cyrilzakka/clinical-trials huggingface dataset:
Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease

This study will evaluate the effectiveness and safety of the investigational drug 683699 in treating subjects with moderately to severely active CD (Crohn's Disease).


Eligibility Criteria:
Inclusion criteria:

* Diagnosed with CD and reconfirmed in previous 2 years by a radiologic or endoscopic assessment including histology.
* CDAI (Crohn's Disease Activity Index) score of 220-450 after 1 week of screening.
* CRP (C-Reactive Protein) level of \>4mg at screening.

Exclusion criteria:

* Significantly abnormal laboratory tests or ECG (electrocardiogram) results.
* Current use of an elemental diet or parenteral nutrition.
* Clinically significant positive stool culture.
* Ongoing neoplastic disease of the bowel.
* Bowel perforation other than fistulae.
* Has an ileostomy or colostomy.
* Fixed symptomatic gastrointestinal (GI) stricture within 6 months or obstructive symptoms within 3 months of screening.
* Any bowel resection within 12 months of screening or bowel resection without subsequent demonstration of recurrence of active CD.
* More than 100cm of bowel resected.
* Non-curative bowel surgery with 2 months of screening.
* Symptoms attributed to short bowel syndrome.
* Uncontrolled bacterial, viral, or fungal infection or congenital or acquired immunodeficiency.
* Women who are pregnant, breast feeding, or planning to become pregnant during the study.

Permitted medications:

* Less than or equal to 20mg/day oral corticosteroids for at least 4 weeks prior to screening and on stable doses for 2 weeks prior to screening.
* Azathioprine and 6-MP (6-Mercaptopurine) stable dose for 3 months prior to screening.
* 5-ASA (5-Aminosalicylic acid) stable dose for 1 month prior to screening.

Prohibited medications:

* Greater than 20mg/day oral corticosteroids, or systemic intravenous corticosteroids, or antibiotics as a treatment for CD within 4 weeks prior to screening.
* Cyclosporine or methotrexate during the 2 months prior to screening.
* Infliximab or other biological treatments within 3 months prior to screening.
Acquisition of Normative Data for Musculoskeletal Ultrasound in Children

The primary objective is to establish normative data for Canadian children for the shoulder, elbow, wrist, finger, hip, knee, ankle and toe joint including the relevant tendons surrounding the joint.

The respective joints will be assessed through ultrasonography and data will be collected and analyzed

Eligibility Criteria:
Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* Do not suffer from any condition that might have an effect on their joints.
Selenium Supplementation of Patients With Cirrhosis

The purpose of this study is to determine whether patients with liver disease can improve their nutritional selenium status by taking supplemental selenium.

Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The most abundant selenoprotein in the plasma is selenoprotein P, which is largely synthesized in the liver. Patients with liver disease often have less than half the selenoprotein P levels of normal individuals. This suggests that people with liver disease are not meeting their selenium requirements and may benefit from additional selenium.

We proposed to compare the effects of two different forms of supplemental selenium on plasma selenium levels among patients with severe liver cirrhosis and healthy individuals (controls). Patients and controls were randomly assigned to one of 3 treatment groups: 200 µg selenium per day as selenate, 200 µg selenium per day as selenomethionine, or a placebo. The intervention lasted 8 weeks. Blood was measured initially and after 2 and 4 weeks of supplementation. Selenium, selenoprotein P and glutathione peroxidase were measured in the plasma. We compared changes in selenium and selenoprotein levels between liver cirrhosis patients and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adults
* Adults with Child-Pugh Class C liver cirrhosis

Exclusion Criteria:

* Diagnosis of renal failure
* Urgent need of liver transplant
* Selenium supplements of \>25 µg per day during the past year
Remote Evaluation of MIND Diet

The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves thinking ability and memory compared to a healthy control diet in persons with Multiple Sclerosis (MS). The main question it aims to answer is:

Does the MIND diet improve cognitive performance relative to a control diet in persons with MS?

Participants will:

Consume one meal that follows the MIND diet or a control meal every day for 3 months, complete online surveys and cognitive testing before and after, and keep a record of the food they eat during the study.

The purpose of this study is to understand how a healthy diet is related to thinking ability and memory in people with multiple sclerosis (MS). This study is fully remote consisting of meals being delivered to participant homes using Daily Harvest meal delivery service. Participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks. The study meals and smoothies will follow either a dietary pattern thought to improve brain health (Mediterranean-DASH Intervention for Neurodegenerative Delay; MIND), or a control diet, and will include foods commonly found in grocery stores. Participants will not know which diet they are assigned to (active or control). Participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided. Participants will complete a series of online forms or surveys. Additionally, participants will complete an online cognitive battery from Cambridge Neuropsychological Test Automated Battery (CANTAB) at the beginning and end of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 18-64 years old
2. Self-reported diagnosis of Multiple sclerosis (MS)
3. 20/20 or corrected vision
4. No other neurodegenerative disease diagnosis
5. Stable disease-modifying therapy (DMT) within 6 months
6. Not Pregnant or lactating
7. No food allergies or intolerances
8. Able to consume study meals
9. Not enrolled in another dietary, exercise, or medication study during the study
10. Access to a computer/laptop with internet

Exclusion Criteria:

1. Individuals younger than 18 or older than 64 years old
2. No self-reported diagnosis of Multiple sclerosis (MS)
3. Not 20/20 or uncorrected vision
4. Other neurodegenerative disease diagnosis
5. Disease modifying therapy (DMT) less than 6 months
6. Pregnant or lactating
7. Food allergies or intolerances
8. Not able to consume study meals
9. Enrolled in another dietary, exercise, or medication study during the study
10. No access to a computer/laptop with internet
Influencing Factors of the Corneal Endothelial Cell Loss

This is a multi-center cohort study with prognostic aims to identify factors associated with endothelial cell loss during cataract surgery.

Patients will have their endothelial density measured by specular microscopy preoperatively, at 1 month and at 3 months after surgery. The rest of their management will be in line with standard practice.

Cataract surgery is the most commonly performed surgical procedure worldwide. Postoperative visual function depends on implant into the crystalline lens, retinal lesion, corneal damage or glaucomatous damage. Moreover, preoperative corneal endothelial damage should be as low as possible to provide corneal transparency. Indeed, the endothelium plays important role in maintaining corneal transparency.

The loss rate of endothelial cell after cataract surgery ranges in the scientific literature from 8 to 15 %. Severe endothelial cell loss contributes to corneal edema. This edema resulting in a loss of visual acuity and may require corneal transplantation as a last resort.

Various studies describe some factors that affecting endothelial cell loss such as the cataract density, pupil abnormalities (small diameter), Advanced age or short axial length.

However, few studies have been demonstrated the link between endothelial cell loss and the volume of fluid used during the intervention or the use of intracamerular substances. This study wants to establish a correlation between endothelial cell loss and predictive factors. Thus, knowledge of these factors would have ensured a better control of endothelial dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cataract surgery
* Visual acuity monoyer scale \<8/10e (\> +0.2 logMar)
* Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification
* Covered by the social security scheme
* Have given their oral agreement

Exclusion Criteria:

* Corneal disease: keratitis, dystrophy or corneal degeneration
* Any disease of the anterior segment
* Low preoperative endothelial cell density \<1000 c/mm²
* Pregnancy, lactation
* Risk factors for surgical per-operative complication
* Uncontrolled ocular pressure
* Combined surgery (cataract with corneal graft, cataract with glaucoma surgery, cataract with vitrectomy, ....)
* Under legal protection
Effect of Radial Extracorpeal Shock Wave on Pain and Function

The purpose of the current study will be focused on the following issues. Evaluation of the effect of radial extracorporeal shock wave on the pressure pain threshold and disability in stroke hemiplegic shoulder.

Further understanding of rotator cuff tendon impairment and other shoulder soft tissue structural abnormalities in stroke patients may help clinicians in assigning more complete therapeutic plans to hemiplegic patients. The radial extra-corporeal shock-wave therapy has promising results in patients with musculoskeletal problems and in those with various causes of HSP, including spasticity, rotator cuff problems, adhesive capsulitis, and complex regional pain syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Patient's age ranges from 40 to 60 years.
2. Spasticity of upper limb ranges from mild to moderate (grade 1+: 2) according to modified aschworth scale (MAS).
3. Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale \>24).
4. Patient who understand the study process and signed the informed consent form.
5. Patient with stroke more than 3 months ago.

8. Patient with shoulder pain and limited range of motion (ROM) or loss of motion in the proximal arm on the hemiplegic side.

Exclusion Criteria:

* 1. Patients who cannot express their own pain intensity. 2. Patients with a history of trauma or surgery to the shoulder on the affected side.

  3. Patients with history of oral NSAIDs 3 days before this study or take warfarin medication with an international normalized ratio above 4.0.

  4. Patients with a history of shoulder pain before the stroke. 6. Patients who have received a previous shoulder intra-articular injection or other interventions on the affected shoulder within one month before rESWT.

  7. Patients with cardiac pacemaker. 8. Patients who have osteoporosis. 9. Patients with psychological problems.
Myocardial Perfusion Magnetic Resonance Imaging Using Regadenoson

This is a pilot study to determine whether the drug regadenoson can be used during magnetic resonance imaging to assess regions of poor blood flow to the heart.

The hypothesis of this study is that a single injection of regadenoson could be used instead of a standard adenosine infusion to produce coronary vasodilatation and demonstrate myocardial ischemia during first-pass perfusion cardiac MRI.

This is a pilot study that proposes to assess the feasibility of using regadenoson (Lexiscan, Astellas), a recently FDA approved A2A receptor agonist, as the stress perfusion agent in cardiac MRI perfusion examinations. While regadenoson has been approved by the FDA, it has not been approved for the specific indications of use 1) during the simultaneous intravenous administration of a gadolinium-based contrast agent, or 2) during magnetic resonance imaging (MRI).

Because this agent can be given intravenously in a single 400 microgram bolus, rather than in an infusion, this agent may be easier to administer than adenosine during an MRI examination.

The objectives for this pilot study are: 1) To demonstrate the feasibility of using regadenoson during cardiac perfusion MRI to visualize known regions of myocardial ischemia as demonstrated on SPECT-MPI and 2) To describe a cardiac perfusion MRI protocol using regadenoson that would have the potential to be used clinically.

Eligibility Criteria:
Inclusion Criteria:

* reversible perfusion abnormalities on a clinically ordered rest/adenosine dual-isotope SPECT-MPI in at least 2 contiguous myocardial segments (per 17-segment model)

Exclusion Criteria:

* myocardial infarction, myocardial revascularization procedure or progression in angina occuring after the SPECT-MPI examination
* pregnancy
* gadolinium-based MR contrast allergy
* glomerular filtration rate (GFR) \> 60 mL/min/1.73 m2
* contraindications to MR imaging (pacemaker, brain aneurysm clips, schrapnel, etc.)
Trial of Print Messages to Support the Role of Partners in Promoting Provider Discussions About Prostate Cancer Screening Among AA Men

The purpose of this study is to determine whether female partners of African American men can promote initiation of a discussion with a healthcare provider about prostate cancer screening when the partner is supported by a print message designed to provide relevant information and strategies for her to use in this effort.

Objective: Although AA men are at elevated risk for prostate cancer (Pca), medical guidelines do not present consistent screening recommendations for this group. However, all guidelines stress the need for screening decision making with a provider. This study evaluated the effectiveness of a brochure designed for the female partners of AA men, designed to help promote such discussion on the part of their mates. We also explored the effect of the partner's monitoring style (i.e., the extent to which the partner typically attends to health threats) on promoting discussion.

Methods: Female partners of AA men (N=231) were randomized to receive either a Pca screening CDC brochure for AA men, combined with a "partner" brochure containing strategies to promote men's initiation of a provider visit to discuss screening, or the CDC brochure only, and completed pre- and post-intervention surveys online.

Conclusions: High monitoring partners may be effective in influencing their AA mates to initiate provider discussion, particularly when tailored messaging is provided.

Eligibility Criteria:
Inclusion Criteria:

* U.S. female aged 18 and over, and having an AA male partner between the ages of 35 and 69 with no history of a Pca diagnosis

Exclusion Criteria:

* None
Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis

To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424), administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).

This is a multicenter, open-label, non-randomized, dose escalation study of ruxolitinib, a small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF, PPEV-MF or PET-MF. The study is comprised of 3 parts:

Part 1: Dose escalation and determination of maximum tolerated dose (complete).

Part 2: Exploration of alternative dosing schedules (complete).

Part 3: Further evaluation of selected dose regimens, including additional response measures to explore effect of ruxolitinib on symptoms and other parameters including daily physical activity and long-term survival (ongoing).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PMF or Post-PV/ET MF
* Patients with myelofibrosis requiring therapy
* Adequate bone marrow reserve

Exclusion Criteria:

* Received anti-cancer medications or investigational therapy in the past 14 days
Examination and Treatment of Pain in Front Foot

Tibial flat foot deformity is the most common reason for metatarsalgia. Flat foot deformity is a sign of degenerated problems such as weakness in ligament or fractures. Furthermore, metatarsalgia can be a sign of excessive load caused by sport activities or at work. The condition is very common at diabetics and patients with rheumatism.

The purpose of the study is to examine the load under the front foot at health people and patients with metatarsalgia. Furthermore, the researchers aim at being able to assess the best treatment of the flat foot deformity at each patient.


Eligibility Criteria:
Inclusion Criteria:

* Examination and treatment of pain in front foot

Exclusion Criteria:

* Normal gait
* No pains
Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)

This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockade. Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of study medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Class 1 or 2 or 3
* \>=18 years of age and of either sex
* scheduled for elective surgical procedure under general anesthesia requiring the use of rocuronium for endotracheal intubation and/or maintenance of neuromuscular blockade in a supine position allowing neuromuscular transmission monitoring and requiring reversal of neuromuscular blockade
* Korean descent born in Korea, never emigrated out of Korea, and have a Korean home address

Exclusion Criteria:

* expected difficult intubation due to anatomic malformations
* expected transfer to intensive care unit after surgery
* neuromuscular disorders affecting neuromuscular blockade
* significant hepatic or renal dysfunction
* require use of pneumatic tourniquet during surgery
* (family) history of malignant hyperthermia
* allergy to cyclodextrins (including sugammadex) or other medication(s) used during general anesthesia; use of toremifene or fusidic acid within 24 hours of study drug administration; contraindication to use of neostigmine or glycopyrrolate
Stem Cells Therapy in Degenerative Diseases of the Retina

The purpose of this study is to test the safety and effectiveness of an autologous bone marrow-derived stem/progenitor cells administered intravitreously in the subjects with degenerative diseases of the retina.

Degenerative diseases of the retina are challenging for ophthalmologists. This is a common term that covers heterogenous group of diseases, f.e. retinitis pigmentosa, Stargardt disease, Best's disease or age related macular degeneration. Undetermined etiology, wide range of factors that may trigger the onset of the disease and modulate it's course impede the implementation of an effective treatment. Currently, a stem cells therapy seems to be promising option in patients with degenerative diseases of the retina. The purpose of this prospective, nonrandomized, open label, pilot study is to conduct the investigation of the safety and efficacy of intravitreal injection of autologous bone marrow-isolated stem/progenitor cells with different selected phenotypes into the subjects with degenerative diseases of the retina. Especially, this clinical trial is designated to test the therapeutic (pro-regenerative and neuro-protective) functions of different stem/progenitor cell populations able to secrete bioactive neurotrophic factors. All patients enrolled will have a documented history of degenerative disease of the retina prior to study enrollment. Next, autologous bone marrow-isolated stem/progenitor cells intravitreous injection will be performed. Finally, treatment safety, adverse events and exploratory parameters, including best corrected visual acuity, visual field and electroretinography parameters, to establish disease progression rate will be recorded throughout the duration of the post-treatment follow up period.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed degenerative disease of the retina,
* age 18-65 years,
* best corrected visual acuity max. 0,2 (Snellen letter chart),
* good understanding of the protocol and willingness to consent,
* signed informed consent.

Exclusion Criteria:

* concomitant eye disease (glaucoma, etc.)
* concomitant of other systemic disease or diseases,
* inflammation (high protein or lymphocytosis in the CSF), active infections.
* diabetes,
* cardio-vascular disorders,
* cancer,
* autoimmune diseases,
* renal failure,
* impaired hepatic function,
* subject unwilling or unable to comply with the requirements of the protocol,
* patient has been treated previously with any cellular therapy,
A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock

The two co-primary objectives of this study are to assess in Japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous AZD9773 and 2) the PK of AZD9773.

The secondary objective is to make a preliminary assessment of the pharmacodynamics of two different doses of intravenous AZD9773 in Japanese patients with severe sepsis and/or septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Japanese adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics.
* At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells \[WBC\])
* Cardiovascular or respiratory dysfunction.

Exclusion Criteria:

* Immunocompromising comorbidities or concomitant medications:

  1. Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
  2. Haemopoietic or lymphoreticular malignancies not in remission.
  3. Receiving radiation therapy or chemotherapy.
  4. Any organ or bone marrow transplant within the past 24 weeks.
  5. Absolute neutrophil count \<500 per μL.
  6. High dose steroids or other immunocompromising drugs.
* Concomitant diseases:

  1. Deep-seated fungal infection or active tuberculosis.
  2. Severe chronic liver disease associated with portal hypertension, cirrhosis, chronic ascites or Child-Pugh class C.
  3. History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
  4. Neuromuscular disorders that impact breathing/spontaneous ventilation.
  5. Quadriplegia.
  6. Cardiac arrest in the past 30 days.
  7. New York Heart Association functional Class III or IV due to heart failure or any disorder.
  8. Burns over \> 30% of body surface area in the past 5 days.
* Medication and allergy disqualifications.

  1. Treatment with anti-TNF agents within the last 8 weeks.
  2. Previously received ovine derived products (CroFab™, DigiFab™).
  3. Sheep product allergy or allergy to papain, chymopapain.