cyrilzakka/clinical-trials huggingface dataset:
Assessing Muscle Metabolic Phenotype by MSK Ultrasound

The purpose of this study is to test whether ultrasound images (pictures) can be used as a valid assessment of muscle quality in different muscle groups during Intensive Care stay. This new approach would allow clinicians to obtain frequent skeletal muscle images and would enable doctors to observe any changes over time in muscle quality that could occur during ICU stay.

Participants in this study will have ultrasound images made of their leg-, chest- and jaw muscles taken on every day until ICU discharge.


Eligibility Criteria:
Inclusion Criteria:

* admission Duke Trauma center, SICU, MICU, or CT ICU
* \>18 years of age

Exclusion Criteria:

* \<18 years of age
* prisoners
A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction

By including patients with acute myocardial infarction, mast cell markers were analyzed and the relationship between mast cells and patients with acute myocardial infarction was analyzed

Percutaneous coronary intervention (PCI) is the best way to improve the prognosis of patients with acute ST-segment elevation myocardial infarction (STEMI). However, ischemia reperfusion injury, inappropriate ventricular remodeling, and myocardial fibrosis may still be present in STEMI after PCI, which may be related to the inflammatory response in STEMI. Mast cells (MC), their degranulation products and induction of a series of inflammatory cytokines play an important role in the inflammatory response. The purpose of this study was to evaluate the relationship between mast cell markers (trypsin, chymotrypsin) levels and prognosis after direct PCI in STEMI patients. We prospectively and continuously included STEMI patients undergoing standard therapy after direct PCI. Clinical data and blood samples were collected and followed up for 1 year to analyze mast cell markers and myocardial infarction size. As well as differences in echocardiography, markers of two-dimensional speck tracking techniques, inflammatory factors and major adverse cardiovascular events, to explore the relationship between mast cells and their products and ventricular remodeling and ischemia-reperfusion injury in STEMI patients, and to provide new ideas for treatment and new basis for optimization of STEMI treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old, regardless of gender;
* 2) Meet STEMI diagnostic criteria (diagnostic criteria: ischemic chest pain lasting ≥30min; ST segment elevation of more than two adjacent leads or new left bundle branch block in ECG; With or without elevated myocardial markers) and receiving standard care for STEMI.
* 3) Agree to and cooperate with the study

Exclusion Criteria:

* 1) The patient is taking or planning to take long-term oral or intravenous glucocorticoids (inhaled and topical hormones are allowed);
* 2) Allergic diseases, autoimmune diseases or malignant tumors.
* 3) Patients with metal implants or claustrophobia are not allowed to undergo an MRI examination;
* 4) Pregnancy or lactation
Amniotic Membrane in Total Knee Replacements to Reduce Scarring

The overall objective of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in total knee replacement patients.


Eligibility Criteria:
Inclusion Criteria:

1. Are adults ages 18 or older.
2. Are diagnosed with advanced osteoarthritis as determined by clinical exam and necessitate total knee replacement.
3. Have a willingness to comply with follow-up examination.
4. Have ability to give full written consent.

Exclusion Criteria:

1. Has had a previous total or partial joint replacement performed at the same site
2. Has a planned bilateral procedure at this time. Bilateral patients can be enrolled if the procedures are staged.
3. Has signs or symptoms of any other disease which could result in allograft failure, or has experienced allograft failure in the past.
4. Has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
5. Is pregnant or may become pregnant during the study.
6. Is a prisoner.
7. Has any condition(s) which seriously compromises the subject's ability to participate in this study, or has a known history of poor adherence with medical treatment.
8. Is currently taking medications which could affect allograft incorporation (supervising physician's discretion).
9. Is confined to bed or a wheelchair.
10. Has clinical signs and symptoms of local infection at the site.
11. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
12. Has current diagnosis of cancer at the site.
13. Has had prior radiation therapy treatment at the site.
14. Is currently taking anticoagulant therapy.
15. Is unable to sign or understand informed consent.
16. Has a history of drug or alcohol abuse within last 12 months.
17. Is allergic to Aminoglycoside antibiotics (such as gentamicin and/or streptomycin).
Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients

Prospective phase IV interventional open label randomized controlled trial to assess safety and efficacy of glutamine in preventing vaso-occlusive crisis (VOC) episodes in sickle cell pediatrics and adolescents' patients

Vaso-occlusive crisis (VOC) episodes are considered to be the cause of 95% of hospitalizations for sickle cell disease (SCD) patients. Prior studies have described pain management in SCD patients with poor outcomes in the short term and decreased quality of life in patients over the long term.

Although that L-glutamine has been recently approved by the FDA for the prevention of acute complications in sickle cell disease. However, there are many gaps in our understanding of its therapeutic implications in SCD. This study will assess the safety and efficacy of glutamine in preventing vaso-occlusive crisis (VOC) episodes in sickle cell pediatrics and adolescents' patients

Eligibility Criteria:
Inclusion Criteria:

Children and adolescents diagnosed with sickle cell disease by haemoglobin electrophoresis and had at least two pain crises (no upper limit) documented during the previous year; a pain crisis is defined as pain leading to treatment with a parenteral administered narcotic or ketolac in an emergency department (ED) (or outpatient treatment centre) or during hospitalization.

Patients receiving hydroxyurea at a fixed dose for at least 3 months before screening.

Exclusion Criteria:

Patients with sickle cell trait and other hemoglobinopathy.

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A Randomized Controlled Trial of Auricular Acupressure in Treating Estazolam-dependent Insomnia

Insomnia is a disorder characterized by difficulties in falling asleep, maintaining sleep or waking up too early, and impairment of daytime functioning. Drug-dependent insomnia refers to insomnia patients taking sedatives and sleeping pills regularly for a long period of time, and becoming psychologically and physiologically dependent on them. In many countries, auricular acupressure (AA) has attracted growing attention as a complementary or alternative treatment for insomnia; however, there is a lack of rigorous randomized, controlled studies evaluating AA specifically for estazolam-dependent insomnia. Our proposed trial aims to assess the therapeutic effect of AA on estazolam-dependent insomnia.

This study is a randomized, single-blinded, three-arm controlled trial. No less than 120 participants will be randomized into one of three groups: AA group, sham auricular acupressure (SAA) group, and conventional dosage reduction group. All treatments will be administered for 4 weeks, with a follow-up period of 1 month. The primary clinical outcomes will be estazolam dosing and reduction rates, serum gamma-aminobutyric acid (GABA) and cortisol (CORT) levels. Secondary outcomes will concern the Pittsburgh sleep quality index (PSQI) and Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ). Both intention-to-treat and per-protocol analyses will be performed, with significance level determined as 5%.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for insomnia;
* Meet the diagnostic criteria for hypnotic drug-dependent insomnia;
* Regularly taking estazolam tablets for more than 2 months, and need to stop the medication;
* The dependent dosage of estazolam is 1mg, and withdrawal reaction occurs when the dosage is less than 1mg;
* PSQI score ≥ 7 (defined as "poor sleep quality", PSQI ≥ 7 is used as the reference threshold for judging sleep quality problems);
* Sign the informed consent.

Exclusion Criteria:

* Patients with cognitive disorders caused by cerebrovascular diseases, psychiatric disorders, and so on;
* Patients with serious heart, liver, kidney and blood system diseases;
* Patients with psychiatric illness/drug abuse (including alcohol);
* Patients who cannot cooperate with treatment, observation and evaluation.
Pharmacokinetics and Pharmacodynamics of Fructose

The purpose of this study is to determine whether sucrose vs high fructose corn syrup from a soft drink results in differences in various metabolic byproducts such as fructose, glucose, serum uric acid, triglyceride and lactate.

Fructose consumption has risen sharply during the past several decades. Since its introduction to the United States in 1967, high fructose corn syrup (HFCS) has overtaken sucrose as the main sweetener in manufactured foods and beverages, and thus, is responsible for the approximately 30% increase in fructose in our diet. Numerous studies have shown that excessive fructose consumption can cause a variety of harmful metabolic effects, suggesting that fructose may partially be responsible for the current epidemic in obesity, hypertension, metabolic syndrome, and diabetes.

This preliminary study will investigate the pharmacokinetics and pharmacodynamics of fructose in a broad population. Specifically, the goal of our research are to compare the impact of the two main sources of dietary fructose, sucrose versus HFCS, on fructose bioavailability and acute metabolic changes by measuring response phenotypes, such as serum uric acid, lactate, and triglyceride levels.

Eligibility Criteria:
Inclusion Criteria:

* adult subjects aged 18 years or older
* either gender
* any ethnicity
* willing to abstain from drinking any alcohol 3 days prior to a study visit

Exclusion Criteria:

* history of liver or kidney disease
* history of diabetes mellitus or fasting blood glucose ≥ 126 mg/dl or random blood glucose ≥ 200 mg/dl
* currently taking any medication (except oral contraceptives)
* consume more than 1 alcoholic drink per day
* pregnant or breast-feeding
* blood donor in the previous 8 weeks
* history of gout
Profiling Fecal Samples for Selection of Donors of Feces

Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis .... A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure.

Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis .... A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure. The aim of our study is to measure fecal biochemical, microbial and immunological parameters that are known to influence gut homeostasis in a group of 40 healthy donors to establish a referential profile of human stools to optimize donor profiling, beyond the infectious parameters, to increase the success rate of FMT.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Healthy volunteers
3. Participant having been informed of the study and having sign a consent to participation
4. Patient affiliated with a social security or beneficiary of such a social protection

Exclusion Criteria:

1. Person subject to legal protection (guardianship, trusteeship, etc.)
2. Chronic disease that can alter the intestinal microbiota: cancer or malignant disease, bowel disease, diabetes, hypertension, hypercholesterolemia, ....
3. Presence in the 1st degree family of one of the chronic diseases mentioned above
4. Blood in stools
5. Chronic drug treatment likely to alter the intestinal microbiota
6. Travel to a tropical country in the last 3 months or extended stay (\> 3 months) for less than 1 year
7. Hospitalization abroad (\> 24h) in the last 12 months
8. Hospitalization abroad (\> 24h) of a family member living under the same roof during the last 12 months
9. Medical consultation in the last 3 months (other than administrative)
10. Contact with a person with an infectious or contagious disease for more than 3 months
11. Digestive disorders / febrile gastroenteritis (diarrhea with fever) in the last 3 months
12. Febrile illnesses for more than 3 months
13. Antibiotic treatment in the last 3 months
14. Treatment with PPIs in the last 3 months
Effect of an E-learning Intervention on Knowledge, Attitudes and Beliefs of Healthcare Professionals Managing Low Back Pain.

The purpose of the current research project is to examine if the healthcare professionals (HCPs) knowledge, attitudes, beliefs and behavior about the management of low back pain (LBP) patients changes following an e-learning intervention (experimental interactive e-learning versus traditional non-interactive e-learning)

The purpose of the current research project is to use an e-learning educational approach to implement guideline-adherent care in first line HCPs. We aim to enhance the knowledge, attitudes, beliefs and behavior of HCPs towards a biopsychosocial approach in the management of LBP patients. We will compare the effect of an interactive e-learning intervention (i.e. experimental intervention) to an e-learning intervention without interaction (i.e. traditional intervention). Both interventions will be based on the most recent scientific literature regarding the management of LBP, but both the focus and the didactical approach will slightly differ between the interventions. We will use a mixed methods approach to gain an in-depth understanding of HCPs behavior in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* To be an healthcare practitioner (general practitioner, physiotherapist, specialist physician, student in medicine including specialization, student in physiotherapy)
* Working or studying in Belgium or France
* Being in possession of an internet connected device (e.g. computer, tablet or smartphone) with speaker
A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering

Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes.

The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically:

1. The effect on three-dimensional spine growth as compared to normal controls
2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
3. Complications associated with both the procedure and the device


Eligibility Criteria:
Inclusion Criteria: Skeletally immature patients that receive AVBT surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. Specifically:

* Diagnosis of idiopathic scoliosis
* Planned recipient of AVBT surgical treatment
* Skeletally immature
* Major Cobb angle ≥30° and ≤65°
* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
* Failed or intolerant to bracing

Exclusion Criteria:

* Presence of any systemic infection, local infection, or skin compromise at the anticipated surgical site
* Prior spinal surgery at the level(s) to be treated
* Evidence of documented poor bone quality
* Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions as determined by the treating physician
* Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
* Unwillingness to sign Informed Consent Form and participate in study procedures
Neonatal Hyperbilirubinaemia in the Democratic Republic of Congo

Neonatal hyperbilirubinaemia (NH) is common among healthy neonates and normally resolves within a week. Untreated pathological hyperbilirubinaemia, however, can result in long-term neurological sequelae, which compromise childhood development, or may result in perinatal death. True population-based data from middle to low-income countries are scarce and NH contribution to morbidity and mortality remains unclear. With this study the investigators aim at assessing the prevalence of neonatal hyperbilirubinaemia in a cohort of newborns in a maternity hospital in Kinshasa, the Democratic Republic of Congo, and at evaluating the possible risk factors for NH in the mother and the baby.

Neonatal hyperbilirubinaemia is common among healthy neonates and normally resolves within a week. Untreated pathological hyperbilirubinaemia, however, can result in long-term neurological sequelae, which compromise childhood development, or may result in perinatal death. Worldwide, this condition aﬀects at least 481,000 term or near term newborn babies annually, causing 114,000 deaths and more than 63,000 cases of moderate or severe disability. In high-income settings, early diagnosis and treatment in neonatal intensive care units have dramatically improved the outcome for babies at risk. However, true population-based data from middle to low-income countries are scarce and NH contribution to morbidity and mortality remains unclear. The Democratic Republic of Congo is one of the 5 countries with the highest neonatal mortality rate: 29 per 1000 live births, with an estimated 96,963 annual deaths. NH diagnosis is mostly performed by visual inspection, which is not very reliable, and it is not systematically reported in maternity records. The primary objective is to evaluate the prevalence of neonatal hyperbilirubinaemia in a cohort of in-hospital consecutive live births. The secondary objective is to evaluate the possible risk factors for NH in the mother and the baby. The results of this survey will provide essential baseline data for the community. If the frequency of the NH and severe NH in the area is higher than routinely reported, prompt and appropriate management guidelines can be put in place to improve treatment to decrease neonatal mortality and neurological disabilities.

Eligibility Criteria:
Inclusion Criteria:

* All live male or female new-borns
* Mothers of any age, willing and able to give informed consent for participation in the survey and agree to stay 72 hours in hospital after giving birth

Exclusion Criteria:

* Newborn health conditions which makes difficult to drawn a blood sample
* Newborn health conditions requiring specific care not compatible with the survey procedures
The Effects of Preoperative and Postoperative Oral Nutritional Supplements in Malnourished Post-gastrectomy Patients

The objective of this study is to evaluate the effect of a perioperative nutrition strategy using oral nutritional supplements (ONS) on postoperative complications and improvement in body weight in malnourished patients who underwent gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years
* Patients who undergo distal, total, proximal, or pylorus-preserving gastrectomy
* Patients who are assessed as moderate or severe malnourished according to PG-SGA or patients with BMI lower than 18.5 kg/m2
* Patients who can take oral meals
* Patients who agree on the informed consent

Exclusion Criteria:

* Emergent operation
* Patients who received preoperative chemotherapy or radiation therapy within 6 months
* Pregnant patients
* Patients who cannot consume the Ensure powder
* Patients who enrolled another clinical trials
Oral and Jaw Health in Bipolar Patients

The assessment of oral health, jaw health and related problems in bipolar patients is important to provide a holistic approach to patients in terms of physical, mental and psychosocial aspects and to improve quality of life. In this study, oral health, temporomandibular dysfunction (TMD) and oropharyngeal dysphagia (OD) were investigated in patients with Bipolar Disorder (BD).

During the remission period, 70 individuals aged 20-60 years with BD were divided into two groups according to the duration of diagnosis as under ten years (Group 1=33) and over ten years (Group 2=37). Oral and dental health-related quality of life was assessed with the Oral Health Impact Profile-14 (OHIP-14), TMJ pain was assessed with the Numeric Pain Scale (NPS), the presence of TMJ discomfort was assessed with the Fonseca Anamnestic Questionnaire (FAQ), chewing functionality was assessed with the Jaw Function Limitation Scale-8 (JFLS-8), and oropharyngeal dysphagia was assessed with the Eating Assessment Tool (EAT-10).

Eligibility Criteria:
Inclusion Criteria:

* Patients between 20 and 60 years of age who volunteered to participate in the study and signed the informed consent form,
* diagnosed with BD at the outpatient department of Bakırkoy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital,
* in remission for at least 3 months,
* had a history of regular lithium use for at least 1 year in any phase of the disease were included in the study.

Exclusion Criteria:

* being in a manic or depressive episode (Young Mania Rating Scale score greater than 7, Hamilton Depression Rating Scale score greater than 7)
* history of comorbid psychiatric illness,
* alcohol and substance use disorder,
* cancer, neurological problems, congenital anomalies, musculoskeletal problems, systemic illness,
* facial paralysis,
* spinal, abdominal and/or TMJ surgery,
* and having received any spinal or TMJ treatment in less than 6 months.