cyrilzakka/clinical-trials huggingface dataset:
Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)

This study examines the effectiveness of the cardiac rehabilitation program for stroke patients. The study will examine if patients with stroke, who receive cardiac rehabilitation in addition to their standard of care treatments, demonstrate improved recovery of function. It will also examine if these patients have reduced hospital readmission, reduced rate of recurrent stroke, and mortality.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Stroke diagnosis (ischemic or hemorrhagic) / radiologic evidence of acute stroke
* Medically cleared by a cardiologist for participation in the cardiac rehabilitation program with no contraindications to cardiac rehabilitation per American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines
* Ability to transfer on/off the recumbent bike with or without an assistive device safely, with or without assistance from another person
* Ability to follow simple commands and communicate pain or distress
* Admission to an Inpatient Rehabilitation Facility post-stroke
* Signed informed consent form

Exclusion Criteria:

* Presence of subarachnoid hemorrhage, intracranial aneurysm, intracranial hemangioma, or arteriovenous malformation
* Medical disorders that preclude participation in the study as determined by the Principal Investigator.
* Inability to have baseline assessment within 60 days post-stroke diagnosis
* Patient considered unable to comply with study requirements
* Known terminal illness with life expectancy less than 1 year
* Compliant diagnosis eligible for traditional cardiac rehabilitation covered by insurance
* Unable to understand/speak English
Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris

The objective of this study is to evaluate the pharmacokinetics of luliconazole cream 1%, as measured by circulating plasma levels of luliconazole, when maximal quantity of luliconazole cream 1% is applied to participants of 12 years to less than (\<) 18 years of age with moderate to severe inter-digital tinea pedis or tinea cruris.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants (or legal guardian) with the ability and willingness to sign a written informed consent.
* Participants of either gender at least 12 years to \<18 years old (12 to 17 years, inclusive).
* Participants with a mycological diagnosis of tinea pedis or tinea cruris confirmed by the detection of fungal hyphae on a microscopic potassium hydroxide (KOH) wet mount.
* Participants with the ability and willingness to follow all study procedures, attend all scheduled visits, have all blood draws, and successfully complete the study.
* Participants must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations.
* Participants must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.

Key Exclusion Criteria:

* Participants with both tinea pedis and tinea cruris.
* Participants with active atopic or contact dermatitis in the treatment area.
* Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Participants who test positive for pregnancy after start of test treatment will be discontinued from test treatment but will be followed for safety purposes.
* Participants who are immunocompromised (due to disease, for example; human immunodeficiency virus \[HIV\] or medications).
* Participants who have a recent history of or current drug or alcohol abuse.
Testing the Efficacy and Mechanisms of an Adapted Resilience Building Intervention in People Aging with HIV

This study will examine the mechanisms and efficacy of a resilience building intervention in older people living with HIV.

A two-group RCT will enroll 100 older (aged 50+) people living with HIV (PLHIV), who will be recruited from the UAB HIV outpatient clinic. Eligible participants will complete a baseline assessment including a 14-day experience sampling method (ESM) protocol, and then be randomized to either the intervention group (n=50) or an attention-matched control group (n=50). We will block randomize groups based on race, sex, and self-reported resilience (Connor Davidson Resilience Scale). If differences are found between groups on influential variables (e.g., SES), such factors will be controlled in analyses and exploratory aim analyses will examine treatment moderators (e.g., sex, race). Both groups will return for four weekly two-hour group visits, followed by a one-month post intervention assessment (including qualitative and quantitative feedback) and a second ESM protocol. A three-month follow-up (comparable to baseline) will assess health outcomes. A blinded research assistant will conduct follow-ups. Our Primary Aims will use ESM via text messaging, and focus on intervention effects on the use of resilience resources following times when stressors are reported and whether such increases drive improved affective stress reactivity and recovery (Aim 1). Our secondary aim will examine effects on health outcomes at three months. Our exploratory aim will examine moderators of treatment response.

Eligibility Criteria:
Inclusion Criteria:

* current UAB HIV Clinic patient
* age 50+
* have a recent history (within the past 12 months) of suboptimal HIV management, defined as having either ≥one record of detectable viral load or ≥one missed clinic visit without prior cancellation/reschedule

Exclusion Criteria:

* neurological or severe psychiatric (e.g., schizophrenia, bipolar disorder, major depression) disorders
Migrant and Seasonal Head Start Study

The MSHS Study is a nationally representative study commissioned by the U.S. Office of Health and Human Services' Administration for Children and Families that will describe the characteristics and experiences of the children and families who enroll in MSHS and the practices and services of the MSHS programs that serve them. The MSHS Study draws heavily on the Design for MSHS Survey Report (2011) and is informed by the current context of key policy and programmatic issues and broader issues impacting the lives of migrant and seasonal farmworkers and their families.

The MSHS Study has two components: a Program/Center component and a Classroom, Family, Child component that are based on distinct samples. The first component is off-site and consists of mailed surveys that will be sent to the universe of MSHS program directors and a representative subset of center directors to provide information on program and center operations. The second component consists of onsite data collection - including classroom observations, surveys with teachers and assistant teachers, parent interviews, teacher and parent child reports, and direct child assessments - with a nationally-representative sample of centers, classrooms, families and children.

Once data are collected, the study will address a set of research questions that can be summarized into three broad categories: (1) What are the characteristics of MSHS programs, families, and children? (2) What services do MSHS programs provide, what instructional and language practices are used, and what is the quality of MSHS classrooms? and (3) What are the associations between MSHS characteristics and child/family well-being?


Eligibility Criteria:
Inclusion Criteria:

* infants, toddlers, and preschoolers in participating Migrant and Seasonal Head Start centers/classrooms across the U.S. and their teachers and parents. Also includes center directors and program directors.

Exclusion Criteria:

-
Lupus Landmark Study: A Prospective Registry and Biorepository

The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).

This is a multicenter registry and biorepository conducted in the United States (US) and Canada. The registry will enroll over 3500 individuals with SLE over the course of five years into one of following four cohorts:

* New Onset: individuals with a new diagnosis of SLE
* Active Lupus Nephritis: individuals with a recent diagnosis of LN
* Extra-Renal Lupus Flare: individuals who have experienced a recent flare
* Prevalent Cases: individuals with lupus who do not meet the criteria for one of the other cohorts

The registry data will include but is not limited to: patient demographics, medical history, clinician-reported outcomes (ClinROs), patient-reported outcomes (PROs), social history and determinants of health, and environmental exposures. Participants will also be asked to allow access to their medical records.

Biological samples, including whole blood, urine, saliva, stool and tissue will be collected throughout the study. These biospecimens will be used for a broad range of analyses, including genetics, genomics, proteomics, biomarker discovery and microbiome profiling.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and comply with study procedures and voluntarily sign a written informed consent document
* Age 18 years or older at the time of enrollment
* Fulfill criteria for SLE based on one or more of the following classifications systems:

Systemic Lupus Erythematosus International Collaborating Clinic (SLICC) 2012 criteria; European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 criteria; 1997 revised ACR criteria; or Lupus is present per clinical assessment.

Exclusion Criteria:

* Not able to obtain consent
* Not able to meet protocol visit requirements
* Pregnant at the time of enrollment
Evaluation for NCI Radiation Oncology Branch Clinical Research Protocols

Background:

-This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols.

Objectives:

-To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.

Eligibility:

-Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.

Design:

-This is a screening protocol. No investigational treatments will be administered on this protocol.

Background:

-This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols.

Objectives:

-To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.

Eligibility:

-Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.

Design:

-This is a screening protocol. No investigational treatments will be administered on this protocol.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.

Patient or guardian is able to provide informed consent.

EXCLUSION CRITERIA:

Candidates who do not meet the inclusion criteria.
We-INtervention Among Chinese HIV-serodiscordant Male Couples

HIV-serodiscordant male couples, in which one male partner is HIV-seropositive and the other is HIV-seronegative, experience multiple risks in HIV care and prevention. As stigma often hinders such couples' access to support and services, leveraging their relational resources is crucial for optimizing their outcomes. The proposed study will assess the efficacy of the three-session We-INtervention focusing on their relationship dynamics to enhance Chinese HIV-serodiscordant male couples' health and well-being.

A total of 160 Chinese HIV-serodiscordant male couples (320 individuals: 160 HIV-seropositive and 160 HIV-seronegative) will be randomized at a 1:1 ratio to either the intervention or control arm. In the intervention arm, the We-INtervention will be delivered to both partners of each couple separately. In the control arm, each couple will receive health information pamphlets.

A pilot randomized controlled trial has already demonstrated the feasibility, acceptability, cultural sensitivity, and preliminary efficacy of the We-INtervention in improving the quality of life, psychological well-being, relationship satisfaction, and health behaviors of both partners in HIV-serodiscordant male couples. The proposed randomized controlled trial will extend the pilot study to examine the effects of the We-INtervention on stigma perception and other HIV-related behavioral outcomes, the mediators that account for the intervention effects, and the conditions under which the intervention is most effective.

The We-INtervention, if found to be effective, will be a valuable supplement to existing medical care modules.

Eligibility Criteria:
Inclusion criteria:

1. both partners are male,
2. both partners are aged 18 or above,
3. both partners report being in a committed relationship for at least 3 months,
4. one partner is HIV-seropositive and the other partner is HIV-seronegative (i.e., serodiscordant couple),
5. both partners have disclosed their serostatus to each other, and
6. both partners are willing to participate in this study.

Exclusion criteria:

1. either partner is unable to complete the assessment due to a low education level or to physical or psychological constraints and
2. either partner has been diagnosed with another chronic disease (e.g., cancer and coronary heart disease).
Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life

Some patients with dry eye may have severe disabling neuropathic pain. They describe spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an important discordance between the high intensity of the symptoms and the poverty of the clinical signs. These pains are often unrecognized and therefore often not sufficiently treated. A significant impact on patient's quality of life may occur. The concept of ocular neuropathic pain being relatively recent, few studies have focused on the subject at present. Our study aims to shed light on these pains in patients consulting for dry eyes at the Ophthalmological Foundation A. de Rothschild.

The objective of our study is to describe precisely the characteristics of neuropathic eye pain and the visual, general and psychological repercussions in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older,
* Presenting at least one of the following symptoms: spontaneous pain, burning sensation in eye, dysesthesia, allodynia, hyperalgesia
* French language-skills

Exclusion Criteria:

* Severe corneal or palpebral damage explaining current pain
Compare the Effect of Aliskiren Plus Valsartan Versus Angiotensin-Converting Enzyme Inhibitor (ACEi) Plus Angiotensin Receptor Blocker (ARB) [Ramipril Plus Telmisartan] on the Renin-Angiotensin-Aldosterone System (RAAS) in Hypertensive Patients

This study is designed as a mechanistic study to compare the effect of two different combinations of anti-hypertensive treatments (aliskiren and valsartan vs. telmisartan and ramipril) on the renin-angiotensin-aldosterone system (RAAS) in patients with moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of non-childbearing potential, 18 to 65 years of age with moderate hypertension
* Patients who are eligible and able to participate in the study

Exclusion criteria:

* Severe hypertension or secondary form of hypertension.
* Serum potassium \> 5.1 mEq/L (mmol/L)
* Heart failure
* Any history of hypertensive encephalopathy or cerebrovascular accident; any history of TIA, myocardial infarction, coronary bypass surgery or percutaneous coronary intervention
* Uncontrolled or life-threatening arrythmia

Other protocol-defined inclusion/exclusion criteria may apply
Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion

This multicenter registry study, which record the therapy strategy and follows up these acute ischemic stroke (AIS) patients with low NIHSS and large vessel occlusion (LVO), is intended to provide the important data for therapy evaluation and prognostic prediction of the LVO patients with low NIHSS.

It was reported that about two third of the stoke patients might present with minor or mild stroke symptoms. 20-40% of those minor stroke patients had large vessel occlusion (LVO). AIS patients with LVO and low NIHSS are common and has been associated with early neurological deterioration and worse outcomes. Until now, the best therapy strategy for the acute stoke patients with minor stroke and large vessel occlusion is unknown. Thus, we sought to (1) explore the potential predictors of acute neurological deterioration and 90-day clinical outcome; (2) and evaluate the best therapy strategy.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older
2. Acute ischemic stroke patients of NIHSS 0-5 with 24 hours after onset
3. Proximal intracranial artery occlusion on NCCT/CTA or MRI/MRA showing occlusion of the intracranial ICA, M1, or proximal M2 vessel
4. Baseline ASPECTS ≥6 or infarct Core Volume of \< 70 on NCCT/DWI/CTP
5. Pre-mRS≤1

Exclusion Criteria:

1. Any sign of intracranial hemorrhage on baseline CT/MR;
2. Seizures at stroke onset
3. Baseline blood glucose of \<2.78 mmol or \>22.20 mmol, or platelet count \< 100,000/uL or serum creatinine levels \> 3.0 mg/dL
4. Participation in any investigational study in the previous 30 days
Stool Ritual: Impact on the Number of Nights Without Stools Among Dependent Residents in Institutions for Dependent Elderly People

As they age, the intestinal elimination function can be altered by external factors. Sleeping is also a vital need for maintaining health. Sleep time varies with age (from 18h / day for an infant to 7h30 on average for an adult) and sleep disorders increase with age (INSERM source). In our study, the night is from 9 pm to 7 am, corresponding to the working hours of the night shift. Between 42% and 50% of episodes of wakefulness of more than 4 minutes in EHPAD are due to noise, light or the practice of care related to incontinence. 87% of all incontinence care practices have been associated with wake-up episodes. A personalized day care program would allow residents to improve the quality of their sleep by minimizing stools at night and therefore interventions by caregivers.

The ritual of stools, can be defined as the set of rules to observe to defecate in good physiological, physical conditions:

* Be in a suitable place for intestinal elimination: personal bathroom preferably on the toilet or on a pierced chair that will perhaps be more secure and comfortable with the armrests. The position to be taken is important.
* Propose a small bench to put under the feet to raise the knees higher than the hips and increase the abdominal pressure.
* Preserve the visual and auditory intimacy of the resident at the time of defecation. Failure to do so may result in the person repressing his desire to defecate.
* Allow the resident the time needed on the toilets the doorbell at hand and with the assurance that the caregiver will come back in a short time. Do not press it and do not forget it, privilege the autonomy and check that there is toilet paper.

The establishment of the stool ritual is not intended to reduce the amount of stool by day, but it aims to postpone the nighttime exemption on the day, and does not prevent the stool emission to other times of the day or night.


Eligibility Criteria:
Inclusion Criteria:

* Dependent elderly people living in institutions for elderly dependents.
* GIR 1 or 2
* Residents being able to sit in a seated position on a pierced chair or a safe toilet.
* Residents who have lived in the institution for at least 1 month in order to limit the biases due to the change of place of life

Exclusion Criteria:

* Residents with the physical and cognitive abilities to go to the toilet alone wisely.
* Residents with stomies
* Residents with a history of intestinal occlusion
* Residents participating in another study.
* Residents under guardianship or safeguard justice
Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Chemotherapy

This trial compares the pharmacokinetics of palonosetron administered subcutaneously and intravenously.

5-Hydroxitryptamine3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. Nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous palonosetron.Patients receiving platinum-based chemotherapy will be randomized to receive palonosetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of subcutaneous and IV palonosetron will be prospectively compared.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients receiving platinum-based chemotherapy adequate bone marrow, hepatic and renal function

Exclusion Criteria:

* Pregnancy
* Serious concomitant diseases, in the invesgator´s criteria
Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations

This is an international, mulitcentre, observational, prospective study into Peak Inspiratory Flow in COPD patients that aims to: A) Determine the prevalence of suboptimal Peak Inspiratory Flow (PIF) and inadequate inhaler choice and assess the baseline characteristics of these groups. B) Assess the clinical role of PIF and inhaler choice in predicting COPD exacerbations and symptom burden. C) Assess the variability and correlation of PIF with other lung function measurements and CAT score in stable COPD. It is a 12 month study comprising one baseline assessment and 2 follow-up visits at 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Spirometry-defined COPD (i.e. post-bronchodilator FEV1/FVC\<0.7)
2. Age ≥40 years
3. Smokers or ex-smokers of at least 10 pack-years
4. Clinically stable COPD (no exacerbations in the last 4 weeks)
5. Capable of performing serial lung function tests
6. Prescribed inhaled medication for at least 6 months

Exclusion Criteria:

1. Occurrence of an COPD exacerbation during the previous 4 weeks
2. Have any concomitant chronic respiratory condition other than asthma or bronchiectasis (e.g. cystic fibrosis, lung fibrosis, tuberculosis)
3. Are unable to understand the instructions of the study or to fill the questionnaires
4. Are unwilling to sign the informed consent
5. Are participating in a clinical trial
Pre- and Post-operative Brain MRI in Carotid Endarterectomy

Patients undergoing carotid endarterectomy in the Department of Vascular Surgery at Oslo University Hospital are consecutively included in this evaluation og pre- and postoperative brain MRI.

Patients undergoing surgery for carotid stenosis in our Department are examined by brain MRI before and after carotid surgery to evaluate the rationale for the MRI. Brain lesions on MRI before and after carotid surgery are registered, and related to clinical findings. The purpose of the study is to evaluate whether brain MRI in relation to carotid endarterectomy gives additional information to clinical findings, and to CT scan of the brain.

Eligibility Criteria:
Inclusion Criteria:

* Indication for carotid surgery

Exclusion Criteria:

* Contraindications to MRI