cyrilzakka/clinical-trials huggingface dataset:
The Effect of Non-surgical Periodontal Therapy Plus Doxycycline on HbA1c in Patients With Type 2 Diabetes Mellitus

Aim:

The purpose of this study is to investigate the effect of nonsurgical periodontal therapy plus doxycycline on glycemic control in type 2 diabetes mellitus (type 2 DM) patients who have periodontitis.

Materials and methods:

A total of 24 type 2 DM patients with periodontitis will be selected for the study, and randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and type II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More than 110 have), and also with periodontal disease are chronic moderate (at least in three areas Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by clinical examination and radiographic signs are being); Takes place. The initial HbA1c Patients should be between 7-9 percent over the past three months has changed his medication also found the necessary explanations on how to do that consent, Plaque index (PI) by Loe \& Silness, bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and its absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded. "Group 1": (12 patients) was treated with oral hygiene instruction, Scaling, and root planing, and doxycycline for 15 days; and "Group 2": (12 patients) has the same treatment but with placebo, After 12 weeks their periodontal condition and Fasting blood sugar (FBS), glycated hemoglobin (HbA1c) level, will be reevaluated.

Doxycycline downregulates the activity of matrix metalloproteinases (MMPs), key destructive enzymes in periodontal disease

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus type II (at least 3 months before diagnosis, and A fasting blood sugar level of more than 125 mg/dl) and has periodontal disease is a chronic moderate (has a clinical attachment level of 3-4 mm) peritonitis
* Minimum of 16 natural teeth, and no periodontal treatment in the prior 6 months, - Had a glycated α hemoglobin (HbA1c) value between 7- 9 percent at screening
* Had reported no changes in diabetes medications within the last 3 months were in the care of a physician for their diabetes.

Exclusion Criteria:

* Pregnancy or lactation
* History of allergy to drugs used in the study
* Smoking
* Diabetes-related emergency within 30 days ago
* Use of nonsteroidal anti-inflammatory drugs
* Or taking low dose daily aspirin (75-325 mg)\\
* Use of immunosuppressive medications; antibiotic use
* Dialysis
* Risk of bleeding complications
* The type of disease periodontal (Aggressive)
* A history of periodontal treatment in the previous 6 months
* Orthodontic treatment
* Using the removal prostheses
* Extensive dental caries
* Dental abscesses or infections.
Post Authorisation Safety Study With Raxone in LHON Patients

This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) of the clinical outcomes for patients with LHON treated with Raxone®.

No medication will be provided as part of this study. Raxone® will be obtained through commercial channels.


Eligibility Criteria:
Inclusion Criteria:

* Patient prescribed Raxone® for the treatment of LHON;
* Patient has completed an Informed Consent Form (ICF) indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study and has agreed to participate in the study;
* Patient is not participating in any interventional study.

Exclusion Criteria:

* No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)

The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in AD patients.

This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female aged ≥ 18 and \< 75 years.
* Moderate-to-severe AD.
* Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable.
* Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception.

Key Exclusion Criteria:

* Known hepatitis B, hepatitis C, or human immunodeficiency virus infection.
* Evidence of active or latent tuberculosis (TB).
* History of untreated or inadequately treated TB infection.
* Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening visit.
* Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement.
* Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
Isolite and Dental Treatment Under Conscious Sedation

Hypothesis

The use of Isolite® system does not produce upper airway obstruction in the pediatric population during dental treatment with conscious sedation.

Purpose:

Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.

Objectives:

1. Determine changes in pulse rate
2. Determine changes in SpO2
3. Recognize breath sound's changes possibly associated with airway blockage
4. Evaluate if the isolite® system is well tolerate by the pediatric population for dental treatment under conscious sedation
5. Relate the use of Isolite® with the frequency of head reposition to open the airway.

Report the changes in airway patency and pediatric patient's behavior when Isolite® system is used for dental treatment with conscious sedation.

Eligibility Criteria:
Inclusion Criteria:

* ASA I (no systemic disease), ASA II (mid systemic disease-well controlled)
* 4-7 years of age
* Patients English and Spanish speaking

Exclusion Criteria:

* Upper airway infection
* Craniofacial anomalies
METHORIVAC - Vaccinal Pharmacoepidemiologic

This project is the pilot step necessary to develop a system of vaccination pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for this challenge and case series analysis, with the use of linked medicoadministrative data for hospitalisations the reimbursement of healthcare costs. This linkage of medicoadministrative data is new in France. The example of the risk of hospitalisation for febrile convulsions in infants less than two years old following vaccination against diphtheria, tetanus and pertussis is given as the reference association. This choice is justified by the numerous publications over many years on the existence of this association (Miller et al BMJ 1981, Farrington et al Lancet 1995). In addition, as case series analyses have been carried out to assess this risk, the results can be compared directly (Lancet 1995). The study to determine whether the analysis tools are suitable for the data will be tackled at the following levels:

* Validity of the selection of cases from administrative records alone using coding based on the international classification of diseases ICD10
* Validity of the risk assessment. This methodology feasibility project must make it possible to identify the different potential problems. This is a prerequisite necessary for the systematic implementation.


Eligibility Criteria:
Inclusion Criteria:

- For reimbursement data: All of the data concerning delivery (purchase of the vaccine at a pharmacy, prescription) and vaccination (consultation following the date of purchase) for infants younger than 2 years old, in the years 2007 and 2008.

- For PMSI data: All of the hospitalisations in 2007 and 2008 for febrile convulsions in infants less than 3 years old in hospitals of the following departments: Côte d'Or, Doubs and Bas-Rhin

Exclusion Criteria:

-
Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease

Freezing of gait (FOG) is a common and devastating symptom in advanced stage Parkinson's disease (PD), which contributes to falls and disability. Unfortunately, there is no effective pharmacological treatment for FOG. It is suggested that the cortex-basal ganglia circuit, especially the frontal lobe, plays an important role in the pathogenesis of FOG. Repetitive transcranial magnetic stimulation (rTMS) effects over the cortex and affects the subcortical neural circuits. Previous studies have demonstrated that rTMS can improve FOG for PD patients. In the present randomized controlled trial (RCT) study, the invastigators aim to investigate the efficiency of rTMS over different motor regions of frontal lobe. The efficacy of treatment is evaluated by the score of FOG questionnaire and FOG provoking test, and the changing of neural network shown by functional magnetic resonance imaging (FMRI). Then the effects of rTMS over different brain regions will be compared for choosing a better target. The study will provide the evidence for non-invasive neuro-modulation of Parkinson's disease with freezing of gait (PD-FOG).


Eligibility Criteria:
Inclusion Criteria:

* Subjects fulfilled the diagnosis of idiopathic Parkinson's disease according to MDS-PD criteria
* Hoehn \& Yahr (H-Y) stage was 2 or 3
* All subjects had freezing of gait which was identified by FOGQ

Exclusion Criteria:

* cognitive impairment (MMSE score\<22) or major depression (HAMD-24 score\>25)
* severe visual and/or haring impairment
* significant medical or psychiatric illnesses
* history of deep brain stimulation (DBS) surgery or pacemaker implantation. MRI cannot be performed in those patients
* current treatment with medication cannot be maintained during the study
Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

The goal of this study is to objectively test one's sense of smell, called olfaction, in participants with Subjective Cognitive Concerns (SCC), Mild Cognitive Impairment, Mild Behavioral Impairment (MBI), and age-matched controls. The main question it aims to answer is whether the AROMHA Brain Health Test could serve as a predictive biomarker of neurodegenerative disorders. This understanding will aid in the development of a noninvasive, cost-effective diagnostic tool that reliably and specifically distinguishes disease and normal aging populations.

Participants will take the approximately 45-minute AROMHA Brain Health Smell Test where they will peel and sniff labels on the physical smell cards and answer questions on the web-based app relating to what they smelled. Participants will undergo tests for odor intensity, odor identification, odor discrimination, and episodic olfactory memory, but will not be provided the results of these tests.


Eligibility Criteria:
Inclusion Criteria:

* A clinical or research consensus diagnosis of the patient's condition or control status.
* Individuals that are at least 18 years of age at the time of enrollment.
* Individuals that are no older than 100 years of age at the time of enrollment.

Exclusion Criteria:

* Primary pulmonary disease such as severe emphysema or asthma not under good medical control.
* Current sinusitis, common cold, upper respiratory infection, or nasal polyps.
* Current or recent (past 6 months) alcohol or substance dependence. A prior history of alcohol or substance abuse will not be grounds for exclusion.
* Pregnancy.
* Severe cognitive dysfunction that would preclude completion of the olfactory testing.
* An adverse reaction to fragrances (ie. they trigger a severe asthmatic attack or nausea).
Calibration of MR and PET-MR Imaging Protocols at RIC

This is a protocol to facilitate on-site calibration of the technical aspects of the Siemens Biograph mMR (molecular MR) Positron Emission Tomography-Magnetic Resonance (PET-MR) scanner and the 3T Siemens Vida MR scanner at the Cedars-Sinai Medical Center (CSMC) Biomedical Imaging Research Institute (BIRI) Research Imaging Core after scanner installation. The mMR is a FDA-approved standard clinical device (non-experimental) and will be used in accordance with clearance and approval from the FDA. The Vida is a state-of-the-art FDA approved scanner and will be clinically licensed within a short time.

PET-MR Protocol on the Biograph mMR: This protocol requires the use of a radioisotope. To avoid administering radioisotope solely for the purposes of this calibration, we will recruit 20 patients from the clinical population at the S. Mark Taper Foundation Imaging Center at CSMC who are already receiving an isotope dose for their standard-of-care examination and are willing to be scanned at the Research Imaging Core on the same day right after their clinical exam. Subjects who are having a PET-MR after receiving FDG will have the same body part scanned as they did for clinical testing.

MR-only Protocol on the Biograph mMR:To set up MR-only protocols, we will enroll 20 volunteers for MR-only on the mMR scanner. This is a standard MR scan with no isotope involved. Those volunteers who are participating in the MR-only scan will have major body parts and organs scanned as needed for calibration.

MR imaging on the Siemens Vida 3T scanner: applications training is taking place and we will build clinical protocols in the future

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* For MR-PET calibration: Outpatient undergoing standard-of-care 18FDG-PET at S. Mark Taper Foundation Imaging Center at CSMC
* For MR-only calibration: Volunteers who are responding to approved advertising to volunteer at the BIRI Research Imaging Core for research MR

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Any contraindications to MR imaging.
* Any contraindication to MRI, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia.
CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies

This phase I trial studies the side effects and best dose of anti-cluster of differentiation (CD)47 monoclonal antibody Hu5F9-G4 in treating patients with haematological malignancies including acute myeloid leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory), or high risk myelodysplastic syndrome. Monoclonal antibodies, such as anti-CD47 monoclonal antibody Hu5F9-G4, block cancer growth in different ways by targeting certain cells.


Eligibility Criteria:
Key Inclusion Criteria:

* Pathologically confirmed relapsed or refractory (primary refractory and relapsed refractory) Acute Myeloid Leukemia (AML) (defined by World Health Organization (WHO) criteria) for which no further conventional therapy is suitable for the patient, or confirmed myelodysplastic syndrome defined according to WHO classification, with an International Prognostic Scoring System (IPSS) risk category of intermediate-2 or high risk, that is relapsed, refractory or intolerant to conventional therapy within 3 weeks of registration.
* Male or female, Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
* Willing to undergo blood transfusions as deemed clinically necessary.
* Adequate hematological, liver, and kidney function

Key Exclusion Criteria:

* Females: Pregnant or breast-feeding women, or women of childbearing potential unless effective method of contraception is used during and for 3 months after the trial. Males: unless an effective method of contraception is used during and for 3 months after the trial.
* Any prior exposure to Hu5F9-G4 or other CD47 targeting agents.
* Treatment with any other investigational agent within 28 days prior to enrolment.
* Previous allogeneic stem cell transplant within 6 months prior to enrolment, active graft vs host disease (GVHD), or requiring transplant-related immunosuppression
* Evidence for active CNS involvement by leukaemia
* Clinical evidence or known history of cardiopulmonary disease
A Comparative Analysis of Ultrasound's Accuracy in Diagnosing HC Using Histopathology as Gold Standard

The study aims to evaluate the accuracy of ultrasound in diagnosing hepatocellular carcinoma (HCC), using histopathology as the gold standard. It addresses HCC's high global incidence and the utility of ultrasound as a non-invasive, cost-effective screening tool. Despite ultrasound's accessibility, its diagnostic limitations necessitate further investigation to improve clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinically suspected liver cancer patients undergoing ultrasound examination.
* Patients undergoing histopathological examination (liver biopsy or resection) for definitive diagnosis.

Exclusion Criteria:

- Patients with history of liver cancer treatment or inadequate data."
A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects

The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Adult Male or Female 18-55 yrs.
* Subject has provided written consent.
* Subject is in general good health.
* If female, subject is postmenopausal.
* If female, subject is not pregnant and is not breast-feeding.
* Subject must use birth control methods or be surgically sterile.

Exclusion Criteria:

* Subject is HAV-IgM, HBsAg or HIV Ab positive.
* Positive screen for drugs of abuse, alcohol, or smoking.
* Cannot be on any medication, including over the counter drugs.
* Cannot have previous history of alcohol or drug abuse.
* Cannot have history of any major diseases or disorders.
Effect of Increased Intake of Low Fat Dairy Products on Weight Loss and Insulin Resistance

The purpose of this study is to determine if increased intake of low-fat milk products and calcium as part of a calorie restricted diet helps achieve a healthier body weight and body composition and decrease blood glucose levels in people with insulin resistance or type 2 diabetes.

Obesity can cause many health problems as it is linked to several chronic diseases including type 2 diabetes. We know that individuals who are overweight or obese, and have impaired glucose tolerance or insulin resistance, have a good chance of developing type 2 diabetes. Research tells us that the risk of developing type 2 diabetes can be decreased by losing weight and making dietary changes. A promising area of study involves using low-fat milk products and calcium to prevent and/or control obesity and diabetes. This study is important because it will determine if including low-fat milk products in weight reducing diets can enhance weight loss, improve fat loss and decrease levels of blood glucose and insulin in individuals with impaired glucose tolerance or type 2 diabetes not treated with medication. This information is directly applicable to treating diseases such as obesity, type 2 diabetes and heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Overweight and obese (BMI of 27 to 37 kg/m2)
* Impaired glucose tolerance (fasting blood glucose \>5.6 mmol/L) or
* Type 2 diabetes treated with diet and exercise alone (no medications)
* One or more of the following criteria for metabolic syndrome:

  1. Hypertriglyceridemia (\> 1.70 mmol/L)
  2. Low high-density lipoprotein (HDL) cholesterol (\< 1.04 mmol/L in men and \< 1.30 mmol/L in women)
  3. High blood pressure (\> 130/85 mm Hg)
  4. High waist circumference ( \> 94 cm in men, \> 80 cm in women)
* Weight stable and no changes in exercise in past 3 months

Exclusion Criteria:

* Type 1 diabetes
* Type 2 diabetes treated with oral hypoglycemic agents or insulin
* HbA1c \> 8%
* myocardial infarction or have undergone a cardiovascular intervention within the past three months
* Subjects taking fibrate or statins who have had a dose change within the 8 weeks prior to randomization
* Liver or pancreas disease
* Major gastrointestinal surgeries
* Pregnant or lactating
* Exhibit alcohol or drug dependence
* Taking drugs influencing appetite
* Have a milk allergy or lactose intolerance
* Following a diet or exercise regime designed for weight loss
* Have a body weight greater than 350 lb (weight limit for DEXA instrument)
* Chronic use of bulk laxatives, antacids or calcium supplements
A Study on Knee Immobilization and Pain Levels After an Anterior Cruciate Ligament (ACL) Reconstruction Surgery

The purpose of the study is to determine if there is difference in immediate postoperative pain levels (48 hours) between patients who wear a knee immobilizer splint compared to patients who do not wear a knee immobilizer splint after an anterior cruciate ligament reconstruction surgery.

This study will attempt to evaluate the efficacy of knee immobilization on patient postoperative pain levels following an ACL reconstruction. There is a lack of consensus in the area of postoperative knee bracing/immobilization. A survey of Canadian surgeons indicates that the primary reason for postoperative knee immobilization is to reduce pain. To the investigators' knowledge, there are no studies comparing the use of immediate (0-48 hours) postoperative knee immobilization versus no immobilization and pain control in this patient population.

Eligibility Criteria:
Inclusion Criteria:

- Clinical: Patients' aged 18-40, ACL deficiency as determined by MRI or physical exam (positive lachmann and pivot shift tests) resulting in giving way episodes (acute or chronic) unresponsive to non-operative management and therefore requiring primary ACL reconstruction.

- Arthroscopic: Concomitant meniscal resection.

Exclusion Criteria:

- Clinical: Previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy,) Concomitant lower extremity fracture, Ipsilateral collateral ligament injury within past 3 months, Time from ACL injury less than 6 weeks, Allergy/intolerance to Tylenol 3 with codeine and to Percocet, Third Party or Medical Legal.

- Radiological: Skeletal immaturity (open growth plates).

- Arthroscopic/surgical: Concomitant posterior cruciate ligament or collateral ligament repairs, Osteochondral lesions requiring microfracture, Meniscal repair, Patients not having both their semitendinosus and gracilis harvested.