cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Voriconazole in Adult ECMO Patients

Given the high burden of fungal co-infection in patients admitted to ICU and improved outcomes with prompt anti-fungal treatment, it is of vital importance that the doses of anti-fungal are optimum to improve the dismal outcome of influenza/Covid-19 Associated Pulmonary Aspergillosis.

Due to the reported difficulties in dosing appropriately in ECMO patients, a prospective observational study is required to accurately evaluate the pharmacokinetics of voriconazole in patients supported on ECMO. This is to ensure that the dose of voriconazole is optimised to improve efficacy and reduce toxicity.

A single centre, open label, prospective, observational, pharmacokinetic study of voriconazole administered to adults (aged \> 18 years) supported on ECMO. This is a low-interventional study. There will be no treatment changes as a result of participation in this study. The decision to initiate voriconazole therapy will be taken independent of this study protocol. Intravenous voriconazole will be prescribed according to the approved dose in the SmPC. All adults requiring voriconazole therapy will be eligible for recruitment into the study.

The only additional procedure in this study will be to take a total of 5 blood samples across 3 occasions/sampling windows (Day 1-4, Day 6-9 and Day 11-14) to determine plasma concentrations of voriconazole. In addition, a single buccal swab to determine the CYP2C19 genotype will be undertaken during the course of ICU stay.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged ≥18 years
2. Admitted to ICU on ECMO support
3. Positive influenza or SARS-CoV-2 PCR from nasal, throat swab, BAL or other respiratory specimen.
4. Positive invasive aspergillosis infection (positive Aspergillus species culture from respiratory specimen or positive serum galactomannan) or strong clinical suspicion of invasive aspergillosis infection based on symptoms, CT, CXR.

Exclusion Criteria:

1. No participants \< 18 years of age
2. Not requiring ECMO support
3. No positive influenza or SARS-CoV-2 results
4. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy.

Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,NSAIDs or 2) opioids/acetaminophen/NSAIDS alone. All drugs are prescribed per approved FDA labeling. Children between the ages of 4-17 will be considered for enrollment.

Participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. Remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 4-17 years at time of surgery
* Scheduled for tonsillectomy or adenotonsillectomy surgery

Exclusion Criteria:

* Prior history of intracapsular tonsillectomy
* Previous diagnoses of Down Syndrome or developmental delay
* Presence of gastrostomy (g) tube
* A contraindication to steroids or steroid usage within 30 days prior to surgery including diabetes, allergy to steroid, already on chronic steroid, immune deficiency
* Active infection or concurrent operative procedures at the time of surgery
* Unable to read or speak English
* Pregnant or breastfeeding females
French Linguistic and Metric Validations of Parent-proxy QOL Chronic Cough Specific Questionnaire (PC-QOL)

Cough is one of the most common reasons for consultation. Even if cough is a non-specific symptom, it can be the first sign of a chronic pathology. Several studies have demonstrated that chronic cough causes quality-of-life (QoL) impairment. Physicians' incapability to evaluate cough impact and patients' QoL has been documented. Therefore, a parent-proxy QoL chronic cough specific questionnaire (PC-QOL) has been developed and validated by Chang A. B.

Objective : The aim of the study is to validate the French version of the PC-QoL, a parent-proxy QoL chronic cough specific questionnaire.

Methods : Linguistic validation will be performed using backward/forward translation guidelines, and cognitive debriefing by 10 parents. Psychometric validation will be tested in 150 patients. Inclusion criteria are: patients with a diagnosis of chronic cough (\> 4 weeks); 18 years of age or younger; all etiologies excepting cystic fibrosis. Informed consent from parents will be obtained. At enrollement, each parent will fulfill the PC-QOL questionnaire and two cough-related measures (visual analogue score, verbal category descriptive). Clinical data (medical history, physical examination) will be collected. Children QoL will be assessed using VSPA, Kidscreen and Qualin questionnaires. For assessing reproductibility and sensitivity to change, parents will be retested 7 and 21 days later. Content validity, construct's validity, external validity and instrument's reliability will be explored.


Eligibility Criteria:
Inclusion Criteria:

Old under age 18

* Male or feminine
* Reached(Affected) by chronic cough ( more than 4 weeks), any confused(merged) étiologie
* Affiliated to a national insurance scheme
* Having given freely their written consent having been informed about the purpose, about the progress and about the incurred potential risks

Exclusion Criteria:

Patients of whom the parents(relatives) are incapable to understand(include) the purpose and the conditions of realization of the study, incapable to give their consent

* Patient whose membership(support) to the protocol is improbable according to the investigator
* Patient participant in another clinical trial or in period of exclusion from a previous clinical trial
Study of an All Polyethylene Tibial Component

This will be a prospective single cohort investigation of the Columbus all polyethylene tibia (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The aim of the project is to determine post-operative outcome of the all polyethylene tibia up to two years.

Thirty consecutive TKA patients under the care of two orthopaedic consultants at the Golden Jubilee National Hospital who meet the inclusion/exclusion criteria will be recruited to the study and will be given the all polyethylene tibia. Participants will return for their standard postoperative followup appointments (6 weeks and 1 year post-operatively). In addition to standard care, a bone density scan using dual energy x-ray absorptiometery (DXA) will be done as part of the 6 weeks post-operative follow-up. A second DXA scan will be done at an additional appointment at the hospital between 18 and 24 months post-operatively for a bone density scan which is not part of standard care.

The data which will be analysed will be the results of the bone scan, computer generated data about the range of movement (RoM) and alignment of the operated knee collected as part of the operation, the RoM, clinical outcome and satisfaction data collected at the pre-operative assessment and post-operative followups, pre- and post-operative x-rays, complications, survivorship and surgeon experience of using the all polyethylene tibia. These data will be investigated to see if the all polyethylene tibia has satisfactory outcomes with no adverse effects.

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral TKA
2. Aged 70 year or older
3. BMI \< 37.5
4. Suitable to receive the study implant

Exclusion Criteria:

1. Revision of existing knee replacement
2. Previous lower limb replacement
3. Proximal tibial bone defects
4. Diagnosed osteopenia or osteoporosis
5. Unable to give informed consent
6. Unwilling to take part
7. Unable to return to the Golden Jubilee National Hospital for followup appointments
Patient Self Monitoring of Physical Therapy Exercise

Our objective is to develop an IBEHR (Image-Based Electronic Health Record) to show patients how to reproduce at home the exercises prescribed by their physical therapist (PT) in clinic. The IBEHR can also record home exercise sessions for review by and feedback from the PT. The HEALTH CARE BENEFITS of the IBEHR for patient self monitoring are: improved transfer of physical therapy exercise from clinic to home, increased adherence to the exercise prescription, and recording home exercise to assist PT decision making.

Our objective is to develop an IBEHR (Image-Based Electronic Health Record) to help patients to transfer and reproduce at home the exercises they were prescribed by their physical therapist (PT) in clinic. More than 17 million (M) patients are diagnosed with conditions that may benefit from PT in the U.S. each year. Adherence to home exercise is the most important factor in functional recovery, and feedback from the exercise prescriber is the most important factor in achieving patient adherence. However in current practice the patient only gets feedback at clinic visits which may be weeks apart.

The proposed IBEHR will give patients visual feedback in real time comparing their performance at each repetition at home with a recording of themselves performing the exercise correctly in the clinic under the PT's supervision. The visual graphics show the patient how to better position his/her body and extremities. Such feedback is likely to improve adherence with the treatment regimen in terms of frequency, duration, and correctness of exercise, and thus facilitates transition of care between clinic and home.

The IBEHR is also a telemedicine tool because the patient can transmit recordings of home exercise to the PT for rapid review and feedback.

A third benefit of the IBEHR is to improve health care decision making by the PT. In current medical practice, it is difficult for a PT to determine why a patient fails to recover as expected. By recording the exercise performed at home, the IBEHR provides monitoring data that informs the PT whether the patient adhered poorly to prescribed exercise frequency or duration, the patient performed the exercise incorrectly, or the PT prescribed the wrong exercise.

Our Specific Aims are to 1) develop the IBEHR software, 2) perform alpha testing of device accuracy and beta testing of user interface ease of use, and 3) perform preliminary evaluation of the efficacy of the IBEHR to improve adherence.

The HEALTH CARE BENEFITS of the IBEHR for patient self monitoring are: improved transfer of physical therapy exercise from clinic to home, increased adherence to the exercise prescription, and recording home exercise to assist PT decision making.

Eligibility Criteria:
Inclusion Criteria:

* anterior knee pain or anterior cruciate ligament (ACL) injury, including non-operative and post-surgical patients

Exclusion Criteria:

* non computer literate
* nonambulatory
* non English speaking
Muscle Atrophy, Physical Performance and Glucose Tolerance Post Stroke

Stroke, a leading cause of disability in the aging population, increases the risk for diabetes, subsequent stroke recurrence, and cardiovascular disease complications. The downsizing of private and federal health care resources, along with the anticipated increase in stroke rates as our population ages, mandate that alternative strategies be developed to reduce the public health burden of stroke. This pilot study may facilitate our knowledge of the timing of paretic leg muscle atrophy, fiber type shift, and the progression of worsening of glucose tolerance after stroke. Knowledge of the skeletal muscle changes occurring in the sub-acute stroke period is essential to create new guidelines incorporating exercise rehabilitation, much like cardiac rehabilitation, in order to facilitate and improve the health care of veteran stroke survivors.

The vast majority of cerebrovascular accidents are reported in persons older than 55 years of age and occur in over 780,000 persons each year in the U.S. As our adult population ages, the number of strokes in the United States is anticipated to double, reaching nearly 1.5 million annually by the year 2050. Following stroke, patients remain at continued high risk for recurrent stroke with almost a third of them suffering recurrent stroke within 5 years, even despite optimal medical management. Age and cardiac disease are among the most important longitudinal predictors of cardiovascular health outcomes and survival after stroke. Notably, 75% of chronic stroke survivors have residual disability emphasizing the need for rehabilitation strategies.

Knowledge of the skeletal muscle changes that occur in the early phases after stroke is essential to create new guidelines which incorporate exercise rehabilitation, much like cardiac rehabilitation, in order to facilitate and improve the health care of stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 21 years of age or older
* BMI between 20-50 kg/m2
* Presenting within a month after stroke onset with residual hemiparetic deficit
* Patients must have adequate language and neurocognitive function to participate in testing and give adequate informed consent

Exclusion Criteria:

* Patients deemed too disabled to participate in physical therapy, or patients with minimal deficits, or patients who fully recovered after their stroke, in which physical therapy is not necessary
* Unstable angina, CHF, severe PAD
* Dementia or untreated major depression
* Severe receptive or global aphasia
* Heavy alcohol use defined by greater than 3 oz. liquor, 12 oz of wine or 32 oz of beer daily
* Muscle biopsy Exclusion Criteria:

  * anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted)
  * bleeding disorder
  * allergy to lidocaine
Eccentric Cycling Exercise During Pulmonary Rehabilitation Pulmonary Vascular Disease

Eccentric cycling allows high intensities with low metabolic costs. Therefore the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with PVD

Eccentric cycling exercise (ECC) allows training at low metabolic costs and may therefore be valuable for patients with pulmonary vascular disease (PVD). For these patients, regular exercise training has an evidence level 1A recommendation in the current guidelines. Exercise training during longer and regular periods provides chronic adaptation, for which ECC was recently found to have a greater effectiveness than CON by increasing muscle strength, hypertrophy, six-minute walking distance and furthermore, by increasing maximum oxygen uptake (V'O2max) especially in patients with chronic obstructive pulmonary disease (COPD), chronic left heart failure or coronary heart disease.

Furthermore, the investigators conducted an RCT in which the investigators exposed patients with PVD to ECC and concluded that ECC is a feasible and well-tolerated exercise modality for PVD patients with severely lower O2 demand and load to the right ventricle.

Therefore the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with PVD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PVD, either PAH or CTEPH according to recent guidelines
* Stable medication for at least 1 month
* Age 18 to 85 years
* No resting hypoxemia (PaO2 \>7.3kPa)

Exclusion Criteria:

* Any co-morbidity that limits the patient to participate the full rehabilitation
* Enrollments in other trials with active treatments
Usability Comparison of a mHealth Application for Pre-anesthesia Evaluation Before and After Re-design of User Interface

Pre-anesthesia assessment is an important part of anesthesiologists daily routine. A thorough assessment leads to an impeccable anesthesia plan. In the past, the department of anesthesiologist in NTUH (National Taiwan University Hospital) utilizes paper assessment form. As government policy leans towards digitization, the department of anesthesiologist in NTUH collaborates with the information technology office to develop an electronic pre-anesthesia assessment system called EVAN, which is an iOS based application (App). EVAN includes an anesthesia patient list, patient EMR (electronic medical record) and pre-anesthesia assessment form. EVAN was online since March, 2018.

This is an observational research to investigate the user experience and improve the user interface of EVAN.

This research subjects include anesthesiologists from NTUH. This research has three parts: user tasks, questionnaires, and a semi-structured interview. First, the research assistant will record how the user use the App to complete the tasks, which includes video recording and App monitoring. After the tasks is completed, the subject will write a questionnaire. Then the principal investigator will give an interview for feedbacks from the users.


Eligibility Criteria:
Inclusion Criteria:

* anesthesiologists in NTUH

Exclusion Criteria:

* none
A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies)

The purpose of this single-center, open-label, non-randomized study is to assess the excretion balance, pharmacokinetics, metabolism and absolute oral bioavailability of \[14C\]-labeled idasanutlin administered orally and \[13C\]-labeled idasanutlin administered intravenously in a single cohort of eligible participants. Participants will be screened for participation in this study within 21 days of receiving the first dose of study drug on Day 1. Treatment period will continue up to Day 28 after which participants will enter 28 day follow-up or the optional treatment extension of idasanutlin, depending on safety parameters and as per opinion of the Investigator.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, at the discretion of the Investigator
* Histologically or cytologically confirmed advanced malignancy, except leukemia and lymphoma
* Measureable or evaluable disease by Response evaluation criteria in solid tumors (RECIST) version 1.1, with no more than a single active malignancy in the previous 3 to 5 years prior to the administration of study drug
* Life expectancy of at least 12 weeks
* Participants taking opioid analgesics for pain should be on a stable pain and palliative care bowel regimen for one month prior to the first dose of study medication
* Adequate bone marrow, hepatic, and renal function
* Agreement to remain abstinent or use contraceptive methods specified in the study

Exclusion Criteria:

* History of any form of leukemia, except for Stage 0 - 1 chronic lymphocytic leukemia, not requiring treatment in addition to their underlying malignancy
* Have received hormonal therapy within the two weeks prior to the first dose of study drug
* Have pre-existing gastrointestinal disorders that may interfere with proper absorption of the drug
* History of seizure disorders or unstable Central Nervous System metastases (participants with stable CNS metastases allowed)
* Have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Receive certain per protocol prohibited medications while on study. These medications must be discontinued 7 days prior to start of study drug
* Have bone marrow disorders, electrolyte imbalance, infrequent bowel movements (less than once per 48 hours), coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
* Positive for human immunodeficiency virus currently receiving combination anti-retroviral therapy
* Regular work with ionizing radiation or radioactive material or treated with radiotherapy within 3 weeks prior to the first dose of study drug
* Refuse to potentially receive blood products and/or have a hypersensitivity to blood products
Decision Aid in Chronic Total Occlusion (CTO) Patients

The aim of this study is to assess the feasibility and validity of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.

This is a parallel, 2-arm, randomized trial to compare an intervention group receiving CTO Choice (decision aid) to a control group receiving usual primary care. 100 patients and 60 cardiologists will be randomize by computer. The investigators will measure the effect of CTO Choice on five outcomes: (a) patient knowledge regarding CTO of PCI or medication (risk and benefit); (b) quality of the decision making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of percutaneous coronary intervention (PCI) or medication; and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, the investigators will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians exposed to the decision aid were able to recreate elements of the decision aid which control patients.

Eligibility Criteria:
Patient:

Inclusion Criteria:

1. At least one lesion occluding the coronary artery detected by angiography or MSCTA.
2. left ventricular ejection fraction ≥ 40% on transthoracic echocardiography measurement.
3. No major barriers to provide written consent.

Exclusion Criteria:

1. Severe coexisting conditions, such as severe renal insufficiency (GFR \< 30 ml/min•1.73m2), severe hepatic dysfunction \[elevated glutamic-pyruvic transaminase or glutamic-oxal acetic transaminase level by more than three-fold of the normal limitation\], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
2. Patients with cognitive impairment, severe hearing loss, or visual impairment who could not complete the survey.

Cardiologist:

Inclusion Criteria:

1. Doctors who work in the department of Cardiology for more than 1 years.
2. No major barriers to provide written consent.

Exclusion Criteria:

None.