cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens Wearers

The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in gas permeable lens wearers.

Subjects with normal eyes (other than correction for refractive error) successfully wearing silicone acrylate or fluoro silicone acrylate gas permeable contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Eligibility Criteria:
Inclusion Criteria:

* Normal eyes (other than correction for visual acuity);
* Successful history of gas permeable contact lens wear in both eyes in one of two brands: Boston XO or Boston II;
* Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
* Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
* Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
* History of intolerance or hypersensitivity to any component of the investigational products;
* Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
* Moderate, severe, abnormal, or other ocular findings;
* Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
* Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
* Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
* Ocular surgery within the last 12 months;
* Other protocol-defined exclusion criteria may apply.
Cognitive Training for Older Caregivers

The purpose of this study is to test whether certain brain training activities can promote cognitive, emotional, and physical health in caregivers of a loved one with dementia. Numerous studies show that family dementia caregiving can be stressful, and can increase mental and physical health risks. This study aims to understand how to reduce those risks.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking (consent process and assessments will be conducted in English only)
* Currently living with or in proximity to, and the primary caregiver for a loved one with dementia who lives in the community-for the purposes of this study, "loved one" refers to a family member such as a spouse, ex-spouse, significant other, sibling, in-law, parent, or other type of close established relationship (e.g., close friend) regarded as family; "primary caregivers" provide daily informal (non-paid) in-person care.
* Currently experiencing moderate to high levels of perceived stress and caregiver burden. Caregivers will be screened for stress levels and caregiving burden using the 10-item Perceived Stress Scale (PSS 10) and the Modified Caregiver Strain Index (MCSI), respectively. Caregivers scoring above the population mean (approx.) on the PSS 10 (\> 11), reporting at least moderate caregiver strain (score ≥ 5) on the MCSI will be eligible for participation.

Exclusion Criteria:

* cognitive impairment or dementia (identified by the Montreal Cognitive Assessment (MoCA)). Cutoff scores on the MoCA will be 23 or lower except for subjects who identify as black or African American, in which case cutoffs will be based on scores from the sample population reported in Rossetti et al (2017); subjects scoring greater than one standard deviation below the published score, by respective age and education, will be excluded.
* current major depression (current Major Depression diagnosis and/or Geriatric Depression Scale (GDS 15) score ≥ 10)
* no recent (within 2 months) major surgery
* History of events that cause neurological injury (e.g., stroke, transient ischemic attack, traumatic brain injury or head injury with loss of consciousness)
* Serious psychiatric or alcohol/substance use disorders, including current alcohol dependence, current non-alcohol psychoactive substance use dependence, psychotic disorders or features (current and lifetime), bipolar disorder (determined from Mini International Neuropsychiatric Exam (MINI) modules)
* Autoimmune disorder (e.g., Crohn's disease, lupus, rheumatoid arthritis)
* Active neoplastic disease or receiving immunosuppressive therapy for cancer (or \< 6 months post-chemo or radiation) or other diseases (\< 3 months prior to enrollment)
* No significant immunodeficiency disorder (e.g., alymphocytosis, hepatitis B or C, HIV)
* Serious cardiovascular disease (e.g., congestive heart failure, pacemaker) or myocardial infarction within past 6 months
* Physical condition precluding required activities as part of the computerized cognitive training (e.g., inability to use a computer mouse; inadequate visual acuity)
Symbicort SMART Satisfaction From Patient Perspective 2009

To characterize the level of asthma control and patient satisfaction amongst diagnosed asthma sufferers who are currently receiving Symbicort Maintenance and Reliever Therapy (SMART) in Malaysia.


Eligibility Criteria:
Inclusion Criteria:

* Have been prescribed Symbicort SMART (1 or 2 inhalation twice daily) by their Dr's for the past 3 months
* Informed consent

Exclusion Criteria:

* Symbicort SMART treatment \< 3 months
* Patients requiring short courses of oral steroids more than twice in a month
Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia

Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the most frequently applied method is laparoscopic total extraperitoneal repair (TEP). In general, this surgery is performed under general anesthesia (GA) in many centers. However, in cases where general anesthesia is inconvenient, local or other anesthesia methods are preferred.

It has been stated in many studies in the literature that this surgery can be performed with methods other than general anesthesia. In a study of 480 patients, one of which was Sinha et al., it was shown that this surgical procedure was successfully performed under spinal anesthesia (SA).

In a prospective randomized study by Dönmez et al., patients who underwent TEP under general anesthesia and spinal anesthesia were compared. It has been reported that TEP repair can be performed safely under SA and that SA is associated with less postoperative pain, better recovery, and better patient satisfaction than GA.2 In a retrospective study by Yıldırım et al. It has been shown that there is significantly less need for analgesics and better patient satisfaction.

There are also many meta-analyses made on this subject in the literature. Compared with GA in these, SA was associated with a longer operative time, and postoperative pain and nausea and vomiting were less in SA. However, the risk of urinary retention in SA was significantly increased. It was observed that there was no significant difference in surgical complications such as seroma and wound infection.

Despite all these studies, until now, there is no clear consensus on which anesthesia should be used.

The aim of the study is to show the effect of both the surgical method and the anesthesia method on the patient during surgery and in the early postoperative period in inguinal hernia

Patients who underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair and open surgical procedure (Lichtenstein) with the diagnosis of inguinal hernia will be divided into 2 groups. General anesthesia (GA) will be applied to the 1st group, and ileoinguinal (II) and ileohypogastric (IH) nerve block together with spinal anesthesia (SA) to the 2nd group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inguinal hernias.
* Over 18 years old

Exclusion Criteria:

* Younger than 18 years
* Those who have had previous abdominal surgery,
* Incarcerated or strangulated inguinal hernias,
* Recurrent hernias,
* Coagulopathies,
* Patients with musculoskeletal deformity,
* Those with chronic pain,
* Those who use drugs that affect the central nervous system daily,
* Those with a body mass index (BMI) over 40 kg/m2,
* Patients with contraindications to the recommended anesthetic technique.
Biological Monitoring by a Nurse for Heart Failure Patients.

The aim of this study is to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

Chronic heart failure is a major public health issue in France. It is the leading cause of hospitalisation in people over 65 years of age and results in many costly and potentially avoidable hospital stays. One third of patients are readmitted to hospital within 3 months of discharge.

A remote monitoring programme and natriuretic peptide monitoring during this vulnerable period can help improve patient management, reducing rehospitalisation rates, emergency room visits and mortality.

Given the increasing pressure on already limited healthcare resources, it is important to examine the delegation of care to specialist nurses, as well as their safety.

This study aims to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18 years old,
* Patient hospitalised for heart failure and discharged,
* Glomerular filtration rate at discharge \> 20ml/min/1.73m²,
* Patient informed and agree to participate,
* Patient able to carry out the follow-up proposed by the cardiology department.

Exclusion Criteria:

* Cognitive disorders with Codex test category C and D,
* Barrier of the language,
* Psychiatric disorder that may interfere with treatment,
* Major surgery scheduled within 3 months,
* Excessive alcohol or drug use with no desire to withdraw
* Cardiac amyloidosis,
* Terminal heart failure,
* Patient discharged to specialised Care and Rehabilitation department,
* Any disease other than cardiac with a life expectancy of less than 1 year according to the investigator,
* Patient under guardianship,
Effect of the XP1100RF Therapy on Thighs Circumference Reduction

This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive temporary reduction of thighs circumference by disruption of adipocyte cells.

This study is a prospective, single-arm, open label study of thighs circumference reduction following 4 treatment sessions delivered once a week over a 4-week period. The objective of the study is to demonstrate the effectiveness of the treatment after 30-day in achieving thighs circumference reduction of ≥1 cm relative to the base line assessment.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 20 to 35 kg/m2.
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation.

Exclusion Criteria:

* Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
* Diabetics dependent on insulin or oral hypoglycemic medications
* Known cardiovascular disease such as arrhythmias, congestive heart failure
* Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
* Prior surgical interventions for body sculpting of thighs such as liposuction
* Medical, physical or other contraindications for body sculpting/ weight loss
* Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
* Any medical condition known to affect weight levels and/or to cause bloating or swelling
* Active infection, wound or other external trauma to the area to be treated
* Pregnant, breast feeding, or planning pregnant before the end of the study
* Serious mental health illness
* Active or recurrent cancer or current chemotherapy and/or radiation treatment
* Negative affection to heat
Sickle Cell Children's Exercise Study (SuCCESs)

The Sickle Cell Children's Exercise Study (SuCCESs) will explore the feasibility and effects of a moderate intensity strengthening, balance, speed, and agility intervention program in children with sickle cell disease.

Participants will perform the baseline assessment and after six weeks of performing the SuCCESs program the participants will perform a post-intervention assessment. Participants will be asked to attend a total of six physical therapy in-person sessions (1x/week) at the University of Maryland Department of Physical Therapy and Rehabilitation Science and to perform 12 home program sessions.

Eligibility Criteria:
Inclusion Criteria:

* Children 6-17 years of age diagnosed with sickle cell disease

Exclusion Criteria:

* Diagnosis of neurological disorder, not related to sickle cell disease
* Lower extremity injury such as a fracture with a cast
The Outcome of Healing Intraoral Sinus Tract With a Single or Multi-visit With Bioceramic Sealer

The aim of clinical trial is to see is there any difference in the outcome of healing of the intraoral sinus tract when treat in single or multi-visit root canal treatment by an endodontist.

Methods and material :

Inclusion criteria as follows:

Tooth with a sinus tract and radiographic evidence of periradicular bone destruction, Tooth with a necrotic pulp confirmed by pulp tests or with previous root canal treatment, Tooth that was restorable and had an indication for root canal treatment or retreatment, Tooth with a mobility score \<3 Absence of periodontal pockets \>4 mm deep Patients without significant systemic disease.

Two groups will be divided into:

Group A: will treat in a single visit. The treatment protocol will be: cleaning and shaping by NITI file ( pro taper gold ) with Naocl 5.25%, EDTA 17% and saline then the canal will be obturate by single cone technique with bioceramic sealer.

Group B: will treat in a multi-visit. The treatment protocol will : cleaning and shaping by NITI file ( pro taper gold ) with Naocl 5.25%, EDTA 17% and saline then ca(oh)2 use as Intracanal medication the after disappear the sinus tract the canal will obturate by single cone technique with bioceramic sealer.

Follow-up examinations were performed at 7, 14, and 30 days postoperatively.

According to the clinical, the outcome was classified as:

1. Healed: the sinus tract disappeared completely.
2. Healing: the sinus tract getting smaller and can't be traced with small gutta-percha ( we need to mention GP size)
3. failed: the sinus tract persisted more than 30 days after treatment

Eligibility Criteria:
Inclusion Criteria:

Tooth with a sinus tract and radiographic evidence of periradicular bone destruction, Tooth with a necrotic pulp confirmed by pulp tests or with previous root canal treatment, Tooth that was restorable and had an indication for root canal treatment or retreatment, Tooth with a mobility score \<3 Absence of periodontal pockets \>4 mm deep Patients without significant systemic disease.

Exclusion Criteria:

Tooth without a sinus tract . Tooth that was not restorable Tooth with a mobility score \>3 Absence of periodontal pockets \<4 mm deep Patients with significant systemic disease.
The Possible Influence of Health Promotion Coaching on Health Related and Organizational Outcomes Among Nurses

Strong evidence shows that physical activity (PA) has favorable psychological and health related outcomes. However, most employees do not perform enough PA to achieve health and well being benefits. Worksite interventions aimed at improving PA often yield modest effect sizes, and their theoretical ground is not profound. The Health Action Process Approach (HAPA), is a novel comprehensive theoretical model for health behavior change, that hasn't been studied as a whole in a worksite intervention study.

The objectives of the proposed study are:

1. To develop a coaching-based group intervention that will be both grounded in theory (HAPA) as well as applicable.
2. To evaluate the feasibility of conducting this intervention among employed hospital nurses, using a randomized controlled design, interviews and other evaluation procedures.

The proposed study will offer the most comprehensive empirical test to date of the full HAPA model.


Eligibility Criteria:
Inclusion Criteria:

* Nurses working in a full time capacity at Tel-Aviv Sourasky Medical Center.

Exclusion Criteria:

* None nurses or nurses working part-time at Tel-Aviv Sourasky Medical Center.
* Nurses not working at Tel-Aviv Sourasky Medical Center.
Study of Meloxicam Capsules to Treat Osteoarthritis Pain

The purpose of this study is to determine whether Meloxicam \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Functional Class I-III OA of the hip or knee
* Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen for OA pain
* Discontinued all analgesic therapy at Screening
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control

Exclusion Criteria:

* History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
* Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
* Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
* Significant difficulties swallowing capsules or unable to tolerate oral medication
* Previous participation in another clinical study of Meloxicam Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening
Hypothermia for Cardiac Arrest in Paediatrics

The investigators hypothesized that, following cardiac arrest in pediatric patients, hypothermia therapy will improve the proportion of patients with a good functional outcome compared to a normothermic control group.

Cardiac arrest is associated with a high morbidity and mortality in children and hypothermia therapy has the potential to be beneficial in children following cardiac arrest. We have a track record of both clinical and laboratory research of hypothermia therapy following cardiac arrest at the Hospital for Sick Children and have completed a 3-site randomized controlled pilot study of hypothermia therapy following cardiac arrest in children funded by The Hospital for Sick Children Research Institute and the Heart and Stroke Foundation of Ontario. This protocol was used to develop the protocol for the THAPCA trials (see 2 manuscripts published Moler et al NEJM 2015 and 2017 and multiple other manuscripts). Hypothermia therapy, compared to active maintenance of normothermia, had no beneficial effect on functional outcome or mortality in children with out-of-hospital or in-hospital cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent by parent or legal guardian
* Age ≥ 38 weeks gestation up to and including 17 years
* Patient admitted with a diagnosis of a cardiac arrest requiring compressions ≥3 minutes
* Remain comatose i.e. have Glasgow Coma Score less than or equal to 10 assessed at the tertiary level pediatric hospital at least 1 hour post- cardiac arrest
* Invasive mechanical ventilation

Exclusion Criteria:

* Cardiac arrest lasting ≥45 minutes, irregardless of commencement of ECMO
* Refractory hemorrhagic shock
* Dysrhythmia leading to cardiac arrest, where cooling would be part of standard therapy
* Suspected diagnosis of brain death as defined as fixed and dilated pupils, Glasgow Coma Score of 3 and no evidence of brain function on neurological examination
* Patients who have had a prolonged cardiac arrest at the scene of a trauma
* Decision to withhold (DNR) or withdraw life sustaining therapies
* Acute Birth asphyxia
* Terminal illness, not expected to survive 12 months
* Cardiac arrest caused by septic shock
* Severe neurodevelopmental disability or persistent vegetative state prior to cardiac arrest
* Near drowning in ice water and temperature \<32ºC on admission to study site
* It has been more than 6 hours following cardiac arrest (estimated by first responder)
* Previous enrolment in the HypCAP Pilot Study
* Pregnant
* Parent/Guardian refuse consent
* Responsible physician refuses to enrol patient
Effect of Simulation Based Safety Mobilization Program on Patient Outcomes

The aim of the study was to evaluate the effect of safe mobilization training given to nurses through simulation-based learning method on patient care results.. The main questions it aims to answer are:

Is the safe mobilization training given to nurses by simulation-based learning method effective on the performance of nurses? Is the safe mobilization training given to nurses through simulation-based learning effective on patient outcomes?

Researchers will compare drug ABC to a placebo (a look-alike substance that contains no drug) to see if drug ABC works to treat severe asthma.

Nurse Participants will:

Experimental group: Take simulation based safety mobilization program for 4 weeks Control group: Theoretical education for 1 week (two hours)

Patient Participans will:

He/she mobilized by experimental/control groups nurse and care outcomes are measured for 1 week (once before and after practice)


Eligibility Criteria:
Nurses Inclusion Criteria:

* Agreeing to participate in the study,
* Having no simulation-based learning experience before the study,
* Being a bachelor's degree,
* Being actively working in the data collection process.
* Working in the Surgery Clinic for at least 3 months.

Patient Inclusion Criteria:

* Agreeing to participate in the study,
* Not having a mental or cognitive disease
* Having undergone major surgery

Nurses Exclusion Criteria:

* Be a simulation-based learning experience
* Have less than 3 months of professional experience

Patient Exclusion Criteria:

* Having undergone minor surgery
* Having a mental or cognitive disease