cyrilzakka/clinical-trials huggingface dataset:
VIenna Pilot Study for Automated Annular Suturing Technology

The objective of this study is to compare surgical outcomes between patients who underwent valve replacement with and without the help of the automated annular suturing technology. In addition, data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters.

This study is a clinical, single-center pilot-study to evaluate safety and performance. 30 Patients (n=20 aortic valve replacement/ n=10 mitral valve replacement) with aortic and mitral valve pathology, highly likely for prosthetic valve replacement, who are planned for surgery at the Vienna General Hospital (AKH) will be included in this study with respect to the inclusion and exclusion criteria. The patients will undergo aortic or prosthetic mitral valve replacement using a specified automated annular suturing system for placement of the annular pledgeted sutures.

Eligibility Criteria:
Inclusion Criteria:

* Patients with low to moderate operative risk (Defined by STS mortality risk below 8%)
* Patients above the age of 18 years
* Patients willing and able to sign the informed consent

Exclusion Criteria:

* Patients with active endocarditis
* Patients with previous cardiac surgery other than pacemaker implantation
* Emergency procedures
* Patient who did not sign the informed consent form and/ or refuse to participate
* Patients unable to read or understand the informed consent
Minimally Invasive Closure of Umbilical Hernias

The purpose of the study is to test the use of "Deflux" injections in a minimally invasive closure of umbilical (belly button) hernias in infants between birth and five years. The study is designed to demonstrate that the use of this device can safely and effectively close an umbilical hernia.

All patients will undergo general anesthesia for their primary procedure, i.e. inguinal hernia repair. Once under general anesthesia, the abdomen will be prepped and draped in the usual sterile surgical fashion. The edge of the umbilical hernia defect will be palpated and in case there are any contents of the hernia present, they will be pushed into the abdominal cavity. Adequate relaxation, again, will be assured. A 24 gauge needle will be used to inject 1cc of Deflux ("Study Product") into each quadrant at the junction between the preperitoneal space and the inner palpable rim of the fascial defect. The surgeon's index finger stays in the center of the hernia defect, protecting the hernia sac contents from re-herniating. Closure of the umbilical defect will be confirmed by palpation immediately after injection. A sterile wound dressing will be applied and the primary surgical procedure will be performed afterwards.

Definition of Primary and Secondary Outcomes/Endpoints:

The endpoint of this study is closure of the umbilical hernia.

Data Collection Methods, Assessments, and Schedule (what assessments performed, how often): A data collection file is started at the time of enrollment in the study. Data collection includes patient age, gender, and weight at the time of operation, inner diameter of the umbilical hernia defect at the time of operation, description of the immediate postoperative results and follow-up exams at two weeks, one month, and six months.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-5 years
* Umbilical hernia\>1cm. diameter.
* Undergoing either a general surgical or urologic procedure under general anesthesia other than umbilical hernia repair.
* No previous umbilical hernia repair.

Exclusion Criteria:

* Over 5 years
* No umbilical hernia
* No other surgery required
* Previous umbilical hernia repair
The American Glaucoma Society (AGS) Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS)

Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.

This is a study comparing short- (1 year), mid- (3 years), and long-term (5 years) cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures in participants who undergo transscleral diode laser cyclophotocoagulation (TLC) for eyes with uncontrolled glaucoma with a single existing aqueous tube shunt procedure.

Eligibility Criteria:
Inclusion Criteria:

* Women and men 18 to 85 years of age
* Glaucoma not adequately controlled (IOP \>18 mmHg on maximum tolerated topical therapy) with a single aqueous shunt (AS).
* Best-corrected visual acuity (BCVA) of hand motion (HM) or better in the study eye

Exclusion Criteria:

* Monocular
* Presence of more than one AS in the study eye
* Previous cyclodestruction in the study eye
* Presence of active iris neovascularization in the study eye
* Binocular diplopia
* Presence of scleral buckle in the study eye
* History or scleritis in either eye
* History of scleromalacia in the study eye
* Insufficient conjunctiva to cover AS in the study eye
* IOP cannot be accurately measured with Goldmann applanation, Pneumotonometry, or Tono-Pen in the study eye
* Presence of silicone oil in the study eye
* Presence of retinal detachment in the study eye
* Presence of intraocular or orbital tumor affecting the study eye
* Need for cataract extraction or concurrent procedure at the time of study treatment, except tectonic aqueous shunt revisions for both groups is allowed.
* In the opinion of the investigator, should not be enrolled in this study
* Unwilling or unable to give consent and satisfy requirements of the study
Closed Loop Auditory Stimulus in Sleep and epilepsY

This is a single-centre pilot study of a non-invasive auditory stimulation during sleep in participants with temporal lobe epilepsy.

The primary objectives will be to pilot the use of home-based auditory stimulation during sleep in 10-20 participants with temporal lobe epilepsy using wireless devices.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing and able to give informed consent
2. Participant diagnosed with temporal lobe epilepsy
3. Will have had fewer than three generalized tonic clonic seizures per month in the last three months
4. Will be taking 3 or fewer anti-seizure medications.
5. Will have access to a computer or cellphone with an internet connection

Exclusion Criteria:

1. Abnormal hearing that cannot be corrected to normal overnight.
2. Abnormal vision that cannot be corrected to normal during the day.
3. Unwilling to abstain from caffeine, alcohol, daytime naps and extreme physical exercise in the 12 hours prior to the study.
4. Cannot read English
5. Engaged in night work in the previous 2 months
6. Any history of seizures triggered by music or sounds
7. Travelled across more than 2 time zones in the last 2 months
8. Prescribed/taking sleeping tablets other than clobazam
9. Cannabis use \>4 joints/day.
Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers

The aim of this study is to evaluate the influence of presence of oral fungal infection, which leads to denture-related stomatitis, on blood pressure, endothelial function and immune cell phenotype in patients wearing dentures.


Eligibility Criteria:
Inclusion Criteria:

* Patients with dental prostheses used for at least 6 months,
* Substantial portion of the oral mucosa covered by dental prosthesis.

Exclusion Criteria:

* acute inflammatory disorders other than denture-related stomatitis, neoplastic disease relapses or chemotherapy courses less than 5 years before the enrolment,
* antibiotics in less than 4 weeks before the enrolment,
* anti-inflammatory drugs (steroids and non-steroidal, excluding aspirin in doses less than 80 mg) in less than 2 months before the enrolment,
* history of myocardial infarction, acute coronary incident or vascular inflammation in 5 weeks or less before the enrolment,
* chronic haematological disorders and immunodeficiencies less than 5 weeks before the enrolment,
* major medication changes less than 5 weeks before the enrolment or during study.
Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

A Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory CLL.

This is an open label Phase 2 clinical study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with R/R CLL.

VEN and R will be administered per standard of care.

Subjects must have histologically confirmed relapsed/refractory CLL and received ≥1 lines of prior therapy

A total 42 subjects will be enrolled and treated with zandelisib in combination with VEN + R.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥18 years
* Histologically confirmed relapsed/refractory CLL who received ≥1 lines of prior therapy
* At least one bi-dimensionally measurable nodal lesion \>1.5 cm
* Adequate renal, hepatic function
* Adequate hematologic parameters at screening

Exclusion Criteria:

* Subjects who relapsed or progressed on BCL-2 inhibitor
* Relapsed within 2 years of discontinuation of prior PI3K inhibitor (PI3Ki) therapy or disease progression on PI3Ki therapy
* History or currently active HBV, HCV; any uncontrolled active infection, HIV infection; HIV-related lymphoma
* History of Richter's transformation or prolymphocytic leukemia
* Known allergies to both xanthine oxidase inhibitors and rasburicase, or any excipients of the drug products
* Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure
* Pregnant women
Effectiveness of Positive Psychological Intervention on Resilience Improvement in Nurses

The nursing profession, comprising over 27.9 million individuals and representing 59% of the health sector, plays a critical role in frontline healthcare globally. However, nurses face significant workplace stress due to factors like high mortality rates and ethical dilemmas, which can negatively impact their mental health. Resilience has emerged as a crucial concept in mitigating workplace stress and protecting nurses' psychological well-being. Studies show a negative correlation between stress and resilience, with higher resilience linked to better psychological outcomes and lower rates of burnout. Resilience, a dynamic process of positive adaptation to stress, can be enhanced through interventions like positive psychology, which focuses on developing traits such as perseverance, interpersonal skills, and emotional stability. These interventions have been shown to reduce burnout, improve job satisfaction, and potentially enhance patient care, making them vital in addressing the unique challenges nurses face.

Gap of Knowledge:

Although existing research has demonstrated the effectiveness of positive psychology interventions in reducing depression, anxiety, burnout, and stress among healthcare workers, including nurses, there is a need for more targeted randomized controlled trials (RCTs) that specifically address the unique stressors and work environments of nurses. Furthermore, the long-term effects of these interventions on nurses' resilience, stress, burnout, and job satisfaction require further exploration through well-designed RCTs.

Research Aims and Hypothesis:

The present study aims to

1. evaluate whether a positive psychology intervention, based on evidence-based activities from several positive psychology theories, can improve resilience in nurses, and
2. assess whether this intervention can also enhance stress levels, reduce burnout, and improve job satisfaction among nurses.

The hypotheses are:

1. the positive psychology intervention will improve nurses' resilience;
2. the intervention will positively impact stress, burnout, and job satisfaction; and
3. it will be more effective for nurses with low resilience in improving these outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. registered nurses working in clinical settings
2. minimum of one year of work experience as a nurse
3. availability to participate in the intervention and follow-up assessments.

Exclusion Criteria:

1. Recent exposure to severe illness, trauma, or major life events in the past three months,
2. having suffered a major traumatic event in the past 6 months,
3. currently undergoing other forms of psychological treatment or counseling.
Beta Testing of a New Assessment in Huntington's Disease (HD)

Huntington's disease (HD) is an inherited neurodegenerative disease for which there are no existing disease-modifying treatments.

Repair-HD is an EU FP7 consortium that aims to establish all the preclinical requirements for transplantation of stem cell-derived neurons in HD in order to replace those lost to the disease process. These requirements include the generation of new clinical assessments for detailed monitoring of patients with HD who have undergone cell replacement therapy.

This protocol describes the beta testing of a new clinical assessment battery: Core Assessment Protocol for Intrastriatal Transplantation in HD version 2 (CAPIT-HD beta / CAPIT-HD2). CAPIT-HD beta represents a substantial revision of a previous CAPIT-HD battery published over 20 years ago, which is in need of updating in order to accommodate knowledge from clinical transplant studies over this time and to take advantage of technological advances in patient assessment.

HD is a complex disorder in which there is relentless deterioration of motor, cognitive and behavioural functions, usually from mid-life onwards. The original CAPIT battery aimed to capture elements of change in all three domains, but was based predominantly on subjective semi-quantitative assessment tools that have poor inter-rater reliability. Moreover, a number of deficits, such as impairments in social cognition, were not recognised when the original CAPIT-HD battery was constructed, so we have developed novel assessments of these deficits, some of which are included in CAPIT-HD beta. The beta testing will take place in established HD clinical centres in Cardiff, Manchester, Paris, and Munster by teams of researchers who are experienced in leading clinic research in HD. Patients with early to moderate HD will be assessed at baseline, and at one and twelve months later, to assess the reliability and sensitivity of the CAPIT-HD beta battery. Arrangements for data storage and analysis are in place.


Eligibility Criteria:
1. Patients Inclusion criteria

   * Must be confirmed to carry the HD gene through genetic testing (CAG ≥ 36)
   * Must be 18 years or above
   * Stage I or II disease (TFC staging)

   Exclusion criteria
   * The inability to approve consent
   * Any comorbid condition that has the potential to confound the results of the study
2. Controls Inclusion criteria - Must be 18 years or above

Exclusion criteria

* The inability to approve consent
* Any comorbid condition that has the potential to confound the results of the study
The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease

This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.


Eligibility Criteria:
Inclusion criteria:

1. Age: 60 - 90 years old.
2. CDR: 0.5 - 2.0.
3. Patients who do not have severe depressive symptoms that affect cognition on depression scale of CERAD-K(C), GDS-K: 19 and below.
4. Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below.
5. NINCDS-ADRDA criteria: Probable AD.

Exclusion criteria:

1. Patients who have delusions and other conscious dysfunction.
2. Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination.
3. Patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis.
4. Patients with severe cerebrovascular pathology.
5. Patients who have present history of major psychological diseases such as depression and mania according to DSM-IV criteria.
6. Patients who have history of alcoholism or drug addiction.
7. Patients who have severe depressive symptoms that affect cognition on depression scale of CERAD-K.
Measuring Hope and Hopelessness in Cancer

The purpose of this study is to develop an accurate and useful way of measuring patients' thoughts and feelings about hope and hopelessness as they relate to their illness. Doctors and psychologists from Memorial Sloan-Kettering Cancer Center, Calvary Hospital, the Peter MacCallum Cancer Centre, and Fordham University are working together to design a new measure. Findings from this research will help us study the nature of illness and develop improved methods of diagnosis and treatment. We hope what we learn from you will help us learn more about how to care better for patients with cancer and other severe illnesses.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Patients who are able to understand verbal and written English.
* Diagnosis of cancer.
* Patients with advanced cancer receiving ambulatory or inpatient care at Memorial Sloan-Kettering Cancer Center in New York City. Patients at Calvary Hospital and Peter MacCallum Cancer Centre admitted for palliative care will also be eligible for participation in this study

Exclusion Criteria:

* The presence of a psychotic mental disorder (e.g., Bipolar Disorder, Schizophrenia, Schizo-affective illness, psychosis due to substance abuse) as indicated in medical chart.
* Cognitive impairment so severe (i.e., Mini-Mental State exam score of less than 20) that, in the opinion of the Principal Investigator or Project Coordinator, would interfere with a patient's ability to give informed consent for research.
Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)

The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* Clinical diagnosis of mild persistent asthma
* Pre-treatment with SABAs only
* FEV1 ≥80% predicted
* Good health with the exception of asthma

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
* Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
Bowel Preparation for Colonoscopy With Oral Lactulose

Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy.

Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥ 18 years
* Colorectal cancer screening
* Lower gastrointestinal bleeding
* Iron deficiency anemia
* Chronic diarrhea

Exclusion Criteria:

* Patients with previous colorectal surgery
* Pregnant
* Emergency colonoscopies
* Use of any other scheme or substance for bowel preparation different from those studied
* Incomplete information
* Clinical conditions considered unsuitable for sedation or colonoscopy
Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

To determine whether a 3-day course of postoperative antibiotics is effective as a 7-day course in reducing pain and reducing time to resumption of normal diet and activity following pediatric tonsillectomy

STUDY DESIGN : A prospective, randomized, placebo-controlled trial METHODS : All pediatric patients (under the age of 18) scheduled to undergo a tonsillectomy with or without adenoidectomy from an outpatient otolaryngology practice will be recruited for the study. Exclusion criteria include prior use of antibiotics 7 days before surgery, penicillin allergy or medical comorbidity necessitating antibiotic use. Preoperative demographic information will be obtained. Tonsillectomy with or without adenoidectomy will be performed by a single surgeon (JJ) using electrocautery. Patients will be randomized to receive either a 3- or 7-day course of amoxicillin. Parents will be asked to record the following information: analgesic use for the first 7 postoperative days, postoperative days the child initiated her usual diet and level of activity and medical treatment for oral hemorrhage or dehydration. Statistical analysis will be performed to determine a real difference between the two groups with regard to analgesic use, resumption to normal diet and activity, and incidence of oral hemorrhage or dehydration.

Eligibility Criteria:
Inclusion Criteria:

* tonsillectomy with or without adenoidectomy
* under the age of 18

Exclusion Criteria:

* penicillin allergy
* took antibiotics within 7 days of surgery
* medical comorbidity requiring treatment with antibiotics
Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control

The aim of this study is to evaluate the effectiveness of an online intervention for people with type 1 diabetes who present not optimal control of the disease.

Study area: adults with type 1 diabetes, HbA1c \>7.5%, \>3 years diagnosed. Methods: randomized clinical trial. It will include 60 participants . The improvement of Glycated Haemoglobin in both groups before and after intervention will be compared; adherence to the treatment, quality of life, time in the glycaemic range, perception of hypoglycaemia and knowledge about diabetes.

Eligibility Criteria:
Inclusion Criteria:

* HbA1c ≥7,5%
* More than 3 years of diagnosis
* Ability to follow online sessions
* Having a device to follow up the education programme

Exclusion Criteria:

* Pregnants
* People on corticosteroid treatment
* People with severe disease
* People with continuous subcutaneous insulin infusion (CSII)