cyrilzakka/clinical-trials huggingface dataset:
Real Time Optical Coherence Tomography (OCT) of Human Tissue

This is a single-arm, prospective, study of an optical imaging device on approximately twenty (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging will be performed on study subjects with results being compared to final pathology.

This study is a single-center, prospective, two-part open label study of an optical imaging device on approximately twenty (20) subjects at one (1) study site. Patients scheduled to undergo a lumpectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the in vivo and ex vivo breast tissue samples using the study device during their lumpectomy.

All specimens will be marked with India ink and undergo standard post-operative histology, and digital histology images corresponding to the inked locations will be obtained. The images and the matched digitized post-operative histology images will then be randomized and read by a blinded, independent pathologist. Sensitivity and specificity will be calculated.

Eligibility Criteria:
Inclusion Criteria:

1. Women 18 years of age or older
2. Signed ICF
3. Women who have been histologically diagnosed with invasive ductal carcinoma or invasive lobular carcinoma of the breast prior to surgery
4. Planning breast preservation
5. Patients undergoing lumpectomy (partial mastectomy) procedure

Exclusion Criteria:

1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
2. Neoadjuvant systemic therapy
3. All T4 tumors
4. Previous radiation in the operated breast
5. Prior surgical procedure in the same quadrant
6. Implants in the operated breast
7. Pregnancy
8. Lactation
9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease

A Phase 1, 2-part, multicentre study to evaluate the safety and preliminary efficacy of the oral administration of EXL01 in the maintenance of corticosteroid-induced clinical response/remission in participants with mild to moderate Crohn's Disease (CD).

Initially, all participants will received standard of care (SoC) corticosteroid induction therapy for 3 to 7 weeks. Participants who meet the protocol defined criteria for response after corticosteroid therapy will enter a Maintenance Period. Participants not in clinical response/remission at the end of the Induction Period will discontinue the study without further study treatment. In the Maintenance Period, participants will receive oral EXL01 or placebo in combination with corticosteroid treatment (that is progressively tapered) and be monitored for safety and efficacy.

The study will be conducted in 2 parts:

* Part A: Participants eligible for maintenance treatment will receive open-label oral EXL01 for up to 24 weeks.
* Part B: Participants eligible for maintenance treatment will be randomised 2:1 to receive double blind oral EXL01 or placebo for up to 24 weeks.

Participants will be monitored for 30 days after end-of-treatment.

Due to the low recruitment rate into Part A, the study was discontinued early; Part B did not start.

Eligibility Criteria:
Key Inclusion Criteria:

Must meet all of the following criteria at the start of the Induction Period:

* Male or female aged ≥18 years and \<75 years at the time of providing informed consent.
* A diagnosis of CD with ileal involvement for at least 3 months prior to Screening.
* A CDAI score \>180 and \<350.
* Part B only: Active mucosal inflammation.

Key Exclusion Criteria:

* Stricture with obstructive syndrome \<3 months prior to Screening.
* Stenosis making endoscopic access to the terminal ileum difficult.
* Received treatment with high dose corticosteroid (≥40 mg prednisone daily) for \>5 weeks within 3 months prior to Screening.
* Part B only: Received \>3 prior biologic treatments or JAK inhibitors for CD including infliximab, ustekinumab, vedolizumab, adalimumab, certolizumab, risankizumab, and upadacitinib.
* Major surgery or significant trauma ≤4 weeks prior to Screening.
* Small bowel resection \>1 m in total or clinical manifestations of short bowel syndrome.
* Current stoma (ileostomy or a colostomy) or had a stoma in the last 6 months or any other intraabdominal surgery within 3 months prior to Screening.
* Started or stopped immunosuppressive therapy (thiopurine, methotrexate, tacrolimus, or other classical immunosuppressant) within 3 months prior to Screening.
* Received faecal microbial transplant within 3 months prior to Screening.
* Systemic infection or other serious infection requiring systemic treatment within 30 days prior to Screening.
* Pregnant, breastfeeding, or expecting to conceive during the study.
Study on Musculoskeletal Disorders in Spanish Pianist

Background: musculoskeletal disorders related to instrumental practice (TMRPI) affect many pianists.

Objectives: to know the prevalence of TMRPI in the population of Spanish pianists and its relationship with gender, age, physical activity, number of years playing the piano and the number of hours per week.

Design: transversal study based on a survey that included 30 volunteers of both genders, aged between 17 and 65, who played the piano for at least 2 years.

Method. due to the absence of specific questionnaires for pianist populations on MMRPI, a questionnaire was conducted combining a validated questionnaire on MMR, the Nordic Musculoskeletal Questionnaire (NMQ) with an "ad hoc" questionnaire created specifically for this study


Eligibility Criteria:
Inclusion Criteria:

* over 16 years old
* at least 2 years playing piano

Exclusion Criteria:

* Traumatism
Blood Flow Restriction Resistance Training Intervention on Vascular Function

The purpose of this study is to investigate the effect of blood flow restriction (BFR) resistance training on vascular function. The investigators aim to compare the effects of different BFR devices (wide-rigid cuffs and narrow elastic bands) on vascular function. The investigators hypothesize that BFR resistance training with wide-rigid cuffs might have a minor negative effect (short-term and reversible) on vascular function, while BFR resistance training with narrow-elastic bands may improve vascular function. Both training methods are equally effective in increasing muscle strength.

Blood flow restriction (BFR) resistance training has been proven to be effective in increasing muscle mass and strength. During BFR training, cuffs (similar to blood pressure cuffs) are placed on the proximal ends of the extremities to partially occlude arterial blood flow to the working muscles and fully restrict venous outflow from the working muscle. The metabolites produced by the working muscle during exercise are trapped in the working muscle, which causes metabolic stress to augment muscle adaptation. Typically, two types of cuffs are used in the BFR training: the narrow-elastic bands and wide-rigid nylon cuffs adapted from surgical tourniquets and blood pressure cuffs.

Currently, the effect of BFR training on vascular function remains unclear. When the cuffs are removed after BFR training, there will be a reactive hyperemic blood flow to wash out all the metabolites produced during exercise. This reactive hyperemic blood flow also will impose shear stress on the arterial vessel wall. The shear stress will lead to an increase in vasodilator factors, which lead to an improvement in vascular function. However, other studies have pointed out that BFR training might cause a negative effect on vascular function when the occlusion pressure was too high. The possible mechanisms of the negative effect might be ischemia-reperfusion injury and retrograde shear stress in the artery. The wide-rigid cuffs are easily available but have the potential to inhibit the expansion of muscle upon increased blood flow accompanying exercise and muscle contraction while the narrow-elastic bands do not prevent the expansion. To the investigators' best knowledge, there is no study directly comparing different BFR cuffs on vascular function. Thus, the aim of the present study is to compare the effects of different BFR cuffs on vascular function (evaluated by flow-mediated dilation, a non-invasive measure of endothelial-derived vasodilation).

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy, sedentary or recreationally active young adults aged between 18 - 40 years old and signed the informed consent.

Exclusion Criteria:

* A current COVID-19 diagnosis
* morbid obesity
* hypertension
* smoking
* overt cardiovascular disease
* using any medication that might affect the cardiovascular system
* current participation in resistance training.
Dietary Fiber and Cardiovascular Inflammatory Markers

To investigate the relationship between dietary fiber and cardiovascular inflammatory markers.

BACKGROUND:

Recent studies have found that diets with higher fiber intake are associated with a reduction in cardiovascular disease (CVD). However, the association does not prove that dietary fiber is actually responsible for lower CVD risk nor does it illuminate potential mechanisms of lower risk if present. Since the diet-CVD connection is strong, and given that CVD is a major contributor to morbidity and mortality, additional information would be valuable. Our preliminary studies and the work of others suggest that there is a significant association between C-reactive protein (CRP) and dietary fiber intake. These observations led us to the following unifying hypothesis: Diets high in fiber are associated with lower levels of inflammatory markers. Our long-term goal is to determine whether inflammation is a key mediator in the link between fiber intake and cardiovascular disease risk.

DESIGN NARRATIVE:

The three specific aims of the project are 1: To determine whether total dietary fiber and or fiber supplementation is associated with levels of inflammatory markers (CRP, fibrinogen, WBC) among adult participants with obesity, hypertension, or diabetes in the National Health and Nutrition Examination Survey 1999-2000; 2: To determine whether 3 weeks on a diet naturally high in fiber (30g/day), or on a diet high in fiber through supplementation, will significantly reduce inflammatory markers compared to a diet low in fiber, in a clinical trial among 30 lean and 30 obese adult hypertensive volunteers; and 3: To determine whether 3 months on a diet supplemented with moderate fiber (extra 7g/day), or high fiber (15g/day), will significantly reduce inflammatory markers compared to a usual diet low in fiber (average 10-15g/day) in a three-month long clinical trial among 180 obese adult volunteers.

To accomplish these aims, three related studies will be conducted. The first will utilize existing data contained in the National Health and Nutrition Examination Survey, a national database of 5773 non-institutionalized adults. The second study will be an additional procedure and laboratory examination to an existing R01 by one of the investigators, to examine the impact of a diet naturally high in fiber on CRP and other inflammatory markers. The third study will consist of new primary data collection in 180 volunteers to evaluate the effect of different levels of fiber supplementation on CRP, fibrinogen, WBC, and interleukin-6. By using existing data, taking advantage of an ongoing protocol, and adding new information through primary data collection, the investigators hope to dramatically increase their understanding of the association between dietary fiber and cardiovascular inflammatory markers. This information could serve to guide constructive changes in nutritional guidelines for reducing CVD risk for millions of at-risk individuals.

Eligibility Criteria:
No eligibility criteria
Evaluation of the Efficacy of Hippotherapy for Children With Developmental Disorders

Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. The purpose of the current research is to evaluate the efficacy of hippotherapy for children with developmental disabilities. The hypothesis is that children with developmental disabilities who are treated with hippotherapy will show better outcomes than children with the same problems who are not treated with hippotherapy.

Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. Most studies that tested hippotherapy were uncontrolled and focused on motor problems, such as cerebral palsy. Today, hippotherapy is used for various developmental problems such as Attention deficit / Hyperactivity disorder (ADHD) and Autism spectrum disorder (ASD), without clear information about its efficacy for these populations.

The purpose of the current research is to evaluate the efficacy of 6 months of hippotherapy for children with developmental disabilities. The hypothesis is that children with developmental disabilities who are treated with hippotherapy for 6 months will show better outcomes than children with the same problems who are not treated with hippotherapy.

Assessment:

* BRIEF questionnaire
* Stony Brook Questionnaire

All questionnaires will be applied at the beginning of the study and after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age: 5-17 years.
* A diagnosis of ADHD or ASD.

Exclusion Criteria:

* None.
First-in-man Study of the Cerebrovascular Interventional Procedural Control System

The objective of this study the first human use of a new device in treatment of acute ischemic stroke, which to evaluate the feasibility, safety, and efficacy of the Cerebrovascular Interventional Procedural Control System.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80.
2. Diagnosed with acute ischemic stroke.
3. Arterial occlusion in the anterior cerebral circulation that was confirmed by CTA or MRA.
4. Subject could be treated intraarterially within 8 hours after symptom onset.
5. Prestroke Modified Rankin Score ≤ 1.
6. National Institutes of Health Stroke Scale (NIHSS) ≥6 and ≤20.
7. Patients or their legally authorised representatives provided signed, informed consent.

Exclusion Criteria:

1. NCCT ASPECT score \<6，or the infarct volume exceeded 1/3 of the middle cerebral artery blood supply area.
2. CT/MR Showed midline shift or cerebral hernia, and ventricle occupying effect. Intracranial hemorrhage. CTA/MRA shows carotid artery dissection, severe stenosis, or complete occlusion, which requiring carotid stent implantation during thrombectomy; Bilateral acute stroke or multiple intracranial large vessel occlusion.
3. Females who are pregnant or lactating.
4. Severe allergy to contrast agents, nickel-titanium metal or its alloys.
5. Drug-resistant hypertension (defined as sustained systolic blood pressure \>185mmHg or diastolic blood pressure \>110mmHg).
6. Hemorrhagic tendency (including but not limited to platelet \<100\*109/L, heparin treatment within 48 hours with APTT ≥35s, taking warfarin with an INR \> 1.7).
7. Surgery or biopsy of parenchymal organs within the last 1 month
8. Any active or recent bleeding (gastrointestinal, urinary, etc.) within the last 1 month
9. Undergoing hemodialysis or peritoneal dialysis; exist of severe renal insufficiency (serum creatinine \>220umol/L or 2.5mg/dl)
10. Previous intracranial hemorrhage, subarachnoid hemorrhage, brain tumor.
11. Life expectancy of less than 1 year.
12. Enrollment in another clinical trial evaluating other devices or drugs during the same period.
13. Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.
Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease

The purpose of this research study is to determine how training to step with a metronome on both a treadmill, as well as overground, will influence the way that people with Parkinson disease walk. Using metronomes is commonly used in clinics, but the investigators will be using a combination of slow and fast frequencies to alter the way that people walk. The use of a slower frequency metronome on the treadmill is intended to help participants take larger steps. The use of a faster frequency metronome while walking overground is intended to help participants take faster steps.This will take place over 12 training sessions. Each session will be about an hour. It will include some walking tests and pictures of the brain (using MRI) before and after training.

Some details regarding the metronome frequency are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete

Eligibility Criteria:
Inclusion Criteria:

* idiopathic Parkinson's disease (Hoehn and Yahr Stage 2-3)
* self-report the ability to walk uninterrupted for 10 minutes both overground and on a treadmill without therapist assistance
* comfortable gait speed \> 0.4 m/s and \< 1.2 m/s
* normal (or corrected to normal \[i.e., hearing aid\]) hearing
* deficits in gait continuity (e.g., shuffling, shortened strides, freezing, festination, bradykinesia, etc) based on observational gait analysis
* Movement Disorders Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS-III) item 10 ≥1 and \<3
* be on stable doses of orally-administered levodopa
* age 50-80 years old

Exclusion Criteria:

* contraindications to MRI (e.g., metal implants, claustrophobia, etc)
* cognitive deficits (Montreal Cognitive Assessment \[MoCA\] \< 26)
* concurrent Physical Therapy
* have undergone deep brain stimulation surgery
* cannot walk without therapist assistance
* uncontrolled cardiorespiratory/metabolic disease, or other neurological disorders or orthopedic injury that may affect gait.
MRI Versus Four Dimensional Ultrasound in Detection of CNS Fetal Congenital Anomalies

Congenital central nervous system (CNS) anomalies are common and most devastating. They occur in frequency of about 1.4 to 1.6 per 1000 live births but are seen in about 3-6% of still births.They account for 40% of deaths of all infants in the first year of life. In survivors, they cause a variety of neurological disorders, mental retardation or drug resistant epilepsy.

CNS anomalies are usually compatible with life, prolonged hospitalization, higher health care costs, uncertain future life quality and significant burden to families and society.

Early detection of congenital CNS anomalies gives time available for the clinician and parents to plan about the outcome of pregnancy.

Prenatal ultrasound has been well established for decades as the primary technique for evaluating the developing fetus in normal as well as in high risk cases. Advantages of US include widespread availability, relatively low cost and quick, lack of harmful effect to fetus or mother and real time imaging.

Although ultrasound can characterize many anomalies accurately, it has many limitations as operator dependent, small field of view, and relatively poor soft-tissue contrast, beam attenuation by maternal adipose tissue and fetal bone, limited visualization of posterior fossa after 33 weeks gestation because of calvarial calcification. Also, ultrasound relies heavily on fetal positioning and presence of sufficient amniotic fluid to provide an adequate acoustic window fetus So, US findings are occasionally incomplete or inconclusive to guide treatment choices.

Fetal brain MRI became embraced as a clinically important imaging technique useful for fetal assessment, which is helpful in formulating prognosis and perinatal management and can detect occult abnormalities in up to 50% of cases for certain indications.

It can overcome many of ultrasound limitations as it is not limited by maternal obesity, fetal position, or oligohydramnios. Additionally, it has better soft tissue contrast resolution, as well as the ability to distinguish individual fetal structures such as brain, lung, liver, kidney, and bowel. In addition, visualization of the brain is not restricted by the ossified skull. Moreover, MRI provides multiplanar imaging as well a larger field of view, facilitating examination of fetuses with large or complex anomalies.

Eligibility Criteria:
Inclusion Criteria:

1. All pregnancies with either suspected or detected fetal anomalies on ultrasound excluding first trimester pregnancies (to allow completion of period of organogenesis).
2. Pregnant females with past or family history of congenital fetal abnormality.

Exclusion Criteria:

1. Pregnancies with normal antenatal US.
2. pregnancies in first trimester
3. Claustrophobic patients.
4. contraindication to MRI as cochlear implants and pacemakers.
Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients

Levosimendan is a relatively new drug that improves cardiac contractility in patients with heart failure. Its main mechanism of action is enhanced binding of calcium to the myocardial contractile proteins. Recent data from our lab showed that levosimendan improves contractility of human diaphragm in vitro (muscle fibers from COPD patient diaphragm) and in vivo (healthy subjects). Accordingly, levosimendan may appear of value in the treatment of disorders associated with impaired respiratory muscle function, such as mechanically ventilated patients.We hypothesize that levosimendan could improve respiratory muscle function in mechanically ventilated patients commencing a CPAP trial.


Eligibility Criteria:
Inclusion Criteria:

* mechanical ventilation \> 3 days
* informed consent
* able to sustain a CPAP trial for 30 minutes
* PaO2/FiO2 ratio \> 200 mmHg
* ventilatory settings: positive end expiratory pressure \<= 10 cmH2O, pressure support \<= 10 cmH2O

Exclusion Criteria:

* pre-existent muscle disease (congenital or acquired) or diseases/disorders known to be associated with myopathy including auto-immune diseases
* pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)
* upper airway/esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
* phrenic nerve lesions
* pregnancy, breast feeding
* severe renal failure (serum creatinine \> 150 umol/L)
* severe hepatic failure
* recent (within 5 days) nasal bleeding
* systolic blood pressure \< 120 mmHg