cyrilzakka/clinical-trials huggingface dataset:
Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects With Hemophilia B

The Study's Primary Objective is to evaluate the pharmacokinetics, safety (acute effects associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding and control of hemorrhaging during prophylaxis) of IB1001 in previously treated pediatric subjects with hemophilia B.


Eligibility Criteria:
Inclusion Criteria:

1. Subject's parent or legal guardian must give written Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent and be willing to make the required study visits and follow instructions while enrolled in the study. For subjects ≥7 years of age, assent will be obtained if required by the institution. For subjects \< 7 years of age, legal assent is not reasonable to obtain.
2. Severe (factor IX activity ≤2 IU/dL) hemophilia B subjects currently on-demand therapy with a minimum of 2 bleeding episodes requiring factor IX therapy over the preceding 6 months or 4 bleeding episodes over the preceding 12 months; subjects on prophylaxis with a bleeding pattern similar to that above demonstrated prior to starting prophylaxis
3. Immunocompetent (CD4 count \>400/mm3) and not receiving immune modulating or chemotherapeutic agents
4. Previously treated patients with a minimum of 50 exposure days to a factor IX preparation
5. Platelet count at least 150,000/mm3
6. Liver function: alanine transaminase \[ALT\] and aspartate transaminase \[AST\] ≤2 times the upper limit of the normal range
7. Total bilirubin ≤1.5 times the upper limit of the normal range
8. Renal function: serum creatinine ≤1.25 times the upper limit of the normal range
9. Willingness to participate in the trial for approximately 6 months (50 exposures)
10. Age ≤12 years
11. Hemoglobin ≥7 g/dL at the time of the blood draw

Exclusion Criteria:

1. History of factor IX inhibitor ≥0.6 Bethesda units (BU)
2. Existence of another coagulation disorder
3. Evidence of thrombotic disease, fibrinolysis, or disseminated intravascular coagulation (DIC)
4. Use of an investigational drug within 30 days prior to study entry
5. On medications that could impact hemostasis, such as aspirin
6. History of poor compliance, a serious medical or social condition, or any other circumstance that, in the opinion of the investigator, would interfere with participation or compliance with the study protocol
7. History of adverse reaction to either plasma-derived factor IX or recombinant factor IX that interfered with the subject's ability to treat bleeding episodes with a factor IX product
Exercise, PA, Sleep Quality and Cognitive Function Among Older Adults.

The rapid increase in the prevalence of dementia in Taiwan poses an economic burden on healthcare systems as well as the families of the patients. Thus, how to prevent dementia is a crucial issue. Mild cognitive impairment (MCI) is defined as cognitive decline objectively and subjectively and it has been deemed as a transitional state between normal cognition and dementia. Identifying and preventing MCI can be a venue for reducing the prevalence of dementia. Sleep and physical activity are modifiable risk factors of MCI. Both factors could influence brain structure, such as the volume of the hippocampus. As a result, physical activity and adequate sleep are helpful to prevent the decline of cognitive function. In addition, sleep could regulate physical activity and change cognitive function indirectly. To our knowledge, there has been no research investigating the relationship between sleep, physical activity, and cognitive function in Taiwan. Hence, this research will aim to explore the relationship between sleep, physical activity, and cognitive function. Whether sleep and physical activity can be predictors of MCI will be investigated. We will recruit 150 participants aged above 65, who haven't been diagnosed with MCI or dementia. The measurements will include the Chinese version of The Pittsburgh Sleep Quality Index (PSQI), the Chinese Version of the Physical Activity Scale for the Elderly (PASE-C), and the Chinese version of Montreal Cognitive Assessment (MoCA). The relationship between sleep, physical activity level, and cognitive function will be analyzed by multiple linear regression and Pearson correlations. A prediction equation will be established.


Eligibility Criteria:
Inclusion Criteria:

* aged above 65
* haven't been diagnosed with MCI or dementia
* be able to read and write in Chinese

Exclusion Criteria:

* elders who unable to talk or communicate
Systematic Follow up of Drug Treatment by Pharmacists in Secondary Prevention After Transient Ischemic Attack

Use of drugs is an important factor in secondary prophylaxis after transient ischemic attack (TIA), but studies show that adherence to the prescribed drugs is often poor. This randomised controlled trial aims to investigate whether a systematic follow up of drug treatment using medication reconciliation, medication reviews and patient counselling by clinical pharmacists, improves adherence and/or decreases cardiovascular events the first three months and the first year after TIA. Patient satisfaction will also be compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Probable or possible transient ischemic attack
* Residing in Central Norway
* Examined within 2 weeks after the onset of symptoms
* Modified Rankin Scale 3 or less and living at home
* enrolled in the MIDNOR-TIA study NCT02038725
* Informed consent
Impairments That Affect Correct Inhaler Use in COPD

INHALE is a one-year, multi-site observational research study funded by Viatris, with two aims:

1. Determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with chronic obstructive pulmonary disease (COPD).
2. Assess the relationship of cognitive impairment and impaired manual dexterity with patient errors using current pMDIs, SMIs and/or DPIs.

To prescribe inhaled therapy for patients with COPD, health care professionals (HCPs) must make three decisions: short vs long-acting medication, medication class (beta2 agonists, muscarinic antagonists and/or corticosteroids) and delivery system.

At present, there is no guidance by national and international groups of experts on selecting the most appropriate delivery system for patients with COPD. On the other hand, there is a general belief among HCPs that there is no difference in efficacy among pressurized metered dose inhalers (pMDIs), slow mist inhalers (SMIs), dry powder inhalers (DPIs), and nebulizer delivery if the patient uses correct inhaler technique. Unfortunately, there is extensive evidence that patients with COPD exhibit numerous errors using hand-held devices. Experts have opined that HCPs should consider prescribing nebulizer medications for patients with COPD based on various factors or conditions, particularly cognitive impairment and problems with manual dexterity. However, there is little if any supportive evidence for these recommendations.

In stable out-patients with an established diagnosis of moderate to very severe COPD (pulmonary function tests within the last 12 months that demonstrate FEV1 \< 60% Predicted required for screening purposes), we hypothesize the following:

1. Cognitive impairment (mild to severe) is present in \> 20% of this COPD population
2. Impaired manual dexterity (minimally functional to nonfunctional) is present in \> 20% of this COPD population
3. Both cognitive impairment and impaired manual dexterity are associated with patient errors using their current hand-held inhalers.

The objectives of this study are:

1. To determine the prevalence of both cognitive impairment and impaired manual dexterity in stable out-patients with COPD
2. To assess the relationships of cognitive impairment and impaired manual dexterity with patient errors using their current pMDIs, SMIs, and/or DPIs.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 60 years
2. \> 10 pack-years smoking cigarettes
3. Diagnosis of COPD based on GOLD Criteria
4. Pulmonary function tests showing FEV1 \< 60% predicted (pre-BD).
5. Current use of one or more hand-held inhalers (pMDIs, SMIs, and/or DPIs).

Exclusion Criteria:

1. Current diagnosis of dementia or known cognitive impairment -OR-
2. Current diagnosis of impairment in manual dexterity including severe rheumatoid arthritis, severe arthritis/weakness of the hand/wrist, Parkinson's disease, and/or history of a previous cerebral vascular accident (CVA) resulting in significant musculoskeletal deficit (in judgement of PI).
Efficacy of Vitamin E in Preventing Contrast-Induced Acute Kidney Injury Following Coronary Angiography

The purpose of this study is to evaluate the effect of vitamin E on preventing from incidence of contrast induced acute kidney injury (CI-AKI) in the patients who undergone coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

1. All patients whon have either stable coronary artery disease (CAD) or recent acute coronary disease (ACS) and are scheduled for coronary angiography.
2. Patients who have eGFR ≤60 ml/min/1.73 m2

Exclusion Criteria:

1. Allergy to contrast media
2. Cardiogenic shock
3. Pulmonary edema
4. Overt cardiac failure or left ventricular ejection fraction ≤ 30%
5. Acute kidney injury
6. The history of receiving contrast media for any medical diagnostic or therapeutic procedures during previous 5 days
7. The history of dialysis
8. Being pregnant
9. Having recent acute myocardial infarction
10. Taking antioxidants and nephrotoxic drugs including NSAID and ACE-I on previous 2 days
Study of AAV-GAD Gene Transfer Into the Subthalamic Nucleus for Parkinson's Disease

The purpose of this study is to determine the safety and efficacy of AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. This study involves the treatment of subjects with medically refractory Parkinson's disease (PD). The gene transfer product, a disabled virus with a gene called GAD, will be infused into the STN bilaterally using stereotactic surgical techniques. The overall goal of this approach is to normalize the activity of the STN and reduce the motor symptoms of PD.

Because the change in UPDRS demonstrated a positive outcome, the sham surgery subjects from the blinded portion of the study will be invited to crossover into the Open-label Arm portion of the study. The Open-label Arm will further evaluate the safety and efficacy of AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* Duration of disease for at least 5 years
* Levodopa responsiveness for at least 12 months
* UPDRS Part 3 score ≥ 25 or more in "off" state

Exclusion Criteria:

* Past history of brain surgery for PD
* Beck Depression Inventory Score ≥ 20
* Any history of cerebral insult or central nervous system infection
* Cognitive impairment score \< 130 on the Mattis Dementia Rating Scale
* Focal neurological deficits
* Evidence of significant medical or psychiatric disorders
* Secondary Parkinsonism
* Atypical Parkinson's disease
* History of substance abuse
Electroencephalographic Changes Under General Anesthesia in Patients With Gynecologic Cancers With and Without History of Chemotherapy

This study compares changes in brain waves in women with gynecologic cancers who have or have not received chemotherapy and who are scheduled to receive surgery as part of their standard care. Electroencephalography is a test that measures brain waves and may help learn if sensitivity to anesthesia is higher in women who have received chemotherapy than women who have not. This study may help researchers learn if receiving chemotherapy before surgery can affect the way the brain responds to anesthesia during and after surgery.

PRIMARY OBJECTIVE:

I. To assess electroencephalography (EEG) changes of women with and without history of chemotherapy exposure undergoing volatile general anesthesia.

SECONDARY OBJECTIVE:

I. To evaluate if chemotherapy-induced cognitive impairment is associated with an increased sensitivity to general anesthetic agents captured by the patient state index (PSI) and observable in changes in alpha (8-12 H) activity in the frontal regions of the EEG) and other study features such as EEG power, burst suppression analysis, burst suppression ratio, and coherence analysis.

EXPLORATORY OBJECTIVES:

I. To assess the relationship between preoperative cognitive function and electroencephalographic changes under general anesthesia.

II. To assess the relationship between EEG signatures under general anesthesia and postoperative cognitive function.

III. To collect blood specimens for extracting information on serum lipids and cytokines at two different times, before anesthetic induction, and 30 to 60 minutes upon arrival to the postoperative anesthesia care unit.

OUTLINE:

Patients undergo cognitive function assessment BrainCheck over 10 minutes before surgery, day 1 after surgery, and day 2 after surgery (if patients are still admitted to the hospital) and 3D-confusion assessment over 10 minutes twice daily (BID) on day 1 after surgery and day 2 after surgery (if patients are still admitted to the hospital). Patients also undergo EEG during surgery and collection of blood samples 30-60 minutes after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent;
2. Women between 40-60 years of age; with or without history of systemic chemotherapy;
3. American Society of Anesthesiologists physical status (ASA) 1-3;
4. Scheduled surgery: open gynecologic surgery;
5. Able to complete all study questionnaires.

Exclusion criteria:

1. Emergency surgery
2. ASA ≥ 4
3. Patients with extra-abdominal metastatic disease
4. Patients unable to complete preoperative and postoperative cognitive tests
5. Non-English-speaking patients
The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers

The objective of this study is to evaluate the systemic exposures of WH-1 ointment which includes Salvigenin and Asiaticoside A in subjects with chronic diabetic foot ulcers following topical application of WH-1.

This trial is designed as an open label, non-comparative study to evaluate the pharmacokinetic profiles of salvigenin and asiaticoside A in subjects who received the treatment of WH-1 ointment for diabetic foot ulcers. A total of 12 subjects will be completed in study. Each subject will be applied the one dose of WH-1 ointment on Day 1 following with the blood sampling collection, then twice a day of WH-1 application from Day 2 to Day 13, and another blood sampling collection scheduled on Day 14 after one dose application.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female is at least 20 years of age;
2. Diabetes mellitus (type I or II) was diagnosed with an HbA1c ≤ 12.0% measured during screening or within three months prior to randomization;
3. The target diabetic foot ulcer must have the following characteristics:

   1. ≤ Grade 2 per Wagner Ulcer Classification System;
   2. Lower limbs;
   3. No-infected;
   4. A cross-sectional area of between 1 and 25 cm2 post-debridement;
4. If female and of childbearing potential has a negative pregnancy test and is neither breastfeeding or intending to become pregnant during the study;
5. Able and willing to follow with study scheduled visits, comply with study procedures, and sign the informed consent.

Exclusion Criteria:

1. Acute Charcot' s neuroarthropathy as determined by clinical and/or radiographic examination;
2. Poor nutritional status defined as an albumin \< 2.5 g/dL;
3. AST and/or ALT \> 3X of the normal upper limit;
4. Clearance of Creatinine (Ccr) \< 30 ml/min;
5. Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids within 4 weeks prior to enroll;
6. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject' s medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance
7. Subjects who have received an experimental agent within 30 days, prior to enroll.
8. Subjects who have received WH-1 ointment within 30 days, prior to enroll.
9. Subjects who have history of smoking (define as more than 20 cigarettes per day) within 3 months prior to admission to the Hospital site.
10. Judged by the investigator not to be suitable for the study for any other reason.
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome

The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome (1999): 1998 research report on immunological intractable diseases specified by the Japanese Ministry of Health and Welfare)
2. Patients aged 20 years or older at time of consent
3. Patients with dry mouth
4. Patients with decreased salivation

Exclusion Criteria:

1. Patients who have developed dry mouth clearly due to a cause other than Sjögren's syndrome
2. Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.)
3. Patients who have received rebamipide within 3 months prior to obtaining informed consent
4. Patients who are pregnant, possibly pregnant, or lactating
5. Patients with a history of hypersensitivity to rebamipide
6. Patients who have received any other investigational drug within 3 months prior to obtaining informed consent
7. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
Influence of Dietary Nitrate on Vascular Dysfunction and Inflammation

The principal research objective is to determine whether inorganic nitrate in the form of beetroot juice compared to placebo control prevents the systemic inflammation that underlies typhoid vaccine-induced endothelial dysfunction

We wish to determine in a prospective manner whether inorganic nitrate affects the endothelial dysfunction induced by systemic inflammation. At baseline we will measure flow-mediated dilatation (FMD) and peripheral augmentation index, as well as aortic stiffness, as measured by pulse wave velocity (PWV). Volunteers will then receive \~8 mmols of dietary nitrate or nitrate free placebo juice once daily for 6 days. After this, depending on availability, volunteers will receive a typhoid vaccine Typherix®, GlaxoSmithKline UK or Typhim Vi ™, AAH Pharmaceuticals Ltd). This vaccine generates a mild systemic inflammation that is associated with vascular dysfunction. All vascular function measures will be repeated at 8 hours and 32 hours after vaccine administration.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers
2. Aged 18-45
3. Volunteers who are willing to sign the consent form.
4. Normal resting blood pressure (\<140/90 mmHg)

Exclusion Criteria:

1. Healthy subjects unwilling to consent
2. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result
3. History of any serious illnesses, including recent infections or trauma
4. Subjects taking systemic medication (other than the oral contraceptive pill)
5. Subjects with self-reported use of mouthwash or tongue scrapes
6. Subjects with recent (3 months) or current antibiotic use
7. Subjects with a history, or recent treatment of (within last 3 months) any oral condition (excluding caries), including gingivitis, periodontitis and halitosis
8. Subjects with a history of typhoid vaccination in the last 6 months
9. Subjects with any history of a blood-borne infectious disease such Hepatitis B or C virus, or HIV
Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps

Cold snare polypectomy (CSP) is now common practice and has proven to be a safe and effective technique for removal of diminutive polyps. Both thick and thin wire snares are now commonly used for CSP. However, because of their physical characteristics, thick wire snares might leave a higher percentage of residual adenoma at the resection site. Since this may result in a higher risk of recurrence, the technique needs to be optimized. Experts have suggested that a thin wire snare might be more efficient, with a lower risk of residual adenoma at the resection site and consequently a lower risk of recurrence and interval cancer.

Approximately 90% of polyps are smaller than 10 mm. Given the risk of transformation of adenomas into invasive cancer over years, it is important that these adenomas are completely resected.

This will be a double-blind, prospective, randomized controlled trial. All eligible patients referred for a colonoscopy will be able to participate. There will be 2 treatment arms, one arm will be treated with a thin wire snare and the other with a thick wire snare. Patients will be randomised through a computer generated programme and blinded for the type of snare used. The treatment arm will be disclosed to the proceduralist after introduction of the colonoscope into the rectum. After resection of the polyp the defect will be carefully examined by the proceduralist. In case of suspicion of residual adenomatous tissue, a re-excision will be performed. If there's a protrusion noticeable at the resection site, this will be biopsied. Ultimately, the margins of the defect will be biopsied on either side for histological confirmation of complete removal.

Eligibility Criteria:
Inclusion Criteria:

* Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
* Patients referred to Auburn Hospital Endoscopy Unit for a colonoscopy for whatever reason
* At least 1 lesion \<10mm beyond the rectosigmoid junction without any endoscopic features of malignancy
* At least 1 lesion \<10mm beyond the rectosigmoid junction that according to the proceduralist, can be safely removed with CSP

Exclusion Criteria:

* Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted
* Known coagulopathy
* Pregnancy
* If any doubt about the benign character of the polyp, the patient will be excluded from the study