cyrilzakka/clinical-trials huggingface dataset:
A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides

This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar lines and crow's feet lines).


Eligibility Criteria:
Inclusion Criteria:

* Glabellar lines and crow's feet lines
* No prior use of botulinum toxin therapy of any serotype for any reason

Exclusion Criteria:

* Previous facial cosmetic surgery, tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers
* Planning a facial cosmetic procedure during the study period
* Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, and/or amyotrophic lateral sclerosis
* Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
ASPIRE (Aub-haS2 Plus bIomaRkErs)

ASPIRE is a prospective, multicenter, observational study that will assess the performance of AUB-HAS2 to predict the occurrence of major adverse cardiovascular events 30-days after a non-cardiac surgery and the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac procedures.

Primary objectives:

Primary objective of the validation arm: to analyze the accuracy of the AUB-HAS2 index in predicting the occurrence of myocardial infarction, stroke and death within 30 days after non-cardiac surgeries.

Primary objective biomarker arm: to analyze the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac surgeries.

Secondary objectives:

To analyze the potentially preventable factors related to adverse outcomes after non-cardiac surgeries in order to offer subsidies for more assertive guidelines regarding the implementation of perioperative protection strategies. Compare the performance of these scores with others that have already been validated (ACP and Lee - see Annex A).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years, in the preoperative period of non-cardiac procedures, with expected hospitalization for at least 24 hours postoperatively.

Exclusion Criteria:

* Refusal to sign the informed consent form.
The Adverse Event of Mitotane Therapy in Patients With Adrenocortical Carcinoma

This work will evaluate the adverse effects of mitotane treatment in patients treated for ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023 and May 2024.

Background: Adrenocortical Carcinoma (ACC) is a rare malignancy of the adrenal cortex. The annual incidence of ACC is thought to be between 0.5-2.0 cases per million. Adjunctive therapy with mitotane may be offered post- surgically to minimise risk of recurrence.

Aims: Evaluate the adverse effects of mitotane treatment in patients treated for ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023 and May 2024.

Methods: Cortisol, ACTH, Gastrointestinal reactions and CNS Toxicity will be measured. SPSS v27 and GraphPad Prism v9.3.1 will be used for analysis and illustrations. Patients will be included, within ACC with mitotane. Data will be tested for normality, described as Mean± SD, compared using paired sample t-test with 5% p-value for significance and 95% confidence interval (CI).

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years old and ≤ 75 years Diagnosis of Patients with adrenocortical cancer Gender: males and females Provide written informed consent Satisfactory compliance

Exclusion Criteria:

Patients with renal insufficiency (Cr\>2 times the upper limit of normal). Patients with a history of liver cirrhosis. Patients who are currently using corticosteroids. Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF\<50%).

Patients with stroke and acute myocardial infarction in the past 6 months. Patients during pregnancy and lactation
Microfracture at Proximal Humerus Lateral to Footprint Could Enhance the Rotator Cuff Healing

The goal of this clinical trial is to test whether there is any effect on rotator cuff healing by making microfracture at the lateral side of the footprint. The main question it aims to answer are:

* \[whether the lateralized microfracture could decrease the retear rate after arthroscopy rotator cuff repair.\]
* \[whether the lateralized microfracture could improve the functional recovery after arthroscopy rotator cuff repair.\] Participants with medium to larger size rotator cuff tears will be randomly assigned to the study group treated with lateralized microfracture immediately after arthroscopy rotator cuff repair or the control group treated with conventional arthroscopy rotator cuff repair without microfracture.


Eligibility Criteria:
Inclusion Criteria:

1. Medium to large Rotator cuff tear(1cm-5cm) diagnosed by MRI
2. Patients can complete the follow-up and comply with all post-operative rehab instructions
3. Failure of non-operative treatment for at least 3 months

Exclusion Criteria:

1. Revision rotator cuff surgery
2. Partial thickness rotator cuff tears
3. Small (less than 1cm) and Massive (greater than 5cm) rotator cuff tears
4. Disease history of the affected shoulder
5. Systemic immune diseases
6. Irreparable rotator cuff tear
STS & ACC Foundation's Transcutaneous Valve Therapy (TVT) Registry Foundation's Transcutaneous Valve Therapy (TVT) Registry

The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies.

The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. Patient-level data are submitted by participating hospitals to The Society of Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving TVT; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; and (iii) permitting and fostering appropriate research based upon the data collected by means of the TVT Registry.

The secondary aim of the TVT Registry is to serve as a scalable data infrastructure forpost market studies.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18 and older) who undergo an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.

Exclusion Criteria:

-
Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients

Peritoneal dialysis (PD) is an important model of renal replacement therapy for end-stage renal disease (ESRD) patients. Thus far, evidence for the initiation dosage of PD treatment is lacking, most patients begin their PD with four 2 L exchanges per day. However, many patients have their residual renal function at the initiation of PD, an 8 L dialysate per day will enhance the toxicity of bioincompatible dialysate and increase the economic burden compared with that of 6 L dialysate per day. Thus, the investigators perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6 L of dialysate per day and 8 L of dialysate per day, follow up will be regularly performed until 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.

To investigate the effect, feasibility and safety of 6L of dialysate per day after initiation of peritoneal dialysis (PD), we perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6L of dialysate per day and 8L of dialysate per day, follow up will be regularly performed at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks and 96 weeks. Serum biochemical parameters, Kt/V, residual renal function (RRF), life quality and cardiovascular test will be regularly recorded. Clinical outcomes such as mortality, technique failure, complications and life quality between the two groups will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 80, male or female.
2. End stage renal disease patients (eGFR \< 15 ml/min/1.73 m2).
3. Maintenance peritoneal dialysis within 6 months after initiation of PD.
4. With informed consent.

Exclusion Criteria:

1. Acute renal injury.
2. Patients with an expected follow up less than 6 months sch as renal transplantation.
3. Transferred from hemodialysis or renal transplantation.
4. Residual renal function eGFR less than 1 ml/min.
5. HIV positive.
6. Cancer patients.
7. Unstable organ disease such as active tuberculosis and severe hepatitis. Patients with an expected follow up less than 48 weeks, such as planned kidney transplant.
8. Other conditions regarded as unsuitability by investigator, such as pregnancy, severe malnutrition and recent peritonitis.
Assessing the Feasibility of the MSPT Device in Routine Clinical Practice in the Swiss Healthcare System

The Multiple Sclerosis Functional Composite (MSFC), a reliable and well-validated instrument, was developed as a multidimensional quantitative measure of neurologic disability in MS. However, the traditional form of the MSFC has various limitations, including the need for MS patients to be assessed in a clinical setting by trained technicians, which requires additional human resources and time in a clinical routine practice setting. Furthermore, storage of MSFC data for longitudinal comparison is difficult and time consuming. The MS Performance Test (MSPT) software tool is designed to objectively quantify the major motor, visual and cognitive function data, and quality of life outcomes, associated with MS and related disorders.

This is a single center observational study that will examine the use of the MSPT in a real world setting. Study enrollment will occur at one center in Switzerland.

Study participation will be offered to MS patients either on day of clinic visit. Patient screening, consent discussion and MSPT test completion is estimated to take approximately an hour prior to the appointment with the treating physician. Participants begin with an instructional overview, which acquaints them with all elements of the MSPT. The tests will be performed in the same order and if a study participant elects to discontinue testing or skip a module, they will be asked to indicate the reasons on the screen. Each module has accompanying instructions.

Upon completion of testing at first and last study visit, patients, research nurse/coordinator and treating physician will be asked to fill in a short satisfaction questionnaire related to the functionality of the MSPT.

HCPs will have the ability to view de-identified longitudinal MSPT outcomes for each patient on the MSPT tool.

De-identified data abstracted from each site will be stored in a cloud-based data repository. Access to the MSPT Cloud and data therein is restricted to the healthcare institution using the registered MSPT tool. The site will periodically send de-identified and encrypted aggregate data to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
* Diagnosis of MS, including Clinically Isolated Syndrome (CIS)
* Ability to understand the audio and visual instructions for the test modules
* Visual function, based on the investigator's clinical judgement, that does not preclude an ability to interact with the MSPT.

Exclusion Criteria:

* Unable or unwilling to provide informed consent.
* Patients under 18 years of age will be excluded.
* Other unspecified reasons that, in the opinion of the Sponsor-Investigator, make the patient unsuitable for participation in the demonstration project. A patient only needs to complete the assessments deemed appropriate by the Sponsor-Investigator.
Special Drug Use Investigation for ALLERMIST (Long Term)

This post-marketing surveillance study is to investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray for long-term use in Japanese subjects with allergic rhinitis under the conditions of actual practical use.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of allergic rhinitis
* Use ALLERMIST for the first time
* Expected to use ALLERMIST for long-term (1 year).

Exclusion Criteria:

* Subjects with infection which fluticasone is not effective
* Subjects with deep mycosis
* Subjects with hypersensitivity to fluticasone
Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety

In this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be:

1. To test the hypothesis that PGY2\&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses)
2. To test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2\&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events and near misses)
3. To test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks \[Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses\] - will be lower on the SCS intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)


Eligibility Criteria:
Inclusion Criteria:

* Must be a second or third year resident of pediatrics or a combined pediatrics program

Exclusion Criteria:

-
Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status of use.

This study will be conducted with all-case investigation system in patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis.

This study will be conducted in patients who used this drug after the day of approval of dosage and administration for psoriasis at contracted medical institutions. Patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included).

Therefore, Time Perspective is retrospective and prospective.

Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who started treatment with this drug
* Patients who received this drug for the first time at the medical institution after the day of launch of this drug.
Metabolic Syndrome of Occupational Drivers

The purpose of this study is to discover the health status of occupational drivers. The health status includes data collection of body mass index, blood pressure, central obesity, anxiety scale scores, smoking habit and related cessation therapy, etc.

Occupational drivers' health is essential for passengers' safety. However, occupational drivers' health is damaged by long-term sitting and driving, lack of exercise, stress from traffic, and irregular diet. The objectives of this study were to assess the health status of occupational drivers in Taiwan. The measures included blood pressure, central obesity, fasting blood sugar, triglyceride, body mass index (BMI), anxiety scale scores, and metabolic syndrome, etc.

Eligibility Criteria:
Inclusion Criteria:

* metabolic syndrome
* hypertension
* anxiety scale scores

Exclusion Criteria:

* hyperuricemia
Urinary Tract Infections in Cirrhosis

Evaluate the prevalence and types of urinary tract infections, the features of the gut and urinary tract microbiota in cirrhosis, to assess its importance in the development of complications and outcomes of cirrhosis.

Asymptomatic bacteriuria in an individual without urinary tract symptoms is defined by a mid-stream sample of urine showing bacterial growth \> 105 cfu/mL in two consecutive samples in women and in one single sample in men. A complicated urinary tract infections occurs in an individual in whom factors related to the host (e.g. underlying diabetes or immunosuppression) or specific anatomical or functional abnormalities related to the urinary tract. Laboratory urine culture is the recommended method to determine the presence or absence of clinically significant bacteriuria.

Catheter-associated urinary tract infections refers to urinary tract infections occurring in a person whose urinary tract is currently catheterised or has been catheterised within the past 48 hours. Signs and systemic symptoms compatible with сatheter-associated urinary tract infections include new onset or worsening of fever, rigors, altered mental status, malaise, or lethargy with no other identified cause, flank pain, costovertebral angle tenderness, acute haematuria, pelvic discomfort and in those whose catheters have been removed dysuria, urgent or frequent urination and suprapubic pain or tenderness. Microbiologically, сatheter-associated urinary tract infections is defined by microbial growth of \> 103 cfu/mL of one or more bacterial species in a single catheter urine specimen or in a mid-stream voided urine specimen from a patient whose urethral, suprapubic, or condom catheter has been removed within the previous 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of cirrhosis

Exclusion Criteria:

* human immunodeficiency virus or acquired immune deficiency syndrome
* autoimmune diseases
* oncology
* organ transplantation
Safety and Surgical Performance Study of Aurosleek Surgical Blades

To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.

Cataract till today remains the most common yet treatable cause of blindness accounting for more than 50% of blindness and visual impairment in the developing world. One of the most important features of a blade for cataract surgery is its predictable and repeatable behavior. The surgeon repeatedly and reliably needs to create similar tunnels of the proper length. Aurolab is producing surgical blades (Aurosleek) intended for making incision in cataract surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Senile cataract
* Willing to give written informed consent
* Ability to follow study instructions and likely to complete required visits.

Exclusion Criteria:

* Intraoperative complication including Posterior Capsular Rent and Zonular dialysis
* Traumatic cataract
* Uveitis and Complicated cataract
* One eyed patients
The Effect of Creative Drama on Postmortem Care in Nursing Students

The goal of this randomized controlled including pretest, posttest and persistence test study is to examine the effect of creative drama method on student nurses' knowledge and skill levels related to postmortem care, learning permanence and satisfaction with the training method.

The main question it aims to answer are:

•Is the postmortem care training given to nursing students with the creative drama method effective on the level of knowledge and skills, the permanence of knowledge and skills and satisfaction with the training method? Participants will participate in an educational activity related to postmortem care. Researchers will compare it with the classical education method to see if postmortem care training given to nursing students with the creative drama method is effective.

The research will be carried out in the form of determining the preliminary knowledge of nursing third year students about postmortem care, providing education with classical education and creative drama methods, evaluating the educational outcomes and permanence in education for knowledge and skills, and determining their satisfaction with the educational methods.

Hypotheses of the research are as follows. H1: There is a difference between the knowledge scores of the experimental and control groups on postmortem care. Is there a difference between the creative drama method and classical education method and the satisfaction of postmortem care students with the training method? H2: There is a difference between the skill scores of the experimental and control groups for postmortem care. H

: There is a difference between the information persistence scores of the experimental and control groups related to postmortem care.

H4: There is a difference between the skill persistence scores of the experimental and control groups for postmortem care.

H5: There is a difference between the satisfaction of the experimental and control groups with the training method

Eligibility Criteria:
Inclusion Criteria:

* Bolu Abant İzzet Baysal University Faculty of Health Sciences, Department of Nursing, 2022-2023 academic year fall semester to be studying in the third year.
* To have taken the "Principles of Nursing" course and the Loss-Death-Mourning process described in this context at the theoretical level.
* Agreeing to participate in the research.

Exclusion Criteria:

* Have previously received skills training related to postmortem care.
* Have previous clinical experience with postmortem care.
* Have previously provided postmortem care.
* Not agreeing to participate in the research.