cyrilzakka/clinical-trials huggingface dataset:
Trauma Informed Guilt Reduction Therapy

The goal of this project is to determine if a 6-session psychotherapy intervention will help Veterans feel less deployment-related guilt and less distress related to their guilt. Half of the participants will receive the guilt focused intervention and half will receive a supportive intervention. A supplemental pilot study added in FY2021 will examine the intervention for pandemic-related guilt events.


Eligibility Criteria:
Inclusion Criteria:

* Participant Served in OEF/OIF/OND, has post-traumatic guilt related to deployment event (for pandemic supplement in 2021, has guilt related to pandemic event)

Exclusion Criteria:

* Moderate or severe cognitive impairment, acute suicidality, current severe substance use disorder, unmanaged psychosis or mania
Optical Tomographic Imaging of Infantile Hemangiomas

The investigators hypothesize that there are differences between infantile hemangiomas (IH) during the proliferating and involuting phases and in response to medical treatment that can be detected by optical tomography of these hemangiomas.

Infantile hemangiomas (IH) are common vascular growths that frequently arise in infants. The clinical presentation is variable, and some hemangiomas have the potential to cause disfiguring and even lifethreatening complications. While there is no FDA approved treatment for IH, certain medications have been shown to be effective in shrinking the growths. Unfortunately, there is no objective tool to monitor IH or to guide treatment. Such a tool would improve the management of these patients. A new handheld wireless device uses diffuse optical imaging (DOI) technology to measure blood flow characteristics.

The device has been used in studies to assess patients with breast cancer. Optical tomography has also been increasingly used to assess neurological function and pathology in newborn infants.

The goal of the investigators' study is to assess the utility of DOI for characterizing and monitoring IH. Fifteen IH will be assessed at three points in time as part of this study, comprising two groups: 'Natural History' and 'Treatment'. DOI measurements will be correlated with clinical findings and existing ultrasound measurements of the IH.

Eligibility Criteria:
For the 'Natural History' Cohort, the following inclusion and exclusion criteria apply:

INCLUSION CRITERIA:

* Infants with IH who present to our practices within the first 2 months of life.
* IH of size \> 2 cm in diameter
* IH located on area of skin that is accessible to contact by 4x2cm probe. Examples include the lateral face, forehead, scalp, trunk and areas of the extremities not overlying joints.

Infants with IH that do not necessitate either medical or surgical intervention at time of presentation.

EXCLUSION CRITERIA:

* IH of size \<2 cm in diameter
* Complicated IH requiring medical or surgical intervention
* IH located within 2 cm of the eye

For the 'Treatment' Cohort, the following inclusion and exclusion criteria apply:

INCLUSION CRITERIA:

* Infants with IH who present to our practices within the first 2 months of life.
* IH of size \>2 cm in diameter
* IH located on area of skin that is accessible to contact by 4x2cm probe. Examples include the lateral face, forehead,scalp, trunk and areas of the extremities not overlying joints.
* IH that necessitate medical intervention with either oral or topical betablockers.

EXCLUSION CRITERIA:

* IH \<2 cm in size
* Complicated IH requiring surgical intervention
* IH located within 2 cm of the eye
Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED

Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.


Eligibility Criteria:
Inclusion Criteria:

1. Age equal to 65 or greater
2. Pain onset within 7 days with severe pain
3. Has capacity to provide informed consent
4. Understanding English or Spanish

Exclusion Criteria:

1. Use of tramadol or opioids within 7 days
2. Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
3. Chronic pain syndrome: daily pain for \> 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
4. Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or severe dehydration
5. Alcohol intoxication
6. Systolic blood pressure: \< 100 mmHg
7. Heart rate: \< 60 beats per minute
8. Oxygen saturation: \< 95% on room air
9. Use of monoamine oxidase (MAO) inhibitors in the past 30 days
10. Use of transdermal pain patch or oral opioid \> 10 days in the prior month
11. Prior enrollment in the same study
Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort

Susceptibility to SPA has been shown to be largely genetically determined. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.

Susceptibility to SPA has been shown to be largely genetically determined but the contribution of environmental factors to disease evolution has not yet been elucidated. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.

Eligibility Criteria:
Inclusion Criteria:

* 18 years SPONDILARTHRITIS: modified New York criteria Systemic vasculitis: ACR criteria

Exclusion Criteria:

no internet access
Measurement of Grip and Pinch Forces Needed for Activities of Daily Living, Work and Prehistoric Stone Tool Production

Very little is known about the pinch and grip forces that are critical for activities of daily living (ADL) or work. Human success in evolution is a result of the combination of great brain power and great hand ability to accomplish with our hands what our minds can conceive. Prehensile grasp in hominins allowed tool production and today allows us to hold fine instruments to perform surgery or do heavy construction. The strength of our hands is matched against the requirements of the activities we need to perform. The hypothesis of this study is that many tasks have an inherent strength requirement that is independent of the person performing the task. Until recently, direct measurement of the forces has not been possible. Ultra thin sensors along with the software to interpret the information is now available to make this force determination possible. We have 3 primary objectives. The primary objective is to measure pressure distribution and resultant forces needed for 3 categories of ADL and 2 categories of work in normal subjects. The second objective is to perform a similar evaluation of patients with basilar thumb arthritis and after wrist fracture. The third objective is to measure pressure distribution and forces needed for tool production and use.

The study will measure pressures and forces for ADL and simulated work using healthy volunteers. Sixteen volunteers will be chosen over a range of ages but specifically include similar numbers of early adulthood (18-44), middle age (45-65), and elderly (\>65). Sixteen volunteers from each age group divided evenly by gender will be selected. Therefore, a total of 48 subjects will be tested, with an even number of male and female performing each of the activities listed above.

Inclusion Critera Volunteers will be recruited through website, personnel, and community contacts. They will be recruited based on age and gender.

Exclusion Criteria Patients will be excluded if they have a history of an inflammatory condition such as rheumatoid arthritis or lupus. They will be excluded if they have symptomatic osteoarthritis of their hands. Additional exclusion criteria will include known neurologic conditions, or prior injury that may be contributing to weakness or atrophy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* At least 18 years old
* Willing to participate in the study

Exclusion Criteria:

* History of an inflammatory condition such as rheumatoid arthritis or lupus
* Symptomatic osteoarthritis of their hands
* Known neurologic condition
* Prior injury that may be contributing to weakness or atrophy
Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

Perform a randomized comparison study of dual-antiplatelet (aspirin, prasugrel) and triple-antiplatelet (aspirin, clopidogrel, and cilostazol) preparation using P2Y12 assay in patients with high on-treatment platelet reactivity undergoing stent-assisted coil embolization for an unruptured intracranial aneurysm

Comparison between dual-antiplatelet and triple-platelet preparation

Eligibility Criteria:
Inclusion Criteria:

* patients with clopidogrel resistance (greater than 220 P2Y12 reaction units using VerifyNow)
* patients with unruptured intracranial aneurysms
* patients over 20 years old
* patients who can communicate with each other
* patients who agreed to this study (with informed consent)

Exclusion Criteria:

* patients with recurrent aneurysms after coiling or clipping
* patients with allergic reaction to antiplatelets
* patients with high risks of hemorrhage
* patients with coagulopathy
* patients with thrombocytopenia (\<100,000/mm3)
* patients with liver disease (\> 100 of aspartate aminotransferase or alanine aminotransferase)
* patients with renal disease (\> 2mg/dL of serum creatinine)
* patients with uncontrolled heart failure or angina
* patients with malignant tumor
* pregnant patients
* patients with past history that may associated with headache, including subarachnoid hemorrhage, head trauma, intracerebral hemorrhage, trigeminal neuralgia, arteriovenous malformation, brain tumor)
* Patients who are determined to be disqualified by researchers
Study of Safety and Dosing Effect on SMN Levels of Valproic Acid (VPA) in Patients With Spinal Muscular Atrophy

This is an open label phase I/II clinical trial to assess safety, tolerability and potential effect on SMN mRNA and protein in vivo of a compound in which preliminary evidence supports a potential effect on SMN levels in vitro.

This is an open label phase I/II trial of valproic acid in 40 SMA subjects \> 2 years of age with severe, intermediate, and mild phenotypes. Primary outcome measures includes laboratory and physical examination assessments to monitor effects on liver, hematologic, metabolic and nutritional status. Secondary outcomes includes measures of gross motor function; electrophysiologic measures of denervation; DEXA estimates of body composition, bone mineral density and content; measures of pulmonary function; and quantitative SMN mRNA and protein levels in blood cells. Subjects will need 2-3 baseline visits over a 3 -6 month period prior to enrollment. Follow-up visits will be scheduled at 3, 6 and 12 months on treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of SMA, confirmed by genetic testing
* Only patients 2 years of age and older at enrollment will be eligible

Exclusion Criteria:

* Patients taking any medications with known hepatotoxicity, congenital metabolic disorders or on multiple anticonvulsant medications
* Patients taking medications which may interact with VPA
* Patients on ventilatory support for more than 16 hours per day
* Patients currently enrolled in other treatment trials
Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China

This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with STEMI. This is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. Further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and team building will be organized for the purpose of quality improvement. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared annually.

Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Acute myocardial infarction is one of the leading causes of mortality and morbidity, both in rural and urban area.

This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with STEMI.

This is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. Demographic characteristics, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be obtained and then, the treatment pattern and outcomes will be evaluated. Further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and professional training will be organized for the purpose of quality improvement. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared annually.

New knowledge will be generated about STEMI management in China, to improve STEMI patients prognosis in future.

Eligibility Criteria:
Inclusion Criteria:

* Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.

Exclusion Criteria:

* None
Evaluating the Addition of Regional Analgesia to Reduce Postoperative Delirium in Patients Having Hip Fracture Surgery.

Post operative delirium is common after hip fracture surgery and is associated with increased length of hospital stay, delayed recovery and increased mortality. Postoperative delirium can also decrease a patient's quality of life and increase treatment costs. Anesthesia and pain relief (analgesia) treatments may also influence the incidence of delirium, but more research is needed into which techniques are effective in improving patient outcomes, care and decreasing costs. This pilot study compares the addition of regional analgesia as part of general anesthesia to determine the incidence of delirium following hip surgery. This is a collaborative study involving anesthesia, orthopedic surgery and geriatrics in the improvement of patient care.


Eligibility Criteria:
Inclusion criteria (must meet all 3):

* Greater than or equal to 65 years
* Have a hip fracture requiring surgery
* Written informed consent for participation of study prior to surgery.

Exclusion criteria:

* Contraindication to peripheral nerve block or local anaesthetics
* Unable to do delirium or cognitive testing due to language, vision or hearing impairment
* Unable to communicate with research staff due to language barriers
* History of chronic opioid use (longer than 1 month)
* Contraindication to general anesthesia
Health Behavior-Related Outcomes With Diaphragmatic Breathing Retraining in Heart Failure Patients

The purpose of this study is to provide information on how the practicing of deep breathing ("DBR" - diaphragmatic breathing re-training) may improve the health outcomes and likelihood of heart failure patients to engage in health-promoting activities by successfully controlling their shortness of breath (dyspnea).

In heart failure (HF) patients, dyspnea (shortness of breath), a key contributor to and the strongest predictor of a chief reason for hospital readmission with fatigue, are the primary reasons for modification in function leading to decreased physical activity (PA). Dyspnea and fatigue lead to activity avoidance, subsequent muscle de-conditioning, and further increases of dyspnea at even lower levels of activity. Depression, because of its moderate relationship both with perceived functional status and dyspnea, can further diminish PA and increase disability in activities of daily living (ADLs). Strategies to minimize or mitigate dyspnea and to boost motivation are imperative for improving adherence to PA, and, in turn, improving fatigue, muscle weakness, PA itself, functional status, disability, and depression in HF patients. Thus, diaphragmatic breathing retraining (DBR) or deep breathing with a slow breathing pattern, a focus on decreasing dyspnea, and mediated by Self-efficacy for DBR and informal caregiver support during the DBR provide an innovative approach to positively impact the spiraling effects of HF. The purpose of this pilot/feasibility study is to evaluate a diaphragmatic breathing retraining (DBR) intervention that incorporates informal caregiver coaching to improve the primary outcomes of dyspnea, fatigue, and muscle weakness, and the secondary outcomes of PA, functional status, depression, disability, and depression.

Eligibility Criteria:
Inclusion Criteria:

* adults age 19 or older who have Class III through IV heart failure as classified by the New York Heart Association (NYHA)
* cognitively intact indicated by being able to describe what participation in the study will involve
* have a consistent informal caregiver, who is willing to provide support to the participants, and a telephone
* residing in a rural area (population less than 2,500) (U.S. Census, 1995).

Exclusion Criteria:

* myocardial infarction or coronary bypass surgery within the last three months
* active chest pain
* uncontrolled arrhythmia (atrial fibrillation or ventricular tachycardia)
* on transplant list or has ventricular assist device
* skeletal or neurological conditions that would impact muscle strength or interfere with 6 minute walk test (6MWT) (amputation, severe arthritis, Parkinson's, stroke, or severe neuropathy)
* history of severe COPD.
Normative Values and Reference Equations of a New Incremental Step Test for the Assessment of Exercise Capacity for Portuguese Adults

According to the official guidelines, a range of settings for cardiorespiratory rehabilitation, including the community- and home-based models, are considered to answer to the inadequate number of rehabilitation services, especially at hospitals, and, also, to respond to the patients' needs. For these settings outside the hospitals, new strategies for the assessment of exercise capacity and exercise training are essential. The modality of stepping can be a promising tool because it is inexpensive, portable, and reflects one of the main activities of daily living (stair climbing). The development of a new field test implies the establishment of normative values and reference equations generated from data of populations without disabilities to aim to characterize a defined population at a specific period of time, and evaluate and compare an individual's performance within a population.

The primary aim of this project is to establish normative values and reference equations generated from Portuguese adults without disabilities of a new step test for the assessment of exercise capacity.

The investigators will perform a cross-sectional study in Portuguese adults (over 18 years) without disabilities. The study will be advertised at the university campus, surrounding areas, and interested participants can contact the research team for participation. The participants who agree will be seen by the principal investigator who will explain the nature of the study and assess eligibility for the study. The participants will sign informed consent.

For each participant, the study will be performed in one day. The participants will perform the incremental step test twice (30 minutes apart).

In addition, socio-demographic information (age and sex), anthropometric measures (weight, height, and body mass index), and clinical data (smoking status, comorbidities, and level of physical activity) will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Portuguese nacionality
* Adults without disabilities aged \>18 years
* Participants with body mass index between 18 and 30 kg/m2

Exclusion Criteria:

* Acute or chronic conditions (respiratory disease, cardiac disease, signs of cognitive or neuromuscular impairment, and significant musculoskeletal disorder)
* Conditions that could interfere with the ability to perform the step test
* Use of walking aids
* Post-symptomatic COVID-19 infected participants
* High-performance athletes
A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.

This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).

In Part A, approximately 12 subjects are planned to be randomized (1:1 allocation) to THR-687 1.2mg and THR-687 2.0mg.

In Part B, in the cohort of Treatment Naïve subjects are planned to be randomized (2:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg.

In Part B, in the cohort of Previously Treated subjects are planned to be randomized (1:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg.

All subjects in the study will receive study treatment in one selected study eye only.

Eligibility Criteria:
The subjects in this study will be subjects with central-involved DME (CI-DME). Both treatment-naïve and previously treated subjects will be included.

Inclusion Criteria:

* Written informed consent obtained from the subject prior to screening procedures
* Male or female aged 18 years or older at the time of signing the informed consent
* Type 1 or type 2 diabetes
* BCVA ETDRS letter score ≥ 39 in the study eye
* CI-DME with CST of ≥ 300µm in men (or equivalent in women), measured from RPE to ILM inclusively, on SD-OCT, in the study eye
* BCVA ETDRS letter score ≥ 34 in the fellow eye

Exclusion Criteria:

* Macular edema due to causes other than DME in the study eye
* Concurrent disease in the study eye, other than DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
* Any condition in the study eye that could confound the ability to detect the efficacy of the investigational medicinal product
* Previous confounding medications / interventions, or their planned administration during the study
* Presence of iris neovascularisation in the study eye
* Uncontrolled glaucoma in the study eye
* Previously received THR-687 or any other experimental therapy for DME, in either eye
* Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
* Untreated Diabetes
* Glycated haemoglobin A (HbA1c) \> 12%
* Uncontrolled hypertension