedatives (defined as use for 3 months or longer).
3. Expected completion time of surgery after 16:00 on the day of operation.
4. Planned transfer to the intensive care unit (ICU) postoperatively.
5. Anticipated hospital stay \<24 hours.
6. Contraindications to wearable device use (e.g., infection at the wrist site, allergy to the wristband material).
Chronical Illness-related Limitations of the Ability to Cope with Rising Temperatures, Third Wave

The CLIMATE-III Observational Study examines to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific health behavior, somatosensory amplification, risk and benefit perception, self-efficacy, health literacy, and the degree of urbanisation of the patients' administration district are associated with these effects. Study participants from Germany and Italy will be included in the sample.

The CLIMATE-III Observational Study aims to analyse to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific health behavior, self-efficacy, or other factors are associated with these effects. This cohort study is based on an online survey of patients with chronic illness who are recruited in general practitioner (GP) practices in Germany and Italy. After the baseline assessment, participants fill out symptom diaries on 12 specific days of observation over a maximum period of 12 weeks. The specific days of observation are selected based on the maximum temperature that can be expected within the respective weeks. The weather forecast will be checked every Monday. If, in the upcoming 4 days, the maximum temperature is expected to exceed 30°C, the warmest day in this time frame will be chosen. Otherwise, the weather forecast will be checked again on Thursday to choose the warmest of the remaining days of the week. On each day of observation, patients are notified by email at 6 pm.

Baseline assessment includes socio-demographic data, chronic diseases, somatosensory amplification, perceived risk for adverse health effects of heat, intention to implement protective behaviour, perceived benefit of this behavior, self-efficacy, and health literacy. Local data on temperatures and humidity will be provided by the meteorological services of Germany and Italy. Data will be analyzed by multivariable, multilevel regression analyses adjusted for possible confounders and random effects on the administration district and practice within administration district level.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years or older
* at least one of the following conditions: Coronary Heart Disease; Myocardial Infarction; Heart Failure; Cardiac Arrhythmias; Peripheral Artery Disease; Stroke; Transient Ischemic Attack; Diabetes Mellitus (Type 1 or 2); Chronic Obstructive Pulmonary Disease; Asthma; Renal Insufficiency; Depressive Disorder; Anxiety Disorders; Schizophrenia; Peripheral Nervous System Diseases.

Exclusion Criteria:

* no capacity to consent
* severe visual impairment
* insufficient German language skills
* not able to use internet browser (eg, lack of hardware)
The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome

The use of fundal pressure in management of the second stage of labor is controversial. The aim of this study is both to evaluate the effectiveness of fundal pressure in shortening the second stage of labor and to examine the related neonatal and maternal outcomes.

Patients will be randomly allocated to two groups by using a computer-generated random number chart: Kristeller maneuver intervention (study) group (n=140) and control group (n=140). Umbilical artery blood gas will obtained to assess the newborn's acid-base status. The umbilical artery levels of creatinine kinase, creatinine kinase with myocardial specific isoform, aspartate amino transferase, alanine amino transferase, lactate dehydrogenase and lactic acid will be measured. Length of episiotomy and length of vagina will be measured at 45 degrees from the midline. Each patient's vaginal laceration, cervical laceration, length of episiotomy and vagina before and after delivery and duration of the second stage of labor in minutes will be recorded. Neonatal information will include: infant birth weight, apgar scores, babies requiring pediatric help, and admission of neonatal intensive care units.

Eligibility Criteria:
Inclusion Criteria:

* Pregnants who were administered for delivery and signed informed consent form were included into the study.

Exclusion Criteria:

* Pregnant who required oxytocin augmentation, multiple gestations, pregnant with medical problems (such as asthma, thyroid, cardiac, liver, kidney disease, preeclampsia and diabetes), pregnant with previous caesarean and pregnant whose estimated fetal weight \<2500gr or \>4000gr were not included into the study.
Feasibility Testing of 7-Tesla Magnetic Resonance Imaging

The goal of the current project is to explore and develop the technical feasibility of non-invasive imaging of the human musculoskeletal system and head with the first 7T MR scanner with a CE mark to identify areas where the higher field promises significant benefits in qualitative image quality. For a subset of the planned exams, state-of-the art 7T or 3T images will be used as standard of reference to comparatively gauge the qualitative image quality of the investigational 7T images.


Eligibility Criteria:
Inclusion Criteria:

* Consent to undergo a 7T (and, if appropriate a comparative 3T) MRI exam.
* For some of the consistent small series: presence of a specific condition of the musculoskeletal system or of the head. This can include traumatic or degenerative changes, e.g., of tendons, cartilage, muscle, peripheral nerves, ligaments, and bones, or in the brain, as well as focal lesions, e.g., tumors.

Exclusion Criteria:

* Contraindications to undergo a MRI examination at a field strength of 7 Tesla or at 3 Tesla.
* Irregular anatomy and/or tissue properties
* Inability to consent - for any reason.
* Body mass above 200 kg.
* Body mass below 30 kg.
* Women: pregnancy.
* Age below 18.
* Known or suspected non-compliance, drug or alcohol abuse.
* Inability to follow the procedures of the study.
Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy

The aim of the study was to evaluate the influence of a systematic extra intravenous fluid supplementation during phototherapy in comparison to a fluid supplementation due to short term demand in preterm infants.

60 preterm infants (GA ≤ 32 week) were assigned randomly to either receive a fluid supplementation due to short term demand (control group, n=30;) or a 20% extra fluid supplementation (study group, n=30) during intermediate phototherapy.

Collected data:

* cardiorespiratory parameters(heart rate, blood pressure, SaO2 and capillary refill time, breathing rate, temperature) and a pain score was completed at the first day of phototherapy
* The maximum total serum bilirubin levels (TSB) within one week after onset of phototherapy

Eligibility Criteria:
Inclusion Criteria:

* Hyperbilirubinemia

Exclusion Criteria:

* Preterm infants \> 33 weeks of gestation