cyrilzakka/clinical-trials huggingface dataset:
Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients with Brain Metastases

This phase II trial studies the effect of neuropsychological evaluation and intervention in maintaining quality of life after radiation therapy in patients with cancer that has spread to the brain (metastases). Quality of life refers to the overall enjoyment of life. It holds varying meanings for different people and may evolve over time. For some individuals it implies autonomy, empowerment, capability, and choice; for others, security, social integration, or freedom from stress or illness. Neuropsychological evaluation is used to examine the cognitive (thinking) consequences of brain damage, brain disease, and severe mental illness. Deterioration of both quality of life and cognitive function is common when receiving radiation to the brain. Neuropsychological evaluation with a certified neuropsychologist may improve quality of life or cognitive function after radiation therapy.

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of neuropsychological assessment and follow up on preventing decline of quality of life (QOL) as evaluated by the Functional Assessment of Cancer Therapy Scale-Brain (FACT-Br) score (validated QOL tool for brain metastases).

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of early neuropsychological assessment and neurocognitive rehabilitation by a neuropsychologist on prevention of neurocognitive decline in patients treated with radiation to brain metastases as evaluated by the Hopkins Verbal Learning Test-Revised (HVLT-R) Delay Recall, Trail Making Test A/B (TMT A/B), and Controlled Oral Word Association Test (COWAT), and Patient Reported Outcomes Measurement Information System (PROMIS)-8 assessment.

II. To identify subsets of patients treated with whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) who receive greater benefits of neuropsychologic evaluation through examining baseline Fact-Br, HVLT-R, TMT A/B, COWAT, and PROMIS-8 completed prior to radiation therapy delivery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.

ARM II: Patients receive usual care.

After completion of standard of care radiation therapy, patients are followed up at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Stage IV histologic diagnosis of solid tumor
* Patient will be treated with radiation therapy for brain metastases
* Primarily English-speaking patient
* Graded Prognostic Assessment (GPA) \>= 2 (estimated survival \> 6 months)

Exclusion Criteria:

* Patient received prior whole brain radiation therapy to the brain
* Patient has multiple sclerosis, Alzheimer's, dementia, or mental disability
Messaging Strategies to Reduce Breast Cancer Over-screening in Older Women

This is an online survey experiment with data collection over 2 time points two weeks apart. This is Aim 2 of a three-aim R01 project; overall project goal is to better understand how messages from different sources interact to affect older women's breast cancer screening decisions. In this current project, the investigators propose to test the effect of combined exposure to a clinician message + a message from another source (i.e. family/friend or media) on older women's breast cancer screening beliefs, attitudes, and intentions.

In a two-wave national online survey experiment, the investigators will randomly assign 3,000 women 65 years or older without personal history of breast cancer to 6 groups, including two control groups and four experimental groups. The experimental groups will read a message at Time 1 (T1) that may be from either family/friend or the media followed by a second message from a clinician one to two weeks later at Time 2 (T2).

The clinician message will be directed at reducing over-screening, mentioning the harms of over-screening and supporting screening cessation. The investigators will systematically vary the non-clinician message to be either consistent with the clinician message (also mentions harms of over-screening and supports screening cessation) or conflicting (mentions benefits of screening, supports continued screening and opposes screening cessation). The investigators include a no-exposure control group (Group 1) where the participants read no message at either time point and will only be asked the assessment questions. The investigators also include a single exposure group that reads only the clinician message (Group 2).

Eligibility Criteria:
Inclusion Criteria:

* Part of an online survey panel called KnowledgePanel
* able to complete survey in English

Exclusion Criteria:

* Personal history of breast cancer
Dose-Ranging Study of an Ophthalamic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataract

This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution in patients with loss of visual function due to age-related nuclear cataract


Eligibility Criteria:
Inclusion Criteria:

* Presence of nuclear sclerosis cataract
* BCDVA within the range of 20/40 and 20/80

Exclusion Criteria:

* Any other clinical condition in the eye that may compromise vision
* Presence or history of glaucoma
* Presence or history of diabetes
* Use of eyedrops
* Use of steroids
Opinions of Healthcare Providers About a European Neuromodulation Register

The goal of this online survey is to gain further insights in the needs and burden for a European registry for neuromodulation, according to healthcare providers.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain (including but not limited to anesthesiologists, neurosurgeons, nurses).

Exclusion Criteria:

* Not involved in management of chronic pain through neuromodulation.
Flavanols and Skin Photo Protection: a Clinical Trial

As flavanols have antioxidants, anti-inflammatory and anti-DNA damaging effects and may increase microcirculation in skin, the purpose of the study is to investigate the chronic effect of flavanol-rich chocolate as an effective strategy to protect against the harmful effect of ultraviolet (UV) radiation.

Recent data suggested that chronic ingestion of high flavanols cocoa might be a promising agent for dietary photo protection against UV light. Moreover, flavanols-rich cocoa intake has been shown to increase microcirculation in human skin.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking women between the ages of 20 and 65 years.
* Normal skin of type I and II as decried by Fitzpatrick classification.

Exclusion Criteria:

* Pregnancy and breast feeding.
* Photo sensibility: history of skin cancers, photosensitizing medication.
* Sun bed use or sunbathing in the previous 3 months.
* Use of supplements or natural health products (fish oils, coenzyme Q10, garlic, lycopene, beta carotene).
* Allergy or intolerance to nuts or chocolate.
Epidemiology and Clinical Course of Pulmonary Embolism During and After Hospitalisation

This survey will allow to identify PE prognostic, but also long-term complications, i.e. recurrence rate, on-treatment bleedings, deep-vein thrombosis sequella, pulmonary hypertension rate, and chronic pulmonary disease rate without PH. This database should help us identify risk-factors for each event.


Eligibility Criteria:
Inclusion Criteria:

* All pulmonary embolisms hospitalised in Nice hospital.
* acceptation to enter in the cohorte survey

Exclusion Criteria:

-
Tolerability and Pharmacokinetics of BIIB 722 CL Drinking Solution and of BIIB 722 CL Filmcoated Tablet in Healthy Subjects

Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* 18 to 55 years of age
* Broca index \>= -20% and \<= +20%
* Written informed consent according to Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
* History or current gastrointestinal hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs, which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)

This study will use retrospective data to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).


Eligibility Criteria:
Inclusion Criteria:

* Macular oedema in the study eye due to BRVO or CRVO
* Received at least 2 OZURDEX® injections in the study eye

Exclusion Criteria:

* Received OZURDEX® injections as part of or during any clinical study
Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

RATIONALE: Stress management techniques such as muscle relaxation, guided imagery, and abdominal breathing may improve quality of life and decrease emotional distress in patients who are undergoing radiation therapy for cancer.

PURPOSE: Randomized clinical trial to determine the effectiveness of stress management training in helping cancer patients cope with the emotional distress of radiation therapy.

OBJECTIVES:

Primary

* Determine whether a modified version of a self-administered stress management training intervention, previously found to be of benefit in chemotherapy patients, is effective in improving quality of life and decreasing psychological distress (anxiety and depression) in patients with cancer who are undergoing radiotherapy.

Secondary

* Compare the efficacy of this intervention on improving quality of life and decreasing psychological distress (anxiety and depression) in male vs female patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive self-administered stress management training (SSMT) in 3 stress management techniques (progressive muscle relaxation training and guided imagery, abdominal breathing, and coping skills) adapted specifically for use during radiotherapy. Patients initially receive a 5-minute standardized presentation regarding the nature and purpose of SSMT. Patients then receive information and instruction regarding the three stress management techniques comprising a videotape, audiotape, and brochure. Patients also receive their institution's usual psychosocial care.
* Arm II: Patients receive their institution's usual psychosocial care only. Quality of life, anxiety, and depression are assessed at baseline and then at 1, 2, and 3 weeks. Intervention helpfulness is assessed at 3 weeks.

PROJECTED ACCRUAL: A total of 327 patients (approximately 163 per treatment arm) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Must be scheduled to receive a minimum of 12 radiotherapy treatments over a 21-day period

  * Must not be scheduled to receive CNS irradiation
  * Must not be scheduled to receive radiotherapy as palliative care only
  * Prostate seed implants allowed

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Able to read and speak English

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* At least 4 weeks since prior chemotherapy
* No concurrent cytotoxic chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* No prior radiotherapy

Surgery

* Not specified
Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia

The purpose of this study is to compare if the effect of levobupivacaine on autonomic nervous system smaller than that of bupivacaine.

Obtain the heart rate variability (in means and standard deviation, including the high frequency, low frequency and its ratio) data of before and after spinal anesthesia with ECG (and Heart Rate Variability Analyzer) in 2 groups. Meanwhile, record the blood pressure on each subject.

Eligibility Criteria:
Inclusion Criteria:

* Indicated for spinal anesthesia

Exclusion Criteria:

* Allergic reaction to local anesthetics
* Coagulopathy
* Severe spinal deformity
* Cardiac diseases
* Metabolic diseases (such as DM, thyroid or adrenal diseases)
The Shauriana Intervention for GBMSM in Kenya

The Shauriana intervention, developed from qualitative work using a community-based participatory approach, aims to integrate PrEP, sexual health, and mental health support for gay, bisexual, and other men who have sex with men in Kenya. This study consists of a brief pilot test phase with 10 participants, followed by a randomized, controlled trial with 60 participants.

Gay, bisexual, and other men who have sex with men (GBMSM) are at high risk for HIV-1 acquisition, especially in rights-constrained settings such as Kenya, where men's access to HIV prevention has been impeded by homophobia, stigma, and discrimination. Pre-exposure prophylaxis (PrEP) has the potential to greatly reduce HIV acquisition risk in this key population if accessible, sustainable PrEP programming with tailored, effective adherence support can be provided. To this end, close collaboration between PrEP program implementers and GBMSM-led community-based organizations is essential. Based on preliminary qualitative work, this theory-based and culturally relevant PrEP support intervention is called Shauriana (Kiswahili for "we counsel each other"). The Shauriana intervention merges peer navigation and "integrated Next Step Counseling" (iNSC) to promote sexual health protection strategies, including PrEP uptake and adherence, among GBMSM in Kisumu. The present proposal aims to pilot the intervention among 10 participants for 3 months, and then to evaluate the Shauriana intervention for acceptability, feasibility, safety, and estimated effect on PrEP uptake and adherence, compared to standard of care, in a small randomized, controlled study with 60 participants followed for 6 months after enrollment. Results of the proposed research will have high impact by ensuring GBMSM involvement in the scale-up of effective PrEP programming for this key population in Kenya and providing a peer-led PrEP support model for GBMSM and other vulnerable and marginalized populations in African settings.

Eligibility Criteria:
Inclusion Criteria:

* Biologically male at birth and identifies as male, according to self-report
* 18 to 35 years of age
* Resident in the Kisumu area for ≥12 months
* Reports anal intercourse with a man in the past 3 months
* Not currently taking PrEP for HIV prevention in the past 3 months
* Willing to provide complete locator information
* Willing to undergo all study procedures, including HIV testing and counselling
* Not currently participating in any HIV prevention or vaccine study
* Planning to remain in the study area for at least 6 months

For the pilot study only, men will be required to speak English, in order to expedite the study team's analysis of feedback from these participants in preparation for the randomized controlled trial (RCT). Of note, approximately 50%-60% of young MSM in Kisumu speak English.

Exclusion Criteria:

* Unable to understand the study purpose and procedures
* Unwilling to adhere to study procedures
* Currently under the influence of alcohol or drugs
* Prior diagnosis of HIV infection
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate

The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.


Eligibility Criteria:
Inclusion Criteria:

* Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 months prior to screening and satisfied the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some point during the 12-month period
* Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA
* Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization
* Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is \> 3× the upper limit of normal and are positive for rheumatoid factor (RF) according to central lab testing during screening
* At least a Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) ≥ 3.2 at screening
* At least 3 tender and at least 3 swollen joints at screening and at randomization

Exclusion Criteria:

* Women who are breastfeeding
* Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus \[SLE\], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's syndrome) or currently active fibromyalgia
* History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease)
* At risk for tuberculosis
* Recent acute infection
* History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
* History of infection of a joint prosthesis or artificial joint
* History of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis)
* History of primary immunodeficiency
* Current clinical findings or a history of a demyelinating disorder
* 5 or more joints cannot be assessed for tenderness or swelling

Other protocol-defined inclusion/exclusion criteria apply
Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments

Minor ailments are non-serious, short-term health problems, not related to the patient's pathologies or to the desired or undesired effects of the medications they are taking. Pharmaceutical indication is the service provided in response to a patient's request, who comes to the pharmacy asking for a medication recommendation for a health problem; for this purpose, over-the-counter medications are used, which are pharmacological agents that can be acquired without a prescription. The practice of pharmaceutical indication turns self-medication into a safe and responsible practice, but it requires agreed-upon protocols.

This study is an experimental investigation with a baseline reference period, involving parallel groups of patients who approach a drugstore or drugstore/pharmacy to purchase over-the-counter medication for the treatment of a possible minor ailment. Drugstores or drugstores/pharmacies will be selected using cluster sampling, and patients will be randomly allocated to one of the study groups (intervention or control). The intervention group will receive care in line with the consensus pharmaceutical indication protocols and will undergo follow-up on days 3, 5, 7, and 10 post-care; the control group will continue with the standard care procedure. The aim of this study is to assess whether the implementation of consensus pharmaceutical indication protocols can shorten the resolution time of minor ailments and reduce the frequency of referrals to physicians. Secondary outcomes include: 1) profiling the population that visits a drugstore or drugstore/pharmacy to purchase an over-the-counter medication for a minor ailment, 2) identifying and classifying the minor ailment, 3) determining the necessity for over-the-counter medication to address the minor ailment, and 4) improvement, time to improvement, and frequency and causes of medical referral among this population.

Eligibility Criteria:
Inclusion Criteria:

Drugstores and drugstores/pharmacies:

* Establishments located in Medellin and Metropolitan area
* Establishments that have a Pharmacy Technician serving as the technical director.

Participants (patients):

* Explicit consent to participate in the study.
* The person requesting the OTC medication must be the end consumer of it.

Exclusion Criteria:

* Subjects who refuse to sign the informed consent
* Subjects with an evident incapacity to complete the data questionnaire
* Pregnant or breastfeeding women
* Patients whose MA result from an ADR
* Patients with symptoms lasting more than seven days