cyrilzakka/clinical-trials huggingface dataset:
Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital

This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system within an adult in-patient setting KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.

RENEW's Surveillance Monitoring system is made up of two main components: a patient-worn wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a central station software platform (Surveillance Station). The Aingeal device measures single lead ECG, heart rate, respiration waveform and rate, and skin temperature. A snapshot of data is transmitted by the devices intermittently to the Surveillance Station, enabling vital signs trends to be plotted. If any heart, respiration rate or skin temperature values move outside of pre-defined high and low limits (individually set for each patient) an alert is raised. ECG arrhythmia detection algorithms automatically record and send ECG data if the patient is suspected to be experiencing an arrhythmia event (Asystole, Ventricular Fibrillation, Tachycardia or Bradycardia). This proposal describes the evaluation of RENEW's Aingeal device within an adult in-patient setting KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients, aged 21 years or over
* Patients admitted to post-operative gynaecological ward at KKH Women's and Children's Hospital, Singapore
* Patients receiving opioid therapy via patient controlled analgesia (PCA)
* Patients that are on electronic nursing charting
* Patients that are on acute pain service monitoring

Exclusion Criteria:

* Patients with active, implantable devices (such as a pacemaker or ICD)
* Patients with any skin condition or injury affecting the electrode placement site
* Patients that are pregnant (Heart Rate detection algorithm has not been designed to reject foetal heart rate)
Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury

The main purpose of this research project is to analyze the effectiveness of a Community-based Occupational Therapy Intervention on mental health for people with acquired brain injury. To this end, variables such as quality of life, occupational performance and balance, participation in significant roles and community integration will be measured.

The research will be carried out as a non-randomized controlled trial study in which the participants in the experimental arm will receive a community-based occupational therapy intervention (domiciliary and telehealth intervention sessions) based on the stages of the Human Occupation Model's Remotivation Process. The participants at the control arm will receive the regular (public or private) services provision for this population profile.

It is expected to be able to demonstrate the effectiveness of the intervention based on a positive result in the change in the variables, so as to increase the chance and performance of occupational participation after the acquired brain injury. Also, it is intended that families and the community are key elements of agency and support in occupational participation.


Eligibility Criteria:
Inclusion criteria:

Adults with a diagnosis of medium or severe ABI and a diagnosis of neurocognitive disorder following ABI (as recognised in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); by definition: evidence of significant cognitive decline from pre-ABI level in one or more cognitive domains (attention, executive function, learning and memory, perceptual-motor ability or social cognition).

It may occur with or without behavioural impairment (apathy, mood disturbance, irritability, disinhibition, psychotic symptoms, etc.)).

This population (A) show difficulties in occupational participation with respect to the pre-ABI situation and present needs for support, counselling and/or specific therapeutic intervention; (B) are in a situation of hospital discharge from ABI specialisation units; (C) are domiciled in the same province to which the providing hospital belongs. In addition, they may or may not have been diagnosed with a mental health disorder other than neurocognitive disorder, either prior or subsequent to the ABI.

Exclusion criteria:

Persons will be excluded if (A) they are in a situation of symptomatological destabilisation of severe functional impairment that, as a priority, requires continued support from specialised mental health units, psychiatric or social-health care admission; and/or (B) they are unable to determine for themselves (for cognitive reasons or by conscious choice) any problem in at least one occupational area.
A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)

The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and well tolerated by the patients.


Eligibility Criteria:
Inclusion criteria:

* Recipients of first or secondary cadaveric heart-beating, living unrelated or living related kidney transplant.
* Currently receiving 1, 1.5, or 2 g MMF/day, tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months.
* In a stable condition in terms of graft function.

Exclusion criteria:

* Patients who had taken an investigational drug within four weeks prior to study entry
* History of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
* Thrombocytopenia (\<75,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (\<2,500/mm3), and/or hemoglobin \<6.0 g/dL prior to enrollment
* Clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, evidence of severe liver disease, HIV or Hepatitis B surface antigen positive.

Other protocol-defined inclusion/exclusion criteria may apply.
The Effect of Core Stability Training on Deep Stabilizing Muscles.

Non-specific low back pain is the most cause of adult disability throughout life. Its prevalence widens in young adults. Background of this pathology can be multifactorial. One of the most common is poor core stability and overloading of the local tissues as a result.

Among treatment methods stabilizing training is commonly used with good effects. This form of therapy affects the transverse abdomen and multifidus muscles. To assess these structures several methods can be applied, e.g. sonofeedback.

Our hypothesis claims that the core muscles morphology will change over the training process duration, in result, the analgesic effect will be achieved.

Non-specific low back pain is the most cause of adult disability throughout life. Its prevalence widens in young adults. Background of this pathology can be multifactorial. One of the most common is poor core stability and overloading of the local tissues as a result.

Among treatment methods stabilizing training is commonly used with good effects. This form of therapy affects the transverse abdomen (TrA) and multifidus (MF) muscles. To assess these structures several methods can be applied, e.g. sonofeedback.

All participants will be randomly divided into two groups:

1. Training group (TG)
2. Control group (CG)

Outcome measure:

Pre- and post-therapy outcome measure will be done. It will include:

* ultrasound (sonofeedback) of the TrA and MF
* Oswestry Disability Index questionnaire (ODI)
* subjective pain scale - Numeric Rating Scale (NRS)

Intervention:

Core stability training including 4 exercise positions, each of 15 repetitions, 4 sets. Once a day, 5 times a week, 20 sessions in total (4 weeks).

Our hypothesis claims that the core muscles morphology will change over the training process duration, in result, the analgesic effect will be achieved.

Eligibility Criteria:
Inclusion Criteria:

* low back pain
* age from 18 to 30 years old
* written consent of the participants

Exclusion Criteria:

* injuries of the spine
* fractures of the spine
* surgery interventions in the spine region prior to the study
* psychiatric disorders
* neurologic disorders
Effects of a Blended Indoor and Outdoor Physical Exercise Program on Depressive Symptoms in Hong Kong Older Adults

Depression is a mental health problem often occurring in the elderly. Performing physical exercise is a key element in decreasing depressive symptoms in older adults. Most studies investigating depression and physical exercise have focused on structured exercise comprise of one or two exercise components and based on the clinical patients associated with major depression. There is limited research combining multicomponent (aerobic+resistance+balance) in an exercise program and targeting non-clinical adults with depressive symptoms, with even less available for older adults.

More attention has been paid to the role of outdoor exercise on human health. Exercise in a natural environment may provide greater physiological and psychological benefits compared to indoor exercise. Findings demonstrated that green exercise provides double the beneficial effect on improving depression among adults. Although green exercise shows effects on the improvement of depression, recently a review has indicated that structured exercise programs in older adults with depressive symptoms were mainly conducted in the indoor environment. Compared with outdoor exercise which is easily influenced by the weather and with low access of available facilities, indoor exercise is more comfortable, quiet, and convenient to operate especially for older adults. Considering the high relevance between nature and mental health, the combination of indoor and outdoor exercise programs might be able to maximize intervention effectiveness while maintaining the benefits for each type of intervention.Therefore, more rigorous RCT studies in this field are needed, particularly for non-clinical older adults with depressive symptoms.

The 16-week double-blinded RCT (2 sessions/week, 90 min/session) will include community-dwelling older adults aged 60 to 74 years old with depressive symptoms. Participants will be randomized to one of three groups (a blended indoor and outdoor group, an indoor-only group or a control group) using 1:1:1 allocation ratio. Structured exercise training with multicomponent (aerobic, muscle strength, balance) will be conducted in two intervention groups. The intervention effects will be evaluated on depressive symptoms, physical fitness, physical activity enjoyment and connectedness to nature. All measured data will be collected at the pre-intervention, post-intervention, and 3-month follow up stages.

Eligibility Criteria:
Inclusion Criteria:

* 60 to 74 years at the start date of the project.
* Chinese version of Geriatric Depression Scale (GDS-C) scoring 5-15 (i.e., mild to serve level of depressive symptoms).
* Passing the PAR-Q plus screening or with the physician's approval for readiness to participate in high-intensity exercise.

Exclusion Criteria:

* Having cognition impairment regarded by specialists.
* are attending other health projects related to physical exercise.
Ultra-Low Contrast Angiography in AKI

The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.

The study is a non-inferiority open-label randomized controlled trial. Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Once indication for invasive coronary angiography is determined, patients will be randomized to immediate angiography or to delayed angiography after renal function stabilizes. Immediate angiography will be performed within 24 of enrollment. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.

Definitions: AKI is defined as an increase in serum creatinine by ≥50% from baseline within 7 days or an increase in serum creatinine by ≥0.3 mg/dl within 2 days. CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial.

Exclusion Criteria:

* Stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment.
* Contraindication for invasive coronary angiography other than AKI.
* Percutaneous coronary intervention is indicated and cannot be postponed by 7 days.
* Need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography).
* Administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography.
* Pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.
Safety and Efficacy Study of MPC-4326 for Treatment of Patients With HIV-1 Infection.

To evaluate the antiretroviral activity and safety of 200 mg BID and 300 mg BID doses of MPC-4326 administered as monotherapy for 14 days to HIV-1 positive patients. Patients with an initial treatment response will have the option to continue MPC-4326 in combination with an Optimized Backround Regimen for a maximum of 72 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age at the time of screening.
* Have HIV-1-infection.
* Have a CD4+-lymphocyte count≥100 cells/mm3
* Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of 2,000 - 500,000 copies/mL (inclusive).
* Be free from any acute infection or serious medical illness within 14 days prior to study entry.

Exclusion Criteria:

* Current opportunistic infection characteristic of AIDS (Category C according to the CDC Classification System for HIV-1 Infection, 1993 Revised Version, Appendix A) that is diagnosed within 30 days or is poorly controlled.
* Patients with systolic blood pressure \< 90 mmHg or \> 140 mmHg or diastolic blood pressure \< 60 mmHg or \> 90 mmHg.
* A history of seizures (excluding pediatric febrile seizures) or current administration of prophylactic anti-seizure medications.
* A history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA).
* Patients with the following laboratory parameters within 30 days prior to first dose of study drug: Hemoglobin \< 10.0 g/dL for men and \< 9.0 g/dL for women Neutrophil count \< 1000/mm3 Platelet count \< 50,000/mm3 AST or ALT \> 2.5 times the upper limit of normal (patients with a positive HBV surface antigen or HCV antibody test at screening must have AST and ALT no more than 1.5 times the upper limit of normal)
Recurrent Crying Spells in Cerebral Palsy

This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.

This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent Crying Spells in Cerebral Palsy with Spastic Quadriparesis.
* Age range 0-12 years.

Exclusion Criteria:

* Crying due to known causes (like hunger, sleep, food intolerance etc.),
* Crying that responded to routine management (changes in food or feeding techniques, anticolic, analgesics),
* Fever of ≥100.4ºF (38ºC),
* The infant refuses to eat or drink for more than a few hours, vomits excessively, has bloody stools, or has a change in behavior (lethargy or decreased responsiveness).
* Colic
* Worst ever crying occurring for the first time
* Respiratory, renal and hepatic diseases,
* Progressive encephalopathies,
* Received Baclofen in the previous 30 days
Research on Optimization of Rotator Cuff Injury Diagnosis Plan

Rotator cuff injury is a common cause of shoulder pain and dysfunction. Finding out patients with suspected rotator cuff injuries through physical examination of the shoulder joints, MRI further assists in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures.

How to apply multiple physical examination programs to make judgments sensitively, efficiently and accurately is a clinical problem that needs to be solved urgently.

Rotator cuff injury is a common cause of shoulder pain and dysfunction. The common symptoms of rotator cuff injury include shoulder pain, weakness, and limited mobility. Arthroscopic exploration is the gold standard for the diagnosis of rotator cuff injury, but it is an invasive examination that is difficult to carry out routinely; MRI is sensitive in diagnosing rotator cuff tears Both sex and specificity are high, but due to the popularity, cost and waiting time, it is difficult to be used as a routine screening method.

Therefore, finding patients with suspected rotator cuff injuries through physical examination of the shoulder joints, MRI further assisting in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures.

However, although there are many physical examination methods for the shoulder joint, the accuracy of each method is different, and each has its own sensitivity and specificity. How to apply multiple examination programs in combination to make it sensitive, efficient and accurate Judgment is a problem that needs to be solved clinically.

This study is expected to adopt prospective research methods to collect and collect patient medical records, preoperative physical examination results, imaging data, and findings during intraoperative exploration, to understand the impact of various shoulder joint physical examination methods and imaging data on rotator cuff injuries

Eligibility Criteria:
Inclusion Criteria:

* Patients who are prepared to undergo arthroscopic surgery for shoulder injuries

Exclusion Criteria:

* Shoulder stiffness, shoulder instability, calcified tendinitis, past surgery, side-to-shoulder disease, hamada osteoarthritis, frozen shoulder, acute joint injury, rheumatoid arthritis, hyperuricemia
Mass Spectral Fingerprinting in Lung Cancer

To answer the question whether a disease specific profile of breath in patients with lung cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed lung cancer based on cytological or histological analysis.
* Group A: any type of lung cancer eligible for surgical resection (up to TNM stage IIIa).
* Group B: any type of lung cancer (small-cell carcinoma, non-small-cell carcinoma) not amenable for surgical resection.
* Group C: matched controls.
* Age between 18 and 85 years at study entry

Exclusion Criteria:

* Another 'active' secondary malignant disease (e.g. breast cancer, colon carcinoma) in group A and B, presence of any active malignant disease in group C (based on personal information).
* Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
* Any other acute lung disease which affects breath measurements
* Acute or chronic hepatic disease.
* Renal failure or renal replacement therapy.
Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion

This research study is being conducted to help improve the pre-operative, intra-operative, and post-operative course for patients and enhance recovery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 89
* Diagnosis of cervical myelopathy, cervical stenosis, cervical disc disorder, or cervical spondylolisthesis

Exclusion Criteria:

* Cervical injury as the indication for surgery
* Emergent surgery
Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry

The purpose of this research is to learn more about the impact of genetic testing on healthcare costs, clinical care, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Tapestry patients who have received genetic results, regardless of positive or negative testing results.
* Age of 18 and older.
* Patients with an established Mayo Clinic provider prior to their enrollment in Tapestry.

Exclusion Criteria:

* Individuals less than 18 years old.
* Patients without capacity to consent (i.e., needing legal authorized representatives).
* Prisoners.
* Subjects eligible for chart review, without a Minnesota Research Authorization on record.
Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)

The purpose of the study is to examine the real-life safety and effectiveness of the novel combination ivacaftor+lumacaftor in eligible patients with cystic fibrosis (CF). All patients with CF were eligible if they were 12 years and older, started ivacaftor+lumacaftor outside of a clinical trial between December 15th 2017 and December 15th 2018 in an accredited CF center in France. Patient followed-up is based on standardized recommendation of the French Cystic Fibrosis Society. Each patient is followed 1 year.

Each patient is followed one year with visits at months 1, 3, 6 and 12.

At each visit, the following data are recorded:

* Treatment discontinuation or not. If the treatment was discontinued, reasons for discontinuation
* Adverse effects
* Lung function (spirometry)
* Body mass index
* Pulmonary exacerbations (intravenous antibiotics)
* Sputum microbiology
* Liver enzymes are measured at each visit

At the initial and 12 visits, a yearly CF examination is proposed to the patients:

* Blood tests
* Chest CT scans
* Body plethysmography

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 12 years or older.
* Patient with Cystic Fibrosis with presence of two mutations DF508 in the CFTR gene
* Patient treated with ivacaftor+lumacaftor (Orkambi)

Exclusion Criteria:

* Refusal to participate in the study
* Start of Orkambi as part of a clinical trial
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects

The objective of this study is to evaluate and compare the bioavailability of mesalamine

The objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule manufactured at a new site versus the approved 375 mg APRISOTM extended-release capsule after a single oral dose administration under fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female, at least 18 years of age
* Body mass index (BMI) between18.5 and below 32.0 kg/m2 (inclusive)
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ECG and laboratory tests

Exclusion Criteria:

* Any contraindication to mesalamine according to the applicable labeling
YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy

The purpose of this study is to determine if patients who take YM598 in addition to mitoxantrone and prednisone (standard therapy) experience improvement in the pain associated with prostate cancer metastases in the bone.


Eligibility Criteria: