cyrilzakka/clinical-trials huggingface dataset:
Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)

Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.

To identify the efficacy of Certolizumab Pegol (CZP) on synovitis in dynamic MRI parameters; to make the correlation between European League Against Rheumatism (EULAR), American College of Rheumatology (ACR)p, Disease Activity Score-28 (DAS 28) responses, and Digital XRay (DXR) assessment with reduction of synovitis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of adult-onset Rheumatoid Arthritis (RA) of at least 3 months duration but no longer than 15 years
* Subjects with an active adult Rheumatoid Arthritis disease
* Subjects who have been on Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy for at least 12 weeks

Exclusion Criteria:

* Subject must not have a secondary, non-inflammatory type of musculoskeletal condition (eg, osteoarthritis or fibromyalgia) that in the investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of Rheumatoid Arthritis (RA)
* Subject must not have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis)
* Subject must not have a history of an infected joint prosthesis at any time with prosthesis still in situ
* Subject must not have received more than 1 biological agent
* Subject must not have a history of lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time
* Subject with known Tuberculosis (TB) disease, high risk of acquiring TB infection or latent TB infection
* Subject must not have a known hypersensitivity to any components of the investigational medicinal product
* Subject must not have contraindications for Magnetic Resonance Image (MRI) and contrast agent
* Subject must not have any other condition which, in the investigator's judgement, would make them unsuitable for inclusion in the study
Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms

This study aims to look at the long term efficacy of using repetitive transcranial magnetic stimulation (rTMS) in relieving Gulf War Illness related headaches and pain.

Headaches (HA), muscle and joint pain, are some of the most common debilitating symptoms in military personnel served in the 1990-1991 Persian Gulf War (GW1). Migraine like HA and diffuse body pain were detected in 64% of Gulf War Veteran (GWV) diagnosed with Gulf War Illness (GWI). Unfortunately, conventional pharmacological treatments for GWI-related pain has not been shown to be effective and drugs such as narcotics contain many long term untoward psychosomatic and abusive side effects. This study is assessing the effectiveness of repetitive transcranial magnetic stimulation (rTMS), non-invasive treatment option, in alleviating headaches, muscle, and joint pain symptoms of GWI.

Eligibility Criteria:
Inclusion Criteria:

* Male or female under 65 years of age who served in the military for at least 30 consecutive days between August 1, 1990, and July 31, 1991 in the Persian Gulf War region
* Center for Disease Control (CDC) Criteria for Gulf War Illness (GWI)
* Kansas Criteria for GWI
* International Headache Society Criteria for Migraine Headache without aura Average Headache Exacerbation Intensity \>3 on 0-10 a Numerical Pain Rating scale (NPS)
* Average Overall Daily Muscle Pain Intensity \>3 on 0-10 a NPS
* Average Overall Daily Extremities Joint Pain Intensity \>3 on 0-10 a NPS
* Headache Exacerbation/attack 3 times per week with the average intensity \>3 on a 0-10 NPS, lasting \> 4 hours in the past three months
* Hamilton Rating Scale of Depression (HRSD) \<14 based on the sum of scores for the first 17 items

Exclusion Criteria:

* Pregnancy
* History of pacemaker implant
* Any ferromagnetic (e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI
* History of dementia, major psychiatric diseases, or life-threatening diseases
* Presence of any other chronic neuropathic pain states such as Complex Regional Pain Syndrome or Painful Peripheral Neuropathy
* History of seizure
* Pending litigation
* Low back pain with mechanical origins such as lumbar radiculopathy or radiculitis or lumbar facet arthropathy
* Lack of ability to understand the experimental protocol and to adequately communicate in English
* History of Traumatic Brain injury
* Chronic Tension or Cluster Headache
* Ongoing Cognitive Rehabilitation or Treatment of PTSD
The Assessment of Movement Disorders Utilizing Live Two-Way Video

The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) examinations conducted via live two-way video versus live examinations completed in-person

Extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) are one of the most frequent and troublesome adverse events when taking antipsychotic agents. The investigators aim in this study to determine if the investigators can conduct examinations for EPS and TD remotely using live two-way video. It is potentially beneficial for patients, especially those who are located far away from psychiatrists if they could be seen by trained clinicians and assessed for EPS and TD via two-way video in the future. Participants will be asked to have a medical assessment which consists of simple questions and some examination of their movements via two-way video and in person. The investigators will compare the results of video examinations with the results of live examinations.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients and outpatients aged 18-75 years old who have been taking antipsychotics for longer than 6 months in their life time, and
* That have been compliant for the past week.

Exclusion Criteria:

* Patients who have medical conditions which make it difficult to perform a physical examination.
* Patients who are clinically too ill to consent and/or unable to cooperate with the examination procedures.
SAIF: Sacroiliac Fusion Study

The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion and pain reduction of the SI joint.

This is a prospective, non-randomized, single center study to collect data on fusion and pain reduction following implantation of the SImmetry device. Up to 15 total subjects will be implanted and followed for 24 months. Data will be collected pre-operatively, at implant, discharge, and at specified follow-up time points (6 weeks, 3 months, 6 months, 12 months, 24 months.)

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be indicated for the SImmetry device according to the approved SImmetry labeling
* Subject has three (3) positive (experiences pain) Provocative Tests for SIJ pain; for example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen's
* Subject has documentation of failed, non-operative management of SIJ pain for ≥ 6 months prior to surgery; for example, use of medications, braces, SI belts, orthotics, physical therapy or manual manipulation
* The subject has one (1) positive diagnostic SIJ injection, resulting in a ≥50% decrease in pain from the anesthetic portion of the injection
* The subject has VAS back pain score of ≥ 60 mm
* The subject has an ODI ≥ 40%
* The subject is at least 18 years of age and skeletally mature
* The subject agrees and is able to comply with study requirements

Exclusion Criteria:

* Subjects contraindicated per the cleared labeling will be excluded from participation in the study
* The subject has pelvic soft tissue or bony tumors
* The subject has had any trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit
* The subject has a history of a central nervous system (CNS) disorder(s)
* The subject is pregnant or is planning on becoming pregnant in the next two years
* The subject has chemical dependency problems as evidenced by a history of drug abuse which is documented in their past medical history or is elicited from an interview
* The subject has a history of significant emotional or psychosocial disturbance (anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview
Maintenance and Cost Effectiveness of Cendres Metaux Locator (CM-LOC) Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures

The single implant overdenture (IOD) represent the simplest form of IODs compared to the 2 IOD which is the traditional gold standard IOD treatment option. Mandibular single-implant overdentures are proven to be a successful treatment option for older edentulous adults but we need to know if the CM-LOC attachment will retain its superiority over the ball attachments intraorally regarding the prosthetic complications in single implant retained overdenture like in 2 IOD


Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous male or female patients between the ages of 50 to 69.
* No contraindications for implantation.
* Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
* Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
* Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm (Class II or III according to McGarry et al\[1\] 1999). This will be confirmed by the CBCT.
* Patients seeking to install a single symphyseal implant and for whom new dentures will be constructed.
* Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
* Patients, who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, it is found that there are technical problems with regard to denture design and/or occlusion; then new maxillary and mandibular dentures will be fabricated
* All patients should have adapted to their dentures for at least six weeks before being included in the trial.
* Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.

Exclusion Criteria:

* Patients with a systemic or local contra-indication for implant placement.
* Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
* Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
* Incompliant and not cooperative patients.
* Patients smoking more than 10 cigarettes per day
Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables

The study aims to evaluate arterial stiffness and endothelial function indexes and their relationship with clinic and laboratory varible in a group of diabetic patients in treatment with dulaglutide

46 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. Giaccone" from April 2017 to April 2018. For all patients treatment with dulaglutide was undertaken. As control group were recruited 46 patients from the same ward not affected by diabetes mellitus or affected by diabetes mellitus but not in treatment with dulaglutide.

The study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.

Each patient treated with dulaglutide was compared for age, sex and cardiovascular risk with control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels\> 200 mg/dl, triglycerides\> 150 mg/dl and HDL levels \<40 mg/dl regardless of the patient's gender.

Among the cases enrolled, 46 (100%) had type 2 diabetes mellitus, 37 (80.43%) had arterial hypertension and 26 (56.52%) hypercholesterolemia.

Clinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, total cholesterol, HDL and LDL cholesterol, triglycerides, creatinine, and a urine sample to assess the presence of microalbuminuria. These withdrawals were then repeated three months and nine months from the time of recruitment.

The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000. Pulse Wave Velocity (PWV) Carotid-Femoral Pulse was measured in the supine position using an automatic device (SphygmoCor version 7.1) that evaluated the propagation time of the sphygmic wave between the carotid and femoral pulse.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus

Exclusion Criteria:

* cancer, severe ckd, end stage liver disease
Prebiotic Effects in Healthy Toddlers

The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.

The fermentation of a novel prebiotic combination leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA).The efficacy of the prebiotic combination to improve toddler's digestive function will be addressed. The overall health will be assessed as a measure of reduced number of febrile days resulting in less days of absenteeism from daycare centers.

Eligibility Criteria:
Inclusion Criteria:

1. Child is healthy at the time of pre-examination
2. Child is aged between 10-36 months and attends a day care center for the duration of the intervention
3. Child attends a daycare center at the time of pre examination for at least 50%.
4. Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale)
5. Weight for height z-score \>-2 and \<2 SD based on Flemish growth charts
6. Child and legal guardian are able and willing to follow the study instructions
7. Child is suitable for participation in the study according to the investigator/ study personnel
8. Informed written consent given by parent / legal guardian

Exclusion Criteria:

1. No legal guardian's command of any local language
2. Child with any chronic disorder or disease, e.g., defecation disorders (incl. Hirschsprung and celiac disease) metabolic or renal abnormalities as well as mental or psychomotor retardation (incl. child´s mental delay and hypotonia)
3. Child is suffering from congenital or acquired immunodeficiency
4. Food allergies or intolerances
5. Child is currently breast-fed more than once daily
6. Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
7. Use of laxatives (4 weeks before intervention) as well as probiotic and prebiotic food supplements. Follow-on formula with L. Reuteri and/or GOS/FOS/HMO is allowed.
8. Child is suffering from an infection at the time of pre examination or previous 7 days
9. Child is currently involved or will be involved in another clinical or food study
10. Child is not suitable for participation in the study according to the study personnel´s opinion
Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence imaging in endometrial cancer staging by sentinel node assessment.

In many cancer types, such as breast cancer and melanoma, sentinel node assessment has become the standard of care surgical treatment. Sentinel nodes are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. Removal of a sentinel node for examination accurately predicts whether the cancer has spread to other nodes further along in the nodal chain. Fluorescence imaging with ICG dye (Indocyanine Green) has been used to detect lymph nodes in patients with gastric, colorectal and breast cancer. To date, the use of this technique in endometrial cancer has not been reported.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven endometrial carcinoma
* Must have planned to undergo standard endometrial cancer staging surgery as part of their routine clinical care
* Must be 18 years of age and older
* Must be able to comply with all the study procedures

Exclusion Criteria:

* Significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, with total bilirubin \> 1.5 times normal, and/or SGOT \> 2 times normal
* Uremia, serum creatinine \> 2.0 mg/dl
* Previous history of adverse reaction or allergy to ICG dye, iodine, shellfish, or iodine dyes
* Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage
* Pregnant
* Currently participating in a drug, biologic and/or device treatment study
* Any medical condition that would normally prevent someone from receiving general anesthesia or undergoing standard surgical procedures
Knowledge and Attitudes Towards Human Papillomavirus Infections and HPV Vaccination

A better understanding of the target audiences about HPV infection and HPV vaccination would surely allow for a better spread of this vaccination in Switzerland. In order to know if the target audiences are properly informed, we have decided to carry out a study evaluating their level of knowledge on a particular audience that are the men and women undergraduate nurse.


Eligibility Criteria:
Inclusion Criteria:

* Eligible women and men aged between 18-36 years
* Understands study procedures and accepts voluntarily to participle of the study

Exclusion Criteria:

.Don't understand french language
Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever

Establish the safety and efficacy of 3 months treatment with canakinumab in patients with colchicine resistant Familial Mediterranean Fever.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 12 and 75 years of age with active type 1 FMF disease (according to Tel-Hashomer criteria for diagnosis of FMF) despite colchicine therapy (1.5 to 2.0 mg/day).
* Patients who are intolerant to effective doses of colchicine (1.5 to 2 mg/day)
* Patients with demonstrated minimum 1 typical acute attack per month and genetic confirmation of diagnosis (with at least one of the known MEFV gene exon 10 mutations). Patients with manifested amyloidosis are excluded.
* Patients must have a historical data showing a frequency of at least 1 attack/month within the last 3 months before they can be enter the run-in period.
* Patients must have type 1 disease characterized by recurrent and short episodes of inflammation and serositis with an average of at least 1 documented acute FMF attack per month during the previous 6 months and lasting approximately 12 to 72 hours.
* Patients treated with IL-1 therapies must complete washout and have experienced at least 2 attacks since (e.g. Anakinra: 3 day washout; Rilonacept: 3 week washout)
* Patients treated with anti-TNF drugs must undergo appropriate washout. Prior to randomization, use of Etanercept must be discontinued for 4 weeks or use of Adalimumab or Infliximab must be discontinued for 8 weeks.
* Female subjects of childbearing potential must be using two acceptable methods of contraception
* Patients treated with Interferon therapies must complete 1 month washout period.

Exclusion Criteria:

* Patients with end-organ dysfunction due to amyloidosis (e.g. existing biopsy proven amyloidosis or proteinuria \> 0.5 gram per day)
* Patients taking steroids within 1 month prior to baseline
* Presence or history of any other inflammatory rheumatic disease
* Positive PPD test (according to local guidance) where a latent or active TB infection cannot be excluded via Quantiferon (T-Spot or radiographic imaging if needed).
* Patients who are pregnant or lactating
* Presence of any active or chronic infection or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 30 days or oral antibiotics within 14 days prior to screening
* History or a malignancy within the last 5 years, except for successfully excised squamous or basal cell carcinoma of the skin

Other protocol-defined inclusion/exclusion criteria may apply
Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns

The study concerns the creation and implementation of a digital tool presenting the various orofacial stimuli that can be offered to premature newborns. This app is intended for parents, to allow them to play a more active role in their child's care, and provide them with special time with their child. The notion of pleasure is very important to us, and it's vital to help parents rediscover this feeling with their child. Different profiles will be created to individualize our recommendations, facilitate the understanding of orofacial stimuli, make them more concrete than drawings, and provide care adapted to each patient and improve the development of newborns through more regular orofacial stimulation.

Two groups will be formed:

Group A - control: receiving the speech therapy currently in place in the department.

Group B - experimental: will receive the same care as the first group, plus access to the videos and the introduction of early orofacial stimulation.

Group B: First, an initial assessment will be performed in speech-language pathology of the oro-myofunctional and oral functions of the newborn. This will determine which orofacial solicitations to give to the baby and create in the patient's profile.

Parents will be trained in orofacial stimulation and will be coached during the first sessions. When parents are ready, access will be given to their personal space on the application. Appointments will be scheduled to remodel the treatment if necessary. Sucking (ECEPAB), feeding (PIBBS) and behavioural (EDIN) abilities will be assessed. Parents will be asked to fill out a questionnaire about their feelings.

Eligibility Criteria:
Inclusion Criteria:

* Child born prematurely before 29 weeks of amenorrhea (SA).
* Alive for minimum 24h.
* Holders of parental authority who have been informed of the study and have not objected.

Exclusion Criteria:

* Child born after 29 weeks of amenorrhea.
* with a genetic or severe neurological pathology or withdrawal syndrome.
* with a vital prognosis.
* whose family home is too far from the service.