cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan

The primary objective of this study was to assess the effects of subcutaneous sumatriptan alone and the effects of a single dose of erenumab (AMG 334) intravenous (IV) and sumatriptan concomitant therapy on resting blood pressure in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects ≥ 18 to ≤ 55 years old
* Good general health
* Laboratory results within range
* Other Inclusion Criteria May Apply

Exclusion Criteria:

* Female subjects pregnant or breastfeeding
* An unstable medical condition
* History of cancer
* Active liver disease
* Positive Hepatitis B or Hepatitis C
* Unwilling or unable to limit alcohol consumption
* Unable to refrain from strenuous exercise
* Other Exclusion Criteria May Apply
A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN

Subjects will be administered multiple doses of VK0214 in a cohort dose escalation process. A total of up to 36 subjects will be enrolled in the study, into one of three dose cohorts. For each cohort, up to 12 subjects will be randomized to receive VK0214 or placebo in a 3:1 ratio so that there will be a total of up to 9 subjects for each of the active doses and up to 3 subjects dosed with placebo in each cohort.

The first part of VK0214-102 will include the first 2 dose cohorts and placebo, which will be dosed in parallel (up to N=24). The first 2 doses used in these cohorts will be 20 mg QD and 40 mg QD for 28 days. A Dose Level Review Team (DLRT) meeting will be held at the end of the first 2 parallel doses.

The DLRT will review safety, tolerability, and preliminary efficacy data from cohort 1 and 2. If the data analyzed show that the first 2 doses are safe and well tolerated the DLRT may make a recommendation for proceeding to commence dosing in the third dose cohort.

Based upon outcomes in Cohorts 1 and 2, the sponsor may decide to include a third dose cohort. Before screening may be initiated in Cohort 3, data to support dosing in this cohort will be submitted to the FDA, together with the amended protocol and the dosing recommendation of the DLRT.

Eligibility Criteria:
Inclusion Criteria:

* Provide a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and is willing and able to participate.
* Have diagnosis of X-linked adrenoleukodystrophy (X-ALD) by genetic testing and elevated VLCFAs.
* Present clinical features of AMN, or adrenal insufficiency.
* Subjects must be 18 years of age and older.

Exclusion Criteria:

* Have the cerebral form of X-ALD, based on medical records, or based on MRI performed within the last 12 months or MRI at screening
* Have been treated with any drug targeting TRβ or with any drug being tested as therapy for X-ALD AMN form within the past 30 days before screening
* History or presence of clinically significant acute or unstable hepatic, renal, gastrointestinal, pulmonary, immunological, endocrine, diabetes, hematological or oncological that in the opinion of the investigator would pose a significant risk for the subject
* Subject has untreated primary adrenal insufficiency based on morning plasma cortisol and ACTH at screening
* Lorenzo's Oil. Currently taking Lorenzo's Oil or erucic acid containing product, or other lipid lowering agent known to effect VLCFA levels
Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs

A comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). This trial was randomly divided into two groups: the anti-AAD drug group and the catheter ablation group.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* The patient is willing and able to comply with the protocol and has provided written informed consent.
* Paroxysmal or persistent atrial fibrillation (AF).（Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than seven days but necessitating pharmacologic or electric cardioversion. Included within the category of persistent AF is 'long-standing persistent AF', defined as continuous AF of \>1-year duration. AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter ECG, Loop Recorder, memory of the implanted device (ICD/CRT-D), or any other suitable device.）
* Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs.
* Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).（(1) a history of hospitalization for HF with symptoms classified as New York Heart Association (NYHA) class II, III, or IV; (2) LVEF ≥ 50%; (3) at least one of the following cardiac structural abnormalities identified by echocardiography: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevated levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), with a threshold of ≥400 pg/mL for pa-tients with SR at admission and ≥600 pg/mL for patients with AF at admis-sion.)
* New York Heart Association class II, III, or IV.

Exclusion Criteria:

* Previous left heart ablation procedure for AF.
* Contraindication to chronic anticoagulation therapy or heparin.
* Documented left atrial diameter \>6 cm, optimally from the parasternal long-axis view.
* Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.
* Planned cardiovascular intervention.
* Listed for heart transplant.
* Cardiac assist device implanted.
* Life expectancy ≤ 12 months.
* Mental or physical inability to participate in the study.
* Requirement for dialysis due to terminal renal failure.
* Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age.
* Enrollment in another investigational drug or device study, or participation in another telemonitoring concept.
Prospective Observation of Failure Patterns in NSCLC Treated With ICIs

By prospectively observing the time to the best therapeutic effect of non-small cell lung cancer after ICI treatment, the characteristics of lesion distribution when the best therapeutic effect is reached, and the phenotype of disease progression after ICI treatment response, the investigators intended to explore the failure pattern of NSCLC after the once effective ICI treatment. The investigators also aim to evaluate the feasibility and clinical value of radiotherapy for the treatment of oligo-progressive lesions after ICI.


Eligibility Criteria:
Inclusion Criteria (Part I):

* Age between 18 and 75 years.
* ECOG PS 0-1.
* Pathologically confirmed stage IV NSCLC.
* Negative for driver genes including EGFR, ALK, and ROS-1.
* Patients achieved PR or CR after ICI treatment, as defined by RECIST 1.1.
* Patients with complete radiological information of baseline lesions.
* Life expectancy of more than 3 months.
* Ability to understand and willingness to provide the informed consent.

Exclusion Criteria (Part I):

* Severe autoimmune disease or other contradictions to ICI treatment.
* Mixed small cell with non-small cell lung cancer histology.
* Driver gene positive, including EGFR, ALK, and ROS-1.
* Pregnant or lactating women.
* History of any other malignancy.
* Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
* Patients receiving immunosuppressive agents,or other investigational treatment. Long-term corticosteroid users are also excluded.
* Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.

Inclusion Criteria (Part II, patients with OPD):

* Patients with oligo-progression disease (1-3 progression lesions in 1-2 organs) when developing acquired resistance to ICI.
* Radiotherapy to at least one of the OPD lesions is indicated in the opinion of the investigator. At least one of the irradiated lesion(s) should be evaluable according to RECIST 1.1.
* ECOG PS 0-2.
* Life expectancy of more than 3 months.
* Complete radiological information of all lesions during the follow-up.
* Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
* Adequate bone marrow function within 1 week prior to the enrollment: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, and platelet count ≥ 100 \* 10 \^ 9/L;
* Ability to understand and willingness to provide the informed consent.

Exclusion Criteria (Part II):

* Secondary malignancy.
* Histology transformation to non-NSCLC.
* Ineligible for radiotherapy in the opinion of the investigator. Or none of the OPD are evaluable by RECIST 1.1.
* ECOG PS 3 or worse.
* Short life expectancy (less than 3 months).
* Unable to provide complete radiological information of lesions.
* Inadequate bone marrow function.
* Cannot understand or unwilling to provide the informed consent.
Life Style and Food Habits Questionnaire in the Portuguese Population Aged 55 or More

The study population will be selected from the "Epidemiological study on the prevalence of Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) where retinal photographic grading (current gold standard for AMD assessment) was performed to confirm AMD diagnostic. This study provides a population-based sample in which precise and contemporary information on the frequency of nutritional and lifestyle risk factors will be collected, enabling to evaluate whether the separate and/or joint effects of these factors, if found significant, are likely to have a major public health impact in terms of AMD.


Eligibility Criteria:
Inclusion Criteria:

* Subjects included in the Epidemiologic Study (Protocol N. CC-01-2009). (Subjects aged over 55 years-old included in health care units of Mira or Lousã).
* Written Informed Consent Form signed.

Exclusion Criteria:

- None
Clinical Study of Immunity Duration of Yellow Fever Vaccine in Military

Yellow fever is an acute viral disease transmitted by mosquitoes in South America, Central America and Africa. It is more prevalente in males gender and the age above 15 years due to the greater exposure in the wild endemic area of yellow fever.

According to the World Health Organization (WHO), a single dose of the yellow fever vaccine is sufficient to maintain protective immunity against yellow fever for a lifetime, therefore a booster dose is not required. This issue is difficult to evaluate because there is no serological correlate of protection against yellow fever and seropositivity is defined with several cut-off points. Although studies indicate that the duration of protection after vaccination is long, many studies have demonstrated a reduction of the antibody titrer over the years. Consequently, there is more concern about people who live in endemic areas. For this reason, Brazil recommends revaccinating once at least until additional studies are performed.

It is important to know the duration of immunity induced by lower doses of YF vaccine. In our knowledge, there is a lack of clinical studies evaluating the immunity duration of the yellow fever vaccine with lower doses. This information is relevant to subsidize the routine recommendation of YF vaccine fractional dose for adults.

This is an observational study in young adult males who received the first dose of the yellow fever vaccine in 2009 when they participated in the "Dose-response study of the yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the "Dose-response study of the yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz" in 2009.
* Not been revaccinated during the "Dose-response study of the yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz" of 2009.
* Not having received another dose of the 17DD yellow fever vaccine after participating in the 2009 "Bio-Manguinhos / Fiocruz" 17DD yellow fever vaccine dose-response study.
* Provide name, address, telephone and other information so that you can contact if necessary.
* Ability to understand and sign the TCLE.

Exclusion Criteria:

* Impossibility or refusal to collect blood
Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers

Two doses of metformin with 12 hour interval

* low dose group (375/250 mg)
* high dose group (1000/1000mg)

A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between different metformin dose groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 45
* Body weight 50 to 100 kg
* fasting serum glucose 70 to 125 mg/dL
* who provide informed consent voluntarily

Exclusion Criteria:

* any significant renal, gastrointestinal, hepatic, and metabolic condition
* any co/prior medication within 14 days of study drug administration
Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation at year 2. Those who, in the opinion of the investigator, are still candidates for continued anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate, randomized, masked phase during which eligible patients will be randomized to the NT-503-3 group or the control group.

Clinical Hypotheses:

* NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the prevention of vision loss due to recurrent CNV secondary to AMD
* NT-503-3 ECT has an acceptable safety profile


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye
* Prior Intravitreal Anti-VEGF injections

Key Exclusion Criteria:

* Significant subretinal hemorrhage
* Significant Scar and/or, fibrosis
* Suspected polypoidal choroidopathy, or pigment epithelial tears or rips
* Inadequate response to anti-VEGF therapy
Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects

This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects.

This study will explore the pharmacokinetics, pharmacodynamics (PD), safety and tolerability of TRV130.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Healthy adult males age 18 - 50 years, BMI 19-32 kg/m2
* Acceptable duration of cold pain test results at screening

Exclusion Criteria:

* Clinically significant medical illness or physical exam findings
* Active dermatological conditions or skin trauma on the non-dominant hand, or peripheral vascular disease
* Partial blindness, keratoconus, nystagmus or any other ophthalmic condition which could interfere with pupillometry
* Use of tobacco or nicotine within 6 months prior to screening
* History of recent (within 6 months) drug or alcohol abuse, as defined in DSM-IV-TR
Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care

The investigators are testing the effectiveness of an eHealth digital tool co-designed with patients and providers to improve diabetes self-efficacy in young adults as they transition to adult type 1 diabetes care.

The intervention is an eHealth digital solution co-designed with patients and providers. The intervention is a text message based algorithm that operates similar to a chatbot and will send SMS messages to participants in the experimental arm, consisting of T1D personalized support, education, resources, and a collection of outcome measures. Participants in the control arm will also be onboarded to the KiT algorithm but will only receive text-messages asking them to complete outcome measures at baseline, 6 and 12 months -- all outcome measures will be URL linkouts to REDCap surveys, housed on the SickKids REDCap servers. An embedded process evaluation of high and low engagers will also be conducted to understand how and why the intervention achieved or failed to achieve the desired effects.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with type 1 diabetes, ascertained from patient's medical chart
2. Receiving out-patient care for T1D at a pediatric diabetes center participating in this study
3. Is within 6 months of either planned transfer or 18th birthday so research coordinator can approach patient and inform them about the study, and then can be re-approached for consenting and enrollment only within 3-4 months of either: planned transfer to adult diabetes care OR 18th birthday
4. Proficient in written and spoken English or French
5. Possession of their own personal mobile device that can support SMS with sufficient capacity to send and receive SMS/texts
6. Valid and working mobile phone number
7. Valid email address
8. Willing to engage with intervention if randomized to intervention arm
9. Willing to complete study outcome measures (questionnaires) at all study time-points regardless of which arm they are randomized to: baseline, 6 months, and 12 months
10. Willing to provide informed consent

Exclusion Criteria:

1. Unable to carry out their diabetes care independently due to an intellectual or neurocognitive disability; discerned from medical chart during pre-screening
2. Non-resident of Ontario or Quebec
3. Planning to move out of either province in the next 6-12 months and after moving, will not be receiving diabetes care in either province and/or will not have a valid and working mobile number
4. Currently enrolled in any other clinical research trial with an SMS-based intervention
5. Currently enrolled in another diabetes intervention trial that will continue beyond the final pediatric diabetes visit
Identification of New Predictive Osseointegration Bio-Markers of the Prosthetic Implant in Patients With OsteoArthritis

The study involves the isolation and cellular, molecular and proteomic characterization of synoviocytes, osteoblasts and chondrocytes from tissue samples obtained from patients undergoing surgery of endo or arthroplasty for osteoarthritis (Experimental Group) or interventions for other causes such as for example periarticular fracture requiring the implantation of a prosthesis (Control Group)

The study involves the isolation and cellular, molecular and proteomic characterization of synoviocytes, osteoblasts and chondrocytes from tissue samples obtained from patients undergoing surgery of endo or arthroplasty for osteoarthritis (Experimental Group) or interventions for other causes such as for example periarticular fracture requiring the implantation of a prosthesis (Control Group) Deeper analysis of micro Ribo Nucleic Acid (RNA) and Non Coding RNA expressed by the synoviocytes, osteoblasts and chondrocytes will be performed in order to understand their possible involvement in pathways of osteogenic differentiation, through suitable experimental in vitro models of co-cultures. In particular, investigators will focus on the cross-talk between synoviocytes and osteoblasts, cell populations involved in the post-surgical articular microenvironment and on which the osteointegration process of the joint prosthesis depends.

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female patients \> 40 years old hospitalized for surgery of endo- or arthroplasty for Osteoarthritis or for surgery for joint traumatic diseases (eg femoral neck fractures) requiring the implantation of a prosthesis
2. Interval of at least three months from any previous infiltrative treatment of any kind;
3. Patients able to provide written informed consent to the study.

Exclusion Criteria:

1. Severe cognitive defects or psychiatric disorders;
2. Tumor pathologies or concurrent antineoplastic therapies;
3. Autoimmune diseases (rheumatoid arthritis);
4. Surgery that involves the joint
Role of Cardiac AngioMR in Diagnosis of Cardiac and Vascular Anomalies in Adult Patients with Turner Syndrome

Considering the high prevalence of cardiovascular disease in Turner syndrome patients, noninvasive cardiac imaging is crucial for diagnosis and follow-up. From the review of the literature, it was evident that the imaging techniques used involved the evaluation of only the thoracic findings, in particular the heart and the thoracic aorta, while no data are currently available on the distal abdominal aorta or iliac arteries, since ultrasound and MRI are interrupted at the diaphragmatic level.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of Turner Syndrome
* patients underwent angioMR 1.5 T
* age \> 18 years
Remifentanil and Remimazolam to Limit Patient Movement

Local anesthetics (LA) may be administered by injection (retrobulbar, peribulbar, subconjunctival, lid, or facial block) or by instillation (topical anesthesia), Considerable drawbacks of local anesthesia in these patients include the fact that a few patients can remain comfortable on an operating table for procedures that exceed two or three hours.

Sedation may be helpful with LA to decrease the experience of discomfort, movement and anxiety, which may in turn positively influence hemodynamic parameters, patient satisfaction, and overall improve surgical safety. Sedatives used in eye surgeries include benzodiazepines, opioids, alpha-adrenoceptor agonists, and propofol.

Ophthalmic surgery is a precise surgical procedure that requires absolute immobilization. Many ophthalmic procedures can be performed safely in an outpatient setting, using local anesthesia.

Propofol is currently the most commonly used intravenous anesthetic. It has a rapid onset of action, a short half-life and is associated with rapid recovery of cognitive ability. However, propofol can lead to injection pain, propofol infusion syndrome, and hemodynamic and respiratory depression. Therefore, there is a need for new anesthetic drugs with high efficacy and fewer side effects while providing stable and controllable anesthesia.

Remifentanil is a short-acting esterase metabolized opioid with analgesic and sedative effects. Its half-life is about 5-10 min so that it can be titrated closely in response to changes in intraoperative requirements and with a low risk of accumulation.

Remimazolam is a novel ultrashort-acting benzodiazepine agonist that works on γ-aminobutyric acid type A (GABA-A) receptors to reduce neuronal excitation and thereby achieve hypoactivity and sedation in the body. Remimazolam is metabolized by a nonspecific esterase, and the metabolite has no pharmacological effect, which allows prolonged infusion without accumulation.

It provides rapid anesthesia and arousal while stabilizing hemodynamics and produces less depression of respiration, making it more suitable for use in elderly and hemodynamically unstable patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Undergoing long-eye surgeries under local anesthesia using peribulbar block with an expected surgical time of more than one hour.

Exclusion Criteria:

* Patients on aspirin or anticoagulants.
* Allergy to any study medication.
* Drug abuse.
* Uncontrolled hypertension.
* Hyperthyroidism.
* Frequent cough.
* Impaired hearing.
* Severe liver and kidney dysfunction.
* Neurological or psychological disorders.
* Partial or failed block.