cyrilzakka/clinical-trials huggingface dataset:
Coronary Artery Bypass Grafting: Factors Related to Late Events and Saphenous Graft Patency

The purpose of this study is to determine the relations between conventional and unconventional risk factors and adverse clinical events at follow-up (including coronary bypass patency) in patients undergoing surgical myocardial revascularization.

Coronary artery bypass grafting represents one of the most frequent surgical procedure performed in the United States and Europe. The clinical benefit of myocardial revascularization is related to freedom of adverse cardiovascular events and to graft patency, above all of great saphenous vein, which is nowadays the main autologous vessel used for grafting coronaries different from anterior interventricular artery. Unfortunately, phenomena leading to early and, above all, late complications and to graft occlusion are not fully clarified and it so not possible to explain interindividual and temporary variability of progressive stenosis rate only on the basis of classical atherosclerosis risk factors. The aim of our study is to prospectively study the role of conventional risk factors (preoperative risk factors and clinical features) and of unconventional risk factors (genetic polymorphisms, inflammation and coagulation markers) with saphenous late patency and postoperative patients outcome, in particular with regard to adverse clinical events (myocardial infarction, successive stenting procedures, arrhythmias etc.)and to bypass patency.

Plasma venous samples will be collected the day before surgery, at discharge from the hospital, and at follow-up from patients undergoing on-pump and off-pump coronary artery bypass grafting and stored at -80°C; Patients will be followed-up periodically with visits and telephone interviews, and will be also invited to undergo multislice (64 rows) CT scan in order to assess graft patency between 12 and 24 months after surgery.

Finally the relation between conventional and unconventional risk factors with adverse events at follow-up will be assessed with multivariable statistical models.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 to 89
* Elective primary CABG
* Female patients must be non-lactating and not pregnant
* Able and willing to comply with study requirements by signing a consent form

Exclusion criteria

* Concomitant surgery
* Major end organ dysfunction
* Serious intercurrent illness or infection
* Known coagulation disorders
* Emergencies
Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX) injections (tone management) and dynamic splinting (contracture reduction) for improving gait patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and resultant excessive plantarflexion.


Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled will be male or female, be at least 18 years of age, and have been diagnosed with spastic hemiplegia and excessive plantarflexion, which includes the following:

  1. Diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study
  2. Reduced AROM and PROM in ankle dorsiflexion
  3. Ability to ambulate safely 20 feet without an ankle-foot orthosis (AFO)
  4. Inability to ambulate with initial heel-contact
  5. No prior BTX treatment within 6 months
  6. R1 of -10° or greater (using the Tardeiu method of assessment)
  7. Mean Ashworth Scale Test ≥3 for plantarflexors

Exclusion Criteria:

1. Bell's Palsy
2. Viral Encephalitis
3. Muscular Dystrophy
4. Multiple Sclerosis
5. Prior heel-cord lengthening or tendon-transfer procedure in the foot/ankle
6. Subjects with a fixed contracture of the ankle
7. Female subjects who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or are of childbearing potential and do not practice a reliable method of birth control
8. Bleeding disorders
9. Diagnosis of a disease that may interfere with neuromuscular function (ie. Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, amyotrophic lateral sclerosis)
10. Subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function
11. Subjects with profound weakness or atrophy of the muscles in the target areas of injection
12. Active systemic infection or infection at the injection site
13. Allergy or sensitivity to botulinum toxin A
Capillary Blood Accuracy

Entia is a health technology company that has developed a blood testing device called Entia Liberty, which analyses blood collected by a finger prick. Entia is sponsoring this research study to compare the results from Entia Liberty finger prick tests to results from the gold-standard laboratory analyser that tests blood from the arm, port, or PICC line.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old at the time of study entry
* Patients undergoing systemic anti-cancer therapy (SACT)
* Patients capable of providing written informed consent
* Patients undergoing routine Full Blood Count (FBC) laboratory blood tests as part of the standard of care

Additional inclusion criteria:

* Phase 1 (Longitudinal, low count data): Neutrophil Count ≤ 1.0 x109/L within 24 hours preceding consenting
* Phase 2 (Low count data): Neutrophil Count ≤ 1.5 x109/L within 24 hours preceding consenting

Exclusion Criteria:

* History or current diagnosis of haematological malignancy
* Inadequate use and understanding of the English language, requiring a translator
Left Lateral Tilt-down Position During Colonoscopy Insertion

The purpose of this study is to determine whether the left lateral tilt-down position, which includes procedures that involve placing patients on their left lateral side at an angle to make their heads lower than their feet, is more beneficial than the left lateral horizontal body position (patient horizontally laying on their left side, traditionally used for colonoscopies) to decrease descending colon insertion time, the difficulty of colonoscopy procedure and patients' pain.

Supine with tilt-down position (trendelenburg position) is used in abdominal and gynecological surgery to allow better access to the pelvic organs, as gravity pulls the bowel out of the pelvic cavity and the rectosigmoid angle straightens, which may also be favorable for colonoscopy insertion. However, few published studies have explored the value of tilt-down position in the colonoscopy (left lateral horizontal body position are usually used) and there is consequently little evidence to support left lateral tilt-down position or left lateral horizontal body position. So the investigators perform a randomized controlled trial of left lateral tilt-down position versus left lateral horizontal position for colonoscopy to investigate the safety and efficacy of lateral tilt-down position.

Eligibility Criteria:
Inclusion Criteria:

1. Patients whose age is between 18-75
2. Patients who have indications for diagnostic or therapeutic colonoscopy .
3. Patients who have signed inform consent form

Exclusion Criteria:

1. Patients who have undergone colonic resection
2. Patients with glaucoma
3. Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
4. Patients with severe chronic cardiopulmonary and renal disease.
5. Patients with uncontrolled acid reflux disease or active nausea/vomiting.
6. Patients who are unwilling or unable to consent.
7. Patients who are not suitable for colonoscopy
To Assess the Effectiveness of Structured Occupational Therapy (OT) Interventions on Patients With SUD in Inpatient Department (IPD) Settings, Focusing on Improvements in Cognitive, Physical, and Functional Domains

OT emphasis lies within the scope of improving daily life activities, cognitive and physical performance in order to regain the proper social role. This work assesses the impact of a 12 session structured OT intervention program for patients with SUD in IPD. Benefitting from checklists like the Montreal Cognitive Assessment (MoCA), the Barthel Index, the Lawton-Brody IADLs scale, it substantiates attaining enhancements in expressive cognitive functions, ADLs, and IADLs to understand how selected OT intervention modalities can enhance functional capabilities.


Eligibility Criteria:
Inclusion Criteria:

* Substance abused disorder
* Admitted in rehabilitation center

Exclusion Criteria:

* Severe cognitive impairment
* Physical disability
Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in Beijing Remin Hospital

The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.

ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over
* Patient able to cooperate with study procedures and able to perform tests reliably
* Patient willing to sign informed consent
* Patient able and willing to complete postoperative follow-up requirements
* Glaucoma：one/both eyes are affected by glaucoma
* Pterygium： patient with pterygium

Exclusion Criteria:

* Known allergic reactions to collagen
Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET

The purpose of the study is to evaluate the efficacy and tolerability of the combination of Lanreotide Autogel 120 mg and Temozolomide in patients with progressive gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All progressive tumours classified according to Response Evaluation Criteria In Solid Tumours (RECIST, 1.1).


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent prior to any study related procedures
* Inoperable, Gastro-Entero-Pancreatic-Neuroendocrine Tumour G1 or G2 (Proliferation Index, Ki67-Index: 0 to ≤20%) confirmed by pathological/histological assessment
* Progressive disease within 12 months before inclusion (RECIST 1.1: increase of \>20% tumour load; by Computer Tomography (CT) or Magnetic Resonance Imaging (MRI)
* Measurable disease according to RECIST 1.1.
* Metastatic disease confirmed by CT/MRI.
* Functioning or non-functioning NET (G1, G2).
* Positive Octreo-Scan (≥ Grade 2 Krenning scale) or positive DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid)-TATE (Tyr3-Thre8-Octreotide or DOTA-Tyr3-octreotate)/TOC (Tyr3-octreotide) -PET (Positron-Emission-Tomography) -CT within 12 months prior to screening

Exclusion Criteria:

* Has the diagnosis of Insulinoma
* Has a diagnosis of a multiple endocrine neoplasia (MEN)
LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing

This is a prospective, colonoscopist-blinded, randomized, controlled study with consecutive outpatients undergoing colonoscopy in Taipei Medical University Hospital.The study would comply with the standards of the Declaration of Helsinki and current ethical guidelines. It have been approval by Taipei Medical University Institutional Review Board.

Written informed consent will be obtained from all the patients. Patients will be randomized to either the LINE re-education or control group for colon preparation at the time of appointment for colonoscopy by using consecutively numbered envelopes that will contain the treatment assignments, which will be generated by a computer-allocated random digit number, in a 1:1 ratio. At least two LINE accounts for all patients or their relatives living together will be recorded in case of failure to contact. All patients will be instructed not to tell colonoscopists, nurses and investigators before, during and after the procedure about their preparation method and when they receive instructions.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged 18-80 years undergoing colonoscopy who will provide written informed consent will be eligible for participation in the study.

Exclusion Criteria:

* history of colorectal surgery;
* severe colonic stricture or obstructing tumor;
* uncooperative mental status;
* significant ileus;
* known or suspected bowel obstruction or perforation;
* severe chronic renal failure (creatinine clearance \<30 ml/min);
* severe congestive heart failure (New York Heart Association class III or IV);
* uncontrolled hypertension (systolic blood pressure \>180 mm Hg, diastolic blood pressure\>100 mm Hg);
* liver cirrhosis;
* toxic colitis or megacolon;
* active gastrointestinal bleeding;
* dehydration or disturbance of electrolytes;
* pregnancy or lactation; and
* hemodynamically unstable.
Applying Nutrient Drink Test in Understanding Pathophysiology of CVS

Cyclic vomiting syndrome is a disorder characterized by nausea and vomiting, separated by periods without any symptoms. There is very little research on this field at this point and most doctors do not fully understand the disorder. The goal of this study is to assess how the stomach empties food. Participants will be asked to participate in this study because either (a) they have been diagnosed and/or treated for cyclic vomiting syndrome in the past, or (b) they are physically healthy. The study seeks to compare how a healthy person's stomach empties to how the stomach of someone with cyclic vomiting disorder empties.

Up to 14% of unexplained vomiting in adults is attributed to an under recognized and often misdiagnosed disorder termed cyclic vomiting syndrome (CVS). As CVS is better understood, gastroenterologists are increasingly recognizing the importance of timely diagnosis and early management for this chronic and debilitating disorder. Currently, the only gold standard diagnostic strategy involves evaluating clinical criteria set by the Rome Foundation, such as vomiting frequency and duration of episodes. Outside of these subjective criteria, no definitive and objective diagnostic strategy for cyclic vomiting syndrome exists.

Developing diagnostic strategies has been difficult given the exact etiology of CVS is still unknown. One physiologic theory includes rapid gastric emptying (GE)-or a dumping-like syndrome related to impaired gastric accommodation. A retrospective analysis observed rapid gastric emptying by standard 4-hour scintigraphic gastric emptying study in 80% of subjects, suggesting a relationship with CVS and rapid GE. In turn, rapid emptying has been hypothesized to relate with abnormal gastric accommodation - the reflex allowing storage of food through increased fundic volume. This physiologic abnormality can be readily and easily measured using non-invasive tools, but have never been tested in CVS. To explore this further, we aim to determine if CVS patients have abnormal gastric accommodation measured by nutrient drink test.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Cyclic Vomiting (or Healthy Volunteer)
* Age 18 or greater

Exclusion Criteria:

* Age Under 18
* History of gastric surgery
* History of marijuana use
* History of Gastroparesis
* History of Diabetes mellitus II
* Upper endoscopy with known obstructive gastric disease
* Current pregnancy or lactation
* Active inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
* Severe renal disease (GFR \<15/dialysis dependent)
* Active malignancy (diagnosed in last 5 years)
* Allergy/intolerance to liquid Ensure®
Pregnancy and Developmental Outcomes After Transfer of Reportedly Aneuploid or Mosaic Embryos

To determine how often embryos reported to be abnormal by preimplantation genetic testing result in liveborn infants. To evaluate whether the pregnancies that result from these embryos are higher risk for complications and whether the resulting babies have higher risk for health or developmental issues in the first five years after birth.

Genetic testing modality and results will be recorded

Pregnancy per transfer will be recorded

Patients in the study agree to provide medical records of their pregnancy.

Any genetic testing or fetal testing will be carefully reviewed and recorded by the study team.

For patients with live births, pediatric records will be collected for up to 5 years.

As well as surveys for developmental milestones.

There is no financial compensation for study participants

Eligibility Criteria:
Inclusion Criteria:

* Available aneuploid or mosaic embryos
* No other acceptable embryos available
* Willing to travel to Stanford for treatment
* English language fluency

Exclusion Criteria:

* Use of international donor eggs or sperm not tested according to FDA guidelines.
* Living outside the United States
* Embryos with Triploidy are not eligible for transfer in this protocol
Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds

The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments. Minimal data will be collected to evaluate the efficacy and safety of Dermacyte Liquid.

The primary purpose is to provide expanded access of Dermacyte Liquid to subjects who have serious cutaneous ulcers and wounds (e.g., ulcers related to diabetes mellitus, venous insufficiency, complications of systemic sclerosis or rheumatic disease; decubitus ulcers, burns, acute trauma, wound dehiscence, ischemic ulcers, and mixed etiology ulcers). Eligible subjects must have a high likelihood of significant morbidity, loss of quality of life, potential amputation, or mortality without efficacious treatment. As there are many types of patients who may be enrolled, study results will not have statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* Must have a cutaneous ulcer or wound refractory to initial treatment or does not have an adequate treatment alternative, as determined by the Investigator

Exclusion Criteria:

* Must not be pregnant or lactating
* Must not have known malignancies
* Must not be less than 18 years of age
CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI)

The purpose of this study is to investigate the effects of POL6326 (CXCR4 antagonist) as a stem cell mobilizing agent, on cardiac function and infarct size and on safety and tolerability, in patients with reperfused ST-Elevation Myocardial Infarction (STEMI).

After acute myocardial infarction and successful stent implantation patients will undergo a baseline MRI (magnetic resonance imaging) for eligibility for the study. Patients will receive POL6326 or placebo in the first week after STEMI. The primary and secondary endpoints will also be determined in a follow-up visit after 12 months. An interim analysis will be performed after 50% of the patients have completed the 4 months MRI assessment and may result in an adjustment of study size. A number of pre-specified subgroups will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with symptoms suggestive of an acute MI with ST-segment elevation or new left bundle-branch block and a rise or fall in cardiac necrosis markers.
2. Patients must be scheduled to undergo coronary angiography for the purposes of primary PCI (percutaneous coronary intervention) culminating in successful stent implantation.
3. Age between 18 and 80 years. Male and WOCBP (women of child bearing potential) willing to use highly effective methods of contraception from the time of first dose until 3 months after the last dose of the drug.
4. Markedly reduced LVEF at baseline cardiac MRI.
5. No previous occurrence of Myocardial Infarction.
6. Estimated glomerular filtration rate (eGFR) equal or higher than 40 mL/minute prior to MRI.
7. Signed Informed Consent.

Exclusion Criteria:

1. Evidence of multi-vessel coronary artery disease likely to require repeat PCI or coronary artery bypass grafting within 4 months.
2. Pulmonary oedema or cardiogenic shock requiring intubation or mechanical support at the time of the planned baseline MRI.
3. Fitted with a non-MRI-compatible cardiac pacemaker or implantable cardioverter defibrillator, or expected to require such a device within 4 months after randomisation.
4. Terminal illness or malignant disease.
5. Advanced hepatic disease.
6. Diagnosis of severe obesity which precludes MRI assessments.
7. Claustrophobia.
8. Acute systemic infection or fever.
9. Anemia (where hemoglobin levels are \<10 g/dL), thrombocytopenia (platelet count \<100000/μL) or coagulopathy.
10. History of multiple drug allergies or with a known allergy to the drug class of CXCR4 antagonists.
11. Pregnancy or females of childbearing potential who are not using double contraception
12. Known history of human immunodeficiency virus (HIV) infection, chronic hepatitis B or hepatitis C infection or significant active chronic inflammatory disease that requires immunosuppressive medication or regular systemic corticosteroids.
13. Patients who have participated in any investigational drug or device trial within 30 days prior to signing informed consent.
14. Patients who are unwilling or unable to abide by the study requirements.