cyrilzakka/clinical-trials huggingface dataset:
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis

The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking diet) will help induce clinical and biochemical response to an advanced therapy in patients with ulcerative colitis. Study period will be 8 weeks during induction of advanced therapies. The primary aims of this study will be clinical response, as determined by the simple clinical colitis activity index (SCCAI). Secondary outcomes will be improvement in fecal calprotectin and C-reactive protein levels.

Advanced therapies included will be:

JAK inhibitors (tofacitinib or upadacitinib) IL-23 inhibitors (ustekinumab or risankizumab) Anti-TNF (infliximab)

Patients will be provided these medications as part of their standard of care, as decided by their treating physician.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with ulcerative colitis who are beginning tofacitinib therapy.
2. Patients with ulcerative colitis who are initiating second line biologic therapy with ustekinumab
3. Patients with ulcerative colitis who are initiating second line biologic therapy with infliximab
4. Patients aged 18 years or older.
5. Patients with active disease defined as simple clinical colitis activity index (SCCAI) \>2
6. Patients who have not been on antibiotics for 2 weeks or probiotics.

Exclusion Criteria:

1. Patients younger than 18 years.
2. Patients that do not meet the inclusion criteria specified above.
3. Patients with clinical signs of fulminant colitis, toxic megacolon, ischemic colitis or impending hospitalization for severe ulcerative colitis.
4. Patients with concomitant infectious colitis.
5. Patients allergic nuts/soy/sesame/oats.
6. Patients who do not like the food items that form part of the kits for the fasting mimicking diet (see below).
7. Patients that are diabetics on a glucose lowering drug.
8. Individuals with a history of syncope/presyncope with fasting or from medical conditions.
9. Women who are pregnant or nursing.
10. Individuals with very low BMI\< or equal to 18.
11. Patients with the following comorbidities: chronic kidney disease, diabetes, active cancer.
12. Prohibited concomitant therapies will include TNF antagonists, azathioprine, methotrexate, and mercaptopurine.
13. Patients who routinely have fasting eating habits
A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data, together with safety data generated in 2 other clinical trials, suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a documented diagnosis of ulcerative colitis at least 6 months prior to screening.
* Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score.
* Subjects must have Modified Baron endoscopic score of at least 2 determined within 7 days of first dosing.
* Subjects must have failed or be intolerant (as determined by the investigator) of at least one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab or adalimumab.
* Subjects must be on stable steroid doses.

Exclusion Criteria:

* Subjects who have abnormal organ and marrow function.
* Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
* Subjects who meet Truelove-Witts criteria for severe ulcerative colitis.
* Subjects receiving or who are expected to receive Infliximab or other biologic treatment within 8 weeks of the Day 1 study visit.
* Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, or tacrolimus within 4 weeks of the Day 1 study visit.
Fast Arm Motor Skill Training

Every year, almost 800,000 people experience a stroke in the United States, which lead to upper-limb impairments, making recovery of motor function a priority in stroke rehabilitation. 1) The primary objective of this study is to determine whether fast arm movement training on a tracking task ("Speed-training"), in chronic stroke survivors with mild to moderate paresis, will generalize to improve arm function better than dose-equivalent accuracy training on the same task. 2) study the effect of intensive arm training on the recovery of anticipatory feedforward control. 3) Determine the involvement of cerebellar-cortical circuits in the recovery of arm movements due to speed training.

About 65% of stroke survivors experience long-term limitations in upper extremity (UE) functions. In particular, limitations in arm reaching movements are prominent and correlate strongly with patients' impairment levels. Because activities of daily living often involve the UEs, retraining reach and grasp skills is critical for return to a full quality-of-life. Yet, the training parameters required for effective rehabilitation of UE function are not known. Recent evidence suggests that high-speed movements during training are effective at improving arm movements in individuals with chronic stroke. Hence, fast movements generating large errors, would promote the restoration of the feedforward controllers and therefore improves arm movements and UE functions in individuals with chronic stroke. Because the cerebellum is involved in learning feedforward controllers from motor errors, the improvements would be proportional to the integrity of the cerebellar-cortical networks.

A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke survivors. Participants will be assigned to either the speed-bias training group or a dose equivalent accuracy-bias training group (control) and will receive 4 days of training over a 1week period by a trained Occupational or physical therapist. Behavioral, EMG, and MRI data will be acquired within two weeks before, 3 days post, and one month after intervention.

Eligibility Criteria:
Inclusion Criteria:

* At least 6 months following an ischemic supratentorial stroke
* At least 21 years of age
* Exhibit residual capability to move the paretic UE (Upper Extremity Fugl- Meyer motor score \>20/66)
* Able to follow a 2-step command (8th item on the MMSE test)
* Able to perform an unassisted arm reach movement of 25 cm ahead of the body within 5 seconds with trunk restraint
* Exhibit no greater than mild/moderate spasticity as assessed with a Modified Ashworth Score \< 3

Exclusion Criteria:

* any neurologic diagnoses other than stroke
* peripheral movement restrictions, such as neuropathy
* orthopedic disorders affecting the paretic UE
* severe pain or sensory/proprioceptive impairment in the more affected UE
* visual neglect (more than 4% of lines left uncrossed on Albert's test).
* had a stroke directly affecting the cerebellum
* any contra-indications to MRI scanning
* mostly resolved impairments with an Upper Extremity Fugl- Meyer motor score \>58/66
The Impact of Sarcopenia on COPD Exacerbation Admission Outcome and Further Exacerbation Risk

Chronic obstructive pulmonary disease (COPD) is more prevalent and has more impact on health status because of progressive air pollution, tobacco smoking and aging society. The COPD prevalence investigation in 2013 by phone call showed at least 6% of the population with more than 40 years-old in Taiwan. It also was the 7th ranking of death causes in Taiwan then. Apart from chronic inflammation in lung and deteriorated lung function, it had extrapulmonary complications, such as cardiovascular problems, osteoporosis and muscle wasting. The concept of sarcopenia was proposed at first in 1989. It increases the risk of falls, disability and lowering life quality. Besides, it increased the mortality risk after admission from acute ward. Thereafter, sarcopenia is one of COPD co-morbidities, which should have great impacts of COPD. The studies showed sarcopenia reduced exercise capacities and worsening dyspnea scores. On the other hand, COPD exacerbation brings significant health burden. But there is limited data about the effect on sarcopenia on COPD exacerbation. We conducted a prospective observational study. We measured skeletal muscle mass and the strength of the used hand grip within 3 days of admission and before discharge. Mortality and exacerbation in one year are the primary end-points


Eligibility Criteria:
Inclusion criteria: Patients more than 45 years-old, were admitted due to COPD exacerbation.

COPD exacerbation criteria:

1. acute worsening respiratory symptoms without any other causes, And
2. Smoking more than 15 pack-years or the history of noxious gas exposure, And
3. Spirometry reports suggests obstructive ventilatory defect (FEV1/FVC \<0.7) or
4. Attending physicians diagnose as COPD by clinical parameters if spirometry data are not available while enrolling.

Definite COPD exacerbation: fulfill 1、2、3 Probable COPD exacerbation: fulfill 1、2、4

Exclusion criteria:

1. Significant fluid retention such as edema, pleural effusion or ascites,
2. Patients with permanent pacemaker or implantable cardioverter defibrillator ,
3. Morbid obesity with BMI \>34
Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis

Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but approximately 5% of all MS cases worldwide involve children that are younger than 16 years.

The aim of care of children with Multiple Sclerosis is to prevent or at least to delay any neurological and cognitive impairment as well as progression of the disease as far as possible. Therefore, it is very crucial to diagnose the disease at an early stage as immunomodulatory treatments are available that can delay the progression of Multiple SclerosisTreatment with the immunomodulatory agent Betaferon® in children diagnosed with RRMS and being 12 years or older has been approved by the health authorities. The aim of this observational study is to obtain further data on the safety, tolerability, and effectiveness of Betaferon® under daily living conditions.

As this is a non-interventional observational study, routine clinical practice is observed. The application of diagnostic measures and medications as well as physician visits follow the normal routine and is decided upon by the treating physician under recognition of the package insert.


Eligibility Criteria:
Inclusion Criteria:

* Treatment naive children and adolescents of 12 to 16 years of age at inclusion with a diagnosis of RRMS according to revised McDonald or Poser criteria and decision taken by the investigator to treat with Betaferon. The local Betaferon product information must be considered.

Exclusion Criteria:

* Contraindications stated in the local Betaferon product information; warnings and precautions must be considered.
Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing <1500 g at Birth

Purpose of this study is determine if skin application of chlorhexidine at birth would reduce infection in infants weighing \<1500 g at birth.

Background

Infants weighing \<1500 g at birth infants are more prone to acquire infections, often through their immature skin which serve as a portal of entry for invasive pathogens. Skin application of antiseptics such as chlorhexidine may reduce infections in these infants. However, there is a paucity of data on the safety and efficacy of such intervention in these infants.

Hypothesis:

Among hospitalized very low birth weight (VLBW; \<1500 g) neonates, single whole body skin cleansing with 0.25% chlorhexidine within 6 hours after birth would reduce the incidence of sepsis in the first seven days of life from 25% to 17.5% (relative reduction of 30%) when compared to skin cleansing with sterile water

Objectives:

Primary- To evaluate the effect of whole body skin cleansing with 0.25% chlorhexidine (single application, at birth) on the incidence of sepsis (culture positive or culture negative) compared to sterile water cleansing in the first week of life in VLBW infants

Secondary- to compare following outcomes in this experiment:

1. Culture-confirmed sepsis within the first week of life
2. Need for repeat hospital admissions within first 28 days of life
3. Mortality within first 28 days of life
4. Cold stress/hypothermia at 0, 5, 15 and 30 minutes of intervention
5. Skin condition at 24 h of life
6. Colonization rates (subset)
7. Serum levels of chlorhexidine (subset)

Methods:

Eligible infants would be randomized within 6 hours of birth to either whole body skin cleansing with chlorhexidine (specially prepared wipes releasing 0.25% chlorhexidine), or sterile water (placebo). The research staff would collect the baseline data, record the axillary temperature and assess the skin condition using the Newborn Skin Condition Scoring (NSCS)score. The research team would follow the infants for development of sepsis and other outcomes. The infants would be subjected to detailed sepsis work up on clinical suspicion of sepsis, until 28 days of life.

Sepsis would be defined based on combination of clinical course, indirect markers, bacterial culture results and antibiotic treatment status.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight less than 1500 g

Exclusion Criteria:

* Birth weight \<750 g
* Major congenital malformations
* Total duration of positive pressure ventilation (PPV) \> 3 mins OR chest compressions
* Shock- requiring inotropes \>10 mic/kg/min
Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety

This Emergency Department based study investigates the feasibility and effectiveness of a mindfulness based stress reduction (MBSR) training program referral for patients with chest pain at low risk for acute coronary syndrome but associated with anxiety. Outcomes assessed for eligible patients randomized to MBSR vs. usual care include mental health (longitudinal Generalized Anxiety Disorder - 7 (GAD-7) scores), quality of life (PROMIS Global Short Form), and ED resource utilization (return Emergency Department (ED) visits).

To determine the effect of an MBSR training program for patients with low-risk chest pain associated with anxiety on mental health (longitudinal GAD-7 scores, quality of life (PROMIS Global Short Form), and ED resource utilization (return ED visits). The working hypothesis is that early referral to MBSR will help patients better regulate their thoughts, feelings, and bodily sensations related to their anxiety symptoms and have a significant positive effect on patient-centered outcomes such as mental health, quality of life as well as decreased ED resource utilization. To this end the investigators will randomize patients identified via a two step process (HEART Score \<4 and GAD-7 score \> 9 to usual care referrals versus MBSR. The investigators will then follow these participants for outcomes including change in GAD-7 scores, PROMIS Global Short Form, ED utilization among other outcomes at 6 weeks, 3 months, 6 months, and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Chief complaint of chest pain
* HEART Score of 0-3 indicating Major Adverse Cardiac Events (MACE) risk equivalent to ≤2%
* GAD-7 score \> or = 10

Exclusion Criteria:

* Age \<18 or ≥ 71
* Chief complaint of anxiety, panic, or similar
* Prior personal acute coronary syndrome (ACS) history (known at time of provider interview)
* Previous enrollment in the study
* Traumatic injury to the chest
* Suicidal ideation or active psychosis or behavioral issues requiring psychiatric monitoring
* Hemodynamic instability
* Non-English speaking
* Potential issues affecting follow up: Prisoners, homeless patients, out-of-town residences
Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma

The purpose of this study is to assess the late and early asthmatic response after an allergen inhalation challenge in adults with mild atopic asthma after receiving multiple doses of tezepelumab (AMG 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with history of mild atopic asthma between 18 and 60 years-of-age
* Body mass index (BMI) between 18 and 35 kg/m\^2
* Normal or clinically acceptable physical examination (PE), clinical laboratory values, and electrocardiogram (ECG); clinically acceptable PE includes history of mild atopic asthma
* Used only inhaled short-acting β2-agonists infrequently to treat asthma
* No current exposure to allergens to which subject experiences asthmatic responses
* No other lung disease, exacerbations of asthma or lower respiratory tract infections for at least 6 weeks prior to screening
* Positive skin prick test to common aeroallergens at screening
* Additional inclusion criteria apply

Exclusion Criteria:

* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
* History or current medical conditions that are contraindicated for methacholine challenge, such as myocardial infarction or stroke within previous 3 months, known cardiac disease, uncontrolled hypertension and aortic or cerebral aneurysm
* Evidence of active or suspected bacterial, viral, fungal or parasitic infections within past 6 weeks
* Subject has know type I/II diabetes
* History of residential exposure to tuberculosis or has a positive purified protein derivative (PPD) or QuantiFERON test within 4 weeks before randomization
* Subject who has history of malignancy of any type within 5 years prior to enrollment
* Subjects tested positive for drugs/alcohol or nicotine use at screening
* Subjects tested positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
* Additional exclusion criteria apply
Innate Immunity and Respiratory Syncytial Virus (RSV) Infection in Children

In this project we will study the capacity for single nucleotide polymorphisms (SNP) in TLR4 gene to induce varying levels of inflammatory chemokine and cytokine production.

Infection with RSV is the most common cause of respiratory tract illnesses (LRIs) in the first 3 years of life. There are significant social and health care costs associated with RSV-LRIs. More than 3% of US children are hospitalized each year due to RSV and 500 die annually. Several longitudinal studies have also suggested that children who have RSV-LRIs are at substantially increased risk of developing asthma in the first 3 years after infection and bronchial hyperresponsiveness (BHR) many years after the primary infection. Mechanisms involved in RSV disease are not well understood. Recent reports suggest that RSV may initiate the innate immune response through the pattern recognition receptor, Toll like receptor-4 (TLR4). In this project we will study the capacity for single nucleotide polymorphisms (SNP) in TLR4 gene to induce varying levels of inflammatory chemokine and cytokine production. It has been suggested that such a mechanism may result in altered immune responses to RSV infection and different clinical outcomes. This research has direct application to improving our understanding of bronchiolitis in early childhood, particularly those factors that influence severity of the disease, and may have implications for possible therapy of patients with bronchiolitis in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Parental or sibling history of asthma.
2. Child must be less than 24 months of age.
3. Presence of viral upper or lower respiratory tract symptoms.

Exclusion Criteria:

1. History of recurrent wheezing requiring systemic corticosteroids.
2. Prior history of lung disease.
3. Birth \< 36 weeks gestation.
4. Immunodeficiency
5. Treatment with ribavirin, systemic or inhaled corticosteroids during the RSV infection.
6. Congenital heart disease.
7. No history of parental or sibling asthma.
8. Less than 48 hour or more than 5 day duration of viral URI symptoms since the peak symptoms from RSV would be expected to occur from 2-5 days into course of infection.
North American Comfilcon A Clinical Study

The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population.

The main objective of this study is to demonstrate acceptable safety and effectiveness (performance) of comfilcon A Sphere, Toric, Multifocal, Toric Multifocal and Energys lenses, when used in the general population after 2 hours of wear.

Eligibility Criteria:
Inclusion Criteria:

1. Age 8 to 75 years (inclusive).
2. Current wearer of the Comfilcon A sphere, toric, multifocal, toric multifocal or Energys contact lens for at least 12 months.
3. At least occasional overnight wear in the last 12 months.

Exclusion Criteria:

1. Current participation in a contact lens or contact lens care product clinical trial.
Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults

In this protocol the investigators will test the effect of dalfampridine (a potassium channel blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in healthy control subjects.

Two overnight sleep studies, a placebo night and a drug night, will be performed approximately one week apart in random order. The placebo or drug will be administered 3 hours before lights out. At least 10 minutes of quiet wakefulness will be recorded to quantify the subject's awake EMG GG activity before the administration of placebo/dalfampridine.

EMG GG activity will be measured again 10 mins before lights off and during stable NREM and REM sleep (free of arousals and other artifacts).

During the second part of the night, the subjects will be connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide a wide range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure and measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness).

Eligibility Criteria:
Inclusion Criteria:

* Healthy control subjects

Exclusion Criteria:

* Cardiovascular disease other than well controlled hypertension
* History of seizures