cyrilzakka/clinical-trials huggingface dataset:
Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study)

This study evaluates using evolocumab, a currently approved and marketed biologic drug, in a novel way. Patients who present to the emergency room or intensive care unit (ICU) with severe infection are eligible. Either the patient or their designated decision maker will be approached for consent. If they choose to participate they will be given either a single dose of evolocumab, a higher single dose of evolocumab,or a single dose of placebo. Participants will be followed during their stay in the ICU and will receive follow up phone calls at Day 28 and 90.

Evolocumab is currently approved and marketed in USA and Canada for lowering cholesterol levels. Evolocumab is an anti-PSCK9 monoclonal antibody, and functions by binding PSCK9 (an inhibitor of LDL removal) and blocking its function. Evidence suggests that since evolocumab increases the removal rate of low-density lipoproteins from the body, it might also help increase the removal of bacterial components that are attached to circulating lipids during sepsis. Quickly removing these bacterial components could prevent a strong and rapid immune response that often leads to organ failure and death in sepsis patients.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* At least 19 years of age
* Known or suspected infection
* AND one or more of the following organ dysfunctions judged due to sepsis:

  1. Cardiovascular- refractory hypotension (a systolic blood pressure (SBP) \< 90 mm Hg or mean arterial pressure (MAP) \< 60 mm Hg despite an IV fluid challenge of at least 30 ml/kg fluids), or use of vasopressor(s) to maintain SAP \> 90 mm Hg or MAP \> 60 mm Hg, or;
  2. Respiratory: PaO2/FiO2 \< 300 or PaO2/FiO2 \< 200 if lung is the only organ dysfunction or SaO2:FiO2 150

Exclusion Criteria:

* Known pregnancy
* Underlying severe congestive heart failure (New York Heart Association (NYHA) IV), severe COPD (need for chronic oxygen or mechanical ventilation), severe liver disease (Child-Pugh Class C), cancer requiring chemotherapy, or transplantation (bone marrow, heart, lung, liver, pancreas, or small bowel) in the past 6 months or likely within the next 6 months
* Previous episode of sepsis during that hospital admission
* Absolute Neutrophil Count \< 500/mm³
* CD4 count \< 50/mm³
* Treating physician deems aggressive care unsuitable (i.e. no commitment to active care)
* Participation in another interventional drug study within previous 1 month
* Allergic to the study drug or any of its components
* Lactation
* Have signed a Do No Resuscitate (DNR) Form
Influence of Yogic Breathwork on Sleep

The purpose of this research study is to determine the influence of a regular yogic breathing practice on sleep, and to find out primarily if a regular practice of 8-week yogic breathing would enhance sleep quality as well as if it would improve participant's quality of life, and reduce existing stress. Study participants will be randomized into two arms for different breathing practices.

The purpose of this study is to determine the effects of two remotely-delivered 8-week breathing interventions on long term sleep patterns.

The study protocol consists of healthy participants (randomized in two breathing groups) undergoing a remotely delivered 8-week intervention and a 12-week sleep tracking period (including 2 week before the intervention, 8 week during the intervention, and 2 week after the intervention). Several sleep metrics will be extracted to characterize long-term sleep patterns and degree of sleep improvement. Participants will also be asked to complete pre- and post-intervention questionnaires.

The two remotely delivered interventions will be guided by two separate certified experienced yoga teachers. Both interventions will include 60-minute weekly group virtual sessions (1day/week) with a 20-minute daily home sessions (in between weekly sessions; 6 days/week) using home-aid practice materials.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* able to provide their consent to be in the study
* available and able to participate in study activities
* who can lie in supine
* who have little to no prior/current regular practice of breath awareness and training
* compatible devices for physiological data trackers

Exclusion Criteria:

* Inability to provide informed consent
* history of neurological disorders, craniospinal disorders, spinal injury
* diagnosed/treated sleep disorders such as sleep apnea with the use of CPAP
* allergic or respiratory disorders
* major or uncontrolled psychiatric illness or trauma or major depression
* lung and heart problems
* any condition requiring the use of medication that acts on the brain like stimulants/sedatives
* current substance abuse issues
* pregnancy or nursing
Descriptive Epidemiology of Clostridium Difficile Infection in Hospitalized Adult Patients in the Asia Pacific Region

Clostridium difficile is an important pathogen, causing disease that ranges from mild self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C. difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical illness. Primary risk factors for C. difficile clinically apparent infection include antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥ 65 years), and increased length of hospital stay. The incidence of CDI both in the hospital and the community is important in the understanding and characterization of the disease and its prevention. This observational, epidemiological study will advance the investigators understanding of CDI risk factors in several hospitals and possibly the community in the Asia Pacific region.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, aged ≥ 20 years at the time of hospitalization in specified wards
* PCR-diagnosed CDI while at the hospital
* Informed consent has been obtained from patients as required by local requirements

Exclusion Criteria:

* Age \< 20 years
Study of the Prevalence of Sexual Dysfunction in Women After Rectal Cancer Surgery and Analysis of the Impact of a Sexologist Intervention

RectSexQoL is a study aiming at determining the prevalence of female sexual dysfunction after rectal cancer surgery. It has the goal as well to analyse the impact of an intervention given by a sexologist to such patients.

The treatment of rectal cancer is multimodal combining surgery, chemotherapy and radiotherapy. Each therapeutic tool may affect the sexual life of treated patients.

The incidence of sexual dysfunction in patients with rectal cancer varies according to literature from 5 to 88%. This may be due to the lack of a common definition relating to sexual dysfunction making it difficult to compare results. On the other hand, it should be noted that all of the work related to sexual dysfunction after treatment for rectal cancer is mainly interested in men. The sexual well-being of women treated for rectal cancer is based on the assessment and management of their sexual functions as well as that of their overall sexual health in a personalized manner. The establishment of a sexology consultation before and after such a surgical procedure could improve the sexual functions as well as the sexual well-being of these women. The main aim of our study is to evaluate the prevalence of sexual dysfunctions at M-1 (before treatment) in the two cohorts "here" and "elsewhere" in the context of surgery for rectal cancer in females. The second aim will be to determine the impact of sexology consultation in the cohort "here" in comparison to the standart cohort without any intervention called "elsewhere".

Eligibility Criteria:
Inclusion Criteria:

* Women
* Diagnosis of stage I-III rectal adenocarcinoma or rectosigmoid junction with anastomosis less than 15 cm from the anal margin
* Surgical management, preceded or not by Radio-chemotherapy, with restoration of continuity
* Age : over 18
* Proficiency in French or English

Exclusion Criteria:

* Current pregnancy
* Significant cognitive/psychiatric disorders
* Guardianship
Quality of Life Influencing Factors

Background: quality of life is impaired in patients with paroxysmal atrial fibrillation. The purpose of this study is to explore the mediating effects of self-efficacy, coping, depression, and anxiety on the quality of life of patients with paroxysmal atrial fibrillation. Methods: It is a cross-sectional study trial. This study aims to enroll 100 patients with paroxysmal atrial fibrillation. Illness perceptions (Brief Illness Perceptions Questionnaire; BIPQ), coping styles (Carver Brief-COPE scale; B-COPE), depression Patient Health Questionnaire-9 ,PHQ-9),anxiety (The Generalized Anxiety Disorder Questionnaire, GAD 7) and quality of life (12-item Short Form Health Survey,SF12) will be analysed. This study intends to use correlation analysis and mediation analyses to assess the mediating effects of self-efficacy, coping, depression and anxiety on the quality of life of patients with paroxysmal atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 years;
2. AF diagnosis, based on a 12-lead ECG and cardiologist-led examination following the 2016 ESC Guidelines for the Management of Atrial Fibrillation
3. paroxysmal AF diagnosis given by a cardiologist according to the conversion back to the normal sinus rhythm occurs spontaneously within a week
4. ability to read and write in Chinese.

Exclusion Criteria:

1. severe complications such as unstable coronary artery disease, heart failure with severe systolic dysfunction(ejection fraction≤35%)
2. AF soon after thoracic surgery;
3. malignant disease with a 1-year survival rate or a terminal illness diagnosis;
4. a diagnosed psychiatric condition that interfered with participation (including severe depression, bipolar disorder, psychotic illness of any type, dementia, acute suicidality, severe personality disorder)
5. participation in another study
6. cognitive impairment interfering with their ability to participate in the study
The Relation of Ankle Mobility and Achilles Tendon, Plantar Fascia and Iliotibial Band Mechanical Properties

The myotonometric assessment is becoming popular and important in athletic population. It is mentioned an alternate method than expensive methods, and it is easy and reliable assessment. Still there is not enough information of mechanical characteristics in athletic population and ankle mobility. Most clinicians or trainers can use this results and technique for enhancing performance, rehabilitation or prevention

The soft tissue mechanical properties can be assessed through elastography and ultrasonography. Both methods can measure passive and active soft tissue properties. These methods are the gold standard to measure stiffness and elasticity, but they are expensive, operator dependent and need a laboratory settings.Recently, myotonometric device has been used to measure the mechanical properties of the muscles and tendons. This method serves many advantages, such as non-invasive, painless and cost-effective. There is an increasing literature on athletic training about how training effects viscoelastic properties. However, to the best of our knowledge, there were no studies assessing stiffness and elasticity of AT, PF and ITB and the relation with ankle mobility in different sport disciplines. The purpose of this study were to demonstrate the mechanical properties of AT, PF and ITB and find out relation with restricted ankle mobility in athletes.

Eligibility Criteria:
Inclusion Criteria:

* being a professional athlete
* right dominant
* not having any lower extremity injury or surgery in the last 6 months,
* following routine training program.

Exclusion Criteria:

* a history of strain or surgery with knee or ankle,
* had any neurological or systemic disease.
Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants

This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age


Eligibility Criteria:
Inclusion Criteria:

* Infants 365-569 days of age.

Exclusion Criteria:

* Subjects who already received a booster dose of Hib vaccine.
* History of serious reaction(s) following vaccination.
* Any vaccination within 7 days of study vaccination.
* Known or suspected immune impairment.
Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture

This study is designed to compare the outcome of patients with proximal femoral fractures with different perioperative regimes: a group with a multimodal intervention and a control group.

Femoral neck fractures constitute both a social and economic challenge. The one year mortality of affected patients amounts to 33%, wherein cardio-vascular complications are the major contributor. It is an objective of the present study to investigate whether a multi-modal perioperative intervention can improve the outcome of these patients.

We plan to carry out a prospective randomized controlled clinical study. Patients with an age above 60 years and proximal femoral fractures (femoral neck fractures or pertrochanteric femoral fractures) are to be included. These are divided into two groups, K and M. General anaesthesia is applied to both groups. In group K a commonly used therapy will be applied whereas in group M an intesified perioperative care will be carried out. The objectives are to provide sufficient analgesia, normotonia and normothermia. Hence, a femoral catheter is applied for pain therapy already preoperatively. Moreover, the pulmonal situation is improved by means of oxygen as needed. The cardiovascular situation is evaluated and optimized by means of extended hemodynamic monitoring both pre- and postoperatively. If needed, the nutrition of the patients is supplemented with highly caloric drinks.

A primary common endpoint is the appearance of postoperative complications. These include cardiovascular, cerebrovascular, pulmonal, renal and surgical complications. Secondary endpoints are mortality, duration of the stay at the hospital and intensive care duration. It is the objective of the study to reduce the probability for at least one postoperative complication from 50% to 25% (α=0,05 and 1-β=0,80). To this end 132 patients would have to be included in the study.

All participants are to be contacted by phone one year after the surgery and their health situation is to be determined.

Eligibility Criteria:
Inclusion Criteria:

* proximal femoral fracture (femoral neck fracture/ pertrochanteric femoral fracture)
* Age ≥ 60 years
* written informed consent

Exclusion Criteria:

* pathological fracture
* multiple trauma
* fracture during a hospital stay due to a different disease
Application of 3D Printed Prosthesis in Limb Salvage Surgery for Bone Tumors

To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years, and collect the postoperative complications and limb function of these patients.

To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years. The basic data, treatment methods, postoperative complications and limb function of these patients were collected.

Eligibility Criteria:
Inclusion Criteria:

Men and women of all ages are welcome.

Pathologically confirmed in our hospital as a subtype of malignant tumor.

He received 3D printed bone prosthesis replacement in our hospital.

Exclusion Criteria:

Not applicable.
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia

Considering the lack of evidence on the effects of combining acceptance and commitment therapy (ACT) with customized sound therapy for tinnitus-related insomnia patients, investigators designed this single-blind, 6-months randomized, controlled trial with two parallel groups. One is the ACT + sound therapy group, and the other is the sound therapy group.

Insomnia is one of the most frequent and severe comorbidities in patients with tinnitus and is highly relevant for the perceived tinnitus severity. Both tinnitus and insomnia significantly affect the quality of life of patients and represent a huge burden to society. While interventions exist to alleviate tinnitus distress, they often do not address sleep disturbances in tinnitus patients. Patients affected by tinnitus and insomnia suffer from long-term functional and psychological problems. Sound therapy is widely used to treat tinnitus, often combined with education and counseling, and can effectively improve the quality of life. In addition, acceptance and commitment therapy (ACT) for tinnitus improves both tinnitus and sleep. However, there is a lack of evidence on the effects of combining ACT with sound therapy for tinnitus-related insomnia patients.

To fully characterize tinnitus patients, standardized measures of tinnitus and insomnia are essential. These measures include pure tone audiometry (PTA), acoustic immittance (AI), tinnitus pitch matching (PM) and loudness matching (LM), minimum masking level (MML), tinnitus handicap inventory (THI), insomnia severity index (ISI), and hospital anxiety and depression scale (HADS).

Investigators hypothesize that the combination of ACT and sound therapy will be superiority to sound therapy alone in reducing tinnitus distress.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged between 18 and 80 years old.
2. Experiencing subjective tinnitus for at least 3 months.
3. A score of 38 or more on THI.
4. A score of 15 or more on ISI.
5. 55 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
6. Ability to read and write in Chinese and use a smartphone with an internet connection to work with text material.

Exclusion Criteria:

1. Pulsatile tinnitus and objective tinnitus.
2. Organic sleep disorders.
3. Other diseases that need to be treated first (e.g., infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss).
4. Severe mental illness.
5. Undergoing other research that may affect tinnitus and sleep.
FET-PET for Diagnosis and Monitoring in Patients With Low Grade Glioma

The aim of the study is to compare the two imaging modalities perfusion weighted MR-imaging and FET-PET in their ability to provide an accurate histological evaluation of low grade glioma and to reveal focal abnormalities within a homogeneously appearing tumor. Additionally, therapeutic effects should be assessed during a time period of two years.


Eligibility Criteria:
Inclusion Criteria:

* neuroradiologically suspected low grade glioma (Astrocytoma WHOI-II, Oligodendroglioma WHO II, Oligoastrocytoma WHO II)
* histological verification will be obtained either by microsurgery or by stereotactic biopsy
* patients older than 18 years
* Karnofsky Performance Score \>=70
* pregnant or nursing female patients will not be included in this study

Exclusion Criteria:

* patients in whom informed consent cannot be obtained due to organic brain syndrome or insufficient language skills
* patients who cannot lie quiet for a time period of app. two hours during the FET-PEt scan
* medical history of a metastatic brain disease
* patients in whom an MRI scan cannot be performed due to claustrophobia metallic protheses or pacemakers etc.
The Use of Incentive Spirometry in Adult Patients Hospitalised in a Rehabilitation Center With Long-covid Syndrome

The aim of this clinical trial is to investigate the efficacy of Triflow in the rehabilitation of patients with long covid syndrome hospitalised in a rehabilitation center. Participants will be divided into 2 groups and follow their exercise regime until the day they are discharged from the rehabilitation center. The intervention group will participate in a rehabilitation program which includes upper and lower limbs exercises, cycle ergometer, walking and the use of triflow. The control group will participate in the same program but without the Triflow.

Randomised controlled trial with 2 groups:Triflow and exercises (intervention) and exercises (control)

Exercises:Exercises in the bed, chair and standing with/without weights, walking, cycle ergometer, treadmill.

Triflow: 10 breaths in and 10 breaths out.

Both groups will have 1 physiotherapy session per day for 6 days per week from admission to discharge.

Sample size:The sample size is 70. We took into consideration the efficacy of completing the recruitment of patients in time. There few published studies with the use of Triflow as their primary intervention with smaller sample sizes.

Population: Adults with long covid hospitalised in the rehabilitation center

Statistical Analysis: will be done through IBM SPSS Statistics 20 and the level of statistical significance will be (p \< 0.05).

From the literature and international guidelines, physiotherapy should be offered to people hospitalized with long-COVID, without any serious risks and offering significant benefit.

Eligibility Criteria:
Inclusion Criteria:

* Adults who were infected with COVID-19 in the last 6 months and were diagnosed with long-covid syndrome
* Patients must be willing to give written consent for participation in the study
* Negative rapid test for COVID-19

Exclusion Criteria:

* History of diseases that do not allow exercise (e.g. unstable cardiac disease)
* Age \< 18 years of age
* Significant cognitive and psychiatric impairments (inability to follow simple commands or give consent)
* Lack of will to do the exercises or refuse to give consent
[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection

This protocol will evaluate the sensitivity and specificity of \[124I\]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients \>/= 18 years on the day of signing consent.
2. A diagnosis of diabetes mellitus, type I or II, as evidenced either by HbA1c\>6.5% or receipt of antidiabetic medication at time of enrollment.
3. Ability to provide informed consent
4. An inframalleolar ulcer of perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2 or 3. At the discretion of the Investigator, patients with PEDIS grade 4 infections may be included if they are sufficiently stable.
5. For females of childbearing potential, a negative urine pregnancy test on the day of dosing.
6. For females of childbearing potential, a willingness to use 2 methods of contraception for 30 days after receiving \[124I\]FIAU.
7. Ability to return for all study assessments.
8. Clinically euthyroid, or on stable thyroid replacement therapy.

Exclusion Criteria:

1. Patients who ar unable to comply with study requirements.
2. Indication, in the opinion of the principal Investigator for urgent surgery that would preclude the time needed for PET-CT scanning, or clinical instability that precludes PET-CT scanning.
3. History of an inherited mitochondrial disorder (eg. Leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis \[NARP\], myoneurogenic gastrointestinal encephalopathy \[MNGIE\], myocolonic epilepsy with ragged red fibers \[MERFF\] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome \[MELAS\])
4. Alanine aminotransferase (ALT)\>5x Upper Limit of Normal (ULN) OR aspartate aminotransferase (AST) \>5x ULN.
5. Body mass that exceeds the rating of the CT table.
6. Hypersensitivity to iodine.
7. Pregnant or breast-feeding.
8. Any condition that would put the patient at unreasonable risk in the opinion of the Investigator.