cyrilzakka/clinical-trials huggingface dataset:
CKD-828 (80/5mg) Pharmacokinetic Study

A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.


Eligibility Criteria:
Inclusion Criteria:

* A healthy volunteer between 20 and 55 years old
* More than 50kg and within 20% of ideal body weight
* No any congenital or chronic diseases and medical symptom
* Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks prior to the first IP administration
* Signed the informed consent form prior to the study participation.

Exclusion Criteria:

* History of relevant hypersensitivity against drug
* Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo, hemato, onco, CNS etc.)
* Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin \> 1.5\*ULN)
* SBP \<90mmHg or SBP \>150mmHg
* DBP \<50mmHg or DBP \>100mmHg
* Creatinine clearance \<80mL/min
* A Disease(ex.inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic disease history , gastro-intestinal surgery except for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug
* The evidence of severe attack or acute disease or surgical intervention within 28 days prior to the first IP administration.
* A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes per a day)
* Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within 7days prior to the first IP administration
* Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug
Effects of Yoga Versus Passive Modality on Pain, Disability, Salivary Cortisol Concentrations, Brain- Derived Neurotropic Factor, Heart Rate Variability and Immune Functions Among Patients With Chronic Low Back Pain: A Randomized Controlled Trial

This study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain.

Low back pain is a common problem, with 70-80% of adults were bothered in their lives, which influence the work and quality of life. Yoga is one of the most popular complementary and alternative medicine for back pain, and this mind-body intervention has increasingly chosen to effectively treat chronic pain.

This is a parallel-arm randomized controlled trial which will compare the outcomes of participants assigned to the experimental treatment group (yoga, with 36 participants) with those assigned to a passive modality control group for 3 months (12 weeks). Each group will receive regular 60-minutes yoga classes or passive modality twice a week. The investigators confer the difference of pain relief and functional life improvement between passive modality and yoga. The latter is expected to have positive effects on Chronic low back pain. The effects and possible mechanisms of action responsible for passive modality and yoga on salivary cortisol concentrations, inflammatory cytokines and autonomic nervous tone will be also evaluated. The study's primary endpoints are (1) back pain relief, (2) functional life improved, (3) Salivary cortisol concentrations decreased, (4) brain-derived neurotrophic factor improved, (5) heart rate variability improved, and (6) immune function improved significantly among the participants in the experimental group than the control group.

This study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain. If the results are positive, clinicians will attain more options for treating patient with chronic low back. Furthermore, the positive results from this study will help focus more future in-depth research on the most promising potential mechanism of action identifies.

Eligibility Criteria:
Inclusion Criteria:

* Patient with idiopathic low back pain of more than 12 weeks.

Exclusion Criteria:

* Current pregnancy
* Diagnosis of ankylosing spondylitis, osteoporosis, fibromyalgia, failed back syndrome and other chronic illnesses.
* Inability to participate yoga exercise regularly.
* Accept steroid treatment within 3 months.
* BMI \> 30
The Impacts of Intermittent Chest Tube Clamping on Chest Tube Drainage Duration and Postoperative Hospital Stay After Lung Cancer Surgery

All patients undergo lateral thoracotomy or video-assisted thoracoscopic surgery (VATS) and are operated on by the same thoracic surgical team. All patients are managed with gravity drainage (water seal only, without suction) on the day of operation. Eligible patients are randomized to control group or clamping group at a 1:1 ratio before 3pm on the postoperative day. Patients in control group and those in clamping group are managed with different protocols after 3pm on the postoperative day.

All patients undergo lateral thoracotomy or video-assisted thoracoscopic surgery (VATS) and are operated on by the same thoracic surgical team. At the end of operation, the lung parenchyma is submerged in sterile saline to test for air leakage, and a single 24-Fr chest tube is placed in each patient. All patients are managed with gravity drainage (water seal only, without suction) on the day of operation.

Once a radiograph is confirmed re-expansion of the lung on the morning of the first postoperative day and no air leak is detected, the patient is a candidate for inclusion in the trial. Eligible patients are randomized to control group or clamping group before 3pm on the postoperative day.

Patients in control group are managed with gravity drainage unchangeably, while patients in clamping group are managed with clamping protocol after 3pm on the postoperative day as follow: the chest tube will be clamped, and the nurses will check the patient every 6 h. If the patient has no problems with compliance, the clamp will be removed for half an hour in the morning to record the drainage volume every 24 h. If patients develops intolerable abnormal symptoms, such as dyspnea, pneumothorax, and severe subcutaneous emphysema after chest tube clamping, the clamp will be removed for 30 min and be reapplied after the symptoms have been resolved. Such patients will be placed under more rigorous surveillance after re-clamping, which requires the medical staff to check on the patients every 2-4 hours in order to promptly detect abnormal symptoms. If abnormal symptoms occur frequently, this clamping protocol will be continued until another radiograph excluded the presence of pneumothorax.

The daily output of pleural fluid was recorded. The criteria for chest tube removal were as follows: (a) drainage volume≤250 mL in 24 h, (b) absence of air leakage and intrathoracic hemorrhage, and (c) absence of signs of purulent pleural effusion and atelectasis.

Eligibility Criteria:
Inclusion Criteria:

Pathological diagnosis of lung cancer Treated with lobectomy and systematic mediastinal lymph node dissection/ systematic sampling Managed with gravity drainage (water seal only, without suction) Re-expansion of the lung confirmed on the morning of the first postoperative day

Exclusion Criteria:

Thoracic cavity infection Prolonged air leakage Reoperation due to chylothorax Atelectasis Liver cirrhosis Renal insufficiency Wound infection
Performance of a Single-use Intermittent Micro-hole Zone Catheter

The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.

The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.

The investigation was a single-centre, randomized, controlled crossover study including 42 male participants comparing the performance of two intermittent catheters (IC).

The study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. There were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day.

Eligibility Criteria:
Inclusion Criteria:

1. Is Male
2. Is at least 18 years of age and has full legal capacity
3. Has given written informed consent
4. Has signed letter of authority (only DK)
5. Has used clean intermittent catheterisation CH12 or CH14 for at least one month
6. Use intermittent catheterisation as the primary bladder emptying method
7. Is able (assessed by investigator) and willing to follow study procedures

Exclusion Criteria:

1. Is participating in any other clinical study during this investigation
2. Has previous participated in this study
3. Has symptoms of urinary tract infection as judged by the investigator 4 Is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris

5. Has any known allergies towards ingredients in the investigational device
High-flow Nasal Cannula vs. Helmet PSV vs. Helmet CPAP During Respiratory Failure

The investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (PSV) and continuous positive airway pressure (CPAP) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure

Setting: 21-bed general ICU, emergency room of the Emergency department (ED), Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy..

Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.

Each eligible patient, in the absence of exclusion criteria, will receive 15 minutes of heated and humidified 60% oxygen at a rate of 50 l/min via a non-rebreathing face mask. An ABG will be then collected and PaO2/FiO2 ratio computed: given the high flows used, actual FiO2 will be approximated to the set one.

Nonhypercapnic patients with a PaO2/FiO2≤200 mmHg will be enrolled. In the absence of exclusion criteria and if all other inclusion in criteria are met, patients showing PaO2/FiO2≤300 and \>200 mmHg will be treated according to the clinical practice eventually reassessed for the presence of oxygenation criterion subsequently.

Enrolled patients will receive all the interventions (helmet CPAP, PSV and high-flow nasal cannula) in a randomized, cross-over fashion, for 40 minutes each.

At the end of the study, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.

Eligibility Criteria:
Inclusion Criteria:

Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.

Patients will be considered eligible whether all the following inclusion criteria are met:

1. Respiratory rate\>25 bpm.
2. PaO2/FiO2 ≤200 in the supine position, measured after 15 minutes of high flow treatment with face mask (60 l/min, temperature of the humidification chamber set at 37°C, FiO2 set to achieve a SpO2 \>92% and \<98%). Given the use of the high flows, nominal FiO2 will be considered a reliable estimate of the actual one.
3. PaCO2 \<45mmHg
4. Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency.
5. Written informed consent

Exclusion Criteria:

* Exacerbation of asthma or chronic obstructive pulmonary disease;
* Cardiogenic pulmonary oedema;
* Haemodynamic instability (Systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg) and/or lactic acidosis (lactate \>5 mmol/L) and/or clinically diagnosed Shock
* Metabolic Acidosis (pH \<7.30 with normal- or hypo-carbia);
* Glasgow coma scale \<13;
* Recent head surgery or anatomy that prevent the application of helmet or nasal cannula to patient's face.
The Impact of Anti-TNF Exposure on Vedolizumab Effectiveness

Vedolizumab is a new medication being used for the treatment of Crohn's disease and Ulcerative colitis. It works by blocking specific white blood cells (alpha 4-beta7 lymphocytes) from migrating to areas of inflammation in the gastrointestinal tract. Previous studies have shown that patients who have previous exposure to another type of medication for Crohn's disease and Ulcerative colitis (anti-TNF medications) do not respond to vedolizumab as well as those who have never been exposed. This study will investigate biologic markers in the blood and tissue the help identify possible reasons for this difference.

Patients will be enrolled in the study when they are selected to initiate vedolizumab therapy. Vedolizumab is an intravenous infusion given at increasing intervals. The first infusion of vedolizumab will be considered baseline. Patients may be enrolled at baseline or at colonoscopy prior to the first scheduled infusion of vedolizumab (pre-treatment visit). The standard induction protocol for vedolizumab consists of infusions at week 0 (baseline), week 2, and week 6. Vedolizumab, as per standard-of-care, is then continued at an interval of every 8 weeks following induction therapy. Vedolizumab treatment will be prescribed as per standard practice and will be prescribed regardless of participation in this study. Patients will not receive medication for the sole purpose of this research. Treatment decisions including timing of wash out period between anti-TNf and vedolizumab will be made by the subject's physician and not per the research protocol. There will not be a protocolized washout period for patients previously receiving anti-TNF therapy because treatment will be standard of care and per the directing physician.

Standard of care laboratory tests will be performed by the clinical laboratory at Mount Sinai Hospital. All other measurements will be completed at Prometheus Therapeutics \& Diagnostics in San Diego, California or at a Takeda identified lab for vedolizumab concentrations and antibodies.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults with a diagnosis of inflammatory bowel disease
* Patients who will be started on vedolizumab therapy as clinically indicated and in discussion with their treating physician will be eligible. Patients will not be started on vedolizumab for the sole purpose of this study

Exclusion Criteria:

-Patients with prior exposure to vedolizumab or natalizumab
Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair

Endovascular abdominal aortic aneurysm repair (EVAR) aims to reduce the risk of aneurysm (AAA) rupture by reducing the blood pressure transmitted to the wall of the aneurysm. Aneurysms that remain pressurized despite EVAR may continue to grow, therefore requiring additional surgical interventions. The purpose of this study is to infer the reduction of pressure transmitted to the aneurysm wall by using intraoperative ultrasound ('M-Mode') to assess the pulsatility of the aneurysm wall. The hypothesis is that intraoperative reduction in aneurysm wall pulsatility after EVAR will correlate with improved aneurysm sac size reduction.

Endovascular abdominal aortic aneurysm repair (EVAR) aims to reduce the risk of aneurysm (AAA) rupture by reducing the blood pressure transmitted to the wall of the aneurysm. Unfortunately, this procedure is not always successful, and patients need to return to the operating room for further procedures because the aneurysm wall remains pressurized and the aneurysm continues to grow. Currently, there is no standard non-invasive way of measuring aneurysm pressure. The purpose of this study is to infer the reduction of pressure transmitted to the aneurysm wall by using intraoperative ultrasound ('M-Mode') to assess the pulsatility of the aneurysm wall. The hypothesis is that intraoperative reduction in aneurysm wall pulsatility after EVAR will correlate with improved aneurysm sac size reduction. This is clinically relevant because physiologic intraoperative feedback of aneurysm pressure may potentially influence surgical decision making in the future, reducing unnecessary re-interventions. This will also improve our understanding of the intraoperative physiologic response to EVAR.

Our primary research question is in patients receiving elective endovascular repair of abdominal aortic aneurysms (EVAR), does the change in intraoperative ultrasound estimated aneurysm wall pressure during EVAR correlate with aneurysm sac size reduction 1 year after surgery? Secondary objectives are to assess correlation between intraoperative ultrasound estimated aneurysm wall pressure and endovascular leaks and aneurysm-related re-interventions.

A prospective, observational, assessor-blinded and surgeon-blinded study will be conducted at the TOH Civic Campus in Ottawa, ON in order to satisfy the objectives of the study.

Eligibility Criteria:
Inclusion Criteria:

* Elective endovascular aneurysm repair (EVAR) surgery
* Infrarenal abdominal aortic aneurysm
* Age greater than 18 years old

Exclusion Criteria:

* Prior abdominal aortic aneurysm procedures
* Inability to visualize aneurysm on ultrasound
* Inability to provide consent
* Irregular arrhythmias
MAP THE SMA: a Machine-learning Based Algorithm to Predict THErapeutic Response in Spinal Muscular Atrophy

Spinal Muscular Atrophy (SMA) is caused by the homozygous loss of the Survival Motor Neuron (SMN) 1 gene, which leads to degeneration of spinal alpha-motor neurons and muscle atrophy. Three treatments have been approved for SMA but the available data show interpatient variability in therapy response and, to date, individual factors such as age or SMN2 copies,cannot fully explain this variance.

The aim of this project is:

* collect clinical data and patient-reported outcome measures (PROM) from patients treated with nusinersen, risdiplam, onasemnogene abeparvovec,
* identify novel biomarkers and RNA molecular signature profiling,
* develop a predictive algorithm using artificial intelligence (AI) methodologies based on machine learning (ML), able to integrate clinical outcomes, patients' characteristics, and specific biomarkers.

This effort will help to better stratify the SMA patients and to predict their therapeutic outcome, thus to address patients towards personalized therapies.


Eligibility Criteria:
Inclusion Criteria:

* confirmed genetic diagnosis of SMA (5q)
* clinical phenotype of type I or II or III;
* able to provide (patient/caregiver) written informed consent

Exclusion Criteria:

* None
Comparing Pertechnetate SPECT/CT and Intragastric Pressure During Nutrient Drink for Gastric Accommodation

Functional dyspepsia (FD) is a common gastrointestinal disorder which can present with early satiety, postprandial fullness, epigastric pain and burning sensation in the absence of underlying disease. The most troubling symptom is weight loss, prevalent in up to 40% of FD patients and is often associated with impaired gastric accommodation.

Gastric accommodation by definition is a reflex, mediated vagally which causes reduction in gastric tone, increased in compliance and increment in gastric volume post meal ingestion. It allows large volumes of liquid or solid ingestion without causing postprandial symptoms. Impairment of gastric accommodation has been linked to gastrointestinal symptoms which includes nausea, bloating, early satiety, weight loss and epigastric pain.

There are several studies aimed to assess efficacy in the treatment of functional dyspeptic patients. A myriad of tests can measure gastric accommodation such as gastric barostat and single photon emission computed tomography (SPECT). An alternative study known as the nutrient drink test has also been proposed and can be combined with high-resolution manometry.

So far, none of the nuclear medicine centers in Malaysia are providing clinical service for radionuclide gastric accommodation study. The gold standard for gastric accommodation assessment is the gastric barostat method. However, the technique is invasive and caused discomfort to patients. Radionuclide gastric accommodation study using 99mTc-pertechnetate with SPECT/CT is a non-invasive method that can be used to assess patient with FD and enables quantitative evaluation of treatment response to medications. Hence, the role of non-invasive gastric volume assessment with 99mTc-pertechenate SPECT/CT in the evaluation of healthy individuals was studied first, and then compared with intragastric pressure measurements from high-resolution manometry and nutrient drink test.


Eligibility Criteria:
Healthy volunteers

Inclusion Criteria:

* Patient is above 18 years-old.
* No current gastrointestinal symptoms
* No previous gastrointestinal illness such as peptic ulcer disease or gastritis
* No chronic medical illness such as chronic neurological, cardiovascular, pulmonary, endocrine and hematological disorders
* Does not fulfill Rome IV criteria for functional dyspepsia

Exclusion Criteria:

* • Had undergone any abdominal surgery except appendicectomy, tubal ligation or Caesarean section

  * Use of medications such as metoclopramide, domperidone, erythromycin and itopride that may alter gastrointestinal function and motility
  * Pregnant woman
Treatment of Misophonia: Comparison of Exposure and Sound Therapy

The goal of this clinical trial is to compare the effects of possible treatments in misophonics. The main question it aims to answer is:

- Is exposure more effective on misophonic symptoms than sound therapy? Participants are randomly assinged to three groups of treatment;

1. Psychoeducation
2. Psychoeducation + Exposure
3. Psychoeducation + Sound Therapy


Eligibility Criteria:
Inclusion Criteria:

* People have Misophonia

Exclusion Criteria:

* Current psychosis
* Mental retardation or dementia
* those who had previously received exposure or sound therapy for misophonia symptoms.
Response Inhibition in Tourette Syndrome

Tics are the hallmark symptoms in Tourette Syndrome. Patients with Tourette Syndrome have difficulties controlling unwanted movements. The ability to control the motor system involves the pre-supplementary motor area (pre-SMA) in the brain. In this study, we will use Transcranial Magnetic Stimulation to modulate the pre-SMA and determine effect on the ability to stop an unwanted action in a behavior task (stop signal task).


Eligibility Criteria:
Inclusion Criteria:

* Tourette Syndrome

Exclusion Criteria:

* Autism spectrum disorder
* Mood disorder
* Epilepsy
* Implanted medical device (e.g. pacemaker, shunt, pumps)