cyrilzakka/clinical-trials huggingface dataset:
Effects of Polynucleotides and Hyaluronic Acid Based Subgingival Periodontal Pockets Re-instrumentation

The purpose of this randomized controlled clinical trial (RCT) was to investigate the clinical and biochemical efficacy of a gel containing PDRN and HA used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets.

The aim of the present study was to investigate the clinical and biochemical efficacy of a gel containing polynucleotides (PDRN) and hyaluronic acid (HA) used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets.

50 patients were enrolled in a randomized, split-mouth clinical trial. For each patient, two teeth with similar residual pockets with probing depth (PD) ≥ 5 mm were selected to receive re-instrumentation with (test) or without (control) the adjunctive use of a PDRN and HA based gel. Differences in changes of PD, gingival recession (REC), clinical attachment level (CAL), modified sulcular bleeding index (mSBI), plaque index (PLI) from baseline to 6, 8, 24, 36 and 48 weeks were analyzed and the frequencies of sites with PD \<4 mm at 48 weeks were compared. Furthermore, changes in the dosage of alpha-2-macroglobulin (α2M) and of matrix metalloproteinase-9 (MMP-9) from baseline to 6 weeks were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* males and females with ≥ 18 years
* stage 3 generalized periodontitis
* 3-6 months after step 1 and 2 of periodontal treatment, at least two non-adjacent teeth showing one residual pocket with probing depth (PD) ≥5, without mobility and without furcation involvement.

Exclusion Criteria:

* full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \>20%
* inadequate restorative therapy or malocclusion
* uncontrolled systemic disease
* immunosuppressive therapy or therapy with corticosteroid or with bisphosphonates
* inflammatory and autoimmune diseases of the oral cavity
* history of malignancy, radiation therapy or chemotherapy for malignancy in the last 5 years
* insulin-dependent diabetes;
* smoking (\> 10 cigarettes per day)
* drug and alcohol abuse
* pregnant or lactating.
Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma

Real-world evidence study to assess the safety and effectiveness of XEN® Glaucoma Treatment System in Chinese patients with refractory glaucoma. Participants will be (prospective) or have already been (retrospective) implanted with XEN via specific urgent medical need.


Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory glaucomas, including cases where previous surgical treatment has failed, cases of POAG, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy

Exclusion Criteria:

* Angle closure glaucoma where angle has not been surgically opened
* Previous glaucoma shunt/valve in the target quadrant
* Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (eg, pterygium) in the target quadrant
* Active inflammation (eg, blepharitis, conjunctivitis, keratitis, uveitis)
* Active iris neovascularization or neovascularization of the iris within six months of the surgical date
* Anterior chamber intraocular lens
* Presence of intraocular silicone oil
* Vitreous present in the anterior chamber
Regisry of the Stroke Patients in Assiut University Hospital

• Aim of the work To register all type of acute stroke admitted in Assiut university Hospital and assessment of their risk factor, morbidity and Mortality


Eligibility Criteria:
Inclusion Criteria:

* All patients with stroke aged ≥18 years of both sex
* Written consent was taken for all patient either from the patient himself of closes relative after explaning to them the type of treatment benefits and possible risks

Exclusion Criteria:

* Stroke due to metabolic causes as hypoglycemia liver, Renal failure and other metabolic causes
* Stroke due to Brain tumors
Study of AI-based Prediction Models for Exercise-Induced Gut Microbiota Alterations in Patients With Type 2 Diabetes

This study is a randomized controlled clinical trial. The participants will be randomized into two groups in a 1:1 ratio: exercise intervention and sedentary control group. The participants (50 participants per group) will undergo a 16-week intervention. Participants in the control group will maintain their sedentary lifestyle unchanged, and the exercise intervention group will receive combined aerobic and resistance exercise training. This study aims to compare the changes in gut microbiota before and after exercise intervention in patients. It will validate and optimize a cross-species microbiota mapping model through an independent exercise intervention clinical trial. Additionally, it will comprehensively assess the effects of combined aerobic and resistance exercise on patients' body composition, the severity of fatty liver, and glucose-lipid metabolism indicators. The study will also analyze the correlation between dynamic changes in the gut microbiota and the improvement of clinical symptoms in patients with type 2 diabetes after exercise intervention, elucidating the regulatory mechanisms of microbiota remodeling in exercise-mediated metabolic benefits.


Eligibility Criteria:
Inclusion Criteria:

-1. Diagnosed with type 2 diabetes; 2. Taking ≤3 types of antidiabetic medications; 3. On a stable medication regimen for at least 6 weeks prior to the intervention and maintaining the same regimen during the study period; 4. Aged between 35 and 65 years; 5. Abdominal obesity: waist circumference \>90 cm for men and \>85 cm for women; 6. Body mass index (BMI) ≤35 kg/m²; 7. Waist-to-thigh ratio (WTR): ≥1.7 for men and ≥1.6 for women; 8. Sedentary lifestyle (engaging in moderate-intensity exercise for ≤60 minutes per week).

Exclusion Criteria:

-1. Glycated hemoglobin (HbA1c) \<6.5% or ≥9%; 2. Use of insulin; 3. Presence of one or more of the following complications: advanced diabetic retinopathy, macroalbuminuria (urine albumin-to-creatinine ratio ≥300 mg/g), or renal dysfunction (estimated glomerular filtration rate \[eGFR\] ≤60 mL/min/1.73 m²); 4. History of cardiovascular events (e.g., myocardial infarction, stent implantation, unstable angina, heart failure, or cardiac dysfunction); 5. History of cerebrovascular disease (e.g., cerebral hemorrhage or ischemic stroke); 6. Muscular, skeletal, or neuromuscular injuries that hinder exercise training; 6. Severe osteoporosis or failure to meet bone mineral density criteria despite treatment; 7. Pregnancy; 8. Inability or unwillingness to undergo MRI examination (e.g., due to claustrophobia, implantable cardioverter-defibrillator \[ICD\], or pacemaker); 9. Diagnosed depression or any psychiatric disorder that prevents the patient from understanding the nature, scope, and possible sequence of the study; 10. Patients taking antihypertensive or lipid-lowering medications are excluded if their medication regimen is unstable or affects glucose metabolism.
Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin. The aim of the present study is to test whether this leads to altered hormone and symptom response during hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects male or female
* Age 18-50 years
* Female subjects save contraception
* Ability to take part in the study
* Signed consent

Exclusion Criteria:

* Chronic disease
* Acute disease during 4 weeks prior to the study
* Pregnancy
* Drug treatment other than hormonal contraception
Ultrasound of Accessory Respiratory Muscles

The aim of this study is to compare the diameter of accessory respiratory muscles in patients with respiratory diseases and patients without such diseases, and to determine whether there is a connection between the ultrasound-measured thickness of accessory respiratory muscles and time of mechanical ventilation, as well as whether there is a the connection between the measured thickness and the treatment outcome of patients in the Intensive Care Unit (ICU).

An informed consent for the study was obtained from Ethics Committee, Osijek University Hospital, and Medical Faculty. Each patient will sign an informed consent prior to the inclusion into the prospective observational study.

In all patients, the thickness of the sternocleidomastoid muscle (SCM), trapezius muscle (TM), and quadriceps femoris (QF) muscle will be measured. A measurement point is in the middle of each muscle. The diameter of each muscle will be measured three times, and the average of the three measurements will be calculated.

In each patient hours of mechanical ventilation, and total time in the ICU will be recorded. Patients' comorbidities, ie. hypertension, cardiac diseases, diabetes, and other metabolic disorders, history of stroke, disabilities, as well as procedures done will be registered.

A Pearson's or Spearman's correlation will be used to calculate connections between specific parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients with and without chronic respiratory diseases
* Mechanically ventilated patients
* Patients who gave consent to participate in the study

Exclusion Criteria:

* Patients with severe head and neck trauma
* Patients who have had upper leg surgery
* Patients who did not consent to participate in the study
SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).

This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with interferon alfa. After 48 weeks therapy with interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4 therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational arm will receive no specific antiviral treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* liver disease consistent with CHB;
* evidence of chronic HBeAg-negative CHB prior to initial course of interferon alfa;
* patients who have responded to previous 48 weeks treatment with interferon alfa.

Exclusion Criteria:

* coinfection with HCV, HDV or HIV;
* decompensated liver disease, hepatocellular cancer, or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
* any other systemic antiviral, antineoplastic or immunomodulatory treatment \<=6 months prior to first dose of randomized treatment.
MorphECOS - Evaluation of the Influence of Fatigue and Sleep on the Performance of 2nd Cycle Medical Students (OSCE)

Objective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is a challenge for medical students.

The aim of this study is to better characterise the population of students taking the OSCEs on the subject of sleep and fatigue and to assess whether these factors have an impact on their performance in the OSCEs.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of legal age, enrolled in the 2nd cycle médical program at the Lyon Est Faculty of Medicine (Claude Bernard Lyon 1 University), taking part in the annual session (February or March 2025) of the faculty's OSCEs and having agreed to participate by completing and signing the dedicated written consent form.

Exclusion Criteria:

* abstenteism or Premature end to the OSCE session.
Reliability and Validity Study of Urdu Version of Modified Barthel Index in Stroke Patients

Aim of the study is to translate and culturally adapt the modified Barthel index into Urdu language and to investigate the reliability and validity of this scale in Urdu speaking Stroke population for performance evaluation. Also check its correlation with Functional independence measure and Katz index of Activities of Daily Living.

The English version of the Barthel index will be translated and traditionally adapted as prior endorsement. In Activities of Daily Livings disabled stroke population, Urdu Version of Modified Barthel Index will distributed among sixty participants choose by convenience sampling technique based on pre-distinct inclusion and exclusion standards. To test inter and intra-observer reliability of the final Urdu Version of Modified Barthel Index will be completed on the same day, by two observers, and for the inter-observers evaluation, with an interval of 30 minute between the first and the second submission. Third evaluation will be carried out after 7 days by Observer-1, for intra-observer assessment. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Core steadiness will be analyzed with Cronbach alpha value. Test-retest reliability will be evaluated using an intra-class correlation coefficient.The Urdu Version of Modified Barthel Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Male and female both genders
* Adults between the ages of 18 and above
* Patient suffering from Stroke
* Ability to provide informed consent

Exclusion Criteria:

* Suffering from any cardiovascular pathologies
* Any disorder of contagious infections
* Any history of neurological disorders
* Having any spinal deformity
Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures

The purpose of this study is to evaluate the preliminary safety and efficacy of the daVinci surgical system (computer-assisted surgery) for use in vascular surgery procedures. Although the daVinci Surgical System is FDA approved and widely used for surgical procedures for urology, cardiac, general, and gynecologic procedures, it is not currently approved specifically for use in vascular surgery and the FDA has required the PI to conduct a small feasibility study under an IDE. The investigators are seeking approval by the FDA to utilize the daVinci Surgical System in vascular surgery and to conduct a future clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with significant femoropopliteal or tibial occlusive disease not amenable to catheter directed therapy (ie angioplasty/stenting). Symptoms include lifestyle-limiting claudication, rest pain and/or tissue loss.
* Patients with an ABI between 0.2 and 0.8.
* Femoropopliteal disease visible on color duplex ultrasound (DUS)
* Patent and minimally diseased common femoral and proximal superficial artery
* Patients with American Society of Anesthesiology (ASA) I, II or III classification
* PT/PTT, EKG, HbA1c, liver function, within normal ranges within 30 days prior to procedure or stable over the last 6 months.

Current University of Chicago Medical Center Lab standards will be used. Pulmonary function will be assessed as needed by preoperative anesthesia evaluation. (Generally for infrainguinal procedures, pulmonary function is not assessed)

* Body Mass Index (BMI) \<40

Exclusion Criteria:

* Previous surgery in the inguinal region (ie: prior femoral artery dissection)
* Myocardial infarction (MI) within the last 6 months
* Laboratory evidence of hypercoagulable state and/or connective tissue disease
* Pregnant women
* History of non-compliance with medical care
Complications of UTI in Patients on Dapagliflozin

The objective of this study is to compare, by insulin use at the index date, the sex-specific incidence of hospitalization or emergency department (ED) visit for severe complications of urinary tract infections (UTI), defined as pyelonephritis and urosepsis, among patients with type 2 diabetes mellitus (T2DM) who are new users of dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy.

The overall goal of this research study is to estimate the sex-specific incidence of hospitalization or emergency department visit for severe complications of urinary tract infections, defined as pyelonephritis and urosepsis, in patients who are prescribed dapagliflozin compared to patients prescribed other specific oral antidiabetic drugs. Dapagliflozin and other antidiabetic drugs are used to treat type 2 diabetes mellitus. Because of the mechanism of action for dapagliflozin and results from small safety monitoring studies, there is interest in further evaluating the safety of dapagliflozin in large populations.

The study will be implemented in three administrative health care data sources in two countries: in the United Kingdom, the Clinical Practice Research Datalink (CPRD); and in the United States, the Centers for Medicare and Medicaid Services (CMS) Medicare databases and the HealthCore Integrated Research Database (HIRDSM). Individuals in the databases will be included in the study if they meet the following age criteria; 18 years and older (CPRD and HIRD), or 65 years or older (Medicare); and if they did not have type 1 diabetes, are new users of one of the study drugs and meet the criteria of at least 180 days of electronic data before their first prescription of the study drug. The study period starts July 1, 2013 in CPRD, January 1, 2014 in PHARMO and January 9, 2014 in the United States data sources, and will end at the latest available data at each database at the time of analysis

Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older (CPRD and HIRD), or 65 years or older (Medicare);
2. no diagnosisi of type 1 diabetes,
3. are new users of one of the study drugs and
4. have at least 180 days of electronic data before their first prescription of the study drug

Exclusion Criteria:

1. The patient experienced chronic pyelonephritis at any time before the index date (i.e., during the available lookback time).
2. The patient was prescribed an SGLT2 inhibitor other than dapagliflozin on or before the index date.
3. The patient initiated metformin or sulfonylurea as AD monotherapy at the index date.
4. The patient initiated insulin therapy at the index date.
5. The patient had evidence of type 1 diabetes before cohort entry or first recorded AD is insulin monotherapy
Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies?

Peripheral central catheter application, especially in extremely low birth weight premature babies, is an intensive care follow-up procedure. There are many clinical studies in areas such as catheter type, skin disinfection, catheter duration, catheter infection. In our practice, it was observed that premature baby was less uncomfortable, the number of trials decreased, and the change in body temperature was less with the application of hot skin disinfection in our practice. With a prospective randomized study, the investigators wanted to document their observational data scientifically.

Babies under 32 gestation week and 1250 g who are treated at level 3 NICU and need peripheral central catheter will be included in the study. In the preparation of peripheral central catheter application, skin cleaning is performed with povidone iodine in our clinic. The investigators used during the povidione iodine preparation phase after heating the bain-marie method with sterile conditions. The investigators predicted that the premature baby would have less discomfort with warm povidion iodine. To demonstrate this, it was planned to take both video recordings during the application and N-PASS evaluation by an experienced person who does not know the povidone iodine temperature used .In preparation of the catheter except the person who did povidone iodine skin cleansing, nobody knows the heat. The catheters were administered by a single experienced person. The study was designed to be unaware of the povidin iodine application temperature of the person applying the catheter and the N-PASS assessment.

Eligibility Criteria:
Inclusion Criteria: below 32 gestational weeks and / or 1250 grams preterm babies neonates requiring total parenteral nutrition, antibiotic therapy for at least 7 days, -

Exclusion Criteria: major congenital anomalilies refusal to sign consent patient with previously attemped or placed central lines

-
Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

The mortality effect of kangaroo mother care in stable newborns \<2000g is well established but mortality effect in unstable newborns is not conclusively known. This pragmatic clinical trial aims to investigate the mortality and clinical effects of early continuous Kangaroo Mother Care (KMC) compared to standard care in mild-moderately unstable neonates \<2000g in a resource limited hospital setting.

This individually randomised controlled trial will compare 2 parallel groups of hospitalised mild-moderately unstable neonates \<2000g and aged \<24h at time of screening who receive either early continuous kangaroo mother care (KMC) (started at \<24h of admission) or standard care with continuous KMC at \>24h of admission and when stable. The intervention will be un-blinded to participants and researchers with blinding of outcomes where possible. If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm. Intention to treat analysis will be used. Duration of time spent in KMC will be documented and compared between arms. All other hospital management will be provided as per a Standardised Preterm Management Protocol, based on current standard care at the study site and compliance to this protocol will be monitored in both arms.

Underlying protective mechanisms for early KMC will also be explored, focusing on causal pathways such as thermal control, cardio-respiratory stability, infection prevention control and gastro-intestinal stability pathways.

Eligibility Criteria:
Inclusion Criteria:

* New admission to study site during study period
* Admission weight \<2000g
* Age 1 - 24h at start of screening
* Alive at enrolment
* Availability of study bed
* Written informed consent from parent or caregiver
* Parent or caregiver available and willing to provide intervention, if necessary

Exclusion Criteria:

* Congenital malformation incompatible with life or needing immediate surgical correction
* Severe jaundice needing immediate management
* Seizures
* Clinically stable as assessed over pre-defined period of cardio-respiratory monitoring
* Severely unstable as assessed over pre-defined period of cardio-respiratory monitoring
* Completed triplet admission
* Mother and/or neonate enrolled in another research study at time of hospital admission