cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm

This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years
* treatment with Xeomin® and BOTOX® for at least 1 year each

Exclusion Criteria:

* having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission
* previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm
Leflunomide in Systemic Lupus Erythematosus

A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide


Eligibility Criteria:
Inclusion Criteria:

* Fulfill the revised ACR criteria for SLE with either evidence of active disease according to SLE Disease Activity Index (SLEDAI)

Exclusion Criteria:

* Patients who are pregnant or nursing women, or those with life threatening disease
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Valvular Heart Surgery

One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

High-mobility group protein B1 (HMGB1) is a protein which is encoded by the HMGB1 gene in human. HMGB1 is secreted by immune cells (like macrophages, monocytes and dendritic cells). Activated macrophages and monocytes secrete HMGB1 as a cytokine mediator of Inflammation. There are many studies suggesting the relationship between HMGB1 and acute coronary syndrome, myocardial ischemic/reperfusion injury, atherosclerosis, heart failure and other cardiac disease as a marker for inflammatory response. However, there are no other study evaluating HMGB1 as a prognostic factor after valvular surgery, so far.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 20
* patients undergoing aortic valve surgery or more than single valve surgery

Exclusion Criteria:

* age \< 20
* patients undergoing single mitral valve surgery
* history of open heart surgery
* emergency surgery
* history of steroid medication
* infective disease and/or malignant tumor
* coronary artery bypass surgery or aortic replacement surgery
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder

The goal of this clinical trial is by using the Cognitive Orientation Approach on Daily Occupational Performance, which is also supported by the literature and applied by occupational therapists, in children diagnosed with Autism Spectrum Disorder, it is aimed to determine how children's executive function scores and occupational participation change.

The main questions it aims to answer are:

* Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect on executive functions?
* Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect on occupational performance?

Participants will:

* Evaluations will be applied to all participants
* Divided into intervention and control groups
* The intervention group will be given "Cognitive Orientation Approach on Daily Occupational Performance" and "Ayres Sensory Integration Therapy" followed up for about 10 weeks.
* The control group will be given "Ayres Sensory Integration Therapy" followed up for about 10 weeks.
* After 10 weeks, the results between the two groups will be compared.
* After the second evaluation, both groups will be followed for 1 month and the same evaluations will be repeated.

Researchers will compare intervention and control groups to see executive functions and occupational participation.

Autism spectrum disorder is a complex developmental disorder that can lead to dysfunctions in cognitive, emotion regulation, and communication skills.

At the beginning of the cognitive problems seen in children with autism, the pathophysiology in executive functions, which is affected by individual differences, comes to the fore. Difficulties related to executive functions such as cognitive flexibility and problem solving cause limitations in many basic areas, especially in daily life in autism.

The Cognitive Orientation Approach on Daily Occupational Performance, designed by Polatajko and others, is an activity-oriented problem-solving approach that uses cognitive strategies to develop motor skills in children who have difficulties during daily activities; It is a therapy method that focuses on the goal or the task itself, rather than the acquisition of functions within the activity performance. It is known that the approach is effective on social, emotional and organizational skills, especially cognitive skills in children with autism spectrum disorder.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Autism Spectrum Disorder according to DSM-V by the Department of Child and Adolescent Mental Health
* Being between the ages of 7 years and 10 years and 11 months
* Score 30-36 points on the Childhood Autism Rating Scale
* Participation must be approved by the parent.

Exclusion Criteria:

* Having a concomitant neurological, psychiatric or orthopedic diagnosis
* Attending a program other than individual education
Study of the Effectiveness of Specific Training of Health Professionals on Adherence in Bipolar Disorder

Bipolar disorders are common psychiatric disorders characterized by severe and recurrent symptomatic periods (Major Depressive Episode, mania, hypomania) and interictal periods characterized by persistent residual symptoms, impaired functioning and quality of life. In addition, the prognosis of bipolar disorder is aggravated by an increased risk of suicide and a high frequency of somatic comorbidities. Poor adherence is one of the major factors influencing the course of the disorder and one of the causes of ineffective treatments. Considering that between 20 and 60% of patients with bipolar disorder have problems with adherence. Adherence is modulated by a number of socio-demographic, clinical and neuropsychological factors. It is also modulated by the knowledge, beliefs and In addition, studies have shown that the reasons attributed to poor adherence are different depending on whether questioning patients or healthcare professionals. This fault diagnosis, assessment of the causes and "fit" into the reasons associated with poor adherence is an aggravating factor of the problem. However, this factor seems modifiable by better training of professionals. A team from Newcastle University in England has developed a training program for all health professionals to improve the diagnosis and understanding of compliance issues in bipolar patients and provide simple tools to fight against patients with this problem. The investigators assume that this training will improve medication adherence among outpatients by trained professionals.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from bipolar disorder type 1, type 2 or unspecified according to the DSM IV
* Do not presenting mood episode as defined in DSM IV
* With at least one medication prescribed mood stabilizer goal, whatever its observance

Exclusion Criteria:

* Patients full-time hospitalized at the time of inclusion
JOint Use of Database to Identify Risk Factors of CARDio-vascular Toxicity Induced by Immune Checkpoint Inhibitors

Immune checkpoint inhibitors (ICIs) might induce high grade immune-related adverse events (irAEs) involving the cardio-vascular system. This study investigates reports of cardio-vascular toxicity associated with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase, Assistance Publique Hopitaux de Paris Entrepot de Données de Santé (APHP.EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis

ICIs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and in combination. Thus, irAEs can occur and risk factors for such events have been scarcely described. Here, the investigators will use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify risk factors for cases of cardiovascular adverse drug reaction following treatment with ICIs, the investigators will also use two french databases : APHP Entrepot de Données de Santé (EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2025
* Case reported in the APHP Entrepot de Données de Santé (EDS) database of individual safety case reports to 01/01/2025
* Case reported in the Système National Des Données de Santé (SNDS) Database of individual safety case reports to 01/01/2025
* Case reported in a retrospective international multicenter registry of ICI-associated myocarditis to 01/01/2025
* Adverse event reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT)
* Patients treated with ICIs included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), Cemiplimab (L01XC33)

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
CT Radiomic Features of Pancreatic Neuroendocrine Neoplasms

The aim of this study is to quantify inter-observer variability in delineating pancreatic neuroendocrine neoplasm (PanNEN) on Computerized Tomography (CT) images and its impact on radiomic features (RF), subsequently to this determination, to use CT texture analysis to predict, histological characteristics of PanNEN on CT scans.

CT imaging is the most widely used modality for studying radiomic features due to its ability to assess tissue density, shape, texture and size before, during and after therapy. To the best of the investigator's knowledge, the impact of inter-observer delineation variability on the reliability of CT RF for PanNEN patients, including Hounsfield unit (HU) values-, shape-, and texture-based features, has not yet been assessed. One this has been determined, an additional evaluation will be conducted to correlate the morphologically observed images with their histopathological characteristics.

The ultimate potential objective of this research is to identify and predict characteristics of aggressiveness of PanNEN in CT scans.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* pancreatic neuroendocrine neoplasm with intervention and biopsy
* availability of pre-operatory CT scan with or without IV contrast agent- inInstitution from 2009-2017

Exclusion Criteria:

* pregnant women
Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244)(COMPLETED)

The current gold standard for treatment of chronic hepatitis C is pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegIntron pen (PegPen). Therefore, it is worthwhile to evaluate patients' satisfaction with this novel device. The results of the study will be used to improve PegPen training techniques for patients and health care providers.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol

Exclusion Criteria:

* Not willing to participate in the study
Fish Oil and Cardiovascular Suboptimal Health

The purpose of this study is to determine whether omega-3 fatty acids supplementation are effective in the improvement of suboptimal health status and cardiovascular risk.

The Suboptimal health status questionnaire (SHSQ-25) is used to evaluate the suboptimal health status. The SHSQ-25 includes 25 questions. The score of the SHSQ-25 is from 0 to 100. Suboptimal health status is defined as the SHSQ-25 score above than 35. The higher scores of the SHSQ-25 one gets, the more severity of suboptimal health status he/she has. All participants are asked to fill in the SHSQ-25 before and after the intervention. If the score decreases after the intervention, it means that the suboptimal health status has been improved.

Eligibility Criteria:
Inclusion Criteria:

1. suboptimal health status, defined as the score of suboptimal health questionnaire ≥35.
2. at least one of cardiovascular risk factors:

   * overweight or obesity, defined as body mass index (BMI) ≥25 kg/m2.
   * systolic blood pressure ≥130 and \<140 mmHg and diastolic blood pressure \<90 mmHg, or diastolic blood pressure ≥85 and \<90 mmHg and systolic blood pressure \<140 mmHg
   * fasting plasma glucose ≥100 and \<126 mg/dL
   * total cholesterol ≥200 and \<240 mg/dL, triglyceride ≥150 and \<200 mg/dL, low density lipoprotein-cholesterol ≥130 and \<160 mg/dL,and/or high density lipoprotein-cholesterol \<40 mg/dL
3. written informed consent

Exclusion Criteria:

1. history of system diseases, such as cardiovascular diseases, digestive system diseases, diseases of respiratory system, blood and immune system diseases, nervous system diseases, endocrine system diseases, and diseases of the genitourinary system.
2. history of mental illness.
3. pregnant or breastfeeding.
4. use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
5. use of fish oil capsules or other supplements containing omega-3 fatty acids within the past two weeks.
6. allergy or intolerance to fish oil, corn oil, omega-3 fatty acids, or vitamin E.
7. participation in another trial.
8. unable to promise to not use drugs and other fish oils during the study.
9. unable to provide informed written consent.
The Effectiveness of Electronic Reminders in Improving Elastic Compliance in Orthodontic Patients

Fixed orthodontic appliances in combination with intraoral elastics are a common and effective method use in the orthodontic correction of malocclusions. However, their success is largely dependent on the patient's compliance. Failure to wear the elastics as instructed will reduce efficacy of treatment, ultimately increasing treatment time and potentially producing imperfect alignment of teeth.

The hypothesis tested is that daily electronic reminders via a mobile application can significantly increase patient compliance, thus effectively improving treatment outcomes.

Despite advancements in various aspects of orthodontic treatment, patient compliance remains a critical factor in attaining a successful treatment outcome. More specifically, patient compliance in the use of intraoral elastics is an important component of the treatment plan of certain patients. Failure to wear elastics as directed will ultimately result in increased treatment time, and imperfect alignment of the teeth.

Persuading adolescent orthodontic patients to wear intraoral elastics consistently is difficult in the short appointment times of a typical practice. Studies have shown that adolescents respond at a higher level to a more constant form of communication, as well as a method more closely associated with their generation. As smartphones have become an everyday appliance for most of the general public, mobile applications (apps) have the capability to serve as an effective avenue for communication between doctor and patient. Recent studies in both dentistry and medicine have reported that active reminders via mobile phone improve appointment attendance, adherence to medication schedules, and positive behaviour changes.

The investigators will utilise the "Calendar" app to communicate via daily reminders with patients undergoing orthodontic treatment with fixed appliances and Class II intraoral elastics, and they will measure the improvement in the malocclusion. This will allow study of whether or not electronic reminders can significantly increase compliance.

As more apps are developed, this communication method may have the potential to greatly impact the way orthodontists and patients interact outside of the office. If effective, these apps could become a cornerstone of the compliance efforts of many orthodontic practices. This would benefit both the orthodontist and the patient, as it would decrease time and money spent for both parties as well as reduce the overall sense of frustration felt during extended orthodontic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Full fixed appliances with intraoral class II elastics full-time
* Wearing class II elastics for between 6 weeks \& 3 months
* Have smartphone with calendar-type app

Exclusion Criteria:

* Orthognathic surgery planned
* Craniofacial disorders
Combined Interventions for Treating Depression and Chronic Back Pain

This study will determine the effectiveness of an intervention consisting of combined strategies in reducing the symptoms of both depression and chronic back pain.

The relationship between depression and back pain is complex. Depression is the most common mental condition associated with chronic back pain. Despite this relationship, many patients with depression and back pain seek treatment only for one of the two conditions, which can worsen the untreated condition. An intervention that reduces the symptoms of both depression and back pain is needed. This study will determine the effectiveness of an integrated intervention in reducing both back pain and depression symptoms.

Participants will be randomly assigned to receive either an integrated intervention or standard of care for 6 months. Participants in the integrated intervention group will receive cognitive behavioral therapy for back pain and antidepressants and/or problem solving therapy for depression. Study visits will initially occur once a week and then taper to once every 2 weeks for the 6-month duration; the time of tapering will depend on participant response to treatment and will be at the investigator's discretion. Depression and back pain symptoms will be assessed in all participants at study entry, at the end of treatment, and 6 months after the end of treatment. The study entry and study completion assessments will occur during study visits. The last assessment will be a telephone interview.

Eligibility Criteria:
Inclusion Criteria:

* Roland back pain score of 7 or greater
* Diagnosis of major depression
* Plan to stay enrolled in Group Health Cooperative for the duration of the study and 1 year after the study

Exclusion Criteria:

* Prior surgery
* Cauda equina syndrome (compression and paralysis of nerve roots)
* Schizophrenia or bipolar disorder treatment within 2 years prior to study entry
* Current or prior psychiatric or psychological care for back pain or depression
* At high risk for suicide
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases

To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases


Eligibility Criteria:
Inclusion Criteria:

* ECOG perfomance 0-1
* pathologically confirmed colorectal carcinoma, with RAS wild type
* inital unresectable liver metastases discussed by MDT
* prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery.
* without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT)
* adequate blood, liver and renal function
* expected survival longer than 6 months

Exclusion Criteria:

* with bleeding risk
* interestinal obstruction or disease
* uncontrolled hypertension and severe heart disease
* previous severe thrombotic events
* central nervous system metastases
* accompanied with other malignant tumor
An Observational Study to Evaluate the Quality of Life in Korean Female Participants With Chronic Constipation

The purpose of this observational study is to investigate health related quality of life (QoL) in Korean female participants with chronic constipation (long term decreased number of or difficulty making bowel movements) having received treatment previously.

This is a cross-sectional (studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at 1 particular time) observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) to investigate the health related QoL in Korean female participants with chronic constipation having received treatment previously by using EQ-5D (EuroQol 5 Dimension), SF-36 (Short Form Health Survey) and PAC-QoL (Patient Assessment of Constipation) questionnaires. The duration of study will be 6 months. Participant's safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

-Korean female participants with chronic constipation having received treatment previously

Exclusion Criteria:

* Male participants
* Participants with psychological disease (disorders of the mind, thoughts, and behavior)