cyrilzakka/clinical-trials huggingface dataset:
Optimized Biventricular Pacing Allograft Recipients

This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure. It examines the effects of atrioventricular delay (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an identical heart rate.

This study is designed to increase the benefit of biventricular pacing (BiVP), which is an established therapy for advanced heart failure. The investigators will test 6 left ventricular (LV) pacing sites and 16 timing sequences in the operating room just before cardiac transplant. Pacing will be implemented after patients have been anticoagulated and connected to the heart-lung machine. Pacing by previously implanted pacemakers will be suppressed. The investigators will measure cardiac output (CO) by aortic flow probe (AFP), left ventricular (LV) contractility by a combination of trans-septal pressure gradients, and simultaneous left ventricular pressure (LVP)and transesophageal echocardiography (TEE) during transient reduction of inflow of blood to the heart by vena caval occlusion. The goal is to prove that this optimization will increase the amount of blood pumped by the failing heart by 15% as compared with standard atrial (AAI) pacing. The testing protocol is 12.5 minutes in duration, and the entire protocol should be executable in 20 minutes. Care will not be altered otherwise. Results will improve management of the general population of patients with advanced heart failure while minimally increasing the risk to patients undergoing cardiac transplantation. Benefits of this study should include: improved patient selection for BiVP and a decrease in the presently recognized 30-40% incidence of BiVP nonresponders.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association (NYHA) heart failure class III/IV
* Left Ventricular Ejection Fraction (LVEF) \<36%
* QRS \>120 msec

Exclusion Criteria:

* Intracardiac shunts
* Sinus tachycardia \>120 bpm
* Second or third degree heart block
* Previous cardiac surgery
* Mechanical circulatory assistance
* Atrial fibrillation
A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel

A Phase 1 study in healthy subjects to determine the safety, tolerability, psychomotor function, and cognitive effects of perampanel when administered alone and with alcohol.


Eligibility Criteria:
Inclusion:

* Healthy male and female subjects
* Females agreed to use two medically acceptable methods of contraception, unless they were surgically sterile
* Aged 18-55 yrs, inclusive
* Achieved a Continuous Tracking Test (CTT )score increase of \>1.5 pixels from pre-alcohol when dosed with alcohol during the Screening Period (Day minus 8 plus/minus 2 days)
* Had a current driving license and drove regularly (e.g., more than 1000 miles a year (Part B only)

Exclusion:

* Any history of significant alcohol abuse or psychiatric disease, requiring inpatient admission or prolonged treatment with psychotropic medication
* Unable to follow the instructions for the psychometric testing
* Intolerant to the driving simulator (Part B only)
* Unable to adhere to long periods of confinement (subjects who could not follow the instructions of the protocol, including the meals)
* Use of prescription drugs or over-the-counter (OTC) medications within 2 weeks prior to Screening (unless drug had a long half life \[i.e., 5 x t 1/2\>2 weeks\]) with the exception of paracetamol (up to 4 g/day), which was allowed up to 12 hours prior to dosing
* Had taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (e.g., grapefruit, grapefruit juice, grapefruit-containing beverages, or Seville orange products)
* Had taken St John's Wort or other dietary aids known to induce CYP3A4 within 4 weeks prior to dosing
Assessing Usefulness of Virtual Reality Mobile Application in Flexible Videoscope Airway Training

Flexible videoscope orotracheal intubation (FOI) technique is considered an important option in the management of predicted difficult airways. However, it is rarely performed in daily practice. Yet emergency physicians are expected to be able to perform this skill expertly during a crisis scenario. If it is not completed in a timely and proper fashion, the patient will deteriorate rapidly, resulting in morbidity or fatality.

There is a significant learning curve to master this complex psychomotor skill. Providing sufficient training in FOI, particularly hands-on experience in real patients is difficult. Patients with known difficult airway requiring FOI present infrequently to the emergency room. Using patients with normal airway purely for teaching of FOI is ethically controversial. To avoid technical and ethical concerns of training involving real patients, conventional teaching methods incorporate the use of a low-fidelity manikin in replacement. However, the manikin anatomy often lacks the realism of a live human.

The addition of virtual reality technology, in the form of a low-cost mobile application (Airway Ex) into the conventional simulation, may optimize learning by providing an ethical, cost-effective and more realistic modality to acquire the basic skills of FOI. If it is proven to be effective, efforts to integrate virtual reality technology into routine training of such procedures in the ED should be promoted.

We hypothesize that the addition of virtual reality mobile application to conventional training will improve procedural skill dexterity and proficiency and hence, improve learner's satisfaction and confidence in performing FOI.


Eligibility Criteria:
Inclusion Criteria:

* All doctors from Accidental \& Emergency Department of National University Hospital, Singapore

Exclusion Criteria:

* Refusal for consent
The Impact of Multimedia Psychological Support Platform and Acceptance and Commitment Therapy Workshops of Oncology Nurses

Based on the high levels of emotional distress, burnout, and turnover intentions among clinical oncology nursing staff, this study will provide a multimedia "Mind-Body Support" Line platform and ACT workshop courses as intervention measures for oncology nursing staff. The study aims to explore the effectiveness of these interventions in alleviating their psychological and physical distress, utilizing both qualitative and quantitative research methods to achieve the research objectives.


Eligibility Criteria:
Inclusion Criteria:

* Currently working as an oncology nurse in a clinical setting

Exclusion Criteria:

* "Unwilling or unable to participate in the full training course"
Consequences of Doing What Should Not be Done in Primary Care

Retrospective observational study in a random selection of 5% of digital records active between 2014 and 2017 to quantify the frequency of Do not do primary care recommendations, calculating the over-cost related to them and study reviewing a random selection of cases previously identified to determine whether patient suffered adverse events and their over-cost.

Basement: Overuse subjected patients to unnecessary risk without promoting a sufficient clinical benefit and over-cost. The Less is More Medicine movement has led to the identification of Do not do in different specialties, also in primary care.

Objective: To analyze the impact of errors (overuse rates based in Do not do recommendations) in clinical practice.

Method: Retrospective observational study in a random selection of 5% of digital records active between 2014 and 2017 to quantify the frequency of Do not do primary care recommendations, calculating the over-cost related to them. Retrospective study reviewing a random selection of cases previously identified to determine whether patient suffered adverse events and their over-cost.

Setting. Primary care in Andalucía, Aragón, Castilla La Mancha, Comunidad Valenciana, Madrid, Murcia, Navarra y País Vasco, eight autonomous communities in Spain.

Eligibility Criteria:
Inclusion Criteria:

* All patients visiting GPs

Exclusion Criteria:

* None
Chronic Kidney Disease-related Sarcopenia With Poor Prognosis

Chronic kidney disease (CKD) has become a global public health priority over the past few decades, affecting 10-12% of the adult population and has received increasing attention. Sarcopenia describes a generalizes degenerative skeletal muscle disorder involving the loss of muscle mass, muscle function and/or physical performance. Indeed, Sarcopenia is a condition with many causes and it can be considered "primary sarcopenia" when no other cause is evident but ageing. While in the clinical practice, it also occurs in patients with chronic diseases, such as chronic kidney disease, which can be considered "secondary sarcopenia". Notably, the occurrence of sarcopenia in CKD patients is not only related with ageing, the accumulation of uremic toxins, inflammation, insulin resistance, malnutrition and oxidative stress also contribute to the muscle depletion. Moreover, sarcopenia increased risk of falls and fractures, impaired ability to perform activities of daily living, disabilities, loss of independence and increased risk of death. Hence, it is of great significance to prevent the occurrence and development of sarcopenia in patients with CKD. The purposes of this project were to investigate the prevalence of sarcopenia, further explore the risk factors for sarcopenia and detect the relationship between sarcopenia and outcomes in CKD patients.


Eligibility Criteria:
Inclusion Criteria:

* 1.aged ≥18 years and \<80 years 2.eGFR\<60ml/min/1.73m2 or had received maintenance dialysis for at least 3 months.

Exclusion Criteria:

* 1.Patients with neuromuscular diseases: such as muscular dystrophy, amyotrophic lateral sclerosis, spinal cord injury, stroke, and myasthenia gravis; 2.Patients with neurodegenerative diseases: such as Alzheimer's disease, Parkinson's disease and Huntington's disease; 3.patients with advanced malignant tumors; 4.Patients with acute infectious diseases in the past 3 months; 5. Patients with serious cardiovascular or cerebrovascular disease; 6.Moderate to severe edema; 7.Patients with rheumatoid arthritis, multiple sclerosis, or acute gout that limit joint mobility; 8.Pregnant ; 9.Patients identified to be unsuitable for enrollment by the study physician
Iron Absorption and Requirements in Pregnancy and Lactation

Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common.

The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya.

In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.


Eligibility Criteria:
Inclusion Criteria:

* Providing consent to the informed consent form
* Participation in a previous stable isotope absorption study and having received an oral dose of 15 mg 57Fe at least 12 months prior to the date of inclusion in the study
* Positive pregnancy test and gestational age \<10 weeks based on history of last menstrual period
* Permanent residence in the study area, and not expected to leave the study site for more than 4 weeks over the following 16 months
* Assessment of good health by professional staff at Msambweni Hospital

Exclusion Criteria:

* Pre-pregnancy body mass index \>30 kg/m2
* Blood transfusion or intravenous iron treatment within 4 months of study start
* Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)
* Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)
Suction Diathermy Adenoidectomy (SDA) : Efficacy and Safety

The aim of this prospective study is to evaluate the efficacy and safety of endoscopic suction diathermy adenoidectomy as regard the operative time, adenoid tissue remnant, blood loss, and clinical events like pain, halitosis, postoperative hemorrhage, speech changes and recurrence.

Suction diathermy adenoidectomy is a procedure that uses thermal energy generated by electric current to ablate adenoid which is removed using suction. This procedure was described in 1997 and the technique has the advantage of complete tissue removal with reduced blood loss and intraoperative time, also reduced post-operative complications as postoperative hemorrhage , nasality and lower recurrence rate.

Eligibility Criteria:
Inclusion Criteria:

1. Obstructive symptoms such as long-lasting nocturnal snoring, sleep apnea, and open mouth breathing, bilateral nasal obstruction, and/or bilateral nasal discharge.
2. Adenoid hypertrophy is the only cause of nasal obstruction.
3. Radiography evidence of adenoid hypertrophy encroaching on the airway column.
4. Age under 15 years.
5. Sex: both males and females.
6. All patients are generally well and fit for surgery.

Exclusion Criteria:

1. Presence of chronic diseases such as chronic heart diseases, chronic liver diseases, chronic renal diseases, and diabetes mellitus.
2. Patients with other causes of nasal obstruction such as acute rhinitis, allergic rhinitis, septal deviation, inferior turbinate hypertrophy, antrochoanal polyp, nasal polypi or anatomical deformities (Choanal atresia).
3. Cases with submucous cleft palate and cases with a previous history of cleft palate repair.
4. Patients with bleeding or coagulation defects.
5. Patients with atrophic rhinitis.
6. Patients with recurrent adenoid.
Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients

The aim of this study is to implement the International Classification of Functioning, disability and health (ICF) in paediatric Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss in a multicenter prospective study to evaluate audiological rehabilitation after cochlear implantation. For this, ICF qualifiers which denote the magnitude of the level of health or severity of the problem will be quantified. Outcome measures include four questionnaires and three standard audiological examinations. Subjects will be assessed up to 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor.


Eligibility Criteria:
Inclusion Criteria:

General

* Children aged \< 18 years with prelingual bilateral severe-to-profound HL
* Signed and dated informed consent, informed permission and/or minor's assent.
* Willingness to participate in evaluations, test sessions, and medical follow-up sessions as defined in the protocol.
* Physical and mental competence to participate in fitting of the device and follow-up sessions as defined in the protocol.

Audiological

* Completion of hearing assessment battery showing suitability of the CI candidates.
* Compliance with cochlear implant candidate selection criteria of the implanting centre.
* First cochlear implantation Medical
* Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI).

Exclusion Criteria:

General

* Re-implantation of the cochlear implant
* No motivation to participate in the study and/or unreasonable expectations. Medical
* Presence of contra-indications for surgery in general and cochlear implantation in particular.
* Presence of central auditory lesions.
* Any disorder that may relate to an increased risk of skin flap problems Use of one of the following electrodes for implantation
* Compressed
* Split
* Any type of custom made electrodes
Capnography At the Bedside: Leading Educational Efforts

The purpose of this dual-site quasi-experimental pilot study is to evaluate if the implementation of an educational intervention paired with an environmental assessment to address accessibility barriers is associated with improvement in staff knowledge and skills, and adherence to national guidelines for use (evaluation in the knowledge transfer framework) in an emergency department (ED) setting.

The objective of this study is to develop a multi-faceted implementation program (referred to as the Capnography At the Bedside: Leading Emergency Education (CapABLE Trial)) to increase the use of capnography during two critical events in the emergency department, intubation and CPR, for better detection of endotracheal intubation, endotracheal tube dislodgement, and quality CPR.

The specific aims of the proposed study are to examine:

1. the effect of a comprehensive theory-based educational intervention on staff knowledge and skills related to capnography (outcome measure).
2. the effect of a multi-faceted implementation program on the adherence to national guidelines regarding the use of capnography during critical events in the emergency department (process measure).
3. the sustainability of effects of the implementation program on adherence, knowledge and skills (outcome and process measure).

The design and methods of this study are based on the knowledge transfer framework, which dictates identification of the message, target audience, messenger, process and communication, and evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Emergency department (ED) staff
* Staff will include registered nurses, respiratory therapists, technical associates, physicians, physician's assistants and advanced practice nurse practitioners who fulfill the majority of their clinical duties in the ED.

Exclusion Criteria:

* Staff who are assigned to work on other units, but who work in the ED on a casual or per diem status will be excluded.
MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

The purpose of this study is to evaluate the activity and the toxicity of capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer.

Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. Standard combination chemotherapy with a platinum derivative (cisplatin or carboplatin) and a taxane are effective in causing remission in 60 - 80 % of cases, yet recurrences are frequent and 5-year survival is only 20%. Current therapies for second line treatment of recurrence in patients who have platinum refractory (who experienced progression of the disease during first line platinum based therapy) or platinum resistant (who experienced a recurrence of the disease within 6 months of completing platinum based therapy)ovarian cancer are limited. Capecitabine, an oral chemotherapy already used in colon and breast cancers, has shown some promise in early clinical trials for treating recurrent ovarian cancer.

Patients entered into this trial will receive oral capecitabine 1250 mg/m2 on days 1-14 every 21 days for up to 6 cycles, depending on response.

Eligibility Criteria:
Inclusion Criteria:

* Cytologic or histologic diagnosis of relapsed ovarian cancer
* Refractory or resistant to platinum salts disease
* Age \< 75 years
* At least one measurable lesion (³ 20 mm with conventional techniques or ³ 10 mm with spiral CT scan)
* Life expectancy of at least 3 months
* Written informed consent

Exclusion Criteria:

* Previous or concomitant malignant neoplasia within 5 years prior to basal evaluation (excluding adequately treated basocellular or spinocellular skin carcinoma or in situ carcinoma of the uterine cervix).
* Performance Status (ECOG) ³ 3
* Previous chemotherapy treatment with capecitabine
* More than 3 lines of chemotherapy
* Heart disease (heart failure, heart attack during the 6 months prior to the trial, atrioventricular block of any degree, serious arrhythmia)
* Leukocytes \< 4000/mm3, platelets \< 100000/mm3
* Modifications of renal function (Creatinine ³ 1.25 times the upper normal limit) or liver function (SGOT or SGPT ³ 1.25 times the upper normal limit)
* Present or suspected haemorrhagic syndromes
* Uncooperative and/or unreliable patients
* Patients' inability to access the centre
Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia

To evaluate the safety and efficacy of CJ-30061 compared with amlodipine/valsartan combination therapy and valsartan/atorvastatin combination therapy in hypertensive patients with hyperlipidemia


Eligibility Criteria:
Inclusion Criteria:

* Aged between 19 and 74 years
* Diagnosed with essintial hypertension(average siSBP ≥ 140mmHg) accompanying hyperlipidemia(LDL-C ≥ 100mg/dL) and were on or off treatment at Visit 1(screening)
* Decided to participate in the study and provided signed informed consent form voluntarily after receiving explanation of the objectives, methods, and effects of the study

Exclusion Criteria:

* Severe hypertension defined as average siDBP ≥ 120mmHg or average siSBP ≥ 200mmHg at Visit 1(screening)
* The difference in BPs between those measured at the reference arm at Visit 1(screening) was ≥ 10mmHg for siDBP or ≥ 20mmHg for siSBP
* LDL-C \> 250mg/dL or TG ≥ 400mg/dL at Visit 1(screening)
* Secondary hypertension
* Diagnosis of type 1 diabetes mellitus(DM) or uncontrolled DM(patients on insulin therapy or patients with HbA1c ≥ 9%)
Maraviroc in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation

This study investigates the effectiveness and safety of Maraviroc (an oral medication given twice daily given in addition to the standard GVHD prophylaxis) in preventing Graft versus Host Disease (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell transplantation (SCT). Subjects will receive Maraviroc bid (in addition to standard GVHD prophylaxis) beginning after the last dose of the chemotherapy conditioning regimen until day 30 after stem-cell infusion.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo non-myeloablative allogeneic stem-cell transplantation.
* meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:

  * Renal function: Serum creatinine \<2; or calculated creatinine clearance \> 40 mL/min/1.72m2;
  * Hepatic function: Baseline direct bilirubin, ALT or AST lower than three times the upper limit of normal;
  * Pulmonary disease: FVC or FEV1 \> 40% predicted; Cardiac ejection fraction \> 40%.

Exclusion Criteria:

* Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
* Patients who are not undergoing standard non-myeloablative SCT with Flu/Bu conditioning and Tax/MTX GVHD prophylaxis
* Patients with uncontrolled bacterial, viral or fungal infections
* Patients who take strong inducers or inhibitors of the CYP450A4
* Patients receiving other investigational drugs for GVHD
* Women who are pregnant, plan to become pregnant or are breastfeeding