cyrilzakka/clinical-trials huggingface dataset:
Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe

The primary objective of the study is to compare, in patients treated with methotrexate injection for rheumatoid arthritis, the compliance and the health assessment questionnaire evolution for the administration by auto-injector versus administration by conventional subcutaneous injection, after 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (18 years or over) of either sex.
* With established rheumatoid arthritis diagnosis
* Treated for rheumatoid arthritis by methotrexate (oral or by injection) since at least 3 months regardless of the prior or combined disease modifying treatment, except biotherapies and justifying injection of methotrexate. For the patient treated by oral methotrexate, the switch decided by the rheumatologist is made for either safety, compliance or efficacy issues.
* Agreeing to participate in the study and having dated and signed the informed consent form.

Exclusion Criteria:

* Patients fulfilling one or more of the following exclusion criteria will not be included in the study:

  * Inability of patient to use an auto-injector.
  * Treated with biotherapies.
  * Pregnant or breast-feeding patients
  * Male and female patients with reproductive potential who are not willing to use effective method of contraception (oral contraceptives, intrauterine device, condoms) during study and at least 1 month after the end of the study.
  * Patients with :
* hypersensitivity to methotrexate or to any of the excipients,
* severe hepatic impairment,
* alcohol abuse,
* severe renal impairment,
* pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia,
* Immunodeficiency,
* serious, acute or chronic infections such as tuberculosis and HIV,
* stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease,
* concurrent vaccination with live vaccines.

  * Association with probenecid, trimethoprim, phenylbutazone.
  * Any other known medical or surgical history, disorder or disease judged by the investigator to be incompatible with the study (such as acute or chronic severe organic disease: hepatic, endocrine, neoplasia, haematological, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc...),
  * Inability of patient to understand the study procedures and thus inability to give informed consent.
  * Participation in another clinical study, at the same time as the present study, or during the month following the end of the previous study
  * Ward of court.
  * Patient not covered by the Social Security.
Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy

The purpose of the study is to determine the impact of a physical activity intervention on the self-management of fatigue in young adults receiving chemotherapy. Half of the participants will receive an intervention which includes education and resources to set physical activity goals and monitor progress toward goals.

Interventions to increase physical activity have been shown to relieve fatigue in patients receiving chemotherapy, but no studies have tested a physical activity intervention to improve fatigue in young adults receiving chemotherapy. This study will determine the impact of a physical activity intervention on the self-management process variables of self-efficacy and self-regulation and their relationships to physical activity and fatigue severity in young adults receiving chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of cancer;
* are within the first two months of a chemotherapy regimen that will last at least another 3 months;
* are ambulatory without assistance;
* have written consent from their physician to participate;
* have the ability to understand English;
* have access to a computer and the Internet.

Exclusion Criteria:

* symptoms of uncontrolled cardiopulmonary disease, neurological disease
* delayed wound healing
* high risk of bone fracture
* pre-existing peripheral neuropathy
The Effect of Foot Deformities on Physical Activity, Fatigue Level and Quality of Life in Elderly COPD Patients

The aim of this study is to investigate the effects of changes in foot structure on physical activity level, fatigue and quality of life in COPD patients.

Chronic obstructive pulmonary disease (COPD) is usually a progressive disease associated with the increased chronic inflammatory response of the airways and lungs to the toxic effects of harmful gases and particles. It causes pathological changes such as increased secretion production in the airways, epithelial changes, inflammation, smooth muscle hypertrophy, and hyperplasia in the submucosal glands. Hyperinflammation in the lungs results in muscle atrophy, shortening of the respiratory muscles, and increased respiratory workload. On the other hand, the increase in pro-inflammatory plasma cytokine levels seen in the systemic circulation causes oxidative stress, leading to the development of musculoskeletal system disorders and a decrease in functional capacity. Pulmonary dysfunction and increased dyspnea lead to a decrease in physical condition, physical exercise tolerance, and activity, while the decrease in muscle mass results in atrophy in the peripheral extremities.

Age and gender are cited as major risk factors for COPD. Therefore, lower extremity atrophy, which is seen in peripheral extremities and increases with aging, causes foot dysfunctions. Considering that the ability of elderly people to maintain their independence is related to a good level of consciousness and ongoing ambulation, and the frequency of foot problems seen in elderly people is approximately twice as high as the general population, foot problems seen in elderly individuals are very important for this group. In particular, the decrease in foot mobility and the fall of the medial longitudinal arch negatively affect the absorption of shocks during heel strike and foot flat and the momentum of the trunk forward. This situation may result in the expenditure of energy above normal and deterioration of balance while ensuring the proper transfer of body weight. All of these cause early fatigue and a decrease in the quality of life in the individual. In the literature, foot deformities in elderly healthy individuals and the parameters these deformities will affect people are stated. However, there is no study examining the effects of foot deformities on physical activity, fatigue, and quality of life in elderly COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of COPD
* Age over 60

Exclusion Criteria:

* Having an orthopedic or neurological disorder that affects the walking pattern
* Having a peripheral vascular disease
* Being diagnosed with Diabetes Mellitus
* Having systemic diseases such as arthritis
* Having a previous history of foot-ankle fractures
* Having a dermatological disease (fungal and bacterial infection etc.)
Translation and Clinical Implementation of a Test of Language and Short-term Memory in Aphasia

This project aims to develop a clinically feasible version of a laboratory-developed assessment battery for language and verbal short-term memory difficulties in aphasia.

Over five years, we will develop a clinically feasible test that can be used to assess in-depth the language and verbal short-term memory abilities of individuals with aphasia (Called the TALSA - Temple Assessment of Language and Short-term memory in Aphasia. Based on a test that we have developed and tested over the past decade, we will create a shorter version that can be used by clinicians in a rehabilitation setting. The data to support this development will come from two sources: (1) clinicians in rehabilitation facilities who will use the new clinical test and provide feedback on the test (administration, value etc) and (2) people with aphasia who will be administered the longer version to help us identify the best test items in the laboratory version of the TALSA to be carried over to the shorter clinical version.

We are recruiting individuals with aphasia as well as people without aphasia (to serve as controls) to help with development of this assessment battery. The battery consists of between 15 and 20 subtests that assess many aspects of language and verbal short-term memory.

Eligibility Criteria:
Inclusion Criteria:

* . single or multiple left hemisphere lesions
* at least one year post-stroke.
* high-school educated
* negative histories for mental illness and alcohol/substance abuse.
* passed an audiometric pure-tone, air conduction screening at 25 dB HL at 1K, 2K and 4K Hz for at least one ear.

Exclusion Criteria:

English as a second language Right hemisphere stroke Less than 6 months post-onset of stroke.
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease

The aim of this study is to demonstrate the efficacy of timed exposure to bright light for the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia patients and their caregivers, and to determine if there are genetic relationships between memory problems and sleep problems

1. Efficacy: Up to 4 weeks of morning bright light exposure will be more efficacious than morning dim light in consolidating nighttime sleep as assessed by actigraphy.
2. Predictors of response: We expect the primary predictor of treatment response will be initial MMSE score. Secondary predictors include baseline sleep/wake and circadian parameters and age.
3. Effectiveness: Bright light treatment will be more effective than dim light in improving quality of life.
4. An understanding of some of the genetic markers of memory and/or sleep problems.

Eligibility Criteria:
Inclusion Criteria:Alzheimer's Disease Patients:

* Stanford Alzheimer's Disease Core Center member or potential member, with diagnostic criteria met for probable AD, living with caregiver willing to participate in the protocol
* Non-institutionalized

Caregivers:

* Living in home of AD patient and willing to participate in protocol Exclusion Criteria:Alzheimer's Disease Patients:
* History of manic or bipolar disorder
* Prior bright light treatment
* Irregular or non-24 hour sleep/wake cycle
* Positive result on multi-staged RLS/PLMD
* Medical/Ophthalmologic Exclusions
* RDI \>20 on overnight EdenTrace® recording

Caregivers:

* History of manic or bipolar disorder
* Medical/Ophthalmologic Exclusions
Firefighters Accessing Care for Trauma: A Clinical Case Series of Distance NET for PTSD/I Symptoms

Repeated exposure to trauma is an unavoidable part of the job for firefighters. Because of this, many Canadian firefighters screen positive for posttraumatic stress disorder/injury (PTSD/I). Unfortunately, like the general population, firefighters face many barriers to accessing mental health care. As a result, additional efforts are needed to increase timely access to effective PTSD/I services that are delivered in a way that reduces confidentiality and stigma risk.

This research study will test the preliminary efficacy and feasibility of distance-delivered Narrative Exposure Therapy (NET) delivered by a paraprofessional for firefighters with PTSD/I. NET is an evidence-based intervention approach developed specifically for PTSD/I resulting from repeated and continuous trauma. The intervention will be conducted via videoconference with a trained paraprofessional supervised by a clinical psychologist. The NET intervention will consist of 12 weekly 90-minute videoconference sessions.

Approximately 25 firefighters will be recruited to participate in the study. To test the efficacy of the intervention, participants will complete self-report questionnaires about PTSD/I and other mental health symptoms pre- and post-intervention as well as two- and six-months following intervention completion. Participants will also complete an open-ended interview at the end of the intervention to assess feasibility and participant satisfaction.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet the following criteria to be eligible to move on to Consent

1. Be at least 19 years of age
2. Be able to understand spoken and written English at a Grade 8 level
3. Be employed, or have been employed, by the fire service or be current or past fire service volunteers.
4. Fulfill the criteria of full or subclinical PTSD/I according to the PCL-5.
5. Have access to a computer with Internet.
6. Live in Atlantic Canada or Ontario.
7. Consent to be audio- (for consent and interview) and video-recorded (for intervention sessions).

Exclusion Criteria:

1. Having a psychotropic medication change in the past three weeks.
2. Are currently engaged in or have previously been engaged in exposure therapy for PTSD/I.
3. Meet criteria for current mania or psychosis.
4. Endorse suicidal ideation with plan or intent.
5. Experience high levels of dissociation (as assessed by a score of \>18.5 on the Shutdown Dissociation Scale).
Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

* Thirty six patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 or matching placebo for 4 weeks.
* During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Have active RA as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum CRP ≥1.0 mg/dL;
* Have received methotrexate for six months or longer and at a stable dose of 7.5 to 25 mg/week (extremes included) for at least four weeks prior to screening and willing to continue on this regimen for the duration of the study;
* If taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least four weeks prior to screening;
* If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least two weeks prior to screening;
* Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses);
* Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least four weeks after the last dose of study drug. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and
* Able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments.

Exclusion Criteria:

* Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background methotrexate;
* Current or previous RA treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents);
* Previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening;
* Receipt of an intra-articular or parenteral corticosteroid injection within four weeks prior to screening;
* Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis, requiring hospitalization;
* Positive serology for human immunodeficiency virus (HIV)1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A;
* History of any inflammatory rheumatological disorders other than RA;
* History of tuberculosis (TB) infection;
* Pregnant or lactating women.
Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic

RATIONALE: Gathering information about how often problems with neurocognitive functioning occur in patients with newly diagnosed upper aerodigestive tract cancers may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying neurocognitive functioning in patients with newly diagnosed upper aerodigestive tract cancers receiving treatment at Henry-Joyce Cancer Clinic.

OBJECTIVES:

Primary

* To establish an estimate of the prevalence of baseline neurocognitive impairment prior to initiation of outpatient cancer treatment.
* To establish an estimate of the incidence of neurocognitive impairment during outpatient cancer treatment.
* To describe how neurocognitive functioning changes over time during cancer treatment.

Secondary

* To identify sociodemographic and clinical factors associated with neurocognitive impairment.
* To examine health-related outcomes associated with neurocognitive impairment.

OUTLINE: Patients undergo interview to complete measures of domain-specific neurocognitive functioning, global neurocognitive functioning, subjective neurocognitive functioning, delirium, physical functioning, symptom prevalence and distress, mood states, and medications at baseline before initiation of cancer treatment, at scheduled treatment visits, and at the follow-up visit 3 months after completion of cancer treatment.

Measures of comorbidity, alcohol use, sensory functioning (vision and hearing), and sociodemographic are completed at baseline only. Cancer-related information (diagnosis, staging, and sites of metastasis, if applicable), treatment-related information (planned treatment regimen - chemotherapy and/or radiation therapy), and current medications are obtained at baseline by medical record review.

Health service use and complications are assessed at each scheduled treatment visit and at the 3-month post-treatment follow-up visit. Measures of domain-specific neurocognitive functioning, coping, and quality of life are completed at baseline and at the 3-month follow-up visit.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed solid tumors of the upper aerodigestive system, including cancers of the head and neck, esophagus, or lung
* Receiving treatment at the Henry-Joyce Cancer Clinic at the Vanderbilt-Ingram Cancer Center
* No known brain metastasis

PATIENT CHARACTERISTICS:

* Able to hear, speak, and understand English
* No prior diagnosis of other cancer except basal cell carcinoma

PRIOR CONCURRENT THERAPY:

* No treatment plans including prophylactic cranial irradiation
Eye Drop Use in Glaucoma Patients Through Patient Surveys and Video Observations

This study will be used to evaluate how patients put eye drops in their eyes and any problems that may arise from this activity. The information gathered will help identify common problems patients are having with putting in their eye medications. Then doctors can be better informed about the issues and provide better advice to their patients to overcome these problems.

Approximately 100 patients will take part in a one time procedure and survey as part of this project. After appropriate consent patients are asked to complete a short 2 page survey about themselves and their eye drops. Then a video recording will be made of the patient instilling eye drops in their habitual manner. The eye drops used will be sterile saline placed in either Travatan-like or Systane bottles to simulate the corresponding prescribed medication. The videos will be graded for instillation technique and combined with scoring of survey answers.

Patients will be asked to instill the drops to their left eye with their dominant hand as we expect this to be most difficult. Patients with severe (\>20/200) vision loss will instill drops into their better seeing eye.

Eligibility Criteria:
Inclusion Criteria:

* Currently using topical glaucoma medications
Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease

The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027 on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly intravenous (IV) infusions of BMS-241027


Eligibility Criteria:
Inclusion Criteria:

* Mild AD Subjects meeting National Institute of Neurological Disorders and Stroke - Alzheimer's Disease Related Disorders Association(NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-Forth Edition, Text Revision (DSM-IV-TR) criteria
* Mini-Mental State Exam (MMSE) Score between 20 \& 26 (inclusive)
* CSF consistent with AD pathology
* Screening brain MRI - normal - commensurate with age or demonstrate atrophy consistent with AD diagnosis (dx); reveal no more than mild white matter disease; up to 2 lacunar infarcts acceptable except in anterior thalamus, genu of internal capsule or basal forebrain; reveal no cortical infarcts; reveal no more than 4 microbleeds; reveal no focal asymmetric lobar atrophy or other findings suggesting primary cause of dementia is attributed to a cause other than AD; reveal no macrohemorrhages (\>10 mm)
* Subjects must have reliable study partners
* Men and Women of Non Child Bearing Potentia (WONCBP), ages 50-90 years

Exclusion Criteria:

* Subjects with any other medical condition other than mild AD that could explain subjects' memory or cognitive deficits
* Subjects diagnosed with moderate or severe AD per DSM-IV criteria
* Subjects with a history (hx) of stroke
* Subjects with a hx of GI illnesses
* Subjects with Vitamin B12 or folate deficiency
* Subjects with any unstable cardiovascular (CV), pulmonary, Gastrointestinal (GI) or hepatic disease within 30 days prior to screening
* Subjects with active liver dx or history of hepatic intolerance
* Subjects with a Geriatric Depression Scale score of ≥ 6 at screening
* Subjects treated for or have had a diagnosis of schizophrenia
* Subjects treated for or have had a diagnosis of bipolar disease within 3 years prior to screening
* Subjects with a history of generalized peripheral neuropathy
A Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Adult

The supraglottic airway device(SAD), as an alternative to the endotracheal tube is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. SAD has evolved in recent years to increase efficiency and secure safety. The recently developed Ambu® AuraGain™ is a second-generation SAD with a built-in gastric port and is designed to be fitted well in the larynx and oral cavity after insertion because the shaft is bent at an angle of 90 degrees and has an inflatable cuff.

In a previous study, Ambu® AuraGain™ showed a higher sealing pressure and better fibreoptic finding compared to LMA Supreme in laparoscopic surgery.

On the other hand, I-gel and Ambu® AuraGain™, both of the second-generation SAD, show comparatively excellent performance according to the results of previous studies. However, there are no studies comparing the characteristics of two airway devices in adults.

The purpose of this study is to compare the performance of I-gel and Ambu® AuraGain™ to make a difficult airway-like situation using cervical collar for adult patients receiving mechanical ventilation under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate.

Exclusion Criteria:

* Body mass index \> 35 kg/m2
* High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
* Criteria for difficult airway
* Patients with cervical disease or previous cervical spine surgery