cyrilzakka/clinical-trials huggingface dataset:
Quadripolar Leads for the Management of Heart Failure Patients in the Middle East

Heart failure is the most rapidly growing cardiovascular condition in developed countries. Despite advances in medical therapy, patients with heart failure are at high risk for death and hospitalization. Cardiac Resynchronization Therapy - defibrillators (CRT-D) are an effective treatment for heart failure.

Despite the high success rate of a CRT-D implant, there is a possibility of 10% that the LV lead cannot be implanted in patients undergoing a trans-venous system implantation. In this case, the patients may undergo multiple procedures before a lead is successfully implanted. These implant failures are not due to patient selection but rather to patients heart anatomy leading to lead stability problems, phrenic nerve stimulation (also called diaphragmatic stimulation) and poor electrical measurements.

The phrenic nerve is not part of the heart but runs near to this area on the way to a large muscle, called diaphragm, which separates the lung space from the space containing stomach, liver, kidneys and other internal organs in the abdomen. If the lead electrode is close to this nerve, it can cause a small part of it to contract giving you an uncomfortable hiccupping sensation.

In many patients, phrenic nerve stimulation is not identified until after the implant procedure when movement and postural changes bring the LV lead into closer contact with the phrenic nerve.

The investigation is performed to demonstrate the equality of performance of two different modalities of optimization of the implanted device and Quartet lead, Empirical (anatomical) optimization and Right Ventricle Left Ventricle (RVLV) conduction delay optimization.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Patient met standard CRT-D device indications (Left Ventricular Ejection Fraction (LVEF) ≤ 35%, QRS ≥ 120 ms, New York Heart Association (NYHA) Class II, III or ambulatory Class IV Heart Failure (HF) symptoms with optimal recommended medical therapy) and will be implanted with an St Jude Medical CRT-D
* Patient is willing to provide written informed consent.

Exclusion Criteria:

* Patient with non left bundle branch block (RBBB, intraventricular delay (IVCD) Block)
* Patient has an epicardial ventricular lead system.
* Patient has limited intrinsic atrial activity (≤ 40 bpm).
* Patient has persistent or permanent Atrial Fibrillation.
* Patient's life expectancy is less than 1 year
* Patient is pregnant.
* Patient is dependent on IV inotropic agents.
Written Exposure Therapy for Nurses

Nurses often experience elevated levels of stress, overwork, and trauma in the workplace, leading to posttraumatic stress disorder (PTSD), depression, burnout, and even nurse turnover. While effective therapies for PTSD exist, barriers to treatment arise from nursing culture, such as workplace stigma about mental health problems, fear that psychological status may impact performance evaluations, and demands of shiftwork. There is a pressing need for scalable evidence-based interventions tailored to nursing culture to effectively address PTSD and related mental health issues. The study aimed to assess the feasibility, safety, and acceptability of a tailored evidence-based treatment, Written Exposure Therapy (WET), for nurses experiencing work-related traumatic stress.

This single-arm open pilot study with pre- and post-intervention assessments, included participants from two nursing schools' alumni. Eligibility criteria included nurses screening positive for work-related trauma with a report of at least two PTSD symptoms. Participants engaged in a self-administered, asynchronous, five-week online writing session, facilitated by WET-trained nurses. Outcomes measures (PTSD, depression, anxiety, burnout, and intention to quit) were assessed at baseline, post-intervention, and 5-weeks follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Work-related trauma
* Posttraumatic stress disorder

Exclusion Criteria:

* Current substance abuse
* Current suicidality
* Current psychiatric treatment with psychotherapy or psychotropic medications other than selective serotonin (and norepinephrine) reuptake inhibitors (SSRI/SNRI).
Feasibility and Acceptability of an Web-based Physical Activity Program, for Those Diagnosed With Lung Cancer.

Lung cancer is a life changing disease which can cause negative effects on an individual's ability to perform daily tasks and their quality of life (QoL). Lung cancer is the third most common cancer in the UK and is estimated affects approximately 33,000 individuals per year.

The most common side effects from lung cancer and treatments are breathlessness, fatigue, nausea, diarrhoea, and depression. Those living beyond cancer often suffer from extreme feelings of isolation and have increased chance of cardiovascular disease and diabetes.

Physical activity is a vital component of the prevention and management of cancer. Being active can improve one's physical health (ability to carry out tasks of daily living and breathlessness) and emotional wellbeing (feelings of depression and isolation).

Electronic platforms (websites and mobile applications) are increasingly popular within developing nations, particularly with products that aim to increase and keep track of physical activity. Though, literature suggests older adults prefer websites opposed to mobile applications. Online delivery of physical activity could be highly beneficial for patients living with and beyond cancer, reducing the location-based inequality of those who can not attend face-to-face programmes, allowing individuals to carry out a session whenever they can, in the comfort of their own home.

Exploring how those living with and beyond lung cancer use a website and investigating the feasibility and acceptability on an online platform which aims to provide tailored physical activity programs will provide fundamental data and possible supporting data for a randomised controlled trail (RCT).


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older.
* Have had a lung cancer diagnosis.
* Be able to speak and read in English.
* Willing and able to provide informed consent.
* Have internet connectivity.
* Access to a laptop, computer, or smart device to access the web-based platform.

Exclusion Criteria:

* Psychological or linguistic inability to provide informed consent.
* Physical or psychological impairments which prevent or inhibit participation in physical activity. Examples include:

  * Uncontrolled atrial fibrillation
  * Abdominal aortic aneurysm (AAA)
  * Recent heart attack (less than one year)
  * Recent stroke (less than one year)
  * Psychiatric disorder
  * Those who lack capacity under the Mental Capacity Act 2005 (MCA).
Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury

This study investigates to which extent recommended nephroprotective measures are implemented in critically ill patients with moderate or severe acute kidney injury.

Acute kidney injury (AKI) is a global problem affecting more than 10% of all hospitalized patients and up to 50% of critically ill patients, with survival related not only to the severity,1 but also to the duration of renal dysfunction.2 Recent evidence suggests that two-thirds of patients with AKI resolve their renal dysfunction within 3-7 days whereas those in whom renal dysfunctions persist have dramatically reduced survival over the following year.2 Persistence of AKI is of grave importance in that it increases an individual's risk of developing chronic kidney disease (CKD) which is a major cause of morbidity and mortality. This link between AKI and CKD has been established over the last decade3 and specific recommendations for the management of patients with AKI have been proposed in order to potentially influence this transition.4 To date, there are no specific pharmacological options for preventing or treating AKI, which is why new approaches and intensive efforts are urgently needed to reduce the occurrence of AKI. The Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines recommend implementing a bundle of different supportive measures, which, in theory, should be initiated in all patients with AKI in order to prevent disease progression. However, clinical practice and recent studies have shown that the implementation of the KDIGO bundle is still not standard clinical practice despite the fact that evidence suggest clear effectiveness in the reduction of AKI rates.5-9 Poor implementation of nephroprotective measures presents a major missed opportunity to reduce AKI-related morbidity and mortality and to improve long-term outcomes. To investigate the extent to which nephroprotective measures are implemented in patients with AKI can reduce the occurrence of persistent surgical AKI, a multi-center prospective cohort study will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Critically ill patients with moderate or severe AKI (KDIGO stage 2 / 3)
2. Requirement of vasopressors or mechanical ventilation
3. Age ≥ 18 years
4. Informed consent

Exclusion Criteria:

1. Chronic kidney disease (CKD) with a glomerular filtration rate \< 20ml/min
2. Chronic dialysis dependency
3. History of renal transplantation
4. Permanent ligation of the renal arteries
5. AKI immediately following nephrectomy
6. Patients requiring permanent administration of nephrotoxic drugs (e.g. immunosuppressive therapy afer liver transplantation)
7. Persons with any kind of dependency on the investigator or employed by the sponsor or investigator.
Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis

This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a randomized, double-blind, placebo-controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal female patient with a clinical diagnosed vulvo-vaginal candidiasis
* Regularly menstruating women with normal gynaecological status
* Patient must use a contraception method
* Having given a written informed consent prior to selection
* Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Exclusion Criteria:

* Pregnancy or breast feeding.
* Tumors in the genital tract or beast.
* Hypersensitivity to the study product.
* Uterine or vaginal bleeding of unknown origin.
* Use of systemic or intravaginal antibiotic or antifungal agents in the previous 14 days.
* Concomitant medication with antimycotics for other diagnoses.
* Woman with known transmitted infections such as Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, herpes simplex, Trichomonas vaginalis, human papilloma virus, HIV 1 or 2.
* Immunocompromised individuals.
* Subjects not willing to stop taking probiotics in the form of dietary supplements or convenient goods
* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.
* Subject under administrative or legal supervision.
* Subject who participate to a previous study within 3 months.
Laparoscopic Cholecystectomy - Fundus First and Harmonic Ace Compared With Conventional Technique

Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as a fundus first dissection.

Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way of dissection has to be established. Patients are at 4 hospitals randomised to the different techniques and the different methods of dissection.

Patients at the participating hospitals are randomized to:

1. dissection starting at the triangle of Calots with electrocautery.
2. dissection by fundus first technique with electrocautery.
3. dissection by fundus first technique with ultrasonic dissection.

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic cholecystectomy

Exclusion Criteria:

* age \>Z65
* ASA \>3
* obesity
* previous extensive gastrointestinal surgery
Peripheral Reservoir of HIV DNA in Monocytes Pivotal to Cognition in HIV

Sixty HIV participants will be enrolled and stratified by PBMC HIV DNA levels, either high (greater than or equal to 5000 copies/106 cells) or low (less than 5000 copies/106 cells). Individuals will be enrolled into each group until filled. Screening PBMC HIV DNA levels will be performed at SEARCH in real-time with less than one-week turn around time. All individuals will intend to initiate ARV due to meeting MOPH guidelines for such. The protocol team will work with the primary care physician to facilitate initiation of standard ARV care; however, initiation of ARV is not a requirement of the study and ARV will not be provided by the study.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected individuals meeting MOPH criteria to initiate HAART and planning to initiate HAART within a month of screening.
* Consequently, all participants will have plasma CD4 counts at less than 250 cells.

Exclusion Criteria:

* Head injury with loss of consciousness greater than 1 hour or cognitive sequela
* Current/past illicit drug use or positive drug screen for methamphetamines, amphetamines, or cocaine at screening or entry.
* Any of the following laboratory abnormalities:

  * PT/PTT \> the upper limit of normal (ULN) or INR \> 1.1
  * Hemoglobin \< 9.0 mg/dL
  * ALT \> 5x ULN
  * serum creatinine \> 2x ULN or creatinine clearance \< 30 cc per min by Cockroft-Gault formula
* Acute illness within 30 days prior, persistent and active AIDS-defining OI of any organ system or autoimmune disease.
* Current or recent fevers or meningeal signs suggestive of CNS opportunistic infection
* CNS opportunistic infection, past or present (Patients diagnosed with opportunistic infection after CSF examination will be excluded from further analysis. In such a situation, an additional patient will be enrolled)
* History of pre-existing neurologic disease to include stroke, multiple sclerosis or psychiatric illness including schizophrenia, bipolar disorder, anxiety disorder, panic attacks, major depression, or post traumatic stress disorder. Patients with past depression that is controlled and patients with or minor depressive symptoms will be allowed to enroll.
* Known learning disability including dyslexia or unable to read or write basic Thai
* Positive Hepatitis C serology (Hepatitis C Ab)
* Confusion or other signs and symptoms of metabolic encephalopathy or delirium
* Other conditions that could explain neurocognitive decline in the opinion of the investigator such as hypothyroidism, vitamin B12 deficiency or neurosyphilis
* Pregnancy or metal objects that would preclude MRI
Validation of the Dutch Translation of the Tobacco, Alcohol, Prescription Medication and Other Substances (TAPS)-Tool

The aim of the study is to investigate the reliability and validity of the Dutch version of the TAPS-tool.

This will be investigated in 2 groups: patients without intellectual disabilities treated in Flexible Assertive Community Treatment (FACT) teams and patients with intellectual disabilities. For the later group, an adjusted version of the TAPS-tool will be developed.

For both groups the TAPS outcome will be compared to a golden standard.

All FACT teams in the participating organization (GGZ Oost Brabant) work through a standardized care pattern which implicates screening and assessment on several areas. At the start of the treatment all patients are assessed for intellectual disabilities, trauma related symptoms, addiction, quality of life, level of psychiatric complaints, social functioning, and phase of recovery. Subsequently quality of life and the level of psychiatric complaints is measured yearly. For this research question a small golden standard instrument was added to the standard screening and assessment.

For people with intellectual disabilities (ID) who get an extensive assessment of substance use problems in their (standard) treatment, permission to participate on the TAPS (version for ID) was asked.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated in the participating FACT teams and for patients treated at the LVB-P (department for patients with intellectual disabilities and psychiatric disorders \[Dutch name\]) department of the GGZ Oost Brabant or the ORO foundation (ORO is no abbreviation but just a name of the institute).

Exclusion Criteria:

* If patients do not have sufficient command of the Dutch language or cannot concentrate for 20 minutes, the instruments are not taken
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been enrolled and dosed in an ongoing venetoclax study and continues to tolerate and derive benefit from the study drug.
* Male subject agrees to refrain from sperm donation.
* Female subjects must not be pregnant or breastfeeding.

Exclusion Criteria:

- None.
Physiopathology of Prosthetic Joint Infections

This study aim to explore cellular responses of bone and immune cells to bacterial infections observed in patients with prosthetic joint infections. The investigators will analyze clinical data and tissue samples collected from patients undergoing surgery as part of their usual care for prosthetic joint infections. These research will be conducted on three different hospitals in Paris: Lariboisière (AP-HP), Cochin (AP-HP) and Croix Saint-Simon.

The number of prosthetic joint infections (PJI) new cases in France is estimated at 2000/2500 cases per year. PJI, mainly caused by staphylococci, are serious infections responsible for significant morbidity result of inflammation and bone destruction (osteomyelitis). Despite optimal medical and surgical management, a risk of failure and recurrence exists, which varies depending on the situation.

In addition to the deterioration in patients' quality of life, the economic cost for the health care system is very high, in particular because of prolonged hospitalizations, complex treatments, and frequent readmissions. Thus, the adequate management of PJI is a major public health issue.

In this context, new therapeutic approaches are urgent medical needs for the management of patients with PJI.

Thus, the identification of the biological mechanisms (immunology, microbiology, bone physiology) underlying these infections is essential. Indeed, the impact of bacterial infections on bone homeostasis is poorly documented. Although several biological mechanisms have been suggested the host-pathogen interaction and the close links between bacterial infection and biological response of bone cells to microorganisms and their environment warrant to be explored.

Eligibility Criteria:
Inclusion Criteria:

* 18 years-old and older
* Patient eligible for lower limb revision surgery (revision surgery for infected or non-infected prosthesis)
* Patient affiliated to a social security system
* Oral consent to the research

Exclusion Criteria:

* NA
Evaluation of Salivary Gland Dysfunction

This study will evaluate patients with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary gland secretions have antibacterial, lubricatory, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning, or ulcerated oral mucosal; problems chewing, swallowing, and speaking; and diminished taste and smell.

Patients with dry mouth complaints suggestive of salivary gland dysfunction may be eligible for this study. In addition, patients with recent onset of arthritis may enroll. Patients with arthritis are at risk for developing a disorder called Sjogren's syndrome, in which the glands that produce saliva may be damaged.

Participants will have a complete medical and dental history. Saliva samples will be collected from the major salivary glands, which are located in the cheeks and under the jaw. Several blood samples will also be drawn for tests. Some patients will have a biopsy of the minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis of Sjogren's syndrome and determine the extent of changes in the salivary glands. The ability to taste and smell may also be evaluated, and patients may have an ultrasound examination of their swallowing function.

This study will evaluate participants with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary secretions have antibacterial, lubricating, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning or ulcerated or oral mucosa; problems chewing, swallowing and speaking; and diminished taste and smell.

Participants with dry mouth complaints suggestive of salivary gland dysfunction may be eligible for this study.

Participants will have a complete medical and dental history. Saliva samples will be collected from the major salivary glands, which are located in the cheeks and under the tongue. Several blood samples will also be drawn for tests. Some participants will have a biopsy of the minor salivary glands, usually from inside the lower lip, to confirm or rule out the diagnosis of Sj(SqrRoot)(Delta)gren s syndrome and to determine the extent of changes in the salivary glands. An eye examination including a standard eye examination and a dry eye assessment is done. The ability to taste and smell may also be evaluated, and participants may have an ultrasound examination of their swallowing function.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Subjects must have dry mouth symptoms (xerostomia) or a reasonable clinical suspicion of having Sj(SqrRoot)(Delta)gren s syndrome or other salivary gland disease
  2. Ability to provide informed consent.

EXCLUSION CRITERIA:

a. Age less than 12 years.