cyrilzakka/clinical-trials huggingface dataset:
The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children

Fever is one of the most common problems in pediatrics. Differentiating between bacterial infections, that require antibiotic therapy, and viral infections that resolve on their own is an important challenge for physicians.

C-reactive protein (CRP) is a protein that increases in response to inflammation and its level is generally higher in bacterial infections compared to viral infections. it can be measured by a simple blood test, however its utility as a sole marker for bacterial infection is limited.

The hypothesis of the study is that measuring CRP velocity, e.g the value of CRP divided by the hours since the fever started will improve the utility of CRP for the diagnosis of bacterial infections in children.


Eligibility Criteria:
Inclusion Criteria:

* children less than 5 years of age,
* children with no comorbidities and fever \> 38 for at least 24 hours, and
* children with no previous antibiotic therapy.

Exclusion Criteria:

* HIV,
* immunosuppressive conditions,
* antibiotic therapy.
Intestinal Parasites in Inhabitants of Kuyavian-Pomeranian Province in Poland

The goal of the proposed study is to assess the prevalence of intestinal parasitic diseases in adults and children. These invasions are included to "dirty hand diseases" (per os invasions), therefore it applies mainly preschool children.

It is estimated that 75% of the world's population is infected with parasites and although parasitic diseases are mostly observed in the poor tropical and subtropical countries, there are also many diseases caused by parasites in Poland. In Poland, particular attention is paid to the following parasitic diseases closely related to the digestive system: giardiasis, taeniasis (including cysticercosis), ascariasis, cryptosporidiosis, toxoplasmosis, trichinosis, echinococcosis.

Symptoms of such invasions may include: allergic rhinitis of unknown origin, chronic fatigue or food intolerance. Moreover, many of them are asymptotic, therefore the study group will consist of both healthy people and individuals with undiagnosed diseases or/and chronic symptoms.

Eligibility Criteria:
Inclusion Criteria:

* healthy and ailing individuals
* men and females
* adults and children

Exclusion Criteria:

* the participants were not be: incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators
Reducing Knee Compression When Sleeping in Those With Knee OA

To determine whether a change in sleeping position so as to prevent the knee being 'pushed' into full extension when lying supine provides pain relief and/or symptom improvement in individuals with knee osteoarthritis (OA).

Only those who normally sleep lying on their back will be recruited. Participants will be recruited into two groups: Group 1, 'intervention'; Group 2, 'control'. Participants in group 1 will be asked to change the position they lie on their bed when sleeping; that is, to re-position themselves when lying on their back so that their feet (and ankles) hang over the end of the mattress. Participants in group 2 will be asked to make no change in the way they normally lie on their mattress when sleeping.

Participants will be asked to complete a questionnaire, asking them about the pain and/or discomfort they are currently experiencing, and their current level of physical functioning. The questionnaire used will be the Knee Injury and Osteoarthritis Outcome Score (KOOS) which has been widely used to assess intervention outcomes in individuals with knee OA. They will be asked to complete this questionnaire three times over a 4-month period; for Group 1 this will be before (x2) and after (x1) changing to the new sleeping position (i.e. day of consent, 1 month later on day of change, and 3 months after change); for Group 2 this will be matching the intervals in the intervention group. The primary outcome measure will be the KOOS Pain score, which will be compared pre and post- changing to the new sleeping position.

Eligibility Criteria:
Inclusion Criteria:

* presence of mild, moderate or severe tibiofemoral-OA (radiologically determined in either or both knees)
* regularly (routinely) spend periods lying on their back when sleeping.

Exclusion Criteria:

* those with: rheumatoid arthritis
* chronic cardiopulmonary problems
* lower-limb joint(or joint surface) replacement and/or previous knee surgery within previous 12 months
* unable to lie supine in bed (medical or practical reason)
* diagnosed with inflammatory arthropathy
* peripheral neuropathy or other sensory problems
* steroid injection in the knee within previous 3 months
* under 18 years of age
* unable to give consent due to lack of mental capacity
* currently involved in any research study related to knee OA.
Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)

The purpose of this study was to determine which treatment strategy, the step-up or the step-down treatment strategy, is the most cost-effective treatment for patients with new onset dyspepsia in primary care.

Dyspepsia is very common in the population. On an annual basis, 20%-40% of the general population suffers from upper gastrointestinal symptoms. The prevalence of dyspepsia presenting in primary care is about 3%, on average 24% of these patients are referred for secondary care in the same year. In spite of consensus statements and guidelines, the most effective treatment strategy for managing dyspepsia in primary care remains to be determined. In 2000 the Health Council of the Netherlands published some advice for the Minister of Health, Welfare and Sport with special consideration to the most cost-effective strategies for the management of dyspepsia. The Health Counsel Committee agrees in general with the existing guidelines of the Dutch College of General Practitioners to start with empirical treatment. However, the committee concluded that more research is necessary for management of dyspepsia in primary care, especially in uninvestigated patients as most research has been conducted in patients with persistent dyspeptic symptoms referred for secondary care.

Comparison: In this study empirical treatment according to the existing guidelines of the Dutch College of General Practitioners (the step-up treatment strategy) is compared to a step-down treatment strategy. According to this step-down treatment strategy the patient begins treatment with a proton pomp inhibitor, which is an expensive acid-suppressor and is often prescribed by general practitioners.

Step-up strategy: Algeldrate-magnesium oxide, in case of persisting/relapsing symptoms continued with ranitidine, if necessary continued with pantoprazole.

Step-down strategy: Pantoprazole, in case of persisting or relapsing symptoms continued with ranitidine, if necessary continued with algeldrate-magnesium oxide.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a new episode of dyspepsia, defined as episodic or persistent symptoms including abdominal pain or discomfort and which are, in the opinion of the general practitioner, referable to the upper gastrointestinal tract.
* Over 18 years of age
* Informed consent (written) given.

Exclusion Criteria:

* Use of prescribed acid suppressive medication during 3 months before consult
* Investigated by upper gastrointestinal endoscopy one year before inclusion
* Malignancy
* Contraindication to the study medication
* Pregnancy
* Alarming symptoms like weight loss, bleeding, and disturbed food passage
* Patients with insufficient comprehension of the Dutch language
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population

One of the first causes of irreversible blindness in mexican population is diabetic retinopathy which is clearly diferent between patients the time of evolution and development of retinopathy and complications. The aim of this study is to explore the inmunogenetic profile and the influence of HLA in this variations of the sickness to predict the severity of diabetic complications.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy
* Diabetes mellitus type 2 with 10 years of diagnosis and proliferative retinopathy

Exclusion Criteria:

* Systemic hipertension
* Cardic disease
* Lupus
* Any kind of artritis
* Allergies
* Optic Neuritis
* VKH
* Cancer
* Inmunological diseases
Measuring Soft Tissue Thickness by CBCT

accuracy of CBCT in measuring soft tissue thickness by using a radiopaque material as the real finding and measurements on pig jaws

* Pig jaws will be included in this study.
* Soft tissue surfaces were lightly covered with barium sulfate powder using a powder spray. CBCT was taken.
* A periodontal probe and a rubber stop were used for the measurement of trans-gingival probing thickness (TPT).
* After that, flap were elevated, and actual thickness of soft-tissue (actual thickness, AT) was measured.

The Analytical phase:

* In order to assess soft tissue thickness and bone levels an electronic digital caliper (Shenhan Measuring Tools Co., LTD, Shanghai) will used for measuring the transgingival probing thickness on the pig jaws.
* A graduated Naber's probe will be used for measuring the transgingival probing thickness.

Soft tissue thickness measurements:

* Intra-observer variability was tested under the supervision of the director.
* For the measurement of radiographic thickness (RT), wet soft tissue surfaces were covered with barium sulfate powder (SoloTop; Taejoon, Seoul, Korea), a radiopaque material used as a contrast medium.
* A probes and rubber stop were used for the measurement of transgingival probing thickness (TPT).
* A rubber stop was placed in contact with the surface to facilitate the measurement of tissue thickness, and then TPT was measured with digital calipers. All measurements were rounded to the nearest 0.01 mm.
* For the measurement of actual thickness (AT), an incision was made onto each marked area. After ﬂap elevation, actual soft tissue thickness was measured using the same method that was used for TPT.

Radiographic examination

* The pig jaws will then be imaged with CBCT.
* CBCT scanning will be performed using a PROMAX R 3DMid CBCT device (Planmeca Oy, Helsinki, Finland) with scanning protocol 90 kVp, 8 mA and 13.58 seconds exposure time with a single 360 degree rotation ROMEXIS software. The jawes will be placed on the horizontal plate of the device. The midline and mandibular position will be adjusted using the laser guide

Eligibility Criteria:
Inclusion Criteria:

* The study samples will not identified by age or gender group.
* The selected pig jaw should be intact with no mechanical damage.
* jaw with attached natural teeth

Exclusion Criteria:

* Teeth with anomalies and fractures.
* Periodontally affected teeth
Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors (NEUROSEX)

This study aim to ensure that the implementation of a paramedical screening program and counseling in sexual health of patients with neurological pathologies (low-grade gliomas and Multiple Sclerosis) improves their sexual health.


Eligibility Criteria:
Inclusion Criteria:

1. Any major patient, followed in the GHPSCF (Groupe Hospitalier Pitié-Salpêtrière Charles Foix) neurology department 2 for a diagnosis of low grade glioma or anaplastic glioma with loss 1p / 19q sub-reserve histo-molecular confirmation after national reading (POLA) and presenting:

   * An MSISQ15 (Multiple Sclerosis Intimacy and Sexuality Questionnaire) questionnaire with at least one of the items rated "4" or "5" and
   * A HAD (Hospital Anxiety and Depression) questionnaire (depression component) with a score ≤ 11
2. Any major patient with MS(Multiple Sclerosis), followed in the GHPSCF Department of Neurology:

   * With an EDSS (Expanded Disability Status Scale) greater than or equal to 1 and
   * An MSISQ15 questionnaire with at least one of the items rated "4" or "5".
   * A HAD questionnaire (depression component) with a score ≤ 11
3. Signature of informed consent
4. Patient affiliated to a social security system

Exclusion Criteria:

1. Minor patients
2. Pregnant women
3. Patients who do not understand and / or speak French and / or are unable to sign consent
4. Patients with neurological impairment
5. Patients with chronic sexual disorders who have already received treatment.
6. Patients with a HAD score (depression component) greater than 11
7. Patients with MS who had a corticosteroid-treated outbreak in the last two months.
8. Patients with low-grade glioma with clinical and / or radiological scalability during the last three months
9. Any patient whose alteration of the general state would not allow to follow the program.
10. Patients under legal protection

For patient's partners:

Inclusion criteria:

1. Any patient partner, whose patient has wished to participate and who has accepted.
2. Signing of informed consent

Non-Inclusion Criteria:

1. Minor partners
2. Pregnant women
3. Any person who does not understand and / or speak French and / or is unable to sign the consent
4. Partners under legal protection
OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN

The aim of this study is to evaluate the safety of use, benefits and risks of repeated use of ketamine for each patient with chronic pain in different structures of pain management.

This is an observational, longitudinal and multicenter study about use of ketamine. Benefits are assessed with pain intensity, anxiety, depression, quality of life and global impression of change. Risks are also assessed with adverse event collection.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* Patients with chronic pain (more than 6 months)
* Patients with peripheral or central neuropathic pain, fibromyalgia, algoneurodystrophy

Exclusion Criteria:

* Patient under 18 years of age,
* Patient not requiring prescription of ketamine
Studio TIARA: Alessitimia Ed Emicrania Cronica

The aim of this observational, cross-sectional study is to investigate the relationship between alexithymia and migraine frequency (considering alexithymia a condition that can influence the severity of the clinical phenotype of migraine, favoring its chronicization), in an analysis adjusted for psychiatric comorbidity (for anxiety and depression, potentially influencing migraine chronicization) and for personalogical factor represented by apathy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of episodic migraine with or without aura, chronic migraine and/or MOH according to ICHD-3 2018 criteria;
* Patients aged 12-65 years;
* Female patients

Exclusion Criteria:

* Ongoing major depressive episode;
* Comorbidities for major internal diseases (hepatopathy, nephropathy, heart failure, etc.);
* Alcohol or substance abuse disorder (eoin, cocaine, cannabis, hallucinogens);
* Language barrier;
* Low cultural/cognitive level;
* No informed consent.
Psychosis Associated With Methylphenidate in Children and Adolescents

perform a study in VigiBase® to assess if methylphenidate was associated with an over-reporting of psychosis including hallucinations in children and adolescents and to characterize those psychosis.


Eligibility Criteria:
Inclusion Criteria:

Case reported in the World Health Organization (WHO) database of individual safety case reports until 16/02/2024 in children and adolescents treated with drugs with an indication in ADHD.

Adverse events reported were including a list of MedDRA Preferred Terms related to psychosis

Exclusion Criteria:

Chronology not compatible between the drug and the toxicity
A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).

VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening.

Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information.

The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old.

The main information that researchers will collect in this study:

* Age, gender, and other information about the child and their illness
* Type of VTE treatment given to the child
* Occurrence of medically important bleeding and its severity

Further information that researchers will collect:

* Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE
* Return of VTE symptoms
* Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study.

The data for this study will be collected from electronic health records and health insurance claims data until 2026.

Researchers will observe each child during treatment until:

* end of the anticoagulation treatment period e.g. discontinuation of all study drugs,
* their information is no longer available, or
* the study ends.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of initiation of an anticoagulant therapy (index drug), either rivaroxaban oral suspension or other anticoagulation therapies (heparins, Vitamin K antagonists (VKAs), other Direct oral anticoagulants (DOACs)). Initiation will be defined as a first record of any anticoagulation therapy (rivaroxaban or SOC) without any anticoagulation therapy in the previous 6 months, or since date of birth for children less than 6 months
* Evidence of a prior VTE diagnosis (index VTE), defined as the presence of at least one primary/main or secondary diagnosis code for VTE recorded in inpatient setting in the previous 30 days
* Age less than two years on index date.
* Baseline period for availability of patient data history in the data source. A minimal baseline period of six months before index date for children aged between six months and two years, and a baseline period since birth for children less than six months of age will be required.

Exclusion Criteria:

- None
Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU

This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been admitted to the institution's EMU for seizure characterization or pre-surgical evaluation, or such admission is planned within 28 days
* Subject body weight is ≥ 40 kg to ≤ 125 kg (inclusive)
* Subject has an established diagnosis of partial or generalized epilepsy

Exclusion Criteria:

* Subject has history of status epilepticus in the 6 months prior to Screening
* Subject has a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 12 months
* Subject has respiratory failure (or is at risk for respiratory failure) or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
* Subject has acute narrow-angle glaucoma
* Subject is receiving chronic benzodiazepine treatment (defined as an average of ≥ 4 administrations per week) and cannot safely withdraw from such treatment within the washout period prior to treatment
Effect of Blue Light Glasses on Screen Usage After a Concussion in College Students

Premature cessation of screen usage is a common behavior post-concussion, given the taxing nature of a screen-time task. In the academic setting, screen-time is a near unavoidable component, however, complete avoidance of class and screen use may in fact provoke psychological symptoms of anxiety and depression in students, for fear of falling behind in their studies. Thus, compensatory measures should be investigated to assist students as they attempt to maintain academic involvement throughout their concussion recovery. Blue light blocking glasses have been shown to significantly increase screen-time usage in individuals with post-concussion syndrome, yet these results are only representative of a small portion of the concussion population. Thus, we propose investigating whether blue light blocking glasses can prolong screen usage prior to symptom exacerbation, specifically in concussed students that are still within the normal recovery timeframe. This cross-sectional randomized clinical trial will provide further evidence of the utility blue light blocking glasses can offer as a therapeutic tool for students recovering from concussion. We would like to test volunteers from the Rochester Institute of Technology who have been treated by a medical provider within the university's health center. Blue light glasses will be worn during a one-time computer reading task while the subject is participating in the study. The total time for the complete the reading task is dependent upon the participant's symptom fluctuations; however, we suspect completion criteria will be met within 20 minutes from beginning. The risks in this study are minimal and results may increase our understanding of therapeutic tools for patients with ocular-driven concussion symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Full-time student at RIT
* Diagnosed mild traumatic brain injury
* Between 18-26 years of age
* Within 3-14 days post-injury

Exclusion Criteria:

* Any head, neck, or face injury in the 1 year prior to the study (e.g., concussion, eye injury) other than the current injury
* History of vestibular or ocular dysfunction\\
* Any neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, history of stroke)
* Injury more severe than mild traumatic brain injury (skull fracture, positive CT or MRI)
* Having taken pain medication within 8 hours prior to testing
* Not able to personally consent
* Pregnant
* Deaf or hard of hearing.