cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®

The primary objective of this study is to compare patient medication satisfaction as measured by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women at least 18 years of age or older.
2. Patients must have a confirmed and documented RRMS diagnosis
3. Patients must be ambulatory with a Kurtzke EDSS score of 0 to 5.5 at screening visit.
4. Patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment 30 days prior to randomization.
5. Women of child-bearing potential must have a negative urine pregnancy test at screening visit and must practice an acceptable method of birth
6. Patients must be able to sign and date a written informed consent prior to entering the study.
7. Patients must be willing and able to comply with the protocol requirements for the duration of the study.

Exclusion Criteria

1. Patient had any contraindication to Copaxone therapy.
2. Previous use of Copaxone 40 mg/mL three times per week.
3. Patients with progressive forms of MS.
4. Patients with neuromyelitis optica.
5. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
6. Patients who have been treated with; immunosuppressive medications, immunoglobulins and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any time
7. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
8. Pregnancy or breastfeeding.
9. Clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
10. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals

    * other criteria may apply, please contact the investigator for more information
Intravenous Versus Peribulbar Dexmedetomidine for Strabismus Surgery in Adults

Using various adjuvants has become a trend in regional anesthesia practice to improve the quality of anesthesia and prolong postoperative analgesia. Dexmedetomidine, an alpha-2 agonist has been proposed as a safe and effective adjunct capable of extending the duration of the single-shot block

Strabismus (misalignment of the eye) results from a difference in extraocular muscle function. Consequently, two different images, one from each eye, are transmitted to the brain, resulting in a loss of visual depth. In adults, cosmetic appearance is the main issue but sudden occurrence of strabismus may cause diplopia because the brain cannot suppress the overlapping images. The goal of strabismus surgery is to align the eyes, reduce diplopia, and restore binocular vision Ophthalmic regional block can be used as the primary anesthetic technique for strabismus surgery. The advantages of ophthalmic regional blockade include a reduced incidence of oculocardiac reflex (OCR) and emergence agitation, postoperative analgesia, and decreased postoperative nausea and vomiting (PONV).

Using various adjuvants has become a trend in regional anesthesia practice to improve the quality of anesthesia and prolong postoperative analgesia. Dexmedetomidine, an alpha-2 agonist has been proposed as a safe and effective adjunct capable of extending the duration of the single-shot block.

Perineural dexmedetomidine, when added to bupivacaine, has been shown to potentiate its effects, providing a better quality of anesthesia and postoperative analgesia. Intravenous (I.V.) dexmedetomidine, when used during regional anesthesia, has been shown to prolong sensory and motor blockade in addition to sedation and postoperative analgesia.

No previous studies where different routes of dexmedetomidine have been compared in adult strabismus surgery.

Eligibility Criteria:
Inclusion Criteria:

1. The patient planned to perform a unilateral strabismus surgery
2. Age: 20-60 years
3. American Society of Anesthesiologists class I and II

Exclusion Criteria:

1. patients under the age of 20
2. uncooperative patients
3. Patients with coagulopathy
4. patients who disincline to participate in the study will be excluded from the study
The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)

This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel.


Eligibility Criteria:
Inclusion Criteria:

* Present with acute coronary syndrome (ACS) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel (administered as a single or cumulative dose).
* Are between the ages of 18 and 85 years.
* Willing and able to sign informed consent.

Exclusion Criteria:

* Have overt ST-segment elevation myocardial infarction (STEMI).
* Have cardiogenic shock.
* Have refractory ventricular arrhythmias.
* Have New York Heart Association (NYHA) Class IV congestive heart failure.
* Have severe and uncontrolled hypertension.
* Have active internal bleeding or history of bleeding diathesis.
* Have an increased risk of bleeding.
* Have history of cerebrovascular accidents.
* Have certain abnormal blood level values.
* Are currently receiving chemotherapy or radiation therapy.
REACH-OUT: Chicago Children's Diabetes Prevention Program

The purpose of this research study is to evaluate two nutrition and exercise programs in children ages 9-12 who are at risk for developing type 2 diabetes. This study also includes the involvement of parents or guardians who are willing to participate in these programs with the child.

This is a prevention study that evaluates a community-based, family oriented intervention called Reach-Out. The University of Chicago will partner with community organizations including the Women, Infants and Children \[WIC\] Clinic at the Chicago Department of Public Health Roseland Clinic, South Side YMCA, the Chicago Park District and the Southside Faith-Based Wellness Network of churches to deliver the intervention. Families will be recruited from the high risk population of patients in the University of Chicago Diabetes database and the Chicago Childhood Diabetes Registry; and La Rabida Children's Hospital; and from the broader south side African-American community ("outreach" population). Families will be randomized to behavioral intervention (Reach-Out Program, hands on nutrition and exercise) or control group(Reach-In Program, standard of care consultation).

All who participate in this study will be seen at the University of Chicago GCRC (General Clinical Research Center). They will be asked to come in at the beginning of the study, after 14 weeks, afer 1 year and after 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Overweight (\>85th percentile BMI for age and gender) African American child age 9-12 with family history of type 2 diabetes in a first or second degree relative. Parents are secondary subjects.

Exclusion Criteria:

* Inability to give informed consent or unwillingness to be randomized
* Prior diagnosis of diabetes in the child planning to participate
* Pregnancy (women who become pregnant during the study will be omitted from the analysis. Pregnant women will not participate in the exercise sessions).
* Uncontrolled hypertension (SBP\> 160 or DBP\>100) (JNC V, 1993)
* Uncontrolled dyslipidemia by NCEP III criteria (NCEP, 2001)
* Evidence of significant cardiovascular, pulmonary disease, or other serious illness
* Evidence of alcohol or drug abuse (identified by self-report)
* Musculoskeletal disease serious enough to prevent participation in exercise sessions
* Known or suspected major psychiatric disorder
* Inability to participate in aerobic exercise activities
* Inability to comply with a calorie or fat restricted diet
* Age over 65 years
Prevalence of Obstructive Sleep Apnea Syndrome in Sarcoidosis and Impact of CPAP Treatment on Associated Fatigue Status

Sarcoidosis is a multisystemic granulomatous disease that affects individuals worldwide without known pathogenesis, and the role of comorbidities has not been fully assessed in the scientific literature. An increased incidence of Obstructive Sleep Apnea Syndrome (OSAS) has been described in Sarcoidosis although this association has not been explained yet and no data is available about the effect of treatment with Continuous Positive Airway Pressure (CPAP) in Sarcoidosis. Also, patients affected by Sarcoidosis usually experience a state of physical and mental weariness called fatigue and reported in approximately 60-80% sarcoid patients and thought to be a consequence of inflammatory mediators but the high prevalence of OSAS could be a remarkable bias in clinical evaluation because fatigue is also strongly associated with sleep disorders.

Thus, there is a real need for assessing not only the real prevalence of OSAS in Sarcoidosis but also the effect of CPAP treatment on fatigue status experienced by sarcoidotic patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline

Exclusion Criteria:

* Ongoing CPAP treatment
* Psychiatric disorders
Occlusal Bite Force Changes After Placement of Stainless Steel Crowns in Children

The aim of this study was to determine if restoring primary molars with SSCs would improve children's OBF.

Occlusal bite force (OBF) is an indicator of the functional status of the masticatory system. The level of maximum occlusal bite force (MOBF) results from the combined action of the jaw elevator muscles modified by jaw biomechanics and reflex mechanisms. The measurement of OBF has been widely used in dentistry to provide useful data for the evaluation of jaw muscle function and activity as well as effectiveness of prosthetic therapy.

Many indicators have been believed to assess the functional status of the masticatory system, such as body size, bite force, number of functional tooth units, and the occlusal contact area. Dental status formed with dental fillings, dentures, position and the number of teeth is an important factor in the value of the OBF.

Many studies were conducted to evaluate the effect of dental caries on OBF. Tsai et al. found a negative correlation between MOBF and the number of decayed teeth. Su et al. reported that the overall tooth decay was not related to the strength of OBF. They suggested that the severity of tooth decay may be more important than the number of teeth exhibiting decay.

Stainless Steel Crowns (SSCs) are considered the treatment of choice for severely decayed but restorable primary molars. A recent systematic review by Seale and Randall confirmed their previous work and reviews and appeared to continue to be supportive and in favor of SSCs.

SSCs has been blamed for premature contact related discomfort in the first few weeks after placement of SSCs. Zee and Amerongen reported that premature contacting SSC restored teeth will equilibrate over time and return to pretreatment levels in 15 to 30 days.

Several opinions have been reported by parents, children and dentists regarding the improved mastication efficiency after placement of the SSCs. However, the effects of SSCs placement on primary molars on OBF have not yet been investigated

Eligibility Criteria:
Inclusion Criteria:- Caucasian

* Healthy child
* In the primary dentition stage
* Class I occlusion
* No facial asymmetry
* No cross bite
* Have caries in the eight primary molars indicating placement of SSCs, with no reported pain on biting and no previous restorations
* No gingival inflammation
* No para functional habits

Exclusion Criteria: did not meet the inclusion criteria stated above

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Brief Evidence-based Psychological Treatments for Emotional Disorders

The present work aims to develop a randomized clinical trial with a sample of 165 patients diagnosed with an emotional disorder. All participants are tested by several self-reports related to common mental disorders in a repeated measures design, pre and post treatment as well as a six month follow up. We think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the Primary or Secondary Care context to improve the patient´s quality of life while simultaneously reducing costs.

Nowadays, the heavy demands placed on health systems exceed the resources in many developed countries. So-called "common mental disorders" and their mostly pharmacological treatment are, in no small part, responsible for this situation. The cost that these disorders generate to the public health service is very high and they are usually associated with other issues like hyperfrequentation and side effects. However, research indicates that psychological treatment should be the first step when caring for these types of problems. We expect that the results show that extensive psychological therapy and combined treatment were the most effective. Nevertheless, brief psychological treatment is expected to be the most efficient in cost-benefit terms.

Eligibility Criteria:
Inclusion Criteria:

* Emotional disorders

Exclusion Criteria:

* Severe mental disorder
* Drug abuse
* Severe depression
Levosimendan and Myocardial Protection

The aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* intention to perform first-time multi-vessel CABG

Exclusion Criteria:

* unstable angina
* valvular disease
* diabetes mellitus treated with sulphonylurea drugs
* renal failure
* severe hepatic disease
* severe chronic obstructive pulmonary disease
* a history of prior CABG surgery
* recent myocardial infarction (MI) within the previous month
TCM Daoyin Therapy in Individuals At-risk for COPD

Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease. The aim of prospective randomized study is to evaluate the effects of TCM Daoyin training on Individuals at-risk for COPD.

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. Early prevention and treatment of COPD is crucial, but there is a lack of specific interventions for individuals at-risk for COPD in clinical guidelines. The study focuses on individuals at-risk for COPD (COPD-SQ≥16, current lung function failed to meet diagnostic criteria for COPD but with manifestations of early airflow limitation).

This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 60 participants (30 for TCM Daoyin intervention group receiving health education plus a TCM Daoyin training program, and 30 for health education control group only receiving health education).

TCM Daoyin is a form of mind-body exercise with a profound philosophical foundation rooted in Chinese culture. Previous researches have provided some evidence of beneficial effects on TCM Daoyin for COPD patients with an established diagnosis, such as Liuzijue and Baduanjin. However, the evidences of TCM Daoyin on patients with early COPD is limited. The aim of prospective randomized study is to evaluate the effects of TCM Daoyin training on individuals at-risk of COPD.

Eligibility Criteria:
Inclusion Criteria:

* Subject at-risk for COPD (Chronic obstructive pulmonary disease screening questionnaire (COPD-SQ) score≥16; and pre-bronchodilator FEV1/FVC ≥ 0.70, or pre-bronchodilator FEV1/FVC\<0.70 but post-bronchodilator FEV1/FVC ≥ 0.70).
* Aged 40 to 75, male or female.
* Subject has a clear mind and the ability to lead an independent life.
* Subject agrees to perform a blood-test.
* Subject agrees to participate in this study and sign to the informed consent.

Exclusion Criteria:

* Subject with acute exacerbation of COPD.
* Subject with respiratory infectious disease (e.g., tuberculosis, influenza, etc.) within 1 month.
* Subject with serious current unstable physical illness and mental illness.
* Subject with definite clinical diagnosis of Alzheimer's disease, or severe cognitive impairment.
* Subject is pregnant or lactating women.
Improving Knowledge About Infertility; an Online Educational Tool

The purpose of this study is to determine the effectiveness of an online informational video in improving knowledge about infertility in couples experiencing problems conceiving. A pilot study will be conducted with first and second year medical students.

This study is being conducted to assess how a short, online educational video changes knowledge about fertility and infertility in couples attending an infertility clinic for the first time. Participants will complete a questionnaire testing knowledge about infertility and general demographic information (age, gender, previous information sources on infertility, etc.) will be collected. Participants will then be directed to a short video on infertility. One week later, participants will return to the site to complete the infertility test questions a second time in order to test memory retention. The focus of both the questionnaire and educational video will be basic reproductive biology, infertility risk factors, etiologies and treatments and fertility myths.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 60 years
* Men between the ages of 18 and 60 years
* Booking an appointment at the infertility clinic for the first time
* Access to a computer with internet connection
* For pilot study: students must be in first or second year medical school before teaching on infertility

Exclusion Criteria:

* Previous appointment at the infertility clinic/ previous medical specialist counsel about infertility
* Completion of the study surveys after their appointment at the infertility clinic
Acceptability and Tolerance Study of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children

This is an acceptability study (including gastrointestinal tolerance, compliance and palatability) of a high energy peptide based paediatric oral nutritional supplement for children over 12 months of age.

The acceptability data from a minimum of 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

Fifteen (15) participants, aged 12 months and over, requiring a high energy peptide based oral nutritional supplement drink for the dietary management.

The ACBS requirement for evaluable data on 15 participants has informed the trial's recruitment target; however, we may need to exceed this target if any patients give their consent to join the study but then decide not to participate in the study. Participants who join the study and begin using the product would count towards the recruitment total and their data would be included in a submission to the ACBS whether they complete the 7-day study period or not.

Each potential participant must meet all of the inclusion criteria and not meet any of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

I. Children aged 1 year and over who require 1-3 bottles of an oral nutritional peptide based supplement drink II. Children who require an oral nutritional supplement or who are already established on a nutritional supplement drink III. Children who require a nutritional supplement drink as bolus feeding via a feeding tube.

IV. Children being able to communicate views of acceptability V. Willingly given, written, informed consent from patient or parent/guardian. VI. Willingly given, written assent (if appropriate).

Exclusion Criteria:

I. Inability to comply with the study protocol, in the opinion of the investigator.

II. Contraindications to any feed ingredients (see nutritional table and ingredients list) III. Require a milk free diet IV. Children under the age of 12 months V. Emergencies
Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma

In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with a histological classification of non-keratinizing carcinoma (according to the World Health Organization, WHO), pathological classification.
2. No evidence of distant metastasis (M0).
3. Age between 18 and 70 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status score:0-1.
5. Undergoing radical intensity-modulated radiation therapy (IMRT).
6. No claustrophobia and able to remain in a fixed position for at least 30 minutes
7. Patients must be informed of the main content of this study, sign an informed consent form, and be willing and able to comply with the treatment, follow-up plan, laboratory tests, and other requirements specified in the study protocol.

Exclusion Criteria:

1. Histological types include squamous cell carcinoma or basal cell carcinoma.
2. Radiation therapy intended for palliative care.
3. History of malignant tumors, excluding adequately treated basal cell carcinoma, squamous cell carcinoma, and cervical intraepithelial neoplasia.
4. Pregnant or lactating women (women of childbearing age should undergo pregnancy testing; effective contraception should be emphasized during treatment.
5. Previous radical radiotherapy for nasopharyngeal cancer.
6. Primary and neck metastatic lesions treated with chemotherapy or surgery.
7. Presence of other serious underlying diseases that may pose a greater risk or affect compliance with the trial. Examples include unstable cardiac diseases requiring treatment, renal diseases, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \&amp;amp;gt; 1.5×ULN), and psychiatric disorders.
8. Initial assessment of treatment efficacy more than 120 days after the end of radiotherapy.
9. Inability to undergo enhanced magnetic resonance imaging due to contrast agent allergies, claustrophobia.