cyrilzakka/clinical-trials huggingface dataset:
Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate

Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate have not been examined in patients with relapsing forms of multiple sclerosis (MS). As patients on long term therapy typically have little or no overt signs of white matter inflammatory activity (T2, gad lesions), brain atrophy measures can provide insight into whether there is continued progression of MS in these patients. What remains unknown is whether patients on a particular therapy have a slower rate of brain atrophy. This would provide convincing evidence that central nervous system tissue injury is further suppressed. Such information would be of substantial clinical benefit when deciding between various therapies.

The investigators will estimate the impact of long term use of fingolimod therapy (defined as a minimum of two years on therapy) on whole brain atrophy in treated patients with relapsing forms of MS as compared to age and gender matched patients on Glatiramer Acetate.

The investigators secondary goal is to determine the correlation between brain atrophy and cognitive performance in treated patients with relapsing forms of MS.

The investigators will also examine the correlation between the NeuroQualityofLife (NeuroQOL) PROs, patient self-reports of disability, clinical assessment of physical disability, work productivity, clinical assessments of cognitive functioning with whole brain volume loss for patients on long term fingolimod vs. long term glatiramer acetate therapy matched on age and gender.

The investigators anticipate the findings of this study will generate relevant hypotheses about these relationships.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide written informed consent
* Between 18-55 years of age at the time of informed consent.
* Diagnosis of any form of MS as defined by the 2010 revised McDonald criteria
* Currently taking fingolimod or glatiramer acetate for a minimum of two years at the time of the initial baseline visit
* Must be willing and able to comply with the protocol requirements for the duration of the study

Exclusion Criteria:

* Suffering from comorbidities that could confound the MRI outcomes or are (relative) contraindicated to receive treatment with fingolimod such as:

  * diabetes,
  * myocardial infarction,
  * unstable angina,
  * transient ischemic attack,
  * decompensated heart failure,
  * history of Mobitz Type II 2nd or 3rd degree atrioventricular block,
  * sick sinus syndrome,
  * history of stroke,
  * history of traumatic brain injury,
  * history of encephalitis,
  * dementia (not related to MS).
* Systemic steroid used (oral or IV) within 30 days of the baseline visit.
* Ever treated with chemotherapy.
* Ever having undergone cranial radiation, or intracranial surgery.
* Unable to tolerate an MRI scan.
* Is pregnant or breastfeeding or planning on pregnancy during the study period.
* Is decisionally challenged, illiterate or blind
* Is non-English speaking (as the PRO instruments are only validated in English)
Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation

In this study, 30 patients admitted to an high acuity department with hemodynamic or respiratory pathologies will be monitored with camera-based monitoring technologies for 24 hours. The camera's will measure heart rate and respiration rate, based on the principle of remote photoplethysmography and laser speckle vibrometry. Data will be analysed retrospectively and will be compared with vital parameters measured with the standard patient monitor.

Rationale: In hospitals, some 40% of unanticipated deaths occur in low-acuity departments. This alarming figure reflects the limited degree to which the cardiorespiratory status of patients is monitored in these departments, due to the obtrusiveness and expense of existing monitoring technologies, as well as the unpractically high clinical workload and cost that deployment of such technologies would entail.

Objective: This project explores video monitoring of the cardiorespiratory status of the patient as an innovative unobtrusive method that could eventually aid to reduce workload for the staff and better predict (acute) deterioration or adverse cardiac events. The objective of this study is to determine the accuracy and validity of the camera-based vital parameters with respect to the measured contact sensors in intensive care unit (ICU) patients.

Study design: Observational study

Study population: Patients with cardiorespiratory pathologies on the ICU.

Main study parameters/endpoints: The primary end-point is the reliability of the video monitoring technology (remote photoplethysmography and speckle vibrometry) compared with contact sensors focusing on heart rate and respiratory rate in a clinical setting. User experience will have a continuous focus during this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to an high acuity unit with a planned stay of at least 4 hours
* Patients with cardiorespiratory pathologies
* Age \>= 18

Exclusion Criteria:

* Pregnant patients
* Inability to provide written informed consent
* Mental disability
* Language barrier
Vitamin C & Exercise Induced Bronchoconstriction (EIB)

The purpose of this research is to assess the association between diet and pulmonary function during standardized EIB testing. Determine the effect of Vitamin C supplementation on airway inflammatory markers and bronchoconstriction after a standardized EIB test compared to usual diet and placebo control.

This study will use a double-blind, randomized, cross-over design with subjects serving as their own controls. This study will be conducted over a consecutive five-week period.

All subjects will be asked to discontinue taking their short- and long-acting beta-agonist medication 12 and 24 hours respectively prior to data collection. Also, all subjects will be asked to refrain from caffeine, physical activity, and NSAID use 24 hours prior to testing. In addition all subjects will be asked to abstain from taking any vitamin supplement during the course of the study.

Eligibility Criteria:
Inclusion Criteria:

* Student or student-athlete who has tested positive for EIB
* Able to communicate in English

Exclusion Criteria:

* Forced expiratory volume in 1 second (FEV1) \< 70% of predicted, cardiac history,
* Current respiratory infection
* \> 10 pack year history of smoking
* Pregnancy.
An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome

This study was conducted to test whether a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as having ischemic heart disease.

Delay to treatment from the onset acute coronary syndrome (ACS)continues to be a significant cause of morbidity and mortality. This study was conducted to evaluate a tailored education and counseling program designed for individuals at high risk for a future event. Study Hypothesis: The central hypothesis of this study was that a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of AMI in patients already identified as having ischemic heart disease. Patients were randomized to receive a nurse-administered education and counseling intervention designed to promote early presentation for medical treatment in the face of cardiac symptoms or to usual instructions by their healthcare provider. Primary \& Secondary Endpoints: The primary endpoint of this trial was prehospital delay time, i.e., time from onset of symptoms to arrival at the hospital. The secondary endpoints were: use of the emergency medical system; use of aspirin; healthcare resource utilization; and knowledge, attitudes and beliefs about heart disease.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of ischemic heart disease, confirmed by their physician or medical record
* lived independently (i.e., not in an institutional setting).

Exclusion Criteria:

* complicating serious co-morbidity such as a psychiatric illness or untreated malignancy
* neurological disorder with impaired cognition
* inability to read or understand English.
* major uncorrected hearing loss
BiOSS LIM C vs 2nd Generation DES in Non-LM Bifurcations

Coronary bifurcations are encountered in about 15 - 20% of percutaneous coronary interventions (PCI). They are considered technically challenging and associated with worse clinical outcomes than non-bifurcation lesions. Percutaneous coronary intervention (PCI) to the target bifurcation lesion. Randomization (by means envelope randomization) to investigational device: Group 1 for BiOSS LIM C implantation vs Group 2 for any DES implantation.

Single stent implantation in the main vessel-main branch across a side branch is the default strategy (provisional T-stenting, PTS) in all patients enrolled. Bifurcation lesions are assessed according to Medina classification using an index of 1 for stenosis greater than 50% and 0 for no stenosis (visual estimation). There is no restriction regarding lesion length in patient selection. If required, additional stent can be implanted (Alex Plus in the BiOSS Lim C Group). A stent in a side branch (Alex Plus in the BiOSS Lim C Group) should be implanted only if there is proximal residual stenosis greater than 70% after balloon dilatation and/or significant flow impairment after main vessel - main branch stenting and/or a flow limiting dissection.

The implantation protocol for bifurcation is as follows:

1. wiring of both branches;
2. main vessel predilatation and/or side branch predilatation according to the operator's decision;
3. stent implantation (inflation for at least 20 s);
4. proximal optimization technique (POT)
5. side branch postdilatation/side branch stent implantation if necessary
6. final kissing balloon inflation at operator's discretion.
7. Second proximal optimization technique (re-POT)

Eligibility Criteria:
Inclusion Criteria:

1. Subject at least 18 years of age.
2. Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
3. Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
4. Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.

Exclusion Criteria:

1. Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
2. Subjects who refuse to give informed consent.
3. Subjects with LVEF\<30%
4. Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
5. Distal LM stenosis
A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors

The purpose of this study is to collect information on the effects of treatment for gestational trophoblastic disease (GTD). We plan to use the findings from this study to better understand GTD survivors' health and quality of life.

We would like to know more about the health, quality of life and pregnancies of women treated for GTD. This information will be used to try and improve the treatments for women who have this disease.


Eligibility Criteria:
Inclusion Criteria:

* Pathology confirmed GTD by MSKCC
* Sufficient proficiency in the English language to respond to quality of life surveys
* Age ≥ 18 years
* Benign or malignant disease
* Treated with surgery and/or chemotherapy or observation

Exclusion Criteria:

* None
Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery

Risk factors associated with perioperative anxiety in parents of pediatric patients undergoing thoracic surgery are unknown. It is therefore necessary to identify them in order to better understand, above all, modifiable factors. This will allow the implementation of psychological interventions tailored to the individual needs of parents to strengthen their coping mechanisms before surgery, and thus facilitate the recovery process of their children after surgery.

The purpose of the study is:

1. assessment of the level of anxiety experienced by parents before and after thoracic surgery,
2. assessment of risk factors for parents' perioperative anxiety,
3. assessment of the relationship between parents' perioperative anxiety and satisfaction with postoperative analgesia

According to the literature, parents of children undergoing various types of surgical procedures are accompanied by high levels of anxiety. It was found that the level of anxiety is higher in female parents and is related to the child's age, fear of postoperative pain in children, the scope of information about the course of surgery and anesthesia, and potential complications that may occur during and after the child's operation. Parental anxiety correlates positively with child anxiety. High levels of anxiety in children can lead to many undesirable clinical, psychological and behavioral symptoms during hospitalization (delirium, increased postoperative pain, greater need for analgesia) and after discharge from the hospital (separation anxiety, sleep disorders, aggression, enuresis).

Eligibility Criteria:
Inclusion Criteria:

* parent of child \<18 years
* parent of child undergoing thoracic surgery
* parent of child with intravenous or epidural postoperative analgesia
* parent of child with 1-3 score according to the American Society of Anesthesiologists

Exclusion Criteria:

* a parent of a nationality other than Polish
* difficult communication with parent
* parent of a child undergoing oncological treatment
* parent of a child without chest drainage
* lack of parental consent.
Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare

The SARS-CoV-2 pandemic and resulting COVID-19 disease causes a substantial burden on healthcare systems. Little is known about how the infection spreads within healthcare. In order to design control strategies, knowledge of the presence of viral nucleic acid and whether an immune response to the virus has been mounted is needed. The purpose of this study is to determine whether personnel and patients/clients in healthcare in Region Stockholm have a currrent SARS-CoV-2 infection or have had an infection. This information will be used to understand how the infection spreads in healthcare, to explore the association with sick-leave among personnel, and to plan high-quality and safe care.

Healthcare providers and organizations participating in the study from the greater Stockholm region include the following: Karolinska University Laboratory, Karolinska University Hospital; Intensive Care Unit, Karolinska University Hospital; SciLifeLab; KTH Royal Institute of Technology; Roo Home Healthcare Services (Roo Hemtjänst och Vård); Health Care Services Stockholm County (SLSO); Region Stockholm; Southern Hospital (Södersjukhuset); Danderyd Hospital; Capio St Göran Hospital; Södertälje Hospital; Tiohundra AB; Ersta Hospital, Sweden; and St Eriks Eye Hospital (St Eriks Ögonsjukhus).


Eligibility Criteria:
Inclusion Criteria (all three criteria must be fulfilled):

* Healthcare personnel or patient/client of healthcare in Stockholm County
* Age 18-99
* Provided consent to participate in the study

Exclusion Criteria:

* No informed consent to participate provided
* Already confirmed with SARS-CoV-2 infection
* Already sampled for SARS-CoV-2 infection based on clinical presention but where the result has not been reported yet
ESICM UNITE COVID-19 Project (UNITE-COVID)

COVID-19 is arguably the biggest challenge critical care medicine has been confronted with since its conception. Critical care services around the world are flooded by patients presenting with severe respiratory failure who require prolonged treatment in the ICU. Despite the support provided, outcomes are poor, particularly in ventilated patients.

Many unanswered questions remain regarding the pathophysiology of COVID-19, particularly in severely ill patients. No evidence-based treatment is currently available, yet different often experimental therapies are administered to patients.

As experience grows, new phenotypes are recognized, and unreported complications are observed in the most severely ill patients. Although many registries are currently including patients, few of them focus on ICU patients and their specific treatments and newly observed complications and challenges.

Although the pandemic may appear on its return in many countries that are now easing the restrictions that were put in place to limit the spread of the disease, it can be expected that COVID-19 will be a continued challenge in ICUs globally until a safe and effective vaccine is found. Efforts to study the disease should continue in order to advance our understanding of the disease as well as improve treatment options.

This is a multicenter, international, anonymized point prevalence study. Patients who were present in the ICU on the day in April 2020 with the highest number of COVID-19 patients in the unit. Data can be entered in the database until July 2020. Retrospective data collection and entry is allowed.

Subjects believed to fulfill all eligibility criteria, and none of the exclusion criteria, detailed in the relevant section of this protocol, will be included in the study.

Data will be entered in the database anonymously.

Data will consist of two core elements:

1. Center data (to be completed once)
2. Patient data

For different domains with specific, highly relevant and un(der)explored ICU research questions, an focused data set is to be completed. These domains include:

1. Respiratory
2. Coagulation and thrombo-embolic events
3. Infectious complications
4. Rehabilitation
5. Renal

Eligibility Criteria:
Inclusion Criteria:

* Patient is present in an ICU or in any other place of the hospital under the care of the critical care team on the day between 15th February 2020 and 15th June 2020 with the highest number of COVID-19 patients in the unit. The exact date can be decided by the local investigator.
* COVID-19 confirmed diagnosis through PCR or equivalent diagnostic technique

Exclusion Criteria:

* Any of the following is regarded as a criterion for exclusion from the study: SARS-CoV2 positive without COVID-19
INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS to TREATMENT for SARCOPENIC OBESITY

The expanded access is designed for patients requesting the treatment, and whose medical condition may benefit from treatment, but are unable to participate in any other IMM01-STEM clinical trial in their physician's opinion for reasons that include: (1) They do not meet enrollment criteria, or (2) They cannot perform the assessment of outcomes, or (3) The trial site is not geographically accessible.


Eligibility Criteria:
Inclusion Criteria:

1. Sex: male or post-menopausal female (as defined by the absence of a period for at least 12 consecutive months)
2. Race/nationality: all races and ethnicities accepted for which there are validated reference values for obesity and sarcopenia diagnostic criteria
3. Disease characteristics: to be eligible, the participant must meet one criterion for obesity and at least one criterion for sarcopenia, as defined below:

Obesity:

1. Abdominal obesity defined by a waist circumference ≥ 40 inches (102 cm) for men, ≥ 35 inches (88 cm) for women (American Heart Association)
2. Abdominal obesity as a waist-to-hip ratio of at least 0.90 in men and 0.85 or more for
3. No obesity, normal BMI women (World Health Organization)

Sarcopenia:

i) Grip strength: \< 16 kg (women), \< 27 kg (men) in the dominant hand, or, ii) Gait speed \< 0.8 m/s (men and women) iii) Clinical evidence of sarcopenia alternative to grips strength and gait speed measurements, as judged by the physician

Exclusion Criteria:

1. Qualifying individuals by the current enrollment criteria that are in a 50-mile geographical radius of any IMM01-STEM clinical trial site or a potential clinical site.
2. Inability to sign an informed consent
3. Concomitant investigational drugs and treatments
4. Concomitant medication included in the table 1.
5. Current malignancy or recent malignancy in complete remission less than 3 years
6. BMI \< 20
7. Major surgical procedures in the past 30 days.
8. Cognitive impairment, Alzheimer disease,
9. Progressive autoimmune disorders including rheumatoid arthritis, muscular dystrophy, multiple sclerosis, systemic sclerosis, inclusion body myositis, idiopathic inflammatory myopathy, and similar conditions.
Physical Fitness and Nutrition Intake in Bariatric Surgery Population

The purpose of this research study is to determine how bariatric surgery affects physical activity and nutrient intake.

This research study is being done because the investigators want to determine better recommendations to provide to bariatric surgery patients.

This is a two-pronged study. The first phase is a cross-sectional study design meaning each participant will only be tested once. The investigators wish to test patients from each of the groups listed below to determine CR fitness, activity level, and nutrient intake. The investigators wish to determine if any improvements from bariatric surgery can be maintained over a 2-year period following surgery. If this is the case, our next project will be to track the patients recruited at their new visit longitudinally at all of the five time points listed below.

1. New visit with GI Nutrition
2. 1 month prior to bariatric surgery (at the time of the patient's initial visit with the surgeon (6-7 months after their new visit))
3. 6 months after bariatric surgery
4. 12 months after bariatric surgery
5. 24 months after bariatric surgery

Eligibility Criteria:
Inclusion Criteria:

* Competent patients enrolled in the pre- or post-operative bariatric surgery program at the Center for Nutrition and Weight Management at GMC, Danville, PA.
* Ability to perform a 6 Minute Walk Test.
* Aged 18 through 70.
* Willingness to receive dietary recall phone calls and accessibility to a telephone.

Exclusion Criteria:

* Patients with severe lung disease requiring oxygen therapy.
* Pulmonary embolus or pulmonary infarction.
* Patients with cardiopulmonary disease (e.g., prior myocardial infarction, coronary artery bypass, or vascular stent).
* Unstable angina.
* Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise.
* Patients with any health reason that limits walking.
* Patients with a temporary injury that limits walking.
* Patients who use a wheelchair, other assistive device for walking, or have difficulty ambulating during activities of daily living.
* Patients predetermined to be illiterate or incompetent.
* Patients who are currently pregnant or have been pregnant at any time since bariatric surgery.
* Tobacco use.
* Patients with electronic defibrillators or other embedded electronic medical devices.
* Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
* Patients who have undergone revisional bariatric surgery.
Buprenorphine Maintenance Protocol - 1

The purpose of this study is to compare the efficacy of buprenorphine versus methadone.


Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and /or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe