cyrilzakka/clinical-trials huggingface dataset:
Tooth Retention After Root Canal Treatment With Endomethasone N

The aim of root canal treatment, or endodontic treatment, is to treat pulpal or periapical diseases and thus transform a pathological tooth into a healthy, asymptomatic and functional entity on the dental arch. The diagnosis of pulp pathology is based on the symptomatology described by the patient, on data from the clinical examination and tests performed as well as the radiographic examinations.

Different families of root canal sealers are used in endodontics: cements based on zinc oxide-eugenol (ZOE), resin-based materials, and calcium silicate-based cements. They provide a stable and hermetic sealing. The Septodont laboratory has developed and manufactured endomethasone N, a zinc oxide-eugenol root canal sealer.

The aim of this retro-prospective PMCF study is to collect long term clinical and safety data on root canal obturation after treatment or retreatment by Endomethasone N.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, \> 18 years of age at the time of inclusion in the study
* Patient who had a non-surgical root canal treatment with Endomethasone N, in a context of an endodontic treatment, or retreatment, before 01-Mar-2016
* Having a documented patient follow-up visit (clinical examination and radiographic examination) at least 5 years after the endodontic treatment or retreatment with Endomethasone N
* Patient affiliated or beneficiary of a social security system
* Patient informed about the study and who confirm their non-opposition in participating in the study

Exclusion Criteria:

* History of malignant tumors in the 5 years prior to the root canal treatment
* Non-stabilized systemic disease during the month prior to the root canal treatment (diabetes, hypertension, thyroid disorders, etc.)
* Patient who developed a systemic pathology after the root canal treatment with Endomethasone N
* Patient who had endodontic treatment with Endomethasone N obturation on a wisdom tooth
* Patient whose tooth has suspected perforation during endodontic treatment
* Patient suffering from active non-stabilized periodontitis, untreated during endodontic treatment
* Patients participating in an interventional clinical trial at the time of root canal treatment
TSA Versus RSA in Patients >75

Total shoulder arthroplasty (TSA) has proven to be a predictable and successful operation for the treatment of symptomatic glenohumeral osteoarthritis (GHOA) with an intact rotator cuff. Results after TSA have not been as good in cases with rotator cuff dysfunction, however. Early glenoid loosening, shoulder pain and the need for revision surgery has been all associated with rotator cuff deficiency. Even in cases without tears, fatty infiltration of the rotator cuff has been associated with inferior outcomes in TSA.

Advanced age has been shown to be associated with increased fatty infiltration of the rotator cuff in shoulders with primary osteoarthritis. Because of this, one may propose that surgeons should avoid the potential complications with TSA and perform RSA for patients with advanced age. It is thus the purpose of this study to evaluate the patient reported outcomes (PROs) of total shoulder arthroplasty (TSA) compared with reverse shoulder arthroplasty (RSA) in patients \>75 years of age


Eligibility Criteria:
Inclusion Criteria:

* All patients (75 years of age) at the time of surgery
* Patient is willing to participate by complying with pre and postoperative visit requirements
* Patient is willing to consent for enrollment
* Patient has advanced imaging (CT or MRI) that demonstrates an intact rotator cuff

Exclusion Criteria:

* Patients under the age of 75
* Need for any structural graft for repair of the shoulder during surgery
* Current infection of the proximal humerus or scapula
* Proximal humerus fracture
* Inadequate or malformed bone that precludes adequate support for prosthesis (B2, B3, C Glenoid morphology)
* Neuromuscular disorder that does not allow control of the shoulder joint
* Significant injury to the brachial plexus
* Diagnosis of inflammatory arthropathy
* Preoperative diagnosis of full thickness rotator cuff tear
* \>Goutallier Stage 1 rotator cuff atrophy
* Prior shoulder arthroplasty
* Non-functioning deltoid muscle
* Patients who are known drug or alcohol abuser, or have a psychological disorder as defined by the DSM4 that could affect follow-up care
* Patient is a prisoner
* Patients who are currently involved in any personal injury litigation, or worker's compensation claims.
EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

This is a pre-post randomized community-based controlled trial aimed at estimating the effectiveness of an educational package developed using PRECEDE PROCEED to reduce the cumulative incidence of Taenia solium cysticercosis in three Provinces of Burkina Faso. The study design included an 18-months baseline study to measure baseline cumulative incidence of cysticercosis followed by an 18-month post randomization study to measure the effectiveness of the intervention. Sixty villages of three Provinces of Burkina Faso were included. The primary outcome was the change in the baseline to post randomization cumulative incidence in the intervention group compared to the control group.


Eligibility Criteria:
The unit of randomization and analysis of this study is the village. Therefore, the eligibility criteria were determined at the village level.

Inclusion Criteria:

* Population of at least 1000 at the 2006 census
* Present on the map of the "Institut Géographique du Burkina 2000"
* Separated from another village by at least 5 kilometers.

Exclusion Criteria:

* Village located on a National or Provincial road
* Village located within 20 km of Koudougou or Ouagadougou
* Regional or Provincial Capital
* Absence of pigs in the village

At the individual level, the following eligibility criteria were used:

Inclusion Criteria:

* Aged 5 years old or more
* Has lived in the village for at least 12 months
* Not planning to move in the next three years

Exclusion Criteria:

* Presence of confirmed epilepsy or progressively worsening severe chronic headaches at baseline.
Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.

Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age and generally healthy
* Subject able to give written informed consent
* Subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion:

  * less than 4 months in age
  * primarily ulcerative, ie not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
  * in a location suitable for collecting samples by dental broach, scraping, and aspiration
* In the opinion of the investigator, the subject is capable of understanding and complying with the protocol

Exclusion Criteria:

• Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome
The Effect of Non-invasive Brain Stimulation on Language Production in Post-stroke Aphasia

Aphasia is a language impairment caused by brain injury such as stroke that affects the ability to understand and express language, read and write due to damage in the language regions of the brain. Non-invasive brain stimulation (NIBS) techniques like transcranial direct-current stimulation (tDCS) have been found to improve aphasia treatment effects in post stroke patient populations such as improved naming abilities.

However, the effect of tDCS on more functional, higher level language skills such as discourse production (i.e. story telling, giving instructions) has yet to be understood.Therefore the aim of this study is to determine the potential effectiveness of tDCS as an adjunct to speech and language therapy (SLT) to improve discourse speech production in people with post-stroke aphasia. It is hypothesised that SLT combined with tDCS will result in greater improvements in discourse language production compared to SLT on its own.


Eligibility Criteria:
Inclusion Criteria:

* aphasia caused by a single stroke
* at least 6 months post stroke
* at least 18 years old
* competent English speaker prior to stroke
* right handed prior to stroke
* normal aided or unaided visual acuity
* willing to participate and to comply with the proposed block of intervention and testing regime.

Exclusion Criteria:

Persons with

* neurological symptoms or history of a neurological event other than their stroke
* contraindications to tDCS including history of epilepsy or seizures and pacemakers
* global/severe aphasia
* cognitive impairment identified by a score less than 20/30 in the Montreal Cognitive Assessment
* left-handed dominance prior to stroke
* visual problems which interfere with persons' ability to access visual materials (i.e. pictures)
* inability to attend sessions
Domiciliary VR Rehabilitation

The purpose of this study is to determine whether domiciliary VR-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Hemorrhagic or ischemic stroke
* Subject had the stroke more than 12 months ago.
* Subject presents mild-to-moderate upper-limbs hemiparesis (Proximal Medial Research Council Scale\>2) secondary to a first-ever stroke.
* Age between 45 and 85 years old.
* Subject has previous experience using the RGS system in the clinic.

Exclusion Criteria:

* Subject presents a major cognitive impairment (Mini-Mental State Evaluation\> 22).
Study to Evaluate the Usability of PointCheck

This a study about the usability of PointCheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia. The study will include patients with cancer visiting the outpatient hematology clinic for their standard of care chemotherapy administration. A final sample size of 60 oncologic outpatients will be enrolled and studied with the technology.

The main objective is to evaluate the usability of PointCheck. Secondary outcomes include a preliminary assessment of PointCheck diagnostic accuracy and precision.

For this, study subjects will be tested twice with PointCheck during the same session and the usability in an at-home simulated environment by naïve users will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Study subjects must be able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
2. Male or Female aged 18 years or above
3. Diagnosed with hematological malignancy (e.g., lymphoma, myeloma) or breast cancer.
4. Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia.
5. Able (in the Investigators opinion) and willing to comply with all study requirements.

Exclusion Criteria

1. Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator.
2. Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold.
3. Participants with circulating tumor cells in previous or current lab determinations.
4. Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
6. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.
A Prospective Observational Study of the Performance of Zarin in Kenya

This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

* a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and
* a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.

A non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

* a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and
* a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant

The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.

Eligibility Criteria:
Inclusion Criteria:

* be aged 18-44 years, inclusive
* be willing to sign an informed consent document
* be willing to give contact information for follow up
* agree to return for follow-up visits
* have decided to receive Zarin as a method of contraception and met the clinic criteria for eligibility of this method of contraception
Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital

With 24 million results associated with Google's searchon keywords "severe acne", Pr Dreno's team understand better thatthis disease, which affects many French people, is a real concern of Public Health and not a "forced evil" of the adolescent period, which will eventually resolve itself. Acne does not affect the vital prognosis, but its psychosocial impact is major and should not be underestimated. Paradoxically, despite the high prevalence of acne, few quality epidemiological studies have been published. Physicians are often helpless when faced with patients' questions. They often need a lot of explanations, especially on the factors aggravating this dermatosis, which greatly affects their quality of life.

This cohort, the first of its kind in France, will determine the predictive factors of therapeutic response, endogenous and environmental factors impacting on the severity of acne assess the quality of life and psychological impact of acne patients, determine the patient's course of care and the associated costs. Pr Dreno's team will also build up a bio collection (bacteriological samples).

All patients going for the first time in specialized consultation "acne" at Nantes University Hospital , and who meet the inclusion criteria will be included in the COPACNE cohort. Inclusion will take place at the first consultation, after information and agreement of the patient and, if applicable, his or her legal representatives. The frequency of each patient's follow-up visits will be determined on a case-by-case basis according to the patient's medical needs (generally, the interval between 2 visits is between 1 and 4 months).

Eligibility Criteria:
Inclusion Criteria:

* Patient with acne
* Patient (or parents/guardians for minors) who are not opposed to participating in the cohort.
* Subjects affiliated to an appropriate health insurance

Exclusion Criteria:

* Dermatosis of the face other than acne
* Refusal to participate by the minor or parent/guardian
* Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)
The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature.

This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.


Eligibility Criteria:
Inclusion Criteria:

* Documented symptomatic atherosclerotic peripheral vascular disease
* Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries
* The patient has been informed of the nature of the study and has provided informed consent
* The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits

Exclusion Criteria:

* Target lesion is located in the iliac artery.
* Target lesion stenosis is \< 70%.
* Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
* Patient is unable to participate for the duration of the study.
* Patient is currently participating or has participated in a study with another investigational medical device or medication.
Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Health care facility based, randomized, controlled, open label, superiority trial with 3 arms

* To assess the effectiveness of a short-course of high dose primaquine (total dose 7mg/kg given unsupervised over 7 days) compared to the current standard low dose primaquine regimen (total dose 3.5mg/kg given unsupervised over 14 days).
* To assess the effectiveness of tafenoquine (single dose of 300mg) compared to the short-course high dose primaquine regimen.
* To assess the safety of tafenoquine compared to the high and low dose primaquine regimens.
* To assess the cost-effectiveness and feasibility of high dose primaquine and tafenoquine compared to the current low dose primaquine regimen

Eligibility Criteria:
Inclusion Criteria

* P. vivax peripheral parasitaemia (mono-infection) as determined by microscopy
* G6PD normal status (G6PD activity ≥ 70% of the adjusted male median as determined by the Biosensor™ (SD Biosensor, ROK))
* Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
* Age ≥18 years
* Written informed consent
* Living in the study area and willing to be followed for six months

Exclusion Criteria:

* Danger signs or symptoms of severe malaria
* Anaemia (defined as Hb \<8g/dl)
* Pregnant or lactating females
* Known hypersensitivity to any of the study drugs
* Regular use of drugs with haemolytic potential
Effect of a trAnSitional Pharmacist Intervention in geRiatric Inpatients on Hospitals Visits After dischargE

A randomized controlled trial will be performed in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health related outcomes.

Since drug-related harm remains persistently prevalent in older adults, there is an urgent and unmet clinical need to optimize pharmacotherapy both during hospital stay and after discharge Therefore, we aim to perform a randomized controlled trial in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health related outcomes. The primary objective is to reduce all-cause unplanned hospital visits in geriatric inpatients. Secondary objective are to optimize drug therapy in geriatric inpatients and improve their health; To empower and educate patients, caregivers,community pharmacists and physicians regarding drug regimen decisions to maximize therapy adherence and the understanding of the (de)prescribing process and to enhance healthy ageing; To optimize transitional care from the hospital to primary care.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to one of the study wards under supervision of a geriatrician
* A written informed consent by the patient or his/her representative
* Discharged from the hospital

Exclusion Criteria:

* Admitted for a maximum of one day
* Unable to understand Dutch
* Being in a palliative stage as stated in their medical record with active withdrawal of drug therapy
* Patients being discharged to another ward within the same hospital or to another hospital