cyrilzakka/clinical-trials huggingface dataset:
Improving Family's Adherence to Dental Care After DGA (HECC-CAN-study)

Early childhood caries (ECC) is a common disease. Its prevalence is highest in poor, socially disadvantaged, and minority groups. Dental treatment under General Anaesthesia (DGA) is common, especially among the youngest patients. Parental adherence to child's post-DGA dental treatment is varying. Non-attendance to preventive care appointments and dental check-ups after the DGA is also common. The primary aim of this study is to explore if a multi-professional (paediatrician and social worker) intervention after the child's DGA can increase the adherence to post-DGA dental care. The secondary aim is to compare its possible influence on children's oral health 18 months after the DGA. Our hypothesis is that multi-professional counselling and support after the DGA will lead to better adherence to the scheduled preventive dental programme and better oral health for these children in the long run.

In an earlier Finnish study 26% of the children did not attend to their first scheduled appointment after the DGA and during a four years follow-up period 63% of the patients had one or more no-shows.

Based on the assumption that reducing the amount of no-shows to half of the reported earlier (60% vs. 30%) is a clinically relevant result, we need 42 patients for both groups (alpha 0.05, beta 0.2, power 0.8).

Eligibility Criteria:
Inclusion Criteria:

* reason for DGA is dental caries
* place of birth is Finland
* primary dentition

Exclusion Criteria:

* chronic disease which needs treatment in tertiary hospital
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients with bipolar depression.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* Must sign informed consent prior to protocol-related procedures

Exclusion Criteria:

* Women who are pregnant, trying to become pregnant, or nursing
* Significant risk of committing suicide
* Any serious unstable medical conditions
Normative Data of Dynamic Gait Index and 5 Time Sit to Stand Test Among Elderly Population

The goal of this observational study is to measure the normative data for dynamic gait index and 5 time sit to stand test in elderly population. This study aimed for to take normative measurement of dynamic gait index and five time sit to stand test among elderly population and to compare the preliminary values of above mentioned tests with age.

Anthropometric factors affect the stability limits of the individual and can affect the motor strategies relating to balance control. The core elements of anthropometry are height, weight, body mass index (BMI), body circumferences (waist, hip, and limbs), and skin-fold thickness. Some anthropometric variables, such as body mass, are directly related to postural balance. Due to lack of normative data for dynamic gait index and five times sit to stand test in elderly population, this study aimed to formulate normative values for dynamic gait index and five times sit to stand test among elderly and correlation with anthropometric measures. Objectives: The objective of this study was to take normative measurement of dynamic gait index and five times sit to stand test among elderly population and to compare the preliminary values of above mentioned tests with age. All possible elder population was taken in current study to calculate the normative values of these two tests, five times STS to measure the ability to get up from a chair and DGI to record dynamic gait tasks in elder people

Eligibility Criteria:
Inclusion Criteria:

* 45-60 years elderly population.
* Both male and female were included in given age group.
* Older adults ambulate without a device or assistance.
* Population who has no deformity will be included.

Exclusion Criteria:

* Older adults who cannot ambulate were excluded
* Pregnant females were excluded from this study
* Population having any deformities was not included in this study.
* Any participants suffering from malignancy, infection or taking anticoagulant therapy were also excluded.
Effects of Balance Training Exercises Fall Risk Among Elderly Females

Falls are the second leading cause of unintentional injury deaths globally, and the literature shows that 40% of community-dwelling older adults who are over 65 years old experience fall accidents annually. It also harms the well-being of the elderly, including the lack of access to daily services. Therefore, exercise interventions that target balance, gait, and muscle strength increase can effectively prevent falls in older adults.

A fall prevention program that includes strength and balance training and patient education can improve muscle balance and mental capacity in older women with a history of falls. dimensions of abilities of the elderly are improved by exercise, such as dynamic balance, static balance, participants fear of falling, balance confidence, quality of life, and physical performance. The study will be a randomized clinical trial and will be conducted in Fatima Memorial Hospital, and Atif Rehab Clinic. The sample size is calculated from the open epi tool. Considering the attrition rate (10%) the sample size is calculated to be 36 altogether. This study will be completed in a time duration of 10 months after the approval of the synopsis. Non-probability convenience sampling technique will be used and participants will be recruited in the study after randomization through the lottery method. The subjects will be divided into two groups. Baseline treatment is isometric of the lower limb and bridging. Group A will receive balance training exercises using unstable surfaces and Group B will receive balance training exercises using stable surfaces. The tools that will be used are the Fall Efficacy scale-international (FES-I), Berg Balance Scale ((BBS), and ABC (Activities-Specific Balance Coordination) Scale, and after data collection, data will be analyzed by using SPSS version 26.


Eligibility Criteria:
Inclusion Criteria

* Age between 60-75 years old (18)
* Sedentary lifestyle females
* No history of fracture and ligamentous injury in the last 6 months
* Muscular strength should be in at least Grade 3
* Berg Balance Scale score ≤ 49

Exclusion Criteria:

* Any chronic disease such as carcinoma
* Athletes
* Women underwent any surgery (hysterectomy) in the last 2 months
Coronary Revascularization in Patients On Dialysis in China-Retrospective Registry

Coronary artery disease (CAD) is the leading cause of death in end-stage renal disease (ESRD) patients requiring dialysis. There are limited data on clinical characteristics, treatment strategies and outcomes in this special patient population in China. As a nationwide, observational, multicenter cohort study, this study consecutively included ESRD patients on dialysis with significant CAD at 30 tertiary care centers in 12 provinces in China from January 2015 to June 2021. Patient data collected included demographics, comorbidities, cardiac history, cardiac function, location and severity of CAD, procedural information, medications, and clinical events.


Eligibility Criteria:
Inclusion Criteria:

* 50% or greater stenosis in any of three main coronary arteries or left main coronary artery on visual assessment of the coronary angiogram
* Receive peritoneal dialysis or hemodialysis for more than 3 months

Exclusion Criteria:

-
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor

This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.

Up to 3 sites will participate in the study across Australia and the EU, collectively enrolling a minimum of 30 and a maximum of 50 subjects into the study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has undergone extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor.
2. Subject was ≥ 18 years of age at time of surgery.
3. Subject status is \> 12 months post-operative.

Exclusion Criteria:

Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
Effect of a Multi-directional Power Toothbrush on Recession

Background: Clinical studies have explored the relationship between toothbrushing and the development of recession, but relevant recession data for the multi-directional power toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association) reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over 12 months

Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized controlled clinical study. Healthy participants without periodontitis but with at least 2 teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession measurements were performed by one calibrated examiner at baseline, 6 and 12 months. Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR), changes in the percentage of recession sites demonstrating a change of ≥1mm as well as changes in pocket probing depths.


Eligibility Criteria:
Inclusion Criteria:

* 18 scorable teeth without orthodontic appliances or crowns and bridges
* at least 2 teeth showing recession of ≥ 2 mm on the mid-buccal surfaces (high risk teeth)

Exclusion Criteria:

* evidence of neglected dental health
* periodontitis and/or major hard/soft tissue lesions
* any physical limitations or restrictions potentially interfering with normal oral hygiene
* therapy with any drug within 28 days prior to the study
* pregnancy or breast feeding
* any systematic condition or significant illness
Personalizing Aspirin Therapy in Peripheral Arterial Disease Patients

Antiplatelet therapies are important to decrease the morbidity and mortality associated with Peripheral Arterial Disease (PAD) through the prevention of thrombus formation. Aspirin (ASA) is a readily available and affordable antiplatelet medication that can help reduce adverse cardiovascular events by up to 25%. However, 25-60% of PAD patients are "ASA insensitive" having a lower than normal ability to inhibit platelet aggregation after standard aspirin dosing. In a previous study conducted by our lab, we were able to demonstrate a methodology for personalizing antiplatelet therapy using two platelet function tests, Platelet Function Analyzer-100 (PFA 100) and Light Transmission Aggregometry (LTA). To investigate this methodology further, we would like to conduct a pilot study on two cohorts of patients, one population continuing with their current medications (81mg ASA), and a second group who will get personalized antiplatelet therapy using our methodology (81-325mg ASA). In this study, 150 PAD patients taking 81mg Aspirin therapy presenting for clinical follow-up, or in-patient intervention, in vascular clinics or the emergency room, will be recruited to our study. 75 patients will be randomly assigned undergo platelet analysis using PFA-200 and LTA, and will have their antiplatelet therapy personalized. Patients will then be followed up in order to see if the patients with personalized therapy have better platelet inhibition. This study will allow us to help personalize antiplatelet therapy in PAD patients, allowing for better patient outcomes and decreased adverse cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported intake of either 81 mg of aspirin per day for 3 or more days
* Diagnosed with peripheral arterial disease

Exclusion Criteria:

* Alcohol ingestion 24 hours prior to blood draw
* Patients receiving glycoprotein (GP) IIb/IIIa antagonists
* Ingestion of a non steroidal anti-inflammatory drug 3 days prior to blood draw
* History of bleeding disorders
* Gastrointestinal bleeding
* Hemorrhagic stroke
* Allergy to aspirin or ticagrelor
* Pregnancy, thrombocytopenia anmia or leukopenia
Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia

The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.

Each year approximately 256,000 children and adults around the world develop a form of leukemia, and 209,000 died from it. Recently, some studies have evaluated the relationship between the concentration of some cytokines and prognosis of acute lymphoblastic leukemia. XCL1 is a lymphotactin that belongs to a cytokine subfamily called C or γ with only one cysteine in the N-terminal residue. It has been found with significant expression of receptor mRNA XCL1 (XCR1) in T and B lymphocytes and related to hematological neoplasms. For these reasons, XCL1 could be a efficient marker of prognosis in patients with acute lymphoblastic leukemia.

Eligibility Criteria:
Inclusion Criteria:

Patients with newly diagnosed acute lymphoblastic leukemia .

Exclusion Criteria:

* Patients with prior treatment with chemotherapeutic agents.
* Patients treated with immunosuppressants.
* Patients under 12 months old.
* Patients with a diagnosis or history of autoimmune diseases.
* Patients with a diagnosis or history of immunosuppressive diseases.
* Patients who do not agree to sign a Letter of Informed Consent.
Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations

This is a single-centre, open-label, non-randomised, period fixed sequence study designed to investigate the PK and safety of Firibastat (QGC001) modified release (MR) prototype tablet formulations and compare this to a reference Firibastat (QGC001) immediate release (IR) capsule formulation in healthy male subjects.

It is planned to enrol 12 subjects to receive single oral doses of investigational medicinal product (IMP).

Subjects will be screened for eligibility to participate in the study up to 28 days before dosing and for each treatment period they will be admitted to the clinical unit on the evening prior to IMP administration (Day -1). On the morning of Day 1, subjects will receive IMP in the fasted state (or following a FDA standard high-fat breakfast, if applicable) and will remain on site until 48 h post-dose. Between the periods, an interim analysis and review of safety and PK data from dosed regimens will be performed in order to determine which Firibastat (QGC001) MR prototype tablet formulation and dose to administer in subsequent periods. A follow-up phone call will take place 7 to 10 days post-final dose to ensure the ongoing wellbeing of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 18.0 to 32.0 kg/m2
* Must adhere to the contraception requirements

Exclusion Criteria:

* Subjects who have received any IMP in a clinical research study within the previous 3 months
* Subjects with pregnant partners
* History of any drug or alcohol abuse in the past 2 years
* Clinically significant abnormal biochemistry, haematology or urinalysis
* Subjects with BP \<90/50 mmHg at screening
Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment.

Objectives High-dose radiotherapy (RT) for head and neck cancer has significant adverse effects on maxillofacial tissues, among which osteoradionecrosis (ORN) is the most severe and potentially life-threatening. Although tooth extractions seem to be the main risk factor, few perspective studies evaluated protocols to minimize the ORN risk due to extractions. The aim of this study is to evaluate incidence and risk factors of ORN in a cohort of patients receiving tooth extractions before RT and evaluate an algorithm about extraction decision.

Methods One-hundred ten patients were consecutively recruited in this study: impacted third molars with radiographic sign of pericoronitis, teeth with periapical lesions, unrestorable teeth, periodontally compromised teeth (pocket probing depth \>5 mm, clinical attachment loss \> 8 mm, grade 2 tooth mobility, II grade furcation involvement) were extracted under antibiotic prophylaxis. A 15-days interval between the last tooth extraction and the beginning of RT was recommended. Patients were visited at 15 days, 1, 3 and 6 months after the beginning of RT. Data of patients with a minimum of 6 months follow-up are presented in this report. ORN was defined as irradiated exposed necrotic bone, without healing for 3 months, in absence of cancer recurrence. The protocol was approved by the Ethic Committee of Catholic University - Fondazione Policlinico Gemelli (Prot. OHHN-1, ID-2132).


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to sign the informed consent form
* Patients with diagnosis of HNC, with specific prescription of local radiotherapy, both for curative and palliative purpose, with or without chemotherapic treatment.
* Patient with diagnosis of HNC, with specific prescription of local radiotherapy as an adjuvant to surgical resection, with or without chemotherapic treatment.

Exclusion Criteria:

* Patients participating to other clinical studies
* Patients who refuse to participate in the study
* Patients unable to attend the ambulatory visits scheduled by the protocol
Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R)

Phase II 3 arm double blinded clinical study, to evaluate pain killing and healing time of Botanical Ear Drops, Ear Comfort™, in Severe External Ear Infection (AOE) patients in comparison to Dex-Otic® and Otidin®.

Study Outcome (hypothesis): if Ear Comfort™ proves to perform as well as Dex-Otic, then ENT's and family doctors will have a botanical non-antibiotic product that does not promote the formation of antibiotic-resistant infections and may be given to anti-biotics sensitive patients.

Ear comfort™ is pharmacologically stable for at least 3 years on the shelves.

Severe External Ear Infection (AOE) also known as Swimmer's ear, is an abundant microbiological contamination disease of the outer ear canal. It causes severe pains and accumulation of fluids in the ear. In some cases it may compromise the hearing. Swimming in contaminated water or cleaning the ear with a hard subject are only two examples of what may cause AOE. The main Pathogenes causing the disease are Gram negative of which Pseudomonas aeruginosa is the most abundant. Occasionally it is a fungoid contamination with Aspergillus Niger being the most abundant.

Eligibility Criteria:
Inclusion Criteria:

* Patients with AOE.
* AOE patient determined by ear canal obstruction, exudates and pain.
* Males and Females between 18 and 65 years of age.
* Patients willing to refrain from using any ear drops products for the entire duration of the study. - - Subjects are willing to use the full 4 steps protocol
* Written informed consent has been obtained.

Exclusion Criteria:

* Known allergy or sensitivity to Chamomile extract or essential oils.
* Injury to tympanic membrane.
* Medical or psychiatric conditions that affect the patient's ability to give informed consent, or complete the study.
* Pregnant or lactating females.
* Use of ear drops or antibiotic or analgesic medications within the last 4 weeks prior to enrolment to the study.
* Other known diseases, including severe allergy, chronic liver or kidney disease, malignancy or contagious diseases, such as HIV or hepatitis.
* Alcohol or drug abuse, according to assessment by the investigator.
* Participation in other clinical trial within the last 30 days.
A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation

This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.

This is a multicenter, prospective study of up to 150 relapsing-remitting MS participants/ The study is looking to see if patients who have not had a relapse in the past year would benefit from switching to ofatumumab.

After giving consent, participants will have a 1 week screening/qualification period. If they qualify to continue, they will start a a six month run-in period during which lab samples will be collected. Patients that are relapse-free during the run-in period will continue into next period of the study in which they will be randomized to either ofatumumab or continued therapy for the next 15 months. Every 3 out of 5 randomized participants will be selected to wear a digital study watch to collect physical activity, sleep, and vitals during this 15 month period. The study watch will be worn 24 hours a day, 7 days a week but can be removed during showers/bathing. At the end of the 15 month period, a study completion visit will be held.

The total study duration is 21 months plus 1 week for screening/qualification.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study.
* Age 18-45 years
* Diagnosis of RRMS per McDonald Criteria (2017)
* EDSS 0-5.5 (Inclusive)
* Able to obtain MRI and attend study visits at sites
* Willing to use wearable device as specified in the protocol
* Able to provide blood sample
* On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening
* No relapse reported within 6 months prior to Screening
* Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment. An absence of MRI activity is not exclusionary.

Exclusion Criteria:

* Primary progressive or secondary progressive phenotype
* Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
* Use of experimental or investigational drugs for MS within 2 years from Screening
* Known sensitivity to gadolinium
* Central Nervous System (CNS) anomalies that are better accounted for by another disease process
* Known active malignancies
* Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS
* Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies
* Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
* IgG or IgM levels below lower limit of normal (LLN) at Screening
Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder

Research has established the incidence of insomnia increases with age and the possible causes contributing to sleep problems in the elderly are still being explored and debated. Older adults use a disproportionately large share of sleep aids with non-prescription sleep aid use having increased over the past decade. This study is a double blind safety and effectiveness trial examining the response of eszopiclone co-administered with escitalopram for the treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.

This is a double-blind, randomized, placebo-controlled, parallel-group study. There are two groups of subjects with Major Depressive Disorder and insomnia symptoms randomized to treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at visit 2. Also, all subjects receive open label treatment with escitalopram 10 or 20mg daily in the morning. Safety and efficacy is evaluated as well as rating scales and patient sleep diaries.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MDD, HAMD score 20 or greater at screening and baseline, total sleep time less than 6 hours at screening and baseline, ISI 15 or greater at screening and baseline

Exclusion Criteria:

* May not use any other psychoactive drugs/psychotropics during study, may not have any type of dementia, may not have any significant/unstable medical problems, no nightshift work permitted, no current seizure disorders/head injuries