cyrilzakka/clinical-trials huggingface dataset:
Effects of Seroquel XR on Sleep Architecture in Patients With Major Depressive Disorder

In this study, patients with major depressive disorder (MDD) who have insomnia symptom are treated with Seroquel XR in an open-label manner for a 4-week period with repeated measurements of insomnia symptoms and sleep parameters using polysomnography.


Eligibility Criteria:
Patient Inclusion Criteria:

* Men and women aged between 20 and 65
* Diagnosis of major depressive disorder as assessed by Structured Clinical Interview for DSM-IV (SCID-IV)
* A score of 1 or greater on any of the sleep items (items 4, 5, 6) from the Hamilton Depression Rating Scale (HDRS)
* Provision of written informed consent

Healthy Control Subject Inclusion Criteria:

* Healthy Men and Women aged between 20 and 65
* Provision of written informed consent

Exclusion Criteria:

* Presence of any major physical or neurological illness (e.g.，head trauma， epilepsy，seizure，stroke，cerebral tumor，multiple sclerosis，cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity，etc.)
* Diagnosis of any Axis I disorder other than major depressive disorder or presence of symptoms requiring hospitalization
* Drug abuse in past 3 months
* Women who are pregnant，breastfeeding, or planning pregnancy
* Contraindications to drugs used in the study (e.g., allergy, intolerance, etc.)
* Unstable medical illness or severe abnormality in laboratory test at screening assessment
* Increase in blood glucose, lipid, and calcium levels at screening
* Low blood pressure at screening assessment
* Intelligence quotient below 80
* Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
* Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
* Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
* Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 3 months prior to enrolment
* Previous enrolment or randomisation of treatment in the present study.
* Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
* Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
* A patient with Diabetes Mellitus
* An absolute neutrophil count (ANC) of \<= 1.5 x 10\^9 per liter
* Insomnia from other causes of medical or neurological diseases
* Involvement in the planning and conduct of the study
Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)

To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise.

The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting.

Eligibility Criteria:
Inclusion Criteria:

1. Age at time of consent 18.0 to 65.0 years
2. Diagnosed with type 1 diabetes for at least one year. Diagnosis is based on investigator's clinical judgment.
3. Total daily dose (TDD) of insulin ≥0.3 units/kg/day and A1C \>6% at screening
4. Currently using an insulin pump with U-100 rapid-acting insulin analogs and on pump therapy for at least 6 months prior to study start
5. Willing to use the study CGM device for the duration of the study
6. Willing to use the Omnipod® Insulin Management System during the study
7. Willing to perform all fingerstick BG testing with the study-approved glucose meter at the frequency specified in the study protocol
8. Willing to abide by meal recommendations for breakfast, lunch and dinner during the study
9. Willing to participate in moderate intensity exercise for up to 45 minutes if taking part in Option B
10. Willing to refrain from use of acetaminophen and supplemental vitamin C (\>2000 mg/daily) for the entire duration of participation in the study
11. Willing and able to sign the Informed Consent Form (ICF)

Exclusion Criteria:

1. A1C \>10% at the screening visit
2. One or more episodes of severe hypoglycemia requiring emergency room (ER) visit or hospitalization within the past 6 months
3. Hypoglycemic unawareness as determined by a score of ≥4 "R" responses on the Clarke Questionnaire
4. One or more episodes of diabetic ketoacidosis requiring ER visit or hospitalization within the past 6 months
5. Used non-insulin anti-diabetic medication within last 30 days
6. Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)
7. Dermatological conditions at the proposed sensor wear sites that in the investigator's opinion could preclude ability to wear the Pod and/or the Dexcom sensor
8. Current or known history of cardiovascular disease, arrhythmia, myocardial infarction (MI) or stroke. An electrocardiogram (ECG) must be obtained within 6 months.
9. Currently undergoing systemic treatment with steroids or immunosuppressive medication
10. Current illness that would interfere with participation in the study
11. Currently participating in another clinical study using an investigational drug or device
12. Recent (within the preceding 30 days) participation in a clinical study using an investigational drug.
Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.

The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible for the study if they meet all of the following inclusion criteria:

  1. Diagnosis of Type 2 Diabetes.
  2. Age between 18 and 75 years.
  3. HbA1c \> 6.0 but ≤ 8.5
  4. If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
  5. BMI \> 18.5 kg/m2 and \< 40.0 kg/m2.
  6. Chronic medication dosage must be stable for at least two months prior to Screening Visit.
  7. Subject states that they are a habitual consumer of a morning meal.

Exclusion Criteria:

* Subjects will be excluded from the study if they meet any of the following criteria:

  1. Use of exogenous insulin or GLP-1 agonists for glucose control.
  2. Diagnosis of Type 1 diabetes.
  3. History of diabetic ketoacidosis.
  4. Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
  5. Active malignancy.
  6. Significant cardiovascular event \< 12 weeks prior to study entry.
  7. End stage organ failure or status post organ transplant.
  8. Active metabolic, hepatic, or gastrointestinal disease.
  9. Chronic, contagious, infectious disease.
  10. Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
  11. History of fainting or other adverse reactions in response to blood collection.
  12. Clotting or bleeding disorders.
  13. Allergy or intolerance to study product ingredient.
Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores

Aim of the work This study aims at; Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leakage with application of scoring scale to assess presence or absence of leakage.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with intestinal or colonic anastomosis either elective or emergent.

Exclusion Criteria:

* Patients with inflammatory bowel disease will be excluded because this could influence plasma levels of inflammatory biomarkers.
* patients using corticosteroids
* Patients unfit for anaesthesia, those having collagen diseases or hematological disorders.
Potential Effect for the Smoking on Periodontitis From the Perspective of Arginine Metabolites

Arginine metabolites are amino acids that are associated with vascular tone regulation and the level of inflammation, with critical roles in the synthesis of NO. Our aim was to determine the ADMA, SDMA, L-NMMA, L-arginine, L-homoarginine and IL-6 levels in saliva and serum samples from periodontitis patients and periodontally healthy individuals and to assess the levels of these compounds according to smoking status and compare these levels to those of healthy individuals.

The study consisted of four groups: healthy individuals (control (C); n=20), smokers with healthy periodontium (S-C; n=20), nonsmokers with Stage III Grade B generalized periodontitis (P; n=20) and smokers with Stage III Grade C generalized periodontitis (S-P; n=18). Clinical periodontal parameters were measured. The determination of methylated arginine metabolites was carried out by LC-MS/MS.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy
* clinical diagnosis of periodontitis
* clinical diagnosis of periodontal health
* For smoking group the so kerr were denied as smoking at least 10 cigarettes per day and the duration should more than 10 years.

Exclusion Criteria:

* history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
* nonsurgical periodontal treatment (previous 6 months)
* surgical periodontal treatment (previous 12 months)
* presence of\<10 teeth
* current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
* diabetes
* diagnosis of rheumatoid arthritis
* pregnancy
* lactating
* excessive alcohol consumption.
A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).

The study will enroll 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity; Population 2 will include participants with moderate to severe subjective symptoms. This study will include 3 periods: screening (5 weeks), treatment period (48 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized to receive subcutaneous (SC) dose of HZN-1116 or placebo.

Acquired from Horizon in 2024.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria.
* Have an ESSDAI score of \>= 5 at screening (only for Population 1).
* Have an ESSPRI score of \>= 5 at screening (only for Population 2).
* Have an ESSDAI score of \< 5 at screening (only for Population 2).
* Positive for anti-Ro autoantibodies, rheumatoid factor (RF) at screening, or both at screening.

Key Exclusion Criteria:

* Concomitant system sclerosis.
* Active malignancy or history of malignancy within the last 5 years with exception of in situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR cutaneous basal cell carcinoma following presumed curative therapy.
* Individuals who are pregnant or lactating or planning to become pregnant during the study.
* Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or HIV infection.
* Individuals with history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity. Individuals with a prior history of ophthalmic herpes zoster will be excluded.
* Active infections requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
* Last administration of experimental biologic or oral agents \< 6 months or 5 half-lives, whichever is longer, before screening.
* Individuals who have had previous treatment with any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, or ofatumumab) within 12 months or other B cell targeting therapy (eg, belimumab) or anti-type I IFN pathway therapy (eg, anifrolumab) \< 6 months before randomization.
Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome

Laparoscopy has revolutionized the approach to a number of surgical problems causing a re-evaluation of several clinical strategies. Now it has become the standard treatment for majority of ailments including symptomatic gall stone disease, appendicitis, GERD (gastroesophageal reflux disease), morbid obesity and colorectal disease. All these developments aim at minimizing perioperative morbidities, providing rapid postoperative recovery and enhancing patient's safety profile. One of the major limitations of conventional laparoscopy is lack of depth perception. Introduction of 3D imaging, has removed many of these technical obstacles. In 1993, Becker et al., reported that a 3D display might improve laparoscopic skills. Since then, many researchers have demonstrated benefit of 3D imaging . Starting from this, we can theorize an impact of 3D technologies on surgeon's learning curves. This concern is recently being demonstrated in experimental and clinical setting with improvement of hand-eye coordination, better laparoscopic skills and less time to learn surgical procedure. Usually junior surgeons (JS) start their activities with cholecystectomy and appendectomy but, despite an amount of literature regarding the first procedure, there is a 'black hole' regarding the use of 3D imaging in laparoscopic appendectomy (LA).

The investigators decided to investigate the impact of 3D visualization on surgeons' and surgical outcome during laparoscopic appendectomy (LA) performed by junior surgeons (JS). Operative details and clinical aspect are both take in account in order to looking for any advantages or concerns conferred on JS in performing LA.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients scheduled to undergo laparoscopic appendectomy. Ages eligible for study: \>18 Sexes eligible for study: All

Exclusion Criteria:

* Patients who decline to join the study
* Patients under 18 years old
* Patients with contraindication to undergo laparoscopic surgery.
* Patients without appendicular disease found at laparoscopy (such as complicated inflammatory bowel disease, tumor, complicated diverticula, gynecological disorder)
* Patients undergoing open appendectomy
Ultrasound-guided Axillary Vein Catheterization in Trauma

It is very important to choose the best central venous catheterization route for trauma patients, the determinants that need to be considered comprehensively include coagulation dysfunction, fracture of the clavicle on the side of the puncture, and tracheotomy care. More importantly, whether it can used simultaneously for accurate volume and invasive hemodynamic monitoring. For the purpose of support of cardiopulmonary function, the ideal position of the catheter tip is vital with regard to an accurate CVP and hemodynamic monitoring. Cannulation of the axillary vein is ideal for patients with severe poly-trauma because it avoids the thoracic cavity, intercostal arteries, tracheostomy, and clavicle, and is prone to compression even if the artery is injured. At present, there is no systematic introduction of ultrasound-guided axillary vein catheterization in the trauma ICU in the literature. Since Oct 2021, the investigators have attempted to practice axillary vein catheterization for this crucial trauma population; unfortunately, the investigators have not know till now whether this procedure is associated with accurate tip placement and its safety should also be weighted. So it is necessary to summarize the relevant clinical data.


Eligibility Criteria:
Inclusion Criteria:

* Trauma patients admitted to TICU
* Receiving axillary vein catheterization during TICU stay

Exclusion Criteria:

* Without record of axillary vein catheterization
* Without imaging confirming （X-ray or chest CT） the location of catheter tip
Medication-taking Preferences & Practices of Patients With Chronic Conditions

"Patients can easily be overwhelmed, confused and many times don't fully understand their need for new medications, or when the dosages are to be administered" (patient research partner quote). The long-term goal of this study is to refine medication science by developing patient-centered assessment, monitoring and management guidelines for patients and health professionals. The objective is to advance knowledge about the medication-taking perspectives, experiences, and behaviors of older adults with multiple chronic medical conditions (MCMC) to inform future research related to patient-centered medication prescribing, monitoring and management. This pilot study addresses the following PCORI interest area: "evaluating methods that can be used to assess the patient perspective when researching behaviors and choices within the patient's control that may influence outcomes." The rationale that underlies the proposed study is that medication-taking practices are wholly within patients' control, and are foundational to reducing complications and improving outcomes for those with MCMC. To meet the overall objective of this application, the following specific aims will be pursued: 1) identify perceptions and behaviors surrounding the medication-taking process of older adults with MCMC; and 2) generate an interpretation of the meaning of medication-taking among older adults with MCMC. To achieve these aims, data will be obtained in "real time" from patients (N=30) receiving a new prescription using smart phone technology. The smart phones will include prompts to help participants record thoughts about medication use throughout the day for 30 days. Findings from electronic diaries will be logged, analyzed and qualitatively analyzed. Some patients (n=15) will provide in-depth hermeneutic interviews to provide rich descriptions and interpretive commentary about the experience of receiving a new medication prescription. The objective is to uncover previously unidentified areas of common experience in older persons with multiple chronic conditions who have received a new prescription. Common experiences and patterns of influences, that are often surprising or unexpected, will be categorized and assessed. The expected outcomes of this pilot study are improved knowledge of medication-taking perceptions, experiences, and practices of older adults with MCMC-knowledge that is critical to advance patient-centered medication science.


Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* Diagnosis of at least 3 chronic medical conditions
* Receiving 5 or more medications
* Receipt of a new prescription medication at enrollment
* Ability to speak English

Exclusion Criteria:

* Any individual that does not meet the 5 inclusion criteria listed above
Investigating the Safety and Effectiveness of Insulin Degludec in a Real World Population With Type 1 and 2 Diabetes Mellitus

This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
* Male or female patients at least 18 years of age at time of informed consent
* T1DM (diagnosed clinically) prior to inclusion in the study, and/or T2DM, insulin using patients (diagnosed clinically) prior to inclusion in the study
* Planned initiation with Tresiba®

Exclusion Criteria:

* Known or suspected hypersensitivity to Tresiba® or any of the excipients listed in Section 6.1 of the SmPC (Summary of Product Characteristics) or related products
* Previous participation in this study (i.e. provision of informed consent)
* Patients who have previously been treated with Tresiba®
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Remineralization Potential of Ginger and Rosemary Herbals Versus Sodium Fluoride in Treatment of White Spot Lesions

To evaluate the effectiveness of ginger and rosemary herbals versus sodium fluoride in remineralization of incipient enamel caries.

Group 1 (intervention)

Ginger and rosemary gel application:

First the participant will be asked to brush his/her teeth thoroughly with 1450 ppm fluoride toothpaste (Colgate total healthy clean toothpaste). Then an application of a thin ribbon of this gel to the teeth using a brush. The medication will be left for at least 1 minute. The participant will be asked to spit out the medication after use and not to swallow it. Also the participant will be asked not to rinse his/her mouth, eat, or drink for at least 30 minutes after use to get the best results.

Group 2 (control group). Sodium fluoride varnish The fluoride varnish will be bifluorid 10 single use by voco (Germany). It Contains 5 % sodium fluoride (equal to 22,600 ppm fluoride).

A thin coat will be applied on the tooth surface by using a brush. 10-20 s are sufficient for the varnish to be absorbed and then dry with air. Participants will be informed that they should not brush their teeth for 12-24 hours after the application and not to eat, or drink for at least 30 minutes after use to get the best results.

Eligibility Criteria:
Inclusion Criteria:

* Patient who has just completed a comprehensive orthodontic treatment.
* Presence of at least one WSL, DIAGNOdent score (0-20).
* Age range between 13 and 35years.

Exclusion Criteria:

* Patients with a compromised medical history.
* Severe or active periodontal disease
* Patients with developmental hypo-calcified lesions