cyrilzakka/clinical-trials huggingface dataset:
COVID-19 Disease & Vaccine Survey in Africa

The COVID-19 pandemic is a public health concern; for which the WHO recommends protective measures and vaccination. There is inadequate data on the impact of COVID-19 vaccination and control measures in Africa. This survey is collecting data about people's knowledge, attitude and compliance regarding COVID-19 disease and vaccines.

The coronavirus disease 2019 (COVID-19) pandemic remains a major public health concern. There is inadequate data on the epidemiology of COVID-19 in Africa. There are emerging COVID-19 variants with high transmissibility and morbidity. The World Health Organization (WHO) recommends protective measures and vaccination; for the control of COVID-19. There is inadequate data on the impact of COVID-19 vaccination and control measures in many nations in Africa.

This study is a survey of specific urban populations in sub-Saharan Africa. The anonymized survey is collecting data about people's knowledge and attitude regarding COVID-19 disease or control measures. The survey is also collecting data about people's knowledge, attitude and compliance regarding COVID-19 vaccines. The study uses a validated questionnaire to collect data. The study aims to inform and improve COVID-19 management or control in Africa.

Eligibility Criteria:
Inclusion Criteria:

* urban population in Africa
* people in sub-Saharan Africa town

Exclusion Criteria:

* rural population
* people outside sub-Saharan Africa
Family Studies of Inherited Heart Disease

Hypertrophic cardiomyopathy (HCM) is a genetically inherited heart disease. It causes thickening of heart muscle, especially the chamber responsible for pumping blood out of the heart, the left ventricle. Hypertrophic cardiomyopathy (HCM) is the most important cause of sudden death in apparently healthy young people.

A genetic test called linkage analysis is used to locate genes causing inherited diseases like HCM. Linkage analysis requires large families to be evaluated clinically in order to identify the members with and without the disease.

In this study researchers will collect samples of DNA from family members of patients with HCM. The diagnosis of the disease will be made by history and physical examination, electrocardiogram (12 lead ECG), and ultrasound of the heart (2-D echocardiogram). The ability of the researchers to locate the gene responsible for the disease improves with increases in the size of the family and members evaluated.

In order to continue research on the genetic causes of heart disease, researchers intend on studying families with specific genetic mutations (beta-MHC) causing HCM. Researcher plan to also study families with HCM not linked to specific gene mutations (beta-MHC).

Hypertrophic cardiomyopathy (HCM) is the most important cause of sudden death in apparently healthy young individuals but its clinical manifestations are highly variable. Linkage analysis is used to localize a gene causing an inherited autosomal dominant disease, such as HCM. Linkage analysis requires that large families be evaluated clinically to determine the members with and without the disease. For this study, DNA needs to be extracted from blood samples of family members. The presence of the disease is determined by history and physical exam, 12 lead ECG and 2-D echocardiogram. The likelihood of localizing the gene increases with the size of the family and the number of members evaluated. The beta myosin heavy chain (beta-MHC) gene has been shown to be responsible for HCM in 10%-30% of affected kindreds. Other linage studies have shown that there are at least 3 other genes which cause HCM in other kindreds, but these genes are presently unknown. We have identified 13 unique mutations in the beta-MHC gene which cause the disease in 17 kindreds. This has allowed us to demonstrate skeletal muscle involvement, study the abnormal physiology which is a consequence of the mutations, make pre-symptomatic diagnosis, and redefine the natural history of the disease. In order to continue our clinical and laboratory studies of this disease over the next 3 years, it is our intention to identify 50 additional HCM kindreds, with approximately 50 members each, that have beta-MHC gene mutations. During this time, in order to map other HCM genes, we will also evaluate at least 6 families, of approximately 300 members each, in which the disease is not linked to the beta-MHC gene.

Eligibility Criteria:
INLUSION CRITERIA

Patients with a family history of hypertrophic cardiomyopathy are eligible.
Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.

The duration of participation will be approximately 6 months for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 to 75 years on the day of inclusion
* A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile

Exclusion Criteria:

* Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study to Test the Pain-relieving Effect of Laughing Gas in Infants

Our proposal is to study infants in the Neonatal Intensive Care Unit (NICU) who are undergoing a heel stick for blood sampling, a standard procedure in patient care. Currently, these infants do not get any pain relief for this procedure. Several recent clinical studies have shown the usefulness of nitrous oxide (laughing gas) for treating pain for minor procedures in children 0 to 18 years, but these effects have not been exclusively studied in the newborn and infant populations. Animal studies have questioned the anti-nociceptive (pain-blocking) effect of nitrous oxide in very young animals. It is unclear if this also applies to humans. The reason for this difference may be due to an immaturity of the neural pathways that modulate pain in the very young. The purpose of this study is to investigate whether or not nitrous oxide has an analgesic (pain-relieving) effect in infants undergoing minor procedures in the neonatal period (less than 3 months).


Eligibility Criteria:
Inclusion Criteria:

- Full-term babies up to three months old scheduled for heel stick blood draw.

Exclusion Criteria:

* preterm, difficult airway (micrognathia, cranio-facial malformation, choanal atresia, Pierre Robin syndrome, or Treacher Collins syndrome), sedated, intubated (including tracheostomy), have an oxygen requirement (FiO2\>40%), anemia, bone marrow suppression, or cardiac defect
18F-LY3950321-01 Biodistribution and Safety Study

18F-LY3950321 (also known as 18F-MNI-1256) is a radiolabeled positron emission tomography (PET) tracer targeting granzyme B. The overall goal of this protocol is to evaluate the safety, tolerability, and radiation dosimetry of 18F-LY3950321.


Eligibility Criteria:
Inclusion Criteria:

* Healthy with no clinically relevant finding on physical examination at Screening and upon reporting to the clinic for the Imaging Visit.
* Female subjects must not be of childbearing potential, or if they are of childbearing potential to agree to use contraception and not donate eggs.
* Male subjects with their partners of childbearing potential must commit to the use of 2 methods of contraception, 1 of which is a barrier method for male subjects for the study duration and 90 days after study completion.
* Male subjects must not donate sperm for the study duration and for 90 days after study completion.

Exclusion Criteria:

* Current or prior history of any alcohol or drug abuse in the past 2 years.
* Currently exposed to nicotine products or had regular nicotine exposure within a six-month period, to be verified by urine cotinine screening.
* ECG or Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
* Known history of hypersensitivity, including hypersensitivity to the active substances used for 18F-LY3950321 or derivatives, or to any of the associated excipients.
* Subject has received an investigational drug within 30 days or five half-lives prior to Day 1, whichever is longer.
* Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit established by the US Federal Guidelines (effective dose of 50 milliSieverts, including the procedures in this clinical protocol).
* Pregnant, lactating or breastfeeding.
* Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
* Unsuitable veins for repeated venipuncture.
* Use of any prescription drugs (except approved forms of birth control) or herbal supplements, within 4 weeks prior to Day 1.
* Use of any over-the-counter (OTC) medication or dietary supplements (vitamins included) within 2 weeks prior to Day 1.
* Subject is, in the opinion of the Investigator, unsuitable in any other way to participate in this study.
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)

This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have presbyopia.

Exclusion Criteria:

Subjects must not:

* Have any contraindications to the study medications or diagnoses that would confound the study.
Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy

The purpose of this clinical trial is to evaluate the efficacy and safety of mexiletine hydrochloride in patients with spinal and bulbar muscular atrophy.

The main questions it aims to answer are:

Does mexiletine hydrochloride improve the ALSFRS-R score in spinal and bulbar muscular atrophy patients?

Participants will:

Take mexiletine hydrochloride or a placebo every day for 3 months Visit the hospital once every 4 weeks for evaluations.


Eligibility Criteria:
Inclusion Criteria:

1. Male patients with a CAG repeat count of 38 or more for the androgen receptor gene in genetic testing and a confirmed diagnosis of SBMA
2. Patients with muscle weakness (limb weakness and atrophy, or bulbar palsy) due to lower motor neuron lesion
3. Patients with a total ALSFRS-R score of ≥ 24 and ≤ 42 at screening
4. Patients who are at least 18 years old and less than 80 years old at the time of consent
5. Patients who give their voluntary written consent after having received adequate information on this study (However, if the patient is unable to sign the consent form due to the condition of the disease, a person equivalent to a regal representative must be present to provide written explanation, the prospective candidate must verbally consent to participate in the study, and a person equivalent to a regal representative must sign the consent form on behalf of the patient. The person who is to be the regal representative may sign the document on his/her behalf, noting the circumstances and his/her relationship to the subject.)

Exclusion Criteria:

1. Patients who have participated or are participating in a clinical trial within 12 weeks prior to enrollment
2. Patients with a history of hypersensitivity to any component of this drug product
3. Patients with a conduction disturbance (such as second- or third-degree atrioventricular block without a pacemaker, or left bundle branch block)
4. Patients with Brugada-type ECG
5. Patients with severe heart failure or heart disease (myocardial infarction, valvular disease, cardiomyopathy, etc.)
6. Patients with sinus bradycardia (\<50 beats/minute)
7. Patients with systolic blood pressure of 90 mmHg or less
8. Patients with serum potassium level less than 3.5 mmol/L
9. Patients on antiarrhythmic drugs
10. Patients on antiepileptic drugs that affect to sodium channels
11. Patients on theophylline
12. Patients on narcotics
13. Patients who used Mexiletine within 1 month prior to enrollment or used Mexiletine for expectations of improvement in symptoms of SBMA
14. Patients with serious complications
15. Patients who cannot agree to use contraception during the study period
16. Other Patients deemed inappropriate by the investigator or subinvestigator
The Accuracy of Detection of Artificial Intelligence Second Mesio-buccal Canal of Maxillary First Molars on CBCT Images

CAD systems are computer applications that assist in the detection and/or diagnosis of diseases by providing an unbiased "second opinion" to the image interpreter, aiming at improving accuracy and reducing time for analysis. With the rapid growth of Deep Learning (DL) algorithms in image-based applications, CAD systems can now be trained by DL to provide more advanced capability (ie, the capability of artificial intelligence \[AI\]) to best assist clinicians.

Countless studies and discussions have been based on the existence of a second canal in the mesiobuccal (MB) root of the maxillary molars , since it is strongly believed that one of the foremost reasons for endodontic failure in maxillary first molars is the difficulty of detecting and treating those second mesiobuccal (MB2) canals .The literature reveals that although MB2 canals of maxillary first molars have been found in more than 70% of in vitro studies , they were detected clinically in less than 40% of cases . Cone beam computed tomography (CBCT) is an imaging modality in the field of endodontics that has several advantages, including the ability to perform three-dimensional (3D) imaging of root canal systems with lower radiation doses, higher resolution, and no superimposition . Researchers have evaluated the efficiency of CBCT when it comes to identifying MB2 canals, and CBCT has been suggested to be a reliable method for the detection of these canals. However, in clinically relevant situations, such a smaller lesions on root-filled teeth, CBCT accuracy is greatly reduced (sensitivity 0.63, specificity 0.69) . Moreover, clinician dependent interpretation of CBCT imaging still suffers from low inter- and intra-observer agreement.

Computer-aided detection and diagnosis (CAD) has been widely applied to biomedical image analysis outside of dentistry .

Eligibility Criteria:
Inclusion Criteria:

* • CBCT scans showing erupted maxillary 1st molar.

  * Vovel size not exceeding 0.1mm.
  * Maxillary molars showing complete root formation.
  * Carious or Non-carious tooth.

Exclusion Criteria:

* • Maxillary first molars with developmental anomalies, external or internal root resorption, root canal calcification, previous root canal treatment, post restorations, and/or root caries.

  * CBCT images of sub-optimal quality or artifacts / high scatter interfering with proper assessment.
Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study

There is no international consensus regarding how to assess and treat patients with immunoglobulin M (IgM)-anti-myelin-associated-glycoprotein (MAG) monoclonal gammopathy associated peripheral neuropathy. The purpose of the IMAGiNe study-Lyon/Bicêtre is to prospectively collect standardized clinical data of 25 patients with IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy in order to participate in the international IMAGiNe Study.

The main objective is to describe in detail the various clinical subtypes, clinical course, treatment responses, antibody titers of IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy using a variety of outcome measures. The obtained observational data will allow the construction of an IgM monoclonal gammopathy associated peripheral neuropathy-specific Rasch-built overall Disability Scale (RODS) that should fulfill all modern clinimetric requirements, including cross-cultural validity. The coordinating centers for the IgM-RODS construction will be the Maastricht University Medical Center and University Medical Center Utrecht, both in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* fulfilling the international criteria for the diagnosis Immunogloblin M (IgM) monoclonal gammopathy, with anti-myelin-associated-glycoprotein (MAG) antibodies, and peripheral neuropathy.
* age of 18 years or older followed in neuromuscular department of Lyon;
* informed consent given by the participant

Exclusion Criteria:

* concomitant diseases possibly interfering with peripheral nerve and function, as well as physical functioning, such as diabetes, renal insufficiency, (prior) treatment with chemotherapy for diseases other than their Immunogloblin M (IgM) monoclonal gammopathy associated peripheral neuropathy, history of hereditary neuropathy, vitamin deficiency, connective tissue disorder, hepatitis B and C and human immunodeficiency virus (HIV) infection, alcohol abuse (more than 5 International Units(IU)/day);
* an active malignancy with poor prognosis, undergoing treatment aside from monoclonal gammopathy associated peripheral neuropathy;
* pregnant;
* the use of any medication that may cause peripheral nerve function
Nurses' Competence in Gastric Ultrasound

The goal of this observational cohort study is to investigate gastric ultrasound skills in surgical nurses. The main question it aims to answer is:

• how much training is required for surgical nurses to obtain competency in performing gastric ultrasound.

Participants will follow a training involving

* theoretical background using e-learning, picture library and lecture
* practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer
* and formative assessments during training sessions scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers).

Aims: To determine the amount of training bachelor nurses require to achieve competence in the bedside point-of-care ultrasound technique for qualitative assessment of gastric content.

Study design: prospective cohort educational study

Study population: The participants are six nurses at bachelor level with at least 1 year of experience with surgical patients. Volunteers are healthy persons without a pre-existing abnormal anatomy of the upper gastrointestinal tract.

Main study parameters/endpoints Primary outcome is the number of ultrasound examinations which is required to achieve competence in the performance of ultrasonography qualitative assessment of gastric content. The number of ultrasound assessments nurses need to achieve 90% success rate in 10 consecutive ultrasound assessments among healthy volunteers. Reference test is the ultrasound assessment of examiners experienced in (gastric) ultrasound.

Methods: The education program is developed according to relevant literature, panel discussion of a project group including relevant experts on gastric ultrasonography and nursing education.

Six nurses will follow the education program including didactic teachting and formal assessments. The didactic teaching include1) theoretical background using e-learning, picture library and lecture and 2) practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer. Formative assessments will be done by scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers). Volunteers will be asked to adhere to a randomized prandial. Participants and examiners will be blinded for the prandial status of the volunteer.

Analysis: Cumulative sum scores will be estimated to determine the number of trainings that is required.

Eligibility Criteria:
Inclusion criteria for nurses:

* nurses with at least 1 year experience at the unit;
* nurses with a bachelor's degree in nursing;
* nurses with a particular interest in ultrasonography.
* nurses without previous experience in ultrasonography;

Inclusion criteria for healthy volunteers:

* no history of abnormal anatomy or surgery of the upper gastro-intestinal tract (previous oesophageal-, gastric-, or upper abdomen surgery, or hiatus hernia);
* no diabetes mellitus

Exclusion criteria

• subjects who do not provide written informed consent.
Bringing Weight Management Into the Primary Care Pediatric Practice

This project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting.

The goal of this project is to create a sustainable clinical model in the primary care setting that improves nutritional health, lessens obesity, and addresses weight-related complications of children and adolescents to reduce risk for metabolic disease in later life. The primary objectives include tracking changes in BMI (both absolute and percentile) and levels of hemoglobin A1c, liver enzymes (AST, ALT levels), and lipids in patients seen in a primary care setting by a general pediatrician board-certified in obesity medicine. Secondary objectives include tracking patient adherence, follow-up, and retention.

Eligibility Criteria:
Inclusion Criteria:

Children with obesity (BMI \> 30 kg/m2 or \> 95th percentile) or in need of weight management of unwanted weight gain.

Exclusion Criteria:

None.
Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease

This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of Chinese descent with full Chinese parentage.
* Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0.
* Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants.
* Subject has a negative Tuberculosis (TB) Screening Assessment.
* Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening Period.

Exclusion Criteria:

* Subject with ulcerative colitis or indeterminate colitis.
* Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future.
* Subject with an ostomy or ileoanal pouch.
* Subject who has short bowel syndrome.
* Subject with symptomatic known obstructive strictures.
* Subject with an internal or external fistula (with the exception of an anal fistula without abscess).
* Active, or chronic or recurring infections, or active tuberculosis.