cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE

ACCOMPAGNE study proposes to evaluate an educational program for the patient / caregiver dyad, intended to accompany the patient towards the implementation of self-regulation strategies in the driving activity. The program, based on group workshops with the presence of the patient and the caregiver, is led by an interdisciplinary team. It follows all the intervention recommendations described in the literature: to make the patient a decision-maker, to allow advanced planning of discussions between the family member and the caregiver, to give information on the consequences of TNCs and sensory disorders. This program provides psychological support in the management of the problems and the mourning of a future cessation of the driving activity, an awareness of the risky and avoidable situations, information on alternative solutions and available resources in the event of reduced driving. The program is created to support the implementation of self-regulation strategies for safe driving and a gradual reduction of driving activity. This study may be included in Measure 5 of the Neuro-Degenerative Diseases Plan (PMND) 2014-2019. This plan recommends to strengthen the self-management of patients and their relatives in the disease.


Eligibility Criteria:
Inclusion Criteria:

* aged between 50 and 95 years-old
* hold a driving license,
* drive at least twice a week,
* to have given free and informed consent,
* present a diagnosis of major or minor CNS according to DSM V, whose clinically probable or definite etiology is Alzheimer's or related or vascular disease,
* have a result in the Mini Mental State Examination (MMSE) greater than 18,
* have the ability to speak orally enough or write enough to perform clinical evaluations and workshops, be accompanied by a family member present at least 4 hours a week.

Criteria for inclusion of carers:

* to be a caregiver helping the patient for activities of daily living,
* to have given their free and informed consent,
* have the ability to speak orally and write enough to perform clinical assessments.

Exclusion Criteria:

* have a major psychiatric history, history of alcoholism, anti-depressant
* have sensory problems preventing participation in workshops,
* be affected by any debilitating pathology compromising the health of the patient in the short and medium term,
* be unable to express consent. Criteria for non-inclusion of caregivers: have sensory disturbances preventing participation in workshops.

Recruited patients and caregivers should have been informed and signed a consent.
Disseminating Evidence-based Practice to the Schools: CBT for Child Anxiety

The present study aims to test the implementation and sustainability of (a) a Computer-Assisted Cognitive-Behavioral Treatment (CACBT) for youth anxiety and (b) the BASC-2 TRS to identify anxious youth in the school setting using a cohort-sequential design (i.e., three years at 20 schools over the span of five years).

'Camp Cope-A-Lot (Computer-assisted CBT program)'

The present study will test the implementation and sustainability of (a) a Computer-Assisted Cognitive-Behavioral Treatment (CACBT) for youth anxiety and (b) the BASC-2 TRS to identify anxious youth in the school setting using a cohort-sequential design (i.e., three years at 20 schools over the span of five years). There are 3 phases: Phase I (baseline): Gather data on prevalence and services provided via screening measures and treatment trackers: Phase II (implementation): Train school staff in the identification of anxious youth (i.e. BASC-2 TRS) and the provision of the intervention (i.e., CACBT), modifying assessment and treatment procedures so as to best fit each individual school. Identify barriers and facilitators of implementation by gathering the qualitative experience of school staff: Phase II (sustainability): Discontinue training and supervision. Assess sustainability of the assessment and intervention. Identify barriers and facilitators of implementation by gathering the qualitative experience of school staff.

'Camp Cope-A-Lot (Computer-assisted CBT program)"

Eligibility Criteria:
Inclusion Criteria:

* All mental health workers (e.g., guidance, social work, school psychologists) in the schools will be eligible to be trained.

Exclusion Criteria:

* None.
Effects of Peripheral Somatosensory Stimulation Via Mechanical Pressure on Lower Limb Muscle Strength in Healthy Subjects.

The proprioceptive system and strength are closely related within the sensorimotor system: proprioception enables effective and coordinated muscle activation (including intramuscular and intermuscular coordination or synergistic abilities), which is essential for maintaining the functional stability of joints and preventing injuries-in short, for controlling motor patterns. This principle provides a window through which changes in strength can be observed via peripheral proprioceptive stimulation that activates the muscular system with the goal of increasing recruitment. This justifies the implementation of proprioceptive input in approaches aimed at motor learning.

Objective: To determine whether the application of a peripheral proprioceptive stimulus to the neuromuscular motor points of the quadriceps increases strength and neuromuscular activation during the squat movement in the lower limbs of healthy, untrained subjects.

Methods: The design of this study is a randomized crossover clinical trial. All participants (n=36) will randomly receive both the Active and Sham proprioceptive stimulation.The proprioceptive stimulus will consist of intermittent mechanical pressure on the skin, localized at the neuromuscular motor points of the rectus femoris, vastus lateralis, and vastus medialis of the quadriceps. The tissue subjected to precise pressure in these highly innervated neuromuscular zones promotes the stimulation of kinesthetic cortical sensitivity. The outcome variable will be the assessment of Maximum Strength (MS) generated by the participant during the squat movement, from a 90º knee flexion position to full extension. At the moment of peak force, the mean velocity (MV) of the concentric phase of the movement and the maximum load the participant can move will be evaluated. The intervention, assessment, and recruitment will take place at the Faculty of Health Sciences, Blanquerna - Ramon Llull University

Eligibility Criteria:
Inclusion criteria :

* State of health with no history of neuromuscular injuries
* Without surgical interventions, or lower limb trauma in the last six months
* No associated cardiovascular disease
* No associated severe COPD.
* AllParticipants are considered untrained if they do not engage in any specific vigorous lower-limb strength training or regularly perform physical exercise or sports activities.
Chronic Periodontitis and Polycystic Ovary Syndrome

Background: The aim of this study was to investigate the levels of malondialdehyde (MDA), total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and saliva samples in female patients with chronic periodontitis (CP) and to compared healthy individuals.

Materials and Methods: A total of 88 women were into four groups each which were consisted of twenty-two subjects. Groups were designed as periodontally and systemically healthy women (PCOS-CP-); periodontally healthy women with polycystic ovary syndrome (PCOS) (PCOS+CP-), systemically healthy women with CP (PCOS-,CP+) and women with PCOS and CP (PCOS+CP+). Serum and salivary samples were obtained, clinical periodontal parameters were recorded. MDA, TAS, 8-OHdG levels were measured as biochemically.

RESULTS:

Salivary 8-OHdG levels in the PCOSCP and CP groups were statistically higher than those in both the PCOSPH and the PH groups (P \< 0.05). There was no statistical difference between the PCOSCP, CP, and PCOSPH groups with regard to salivary MDA and TAS levels (P \> 0.05). Highest serum 8-OHdG and MDA levels and lowest serum TAS levels were seen in the PCOSCP group (P \< 0.05). Serum 8-OHdG and MDA levels in the PCOSPH group were higher than those in both systemically healthy groups (PH and CP) (P \< 0.05). Salivary TAS levels were highest (P \< 0.05) in the PH group. There was no statistical difference between the CP and PCOSPH groups, but serum TAS levels were lower than those in the PH group (P \< 0.05).

CONCLUSIONS:

CP, which led to an increase in serum and salivary 8-OHdG and MDA levels and a decrease in serum TAS levels in patients with PCOS, contributed to increased OS. This effect was more prominent in serum levels than in salivary levels.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed non-obese PCOS patients
* Never smokers
* Had no history of systemic disease
* BMI\<25 kg/m2
* Participants had ≥20 teeth present.

Exclusion Criteria:

* Pregnancy
* Lactation
* Hemoglobin A1c (HbA1c) ≥ 6.5%
* 2-h oral glucose tolerance test (OGTT-2h) ≥200
* Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors
* Any drug use within the past 6 months
* Periodontal treatment within the past 6 months
Comparing Labial and Lingual Orthodontic Appliances on Root Resorption and Bone Height

Patients who have moderate crowding that could be treated on a non-extraction will be treated in this study. The apical root resorption and alveolar bone height of the lingual and labial fixed appliances will be assessed. All patients will receive a cone-beam computed tomography (CBCT) scan at two different times (T0: Before treatment, T1: After treatment).

There are two groups: The first group (Experimental): The patients in this group will be treated using Lingual Fixed Orthodontic Appliances. The second group (Control): The patients in this group will be treated using Labial Fixed Orthodontic Appliances.

Recently, the therapeutic results of lingual orthodontics have become similar to those produced by labial orthodontics. However, lingual appliances act differently. The application of force near the center of resistance and the distance between the lingual brackets leads to an increase in friction and, thus, an increase in the force applied during treatment. In addition, the contact of the lower incisors with the brackets of the upper incisors in the lingual technique can lead to the intrusion of these incisors. Therefore, these factors can be potential risks for apical root resorption and alveolar bone height in lingual orthodontics.

2D radiographs may not accurately depict the true amount of root resorption due to magnification errors and difficulties in obtaining repeatable images. Besides, conventional two-dimensional radiographs cannot accurately assess alveolar bone height in the anterior region. CBCT has proven to be valuable in diagnosing root resorption due to its capability to produce distortion-free images, as well as its ability to maintain a high level of reproducibility despite changes in tooth positions after treatment, with high sensitivity and specificity. On the other hand, the use of CBCT allows for an evaluation of alveolar bone height in the anterior region with high accuracy and precision.

Eligibility Criteria:
Inclusion Criteria:

1. Class I molar and canine relationships on both sides.
2. Moderate crowding of both arches of about 4 to 6 mm treated on a non-extraction basis.
3. Age from 18 to 25 years.
4. The presence of permanent dentition (except third molars).

Exclusion Criteria:

1. The existence of craniofacial syndromes, cleft lip and/or palate (soft and/or hard).
2. Skeletal or dental crossbite.
3. Patients with missing teeth or periodontal diseases.
4. Previous orthodontic treatment.
Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection (COVID-19).

The virological diagnosis of SARS-CoV-2 infection is pivotal for the control of the outbreak by large screening of a- or pauci-symptomatic subjects. Despite nasopharyngeal swabbing tested by RT-PCR is considered as the gold standard, new strategies based on self-samples are considered as valuable alternatives because of their non-invasiveness and ability to be performed in the absence healthcare worker, especially when the subject is asymptomatic and needs to be tested repetitively. The aim of the present project is to evaluate two strategies both based on self-samples: (i) a saliva sample combined to an anterior nare self-swabbing tested by antigenic test versus (ii) a saliva sample tested by RT-PCR. The comparison will be performed during a mass screening of the population of the city of Saint-Etienne (170000 inhabitants), France. The sensitivity of the rapid antigenic test will be evaluated in comparison to that of RT-PCR considered as gold standard.

The main objective is to evaluate the performance of a strategy for screening for CoV-2-SARS infection that would combine 1) a salivary self-sample with an anterior nasal swab and 2) a diagnostic antigenic test, in comparison with the reference salivary RT-PCR technique recently validated by National Authority for Health (HAS).

Eligibility Criteria:
Inclusion Criteria:

* Adult age or at least 10 year old able to perform self-sampling of saliva and anterior nare swabbing
* Subject or legal tutor agreeing to participate to self-sampling and to collect anonymized data required by the present research

Exclusion Criteria:

* Inability to understand the protocol (language barrier notably)
* Deny to participate to the proposed research
* Patients under tutorship
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)

The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as designed. The study will last about 3 months with up to 6 days of inpatient time.


Eligibility Criteria:
* Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months
* Have a body mass index of 18.5 to 37 kilogram per meter squared
* Have a hemoglobin A1c level ≥6.0% and ≤9.0%

Exclusion Criteria:

* Have known allergies or history of hypersensitivity to insulin lispro
* Have had an episode of severe hypoglycemia within the past 6 months
* Have had more than 1 episode of diabetic ketoacidosis in the past 6 months
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding

The aim of this pragmatic, stepped wedge cluster-randomized trial is to measure the comparative yield (number of incident TB cases diagnosed during active case-finding camps) using a site selection approach based on predictions generated via an artificial intelligence software called MATCH-AI (intervention group) versus the conventional approach of camp site selection using field-staff knowledge and experience (control group). The trial will help inform whether a targeted approach towards screening for TB using artificial-intelligence can improve yields of TB cases detected through community-based active case-finding.

Despite significant progress over the past decades, an estimated 10.6 million individuals fell ill with tuberculosis (TB) in 2021 and the disease caused 1.6 million deaths globally. Pakistan is ranked as the 5th highest TB burden country in the world and TB causes 42,000 deaths annually in the country. A key challenge in the Pakistan's response to TB is ensuring diagnosis and treatment of all individuals with TB. In 2020, out of the 573,000 cases, a total of 276,736 (48%) were notified. Bridging this case-detection gap is a critical objective for the National TB Program (NTP). Active case-finding (ACF), is a potential strategy to increase case-detection by systematic screening of communities for TB. Recent evidence, indicates that ACF can also reduce population-level TB incidence and prevalence through early detection. While ACF interventions have demonstrated effectiveness in community-trials and are now being conducted at scale in Pakistan, concerns remain regarding their yields and cost-effectiveness in programmatic settings.

The primary aim of this study is to investigate whether a targeted approach towards community-based screening using MATCH-AI, an artificial intelligence software that models sub-district TB prevalence, can improve the yield of ACF interventions in Pakistan. In the intervention arm, field-team will conduct community-based ACF activities (called chest camps) primarily in locations predicted by MATCH-AI to have a higher prevalence of TB. In the control arm, field-teams will continue to utilize existing approaches towards camp site-selection. The trial will be conducted in 65 districts of Pakistan in collaboration with implementation partners of the NTP.

Eligibility Criteria:
Inclusion Criteria:

* All individuals \>15 years of age presenting to camp sites
* Individuals with previous history of TB disease

Exclusion Criteria:

* Children and adolescents \<15 years of age
* Pregnant women
A New Portable Monitor for Measuring Odorous Compounds in Oral, Exhaled and Nasal Air

The B/B Checker, a new portable device for detecting odorous compounds in oral, exhaled, and nasal air, is now available. As a single unit, this device is capable of assessing several kinds of gases mixed with volatile sulfur compounds (VSCs) in addition to other odorous gasses. The purpose of the present study was to evaluate the effectiveness of the B/B Checker for detecting the malodor level of oral, exhaled, and nasal air.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of oral malodor

Exclusion Criteria:

* Smoker
* Medical disorders
* Undergoing any antibiotic or other antimicrobial therapy
Deep Learning for Prostate Segmentation

Because the diagnostic criteria for prostate cancer are different in the peripheral and the transition zone, prostate segmentation is needed for any computer-aided diagnosis system aimed at characterizing prostate lesions on magnetic resonance (MR) images. Manual segmentation is time consuming and may differ between radiologists with different expertise. We developed and trained a convolutional neural network algorithm for segmenting the whole prostate, the transition zone and the anterior fibromuscular stroma on T2-weighted images of 787 MRIs from an existing prospective radiological pathological correlation database containing prostate MRI of patients treated by prostatectomy between 2008 and 2014 (CLARA-P database).

The purpose of this study is to validate this algorithm on an independent cohort of patients.


Eligibility Criteria:
Inclusion Criteria:

* Prostate MRI contained in the PACS of the Hospices Civils de Lyon
* Performed in 2016-2019

Exclusion Criteria:

* MRIs from patients who already had treatment for prostate cancer
Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain

This is a randomized Phase II study testing the effectiveness of the combination of morphine and methadone versus morphine alone in relieving pain. A second goal is to further evaluate any side effects of the combination of morphine and methadone.

Rationale: Experimental data demonstrates a profound analgesic synergy between morphine and methadone when co-administered systemically in mice. If this type of synergy can be demonstrated in clinical pain, it will be a relatively unique example of translating concepts of fundamental aspects of opioid actions seen in the laboratory to the clinical area, and provide a basis for offering new and scientifically- based analgesic regimens. This may provide better pain relief with less opioid related side effects in clinical practice.

Purpose:

This is a randomized, double blind, parallel arm Phase II study comparing a single dose of 1:1 combination of methadone and morphine with morphine alone in patients with post-operative pain.

* The primary objective of this randomized, double blind, parallel arm Phase II study is to compare the analgesic effects of a combination of morphine and methadone with morphine alone to determine synergistic activity of mu opioid analgesics in patients with post-operative pain.
* A second goal is to further evaluate any side effects of the combination of morphine and methadone.

Eligibility Criteria:
Inclusion Criteria:

* Retroperitoneal lymph node dissection
* Planned post-operative analgesia with PCA at 1 mg continuous infusion and 1 mg every 10 minutes
* 18 years of age or older
* English-speaking
* Give informed consent to participate in this study

Exclusion Criteria:

* Known hypersensitivity to methadone or morphine
* Patients with past or present history of substance abuse
* Patients with a history of methadone treatment
* Patients with a history of chronic pain requiring daily analgesic use for more than 3 months
* Patients treated with opioids within one month from the scheduled surgery
* Creatinine clearance less than 50 mg/kg (using Cockcroft-Gault Equation).
* Neurologic or psychiatric disease sufficient, in the doctor's opinion, to compromise data collection
Absorption, Metabolism, and Excretion Study of BIIB074

The primary objectives of the study are: To determine the mass balance and routes of elimination of BIIB074 and its known metabolites following administration of a single oral dose of BIIB074 in healthy male participants and To describe the pharmacokinetics (PK) of BIIB074 and its known metabolites and the disposition profiles of total radioactivity in whole blood and plasma following a single oral dose. The secondary objectives of this study are: To assess the safety and tolerability of BIIB074 in healthy participants and To identify and characterize any additional metabolites of BIIB074 in plasma, urine, and feces.


Eligibility Criteria:
Key Inclusion Criteria:

* All subjects must practice effective contraception during the study and be willing and able to continue contraception for 90 days after the administration of study treatment.
* Must be in good health as determined by the Investigator, based on medical history and screening evaluations.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* Previous exposure to BIIB074.
* Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.