cyrilzakka/clinical-trials huggingface dataset:
The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.

To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. written informed consent；
2. pediatric patients admitted to intensive care unit after general anesthesia;
3. expected mechanical ventilation time \>6 hours; （4）1 months to 16 years old; -

Exclusion Criteria:

1. congenital heart disease, arrhythmias and heart failure;
2. Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
3. Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
4. central nervous system disease;
5. spinal analgesia or muscle relaxants is used during PICU;
6. the drug that affects the nerve conduction is used in one month;
7. allergy to the test drug or having other contraindications;
8. participated in other studies 30 days prior to admission of PICU; -
Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block for Mastectomy

In this study, we are comparing two different techniques of plane blocks to control postoperative mastectomy pain serratus anterior plane block and erector spinae plane block, both are done with ultrasonic guidance We are recording the first time of analgesia request postoperatively as a primary outcome


Eligibility Criteria:
Inclusion Criteria:

* Female patient age 20 to 65
* ASA I, II
* Scheduled for mastectomy

Exclusion Criteria:

* Allergy to local anaesthetics
* Infection at the site of performing the block
* Morbidly obese patient of body mass index more than 40 kg/m2
Endoscopic Stenting in Crohn Related Strictures

Prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon dialtation only for the endoscopic treatment of benign strictures related to Crohn´s disease.


Eligibility Criteria:
Inclusion Criteria:

* Benign high-grade Crohn stricture

Exclusion Criteria:

* Unwillingness to participate
* Planned surgery
* High risk for bleeding
Effect of MetS* on Cognitive Performance and Physical Activity (Metabolic Syndrome)

Metabolic syndrome (MetS) increases the risk of developing diabetes and cardiovascular disease risk factors that are linked with each other, which is a metabolic dysfunction, which contains a combination of multiple.

It is known that METS plays a role in the development of many diseases such as cardiovascular diseases, stroke, cancer, Alzheimer's. Studies have revealed that neuroinflammation, oxidative stress, abnormal lipid metabolism and impaired vascularization, which play a role in the pathogenesis of MetS, affect the structure of the brain and cognition. Atherosclerosis of the carotid artery, increased brain atrophy and white matter damage are potential explanatory mechanisms that lead to an impact on cognitive skills in patients with MetS. In addition, the existence of MetS components such as obesity, diabetes, hypertension alone also negatively affects cognitive functions, and the level of cognitive influence also increases as the number of components an individual has increases.

The literature reports that learning, executive functions, processing speed, attention/working memory and global cognitive functions are affected in individuals with MetS, but no consensus has been reached on this issue. Some studies say that MetS causes a significant decrease in cognitive functions, while some studies indicate that this difference is not significant.

The aim of our study is to proof the relationship between MetS and cognitive functions with metabolic syndrome components.

H1:There is a relationship between the MetS and cognitive functions.

Voluntary participants who have been diagnosed with MetS and agreed to voluntary health subjects will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. There will be individuals diagnosed with MetS in the intervention group and healthy individuals who do not have any problems in the control group.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 18-50
* Having been educated for at least 5 years and know how to read and write
* Having been diagnosed with MetS by meeting 3 of the NCEP-ATP III criteria (for participants in the MetS Group)
* To have a biochemistry test performed within the last 6 months (for the Healthy Group)
* Not having any MetS components (For the Healthy Group)

Exclusion Criteria:

* Having any neurological, psychiatric and psychological diseases that may affect cognitive status
* Taking antipsychiatric medication
* The presence of any visual-auditory intellectual disability
* Having undergone bariatric surgery
Nevanac 3-Month Safety Study With QID Dosing

The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 10
* Other protocol-defined exclusion criteria may apply
Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result in shorter cystoscopy times.


Eligibility Criteria:
Inclusion Criteria:

* - Patients must be 18 years or older as well as willing and able to provide informed consent
* Patients undergoing a scheduled gynecologic procedure with cystoscopy

Exclusion Criteria:

* - Patients are younger than 18 years
* Patients are unable or unwilling to provide informed consent
* Patients with a history of an allergic reaction to sodium fluorescein or phenazopyridine
* Patients with a history of renal insufficiency
* Patients with a history of liver disease
* Patients with a history of sickle cell disease
* Patients with a history of glucose-6-phosphate dehydrogenase deficiency
* Patients with a history of chronic obstructive pulmonary disease or currently being treated for asthma
Efficacy and Safety of GENOSS® SES in Patients with Acute Coronary Syndrome (GENOSS ACS)

The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice.

The Genoss SES is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of the Genoss SES in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention.

The Genoss SES study is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss SES implantation in ACS patients undergoing percutaneous coronary intervention from 10 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 10 months.

Eligibility Criteria:
\<Inclusion Criteria\>

1. Patients of 19 and over
2. Patients with acute coronary syndrome treated with GENOSS SES
3. Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants.

\<Exclusion Criteria\>

1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents

   - However, patients with hypersensitivity to contrast agents may be eligible if it can be controlled by steroids and pheniramine. Patients with known anaphylaxis are excluded
2. Patients who are pregnant or planning to become pregnant
3. Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration.
4. Patients with a life expectancy of less than 1 year
5. Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment.
6. Patients who have already received treatment with another DES (Drug Eluting Stent), BVS (Bioresorbable Vascular Scaffolds), or BMS (Bare Metal Stent) at the time of registration.
7. Patients currently participating in a randomized controlled trial involving medical devices.
Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors

The investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming.

Participants will be stratified by early (within 18 months of surgery) and late (\> 18 months of surgery) and randomized on a one-on-one basis to (1) a supervised therapeutic exercise program for the neck and shoulder (serving as standard care) or (2) a combined therapeutic and lower body resistance exercise program. The randomization sequence will be generated by staff in the Rehabilitation Research Centre at Corbett Hall and placed in sealed opaque envelopes.

The exercise program will be offered in a group setting. Participants will exercise 2 times per week for a 10-week session and will have the option to continue for an additional 10-week maintenance session. The primary outcome for the study will be quality of life as measured by the Functional Assessment of Cancer Therapy (FACT)-Fatigue Scale at 12-weeks.

At each measurement point following the baseline assessment, including the 12-week and 24-week and one year follow-ups, an Independent Assessor will perform the objective fitness measurements. The Independent Assessor will also administer the Neck Dissection Impairment Questionnaire and the FACT-Fatigue quality of life questionnaires. The Physical Activity Adherence Diary will be collected by a Research Coordinator at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma/ thyroid cancer/ melanoma or lymphoma involving: oral cavity, oropharynx, larynx or hypopharynx, or lymph nodes in the neck region
* Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection OR radiation therapy to lymph node regions
* Presenting with shoulder and/ or neck dysfunction related to cancer treatment
* Karnofsky Performance Status greater than or equal to 60%
* No evidence of residual cancer in the neck and no distant (M0) metastasis. Potential participants with symptoms suggestive of distant metastasis (M1) must have appropriate investigations (e.g. bone scan) to rule these out.
* Participants must have completed their head and neck/ thyroid/ melanoma/ lymphoma cancer treatment (minimum 4 weeks post treatment)
* Pre-participation Screening: Prior to participation in the exercise program, potential participants will complete general and cancer-specific Physical Activity Readiness Questionnaires (PAR-Q+) to determine appropriateness for the exercise program. Physician consent and approval for supervised exercise will be required prior to enrollment.

Exclusion Criteria:

* A participant will be ineligible if they present with medical illness or psychiatric illness, which, in the opinion of the investigators, would impact his/her ability to participate in exercise or interfere with follow-up.
Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)

Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.

Children, ages 2-11, with a history of perennial allergic rhinitis

Eligibility Criteria:
Inclusion Criteria:

* Children patients of both sexes aged between 2-11 years, of either gender and any race
* Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation
* Minimum score for inclusion: 10
* Capable of complying with the dosing regimen
* Free of any clinically significant disease (other than allergic rhinitis)
* Antihistamine must be justified by investigating doctor

Exclusion Criteria:

* Patients with asthma who require chronic use of inhaled or systemic corticosteroids
* History of frequent, clinically significant sinusitis or chronic purulent postnasal drip
* Patients with rhinitis medicamentosa
* History of hypersensitivity to desloratadine or any of its excipients
* Doctor deems unsuitable
A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors

The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir


Eligibility Criteria:
Inclusion:

* HIV positive
* Are at least 18 years old
* Subject has not been treated for an active AIDS-defining opportunistic infection within 15 days of screening
* HIV RNA level \> 1000 copies/mL
* Previous therapy with at least one protease inhibitor, at least one non-nucleoside reverse transcriptase inhibitor and at least one nucleoside reverse transcriptase inhibitor

Exclusion:

* Subject is pregnant or breast-feeding
* Subject has received an investigational drug within 30 days prior to screening
* Have a history of pancreatitis
* History of intolerance to ritonavir
* Abnormal laboratory tests at screening
Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations

Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar performance in clinical service to conventional ceramic CAD/CAM restorations.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or over
* To have at least one carious lesion or defective restoration in a molar or premolar tooth, cavities to be large enough to warrant a milled restoration of either a crown or onlay
* Teeth to be vital and asymptomatic

Exclusion Criteria:

* Devital or sensitive teeth
* Teeth that have had root canal treatment
* Patients with significant untreated dental disease including periodontitis and rampant caries
* Pregnant or lactating women
Diet Interactions With Human Gut Microbiota. The Potential Role of Mediterranean Diet Adherence. DIAGRAM, a Pilot Study

Despite the strong evidence on health benefits of traditional MeD, not many studies have broadly and systematically been made for the potential role and relationship of the MeD in the composition of the gut microbiota.

Furthermore, little is known about the composition of the gut microbiota in individuals with defined dietary habits on the Mediterranean pattern.

This work is aiming at comparatively studying the gut microbiota of three different dietary oriented european populations. In particular, biological samples and related information will be collected from populations with high adherence to Mediterranean diet (MeD) in Crete - Greece and Molise region - Italy. These data will be comparatively assessed with those provided by a sample population with high adherence to Western diet in Auvergne - France.

All the participants will give freely their written informed consent before their selection in the study.

Information on demographics, anthropometrics, vital signs, relevant medical history and concomitant medication, dietary habits, usual dietary intake and nutritional supplements will be collected. Habitual physical activity will be performed using the short form of the IPAQ survey. All inclusion and exclusion criteria will be checked by the investigator or co-investigator.

All selected volunteers will be asked to maintain their usual dietary habits and continue their normal physical habits. All volunteers will complete a follow-up questionnaire to obtain information about any changes in medication use, disease etc.

All selected volunteers will collect one stool sample and will complete two 24h dietary recalls, and questionnaires related to digestive function and life style.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40 to 60 years
* Healthy (apparently free of diseases)
* Moderately physically active
* Habitually eating foods representative of their community (Cretan diet, Italian Mediterranean diet, French Auvergnat diet). The assessment of the consumption of such food will be based to a detailed dietary history retrieved by a nutrition specialist)

Exclusion Criteria:

* Following any kind of treatment, notably antibiotics the last 3 months
* Sedentary lifestyle
* BMI \<18.5 Kg/m2-or \>27Kg/m2
* Smokers
* Excessive alcohol consumption (\>3 glasses/d for men and \>2 glasses/d for women)
* To be frequent travelers, particularly to overseas destinations
* Pregnant or women at lactation
* Individual unable to give informed consent or refusing to sign informed consent
Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children

The Autonomic Nervous System (ANS) regulates the inflammatory response in real time, just as it controls heart rate and other vital functions.

Many studies have investigated induced stimulation of the vagus nerve and its therapeutic effect in inhibiting TNFα (Tumor Necrosis Factor alpha) secretion, and therefore the risk of hypotension, septic shock, organ dysfunction during inflammation.

While the anti-inflammatory effect of the autonomic nervous system on inflammation has been well studied, conversely, the effect of major inflammation on the balance of the autonomic nervous system is more difficult to understand. The inflammatory reflex could be overwhelmed and the regulatory centers of the brainstem dysregulated during situations of extreme inflammation.

The purpose of this study is to follow the short-term evolution of sympathetic and parasympathetic markers of dysautonomia in children hospitalized in intensive care units for severe sepsis, to characterize the evolution of the different autonomic indices according to the site of infection (meningitis, pulmonary infection, organ failure, bacteraemia) and types of pathogens (viral, bacterial, atypical germs) and correlating the evolution of the various inflammation biomarkers and cytokines with the degree of dysautonomia.

Eligibility Criteria:
Inclusion Criteria for cases group :

* Hospitalization in a pediatric intensive care unit.
* Presenting the sepsis criteria
* Patient affiliated or entitled to a social security scheme
* Holders of parental authority having received informed information about the study and having signed the consent form

Exclusion Criteria for cases group :

* Parents or legal guardians who do not speak French
* Chronic or acute pathology that can alter autonomic balance (congenital heart disease, encephalopathy, neuropathy, acute pain, etc.)
* Recent general anesthesia less than 48 hours old. (inclusion may be made beyond 48 hours from the last general anesthesia if the inclusion criteria remain present)
* Taking treatments that can alter the ANS (β-blockers, etc.) or inflammation (NSAIDs, corticosteroids)

Inclusion criteria for control group :

* Patient affiliated or entitled to a social security scheme
* Holders of parental authority having received informed information about the study and having signed the consent form

Exclusion Criteria for control group :

* Parents or legal guardians who do not speak French
* Chronic or acute pathology that can alter autonomic balance (congenital heart disease, encephalopathy, neuropathy, acute pain, etc.)
* Recent general anesthesia less than 1 month.
* Taking treatments that can alter the ANS (β-blockers, etc.) or inflammation (NSAIDs, corticosteroids)
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

This is a Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.


Eligibility Criteria:
Key Inclusion Criteria:

* Males and females, aged 18 to 65 years, inclusive.
* Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
* In generally good physical health, in the opinion of the Investigator.
* Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m2.

Key Exclusion Criteria:

* Female who is pregnant, breastfeeding, or less than 6 months postpartum at screen.
* A history of or current DSM-5 diagnosis of MDD with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder.
* Presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension.
* Presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (SBP) \>160 mmHg or consistent sitting diastolic blood pressure (DBP) \>95 mmHg despite present therapy.
* Screening laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, thyroid function, and urinalysis).
A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C

This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>/= 18 years of age
* serologic evidence of chronic hepatitis C infection
* compensated liver disease
* negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment

Exclusion Criteria:

* history or other evidence of a medical condition associated with chronic liver disease other than HCV
* hepatitis A, hepatitis B or HIV infection
* hepatocellular carcinoma
* severe concomitant disease