cyrilzakka/clinical-trials huggingface dataset:
Psychosocial Risk Factors for Coronary Heart Disease in Swedish Women

To study psychosocial risk factors for coronary heart disease in Swedish women.

BACKGROUND:

The incidence of non-fatal myocardial infarction in Swedish women below age 60 increased during the past 20 years. Standard risk factor change includes a decrease in average systolic blood pressure and S-cholesterol but a moderate increase in smoking and diabetes prevalence. During the same time period Swedish women have 'moved' into the labor market, so that employment rates are now similar in Swedish men and women. However, women have kept the main responsibilities for household and child care. In spite of generous legislation for maternity leave and child care, the strains from multiple roles and responsibilities have probably increased in Swedish women. The study sought to provide an answer to: 1) which factors - biological and behavioral - influenced both the extent of and progress of coronary artery disease, 2) which physiological, biochemical, or neuroendocrine mechanisms participated in the process. In addition to conventional statistical methods, canonical correlations analyses were used to describe direct and indirect pathways of the pathogenesis. Furthermore, by means of the two comparison groups, information was obtained about the specific characteristics of the female psychosocial and behavioral coronary heart disease risk profile.

DESIGN NARRATIVE:

The role of social strain was studied within a broader psychosocial context including social networks, social supports, social skills, reciprocity, coping, stressors, chronic work strain, family structure, personality and behavior characteristics. These aspects were related to possible physiologic cardiovascular mechanisms including reactivity of and persistent elevated heart rates and blood pressure on ambulatory monitoring as well as cardiac dysrhythmia and silent or symptomatic ischemia. Psychoneuroendocrine pathways were also investigated. These included catecholamines, cortisol, prolactin, estrogen, testosterone, gastrin, somatostatin. Other biochemical measures included lipid profile, coagulation, thrombolysis and immune function. These examinations were applied to all women below age 60, living in the greater Stockholm area, with signs or symptoms of coronary heart disease. The women were followed and reexamined (including angiograms) after 2 to 2.5 years. They were compared to an equal number of age matched men and to an equal number of age matched healthy women from the same catchment area.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Registry of Chronic Subdural Hematoma

The goal of this observational study is to better understand how chronic subdural hematoma (CSDH) progresses and how patients are treated and cared for. The study focuses on three main questions:

1. What are the characteristics of patients with CSDH when they are diagnosed?
2. What treatments do patients with CSDH receive?
3. What are the outcomes for patients with CSDH, including their functional ability, cognitive health, and neurological status?

Participants will receive their usual standard treatment. As part of the study, they will complete a brief telephone interview three months after their treatment.

Rationale:

Chronic subdural hematoma (CSDH) is a common condition encountered by neurologists and neurosurgeons. While guidelines for the management of CSDH have recently been developed, high-quality evidence to inform these recommendations, particularly level I evidence from randomized clinical trials (RCTs), is awaited. Significant variability in the management of CSDH persists at international, national, and inter-hospital levels. To further refine and implement evidence-based guidelines, a detailed understanding of current clinical practices and their associated outcomes is essential.

Objective:

To describe the baseline characteristics, treatment strategies, and outcomes of patients diagnosed with chronic subdural hematoma.

Study design:

A prospective, observational multicenter cohort study.

Study population:

All adult patients diagnosed with chronic subdural hematoma.

Main study parameters/endpoints:

The primary endpoint is functional outcome, measured by the modified Rankin Scale (mRS) at 3 months. Secondary endpoints, also assessed at 3 months, include recurrence, mortality, complications, hospital length of stay, Markwalder Grading Scale (MGS), modified National Institutes of Health Stroke Scale (mNIHSS), and Telephone Interview for Cognitive Status (TICS).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Patients will be treated in accordance with standard clinical practice. Study participation imposes minimal additional burden, consisting of a single telephone interview at three months, estimated to take approximately 10 minutes. The findings from this registry are expected to benefit future CSDH patients by informing evidence-based guidelines and improving care practices.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CSDH
* 18 years or older

Exclusion Criteria:

* Patients who do not consent to participate in the registry
Feasibility of a Digital Therapeutic for Adults with Posttraumatic Stress Disorder (PTSD)

This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.

The purpose of this study is to conduct a randomized controlled trial to evaluate the usability and feasibility as well as the safety and effectiveness of OTX-601 (version 1) + TAU compared to OTX-601 (version 2) + TAU in reducing PTSD symptoms from baseline to 7 weeks.

Eligibility Criteria:
Inclusion Criteria:

The primary inclusion criteria for this study will be a PTSD diagnosis, ASI-3 scores above 24, PCL scores above 30, and understanding and speaking English. The only software/hardware requirements are that participants have access to a smartphone that is connected to the internet.

Exclusion Criteria:

1) Score of 24 or lower on the ASI-3, 2) score of 30 and below on the PCL-5, 3) no PTSD diagnosis, 4) active psychosis, 5) Acutely intoxication during study baseline, 6) enrolled in another treatment research study, 8) If applicable, medical illness that would prevent the completion of interoceptive exposure exercises.
Microcirculation in Dehydrated Older Patients

This proof-of-concept study examines whether 1) sublingual measurement in dehydrated old patients is feasible, 2) frailty and incompliance in old, awake patients affects video-quality, 3) dehydration impacts microcirculation This prospective observational study includes clinically dehydrated patients aged ≥ 65 years, who have spontaneous circulation and access to the sublingual mucosa, immediately after admission. Dehydration will be assessed clinically. A sidestream dark field camera (SDF) will be used for measurement. Video-quality will be evaluated with MIQS (microcirculation image quality score). Both AVA 4.3C- and AVA POEM-software analyzed the videos. Seventeen patients ≥ 65 years not showing dehydration served as control.


Eligibility Criteria:
Inclusion Criteria:

* 65 years old or older
* diagnosed with dehydration according to the clinical impression of the treating physician
* informed consent
* the sublingual mucosa had to be accessible.

Exclusion Criteria:

* \<65 years
* Lacking informed consent
* time-critical disease
* previous resuscitation
* inaccessibility of sublingual area
Evaluation of Intestinal Bacterial and Fungal Translocation and Intestinal Microbiota in Febrile Neutropenic Patients in Pediatric Onco-hematology

This pilot study aims to study intestinal bacterial and fungal translocation and the evolution of the intestinal microbiota in patients over the course of their medical surveillance to search for a link between dysbiosis and bacterial/fungal translocation, but also to better understand the elements involved in febrile episodes in these patients (lack of detection of blood microorganisms, translocation of constituent elements of these microorganisms, etc.). We hypothesize that the composition of the intestinal microbiota as well as the phenomenon of intestinal microbial translocation will have an influence on the occurrence of fever and/or bacteremia in neutropenic patients hospitalized in pediatric onco-hematology.


Eligibility Criteria:
* Inclusion Criteria:

  * Information concerning the study set-up, objectives, constraints and the patient's rights is transmitted
  * The patient and/or their legal guardian must have given their free and informed consent. If the patient is over 18, it is the patient who signs the consent form
  * The patient must be a member or beneficiary of a health insurance plan
* Exclusion Criteria:

  * The patient is under state guardianship or safeguard of justice
  * Refusal to sign the consent
  * It is impossible to give the subject informed information
  * Pregnant, parturient or breast feeding patient
A Study to Evaluate the Safety and Efficacy of Ex Vivo Expanded Autologous Immune Killer Cells (IKC) in Stage IV Non-small Cell Lung Cancer (NSCLC) in Patients Who Failed Chemotherapy or Target Therapy

In this study, whole blood is drawn from the patient to be used to grow Immune Killer Cells (IKC). After proliferation, the IKC will be infused back into the patient to treat the cancer for a total of 24 weekly treatments.

Possible adverse reaction can include slight fever and headache.


Eligibility Criteria:
Inclusion Criteria:

1. Age≧20 years old
2. Life expectancy≧3 months
3. Eastern Cooperative Oncology group (ECOG) score 0\~2
4. Cytologically-or histologically-confirmed non-small cell lung cancer（NSCLC)
5. Patients with clinical TNM classification of Malignant Tumours (TNM) stage IV...

Exclusion Criteria:

1. Patients with history of cardiovascular disease, including uncontrolled hypertension, congestive heart failure, myocardial infarction, angina pectoris, coronary artery disease, uncontrolled arrhythmia , previous history of encephalopathy within the past six months of screening period
2. Patients with HIV, HTLV or active tuberculosis
3. Women who are pregnant or breast-feeding
4. Patients with drug or other substance abuse
5. Patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)
Impact of Family-Centered Empowerment on Caregivers of Children with Cancer: a Quasi-Experimental Study Protocol

The purpose of this trial is to understand the impact of a family empowerment-based intervention program on family caregivers' readiness to care and ability to care. It aims to elucidate whether a health education intervention program based on the Family Empowerment Model improves family caregivers' readiness for care and ability to care.

Participants will receive a health education program based on the family empowerment model and will complete questionnaires three days prior to admission, during hospitalization, and three days prior to discharge.This study is a non-pharmacological intervention and will not involve any changes in treatment or chemotherapy regimens.


Eligibility Criteria:
Inclusion Criteria: (1) children aged 0-18 years old, (2) those clinically diagnosed with malignant neoplasms, and (3) first-time visitors to our hospital.

Primary caregiver inclusion criteria: the caregiver is enrolled along with the child, (1) was ≥18 years of age; (2) was a member of the child's immediate family; (3) had cared for the child for the longest period among multiple caregivers; (4) had basic communication and reading skills and was proficient in Chinese; and (5) had no previous or current history of psychiatric illness or consciousness-related disorders.

Exclusion Criteria: (1)Children who abandon treatment or are transferred to a hospital while the study is in progress.
Evaluating the Efficacy of SyMRI in Clinical Pediatric Populations

Synthetic MR Technologies has created a quantified imaging solution - SyMRI - to enable radiologists to acquire quantified images and always obtain the best contrast images. This study represents an attempt to assess the clinical utility of this software.

Typical magnetic resonance imaging (MRI) involves taking many images called 'contrasts' to look at the body in different ways. Standard scan settings are usually good enough for a radiologist to review. The best settings often change with the age of the patient and their health, and are time consuming to determine. Quantified imaging is an alternative to contrast-based imaging which explicitly measures tissue properties and can be used to create almost any contrast. This method of imaging has been held back by a lack of the right software. Synthetic MR Technologies has created a quantified imaging solution - SyMRI - to enable radiologists to acquire quantified images and always obtain the best contrast images.

The objective of this study is to evaluate SyMRI in a pediatric population to determine if Sickkids would be interested in purchasing this product / support Health Canada approval. Specifically, the investigators are interested in determining if SyMRI is clinically useful:

* Is synthetic imaging quality comparable / better than conventional imaging?

  * Qualitative - Are radiologists more confident using synthetic MR vs conventional
  * Quantitative - Signal-to-noise (SNR) and Contrast-to-noise (CNR)
* To what extent can total exam times be reduced?
* Is the software user friendly and would investigators use it?

Eligibility Criteria:
Inclusion Criteria:

* Any stable patient undergoing clinical MRI of the brain is eligible for this study.
* Research patients undergoing research MRI of the brain for another study will be eligible.

Exclusion Criteria:

* Only those patients where an additional 10 minutes of MR imaging would not be advisable (ie. unstable, implants) or possible (due to scheduling constraints) will be excluded.
Cervical Manipulation (OAA Technique) in Exophories

Objetive: to assess the efficacy of the occipito-atlas-axis cervical manipulation technique to correct ocular divergence in subjects with exophoria.

Design: quantitative, experimental, longitudinal and prospective study.

Subjects: subjects over 18 years of age, with exophorias, without heterotropies and who do not present a contraindication to cervical manipulation.

Methods:Subjects with this ocular mobility dysfunction are going to be evaluated objectively with the Alternate Cover Test. The ocular deviation will be measured at 40 cm and at 4 meters. The individuals who were part of the experimental group underwent the OAA manipulation technique, and to those who were part of the control group a placebo maneuver. Two measurements were taken from this moment, one immediately after the execution of the technique and another one week later.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of exophoria
* Being 18 years old.

Exclusion Criteria:

* Having heterotropia or have been treated for it.
* Present contraindication to manipulation (recent fractures, sprains, or dislocations, local tumor, rheumatic polyarthritis, Down syndrome, vertebrobasilar insufficiency, basilar impression, refusal to be manipulated).
* Having cervical manipulation before two weeks.
Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease

TNFα inhibitors have revolutionized the management of patients suffering from inflammatory diseases in the field of rheumatology. Infliximab remains widely used in France, and infliximab biosimilars have been routinely used since 2015 in Cochin Hospital with an interchangeability strategy validated by two real life studies. REMSIMA® 120 mg is the first authorized subcutaneous (SC) form of infliximab to be administered at a fixed dose of 120 mg every 2 weeks. Scarce information is available regarding the safety and efficacy of proposing a switch from IV infliximab to SC REMSIMA® in the subsets of patients suffering from different rheumatic diseases in daily care. The primary objective of the SIC2 study will be determine the retention rate of Remsima SC at 6 months. The investigators will recruit adult patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis.

TNFα inhibitors have revolutionized the management of patients suffering from inflammatory diseases in the field of rheumatology. Infliximab remains widely used in France, and infliximab biosimilars have been routinely used since 2015 in Cochin Hospital with an interchangeability strategy validated by two real life studies. REMSIMA® 120 mg is the first authorized subcutaneous (SC) form of infliximab to be administered at a fixed dose of 120 mg every 2 weeks. Scarce information is available regarding the safety and efficacy of proposing a switch from IV infliximab to SC REMSIMA® in the subsets of patients suffering from different rheumatic diseases in daily care. The primary objective of the SIC2 study will be determine the retention rate of Remsima SC at 6 months. The investigators will recruit adult patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis. Main inclusion criteria will be patients who have received at least 3 IV infliximab infusions and suffer from chronic inflammatory rheumatic condition with the absence of disease flare / progressive disease preventing the continuation of infliximab. The primary endpoint will be the percentage of patients who have agreed to receive SC REMSIMA® and who continued this treatment for at least 3 months. Secondary objectives will be the reasons of switching or not to Remsima, the need for patients to be re-established on iv infliximab, SC Remsima® discontinuation and adherence, changes in disease activity between the inclusion visit and the last visit, the safety profile of sc remsima®, the immunogenicity profile of sc remsima®.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older
* Patients who has received at least 3 IV infliximab infusions and suffer from chronic inflammatory rheumatic condition
* Absence of disease flare / progressive disease preventing the continuation of infliximab
* Patient affiliated to national insurance

Exclusion Criteria:

* Any patient whose doctor considers that he will not be able to comply with the obligations of the trial
* Patients under curatorship or tutorship
* Pregnant women
Effect of Probenecid on Synovial Fluid ATP Levels in CPPD

This study will investigate the hypothesis that probenecid, a medication currently used for gout, reduces levels of ATP in the joint fluid of patients with calcium pyrophosphate deposition disease (CPPD), another common type of crystal-related arthritis. There is good evidence that CPPD results from an excess of ATP in joints. The investigators will measure levels of ATP in joint fluid before and after 5 days of treatment with probenecid. This study will serve to rationalize larger studies of probenecid in CPPD.

Objective: The objective of this study is to determine whether pharmacologic doses of the drug probenecid significantly decrease ATP and inorganic pyrophosphate (PPi) levels in the synovial fluid of patients with calcium pyrophosphate deposition disease (CPPD). The investigators have considerable evidence that synovial fluid ATP levels are high in patients with this disease and these high levels lead to calcium pyrophosphate (CPP) crystal formation which then produces acute and chronic arthritis. The investigators have identified the transmembrane protein known as ANK as the chief regulator of ATP levels in and around cartilage. Probenecid blocks function of ANK in vitro. The purpose of this study is to determine if probenecid used at normal doses are sufficient to block ANK function in vivo and whether this results in reduced ATP and PPi levels in synovial fluid.

Research design: This is a randomized un-controlled trial of probenecid vs. no drug in patients with a joint effusion and known CPPD.

Methodology: Power analysis based on an 80% chance to show a 20% difference in ATP levels in the treatment group resulted in a sample size of 20 patients in each group. Patients with known CPPD and a joint effusion will have an arthrocentesis to remove 2 ml of synovial fluid from their joint. Fluid will be sent to the investigators' research laboratory and ATP and PPi levels will be measured. Patients will be randomized to treatment with 2 grams/day of probenecid or no therapy. After 5 days, the remainder of the joint fluid will be removed and tested for ATP and PPi levels. The investigators will compare differences in ATP and PPi levels in the probenecid treated and the untreated group.

Eligibility Criteria:
Inclusion Criteria:

* Age \>21 years,
* CPPD diagnosed by Ryan /McCarty criteria
* Joint effusion in a shoulder or knee

Exclusion Criteria:

* Inability to sign informed consent
* Age \<21 years
* History of renal stones
* Significant renal dysfunction (CKD \>stage 2)
* Blood dyscrasias
* Current use of drugs which interact with probenecid
* Concurrent gout
* Active infection, including bacteremia and overlying cellulitis
* Recent joint trauma
* Intra-articular corticosteroids in the affected joint within three months
Nutritional Supplements & Complementary/Alternative Medicine by Prostate & Breast Cancer Patients

This study was a survey to determine the frequency of Complementary and Alternative Medicine (CAM) use in patients recently diagnosed with breast or prostate cancer who were starting radiation therapy. The survey was repeated at three time points to assess changes in CAM use over time.


Eligibility Criteria:
Inclusion/Exclusions

* Men that have histologically proven carcinoma of the prostate and have chosen some form of radiation therapy as their primary therapy for prostate cancer.
* Women who are undergoing external beam radiation therapy to the breast as primary or adjuvant therapy are eligible.
* All participants must be able to read and write.
* Subjects with dementia and mental retardation that complicates completing the questionnaires will not be enrolled.
* Subjects with known metastatic disease will be excluded.
* There are no age restrictions for this study.