cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Trial of Ultrasound-guided Platelet-Rich-Plasma (PRP) Injection Versus Extracorporeal Shock Wave Therapy (ESWT) for Great Trochanter Pain Syndrome (GTPS) With Gluteus Medius or Minimus Tendinopathy

The purpose of this study is to compare the efficacy of ultrasound-guided platelet-rich plasma (PRP) injection versus extracorporeal shock wave therapy for management of refractory Greater Trochanteric Pain Syndrome (GTPS).

The purpose of this study is to compare the efficacy of ultrasound-guided platelet-rich plasma (PRP) injection versus extracorporeal shock wave therapy for management of refractory Greater Trochanteric Pain Syndrome (GTPS).

GTPS is a common cause of extra-articular lateral hip pain which occurs in up to 10- 25% of the population, and is a common presenting complaint to primary care and Sports Medicine clinics. Previously, most cases of GTPS were diagnosed as trochanteric bursitis, for which the standard treatment focused on relieving inflammation with non-steroidal anti-inflammatory medications and corticosteroid injections. However, corticosteroid injections typically only provide short term pain relief, likely secondary to the fact that the underlying pathology is likely not from an isolated bursal inflammation. Recent studies suggest that in fact the most common cause of GTPS is gluteus medius or minimus tendinopathy or tear. Platelet rich plasma (PRP) has been used in treating tendinopathies and tendon tears throughout the body to promote healing through the concentrated growth factors released from platelets. Extracorporeal shock wave therapy (ESWT) is another treatment which has been used increasingly in the treatment of tendinopathies. The purpose of this randomized prospective study is to compare the efficacy of PRP injection to ESWT in treating patients with a clinical diagnosis of GTPS.

Eligibility Criteria:
Inclusion Criteria:

Individuals with documented diagnosis of greater trochanter pain syndrome, with MRI evidence of gluteus minimus or medius tendinopathy, whose lateral hip pain has been refractory to conservative management with non-steroid anti-inflammatory medications and at least 6 weeks of Physical Therapy.

Exclusion Criteria:

1. Age \< 18 or \> 65 years
2. Pregnancy
3. Full-thickness tear of the involved gluteal tendons, bursa, and intra-articular structures.
4. Evidence of concomitant injury to the involved lower extremity, including radiculopathy or radiculitis, piriformis syndrome, ischial tuberosity avulsion
5. History of prior steroid injection and Orthobiologic injection or surgery to the involved lower extremity f. Any inflammatory or neoplastic disorder

g. Blood coagulation disorders or use of antiplatelet or anticoagulant drugs h. Severe knee or hip osteoarthritis i. Patients with symptoms of more than 6 months' duration were not considered as patients in the chronic stages of this condition and may require a different therapeutic approach including surgical treatment.

j. Severe Diabetes Mellitus who need insulin injection k. Severe active lumbar radiculopathy with pain, numbness, or weakness in a dermatomal distribution l. Implanted pacemaker
Biodegradable Airway Stent Post Lung Transplant

Introduction and rationale

Benign airway stenosis or malacia is a frequent complication of lung transplantation occurring in 4-24% of patients, most often occurring two to nine months post-transplant. Initial therapeutic approach consists of conservative endobronchial treatment with recurrent balloon dilatation, radial incision, and electro cautery. For severe case of recurrent stenosis or malacia, airway stent placement can be considered. Different types of airway stent exist, for instance self-extendable metallic stent (SEMS), silicone stent and biodegradable airway stent. Conventional airway stents (SEMS, silicone) are associated with complications as granulation tissue and recurrent infections and can be difficult to remove. Newly developed biodegrabale stents are made of polydioxanone and disintegrate after a period of time are thought to have less side effects, and has been standard of care for the last few years. A sub selection of patients have been treated with conventional stent before treated with biodegradable stent.

Research question

* To assess the efficacy and efficiency of biodegradable airway stent.
* Compare occurrence of adverse events such as infection, dislocation, in stent granulation and difficulty of removal to conventional metallic or silicone stents.
* Asses if biodegradable stent lead to improvement of lung function.
* Assessment of the life span of biodegradable stents.

* Background Recurrent airway stenosis or malacia can be treated with airway stents. Conventional airway stents, for instance self-extendable metallic stent (SEMS) and silicone stent are associated with adverse events as recurrent infection or granulation tissue and can be difficult to remove because of in stent-granulation. Therefore they are used with restraint for benign airway problems. Biodegradable stents are made of polydioxanone and disintegrate after a period of time. They are thought to be well tolerated and associated with less adverse events compared to traditional airway stent and have been used as standard care for multiple years.
* Main research question

  * To assess the efficacy and efficiency of biodegradable airway stent
  * Compare occurrence of adverse events such as infection, dislocation, in stent granulation and difficulty of removal to conventional metallic or silicone stents.
  * Asses if biodegradable stent lead to improvement of lung function.
  * Assessment of the life span of biodegradable stents.
* Design (including population, confounders/outcomes) Retrospective cohort study of patients with airway stenosis or malacia treated with biodegradable airway stent from 2019 in the UMCG and Amsterdam UMC.
* Expected results

  * Less adverse events, hospital admittance and need for bronchoscopic interventions compared to patients treated with conventional stents. No complications associated with removal of stents.
  * Life span around 4 months

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a lung transplantation and developed airway stenosis or malacia with airway stent requirement

Exclusion Criteria:

* No
Fasciocutaneous Flaps for Leg Defects

The purpose of this study is to determine the effects of fasciocutaneous flaps for leg defects.

The fasciocutaneous flaps are tissue flaps which include skin, subcutaneous tissue, and the underlying fascia. Including the deep fascia with its prefascial and subfascial plexus enhances the circulation of these flaps. The investigators determined long-term outcomes of fasciocutaneous flap reconstruction in patients with lower limb defects.

Eligibility Criteria:
Inclusion Criteria:

* patients with leg defects

Exclusion Criteria:

* patients with underlying diseases
Pain Perception: Lidocaine Rate/Temp/Buffer

This study will collect data from multiple academic institutions. The primary objective for part A of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part B of this study is to determine if buffering of the anesthetic solution alters pain perception.

This study is a pilot study designed to determine feasibility of these procedures.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are undergoing dermatologic procedures.
* Subjects ages 18-89 year old.
* The subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Exclusion Criteria:

* Subjects who are allergic to lidocaine.
* History of bleeding tendency or coagulopathy.
* Pregnant or lactating.
* Active skin disease or skin infection in the treatment area.
* Unable to understand the protocol or give informed consent.
* Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.
Let's Play! Healthy Kids After Cancer

This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.

Acute lymphoblastic leukemia (ALL) is the most common childhood cancer, accounting for 25% of all childhood malignancies. Treatment of childhood ALL has a high success rate, with long-term event-free survival of \>85%. Treatment success, however, has not come without cost. Recognition of long-term health problems related to childhood cancer therapies is growing. Both during and after therapy, children treated for ALL are at risk for fatigue, reduced physical activity, poor dietary intake, and excessive weight gain, which are driven by physiological (chemotherapy-induced) changes and social (home/environmental) factors. The goals of this pilot study are to evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-delivered nutrition and physical activity program to prevent unhealthy weight gain among 60 childhood ALL survivors, 4-10 years of age. Participants will be randomly assigned to either the phone-delivered parent-targeted nutrition and physical activity intervention or a standard-of-care control group. Intervention success will be benchmarked by changes in key weight-related behaviors (physical activity and dietary intake) over the 6-month trial, and initial impact of the intervention on biomarkers of inflammation and oxidative stress, fatigue, and body composition will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Between 4.0 years and \< 11.0 years of age at the time of recruitment
* Previously diagnosed of ALL and currently in remission
* Between 1-5 years post completion of chemotherapy
* BMI ≥ 85 percentile for age and sex (overweight or obese) OR at risk for obesity (BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2)

Exclusion Criteria:

* History of cranial radiation therapy
* History of bone marrow transplant
* History of relapse of ALL
* Diagnosis of Down's Syndrome
* Comorbidities of obesity that require immediate subspecialist referral
* Significant pulmonary, cardiovascular, orthopedic, or musculoskeletal problems that would, in their oncologist's judgment, limit their ability to participate in physical activity
* Significant psychiatric or neurologic disorders that would impair compliance with study protocol
* Current participation in a weight-loss program
Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome

The purpose of this study is to investigate whether dry powder inhalation of Cyclosporine A is beneficial in lung transplant patients with Bronchiolitis Obliterans Syndrome. For patients suffering from this syndrome often no therapeutic options are available. Furthermore, the side effects of the maintenance therapy leaves no room for dose increments. The hypothesis for this trial is that when Cyclosporine A is administered locally (in the lungs) chronic rejection can be treated more effectively without extra systemic side effects.

Because calcineurin inhibitors are not completely effective in a full prevention of acute rejection and the corresponding chronic disfunction of the transplanted organ (Bronchiolitis Obliterans Syndrome, BOS) a rejection risc remains. To effectively treat BOS high doses of calcineurin inhibitors are necessary. On the other hand these high doses lead te serious side effects. The search for a balance between effectiveness and side effects leads to dose adjustments. Ultimately, chronic rejection is unstoppable.

In order to treat chronic rejection higher doses of calcineurin inhibitors are not a therapeutic option. The only option to reach a high dose in the target organ without extra systemic side effects would be inhalation. Indeed, this has been extensively investigated at the University of Pittsburgh (lead investigator Iacono).

The intervention in the Pittsburgh trials existed of nebulization of Cyclosporine in propylene glycol with pretreatment of nebulization of lidocaine/albuterol in order to make the inhalation tolerable.

The investigational drug in this trial consists of dry powder inhalation of a sugar-glass based solid dispersion containing cyclosporine A. The effectiveness is measured by comparing the Forced Expiratory Volume in 1 second (FEV1) before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Primary lung transplant
* Tacrolimus as maintenance therapy
* Bronchiolitis Obliterans Syndrome stages 1 - 3: FEV1\<80% of baseline
* At least 3 months after last usual BOS intervention
* Declining FEV1 after last usual BOS intervention

Exclusion Criteria:

* Cyclosporine as maintenance therapy
* Bronchiolitis Obliterans Syndrome 0: FEV1\>80%
* Renal failure: Glomerular Filtration Rate \< 30 ml/min
* Chronic airway infections
* Clinical stability
* Pregnancy
OHANA: Optimizing Cross-Cultural Care

Increasing globalisation and international migration have led to greater cultural diversity in Western societies, including healthcare settings. Hospitals and healthcare environments have become meeting places for individuals from different cultural backgrounds.

This diversity presents significant opportunities for improving healthcare, but also introduces complex challenges related to communication, trust and mutual understanding between healthcare professionals and patients. In this context, the concept of culturally competent care, i.e. the ability of healthcare professionals to provide respectful and appropriate care to patients by taking into account their cultural beliefs, values and practices, emerges as a crucial approach to address the specific needs of patients from different cultures. The concept of cultural competence was first introduced by Cross, who defines it as a set of behaviours, attitudes and policies that, when integrated into an organisation or among professionals, enable them to operate effectively in intercultural contexts.

Although there is preliminary evidence on the benefits of cultural concordance, the literature is still scarce and fragmented. In particular, there is a lack of in-depth studies on the subjective experiences of the main actors involved. For healthcare professionals, cultural concordance could be a valuable resource, but also a source of additional stress or pressure, especially if perceived as a task requiring cultural or linguistic competence that is not always adequately supported. For patients, the experience of being cared for by a professional from the same culture might enhance a sense of trust and comfort, but also generate unrealistic expectations or influence perceptions of quality of care. Exploring the lived experiences of healthcare professionals and patients in a context of cultural concordance is essential to understanding perceived benefits, criticisms and areas for improvement. This multicentre study, coordinated by the Gemelli Hospital in Italy in collaboration with several Italian hospitals , aims to explore cultural concordance in a variety of healthcare settings, providing an in-depth understanding of the potentials and criticisms of cultural concordance in hospital settings

Eligibility Criteria:
Inclusion Criteria:

* All nurses or caregivers involved in the concordance system cultural will be included, with direct experience in caring for foreign patients
* All foreign patients admitted to hospital who speak a language other than the main language of the host country and who have been involved in the concordance system cultural will be included

Exclusion Criteria:

* All patients with severe cognitive conditions that prevent participation and nurses or caregivers who do not work closely with assigned patients will be excluded.
A Comparison Study of Feeding Prematures in the Side-lying Position on the Right and Left Side - a Pilot Study.

Methods and techniques to improve the quality and safety of oral feeding in preterm infants are still a significant challenge in modern neonatology. One of the areas that can help improve feeding is choosing the optimal feeding position for premature babies.

PURPOSE: The aim of the study is to compare the advantages of side-lying positioning on the right (SLP-R) and left side (SLP-L) of infant's body, during bottle-feeding of preterm infants.

METHOD: The study will include eight neonates (n=8) born ≤34 weeks of gestational age. Four bottle-feeding sessions will be tested in each of the newborns: two in the SLP-R and two in the SLP-L. The position for the first study will be randomly assign, then positioning will be change after each feeding session. In one day, only two consecutive feeding sessions will be tested which will be included to the study in order to minimize fatigability as a disrupting factor. The levels of saturation (SpO2) and heart rate (HR) will be measured as the parameters indicative of the newborn's physiological stability. The factors determining the qualitative aspect of feeding include the total time of declines of SpO2 ≤85%, level of the newborn's alertness according to the Neonatal Behavioral Assessment Scale (NBAS), and the occurrence of choking episodes. The proportion of milk consumed (volume of milk eaten relative to the expected volume) and the duration of the feeding and feeding session were also will be record. Maximum time of feeding session will be 40 minutes.

Also the posseting during/after feeding and regurgitations will be record in each tested positions.

Eligibility Criteria:
Inclusion Criteria:

* circulatory and respiratory stability;
* readiness for oral feeding according to each child's Speech-Language Pathologist assessment;
* prematurely born infants who will be in the process of transfer from enteral nutrition to full oral feeding and will be fed orally at least 4 times within twenty-four hours;
* researcher must be a right handed person (right hand is the dominant hand);
* each infant will be fed with one kind of bottle and nipple;
* parents will give a informed consent to participate their infant in the study.

Exclusion Criteria:

* disorders which could significantly affect the feeding course, such as cleft lip and/or palate, facial paralysis and/or congenital defects of the facial skeleton;
* the presence of detected congenital abnormalities and metabolic diseases;
* newborns after abdomen chirurgical treatment;
* low Apgar score (less than 5 points at the 5th and 10th minute of the measurement);
* administered analgesics, anticonvulsants and sedatives \<72 hours from extubation prior the trial;
* parenterally fed infants;
* infants with administered intravenous infusion with glucose;
* parents refusal to participate in the study or when bottle-feeding will not be the parental preference.
Remote Ischaemic Conditioning (RIC) in Heart Failure

This study will test the impact of remote ischaemic conditioning combined with exercise on myocardial perfusion in patients with or at risk of heart failure

Heart failure (HF) is a disease which affects the heart's ability to pump or fill with blood. It can affect a person's quality of life and their ability to exercise. Recent work has shown that a reduction in the blood supply to the heart may contribute to the problem. It is therefore possible that improving the blood supply to the heart may help patients with HF. One possible way that this might be achieved is with a method called remote ischaemic conditioning (RIC). This involves placing a cuff on a person's arm (identical to a blood pressure cuff) and inflating it for a few minutes to reduce the blood flow in a person's arm. This is thought to release chemicals into the bloodstream which can have positive effects on the heart. This has been studied in patients with other forms of heart disease, but is yet to be tested properly in patients with heart failure. It is hypothesized that combining the RIC procedure with a low level of arm exercise may result in further improvements in the person's blood vessels and heart. This will be tested in a single-centre prospective study.

Eligibility Criteria:
Inclusion Criteria:

* Age \&gt;18 years
* Ability to provide written consent
* clinical diagnosis of HFpEF (LVEF ≥50%; symptoms and signs of heart failure \[HF\] caused by a structural and/or functional abnormality, and at least one: elevated natriuretic peptides; ambulatory; BNP ≥35 pg/mL or NT-proBNP ≥125 pg/mL or hospitalised; BNP ≥100 pg/mL or NT-proBNP ≥300 pg/mL, and objective evidence of cardiogenic pulmonary or systemic congestion) OR stable type 2 diabetes (determined by formal diagnosis in hospital or GP case records with diagnostic oral glucose tolerance test or glycated haemoglobin level ≥6.5%) and with ACC/AHA stage B HF (structural disorder of the heart but no current or previous symptoms of HF) OR confirmed diagnosis of dilated cardiomyopathy

Exclusion Criteria:

* Absolute contraindications to MRI or contrast (e.g. severe claustrophobia, pregnancy, ferromagnetic implants, inability to lie flat, severe renal impairment eGFR\&lt;30ml/min/m2)
* Moderate to severe valvular heart disease
* Confirmed coronary artery disease (\&gt;50% narrowing in any major epicardial coronary artery on invasive or computed tomography coronary angiography, previous myocardial infarction, previous percutaneous intervention or coronary bypass surgery)
* Known arterial stenosis of the upper extremity
Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery

Digital technologies could reduce the length of hospital stay and improve post-operative recuperation after discharge by offering a remote follow-up. No study has investigated the effects of connected follow-up on lumbar spine inpatients.

The purpose of this project is to assess the effects of connected follow-up on pain and quality of life after lumbar spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* First ever lumbar spine surgery in the context of a degenerative spinal pathology
* Age between 18 and 60 yo
* Providing free and informed consent to participate
* Having a smartphone able to process MAELA application
Humanistic Care in Healthcare Workers in Coronavirus Disease 2019

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. The impact factors of clinical outcomes among hospitalized patients still need to be clarified. The healthcare workers faced greater mental and physical pressure under long-term, high-intensity, high-risk working conditions. Investigators aim to evaluate the positive effect of humanistic care for healthcare workers participated in the treatment of COVID-19.

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. As the national medical team sent to Wuhan, the investigators proposed a psychological and physical rehabilitation based humanistic care regimen generated from experience in treating patients with COVID-19. The healthcare workers faced greater mental and physical pressure under long-term, high-intensity, high-risk working conditions. The investigators want to apply this regimen to the healthcare workers who participated in the treatment of COVID-19, to evaluate the positive effect of humanistic care on preventing depression and post-traumatic stress disorder.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare-personnel who are working for treating COVID-19
* Agree to informed consent

Exclusion Criteria:

* disagree to consent