cyrilzakka/clinical-trials huggingface dataset:
CoQ10 and Omega-3 as Adjuncts to Periodontal Therapy, TAC of Saliva.

Comparative evaluation of CoQ10 and Omega-3 as adjuncts to periodontal therapy and total antioxidant capacity of saliva (randomized Double-Blind Clinicalials)

This study was designed as a blind, randomized clinical trial to evaluate teh efficacy of Coq10, Omega-3 supplement on periodontal parameters in chronic periodontitis patients, total antioxidant capacity in saliva after 2 months of administration;75 patients to department of periodontics were selected from teh patients referred to Broujerd dental school of teh Islamic Azad University of Medical Sciences; before commencing teh study, several clinical periodontal parameters were evaluated, including plaque index, bleeding on probing, gingival index, probing depth, and clinical attachment level(CAL) in six different areas of teh tooth surface; subsequently, scaling and root planning(SRP) were performed, and oral hygiene practices were improved for all participants. Teh subjects were then randomly assigned to three groups: Group A received 30 mg of CoQ10, Group B was given 200 mg of Omega-3 daily supplements, and Group C did not receive any medication; after teh two-month study period, teh clinical periodontal parameters were reassessed. Additionally, to compare teh total antioxidant capacity in saliva before and after teh intake of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at teh beginning and end of teh study for analysis using UV-spectrophotometric methods, furthermore, teh following criteria determined teh selection of eligible participants for this study.

Eligibility Criteria:
Inclusion Criteria:

Aged between 28 and 35, chronic initial periodontal disease (newly classified as Stage-I), with a maximum pocket depth of 5 mm, and mandibular molar teeth. in each quadrant

Exclusion Criteria:

Systemic disease Orthodontic treatments in progress Pregnancy and breastfeeding Taking medicines affecting periodontium such as antibiotics for the last 6 months Malignancy, radiotherapy, and chemotherapy for malignancy in the last 5 years Plaque index and bleeding scores below 25% History of periodontal surgery at the desired site for the last 6 months Taking medicinal supplements within the last 6 months Cigarette smoking or tobacco use

Study population 80eligibles were enrolled in this study, which was designed for Randomized Double-Blind Clinical Trials
Safety and Long-term Effectiveness of High Frequency Repetitive Transcranial Magnetic Stimulation of Stroke (RAICup)

The aim of the study is to determine if 2-week repetitive transcranial magnetic stimulation at the subacute phase of stroke (between day 7 and day 14) improves significantly arm motility at 3 months with remaining effect at one year, without significant adverse effect.

Stroke survivors may be left with disability involving speech or residual arm or leg weakness. Despite spontaneous improvement on the weeks following stroke, the importance of final disability is unpredictable. If the core of the infarct is represented by dead neurons, the neurons from adjacent areas seem to be staggered and their lack of excitability has been correlated to a bad prognosis. Repetitive transcranial magnetic stimulation (rTMS) seems to be a promising technique since high frequency rTMS can increase excitability of the targeted neurons.

The aim of the study is to evaluate after 2 weeks of 20 min of rTMS each day: 1) the improvement of arm function and neurological and disability scales, immediately after the 2-week session, at one month, 3 months and evaluate the remnant effect at 12 months, 2) to correlate these scales to physiological parameters in order to assess the clinical modifications to the electrophysiological modifications, 3) to assert the safety of high frequency rTMS at the subacute phase of ischaemic stroke.

Eligibility Criteria:
Inclusion Criteria:

Single mono hemispheric subcortical and/or cortical ischaemic stroke (documented by CT or MRI) 7 to 21 days before, with moderate arm paresis as defined by a Rankin score \<= 4 or not at 4 (in paragraph 5 of NIHSS), in the territory of middle cerebral artery Patients between 18 and 80 years old

Exclusion Criteria:

severe peripheral neuropathy pace-maker, implanted medical pump, metal plate, metal object in the skull or eye History of previous stroke, epileptic seizures, craniotomy, brain trauma Score Rankin \> 4 and arm deficit at 4 (paragraph 5 of NIHSS) Score Rankin \<=1 Cortical stroke Alertness problems at the time of inclusion Disability previous to stroke Stenosis of internal carotid artery with surgery foreseen within 3 months Uncontrolled medical problem Not able to give informed consent Pregnant or breast-feeding woman
Evaluation of Copeptin in Patients With Cirrhosis and Ascites

Copeptin is a glycopeptide released by the post-pituitary gland. In case of decrease in blood volume or blood pressure, it is secreted in the serum in an equimolar quantity to arginine vasopressin (AVP) . Unlike AVP, copeptin is readily assayable in serum and its prognostic value has been recently observed during cirrhosis. However, the pathophysiological relationships between serum copeptin concentrations and indirect markers of inflammation are unknown.

The main objective of this multicenter pilot study is to study the relationship between serum copeptin and markers of inflammatory stress in cirrhotic patients with ascites. It is indeed in this population with high-risk of complications that most need biomarkers of events (like death) are needed. The main secondary objective is to evaluate the prognostic interest at 6 months of the variation of copeptin between day 0- day15.

The investigators wish to include prospectively 100 cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals. The inclusion and follow-up periods will be six months each. At the inclusion of the patients we will evaluate the correlations between the plasma concentration of copeptin and 1 / the severity of cirrhosis (Child-Pugh and MELD scores) and serum sodium; 2 / systemic inflammation markers (CRP, leukocytes, IL-6 and lipopolysaccharides), 3 / calprotectin concentration in ascites. "

Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* Age between 18 and 80 years
* Acute decompensation of cirrhosis with occurrence of ascites
* Hospitalisationfor a complication of cirrhosis (first occurrence of ascites or recurrent ascites requiring hospitalization, gastrointestinal bleeding, hepatic encephalopathy, etc..)
* Patients participating to Ca-DRISLA study
* Information and Consent form signed

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Age minor to 18 years
* Age major to 80 years
* Adult under protection law
* outpatients hospitalized for paracentesis
* ascites not related to portal hypertension (pancreatic ascites, peritoneal carcinosis...) Patients with hepatocellular carcinoma could be included
Tolerance of a Calorically Dense Enteral Nutrition Formula

This prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult aged \> 18 years
* Admitted to Medical ICU with expected admission of ≥ 3 days
* Established enteral access
* Having obtained his/her or legal representative's informed consent.

Exclusion Criteria:

* Pregnant or lactating
* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Lack of enteral access
* Parenteral nutrition
* Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, etc.)
* Subject who in the Investigator's assessment cannot be expected to comply with study protocol
* Currently participating in another conflicting clinical trial.
pBFS-guided Noninvasive Neuromodulation for Pre-school Children With ASD

This randomized controlled trial aims to evaluate the efficacy and safeness of the pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism spectrum disorder (ASD).

Autism spectrum disorder is a neurodevelopmental disorder, begins early in life. Using the personalized brain functional sectors (pBFS) technology, investigators could precisely identify individualized brain function networks based on the functional MRI scan. For each participant, two personalised TMS intervention targets will be chosen by blinded researcher. One executive function network target is located in the dorsal lateral prefrontal cortex (DLPFC) , and the other social function network target is located in the dorsal medial prefrontal cortex (DMPFC).

The participants will be equally randomized to the following four groups, active iTBS to the left DMPFC or the left DLPFC, and sham iTBS to either the left DMPFC or left DLPFC at a ratio of 2:2:1:1. Later analyses will combine the two sham groups as one control group. Each participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3 sessions daily, 5 days per week for 8 weeks, as well as background behavioral training between iTBS sessions. Pre-and post-treatment functional MRI data will be collected under sedation.

Eligibility Criteria:
Inclusion Criteria:

* 2.5-6 years old
* Have the diagnosis of autism spectrum disorder
* ADOS-2 score is higher than the ASD cut-offs
* Capacity to follow the study procedures, including fMRI scan under sedation, assessment, and rehabilitation training
* Participant's parents or other legal guardians give informed consent

Exclusion Criteria:

* Current or history of psychotic disorders, such as schizophrenia, schizoaffective disorder, bipolar disorder
* Severe self-injury or suicidal behavior presented in the last 1 year
* Severe visual, auditory, or motor disability that interferes with any study procedure
* Current, history or family history of epilepsy
* Known severe physical diseases, such as congenital heart defect, traumatic brain injury
* Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac pacemakers, stents, cochlear implants
* Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months
* Currently participating in other clinical trials
Detection of EGFR Mutations in the Blood of Patients With Non-small Cell Lung Cancer: a Feasibility Study

The overall objective of the study is to assess the feasibility of the use of blood for the detection of EGFR mutations in patients with non-small cell lung cancer (NSCLC)

Specific aims are:

1. To assess the use of immuno-separation techniques to enrich the tumor cell population in the blood of NSCLC patients.
2. To assess the use of denaturing high performance liquid chromatography (DHPLC) assay for the detection of EGFR mutations in the blood of NSCLC patients.

The oral tyrosine kinase (TK) inhibitors of Epidermal Growth Factor Receptor (EGFR), gefitinib and erlotinib, have produced dramatic responses, encouraging response rates and possibly improved survival in a subset of NSCLC patients. Evidence suggests that somatic EGFR mutations in the tumor are at present the single most reliable biological marker of predicting response to EGFR TK inhibitors. In addition, these mutations may be an early event in the pathogenesis of NSCLC in a subset of patients. Unfortunately, the technology of EGFR mutations sequencing incurs high costs and requires sufficient tissue, which is often a problem in NSCLC. We hypothesize that EGFR mutations can be detected in the blood and propose a study to determine the feasibility of detecting EGFR mutations in the blood of NSCLC patients. We will approach newly diagnosed NSCLC patients as well as patients who are known to be responding to the oral TK inhibitors. We will perform EGFR mutations on the tumors. For the blood, we will use new immuno-separation techniques to isolate tumor cells and perform denaturing high performance liquid chromatography to detect EGFR mutations. If we prove that it is feasible to detect the mutations in the blood, we will follow up with a validation study. Many applications can result if our hypothesis holds true: 1) it will be proof of principle that our technique can effectively isolate and detect somatic mutations in circulating tumor cells, 2) it will be a simple way to overcome the problem of insufficient tumor samples, 3) it can be used for early detection of lung cancer if EGFR mutations proves to be important in pathogenesis in a subset of patients and 4) the technology can be extended to detect new mutations in patients who become resistant to oral TK inhibitors which can lead to new targeted therapies.

Eligibility Criteria:
Patients with non small cell lung cancer.
A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery

The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.

Non-steroidal anti-inflammatory drugs(NSAIDs) are an effective adjunct to opioid analgesia for moderate-severe pain, with improvement in the quality of pain relief and consistent evidence of opioid dose sparing. NSAIDs alone could provide effective analgesia post-surgery when mild-moderate pain is expected. There is also evidence that the use of NSAIDs, by avoiding or decreasing the need for opioids, can lead to a reduction in the incidence of adverse events which are commonly attributed to, or exacerbated by, opioids.

The intent of this study is to assess the analgesic efficacy of IV ibuprofen when administered at induction of anesthesia. Results from this pilot study will be used to design and determine the appropriate statistical power for a larger, multi-center randomized study.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for knee arthroscopy

Exclusion Criteria:

* Inadequate intravenous (IV) access.
* History of allergy or hypersensitivity to any component of ibuprofen or other NSAIDs, aspirin (or aspirin related products), opioids or cyclooxygenase-2(COX-2) inhibitors.
* Less than 18 years of age.
* Use of analgesics less than 8 hours prior to surgery.
* Patients with active, clinically significant anemia.
* History or evidence of asthma or heart failure.
* Pregnant.
* Recent history of chronic non-steroidal anti-inflammatory drug (NSAID) or opioid use.
* Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions and to return for the required assessments.
* Refusal to provide written authorization for use and disclosure of protected health information.
Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care

The objective of this pragmatic, multicenter, randomized controlled clinical trial is to determine whether an educational intervention regarding benzodiazepine use can reduce the consumption and/or dosage of these drugs in individuals over 64 years old.

It aims to provide knowledge and skills to help participants tolerate or reduce discomfort, enabling them to begin decreasing or discontinuing benzodiazepine (BZD) use.

The focus is on the effect of combined care, but the implementation of this approach is also assessed, providing valuable insights for further health developments in Primary Care.

Researchers will compare a minimal intervention, consisting of sending a "Benzoletter" to each participant's mailing address, with an intensive intervention that additionally includes psychoeducational sessions and therapeutic exercises.

Participants in the intervention group will attend sessions at the Primary Care Center for a total duration of eight weeks.


Eligibility Criteria:
Inclusion Criteria:

* People over 64 years old who have been using benzodiazepines for a period of three months or more.
* People with an active diagnosis of anxiety and/or insomnia.

Exclusion Criteria:

* People with psychiatric comorbidities, dementia, epilepsy, included in the home care program (ATDOM), institutionalized, or in palliative care.
* People with no possibility of contact or language barriers.
* People with difficulty traveling to the Primary Care Center (CAP).
Impact of an Interventional Program on Self-Management

The goal of this randomized clinical trial study is to assess the effect of an interventional program on diabetes self-management and therefore on effective glycemic control among diabetic students in Assuit university

1. To formulate a strategy aiming to reduce the burden of diabetes morbidity \& mortality;
2. To determine degree of self-management in diabetic participants
3. To identify the obstacles facing the diabetic students to achieve an accepted self-management;
4. To assess the impact of the interventional program on overcoming such obstacles; and
5. To assess the impact of diabetes self-management on glycemic control among diabetic students in Assiut University All university students who suffer from diabetes and attend the study's clinic seeking medical treatment during a full academic year (2023/2024) with inclusion and exclusion criteria are recruited. The sample is divided into 150 cases for intervention group and 150 for control group (traditional care), by Systemic random technique. All participants will be exposed to Questionnaires for assessment of Diabetes Self-management, and measurements of glycated hemoglobin (HbA1c), body weight, height, at base line, three months, and 6 months after the end of the program.

Eligibility Criteria:
Inclusion Criteria:

•Confirmed cases of diabetes mellitus (IDD" type I" \& NIDD "type II") among Assiut University students

Exclusion Criteria:

* Diabetic students with severe disability or handicapped
* Diabetic students known to have another health problem make him un tolerable to do exercise such as cardiovascular disease, bronchial asthma
* Diabetic students with speech and hearing difficulties.
BioFreedom QCA Study in CAD Patients

This study aims to demonstrate that the BioFreedom™ Cobalt Chromium Drug Coated Stent is non-inferior to the market authorized BioFreedom™ Stainless Steel Stent with respective to efficacy and shows a similar safety profile.

The BioFreedom™ QCA trial is designed to evaluate the safety and efficacy of the BioFreedom™ CoCr DCS coronary stent system compared to the Biofreedom™ stainless steel DCS coronary stent system, in a randomized controlled trial on an all-comers patient population.

The primary objective is to measure non-inferiority of the BioFreedom™ CoCr stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary endpoint is to assess safety as measured by MACE and ST. Two hundred (200) patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed-up to 2 years to measure for late MACE and ST events.

Eligibility Criteria:
Inclusion Criteria:

"Real world, all comer" patients

1. Age ≥18 years;
2. Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
3. Presence of one or more coronary artery stenosis \>50% in a native coronary artery or a saphenous bypass graft from 2.50 to 3.5 mm in diameter that can be covered with one or multiple stents (angiographic inclusion);
4. No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria:

1. Individual is pregnant, nursing or planning to be pregnant;
2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium, Biolimus A9™ or contrast material
3. Inability to provide informed consent;

Note: Not all exclusion criteria are listed.
The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes

This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.

This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes. In the study, newly diagnosed children in the experimental group will be shown a 10-minute movie and read the educational booklet. Routine care will continue for the control group.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* Parental approval
* Being between the ages of 7-12,
* Being diagnosed with T1D for the first time,
* Being literate and able to communicate in Turkish

Exclusion Criteria:

* Having a mental, visual, hearing or communication impairment,
* Having mental and spiritual health problems,
Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy

In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Understand and sign the informed consent form.
* Participated in NCT01760122 study (TB1211IFN) and has received at least 39 doses of peginterferon.

Exclusion Criteria:

* Conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).
PINS Stimulator System for Patients With Treatment Resistant Depression

Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to evaluate the influence of acupuncture on patients, which will be afford objective evidence for the mechanism of Acupuncture on depression.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is aged ages 20-70 years
2. Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria
3. First episode onset before age 45
4. Current episode \> 12 months duration
5. In the current episode: Documented resistance (i.e. persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's)
6. SNRI's, TCA's, MAO-inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score of at least 3 according to the amended Antidepressant Treatment History Form (ATHF) criteria
7. Hamilton Depression Rating Scale (HDRS) of \> 20 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 HDRS scores cannot improve ≥ 25%

Exclusion Criteria:

1. Patients with hearing impairment
2. Failures of important organs and in severe conditions
3. Be reluctant or disabled to receive neuropsychological assessments;
4. Participate in other clinical trial
5. Has a life expectancy of \< 1 year
6. The investigator and/or enrollment review committee, would preclude participation in the study