rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Sequential Administration of WJ-MSCs for the Treatment of GvHD Refractory to Second Line Treatment
Status: Not yet recruiting

Hematopoietic stem cell transplantation (HSCT) is the treatment of choice for malignant hemopathies, but highlights the limitations of long-term results due to the high toxicity of the procedure and the development of Graft versus Host Disease (GVHD). Conventional treatments for GVHD have limited success rates, and some patients may be refractory to ruxolitinib, a second-line treatment option. As a result, there is a need to explore alternative immuno-modulatory therapies, such as the use of Wharton's jelly mesenchymal stem cells (WJ-MSCs).

The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population. This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Aged between 18 and 65 years. With a diagnosis of malignant hemopathies, who have undergone allogeneic HSCT and who are diagnosed with acute GVHD refractory to second-line treatment. Patients who have received bone marrow and/or peripheral blood as a source of cells. Patients who have received cells from a family or unrelated donor Myeloablative or non-myeloablative conditioning method. Adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure, angor pectoris, or acute myocardial infarction in the 6 months prior to the process. Adequate lung function without evidence of severe obstructive or restrictive lung disease. Informed consent signed by the patient.  Exclusion Criteria:  Patients from the Transplant Unit of the FOSCAL. Patients with a diagnosis of hemopathy that has not been controlled by the transplant or is progressing at the time of treatment. Bacterial, viral, or fungal infection that is not being controlled with adequate treatment. Cardiac and/or pulmonary function in uncontrolled altered conditions. According to medical criteria, patients who are not in an adequate situation to tolerate the treatment. Pregnant women or women at risk of pregnancy due to inadequate contraceptive measures. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
Status: Recruiting

Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS). The prevalence of opioid use during pregnancy has increased by 333% from 2013 to 2014 and continues to rise. Approximately 1 in 3 women were prescribed opioids during pregnancy from 2008 to 2012. In the US, NAS was diagnosed every 25 minutes in 2014. By 2019, it became every 15 minutes. Although there are medication-based interventions for the treatment of NAS, used in up to 80% of opioid-exposed infants, these treatments carry risks of toxicity and drug interactions. Despite the steep medical costs and the risks of treatment, current tools to assess the severity of NAS are subjective and suffer from examiner bias, resulting in poorer clinical outcomes, such as longer lengths of stay in the Neonatal Intensive Care Unit (NICU), for these babies. Studies have shown that continuous vital sign monitoring improves outcomes and decreases the length of stay in general practice. Preliminary machine learning models have been able to predict pharmacological treatment for Neonatal Opioid Withdrawal Syndrome (NOWS). This project will collect physiological and behavioral data of NAS patients to develop an AI algorithm and establish the advantages of continuous monitoring in NAS. The AI algorithm, processed by machine learning, will help predict NAS symptoms, automate scoring, and provide healthcare personnel with predictive analytics to guide suggested treatments.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The subject selection criteria per site will be 80% term neonates affected by neonatal abstinence syndrome (NAS) and 20% term neonates without any health complications. The eligible screening process for the NAS neonates in the study will include neonates affected by NAS, newborn infants diagnosed with NAS, infants with confirmed history of prenatal exposure to opioids or other drugs that can cause NAS, and infants who meet specific diagnostic criteria for NAS based on standardized clinical assessments. The eligible screening process for neonates without any health complications include newborn infants without any known health complications or medical conditions, infants with a normal physical examination and absence of clinical signs or symptoms suggestive of NAS or other health issues. Given the simple nature of the study, wards of the courts will also be enrolled upon evaluating the appropriateness, identifying an advocate if required, and providing an approved consent for the ward subject.  Exclusion Criteria:  The investigators are NOT purposefully excluding or including any gender or race in our studies. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MaximumAge: 4 Weeks - StdAgeList: Child - StudyPopulation: NAS affected neonates and healthy neonates. - SamplingMethod: Non-Probability Sample
Bilateral or Unilateral Cerebellar Deep Brain Stimulation for Chronic Post-stroke Motor Rehabilitation
Status: Recruiting

Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. We hypothesized that bilateral stimulation was superior to unilateral stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 12-36 months before surgery. Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42 Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).  Exclusion Criteria:  Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) Severe cognitive impairment (Mini Mental State Examination < 24) - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Effect of Oral Enteral Nutrition Feeding in Parkinson Disease
Status: Not yet recruiting

The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.

Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >18 years. Meeting the diagnostic criteria for Parkinson's disease. Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study. Water swallow test> Level 3. Stable vital signs, conscious, able to cooperate with assessment and treatment.  Exclusion Criteria:  Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases. Complicated with cognitive impairment or consciousness dysfunction. Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. Complicated with severe liver and kidney failure, tumors, or hematological disorders. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Pilot Study of 11C-M503
Status: Recruiting

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). We will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (non-clinical site) Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients in all cohorts will be male or female adults from 40 to 85 years of age. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures or Participants who are deemed unable to provide informed consent must have a designated study partner present for consent and to accompany them to study visits We will ask PD/MSA/PSP participants to agree to brain donation but this choice is not mandatory for participation in this study. Diagnosis-specific inclusion criteria: Clinical diagnoses will be determined by consensus committee for diagnostic agreement (PD, MSA, PSP or Healthy Control)  Exclusion Criteria:  Females who are pregnant or breast feeding will be excluded, a urine pregnancy test will be performed in women of child-bearing potential prior to injection of 11C -M503, 11C-PiB or 18F-Florbetaben Forms of parkinsonism other than PD, PSP and MSA as defined above Major psychiatric disorder (e.g. schizophrenia or bipolar disorder) - major depressive disorder is allowed History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician Contraindication to MRI, such as non-compatible implanted medical device Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
How Traditional Chinese Medicine Exercise Improves Parkinson Disease
Status: Not yet recruiting

The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >60 years. Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.  Exclusion Criteria:  Complicated with cognitive impairment or consciousness dysfunction. Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. Complicated with severe liver and kidney failure, tumors, or hematological disorders. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
How Acupuncture Therapy Improves Dysphagia in Parkinson's Patients
Status: Not yet recruiting

We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >18 years. Meeting the diagnostic criteria for Parkinson's disease. Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study. Water swallow test> Level 3. Stable vital signs, conscious, able to cooperate with assessment and treatment.  Exclusion Criteria:  Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases. History of mental diseases or use of antipsychotics. Complicated with cognitive impairment or consciousness dysfunction. Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effect of Computer-based Cognitive Function Training on Cognitive Dysphagia After Stroke
Status: Not yet recruiting

This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years. Meeting the diagnostic criteria for traumatic brain injury, confirmed by magnetic resonance imaging. Montreal Cognitive Assessment score < 26 and > 18 (adjusted by 1 point if the educational level is high school graduation or above). Confirmed swallowing disorder through Fiberoptic Endoscopic Examination of Swallowing. Duration of illness greater than three months. Patients or their family members are aware of and consent to participate in the study.  Exclusion Criteria:  Presence of other intracranial lesions, such as stroke. Cognitive impairment caused by other diseases. Mental abnormalities. Inability to complete treatment and assessments due to other impairments. Concurrent severe injuries. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
How Active Breathing Training Improves Dysphagia in Elderly People
Status: Not yet recruiting

The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age over 60 years old. No hospitalization within the past six months. With clear consciousness and able to cooperate with questionnaires and training. The elderly people who voluntarily participate and agree to adhere until the end of the study.  Exclusion Criteria:  Complicated with severe liver and kidney failure, tumors, or hematological disorders. Physical disability. Difficulty in mobility. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective
Status: Not yet recruiting

The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must identify as Hispanic/Latino/a descent Have an adolescent between the ages of 15 and 17 years old living in their home a majority of the time Have English or Spanish proficiency  Exclusion Criteria:  Adolescent or parent currently in opioid treatment Parent self-reports a substance use (including opioid use) disorder for themselves or adolescent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Combining a Smartphone App With Medications to Manage Heavy Drinking
Status: Not yet recruiting

One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  To be eligible, Veterans must be:  1) diagnosed with an AUD and report 4 HDD  (defined as 5 standard drinks per day for men and 4 standard drinks per day for women) in prior 30-days 2) enrolled in VA primary care 3) planning to initiate MAUD, as determined by a medication order 4) between ages 18-80 5) willing to be randomized 6) Android or iPhone smartphone owners  Exclusion Criteria:  1) past 30-day participation in VA or non-VA SUD treatment 2) prior episode of MAUD receipt in the last 30 days (initiation of a new episode of MAUD in the 7 days prior to screening allowed) 3) plans to be or are pregnant 4) severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol, as determined by the referring provider. Veterans aged >80 were excluded because ownership and use of mHealth apps decreases with advancing age. Participants who enter SUD specialty care following randomization will be allowed to continue in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Evaluating the Practice Resource for Driving After Stroke
Status: Recruiting

After stroke, individuals must be assessed to determine if they can resume driving. Return to driving is very important to people who have experienced a stroke. Unfortunately, health care providers face challenges in addressing driving after stroke. Common issues include being unsure of the best screening practices, difficulty discussing driving with patients, and challenges making informed recommendations about driving that balance the risk of public safety along with supporting patient goals. Occupational Therapists (OTs) are health care providers that provide screening, assessment, and intervention for driving to individuals who have had a stroke. OTs working in stroke care have highlighted the urgency for evidence-based resources to support practice to address driving with patients. The Practice Resource for Driving After Stroke (PReDAS), is an evidenced-based resource to support the clinical practice of OTs in addressing driving in acute stroke settings. A previous pilot study has demonstrated that the PReDAS is considered useful by both health care providers and patients. Further study is needed to evaluate how the PReDAS can support OTs in addressing driving with patients. The current study proposes to provide the PReDAS as an intervention to OTs working in acute stroke settings to see if the intervention increases OT's self efficacy and clinical reasoning for addressing driving. The study will take repeated measures of self-efficacy and clinical reasoning among participating OTs to determine if the PReDAS intervention supports improved self-efficacy and clinical reasoning.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Occupational therapists are eligible to participate if they currently practice on an acute stroke unit.  Exclusion Criteria:  To avoid threats to treatment fidelity, occupational therapists are ineligible to participate if there is already a participant enrolled from their local workplace (same physical building), or if they have viewed a copy of the PReDAS previously. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult