cyrilzakka/clinical-trials huggingface dataset:
Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers

The investigators will compare a dyadic intervention (Recovering Together) with an attention placebo educational control in dyads of patients with acute neurological illnesses and their caregivers at risk for chronic emotional distress. The primary aim of this study is to determine the feasibility, credibility, and satisfaction with Recovering Together. The second aim is to show proof of concept for sustained improvement in emotional distress, post traumatic stress (PTS), resiliency and interpersonal communication outcomes in patients and caregivers.

The investigators aim to improve the care of patients (pts) admitted to the Neuroscience Intensive Care Unit (NICU) and their family caregivers (cgs) by conducting a pilot feasibility randomized controlled trial (RCT; N=80 dyads; 60 completers) of the dyadic resiliency program ("Recovering Together") to prevent chronic emotional distress in both pts and their cgs. Eligible dyads include adult, English speaking pts with acute neurological injury (ANI) admitted to the NICU, cleared medically and cognitively for participation by the nursing team, and their primary cgs. Dyads who are randomly assigned to "Recovering Together" will receive 6 manualized sessions (2 in person at hospitalization and 4 through live video after discharge, to reduce burden and facilitate access to care) led by a clinical psychologist. Dyads who are randomly assigned to the attention placebo educational control condition will receive 6 manualized sessions (2 in person and 4 through live video with a clinical psychologist), modeled after the Recovering Together program that will control for the dose of the intervention and support from therapist. Dyads will complete assessment surveys before, after the intervention and 3 months later. Clinical data on demographics, diagnosis, ANI severity, and any medical complications will be extracted from electronic health records.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, 18 years or older
* English fluency and literacy
* Access to high speed internet for video sessions
* Patient with an informal cg (family or friend who provides unpaid care) available and willing to participate
* Hospitalized with an acute brain injury within 1-2 days when first approached, OR the primary caregiver of a patient currently admitted with an acute brain injury
* Either patient or caregiver within the dyads screens in for depression, anxiety, and/or PTSD

Exclusion Criteria:

* Permanent or severe cognitive impairment severe enough to impede participation - This will be determined by nurses through an assessment conducted as part of usual care (MMSE).
* Dyads where the patient is anticipated to die or to never be able to participate due to medical sequelae.
Longitudinal Follow Up of Subjects Enrolled in Randomized Trial of Prenatal and Infancy Home Visitation

The Elmira follow-up study is designed to assess the extent to which prenatal and infancy home visitation by nurses affects the life-course development of 19-year-old youth whose mothers received those services during pregnancy and the first two years of the child's life.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women prior to the 25th week of gestation
* no previous live births
* one of the following sociodemographic risk characteristics:

  * young age (\< 19 years at registration);
  * unmarried
  * low socioeconomic status (Medicaid status or no private insurance)
Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent

The HEPAFIT Study aims to examine whether a 6-months physical education program has benefits on hepatic metabolism and cardiovascular health as well as on selected physical fitness and mental health outcomes among adolescent overweight/obese from Bogota, Colombia.


Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity status
* 11-17 years old
* Written informed consent
* Interested in improving health and fitness

Exclusion Criteria:

* Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
* Clinical diagnosis of diabetes
* Pregnancy
* Drugs/alcohol abuse
Placental Volume Analysis During Pregnanay

Placenta grows with advancing gestational age amonitoring of placental growth is important in pregnancy evaluation

assessment of placental size is very important in evaluating the pregnancy Placenta is one of the most important organs that control pregnancy outcome

Eligibility Criteria:
Inclusion Criteria:

* pregnant ladies between 20 - 40 years old
* ladies pregnant from 14 weeks till term

Exclusion Criteria:

* pregnant ladies in first trimester
Language and Motricity in Preterm School Age Children

A total of 40% of neurodevelopmental difficulties have been reported in very premature infants less than 32 weeks of age. The Epipage1 study reported a decreasing prevalence of cerebral palsy (9-6%) but a high prevalence of specific cognitive neurological difficulties and an increase in school failure.

Neurocognitive difficulties are numerous: visuospatial dyspraxia, language disorders, executive function disorders as well as attention and behaviour disorders. Developmental language disorders have been rarely reported in the literature. This originally prompted our request i.e. PHRC 2010 National Multicenter: LAMOPRESCO. For the past 3 years this protocol has studied the language development of children who were born very prematurely, aged 3 and a half years free of cerebral palsy, in particular the impact of a short rehabilitation period, precise, at an early stage, and protocolized on a fundamental sensorimotor language. The principal assessment criterion was the measurement of phonology, the cornerstone of oral and written language in humans. The aim of the present project is an analysis of the effect that this specific language stimulation has on the learning of written language. The hypothesis is that a specific work modifying various aspects of a child's language, during the age of 3 to 4, alters the development of phonological skills in a sustainable way. The acquisition of reading skills is basically dependent on the quality of its phonological components. The randomized study of children up to 8 years of age in a cohort of 150 children (LAMOPRESCO) will permit to confirm or refute this hypothesis. These increasing difficulties have been reported as regards the language understanding of 3 to 15 year old children. It is as if the initial difficulties and weaknesses, which moreover constituted oral language, prevented the use or development of neural networks, which became more complex and required both an oral and written language. Are these elements which constitute phonology, at an early stage, modifiable before the close of the clinically measurable developmental window?


Eligibility Criteria:
Inclusion Criteria:

* Randomization in LAMOPRESCO-1 study

Exclusion Criteria:

* None as the same population as in the LAMOPRESCO study will be included
Leaving Care - a Comparison Study of Implementation, Change Mechanisms, and Effects of Transition Services for Youth Leaving Out-of-home Care

The purpose of this project is to increase understanding of the development, implementation and effectiveness of interventions for young people transitioning from societal care to independent living. The project examines the effect of interventions and how change mechanisms relate to a range of outcomes.

The purpose of this project is to increase the empirical understanding of the development, implementation and effectiveness of interventions for young people transitioning from societal care to independent living. The project examines the effect of interventions and how change mechanisms relate to a range of outcomes. In a pilot project, the investigators developed an intervention in collaboration with municipal social workers, section heads and organizational developers. In another pilot project, the investigators studied whether the content of empirically tested interventions in the USA can be generalized to a Swedish context. These two projects have resulted in a Swedish intervention: My choice - my way! Previous research shows that young people who are placed in social care are a particularly vulnerable group. Swedish social places little attention to what happens to prepare young people for leaving care. There are currently no interventions in Sweden that have empirical support of their effectiveness for this group. The aim of the project is to develop practical and empirical understanding of how interventions for young people placed in societal care in Sweden can be developed and implemented. The project takes place in close collaboration with municipalities and other youth serving organizations. Short-term, long-term and implementation effects are investigated by comparing My choice - my way! with usual services. The comparisons will shed light on practice components and change mechanisms related to outcomes and thus important to take into account in the future development of interventions. The outcomes will shed light on a range of self-reported outcomes, as well as register-based outcomes such as education, employment and crime. The analyses also include health economic outcomes. In addition, the attitudes of social workers and youth and organizational implementation initiatives will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Living in out-of-home care
* 15 years or older

Exclusion Criteria:

* none
Post-treatment Care of Breast Cancer Survivors

The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women.

The proposed investigation is a randomized prospective evaluation of a Survivorship Intervention in improving the quality of care, treatment satisfaction and understanding of care in Latina and Caucasian breast cancer survivors treated in an urban academic medical center. Patients will be recruited within 6 weeks of completing their last definitive breast cancer therapy (radiation or chemotherapy). Patients will complete self administered baseline and follow-up questionnaires. Following baseline evaluation patients will be randomized to receiving either written information for follow-up care of cancer survivors published by the National Cancer Institute (Facing Forward), or the Survivorship Intervention. Patients will not be aware that they are participating in a randomized intervention. After verbally agreeing to participate they will be randomized to group A or B and will receive the corresponding consent. Patients will be re-assessed 3 and 6 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be screened for the following inclusion criteria:
* Age \>18 years
* History of stage 0, I, II, or IIIa breast cancer and no evidence of recurrent disease
* Within 6 weeks of completion of breast cancer therapy (Surgery, Radiation or Chemotherapy)
* Caucasian and/or Hispanic (English or Spanish-speaking)
* Willing to undergo a 1 hr cancer survivorship evaluation

Exclusion Criteria:

* Patients with the following active conditions or behaviors will be excluded from participation:
* Evidence of recurrent or metastatic breast cancer
* Patients who have received surgery only with no adjuvant therapy
* Uncontrolled or significant psychiatric illness/social situations that would preclude completion of questionnaire or follow-up evaluation.
A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy

A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.

In patients with advanced NSCLC to compare the added benefit of High Dose Rate Intraluminal Brachytherapy (HDRIB) with External Beam Radiation (EBR). Benefit will be assessed by measuring the proportion of patients who achieve symptomatic improvement in lung cancer symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Cytologic or histologic proof of non-small cell lung cancer (NSCLC)
* Stages III, IV or recurrent disease
* Documented endobronchial luminal disease by either endoscopy or CT-imaging
* Candidate for palliative thoracic radiation therapy because of cough, shortness of breath or hemoptysis

Exclusion Criteria:

* Age less than 18 years of age
* Uncontrolled or symptomatic brain metastases
* Anticipated survival of less than 3 months
* Systemic therapy planned to begin within 6 weeks following randomization
* Systemic therapy within 4 weeks of planned study randomization
* Any prior radiotherapy involving the lungs
* Cardiac arrest or myocardial infarction within 6 months prior to study randomization
* Inability to receive sedation or undergo invasive procedures due to severe chronic obstructive pulmonary disease (COPD), bleeding disorders, or other medical conditions which will preclude the use of HDRIB
* Pregnancy, lactation, or failure to use dual-method contraception in pre-menopausal women
* Unwillingness or inability (e.g. incompetence, severe psychiatric disorders) to complete informed consent and the baseline QoL assessments required for the trial
* Having received an investigational agent within one month of study randomization
* Inability to attend regular follow-up evaluations due to psychiatric or addictive disorder or geographic inaccessibility
Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP)

The goal of this clinical study is to examine the effectiveness of the Cognitive Orientation to daily Occupational Performance (CO-OP) in adults (45+) with accuired brain injury when applied in Danish rehabilitation context. The primary research question is: What is the effectiveness of the CO-OP approach on improvement of performance of daily activities (ADL) and quality of life compared to usual rehabilitation practice.

Participants in the intervention group will recieve the CO-OP intervention as part of their rehabilitation in the following phases:

Initial phase: Goalsetting is mandatory and based on the participant's prioritized ADL performance issues identified in their baseline COPM. Education phase: Individual education in the metacognitive Goal-Plan-Do-Check strategy. Training phase: CO-OP training that involves repetitive use of the Goal-Plan-Do-Check for problem solving and skill acquisition. The therapist employs dynamic performance analysis and guided discovery to help participants understand performance issues and formulate plans for achieving their goals. Participants then execute and evaluate these plans, with a focus on developing domain-specific cognitive strategies. The therapist actively encourages generalization and transfer of skills. Homework is mandatory.

Participants in the control group will recieve usual rehabilitation practice in the following phases:

Initial phase: Goalsetting is optional and may be based on previous assessment or on a conversation with the participant. Training phase: Different approaches may be taken such as observation and practice of activities or consultation about performance issues and how participants may deal with them. The therapist may guide the participant's performance verbally, physically or trough picture materials. Homework may be included.


Eligibility Criteria:
Inclusion Criteria:

* Stroke or traumatic brain injury
* Reffered from acute hospital or specialized rehabilitation units to municipal rehabilitation
* Having at least on ADL performance issue

Exclusion Criteria:

* Dementia, Psychotic diagnoses, commotio, Brain tumor or degenerative neurological conditions.
* Alkohol or drug abuse
* Not speeking or understanding Danish
Exploratory Study of PD-1 Neoadjuvant Treatment of Recurrent Meningioma

This research study is studying a drug as a possible treatment for High Grade Meningioma.

Meningioma is one of the most common primary intracranial tumors, accounting for 13% to 26% of all intracranial tumors. Although most meningiomas are benign tumors and can be cured by surgical resection, more than 20% of WHO II (atypical) and about 3% of WHO III meningiomas are more likely to have local recurrence after initial treatment , And the lifetime is poor. The immunotherapy represented by PD-1 has achieved remarkable efficacy in the treatment of solid tumors, but the application of PD-1 in recurrent meningioma is rarely reported. The study found that the expression of PD-L1 mRNA and protein in high-grade meningioma cells increased, and the total number of T cells, including CD4+ and CD8+ cells, was significantly reduced, suggesting an inhibitory tumor immune microenvironment. Recent studies have shown that giving patients anti-PD-1 antibody immunotherapy prior to conventional treatment can improve the pathological response, enable the body to produce an enhanced and sustained anti-tumor immune response, and form a tumor microenvironment conducive to immunotherapy. Therefore, giving PD-1 antibody before surgery is a new idea for the treatment of meningiomas. This project aims to investigate whether patients with recurrent meningioma will change their immune function and prolong survival after preoperative PD-1 antibody treatment. It is planned to use flow cytometry, multiple immunofluorescence histochemistry technology, T cell receptor sequencing, etc to detect the changes in the patient's immune function before and after treatment, observe the pathological remission rate of PD-1 monoclonal antibody neoadjuvant treatment of recurrent meningioma, and identify potential response biomarkers, and conduct in-depth discussions on this treatment plan to further determine the treatment mode Clinical value and specific mechanism of action in order to improve the clinical treatment level of patients with recurrent meningioma.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed as a patient with WHO grade III recurrent meningioma
* Age ≥ 18 years
* Kps≥70
* able to accept second surgery
* ECOG Performance Status \< 2
* Glucocorticoid dosage dexamethasone ≤5mg/ day or equivalent dose

Exclusion Criteria:

* Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days of protocol treatment, or those who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier.
* Participants who are receiving any other investigational agents.
* Participants who have a diagnosis of an immunodeficiency.
* Requires treatment with high dose systemic corticosteroids defined as dexamethasone \>2mg/day or bioequivalent within 7 days of initiating therapy.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Unable to undergo brain MRI.
The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines

This study will be conducted in Phase I/II clinical trials. In Phase I, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. Safety is assessed after 12 weeks. In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter, efficacy and safety are assessed by comparing with BOTOX®.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 19 to 65 years old
* Subjects attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown
* Fertile women who have properly agreed to contraception during the clinical trial period
* Subjects who voluntarily sign the informed consent

Exclusion Criteria:

* Subjects who answered 'Yes' any of the C-SSRS questions (only Phase I)
* Subjects with the general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome)
* Subjects who suffer from muscle weakness or paralysis in the forehead area
* Subjects with infection, skin disorders, or scars at the glabellar region.
* Subjects with noticeable facial asymmetry
* Subjects with allergy or hypersensitivity to the botulinum toxin or their components
* Subjects who have taken Anti-Coagulant, Anti-Platelet agent, Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
* Subjects who were injected facial with botulinum toxin within the past 6 months or whose dose exceeds 200 U for the whole body
* Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in the glabellar region
* Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks of the screening date.
* A history of drug or alcohol abuse
* Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception
* Subjects who are not eligible for this study based on the judgment of an investigator
Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative DES

Dry eye disease (DED) is a multifactorial condition often exacerbated by cataract surgery, leading to discomfort and visual disturbances. Meibomian gland dysfunction (MGD), a key cause of DED, contributes to tear film instability, which can be managed with warm compress therapy.

This study aims to evaluate the effectiveness of perioperative warm compress therapy (TPT) in improving tear film stability and reducing dry eye symptoms following cataract surgery. This randomized controlled trial (RCT) will involve 54 patients with estimated attrition rate 60 participants aged 50-70 with moderate to severe dry eye symptoms and tear film instability, as indicated by high Ocular Surface Disease Index (OSDI) scores. Participants will be randomly assigned to either an intervention group, receiving warm compress therapy before and after surgery, or a control group receiving standard dry eye treatments for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 30 to 70 years
* Patients scheduled for cataract surgery (both unilateral and bilateral).
* Patients with preoperative moderate to severe dry eye symptoms, which will be assessed using the Ocular Surface Disease Index (OSDI).

Exclusion Criteria:

* Patients with OSDI, indicating severe dry eye disease which suggests severe dry eye disease. These patients might require more intensive treatments beyond Warm Compress therapy.
* Patients with systemic diseases (e.g., rheumatoid arthritis, lupus) that affect tear production or who are using medications that severely reduce tear production (e.g., chronic use of antihistamines or systemic corticosteroids).
* Patients with significant pre-existing corneal pathology (e.g., corneal dystrophies, corneal scars) that could affect the results of cataract surgery or thermal pulsation therapy.
* Patients with active ocular infections (e.g., conjunctivitis, keratitis) or inflammation at the time of screening or surgery.
* Patients with a history of previous ocular surgeries (excluding cataract surgery) in the study eye, such as refractive surgery (LASIK, PRK) or corneal transplants.
* Patients with a known allergy or contraindication to Warm Compress therapy or its components.