cyrilzakka/clinical-trials huggingface dataset:
Predicting Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs

Background The risk for hospitalized infection (i.e. infection leading to hospitalization) in patients with inflammatory arthritis (rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) treated with biological drugs is known to be increased compared to the background population. In daily clinical practice, there is a need for a simple way to assess the absolute risk for hospitalized infection in individual patients based on easily available information such as age, diagnosis, functional status, comorbidities and medication. This risk estimate will be useful in clinical decision making e.g. when advising patients on whether or not to initiate biologic therapy or when advising patients on influenza or pneumococcal vaccination.

Objectives The objectives are 1) to assess the risk for hospitalized infection (infection leading to hospitalization) in patients with inflammatory arthritis during 12 months of follow-up after initiating treatment with their first biological drug (bDMARD) with the risk in the general population, and 2) to develop a simple, clinically useful algorithm that allows prediction of the risk of hospitalized infection in individual patients.

Methods Observational cohort study based on existing data in: The Danish Rheumatology Register (DANBIO), The Danish National Patient Register, The Danish National Prescription Register and The Danish Register of Causes of Death. All patients registered in DANBIO with RA, PsA or axSpA who initiated treatment with their first biological drug between January 1, 2006 and December 31, 2016 will be identified. Baseline predictors and outcomes (hospitalized infection or death) during 12 months of follow-up are obtained. Logistic regression analysis and 10-fold cross-validation will be used to develop and internally validate the prediction model.


Eligibility Criteria:
Inclusion criteria:

* Patients with RA: Registered in DANBIO with a diagnosis of M05.9, M06.0 or M06.9.
* Patients with SpA: Registered in DANBIO with a diagnosis of M45.9, M46.1, M46.8+M02.9, M46.8+M07.4, M46.8+M07.5 or M46.9.
* Patients with PsA: Registered in DANBIO with a diagnosis of M07.3 or M46.8+M07.2.
* First bDMARD treatment course.
* Start of treatment with first bDMARD in the period January 1, 2006 to December 31, 2016.
* Age at start of treatment with first bDMARD ≥ 18 years.

Exclusion criteria:

- Not followed in DANBIO since start of first bDMARD.
Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis

The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; calculated best-corrected visual acuity of 0.6 logMar or better in each eye; positive bilateral conjunctival allergy challenge reaction

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Exclusion Criteria:

narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or diagnosis of dry eye; ocular surgical intervention within 3 months; history of refractive surgery within 6 months; known history of retinal detachment, diabetic retinopathy, or progressive retinal disease; presence of active ocular infection positive history of an ocular herpetic infection; preauricular lymphadenopath; manifest signs or symptoms of clinically active allergic conjunctivitis
Foster Care Mental Health Family Navigator

This study will focus on developing and testing a family-based mental health navigator intervention, the Foster Care Family Navigator (FCFN), to evaluate whether the intervention combined with mHealth would be efficacious in improving mental health service initiation and engagement for child welfare-involved youth.

The study will demonstrate how a family-based navigator intervention combined with mHealth may lead to improved mental health treatment initiation and engagement among child welfare-involved (CWI) youth. CWI youth have high rates of mental health symptoms relative to youth in the community, and are disproportionately racial and ethnic minorities, only perpetuating disparities in this population's mental health access and engagement. The proposed project will develop and test a family-based navigator intervention, the Foster Care Family Navigator (FCFN), a natural fit for improving CWI youth mental health service and clinical outcomes. The study will start with identifying the feasibility and acceptability of the FCFN intervention. Then, the study will determine whether the FCFN intervention improves CWI youth mental health treatment initiation and engagement, relative to standard of care (not participating in FCFN intervention). Finally, the study will characterize patterns of pre- and post-service outcomes along the behavioral health services cascade of care, to further evaluate the feasibility, acceptability, and preliminary impact of the FCFN model.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking youth
* Ages 12-17
* Have an active dependency petition with the SF Unified Family Court (newly filed or existing when the trial starts)
* Are open to SF DPH Foster Care Mental Health Clinic services
* Have an involved caregiver/legal guardian for consent
* Family has mobile phone access

Exclusion Criteria:

* Youth is not English-speaking
* Caregiver has impairment that would preclude providing informed consent
* Unavailable guardian for consent
Role of Diffusion MRI in Differentiation of Various Bone Marrow Lesions

Bone marrow lesions are common, and imaging findings are associated with various aetiologies, as compared to conventional radiography and computed tomography (CT), MRI is a better non-invasive imaging modality to evaluate vertebral bone marrow, due to better soft-tissue contrast, so the aim of our study is the use of MRI diffusion in differentiating various vertebral bone marrow pathological lesions.

Bone marrow lesions are common, and imaging findings are associated with various aetiologies, such as degenerative, infectious, traumatic, malignant, metabolic, and haematopoietic .

As compared to conventional radiography and computed tomography (CT), MRI is a better non-invasive imaging modality to evaluate vertebral bone marrow, due to better soft-tissue contrast as well as being non-ionising in nature .

Although conventional MRI is essential for anatomical visualization and lesion detection in bone marrow pathologies ,but it often insufficient in distinguishing different vertebral bone marrow lesions, due to overlapping imaging features and often due to coexistence of bone marrow oedema that can be caused by fractures, infection, and bone marrow hyperplasia, thus reducing the specificity of conventional sequences .

MRI diffusion provides complementary information about tissue microstructure and cellular .it exploits the translational mobility of water molecules to obtain information on the microscopic behaviour of the tissues.

On the other hand, apparent diffusion coefficient (ADC) values provide quantitative measure of Brownian movement with low ADC values implying restricted diffusion and high values being a measure of free diffusion.

Therefore, DWI provides both qualitative and quantitative functional information concerning the microscopic movements of water at the cellular level. The benefits of DWI comprise a small scanning period that allows it to be easily included in the routine imaging protocols .

For example, In healthy bone marrow, water diffusion is relatively unrestricted due to its cellularity and vascularity, while pathologies such as metastatic disease or myelofibrosis typically exhibit restricted diffusion.

Diffusion MRI can also distinguish bone marrow edema like acute injury or inflammation, from infiltrative diseases such as multiple myeloma. Edema typically shows higher ADC values due to the increased water content, whereas infiltrative diseases reduce diffusion, resulting in lower ADC values.

These examples illustrate how MRI diffusion can differentiate various vertebral bone marrow pathological lesions.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with vertebral lesions Clinically suspected or diagnosed by other modalities as X-ray or CT were included in the study.

Exclusion Criteria:

* Patients with metallic prosthesis which are not MRI compatible .
* patients with previous Vertebral surgery.
* patients with Vertebral Congenital anomalies
* Patients refused the examination.
* Patients who suffer from claustrophobia
Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

The goals of this multi-site study are to evaluate the union rate, patient satisfaction, and functional results of the Section 510(K) approved Anser Clavicle Pin in a prospective 50 patient clinical trial in a U.S. population.


Eligibility Criteria:
Inclusion Criteria:

* Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification
* Skeletally mature
* Surgery performed within 4 weeks after trauma

Exclusion Criteria:

* Not fit for surgery by the anesthesiologist
* Nonunion or previous malunion
* Possible noncompliant patients (eg, alcohol and drug addiction, dementia)
* Additional neurovascular injury
* Pathologic fractures
Prevalence of the Victimization and the Perpetration of Intimate Partner Violence Among the Patients From Puy-de-Dôme and Paris Consulting or Being Hospitalized for Addiction Problems and Their Expectations From General Practitioners (VIA-MG)

Intimate partner violence and addictions are two frequent problematics with many consequences on health. A link between intimate partner violence and addictions has been found in many studies. Being a drug user increases the risk to be a perpetrator and also a victim of intimate partner violence.

So, it is legitimate to question ourselves about the prevalence of the victims and perpetrators of intimate partner violence among the patients consulting or being hospitalized for an addiction problem. We believe that this prevalence will be high among these patients.

On the other hand, the general practitioners are in first line receiving victims and perpetrators of violence and patients with addiction problems. So it is important to know the profiles of these patients and their expectations from their general practitioners.

The different places where the study will take place are:

* 7 outpatient addiction centers: Addictology consultations in CHU Clermont-Ferrand, CH Sainte-Marie, CH Thiers, CH Ambert, ANPAA (Association Nationale de Prévention en Alcoologie et en Addictologie) of Clermont-Ferrand, Thiers and Ambert.
* 3 hospital addiction centers: Addictology hospital services of CHU of Clermont-Ferrand, CH Thiers and Clémentel.

This study will be based on the filling of self-answered questionnaires by the patients consulting or being hospitalized in the different recruited centers. The questionnaire will be proposed to the patient after the consultation with the practitioner. An information about the study and the anonymity will be given to the patient. The filled questionnaire will be put by the patient in a closed envelope and then in a collection box located in the waiting room.

The different boxes of the different centers will be checked regularly and then the questionnaires will be analysed. The analysis of these questionnaires will allow to describe the population consulting or being hospitalized for addiction problems in the Puy-de-Dôme: age, gender, type of the addiction, the presence of intimate partner violence, associated factors of the violence, recourse characteristics to general practitioners and expectations of GP. We will evaluate the prevalence of victimization and perpetration of intimate partner violence among patients consulting or being hospitalized for addiction problems in the Puy-de-Dôme.

We estimate the duration of the study at around 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18, being or having been in a relationship, consulting or being hospitalized for an addiction problem
* Patient speaking and writing French
* Patient capable of giving his informed consent to take part to the study
* Affiliation to the social security
* Patient who doesn't have a tobacco addiction only

Exclusion Criteria:

* refuse to participate
Azacitidine Plus Deferasirox (ICL670) in Higher Risk Myelodysplastic Syndromes (MDS)

Myelodysplastic syndromes are common blood disorders that can affect as many as one in 1000 Canadians over the age of 65. They are characterized by low blood counts that require frequent blood transfusions. The development of iron overload in these patients is inevitable. The iron deposits in vital organs such as the heart and the liver and can lead to organ dysfunction. Deferasirox is a well-studied drug that helps remove iron from the body. Most people with this disorder die due to progression of their disease to acute leukemia through multiple mechanisms. Iron overload in patients with myelodysplastic syndromes has been shown to be associated with shorter survival, and potentially a higher chance of leukemia. In a certain sub-group of higher risk patients, the drug azacitidine has been shown to decrease the chance of progression to leukemia and death from it. Thus, it is presently the standard of care for these patients. However, 50% of higher risk patients are still unresponsive to this medication, leaving a large group of patients for which other treatment options are emergently needed. Given that a large proportion of higher risk MDS patients fail to respond to azacitidine, and the evidence that iron deposition may lead to increased leukemic transformation, we would like to study whether iron removal from the body with deferasirox potentiates azacitidine in its effects on overall survival, as well as the chance of leukemia transformation. This question needs to be addressed in a randomized controlled trial, and the first step is a preliminary study to determine if the combination of azacitidine and deferasirox has any biologic effect. This study will determine whether this combination leads to blood count improvement over azacitidine alone. If this drug combination ultimately proves more useful than azacitidine alone with respect to survival, this has the potential to impact the care of a large proportion of patients with myelodysplastic syndromes.

Patients with stable disease after 6 cycles of AZA with higher risk MDS will be randomized to either standard of care (continued AZA until progression ) or AZA + defasirox. Primary endpoint is augmented response rate by the addition of deferasirox

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 yrs of age
* WHO defined MDS with Higher risk MDS (IPSS int-2/high)
* Azacitidine X at least 6 cycles with no hematologic improvement/no disease progression as per IWG 2006 criteria
* Ferritin \>500 µg/L
* If transfusion independent, must have Hb \<110 g/L OR Neutrophils \< 1,000/mL OR Platelets \< 100,000/mL
* ECOG ≤2
* CrCl \>40 ml/min

Exclusion Criteria:

* Increased ALT (\>300 U/L)
* Uncontrolled infection
* HIV+
* Pregnant or breast-feeding
* Previous and concurrent iron chelation
* Concurrent use of hematopoietic growth factors including erythropoietin, darbepoietin and granulocyte colony stimulating factor
* Concurrent use of other disease modifying agents including cytotoxic chemotherapy, histone deacetylase inhibitors, other hypomethylating agents or lenalidomide
Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures

To verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures


Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18 years old, gender is not limited;
2. Patients diagnosed with femoral neck fracture;
3. Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
4. The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.

Exclusion Criteria:

1. Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit;
2. The patient is known to have a history of allergy to one or more implanted materials;
3. Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
4. Active infection of the hip joint or other parts of the body is determined by the investigator;
5. Diagnosed as metabolic bone disease, radiation bone disease, etc.;
6. Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain;
7. have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
8. The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate;
9. Other conditions deemed unsuitable for inclusion by the investigator.
Methotrexate Iontophoresis Versus Coal Tar Ointement in the Treatment of Primary Palmer Hyper Hidrosis

The purpose of the study is to compare the therapeutic effect of methotrexate iontophoresis versus coal tar ointment on the the treatment of primary palmer hyperhidrosis?

Some researchers stated that hyperhidrosis can render the skin susceptible to infection because of the continuous dampness of the skin. The condition may become socially, psychologically and professionally debilitating.

There are a lot of literatures concerned with studying the modalities used in the treatment of primary palmar hyperhidrosis, so this study will be conducted to compare between two of them and to show the best one for treating primary palmar hyperhidrosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient with primary palmar hyperhidrosis to extend that their palms are wet during most of the day (score 3 and 4 in the Hyperhidrosis Disease Severity Scale) was included in this study.
* The palmer hyperhidrosis patient's age ranged from 15 to 35 years.
* All patients will be examined by dermatologist before starting the study.

Exclusion Criteria:

The study excluded the following patients:

* Patients with medical conditions that associated with hyperhidrosis are excluded, these conditions include:- hyperthyroidism, diabetes mellitus, parkinsonism, spinal cord injury, brain damage, congestive heart failure, anxiety, alcoholism and menopause.
* Patients who received any treatment with a drug that was affecting sweating e.g. (thyroxin, anxiolytics.....) that is not stopped at least 4 weeks preceding the study.
* Patients with cardiac conditions such as arrhythmia, ischemic heart disease, low exercise tolerance, low respiratory reserve were excluded.
* Patients, who have a local wound, sever eczema and severe fungal infection of the palms to minimize risk of local burn.
* Patients who have sensory disorders.
* Female patients who are pregnant and lactating.
Estimation of Average and Beat-to-beat Heart Rate With a Novel Wrist-worn PPG Device in Surgery Patients

The aim of the study is to the reliability and feasibility of a novel optical heart rate monitor in hospital patients. Especially patients with atrial fibrillation are included. Patients will be monitored for two hours during routine post-operative care. The data from study device will be compared to routine monitoring. The design of the study is a Pilot feasibility study.

The primary use of photoplethysmography (PPG) measurement in clinical settings is usually the determination of the blood oxygen saturation level of the patient. The same device often reports also an average pulse rate of the subject.

If the subject has low blood perfusion in the hands or suffers from acute atrial fibrillation, the determination of the pulse rate is challenging and therefore the readings provided by current technology are unreliable.

Optical heart rate monitors (OHR) have recently become popular in sports and wellness applications and their performance in healthy subjects having normal blood perfusion in the extremities is well studied and documented and good accuracy has been shown healthy subjects. The performance of wrist-worn OHR monitors in hospital patients, however, has not been extensively studied.

The aim of the study is to test novel wrist-worn photoplethysmographic (PPG) device in surgery patients and study its feasibility in detecting heart rate and beat to beat heart rate of patients having normal sinus rhythm or arrhythmia, such as atrial fibrillation (AF).

Eligibility Criteria:
Inclusion Criteria:

* Age: \> 18 years
* Subjected to surgery at Tampere University Hospital
* Spontaneously ventilating
* Volunteering for the study
* Able to give a written informed consent

Exclusion Criteria:

* Having a cardiac pacemaker
* Surgical operation performed in wrist area or any other reason that prevents placing the wrist-worn device in correct location
* Neurological disease (e.g. Parkinson's) possibly causing notable amount of shivering
* Non-Caucasian skin colour
* Inability to give an informed consent
* Denial of participation
Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography

The aim of our study is to determine the efficacy of Ketoprofen with or without vaginal isonicotinic acid hydrazide on the pain scores during HSG.

hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Eligibility Criteria:
Inclusion Criteria:

* any patient came for Hysterosalpingography

Exclusion Criteria:

* any patient has contraindication to HSG
An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy

This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) or other biological drugs
* Patients treated with biologic DMARDs alone for at least 6 months

Exclusion Criteria:

* Patients not willing or unable to give written informed consent for participation in this study
* Patients who are participating in any clinical trial at the time of this study
Resistance Exercise Training at Different Intensities

The aim of the current study, therefore, is to determine the feasibility of recruitment and adherence to resistance exercise training interventions performed at low and high loads, to volitional muscular failure, in a trial population that includes both healthy and frail older people.


Eligibility Criteria:
Inclusion Criteria:

* Over age of 65 years

Exclusion Criteria:

* Current participation in an exercise programme
* Exercise deemed unsafe by clinical team
Video-Conferenced Stress Management and Relaxation Training (VSMART) For Alabama Breast Cancer Survivors

In a sample of Alabama breast cancer survivors, the proposed study tests the feasibility and acceptability of a stress management program that has been shown to improve health and wellbeing in a general population of patients with a history of breast cancer. The study will also get feedback (e.g., implementation barriers and facilitators) from relevant stakeholders.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer survivor
* Currently living in Alabama
* Living in neighborhood with high deprivation index

Exclusion Criteria:

* Non-Alabama resident
* No history of breast cancer
* Living in neighborhood with low deprivation index