cyrilzakka/clinical-trials huggingface dataset:
An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246)

The primary objective of this study is to examine the safety and tolerability of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA) who previously participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246). The secondary objective is to examine the plasma and cerebrospinal fluid (CSF) pharmacokinetic(s) (PK) of nusinersen administered intrathecally to participants with SMA who previously participated in ISIS 396443-CS2 or ISIS 396443-CS10.

This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc.

In August 2016, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Clinical signs attributable to Spinal Muscular Atrophy
* Satisfactory completion of dosing and all study visits in ISIS 396443-CS2 (NCT01703988) or ISIS 396443 CS10 (NCT01780246) with an acceptable safety profile, per Investigator judgement.
* Able to complete all study procedures, measurements and visits and parent/participant has adequately supportive psychosocial circumstances, in the opinion of the investigator
* Estimated life expectancy \> 2 years from Screening
* Meets age-appropriate institutional criteria for use of anesthesia/sedation, if use is planned for study procedure

Key Exclusion Criteria:

* Have any new or worsening of existing condition which in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the participant participating in or completing the study.
* Dosing in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246) within 180 days (6 months) of screening, or longer ago than 396 days (13 months) from screening
* Hospitalization for surgery (i.e. scoliosis surgery) or pulmonary event within 2 months of screening or planned during the duration of the study
* Presence of an untreated or inadequately treated active infection requiring systemic antiviral or antimicrobial therapy
* Clinically significant abnormalities in hematology or clinical chemistry parameters
* Treatment with another investigational drug, biological agent, or device within 1-month of Screening or 5 half-lives of study agent, whichever is longer. Any history of gene therapy or cell transplantation.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Paracetamol Metabolism Research in Postoperative Hepatic Surgery

The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. The clearance of indocyanine green is a marker of hepatic perfusion but also of the proper hepatocyte functioning, if hemodynamic conditions are stable.

Some patients may be operated on up to four or five times in the liver. Moreover, these patients probably present an increased risk of postoperative hepatocellular insufficiency due to a quantitative and qualitative decrease in their hepatic parenchyma. It is therefore interesting to evaluate the use of paracetamol in this situation.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring surgery for hepatic resection by initiation under chest or laparoscopic without hepatocellular insufficiency,
* ASA score 1 to 3 (American Society of Anesthesiologists score ranging from 1 to 5 evaluating the preoperative health status of a patient),
* Verification of the understanding of the protocol,

Exclusion Criteria:

* Patients classified ASA 4 or 5,
* Allergy or intolerance to indocyanine green
* Allergy or intolerance to paracetamol,
* Taking of paracetamol the week before the intervention,
* Patient less than 60 Kgs (because decrease of doses of paracetamol),
* Emergency surgery, palliative surgery and surgical recovery,
* Psychic disorder,
* Contra-indication to a treatment used during the study,
* incapable major,
* Intellectual incapacity preventing proper understanding of the protocol,
* Pregnant or nursing woman,
African-American Pharmacogenetics

This is a genetic and platelet reactivity study of African-American versus Caucasian patients undergoing percutaneous coronary intervention and receiving clopidogrel or prasugrel. The investigators aim is twofold: to describe differences in allele frequencies between African-Americans and Caucasians, and to explore associations of platelet reactivity and genetic polymorphisms in these two groups.

The investigators propose a pharmacogenetic cohort study of 100 African-American versus 100 Caucasian patients presenting with an acute coronary syndrome, receiving clopidogrel or prasugrel and undergoing PCI. The study will have four arms: African-American on clopidogrel; African-American on prasugrel; Caucasian on clopidogrel; and Caucasian on prasugrel. All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose, but before hospital discharge. All patients will be treated with aspirin 325 mg/day as well.

Race determination will be based on a patient's self-report, but patients enrolled in the trial must also report that all four of their grandparents were of the same race as theirs. Other races (Asian, Native American, et al) will be excluded from this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 18 or older, of both genders
2. Presenting with an ACS, defined as at least two of the following:

   * symptoms consistent with myocardial ischemia;
   * ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG;
   * a cardiac troponin I level above upper limit of normal.
3. Self-reported African-american or Caucasian race

   a. all 4 grandparents of same race
4. No contraindications to prasugrel therapy.
5. Patient is scheduled for, or has already undergone, PCI.

Exclusion Criteria:

1. Known allergies to aspirin, clopidogrel, or prasugrel.
2. Patient known to be pregnant or lactating.
3. Patient with known history of bleeding diathesis or currently active bleeding.
4. Platelet count \<100,000/mm at the time of enrollment.
5. Hematocrit \<25% at the time of enrollment.
6. On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy post-PCI.
7. Received fibrinolytics within the past 48 hours.
8. Received a glycoprotein IIb/IIIa inhibitor within the past 48 hours, or if such a strategy for PCI involving a glycoprotein IIb/IIIa inhibitor is planned.
9. Taking maintenance thienopyridine therapy in the previous 5 days.
10. Known blood transfusion within the preceding 10 days.
11. Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
12. Patients with known chronic liver disease.
13. Age greater than 75 years
14. Body weight less than 60 kg
15. History of stroke or transient ischemic attack
16. Surgery planned within 1 month
17. Patient likely to require coronary artery bypass grafting
18. Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Automatic Classification of Colorectal Polyps Using Probe-based Endomicroscopy With Artificial Intelligence

Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables real-time histological evaluation of gastrointestinal mucosa during ongoing endoscopy examination. It can predict the classification of Colorectal Polyps accurately. However this requires much experience, which limits the application of pCLE. The investigators designed a computer program using deep neural networks to differentiate hyperplastic from neoplastic polyps automatically in pCLE examination.


Eligibility Criteria:
Inclusion Criteria:

aged between 18 and 80; agree to give written informed consent.

Exclusion Criteria:

Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer

Primary: To compare the efficacy of TACE and TAIE.

Secondary: To compare the side effects of TACE and TAIE.

The outcome measurements include survival benefit and tumour regression induced by the two therapies.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed hepatocellular carcinoma not suitable for surgery

Exclusion Criteria:

* Portal vein thrombosis
* Severe arteriovenous shunt
* Bilirubin level \> 50 umol/mL
* Prothrombin time \> 5 seconds
The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome

An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.

This is a multi-center, open-label study for FCS participants rolling over from the ISIS 304801-CS6 (NCT02211209) index study, FCS participants rolling over from the ISIS 304801-CS16 (NCT02300233) index study and Treatment-naïve group. All participants were to receive volanesorsen 300 milligrams (mg) once per week for 52 weeks. Participants were allowed dose adjustment/dose reduction based on monitoring rules. Participants had the option of continuing dosing for an additional 52 weeks (France: up to an additional 104 weeks for a total of 156 weeks) until an expanded access program was approved and available in their country. Participants who were not participating in an expanded access program were to enter a 13-week (France: 26-week) post-treatment evaluation period.

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent to participate in the study (signed and dated) and any authorization required by law.
* Able and willing to participate in a 65-week study.

Group 1 and 2:

* Satisfactory completion of ISIS 304801-CS6 (NCT02211209) or ISIS 304801-CS16 (NCT02300233) index studies with an acceptable safety profile, per Sponsor and Investigator judgment.

Group 3:

* Participants who did not participate in the CS6 or CS16 index studies and meet additional inclusion criteria of FCS may enroll in the study.
* History of chylomicronemia.
* A diagnosis of FCS (Type 1 Hyperlipoproteinemia.)
* Fasting triglycerides greater than or equal to (≥)750 milligrams per deciliter \[mg/dL\] (8.4 millimoles per liter \[mmol/L\]) at Screening.

Exclusion Criteria:

* Unwilling to comply with lifestyle requirements for the duration of the study.

Group 1 and 2:

* Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study.

Group 3:

* Diabetes mellitus if newly diagnosed or if hemoglobin A1c (HbA1c)≥ 9.0%.
* Active pancreatitis within 4 weeks of screening.
* Acute Coronary Syndrome within 6 months of screening.
* Major surgery within 3 months of screening.
* Treatment with Glybera therapy within 2 years of screening.
* Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study.
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171022 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus

Exclusion Criteria:

* severe asthma or COPD
* smoking
* brittle diabetes
Clinical Evaluation of 2-Week Reusable ACUVUE 2 Vivid Style

This will be a single site, non-randomized, dispensing, brand-masked to the subject, bilateral single treatment study. There will be 2 study visits with a 10 to 14-day contact lens wear period between visits.


Eligibility Criteria:
Inclusion Criteria:

-Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e., willing to wear only the study lenses and not use habitual lenses during the study).
3. Females between 18 and 39 (inclusive) years of age at the time of screening.
4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
5. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
6. Have spherical best corrected visual acuity of 20/30 or better in each eye.
7. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report.
8. The subject must be willing to be photographed and/or video-taped.

Exclusion Criteria:

1. Currently pregnant or lactating
2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion).
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion).
4. Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
5. Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear.
6. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment.
7. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician).
The Effect of Two Aspirin Dosing Strategies for Obese Women at High Risk for Preeclampsia

Low dose aspirin (LDA) is used for preeclampsia (PE) prevention in high risk women, but the precise mechanism and optimal dose is not known. Evidence in the non-obstetric literature suggests AR may be more common among patients with a high body mass index (BMI). Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40. This data suggests that higher doses of ASA may be necessary in obese women. Therefore we plan determine if use of 162mg compared to the traditional 81mg ASA decreased rates of preeclampsia in women considered high risk for developing preclampsia.

Evidence suggests that an imbalance in prostacyclin and thromboxane A2 (TxA2) plays a key role in PE. Aspirin (ASA) has a dose-dependent effect blocking production of TxA2, a potent stimulator of platelet aggregation (PA) and promoter of vasoconstriction. Incomplete inhibition of PA, designated aspirin resistance (AR), can be reduced by increasing the ASA dose.

Eligibility Criteria:
Inclusion Criteria:

* BMI at enrollment \>/= 30
* plan for ASA for preeclampsia prevention

Exclusion Criteria:

* BMI \< 30
* already on ASA
the Influence of Sleep Improvement Through Different Methods on Patients in ICU

In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic level, the inflammation and nutrition status would be detected.

In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic level, the inflammation and nutrition status would be detected. The research aims to confirm that the sleep quality could have a great influence on patients in the ICU and different interventions would make various changes.

Eligibility Criteria:
Inclusion Criteria:

* the postoperative patients that admission to icu is more than 48h

Exclusion Criteria:

* pregnant or breastfeeding
* sleep disorders before operation
* poor liver or kidney function
* post craniocerebral operation
Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Type 1 Diabetes

The investigators are doing this research study to find out if the type of needle used to administer them affects the speed with which insulin and glucagon get into the blood. The investigators will compare a traditional insulin needle to an injection device, called the MicronJet, that uses microneedles to deliver medication into the top layer of your skin.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older with clinical type 1 diabetes for at least one year
* Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (Novolog), insulin lispro (Humalog), and insulin glulisine (Apidra).
* Ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 5 units of rapid acting insulin
* Stimulated C-peptide \<0.1 nmol/L at 90 minutes after liquid mixed meal tolerance test.

Exclusion Criteria:

* Unable to provide informed consent
* Unable to comply with study procedures
* Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. Potential subjects enrolled in trails of passive monitoring equipment, such as continuous glucose monitors (CGMs), are not excluded
* Inadequate venous access as determined by study nurse or physician at time of screening
* Pregnancy
* Hemoglobin less than 13.5 for men and less than 12 for women
* History of pheochromocytoma (fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor to include episodic or treatment refractory hypertension defined as requiring 4 or more medications to achieve normotension, paroxysms of tachycardia, pallor, or headache, or personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease)
* History of adverse reaction to glucagon (including allergy) besides nausea and vomiting
* History of adrenal disease or tumor
* Hypertension (blood pressure \> 160/100 mm/Hg at screening or day of study visit
* History of allergy to aspirin or any history of aspirin intolerance, including Reye's syndrome, or gastric ulcer or bleeding associated with salicylates.
* Blood dyscrasia or bleeding diathesis, such as hemophilia, Von Willebrand's disorder, and idiopathic thrombocytopenic purpura (ITP)
* Peptic Ulcer
Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study

Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.

Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.\[12\] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will consist of all regular clinic patients who elect and are deemed fit by the surgeon to undergo facelift surgery, including patients undergoing ancillary procedures
* age 18 and older
* English speaking.

Exclusion Criteria:

* younger than 18
* previously had an adverse reaction to tranexamic acid
* non-English speaking
* patients who elect not to participate or withdraw from the study.