cyrilzakka/clinical-trials huggingface dataset:
Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation

Prospective, randomized, controlled, multicentre study to compare the safety and efficacy of a Same Day Discharge (SDD) protocol in combination with a Perclose ProStyle (PPS) /ProGlide (PPG) suture mediated vascular closure device to the current gold standard: an overnight stay (ONS) protocol associated with manual compression ± figure-of-eight suture for the patients receiving interventional pulmonary vein isolation (PVI).

The aim of the study is to prove that the use of a SDD protocol does not lead to a higher rate of adverse events (minor and major), unplanned medical visits (emergency department or outpatients' clinic) and unplanned readmissions, while substantially reducing the costs associated with the medical care and increasing the comfort of the patients on a period of 30 days, when compared to ONS and manual compression ± figure-of-eight suture. Moreover, the safety, efficiency, and feasibility of the SDD protocol should be proven during a follow-up (FU) period of 12 months. The definition of endpoints will be trained in all participating study sites to preserve consistency.

Eligibility Criteria:
Inclusion Criteria:

* Patients age \>=18 years
* Elective catheter ablation for atrial fibrillation using 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites, independent of the energy source use

Exclusion Criteria:

* Active systemic or cutaneous infection, or inflammation in vicinity of the groin
* Platelet count \< 50,000 cells/mm3
* Body mass index (BMI) \> 45 kg/m2 or \< 18 kg/m2
Mesalazine Therapy in Patients With Irritable Bowel Syndrome

The purpose of this study is to determine whether Mesalazine is effective in the treatment of the abdominal discomfort or pain of Irritable Bowel Syndrome patients.

The present study is a prospective, double blind, randomised, multicenter trial designed to study the efficacy of mesalazine treatment on symptoms of IBS. In a subgroup of patients the efficacy of this treatment will be also assessed on low-grade inflammation. We expect to confirm that mesalazine treatment reduces the number and activation of inflammatory cells in the colonic mucosa of IBS patients, thus providing the rationale for the assessment of this treatment on symptoms of IBS.

Eligibility Criteria:
Inclusion Criteria:

* IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion Criteria:

* Any organic or metabolic disease
Safety During Use of Paediatric Triple Chamber Bag Formulas

The primary objective of this study was to provide daily information on the performance safety of the Ped3CB in practical therapeutic use in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized preterm newborn infants, term infants and toddlers, and children and adolescents requiring parenteral nutrition (PN) for at least 5 consecutive days.
* Preterm infants were to require PN representing, at baseline, 80% of total estimated nutritional needs, and patients in the other groups (term infants toddlers; children) were to require PN representing, at baseline, at least 50% of total estimated nutritional needs.
* Patient whose parents or legally authorized representative had provided signed written informed consent

Exclusion Criteria:

* Patients with a life expectancy \< 6 days or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study were not included in the study.
* Patients with a diagnosis of shock, cardiac or renal failure with fluid overload, metabolic acidosis, respiratory failure, signs of sepsis, severe dyslipidemia, uncorrected metabolic disorders, severe sepsis, severe liver disease including cholestasis icterus, blood coagulation disorders and/or thrombophlebitis, acute myocardial infarction, or hypersensitivity to the active substance or any of the excipients of the test product, were not included in the study.
* Patients with specific nutritional requirements that could not be met by Ped3CB formulas were also excluded.
Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients

The main aim of the current study is to assess cardiovascular effects of remote ischemic conditioning in patients who have suffered from stroke. A group of stroke patients will be subjected to four weeks of daily remote ischemic conditioning and four weeks of placebo and vascular function is assessed as a primary outcome.

Remote ischemic preconditioning (RIC) has been shown to reduce myocardial damage in association with a myocardial infarct but less is known about the potential effects on vascular function in patients who have suffered a stroke. RIC is a procedure by which blood flow to a limb is repeatedly occluded during a short period by an inflatable cuff. This project evaluates the effect of a two week period with RIC on vascular function and cerebral blood flow velocity as well as on factors associated with blood clot formation in patients who have suffered a stroke. The study also aims to provide mechanistic insight into the beneficial effects of the RIC procedure.

Subjects are patients who within the past five years have suffered from lacunar infarct. The study is of a cross-over design with two weeks of homebased RIC treatment and two weeks of control period in a randomized order. Before and after the experimental periods the subjects undergo a number of tests assessing general health status, vascular function and cerebral blood flow velocity. Skeletal muscle samples are obtained for the determination of selected proteins related to vascular function and angiogenesis and blood samples are obtained for the determination of platelet function.

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Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms and corresponding computer tomographytomography/magnetic resonance (CT/MR)-scanning results for lacunar infarct within past five years.
* Small vessel disease stroke (lacunar infarct) is defined by the TOAST criteria

Exclusion Criteria:

Clinical significant carotid stenosis. Cardioembolic stroke

* Clinically significant chronic diseases other than lacunar infarct and associated factors
* Current or past smoker within the past ten years
* Current treatment with beta-blockers, peroral steroids or NSAIDS
* Alcohol- or drug-addiction.
* Pregnant or lactating.
* Inability to understand the content of the study information provided.
Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas

This study will evaluate the effectiveness of skin cooling in increasing tolerability of four treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 980nm laser, a 755nm laser, radio-frequency injection, and a Kybella injection. Each patient will have a treatment and a control site..


Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥18 years of age
2. Have a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria:

   1. Family history of NF1
   2. Six or more light brown ("cafe-au-lait") spots on the skin
   3. Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas
   4. Freckling under the arms or in the groin area
   5. Two or more pigmented, benign bumps on the eye's iris (Lisch nodules)
   6. A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg
   7. Tumor on the optic nerve that may interfere with vision
3. Patients must be seeking treatment for cNF
4. Patients must have ≥ 6 paired cNF (3 to be treated and 3 untreated) that are visible and measure between 2-8mm in size. These must be in areas amenable to treatment and surveillance with digital photography.
5. cNF must be located on the trunk, arms or legs of the patient
6. Able and willing to comply with all visit, treatment and evaluation schedules and requirements
7. Able to understand and provide written informed consent

Exclusion Criteria:

1. Individuals who cannot give informed consent or adhere to study schedule.
2. Actively tanning during the course of the study.
3. Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
4. Known allergy to injectable anesthetics, deoxycholic acid or polidocanol.
5. Women who are pregnant.
6. Those with acute thromboembolic diseases.
7. Those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy.
8. Those with dysphagia.
9. Any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study.
Study of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults

Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.


Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18 to 80 years
* Two blood pressure readings of \>/=135/80 mmHg at rest, thus representing prehypertension
* Informed consent

Exclusion Criteria:

* Existence of any significant internal or cardiovascular disease;
* Current use of any antihypertensive medication.
* Inability to give informed consent, or fill out standard questionnaires or inability to follow up clinically.
Reducing CVD Risk in African Americans Faith Communities

The ultimate goal of our partnership with local African-American churches is to implement an effective, multi-component intervention to increase awareness of the critical importance of healthy lifestyle in the prevention of cardiovascular disease (CVD). We will utilize the American Heart Association (AHA) prevention strategy, \&quot;Life's Simple 7\&quot; to address the major risk factors for CVD: diet, smoking, physical inactivity, hypertension, diabetes, cholesterol and obesity in order to improve overall cardiovascular health. Our main strategy consists of a community-based participatory research approach that involves focus groups to assess participant knowledge and beliefs about CVD risk factors prior to program initiation. We will also determine participant dietary and exercise practices, knowledge and perceptions related to healthy lifestyle and chronic diseases, demographic/health status information, health care utilization, biometrics (weight, blood pressure, blood tests for glucose and cholesterol, etc.) and attitudes about medical research at baseline, program completion and 6-month follow-up.

Church goers will undergo, baseline assessment of knowledge attitudes and behavior survey as it relates to CVD risk and anthropomorphic measurements. A 3 month experiential educational program will be provided at 2 locations. At 6 months after baseline a followup measure will be obtained

Eligibility Criteria:
Inclusion:

* Age \>18 yrs,
* able to consent
Time Management in Nurse Anaesthetist Students

Nurse anaesthetist student is a registered nurse who spends 1- year training in anaesthesia, has to work laboriously to cope with all assigned activities day and night. Time management, therefore, becomes a practical tool for nurse student to reach her goal. However, many factors act as barriers to nurse students' attaining and maintaining a high grade point average (GPA). Investigators would like to determine the effect of skills in time management on GPA amongst faculty nursing students.

Skills in time management are crucial for academic success. It can be defined as clusters of behavioural set that are essentials in the organisation of learning load. These are comprised of activities such as planning, prioritising, preparation, and following schedules. Consequently, it yields an impact on students' achievement.

Nurse anaesthetist student is a registered nurse who spends 1- year training in anaesthesia. She has to work laboriously to cope with all assigned activities day and night. Time management, therefore, becomes a practical tool for nurse student to reach her goal. It has many good aspects; namely, problem analysis, target determination, planning, implementation, evaluation and revision for improvement .

However, many factors act as barriers to nurse students' attaining and maintaining a high grade point average (GPA) at their training. Faculty members target all these issues in developing strategies to improve students' academic performance and learning achievement. As a result, time management would be a solution to solve these problems.

Investigators would like to determine the effect of skills in time management on GPA amongst faculty nursing students. The research questions are as follows:

1. What is the nurse student's competency on Time management?
2. What is the relationship between GPA and Time management skills among faculty nursing students?

Eligibility Criteria:
Inclusion Criteria:

* volunteered nurse anaesthetist students in 1-year training program

Exclusion Criteria:

* none
Active External Rewarming from Accidental Hypothermia - a Dose-response Pilot Study

The aim of this pilot study is to evaluate if there is a dose-response relationship between the use of active external rewarming devices and core temperature rewarming rate from simulated accidental hypothermia. Volunteer research participants will be cooled in a field laboratory, and they will recieve medications to inhibit shivering, enabeling a drop in core temperature. Subsequently, they will be treated with either one, two or four heating blankets, and analyses will be performed to investigate whether we are able to find a difference between the three groups.

The aim of this pilot study is to evaluate if there is a dose-response relationship between the use of active external rewarming devices and core temperature rewarming rate from simulated accidental hypothermia. Volunteer research participants will be cooled in a field laboratory, and they will recieve medications to inhibit shivering, enabeling a drop in core temperature. All participants will be monitored extensively using a trans-nasal esophageal temperature probe, ECG, SpO2, Blood pressure, skin temperature and with subjective scores. After the cooling phase, the participants will be treated with either one, two or four heating blankets assigned in a randomized order, and analyses will be performed to investigate whether we are able to find a difference between the three groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Normal BMI
* Smoking
Pinch Grip and Functional Outcomes Between Hematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis.

To date, there is no gold standard for the treatment of severe trapeziometacarpal joint osteoarthritis. Despite the fact that new procedures have been described, techniques such hematoma distraction or ligament reconstruction tendon interposition are still valid non-implant options. The main hypothesis was that patients treated with LTRI technique would show superior clinical outcomes at one-year follow-up in terms of tip and key pinch and DASH scores in comparison with HDA technique. As secondary objectives, complication rates and surgical times were recorded.


Eligibility Criteria:
Inclusion Criteria:

Patients who attended the hand unit's outpatient clinic at a regional trauma center with a diagnosis of grade III-IV TMC OA according to the Eaton-Littler radiological scale, who had previously failed conservative treatments (NSAIDs, splints, RHB, and corticosteroid injections) and desired surgical intervention with sufficient comprehension to participate in this study.

Exclusion Criteria:

Previous procedures on the same extremity distal to the elbow, central or peripheral neurological disease, and patient withdrawal.
Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)

The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male/ female with solid, malignant tumour which is unresponsive to standard therapies (Phase I). Female patients with advanced breast cancer with low HER2 expression (Phase II)
* Suitable for paclitaxel chemotherapy
* Life expectancy more than 12 weeks

Exclusion Criteria:

* Inadequate kidney, liver, heart, gastric, lung or eye function
* Hypersensitive to paclitaxel
* No symptomatic uncontrolled brain metastases
* Previous taxane chemotherapy within 12 months (Phase II)
Gardening Activities for the Elderly Psychological Well-Being and Depression

Purpose of the Study: This research will be conducted to determine the effects of gardening activities applied to the elderly in nursing homes on psychological well-being and depression.

Research Hypotheses H0: Gardening activities applied to the elderly in the nursing home do not affect the psychological well-being of the elderly.

H1: Gardening activities applied to the elderly in nursing homes increase the psychological well-being of the elderly.

H0: Gardening activities applied to the elderly in the nursing home do not affect the depression level of the elderly.

H1: Gardening activities applied to the elderly in nursing homes reduce the depression level of the elderly.

This study was planned as a single-blind randomized controlled experimental study.

Eligibility Criteria:
Inclusion Criteria:

* Staying in a nursing home for at least 3 months,
* Does not have a physical disability that may hinder gardening activities,
* No vision or hearing loss that may hinder gardening activities,
* Open to communication and cooperation,
* The elderly who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Having a serious medical disability (such as paralysis, Parkinson's),
* Having a serious psychiatric diagnosis,
* Severely demented and
* The elderly who do not want to continue the research will be excluded from the research.
Teen Success Project

The purpose of this study is to examine the effectiveness of Juvenile Probation Officers (JPOs) delivering Contingency Management (CM) to teens on their caseload who have problems with drug use. CM has already been shown to be effective at helping teens with drug problems but CM has never been delivered by JPOs. This study will test how well it works to have JPOs deliver CM during their regular meetings with teens.

The overarching purpose of this study is to increase justice-involved youths' access to an evidence-based practice for substance abuse, specifically Contingency Management (CM). This randomized controlled trial will examine the effectiveness of using juvenile probation officers (JPOs) to deliver CM to youth (aged 12-17 years) on their caseloads. CM is an evidence-based practice for substance abuse. The Investigators posit that JPOs are in an ideal position to deliver an evidence-based practice such as CM to youth because of their intensive involvement and frequent contact with the youth offenders under their supervision. The study randomizes 36 JPOs to 2 conditions: CM versus control (usual JPO services), and then randomizes 504 drug-abusing adolescent probationers across those 2 conditions. The research team will work with JPOs employed by the Department of Youth Services (DYS) in various counties in Oregon. JPOs will participate in focus groups and research interviews and will submit monthly audio-tapes of sessions with participating youth. JPOs randomized to the CM condition will receive training in how to deliver CM. As stated, participating youth will also be randomized to CM or control and assigned to a JPO in the same condition. For those in the CM group, the delivery of CM will be added to their regular meetings with their JPO. Research data will be collected from families via audio-taped interviews and questionnaires from youth and one caretaker. Urine samples for drug testing will also be collected from youth. Lastly, arrest records will be collected on youth for the 18 months pre- and post-entry into the study. The study involves 2 types of participants: youth (n=504) and juvenile probation officers (n=36), for a total of 540 anticipated participants.

Eligibility Criteria:
There are 2 types of participants in this study: youth and juvenile probation officers.

Inclusion Criteria for youth:

* Newly opened probation case (can have previous cases)
* 12-17 years old
* Diagnostic and Statistical Manual-5 (DSM-5) substance use disorder

Exclusion Criteria for youth:

* Pervasive developmental disorder
* Active psychotic disorder
* Severe/profound mental retardation

Inclusion Criteria for juvenile probation officers:

* Employed as a juvenile probation officer with the Department of Youth Services in a participating county in Oregon
* Serving clients aged 12-17 years old with a substance abuse problem

Exclusion Criteria for juvenile probation officers:

* Not employed as a juvenile probation officer with the Department of Youth Services in a participating county in Oregon
* Not serving clients aged 12-17 years old with a substance abuse problem
Multicentre SMS Study - FR

Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from a severely painful and/or disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement.
* Patient who will receive a Medacta SMS femoral stem.
* Patient agrees to comply with the study requirements.
* Patient has signed the consent form.
* Patient is affiliated with a social security system.
* Patient aged 18 to 75 years

Exclusion Criteria:

* Participation in biomedical research.
* Minor patient.
* Protected adult patient.
* Vulnerable individuals as defined by Article L1121-6 of the Public Health Code.
* Pregnant or breastfeeding women.
* Patient unable to express their non-opposition.
* Patient refusing the collection of their personal data.
* Acute, systemic, or chronic infection. Skeletal immaturity.
* Grossly deformed anatomy (at the surgeon's discretion).
* Osteomalacia for which the fixation of an uncemented implant is contraindicated.
* Patient suffering from active rheumatoid arthritis or osteoporosis.
* Patient with metabolic disorders likely to impair bone formation when the fixation of an uncemented implant is contraindicated.
* Patient suffering from muscle atrophy or neuromuscular disease.
* Patient with an allergy to the implant material.
* Any patient who cannot or does not wish to give their informed consent to participate in the study.
* Patient whose prospects of regaining independent mobility would be compromised by known coexisting medical problems.
* Any contraindication mentioned in the instructions for use of the investigational medical device.