cyrilzakka/clinical-trials huggingface dataset:
Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)

The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\[s\] it aims to answer are:

* what is the prevalence and development of sarcopenia in cirrhosis?
* what is the role of malnutrition? Participants will

  * undergo a muscle ultrasound of the lower and upper limb muscles
  * handgrip strength will be measured
  * malnutrition screening and assessment
  * complete a questionnaire to assess quality of life

In this study, the investigators will assess the prevalence and development of sarcopenia in the large in- and outpatient population with cirrhosis (n= 1346) of the University Hospital of Antwerp, using ultrasound assessment of muscle mass and quality in the lower as well as the upper limb muscles. Handgrip strength will be tested for muscle functional status. Findings will be correlated with clinical outcome (MELD, survival, decompensating events). The etiology of the cirrhosis and its underlying activity will be taken into account as dependent variables, e.g. whether there is a difference between compensated vs. decompensated cirrhosis. The investigators will screen for malnutrition using the RFH-NPT and compare with the GLIM criteria. The effect of sarcopenia on the quality of life will be evaluated using the validated "SarQoL®" (Sarcopenia Quality of Life) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cirrhosis and follow-up in the University Hospital of Antwerp

Exclusion Criteria:

* known patient will against participation in the study or against the measures applied in the study
* a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours
* no complete remission of malignancy including hepatocellular carcinoma within the past 12 months
T-MACS Decision Aid: a Randomized, Controlled Point of Care Trial

The aim of the study is to establish whether the safety of the T-MACS decision aid to immediately 'rule out' acute coronary syndromes with one blood sample for the cardiac damage marker troponin, is non-inferior to an approach requiring serial troponin sampling over three hours.

We will conduct a randomized, controlled point of care trial embedded in routine practice. We will ask clinicians to obtain written informed consent during the course of their clinical duties. Patients who have suspected cardiac chest pain, who are identified as being at very low risk by the T-MACS algorithm, will be invited to participate.

Patients will then be randomly allocated to be advised that they can be discharged immediately (so long as the doctor and patient have no other concerns; this is the originally intended use of T-MACS; intervention arm) or to receive a second blood test after 3 hours (current practice; control arm).

Participants will then be followed up by electronic record review after 30 days and 12 months. Other than the difference in the requirement for a second blood test, participants will not notice any change to their care.

The accelerated pathway (involving a single blood test) has been shown to be safe in observational research involving over 5,000 patients. All of the data that are collected are the same of those that are collected in routine care, and they will be anonymised for analysis.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Presents to the Emergency Department with pain, discomfort or pressure in the chest, epigastrium, neck, jaw, or upper limb without an apparent non-cardiac source which the treating physician believes warrants investigation for possible acute coronary syndrome
* The patient is identified as being at 'very low risk' by the T-MACS decision aid following a single hs-cTn test at the time of arrival in the Emergency Department

Exclusion Criteria:

* No capacity to provide informed consent
* Inability to communicate in English language if translation services are unavailable
* Patient is a prisoner
* No NHS number (precluding electronic follow up)
The TransEnterix European Patient Registry

An open label observational registry trial in which participating centers enroll subjects who had or will have a laparoscopically assisted surgery using the Senhance Surgical System.

This is a prospective multi-center registry in which sites may also choose to retrospectively enroll subjects meeting the inclusion criteria, but whom have already been treated using the Senhance system. The data collection includes baseline patient characteristics, surgical details, and adverse events. Patient follow-up time point is open to the clinical practice of each center and only adverse events are tracked post discharge.

Eligibility Criteria:
Inclusion Criteria:

* patients 18-80 years old
* Signed the informed consent
* life expectancy 12 months or more

Exclusion Criteria:

-
Fit in the Aged by Professional Training

This intervention study tests training methods to stabilize or improve functionality in the high risk group of prefrail elderly persons.

This study aims at the improvement of muscular function by physical exercise in prefrail elderly persons. Prefrail participants are recruited according to the frailty score of Fried. Taking into account, that vitamin D supplementation reduces falls and improves muscle strength in older people, all participants are supplemented by vitamin D. Two different training methods are tested.

After a run-in period of supplementation of vitamin D for two months, participants will be randomized into three different equally sized groups (n=25): Group A will receive power training. Group B will have progressive strength training. Group C will serve as a control group. They will receive a consultation about leading a healthy life with special attention being paid to nutrition and physical activity. The intervention period lasts for 12 weeks. The 60 minutes training sessions will be held two times a week by members of the Institute of Sport Science and Sports of the University of Erlangen-Nuremberg. Follow-up visits are scheduled three and six months after intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Prefrailty according to the frailty score of Fried

Exclusion Criteria:

* Sarcoidosis
* Nephrolithiasis
* Plasmacytoma
* COPD
* Inflammatory bowel disease
* Rheumatoid arthritis
* History of cancer
* Instable heart disease
* Depression (GDS\>=6)
* Dementia (MMSE\<=24)
* BMI\>35kg/m²
* Current attendance of muscle training
* Medication: immunosuppressive drugs
An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)

This open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. In this observational study, ibandronate (Bondronat) will be prescribed and used in accordance with the standards of care. Data will be collected for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* All criteria in accordance with the Summary of Product Characteristics of Bondronat (ibandronate)
* Adult patients greater than (\>) 18 years of age
* Histologically confirmed breast cancer
* Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or magnetic resonance imaging)
* Life expectancy \>6 months
* No previous bisphosphonate therapy
* Patients signed written informed consent form before study start

Exclusion Criteria:

* All criteria in accordance with the Summary of Product Characteristics of Bondronat(ibandronate)
* Hypersensitivity to the active substance or any of the excipients of Bondronat (ibandronate)
* Hypersensitivity to bisphosphonates
Citizen Science: The People's Trial: A Randomised Controlled Trial

The People's trial is an online pragmatic, randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.

The People's Trial seeks to help enhance the public's understanding of randomised trials by facilitating the involvement of the public in the trial research process. The public have, through an online format, guided the development and design of The People's Trial randomised controlled trial. The People's trial is a parallel, online randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.

Members of the public will be recruited through online platforms. Informed consent will be obtained from all participants prior to trial registration. Consent forms will be provided online prior to registration for The People's Trial. Participants will be required to acknowledge that they have read the consent form and give consent to proceed with trail registration.

Participants will be randomly allocated into one of two groups:

Group 1: Reading a book in bed

Group 2: Not reading a book in bed

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age on enrollment;
* English speaking;
* ability to read;

Exclusion criteria

* Members of the public who are unwilling or unable to give informed consent.
* Unable to go to bed and wake up at the same time as normal for the study duration.
* Unable to sleep in their own bed, in their own home for the study duration
* Unable to not eat food or drink caffeinated drinks within 1 hour of bed for the study duration
Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis

Knee osteoarthritis has a very high prevalence in the population over 50 years of age. Patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. This pathology has also been linked to maladaptive plasticity in the brain, which can contribute to chronic pain. Therapies with neuromodulatory approaches, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (TENS), have been used therapeutically to counteract the maladaptive plasticity of the brain.

Transcranial therapy and TENS can be a possible effective treatment in the rehabilitation services of the health system for the improvement of chronic pain and quality of life in different pathologies, such as chronic low back pain, fibromyalgia or knee and hip osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography.
* Chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the Osteoarthritis Research Society International (OARSI) guideline:
* Pain in Analog Visual Scale more than 4/10
* Matutinal less than 30 minutes
* Absence of hyperthermia upon palpation in the joint
* Alteration of the bone image
* Crepitus

Exclusion Criteria:

* Patients who can provide low-quality or biased information discriminated by the Mini-Mental State Examination (Score less than 24).
* Severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities.
* Patients who have undergone knee replacement surgery on the contralateral knee.
* Patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks.
* Pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia.
* Patients who decline to participate out of fear or denial of therapy.
* Severe heart disease that prevent exercise.
* Body Mass Index above 45.
* Patients with neuropsychiatric disorders (schizophrenia, epilepsy or bipolar disorders) or taking medication for these conditions (antiepileptic drugs).
* Patients with metallic implants in the area (skull or knee).
Influence of Expectations on Rumination

The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.

Healthy volunteers are informed that a new application method for an antidepressant, specialised on protecting from rumination, would be tested. They will randomly be assigned to the treatment group (taking the antidepressant which is in fact an active placebo) or the no treatment control group (not taking a placebo). Then sad mood is induced by mood-suggestive music and negative autobiographic recall. Then participants in the experimental group take the "medication". Afterwards both groups are asked to focus on emotion-focused, symptom-focused and self-focused thoughts to induce rumination (e.g. "Think about what your feelings might mean."). Sadness will be assessed before and after the negative recall task and also after the rumination induction. State Rumination will be assessed before the recall task and after the rumination induction.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* fluent in German language

Exclusion Criteria:

* mental disorders
* allergic to capsaicin
* allergic to sesame oil
* intake of psychopharmacological drugs in the last four weeks
* intake of illegal drugs in the last two weeks
* consumption of alcohol in the last twelve hours
* students in medicine, pharmacy, or psychology
* completed studies in medicine, pharmacy or psychology
* current pregnancy or lactation
* cardio vascular disease
* kidney disease
* liver disease
Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly

The primary objective of this non interventional study is to evaluate symptom burden in adult patients with PV without symptomatic splenomegaly during treatment with ropeginterferon alfa-2b in a real-world setting. Further patient-relevant endpoints include effectiveness including complete hematologic response (CHR), event-free survival (EFS), safety and tolerability, treatment reality including dosing details as well as factors affecting treatment decision making.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Confirmed diagnosis of PV without symptomatic splenomegaly
* Indication and decision for treatment with ropeginterferon alfa-2b in accordance with current SmPC
* No prior treatment with ropeginterferon alfa-2b (Patients are allowed to be enrolled up to 6 weeks after their first dose of ropeginterferon alfa-2b but must still be on treatment at the time of enrollment.)
* Dated signature of informed consent form
* Participation in Patient-Reported Outcome (PRO) assessment in German language and completion of questionnaire at time of study enrollment
* Other criteria according to current Summary of Product Characteristics

Exclusion Criteria:

* Participation in an interventional clinical trial (except follow-up)
* Other contraindications according to current Summary of Product Characteristics
Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

Objectives: Efficacy of a meningococcal vaccine against Neisseria gonorrhoea (NG) infection among men who have sex with men (MSM).

Design: Parallel randomised double-blind placebo-controlled trial.

Setting: A teaching hospital in Hong Kong.

Participants: 150 adult MSM at risk of gonorrhoea infection (condomless sex with more than one man within the last six months, history of sexually transmitted infection \[STI\] diagnosis, inclination to have condomless sex, and other PrEP-eligible criteria) would be recruited into the trial, with half allocated to intervention and control group each.

Intervention: Intervention and control group would receive, one month apart, two doses of meningococcal vaccine and normal saline, respectively.

Main outcome measures: Safety and efficacy of vaccine against gonorrhoea (time to first gonorrhoea infection and incidence), and behavioural change after vaccination.

Expected results: NG incidences in two groups would be compared. Efficacy of vaccine against gonorrhoea would be determined after controlling confounding variables. Characteristics of participants with incident NG would be distinguished from those without incident infections. Change of frequency of sexual activities and networking would be noted.

Implications: Strategies on STI screening and vaccination could be informed. Reduced STI burden post-vaccination could be measured with surveillance system.


Eligibility Criteria:
Inclusion Criteria:

* Male adult who has had sex with another male in the past six months
* Ages 18 years or above
* Normally resides in Hong Kong
* Able to communicate in written and spoken Chinese or English
* At risk of gonorrhoea infection (had condomless sex with more than one man within the last six months, history of STI diagnosis, inclination to have condomless sex, and other PrEP-eligible criteria)
* Negative NG test result at the time of recruitment
* No history of previous vaccination with MenB vaccines
* Able and willing to attend all study visits

Exclusion Criteria:

* Contraindications to receive MenB vaccine
* Unable to give informed consent
The Significance of Funguria in Hospitalized Patients

This investigation is a epidemiologic case-control study of the risk factors associated with nosocomial funguria (fungi in the urine).

A recent large multi-center national surveillance survey of almost 5000 nosocomial (hospital based) urine isolates from medical intensive care units demonstrated that fungi comprised nearly 40% of urine isolates. Little is known about distinguishing fungi that cause colonization from those causing infection.

The objective of this study is to define the epidemiology of nosocomial funguria and natural history of patients that develop funguria while hospitalized.

Patients who may have eligible for this study will be identified from microbiology laboratory specimens at the Harbor-UCLA Medical Center and Cedars-Sinai Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized at least 12 hours of any age (\< 1 day to \> 100 years of age) AND a urine or blood culture positive for fungi, OR urine culture negative for fungi (control group)

Exclusion Criteria:

* Patients already surveyed for funguria during current hospitalization and patients already being followed for recognized funguria
Study of UX003 Recombinant Human Beta-Glucuronidase (rhGUS) Enzyme Replacement Treatment in Mucopolysaccharidosis Type 7, Sly Syndrome (MPS 7) Patients Less Than 5 Years of Age

The primary objective was to evaluate the effect of UX003 treatment in pediatric MPS VII participants less than 5 years of age on safety, tolerability, and efficacy as determined by the reduction of urinary glycosaminoglycans (uGAG) excretion.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of MPS 7 based on leukocyte or fibroblast glucuronidase enzyme assay, or genetic testing.
2. Under 5 years of age at the time of informed consent.
3. Written informed consent of Legally Authorized Representative after the nature of the study has been explained, and prior to any research-related procedures.

Exclusion Criteria:

1. Undergone a successful bone marrow or stem cell transplant or has evidence of any degree of detectable chimaerism with donor cells.
2. Any known hypersensitivity to rhGUS or its excipients that, in the judgment of the Investigator, places the subject at increased risk for adverse effects.
3. Use of any investigational product (drug or device or combination) other than UX003 within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments at any time during the study.
4. Has a condition of such severity and acuity, in the opinion of the Investigator, which may not allow safe study participation. For patients with hydrops fetalis, the ongoing interventions to manage fluid balance can be continued; if the addition of enzyme replacement therapy (ERT) is considered a fluid-overload risk, the individual should be excluded.
5. Has a concurrent disease or condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or affect safety. Since hydropic patients have a high rate of mortality, the risk of death prior to 1 year of age should not be considered sufficient to exclude the patient from the study for compliance.
Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort

This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed to assess the biochemical, immunological and pharmacokinetic profiles of a large, actively infusing natalizumab patient population. A duration effect for progressive multifocal leukoencephalopathy (PML) risk associated with natalizumab therapy appears to exist. There is minimal data available to understand this effect at the biochemical and cellular level. The purpose of this study is to gather preliminary data on several parameters to guide in more focused research on the duration effect.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Aged 18 to 75 years old, inclusive, at the time of informed consent.
3. Must be a patient with a relapsing form of Multiple Sclerosis enrolled in the TOUCH Prescribing Program who is not expected to discontinue Tysabri® therapy prior to completion of the requirements of this study.
4. Must have been treated with monthly IV infusions of Tysabri® 300 mg for at least 1 month.
5. Must have a magnetic resonance imaging (MRI) brain scan, performed prior to the initiation of treatment with Tysabri®, on file.
6. Must weigh between 42 and 126 kg, inclusive.
7. Fifteen patients who are 1 month to-12 months of natalizumab therapy, fifteen patients who are 24 months and over of natalizumab therapy will be asked to participate in the TNF alpha subset.

Exclusion Criteria:

Medical History:

1. History of, or abnormal laboratory results indicative of, any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
2. If subject answers 'Yes" to any question on the PML questionnaire that is not resolved prior to infusion as per standard operating procedure for natalizumab infusion.