cyrilzakka/clinical-trials huggingface dataset:
Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures

Three weeks of cast immobilisation versus one week of brace immobilisation in non- or minimally displaced distal radius fractures in adult patients \<50 years of age treated non-operatively.

Background: Currently, non- or minimally displaced distal radius fractures are treated by three to five weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that one week of immobilisation might be safe, however, no level one evidence is available. This trial aims to compare one week of brace immobilisation with three weeks of cast immobilisation in patients with distal radius fractures that do not need reduction.

Methods: The aim of this trial is to evaluate the non-inferiority of one week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18-50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with one week of brace immobilisation, and the control group with three weeks of cast immobilisation. Primary outcome is the Patient-Related Wrist Evaluation-score at six months. Secondary outcomes are: Quick Disabilities of the Arm, Shoulder and Hand-score at six weeks and six months, PRWE at six weeks, range of motion, pain, radiological outcome, complications and cost effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire.

Discussion: This study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level one evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.

Eligibility Criteria:
Inclusion Criteria:

1. 18-50 years (to eliminate osteoporosis);
2. Primary non- or minimally displaced DRF;
3. Independent for activities of daily living.

Exclusion Criteria:

1. Fracture of the contralateral wrist;
2. Ipsilateral fractures, proximal of the DRF;
3. Pre-existent abnormalities or functional deficits of the fractured wrist;
4. Open fractures;
5. Polytrauma patients
6. Language disability to understand the Dutch patient information and questionnaires.
Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Cancer

Chemoradiotherapy（CRT） is the main treatment for esophageal cancer patients with recurrent desease，and checkpoint blockade (PD-1) have been shown to be effective in advanced esophageal cancer. Therefore, PD-1 combined with chemoradiotherapy （CRT）may further improve the efficacy and become a new method for the treatment of esophageal cancer.This study intends to conduct a single-arm, prospective clinical study, aiming to evaluate the safety and efficacy of PD-1 combined with chemoradiotherapy(CRT) in patients with oligometastatic esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

•≥18 years；

* Esophageal squamous cell carcinomas；
* After radical treatment including surgery or definitive chemoradiotherapy
* Definition of oligometastases：≤3 metastases, including tumor beds and recurrent anastomotic sites；regional lymph node is defined as one metastatic site（AJCC8th, supraclavicular, mediastinal, abdominal）；metastases lesion in liver, lung, bone and brain is no more than 1.
* Karnofsky performance status(KPS)≥ 70；
* No immunotherapy were performed after recurrence；
* a white-cell count of at least 3500G/L, a hemoglobin concentration of at least 100 g/L, a platelet count of at least 100,000/lL, aspartate aminotransferase and alanine aminotransferase levels of within 1.5 times the upper limit of normal, a serum bilirubin level of 1.5 mg/dL or less, a creatinine level of 1.1 mg/dL or less;
* Hepatitis virus indicators: normal or hepatitis virus DNA titer less than 500 at the same time in an infectious disease hospital, and with the consent of the doctor can be treated；

Exclusion Criteria:

* Pregnancy, possible pregnancy, or breast-feeding;
* Psychological, family, social and other factors lead to uninformed consent;
* An esophageal mediastinal fistula and/or an esophageal tracheal fistula prior to treatment;
* Serious complications such as ischemic heart disease, arrhythmias, or other types of heart disease requiring treatment; liver cirrhosis; interstitial pneumonia or pulmonary fibrosis; active gastrointestinal bleeding; mental disorders being treated with antipsychoticagents or requiring treatment;
* Controlled diabetes mellitus;
* A history of autoimmune disease, autoimmune disease (such as colitis, hepatitis, hyperthyroidism, including but not limited to these disease or syndrome) and a history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or have a history of organ transplantation and the history of allogeneic bone marrow transplantation;
* A history of interstitial lung disease and a history of non-infectious pneumonia;
* Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 Copies /mL), hepatitis C ;(positive HCV antibody and HCV-RNA above the detection threshold of the assay）
* Any situation that is unstable or may compromise patient safety and compliance ;
* Active infections, such as active tuberculosis, are present;
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.


Eligibility Criteria:
Inclusion Criteria

* Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
* Meets the Classification Criteria for Psoriatic Arthritis at Screening.
* Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening.
* Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1.
* Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening.
* ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.
* Must have completed the week 52 treatment for the optional open-label long-term extension period.

Exclusion Criteria

* Nonplaque psoriasis at screening or day 1.
* Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.
* History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
* Active fibromyalgia.
* Received an approved or investigational biologic therapy for the treatment of PsA or PsO.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation

Pediatric patients are at high risk to acquire mycotic infections following allogeneic bone marrow transplantation. In the present retrospective analysis we assess the safety and efficacy of different regimens in antimycotic prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients under the age of 18 years
* Pediatric patients after HSCT treated with caspofungin
* Pediatric patients after HSCT treated with liposomal amphotericin

Exclusion Criteria:

* Pediatric patients with uncontrolled hematological malignancies
* Pediatric patients with IFI at start of HSCT
A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction

This study compares the outcome using a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in immediate breast reconstruction.

The scientific evidence using different types of mesh in breast reconstruction is low at present with very few randomized controlled studies.

This study aims to compare a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in patients with hereditary increased risk of developing breast cancer operated with bilateral immediate breast reconstruction regarding implant loss rate,infections,total complication rate,aesthetic outcome, HQOL (health related quality of Life) and economics.

The patients will be enrolled to the study and sign an informed consent. At the operating theater the patient is randomized either to be reconstructed with Veritas® in one breast and TIGR® in the other breast..

The patients will be followed up according to a specified schedule until one year postoperatively as above.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed breast cancer gene mutation or a calculated increased risk \> 20% of developing a breast cancer during her lifetime.

Exclusion Criteria:

* All patients that don't fulfill criteria above
* Previous breast surgery
Short-term Effects of Live Music in Preterm Infants

The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age 26-34 weeks; no use of CPAP (Continous Positive Airway Pressure) or any other form of mechanical ventilation; signed informed consent of the parents

Exclusion Criteria:

* Heart defect or known cardiac arrhythmia; other diseases of the preterm and newborn period (including infections and chromosomal aberrations) which make an additional diagnostic and therapeutic intervention unacceptable; detection of deafness (TEOAE, transitory evoked otoacoustic emission)
Determination of Risk Factors of Ventricular Arrhythmias (VAs) After Implantation of Continuous Flow Left Ventricular Assist Device With Continuous Flow Left Ventricular Assist Device (CF-LVAD)

Determination of risk factors of ventricular arrhythmias (VAs) after implantation of continuous flow left ventricular assist device in order to characterize which patient requires ICD implantation in primary prevention.


Eligibility Criteria:
Inclusion Criteria:

* Patient above 18 years old
* Patients with CF-LVAD with or without ICD

Exclusion Criteria:

* Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Effects of Point-of-Care Ultrasound in Multidisciplinary Medical Wards

Point-of-care ultrasound (POCUS) is a bedside portable ultrasound technique utilized by healthcare providers to offer rapid and non-invasive diagnostic imaging. POCUS has proven particularly effective in critical care and emergency settings. However, its application in general medical wards, where patients often present with multiple comorbidities, remains under-researched. Additionally, the feasibility of nurse practitioners (NPs) performing POCUS is promising. Despite limited research on POCUS by less experienced operators, NP-conducted POCUS could provide timely, high-quality care, especially in situations with limited physician availability. The routine use of POCUS in patient admissions to medical wards may improve diagnostic accuracy, reduce diagnostic resource utilization, and shorten hospital stays.

Point-of-care ultrasound (POCUS) is a bedside portable ultrasound technique utilized by healthcare providers to offer rapid and non-invasive diagnostic imaging. This method significantly aids in diagnosis and treatment by enhancing accuracy, guiding treatment adjustments, aiding procedural interventions, and reducing the time to appropriate treatment, ultimately leading to better patient outcomes. POCUS also decreases the reliance on other imaging modalities, providing real-time information and minimizing additional imaging needs.

POCUS has proven particularly effective in critical care and emergency settings. However, its application in general medical wards, where patients often present with multiple comorbidities, remains under-researched. The potential value of POCUS in these wards is notable, as it can facilitate early complication detection and timely treatment adjustments, reducing complication incidences.

Additionally, the feasibility of nurse practitioners (NPs) performing POCUS is promising. NPs, as frontline healthcare professionals, can use POCUS to enhance diagnostic and therapeutic capabilities. Despite limited research on POCUS by less experienced operators, NP-conducted POCUS could provide timely, high-quality care, especially in situations with limited physician availability. The routine use of POCUS in patient admissions to medical wards may improve diagnostic accuracy, reduce diagnostic resource utilization, and shorten hospital stays.

Eligibility Criteria:
Inclusion criteria:

1. Age 18 years or older
2. Admitted directly from emergency department

Exclusion criteria:

1. End-of-life care
2. Immediate need for life-support therapy or ICU transfer
3. Airborne isolation
MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics

The goal of this research study is to learn more about the pancreas. The investigators want to use Magnetic Resonance Cholangiopancreatography (MRCP) to learn more about the size of a normal pancreas. MRCP is a special kind of MRI exam that produces detailed images of the pancreas. The investigators also want to figure out how much fluid the pancreas releases in response to secretin. Secretin is a chemical in the body that causes the pancreas to release fluid that helps with digestion. Secretin is used during the MRCP (MR-PFT) to help identify dysfunction of the pancreas. MR elastography (MRE) will be used to measure how hard the pancreas is. MRE is a special kind of MRI that uses vibrations to image tissue.

Introduction/Methods: Pancreatic fibrosis is the end stage of chronic pancreatitis (CP), which leads to loss of acinar volume and secretory capacity, and ultimately pancreatic insufficiency (PI). CP and congenital PI affect the pediatric population, and are both increasingly recognized in children. PI has serious negative implications on a child's growth and health but, if diagnosed early, PI can be treated, minimizing the detrimental effects of PI. Currently, direct pancreatic function testing (PFT) via collection of pancreatic fluid is the "gold standard" for diagnosis of PI but it is an invasive testing that may require sedation or general anesthesia. Magnetic resonance cholangiopancreatography (MRCP) with secretin administration (MR-PFT) and MR elastography (MRE) may allow non-invasive, and potentially early diagnosis of CP and PI. Currently, however, normative data with which to compare MR-PFT and MRE results in pediatric patients with suspected CP/PI is not available.

Aims: The investigators propose to determine the normal range for secreted pancreatic fluid volume in response to secretin administration and determine the normal range for pancreatic parenchymal stiffness in a pediatric population that is not affected by pancreatic disease. To date, the investigators have validated their MRCP technique and have successfully performed both MR-PFT and MRE in CP patients; however normative data is essential for validation of our non-invasive technique.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects between the ages of 6 and 15.9 years.
2. Subjects without a documented history of (or suggestive of) pancreatic disease

Exclusion Criteria:

1. History of pancreatic disease, liver disease, intra-abdominal neoplasm, abdominal inflammatory process such as inflammatory bowel disease (IBD), or systemic illness that may affect pancreatic state (e.g. cystic fibrosis).
2. Subjects with surgical hardware/implanted devices making them ineligible for MRI (e.g. pacemaker or other implanted medical device not approved for MRI).
3. Subjects who require any form of sedation or general anesthesia for MRI.
4. Subjects unable to breath-hold for the required 15-20 second imaging sequence.
5. Subjects who are pregnant or less than 12 months post-partum.
Varenicline for Adolescent Smoking Cessation

This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo.

The objective of this protocol is to examine the efficacy and safety of varenicline for smoking cessation in adolescents. The guiding design philosophy was to model the adult smoking cessation literature (allowing for indirect comparisons of efficacy in different populations) while fine-tuning some elements specifically geared for adolescents. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo. Participants will provide smoking self-report (cigarettes per day) throughout the study. Biological confirmation with carbon monoxide breathalyzer will occur at all visits, and urine cotinine measurement will occur at key time points (baseline, end of treatment and final post-treatment follow-up). Psychiatric/medical visits will occur weekly throughout active treatment to systematically monitor safety and tolerability. After the 12-week treatment course, participants will return for 3 post-treatment follow-up visits (Week 13, Week 18, and Week 26).

Eligibility Criteria:
Inclusion Criteria:

* Age 14-21
* Daily smoker for ≥6 months
* Desire to quit smoking, with at least one prior failed quit attempt and willingness to participate in a treatment study
* If under age 18, parent(s) or guardian(s) able to participate in informed consent and initial assessment (unless the participant provides evidence of emancipated status)
* If female, agreement to use birth control (any form of hormonal contraception such as Depo-Provera, daily oral contraception, transdermal patch, or Nuva-ring; intrauterine device; sterilization; or double barrier contraception, which is a combination of any two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy

Exclusion Criteria:

* Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia)
* Lifetime history of suicidality, homicidality, or clinically significant hostility/aggression
* Current substance dependence, other than nicotine
* Current unstable major medical disorder
* Current pregnancy or breastfeeding
* Current use of medications with smoking cessation efficacy
* Known hypersensitivity to varenicline
Virtual Reality Avatar Therapy for People Hearing Voices

Hearing voices is probably the worst form of acoustic hallucinations; which can be experienced as severely disturbing and is influenced by diverse factors including the ability of the individual to influence and control the hallucinatory experience itself. In recent years virtual reality has become a treatment option. In the so-called AVATAR Therapy, patients with schizophrenia and acoustic hallucinations design a visual and auditory recreation (avatar) of the entity to which they attribute their hallucinations. Working with a therapist over the course of several sessions, participants change the avatar from controlling to benevolent. Avatar Therapy involves similar processes to learning and cognitive restructuring, comparable to other psychotherapeutic interventions. The investigators plan to conduct an interventional study using a cross-over design, to compare the feasibility and efficacy of virtual reality avatar therapy for patients with acoustic hallucinations (independent of psychiatric diagnosis) with a cognitive behavioural group therapy aimed to improve social competence.


Eligibility Criteria:
Inclusion Criteria:

* Consistent acoustic hallucinations, with the presence of voices for at least two months.
* Participants are competent to give informed consent, as determined by the referring physician or psychiatrist.
* German language proficiency as a native speaker or level B1 Common European Framework of Reference for Languages (CEFRL)

Exclusion Criteria:

* Current neurological disorder.
* Current substance use or withdrawal.
* Concomitant group psychotherapeutic intervention.
Multiparameter Ultrasound Based-AI for the Diagnosis of Thyroid Nodules

The cases that fulfill the inclusion criteria will be enrolled with written informed consent. Images and videos will be collected in accordance with the procedure, uploaded to Ruiying Cloud, followed up, and registered with basic case information, such as thyroid function, FNA/surgical pathology results, etc.


Eligibility Criteria:
Inclusion Criteria:

* 18\~80 years old;
* Thyroid nodules (ACR-TI RADS category 3-5，category 3 nodules ≥1cm submitted for FNA) or clustered micro-calcifications;
* The patients schedule to perform FNA/surgery within 1 month;
* Without any history of invasive procedure of thyroid before (such as FNA,CNB, ablation, radiation, or surgery).

Exclusion Criteria:

* Incomplete data;
* Contraindications of CEUS
Safety and Effectiveness of Flaxseed for Reducing High Cholesterol

Flaxseed, a rich source of fiber, may be a significant component of a cholesterol-reducing diet. The purpose of this study is to evaluate the safety and effectiveness of flaxseed in reducing high cholesterol.

Hypercholesterolemia is an established risk factor for atherosclerotic cardiovascular disease (ASCVD). The National Cholesterol Education Program estimates that 65 million Americans with hypercholesterolemia could be treated with diet and exercise alone. Flaxseed is a potential component of cholesterol-reducing diet regimens. Flaxseed contains significant amounts of soluble fiber and is a rich source of both alpha-linolenic acid and phytoestrogenic ligands, which have been implicated in the prevention of ASCVD. However, flaxseed's phytoestrogenic ligands may have undesirable hormonal effects. This study will systematically evaluate the safety and efficacy of ground flaxseed ingestion in both men and women with hypercholesterolemia.

Participants will be randomized to receive flaxseed or a matching wheat bran control. The test dose of flaxseed will be 40 grams administered in baked products (muffins, bread, or bars). The first 6 study weeks are a diet stabilization phase, followed by a 10-week study phase in which participants are expected to eat two servings of the test food daily. Blood and urine are collected for analysis, which will include measurement of low density lipoprotein cholesterol (LDL-C), post-prandial triglycerides, and urinary isoprostane secretion.

Eligibility Criteria:
Inclusion Criteria

* Men over 45 and post-menopausal women
* LDL cholesterol \> 130 mg/dl

Exclusion Criteria

* Established heart, kidney, or liver disease
* Diabetes
* Cancer