cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients

The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.


Eligibility Criteria:
Inclusion Criteria:

* Requires cataract surgery;
* Acceptable health status (medical history, physical, laboratory and ophthalmologic exams);
* Able to follow instructions and willing to attend all study visits;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any known or suspected allergies/hypersensitivity to any of the investigational test product components;
* History of invasive intraocular surgery in the eye to be operated, within 4 months before enrollment;
* Use of medications, as specified in protocol;
* Severe dry eye syndrome;
* Use of contact lenses two days before surgery until the last visit;
* External eye disease, infection or inflammation of the eyes or eyelids;
* Excessive bleeding tendency;
* No vision in the eye not included in the study;
* Pregnant or breastfeeding;
* Other protocol-defined exclusion criteria may apply.
Multimodal Educative Data Feedback for Deprescribing BZD and Related Drugs in Outpatients: a Cluster RCT

Benzodiazepine (BZD) and related drugs are sedative anxiolytics and hypnotics that should be avoided especially in people aged 65 years and older, given the high risk of falling, fracture, dependence, respiratory depression and cognitive disorders. Despite these contraindications, their consumption continues to increase in Switzerland.

Although it can be assumed that deprescribing a drug has a direct benefit, it is nevertheless necessary to determine how to implement this process effectively and safely. To change healthcare professionals' prescribing behaviours for BZD, the most common deprescribing interventions include identification of appropriate patients, education and training of GPs and patients, and gradual and appropriate reduction of the dose of BZD. Thus, the DELTA CARE NETWORK and the DELTA VAUD CARE NETWORK have set themselves the task of evaluating the effectiveness of a multimodal deprescribing intervention for Delta primary care physicians and their patients aged 65 and over, in the cantons of Geneva and Vaud. The goal is to reduce the total BZD prescription rate among this population.

This quality development project is fully in line with the Quality Federal Commission's objectives of efficiency, safety, patient-centred and in the interests of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Physician who attended a quality cercle in the cantons of Geneva and Vaud
* Prescribed at least one prescription of Benzodiazepines during the year of analysis to patient aged 65 years and older
Tele Nursing Counseling on Anxiety and Patient Satisfaction in Same Day Surgery

The study was planned to be conducted as a randomized controlled experimental study to examine the effect of preoperative tele-nursing counseling on anxiety and patient satisfaction in same day surgery.

The main Research Hypotheses are; Preoperative tele-nursing counseling has no effect on anxiety in same day surgery.

Preoperative tele-nursing counseling has an effect on anxiety in same day surgery.

Preoperative tele-nursing counseling has no effect on patient satisfaction in same day surgery.

Preoperative tele-nursing counseling has an effect on patient satisfaction in same day surgery.

Power analysis was performed using the G\*Power (v3.1.7) program to determine the number of samples. The power of the study (α) was accepted as 0.05 (95% confidence level), Type 2 error probability (β) was accepted as 0.20 (80% power level) and the effect size of 0.46 in the relevant literature (Pehlivan, 2021) was taken into account, and the minimum required minimum in the groups was taken into account. It was found that taking the sample size as 74 would be sufficient. In the study, it was aimed to have a total of 148 participants, 74 for the control group and 74 for the experimental group. Considering the possible loss, the study was completed with a total of 160 patients, 80 of which were in the control group and 80 in the experimental group.

While evaluating the findings obtained in the study, SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA) program will be used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old,
* Agreeing to participate in the research,
* Persons who will undergo day surgery in the field of general surgery, urology, orthopedic surgery, plastic surgery, neurosurgery,
* GKS score of 15,
* Not addicted to alcohol
* No psychiatric problems,
* Not using antipsychotic, antidepressant and anxiolytic drugs
* According to the ASA (American Society of Anesthesiologists) classification, ASA 1-2-3 -classification
* Speech and hearing impaired
* It is planned to include patients who have an open phone in the study.

Exclusion Criteria:

* Preoperative hospitalization
* Patients undergoing emergency surgery
* Patients who want to leave the study at any stage of the study
Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.

This is a multicenter, prospective cohort. About 20,000 patients with FFR will be enrolled at multi centres in Korea.

Eligibility Criteria:
Inclusion Criteria:

* Age 35 years and older
* FFR measurement on one and more coronary artery stenosis
* Willing and able to provide informed, written consent

Exclusion Criteria:

* Stenosis with TIMI\<3 flow
* Graft vessel
* Ejection fraction \< 30%
* Angiographic evidence of extreme tortuosity or calcified coronary vessels
* Suspected coronary spasm even after sufficient nitrate injected
* Life expectancy \<2 year
* Planned cardiac surgery or planned major non cardiac surgery
* Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

Imaging study specific exclusion criteria

* visually-estimated angiographic reference segment diameter of \<2.75mm or \>4.0mm
* Inappropriate for IVUS/VH/OCT procedures : inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation
Shared Care Rehabilitation After Acute Coronary Syndrome

Cardiac rehabilitation is an individual adapted multidisciplinary intervention for people suffering from Heart Disease. It involves;

* Dietary counseling,
* Exercise training,
* Psychosocial support,
* Physician
* smoking cessation
* Patient education

The purpose is quick and complete recovery and to reduce the chance of recurrence.

In Denmark people admitted with Acute Cardiac Disease is referred to a course of hospital based cardiac rehabilitation at discharge.

The Danish Municipal Reform of 2007 changed the responsibility of rehabilitation from the Regions, who runs the hospitals, to the municipalities.

Shared care is in this setting that elements of treatment are completed different places in Health Care.

The aim of this study is:

* to establish a shared care model for Cardiac rehabilitation following admission with Acute Coronary Syndrome and
* to compare this model to the existing hospital based cardiac rehabilitation after admission with Acute Coronary Syndrome.

Primary outcome is participation in cardiac rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Admission with Acute Coronary Syndrome
* Resident in district of Department of Cardiology, Aarhus University Hospital, Silkeborg or Viborg Hospital, part of the "Hospitalsenheden Midt" Viborg, Silkeborg, Skive, Hammel.
* Accept both models of cardiac rehabilitation
* written informed consent

Exclusion Criteria:

* Resident outside the district of Department of Cardiology, Aarhus University Hospital, Viborg Hospital or Silkeborg Hospital, part of "Hospitalsenheden Midt" (Viborg, Silkeborg, Skive, Hammel).
* Age 80 years or older
* Heart Failure (Ejection Fraction less than 40%)
* Severe Comorbidity
* Resuscitated and need of support from ergotherapist after discharge.
Set-back Suture Versus Traditional Vertical Mattress Suture

The investigators hope to compare two different methods of closing skin wounds using sutures. One of these methods (the set-back technique) was recently described in 2010 and has been reported to be technically easier and reduces the chance of spitting sutures (deep sutures that are pushed to the surface of the skin as the wound heals). The other method (the vertical mattress technique) has been used for many years with good results. However, no controlled studies have been performed to clearly demonstrate a difference between the two methods. We hope to find differences in the height of the wound edges immediately after surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms associated with the scar 3 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elliptical surgical wound that needs to be closed with a layered closure
* Wound 3 cm in length or longer

Exclusion Criteria:

* Incarceration
* Active pregnancy
* Less than 18 years of age
* Unable to give informed consent
* Non-English or Dutch speaking (the scar assessment scale described below has only been validated in the English and Dutch languages)
* Wound closure projected to be less than 3 cm in length
* Skin less than 3 mm in thickness (dermis and epidermis combined)
A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes

This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.

The overall study duration will be approximately 16 weeks. After a screening/baseline period of up to 4 weeks patients will be randomized to receive either placebo tablets or Cenestin 0.3mg tablets

Eligibility Criteria:
Inclusion Criteria:

* Naturally or surgically postmenopausal
* At least 12 months since last menses or 6 weeks past surgery
* Minimum of 7 daily or 50 weekly moderate to severe hot flashes

Exclusion Criteria:

* Any contraindication to natural or synthetic estrogens
Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)

This study will investigate the efficacy and safety of the monophasic

combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in

healthy fertile Indian women.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active and at risk for pregnancy
* Of Indian descent, born in India, never emigrated out of India, with Indian

home address

* Body mass index (BMI) ≥17 and ≤35 kg/m\^2

Exclusion Criteria:

* Presence or history of venous or arterial thrombotic/thromboembolic events

or cerebrovascular accident

* Presence or history of prodromi of a thrombosis
* History of migraine with focal neurological symptoms
* Diabetes mellitus with vascular involvement
* Presence of a severe or multiple risk factor(s) for venous or arterial

thrombosis

* Severe hypertension
* Severe dyslipoproteinemia
* Presence or history of pancreatitis associated with severe

hypertriglyceridemia

* Presence or history of severe hepatic disease
* Undiagnosed vaginal bleeding
* Known or suspected pregnancy
* Currently breastfeeding or breastfeeding within 2 months of starting

trial medication

- Investigational drug use or participation in another clinical trial within

2 months of signing Informed Consent Form for current trial
LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

The purpose of this signal seeking study was to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.


Eligibility Criteria:
Inclusion Criteria:

* Patient had a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative was included), liposarcoma, CRPC, melanoma and teratoma) or hematological malignancy (except mantle cell lymphoma).
* Patient must have been pre-identified as having a tumor with CDK4 amplification or mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3 (CCND3) amplification, or p16 (CDKN2A) mutation
* Patient had received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
* Patient had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
* Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

* Patients had received prior treatment with LEE011.
* Patient had clinically significant resting bradycardia (heart rate \< 50 at rest), tachycardia (heart rate \> 90 at rest), PR interval \> 220 msec, QRS interval \> 109 msec, or QTcF \> 450 msec.
* Patients had primary CNS tumor or CNS tumor involvement
* Patient had received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug
Effects of Carnitine Supplementation on Liver and Muscle

It will be evaluated whether carnitine, a dietary supplement, reduces liver fat and improves metabolism in individuals who have a high concentration of fat within their liver. Participants will be given either Carnitine or placebo, together with a meal replacement milkshake twice daily for 6 months.

NAFLD occurs when too much fat accumulates in liver tissue. This can, over time, cause inflammation and scarring of the liver, eventually leading to chronic liver disease and cirrhosis. It is strongly associated with diabetes and obesity, both of which are endemic in Western societies.

Carnitine enables cells in the body to use fat as a fuel, and recent studies have suggested that carnitine supplementation may reduce liver triglyceride content. Muscle and liver are the major sites in the body which coordinate glucose and fat metabolism. As well as assessing the effect of carnitine supplementation on liver fat, its effect on metabolic processes within these tissues will also be measured

Eligibility Criteria:
Inclusion Criteria:

* Elevated liver fat on screening abdominal ultrasound
* Capable of providing informed consent
* Non-vegetarian diet
* BMI \<40 kg/m2
* Weekly ethanol consumption \<21 units/week
* Negative non-invasive liver screen, including Hepatitis B and C serology, liver autoantibodies, transferrin saturation, α1-antitrypsin levels.

Exclusion Criteria:

* Known history of cardiovascular disease
* Known diabetes mellitus
* Known psychiatric comorbidity
* Chronic kidney disease
* Surgery within 6 months prior to start of study
* Exposure to drugs known to influence hepatic steatosis (including steroids, statins, omega-3-fatty acids)
* Current smokers
* Contraindications to magnetic resonance scanning, including implanted ferrous material (implantable pacemakers or defibrillators), metallic ocular foreign bodies, ferromagnetic aneurysm clips or severe claustrophobia.
Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under GA

To assess Oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with special healthcare need.

* The study will be conducted in Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt.
* Demographic variables (caregiver age and gender), socio-economic condition, , medical history, and dental history will be collected from the parent or caregiver. The height and weight of each child will be measured in the same manner to standardize the result and their body mass index will be calculated before and after in follow up period.
* On the day of the GA, parent or caregiver will complete questionnaires about their child's oral state and well-being over the previous 3 months and oral hygiene instructions will be given to the parent.
* The questionnaire will be delivered to the parents/caregivers at baseline and at the 6-month post-operative follow-up visit. Dental examination will be assessed at baseline (pre-operatively) and at 1,3, 6, months post-operative visits.

Eligibility Criteria:
Inclusion Criteria:

1. Age range 5 to 14 years.
2. Diagnosed with physical, mental, or sensory disability (separately or combined).
3. Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.

Exclusion Criteria:

1. Participation in any other concurrent clinical trials.
2. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
3. Children whose parents had no home or mobile phone to enable post-operative contact.
4. Parent that will not sign the consent.
Does Re-surgery Improve Somatosensory Outcomes in Persistent Pain After Groin Hernia Repair

Groin hernia repair is accompanied by persistent severe pain in 2-4% of the patients significantly restraining psychophysical functions. Re-surgery with meshectomy and selective neurectomy may improve the pain condition, compared to non-surgical alternatives. In the current study, the primary objective was to examine and describe the underlying pathophysiological perturbations by quantitative somatosensory testing before and after re-surgery.

Persistent severe pain occurring in the aftermath of a surgical procedure is frequently associated with significant impairment of physical and psycho-social functions. After groin hernia repair (GHR), 2-4% of patients develop persistent severe pain. The GHR procedure, previously considered belonging to "minor" surgeries, qualifies as a rather complex procedure performed in a territory with a high density of nerve fibers, accommodating essential functions for locomotion and reproduction. More than 20 million repairs are performed annually worldwide, and consequently, it is estimated that 400.000-800.000 patients each year will develop persistent severe pain after the groin hernia repair (PSPG). Management of PSPG is medically challenging and may require re-surgery with mesh removal and selective neurectomy. After re-surgery for pain after open primary GHR, a potential pain-relieving effect, as well as an improvement of the deteriorated physical functions, has been demonstrated.

Quantitative somatosensory testing (QST) is an investigational psychophysiological tool with the potential to uncover the putative pathophysiological substrate in PSPG, i.e., neuropathic and inflammatory constituents. The method may also be used to quantitate changes induced by the re-surgery. Since re-surgery is a neuroablative procedure, essentially performed in previously damaged tissue, it is of interest to examine the extent of neurological perturbations, i.e., 'loss' and 'gain' of sensory functions and the relation to clinical outcome measures.

The authors are only aware of one previous PSPG-study (n = 21) finding that re-surgery, including meshectomy and selective neurectomy, was associated with increased pain pressure thresholds, decreased pain ratings and improved pain-related functional measures. The objectives of the current study, comparing pre with post-re-surgery data, were first to perform a more detailed analysis of the quantitative somatosensory data regarding 'loss' and 'gain' of sensory functions and their relation to clinical outcome measures. Second, to corroborate the clinical outcome findings of the previous study using a threefold larger cohort.

Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent severe pain (activity-related or maximal pain intensity \> 7 NRS-scores \[numeric pain rating scale 0-10\]) following unilateral, uncomplicated, open groin hernia repair.

Exclusion Criteria:

* All that contradicts the above.
A Comparative Efficacy Study of DermaPure™ to Treat Diabetic Foot Ulcers

This study has been designed to help determine how safe and effective DermaPure™ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care.

DermaPure™ is a decellularized dermal skin substitute using the Tissue Regenix dCELL® patented Technology to remove cells and other components from human and animal tissue while maintaining the native structural and biomechanical properties. The primary objective of the study is to establish the wound healing performance and safety of DermaPure™ over a 12 week period, when administered to "hard to heal" chronic, neuropathic diabetic foot ulcers. This study has been designed to compare the performance of DermaPure™ (in combination with standard care) versus standard care alone.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes with HbA1c ≤12%
* Adequate perfusion
* A full thickness chronic, neuropathic diabetic foot plantar ulcer defined by Texas or Wagner classification.
* Target ulcer decreases in size (surface area) by less than 30% in the 2 week screening period.

Exclusion Criteria:

* BMI greater than 45kg/m2.
* Presence of infection
* Presence of necrosis, purulence or sinus tracts that cannot be removed by aggressive debridement.
* A clinical diagnosis of an active/acute Charcot neuroarthropathy. Inactive/chronic Charcot does not exclude the patient.
* Therapy with any investigational agent or drug within 4 weeks preceding the screening visit.
* More than 2 weeks treatment with immunosuppressive agents within 3 months of enrollment.
* Evidence of malnutrition as confirmed by serum pre-albumin level at screening.
* Evidence of drug or alcohol abuse,
Effects of Fatty Acid Supplementation on Substance Dependent Individuals

Many substance dependent individuals continue to abuse a variety of substances during treatment for their disorder. Often, substance dependent individuals are co-diagnosed with depression and violence problems. Supplements of n-3 polyunsaturated fatty acids (PUFAs) may play a role in treating individuals with such substance abuse problems. The purpose of this study is to evaluate the effectiveness of the n-3 PUFAs eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA) in treating relapse, aggression, and depression in substance dependent individuals.

Past research suggests that low levels of some PUFAs play a role in the pathophysiology of depressive and aggressive disorders. In addition, there is also evidence that PUFAs play a role in treating substance dependent individuals. The purpose of this study is to determine the efficacy of EFA and DPA in treating substance dependent individuals.

Participants will be randomly assigned to receive either 3 grams of n-3 PUFAs or placebo. Treatment will last 3 months, followed by an observation period of 3 months. Study visits will occur monthly and will last approximately one hour. Study visits will include blood tests and a physical exam. Throughout the study, participants will continue to receive standard substance abuse treatment and will complete urine tests at regular intervals.

Eligibility Criteria:
Inclusion Criteria:

* Current or history of drug or alcohol dependence
* Used substances of abuse during the 3 months prior to study entry
* Enrolled in one of the VA New York Harbor Healthcare System Brooklyn campus substance abuse clinics

Exclusion Criteria:

* Current or history of hallucinations, delusions, or memory problems
* Major physical illness (e.g., cardiovascular, pulmonary, gastrointestinal, renal, neuromuscular, or endocrine disorder)
* Liver function test greater than one standard deviation above upper normal limit
* Allergic to fish