cyrilzakka/clinical-trials huggingface dataset:
A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent

This is a first in man study to determine if \[203Pb\]VMT-α-NET identifies neuroendocrine tumors with SPECT/CT. This is the first step to testing \[212Pb\]-based alpha radiation therapy in neuroendocrine therapy.

The goal of this work is to use \[203Pb\]VMT-α-NET as the imaging agent to create a specialized patient treatment plan using \[212Pb\]VMT-α-NET as a first-in-human therapy for treatment resistant or refractory neuroendocrine tumors of the foregut or midgut. The first step is to test the imaging agent \[203Pb\]VMT-α-NET. This requires a very small dose of the drug (microdose) which is then measured by a series of images (like CT scans) over 4 days. Blood samples are also drawn that that time. It is hoped the imaging will identify the tumors so that a therapy using \[212Pb\]VMT-α-NET can be created.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to provide informed consent
* Stated willingness to comply with all study procedures and availability for duration of study
* Aged ≥ 18 years at the time of study drug administration
* Pathologically confirmed (histology or cytology) well-differentiated neuroendocrine tumor (WHO Grade 1 or 2) with primary location known or believed to be midgut or foregut
* At least 1 somatostatin receptor positive tumor site as demonstrated by PET/CT study utilizing an FDA approved PET agent within 12 months of consent
* ≥1 evaluable site of disease measuring ≥ 2.0 cm in any dimension on CT or MRI
* Adequate performance status (ECOG of 0 or 1; or KPS of ≥70).
* Not experiencing an uncontrolled intercurrent illness such as: infection requiring inpatient admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.

Exclusion Criteria:

* Individuals who are pregnant or breast feeding. A pregnancy test will be administered to individuals of child-bearing potential (per institutional policies) at screening. Individuals must agree to pregnancy tests prior to each administration of a radionuclidic agent for this study.
* Individuals of reproductive potential who decline to use effective contraception through the study (22 days equaling 10 half-lives).
* Lactating individuals who decline to withhold breastfeeding their child. As the effects of \[203Pb\]VMT-α-NET on the infant are unknown and relatively long half-life, women may not resume breast feeding for the current child.
* Therapeutic investigational drug within 4 weeks of C1D1
* Patients for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.
* Subject's weight exceeds the limit of the imaging system.
* Long-acting somatostatin analogue treatment ≤ 20 days of C1D1
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to \[90Y\]DOTA-tyr3-Octreotide, Octreoscan®, or \[68Ga\]Octreotide.
Investigation of a Sub-Conjunctival Insert

The study is intended to evaluate a non-invasive method of glucose measurement in diabetics. The medical device that is evaluated consists on a sensor-insert which is placed under the conjunctiva of the eye of diabetic patients and a photometer. The goal is to prove that the sensor signal correlates with the blood glucose of the patients determined by standard laboratory blood glucose measurement.


Eligibility Criteria:
Inclusion Criteria:

* Be of legal age
* Insulin dependent diabetes requiring daily finger pricking to monitor blood glucose
* Sign written Informed Consent

Exclusion Criteria:

* Inability to follow the protocol schedule
* Participating in another clinical study
* Pregnant or lactating females
* Any ongoing condition that would prevent from proper handling of the instrument (e.g. blindness, strong impaired vision, impaired motor skills)
* Any known hypersensitivity to any of the products to be used in the study, including preservatives etc.
* Malignancies requiring therapy during the study
* Severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study
* Poorly controlled diabetes mellitus with prior hemoglobin A1C greater than 10%
* Any ocular disease requiring topical medication besides those permitted by this protocol.
* Ocular or other condition which increase the risk of ocular surgery, e.g. acute or chronic conjunctivitis or blepharitis, corneal disorders, previous eye surgery or eye surgery within the following 12 weeks, coagulation disorders.
Long Term Effects of Nutritional Supplementation on Final Height

The proposed study is an extension study to two ongoing double blind, randomized, placebo-controlled studies evaluating the effect of gender-specific nutritional supplementation on growth of short and lean adolescent boys and girls. The aim of the current study is to extend these short term double blind, randomized, placebo controlled studies (one in boys and one in girls) and to add an extension study, which will evaluate the long term effect of the gender specific nutritional supplementation on final height. Patients completing the ongoing studies will be offered to continue treatment with the study formula until final height. Patients reluctant to continue to consume the study formula will be offered to continue followup only during the extension study without any intervention.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the former double blind, randomized, placebo controlled study to evaluate the effect of nutritional supplementation on growth of short and lean adolescent boys (protocol no. 0676-14) and girls (protocol no. 0002-15).
* Completing at least the double blind phase of the previous studies (protocol no 0676- 14 or 0002-15)
* Signing informed consent forme

Exclusion Criteria:

* Diagnosis of Growth Hormone Deficiency or treatment with Growth Hormone
* Any known chronic disease or dysmorphic syndrome including: bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems
* Any known gastrointestinal disease including malabsorption
* Any known organic reason for growth retardation
* Any chronic treatment with medication that might affect appetite, weight or growth
Longitudinal Study of Asymptomatic Rotator Cuff Tears

The purpose of this study is to analyze the natural course of asymptomatic rotator cuff tears.

Fifty subjects with an asymptomatic rotator cuff tear were identified in an earlier study. Clinical, sonographic and MRI reexamination of these subjects is performed after an interval of three years. Findings of interest include: (1) the symptomatic status of the subjects (still asymptomatic or symptomatic); (2)tear size on sonography and MRI (unchanged or increased); (3)degree of muscle atrophy on MRI (unchanged or deteriorated); (4)degree of fatty muscle degeneration on MRI (unchanged or deteriorated). We want to analyze whether a change in these tear characteristics is associated with a change of the symptomatic status of these subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with an asymptomatic rotator cuff tear at least in one shoulder, tear demonstrated both on MRI and sonography, ASES score exceeding 90 points

Exclusion Criteria:

* Earlier periods with shoulder pain and dysfunction, earlier treatment for shoulder problems
MicroRNA Mediates Volatile Anesthetics Preconditioning Induced Artery Protection

It has been reported that volatile anesthetics preconditioning mediates protection of organ via microRNA. We want to study on the effects of isoflurane preconditioning on expression of microRNA and mRNA in the specimens of internal mammary artery and ascending aorta.

1. Sixty patients scheduled for off-pump coronary artery bypass surgery were randomly assigned to isoflurane wash-in/wash-out group(S-I group, n=30)or propofol intravenous anesthesia group(P group, n=30).
2. Anesthesia and monitoring method All patients were monitored according to the American Society of Anesthesia guidelines and received standard general induction of anesthesia.
3. SI group:10min after intubation,begin to isoflurane wash-in/wash-out operation:isoflurane administration was interrupted for at least 10 min,by washout with a high fresh gas flow(10 l/min)to achieve a MAC value below 0.2. Following the interruption,sevoflurane was again washed in with a high fresh gas flow(6 l/min)to achieve 1 MAC end-tidal concentration as soon as possible,and repeated twice periods of 10 minutes.Discontinuation of the halogenated agent for at least 15 minutes during the last wash out time.
4. P Group:propofol infusion 3-5μg/kg/h.
5. When isoflurane inhaled anesthetic,propofol are stopped infusion.If during this interruption the BIS value increased to\>50,0.5 mg/kg propofol was administered repeatedly in boluses until the BIS value have returned to\<50.

6.1h after isoflurane preconditioning,specimens of internal mammary artery(surplus arterial tissue is obtained from the repair internal mammary artery)and ascending aorta(the stump after ascending aortic punch)will be saved, and before isoflurane preconditioning,1h,3h,5h after isoflurane preconditioning, central venous blood samples will also be drawn.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* written informed consent;
* scheduled procedures;
* planned isolated OPCABG(multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed);
* ejection fraction\> 50%;
* NYHA class Ⅱ\~Ⅲ;
* serum creatinine \<150μmol / l;
* preoperative platelet content \> 100 × 109 / l;
* preoperative hemoglobin\> 120 g / l

Exclusion Criteria:

* pregnancy;
* planned valve surgery or surgery on the aorta;
* left main coronary artery stenosis\> 75%;
* echocardiographic examination revealed moderate to severe mitral, tricuspid, or aortic regurgitation or stenosis;
* unstable or ongoing angina;
* recent (\< 1 month) or ongoing acute myocardial infarction;
* use of sulfonylurea, theophylline or allopurinol;
* previous unusual response to an anesthetic agent;
* inclusion in other randomised controlled studies in the previous 30 days; (10)any general anesthesia performed in the previous 30 days;
* emergency operation (not scheduled);
* kidney or liver transplant in medical history, liver cirrhosis (Child B or C);
* chronic respiratory disease (such as chronic obstructive pulmonary emphysema)
Impact of Consumption of Cowpea Leaves on Postprandial Blood Glucose in Black Adults, a Pilot Study

Intake of foods high in carbohydrates causes a spike in glucose in the blood. Repeated high blood glucose spikes are associated with an increased risk of diabetes. People of black ethnicity have higher risk of diabetes. Vegetables may help in the regulation of blood glucose. Cowpea, also referred to as black-eyed peas (Vigna unguiculata) leaves, contain polyphenols and fibre that can help regulate blood glucose.

The study will be an acute, single-blind, randomised control trial with a cross-over design involving healthy black participants aged ≥18 years. This clinical trial aims to investigate if consuming cowpea leaves can reduce blood glucose spikes after consuming a meal high in carbohydrates. Participants will be randomised to consume either bread with jam containing freeze-dried cowpea leaves (active intervention) or jam without any freeze-dried powder (control group). Blood glucose will be monitored before the intervention and every 15 minutes after the intervention using a continuous glucose monitor.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years
* Participants from Black, Black British, Caribbean or African ethnic backgrounds,which includes: Caribbean, African, Any other Black, Black British, or Caribbean background
* Should be able to give informed consent
* Should be willing to provide GP's contact details

Exclusion Criteria:

* Pregnant or lactating mothers
* Special dietary requirements such as vegetarians and vegans
* Participants who are on a specialised diet such as a weight reduction diet
* Having any chronic illness or taking medication for chronic illness
* Participants whose blood results indicate illness
* Participants on mediation for hypertension or hyperlipidaemia
* Sportsmen or women or vigorous exercise for more than 5 times per week
* Alcohol (more than 14 units per week) or drug abusers.
Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)

The objective of this study is to assess the safety and tolerability of Venofer in patients with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron containing a dextran (INFed or Dexferrum).

This is a Phase IV, multi-center, open label study that assesses the safety and tolerability of Iron Sucrose (Venofer) in subjects with CKD who require intravenous iron for the treatment of iron deficiency anemia (IDA) but cannot tolerate Ferumoxytol or Iron Dextran.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \> or = to 18 years of age
* Determined by treating physician to have chronic kidney disease and require a course of intravenous iron
* Subject did not tolerate an intravenous iron containing a dextran or Ferumoxytol within the last year
* Subjects with hemodialysis-dependent or peritoneal dialysis chronic kidney disease should be receiving an erythropoiesis stimulating agent (ESA) as per the iron sucrose package insert

Exclusion Criteria:

* Known history of hypersensitivity or significant intolerance to iron sucrose
* Evidence of iron overload
* Hemochromatosis or other iron storage disorders
* Received an investigational drug within 30 days of screening
* Any other laboratory abnormality, medical condition or psychiatric disorder which would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
* Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
To Establish a Novel Prototype of Clinical Pharmacy Services by Warfarin Consultation in a Pharmacist Clinic

Warfarin, the major oral anticoagulant currently available in Taiwan, is used for the prevention and treatment of a variety of thromboembolic disorders. Under dosing of warfarin may cause treatment failure and over dosing may cause bleeding because of its narrow therapeutic index. Therefore, it is important to monitor prothrombin time (PT) and international normalize ratio (INR) periodically in order to evaluate the appropriateness of warfarin dosing.

Lots of factors influencing warfarin anticoagulation effects include polymorphisms of Cytochrome P450 2C9(CYP2C9)and Vitamin K epoxide reductase complex subunit 1(VKORC1)genes, age, weight, diet and concurrent medications. Taking into consideration of physicians' work load, pharmacist-managed anticoagulation clinics were set up to help strengthen patient care in US to ensure patient medication safety. In addition, differences in genetic polymorphisms between Chinese and Caucasian have great impacts on warfarin dosage, and there is still no consensus on warfarin utilization guideline in Taiwan. Pharmacist-managed anticoagulation clinics provide individualized care, consistent monitoring and patient education. Through this service, physicians can get the latest integrated information about their patients, patients themselves are more familiar with their medication, and adherence can be improved. Therefore, those who take warfarin will get better INR control, less adverse drug-related events and treatment failure.

This is the first prototype of pharmacist clinic for a specific medication in our hospital. The adverse drug events and coagulation function data collected through this program can be used for the implementation of warfarin treatment guideline in Taiwan in the future. The impact of pharmacist clinic can be evaluated by questionnaire of satisfaction and knowledge survey. It can be used as a model for implementing other pharmacist-managed clinics and improving patient medication safety.


Eligibility Criteria:
Inclusion Criteria:

* \>20 y/o
* Has been received warfarin therapy for 3 months and anticipated treatment duration of more than 3 months and a week
* Has legitimate indication for warfarin
* Has the capacity to understand the condition and implications of anticoagulant therapy

Exclusion Criteria:

* Who can't be regular follow-up at National Taiwan University Hospital.
Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks.

This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks. Subjects will be titrated to an optimum dose of study treatment and assessed for safety and efficacy. Dermal response will be evaluated at each visit by the investigator. Subjects with high dermal response scores or scores that persist at the same application site and have no improvement after up to 4 evaluations (not to exceed a two week period) will be discontinued from the study and referred to a study specific dermatologist for specialized skin sensitivity skin patch testing.

Eligibility Criteria:
Inclusion Criteria:

* Must sign informed consent.
* Male or female 6-12 years old.
* Negative pregnancy test.
* Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD.
* No co-morbid illness that could affect safety, tolerability or interfere with participation.
* Blood pressure (BP) within the 95th percentile for age, gender, and height.
* Willing and able to comply with all the requirements defined in protocol.

Exclusion Criteria:

* Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder \[ODD\]).
* At risk for suicidal or violent behavior towards self or others.
* History of a suicide attempt.
* History of a structural cardiac abnormality or other serious cardiac problems.
* Non-responder to psychostimulant treatment.
* Is overweight.
* Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
* Has Conduct Disorder.
* Known history of alcohol or other substance abuse within the last 6 months.
* Any abnormal thyroid function.
* A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments.
* Has had treatment with any known liver altering agents within 30 days prior to Screening.
* Taking any excluded medication.
* Previous use of DAYTRANA.
* Taking other medications that have Central Nervous System (CNS) effects.
* Female subject is pregnant or lactating.
* Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions.
* Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
* Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites.
* A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.
A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

An eight-week, randomized, double blind, two parallel groups, study to assess clinical response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for severe depression.


Eligibility Criteria:
Inclusion Criteria:

Male or female patients of ≥ 18 years of age that meet criteria for severe Major Depressive Disorder, without psychotic features (according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, \[DSM-IV\] and confirmed by Mini International Neuropsychiatric Interview \[MINI\]).

* With a total score Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 30 and 6-item Hamilton Depression Rating Scale (HAMD-6) ≥ 12 and Clinical Global Impression of Severity (CGI-Severity) ≥ 4 at both screening and baseline.
* Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit 4.
* Patients willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol.
* Informed consent document must be signed at screening visit, in accordance with Good Clinical Practice (GCP) and local regulatory requirements, prior to any study procedure.

Exclusion Criteria:

* More than two previous episodes of major depression that did not respond (according to investigator's opinion) to adequate doses and duration of two different antidepressant therapies.
* Lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode.
* Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major Depressive Disorder, in the investigator's judgment.
* Any previous diagnosis of a bipolar disorder, schizophrenia or OCD.
* Depression with catatonic features (according to DSM-IV), depression with post-partum onset, or organic mental disorders.
* The presence of an Axis II disorder