cyrilzakka/clinical-trials huggingface dataset:
MRI-SWI as a Predictor of Functional Outcome in Acute Ischemic Stroke

The purpose of the study is to use diffusion tensor imaging (DTI) derived axial diffusivity and susceptibility weighted imaging (SWI) to evaluate the severity of acute ischemic stroke and to predict its functional outcome.

Stroke is the second leading cause of death in Taiwan. The morbidity and mortality of stroke is also very high worldwide. In the United States, about one third of 800,000 stoke patients became disabled; while in Taiwan, 13,000 out of 68,000 stroke patients died each year.

Diffusion tensor imaging (DTI) characterizes the three-dimensional distribution of water diffusion, which is highly anisotropic. Previous studies utilized DTI derived mean diffusivity (MD) and fractional anisotropy (FA) have found correlation between pathological changes of white matter and prognosis of stroke. However, the result was not specific due to the reason that any change at either axon or myelin sheath resulted in FA reduction. DTI, on the other hand, differentiate morphological change at axon and myelin sheath with axial and radial diffusivity, respectively. With this data, we hypothesized that the prognosis might be more relevant to pathological change with axon post-stroke when compare to Diffusion-Weighted imaging (DWI)/Apparent Diffusion Coefficient (ADC).

Susceptibility-weighted imaging (SWI) is a newer technique which use fully velocity compensation gradient echo sequence to receive magnitude and phase imaging. SWI can be used to detect early phase bleed, intra-arterial thrombus, cerebral venous thrombosis, thus evaluate the prognosis of patients by detect leptomeningeal collateral circulation and intravascular deoxygenation changes. We hypothesized that the prognosis is better in post-stroke patients with preserved leptomeningeal collateral circulation and venous circulation of large blood vessel. Therefore, we conduct the study to use DTI derived axial diffusivity and SWI to evaluate the severity and to predict the functional outcome in acute ischemic stroke patient.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 20 years
* Patients with acute pathological changes in CNS within 7 days admitted from outpatient, ER, or inpatient department
* Confirmed diagnosis of acute ischemic stroke by clinical testings and CT scan performed by a neurologist
* Signed informed consent from patient

Exclusion Criteria:

* Any person with pacemaker, metal implant, claustrophobia, or any other contraindication for MR examination
* Any person with epilepsy, brain hematomas, brain tumor, or any neurological disease confirmed by CT scan
* Any other clinical condition which, in the opinion of the principal investigator, would not be suitable for this study
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are:

* Does AP301 lower blood phosphate levels?
* Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level?
* What discomfort or medical problem do the patients have when taking AP301?
* Does AP301 improve quality of life in Chinese patients?

The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate.

In the study, the patients will experience the following stages in a chronicle order:

* Stop all using blood phosphate-lowering drugs,
* Take AP301 or the comparator three times a day for 8 weeks,
* Take AP301 three times a day for 24 weeks, and
* Take AP301 or the comparator three times a day for 3 weeks.

In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment.

If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.


Eligibility Criteria:
Key Inclusion Criteria:

* Provision of signed and dated ICF
* Adult when signing the ICF
* Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
* For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
* Patients who receive phosphate binders over 4 weeks and their serum phosphate level is:

  1. Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL)
  2. After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)

Key Exclusion Criteria:

* History or plan of kidney transplantation
* History or plan of parathyroid intervention 6 months before signing the ICF
* Serum calcium \< 1.9 mmol/L (7.6 mg/dL) or \> 2.75 mmol/L (11 mg/dL) at screening
* Serum intact parathyroid hormone \> 127 pmol/L (1200 pg/mL) at screening
* Presence of clinically significant gastrointestinal (GI) disorder
* History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
* Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care
* Female who are breastfeeding
Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients

The main goal of this pilot study is to assess the time course of eicosanoid profiles in intensive care unit (ICU) patients requiring packed red blood cell (PRBC) transfusion. Moreover we will analyze the change of levels of eicosanoids in patient plasma prior and after a PRBC transfusion as well as its correlation with levels of eicosanoids in the transfused PRBCs. These data will then be used to determine the estimated effect size necessary for the planning of future larger studies. We hypothesize that transfusion of PRBCs will modulate the eicosanoid profile in ICU patients.

According to the Protocol filed with the Institutional Review Board of the Medical University of Vienna and patient's informed consent, subsequent sub analyses using samples of this study (e.g., determination of extracellular vesicles in PRBC samples and patient's plasma) will be performed.


Eligibility Criteria:
Exclusion Criteria:

* Age \<18 years or \>99 years
* Pregnancy
* \<12h since last PRBC transfusion
* intake/administration of acetylsalicylic acid in groups 2 and 3
* intake/administration of cysteinyl leukotriene receptor antagonists (e.g. montelukast)
* intake/administration of celecoxib, etoricoxib, parecoxib, ibuprofen, diclofenac, and naproxen in all groups
* glucocorticoids given within 24h of transfusion in groups 1 and 3
* treatment with calcineurin inhibitors (e.g. tacrolimus) in groups 1 and 3
* treatment with alemtuzumab in groups 1 and 3
* administration of protamine for heparin reversal in groups 2 and 3
Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.

It has been demonstrated that photodamage leads to wrinkles, mottled pigmentation, lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to pre-cancerous conditions with the development of actinic keratosis (AK). The majority of photorejuvenation or photodamaged published studies have used 5-Amino-Levulinic acid (5-ALA) as a photosensitizer, and either a blue light or an Intense Pulsed Light source with a 70%-95% global facial skin improvement. The molecular mechanism of such improvement is unknown, but activation of a non-specific immune response in addition to increased fibrosis and new collagen formation, have both been suggested.

Methyl Aminolevulinate ( MAL) is another marketed photosensitizer mainly utilized in Europe. Lipophilicity, higher penetration depth and tumor selectivity has been advocated for MAL compared to 5-ALA. However, its effect in photodamaged skin has not been well documented.

The aim of the study is to determine the efficacy of MAL + Aktilite (PDT) in facial photodamage.

Study Type: Interventional

Study Design: Randomized, double-Blind, placebo-controlled trial. Official Title: A randomized, double-Blind, placebo-controlled trial of Methyl Aminolevulinate + Aktilite in patients with facial photodamage.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects older than 35 years of age and less than 75 years of age
* Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale
* Subjects willing to participate according to protocol requirements.
* Patients with signed Informed Consent
* Patients with no exclusion criteria

Exclusion Criteria:

* Pregnant or nursing females.
* Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization.
* Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts )
* Subjects with less than 6 months of previous rejuvenation interfering treatments
* Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.
Smoking Topography and Harm Exposure in Menthol Cigarettes

This study will examine how menthol affects smoking when menthol smokers switch to non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples, track cigarette usage and complete smoking topography assessments of smoking behavior.

This study will examine how menthol affects smoking behaviors and biomarker level when menthol smokers switch to non-menthol cigarettes. Participants will initially smoke their preferred brand (control) cigarettes, followed by smoking Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples to measure smoke exposures, track cigarette usage to establish changes in daily cigarette consumption and complete smoking topography assessments of smoking behavior, such as puff volume.

Eligibility Criteria:
Inclusion Criteria:

* Self-report smoking daily cigarettes
* Self-report smoking menthol flavored cigarettes
* Not currently trying to quit or planning to quit in the next 2 months.
* Interested in trying a novel cigarette product and willing to smoke a non-menthol cigarette
* Self-report smoking only filtered commercially made cigarettes

Exclusion Criteria:

* Self-report drinking equal to or greater than a certain number of alcohol-containing drinks per week
* Self report using any nicotine replacement products or nicotine-containing products other than cigarettes
* Self-report substance use disorders in the last 5 years
* Self-report current Axis I psychiatric disorders
* Self-report past history of Axis I psychiatric disorders other than depression
* Self-report myocardial infarction, angina or abnormal rhythms requiring medication
* Self-report use of select medications and illicit drugs within past six months
* Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating
* Provide a baseline carbon monoxide (CO) reading \< 10 ppm at initial session
* Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator
A Study on Patients With Chronic Kidney Disease (CKD) to Assess Treatment Experience and Patterns, Effect of the Treatment, Patient Outcomes and Patient Quality of Life

DISCOVER CKD is an international observational cohort study in patients with CKD, comprising both prospective and retrospective patient cohorts. The study does not attempt to test any specific a priori hypotheses, is largely descriptive, and utilises data collected only under conditions of routine clinical care.

DISCOVER CKD is an international observational cohort study in CKD patients, comprising both prospective and retrospective patient cohorts. The study does not attempt to test any specific a priori hypotheses, is largely descriptive, and utilises data collected only under conditions of routine clinical care. No additional invasive clinical tests or procedures are mandated per study protocol, and all data collected/extracted is based solely on observations of disease management and treatment decisions made between the treating physicians and their patients, and is not intended to be interventional in anyway. Patients will not receive any experimental intervention or experimental treatment as a result of participating in this study. Analyses will be conducted separately for prospective and retrospective CKD cohorts (via interim reports), and then in aggregate by combining prospective and retrospective data, to the extent possible, at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

1. For all countries, except Japan: Male or female patients aged 18 years and over. For Japan: Male or female patients aged 20 years and over.
2. First documented diagnostic code (eg, International Classification of Diseases-10) of CKD (Stages 3A, 3B, 4, 5, or end stage renal disease) or two measures of eGFR of \<75mL/min/1.73 m\^2 recorded at least 90 days apart on or after 1 January 2008, or a code for chronic Renal replacement therapy (hemodialysis and peritoneal dialysis), whichever comes first.
3. Provision of written informed consent - specific for prospective data capture.

Exclusion Criteria:

1. Concurrent participation in any interventional trial at baseline (index) (prospective only). To be implemented based on local regulatory requirements.
2. The patient is undergoing treatment for active cancer, except for non-melanoma skin cancer.
3. Patients with a life expectancy of less than 12 months (prospective only).
4. Diagnosis of cancer on or within the 1-year prior to index (retrospective only).
5. Less than 1-year registration/medical history (pre-index) (retrospective only).
Attain Success Clinical Trial

The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age or older
* Subject will be implanted with Medtronic cardiac resynchronization therapy (CRT) device and Medtronic left heart lead utilizing (or attempting to utilize) Attain Family of delivery catheters. The implant procedure may include upgrades to CRT from implantable pulse generator (IPG) or implantable cardioverter-defibrillator (ICD).

Exclusion Criteria:

* Subject is enrolled in a concurrent study with the exception of a study approved by the Medtronic Clinical Trial Leader prior to enrollment
* Subject has existing CRT system implanted or was previously implanted with a CRT system.
A Study to Evaluate the Safety Profile of an e-Vapour Product

Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes or electronic nicotine delivery devices/systems. These may look like conventional cigarettes but do not contain tobacco.

The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.

This trial is to evaluate the safety of an e-vapour product.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 18-35kg/m2
* Subjects must be established smokers
* Subjects must have smoked five to 30 cigarettes per day for at least one year

Exclusion Criteria:

* Subjects who have used nicotine replacement therapy within 14 days of the screening
* Subjects who have donated blood within 12 months preceding study
* Subjects with relevant illness history
* Subjects positive for hepatitis or Human Immunodeficiency Virus (HIV)
* Subjects with history of drug or alcohol abuse
* Subjects with lung function test or vital signs considered unsuitable
* Subjects who are trying to stop smoking
* Female subjects who are pregnant, or unwilling to use acceptable contraceptive method for the duration of the study.
The Relationship Between Microbiota and Coronary Ectasia

Introduction: It is now known that the microbiota is far beyond the microbial communities living in certain parts of our body and functions like a metabolic organ. In addition, the microbiota, through its metabolites, is involved in the pathophysiology or progression of a wide range of diseases, from atherosclerotic diseases to metabolic diseases and even neurological diseases. Among these metabolites, trimethylamine n-oxide metabolite has been shown to be particularly effective on atherosclerotic heart diseases.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* not having occlusive coronary artery disease
* having coronary ectasia

Exclusion Criteria:

* patients with chronic kidney disease,
* revascularized coronary artery disease,
* previously documented critical coronary stenosis,
* acute or chronic inflammatory disease,
* rheumatologic disease,
* known active malignant disease,
* heart failure,
* moderate-to-severe valvular pathology
* patients who were on any steroid or immunosuppressive therapy
TECHNIQUES USED IN EVALUATION OF GINGIVAL PHENOTYPE

This study evaluates the 4 different techniques used in clinical measurement of gingival phenotype. 1) Tranclusency of UNC-15 Periodontal Probe, 2) Transgingival probing with Endodontic file (#20), 3)Transgingival Probing with Modified Florida Probe and 4) Translucency Colorvue Biotype Probe.

The aim of our study is to evaluate the reliability and applicability of the current examination methods recommended in order to improve the deficiencies of the traditional examination methods used in the evaluation of the gingival phenotype.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy individuals,
* Periodontal healthy individuals with a whole mouth plaque score of 15% and a whole mouth bleeding score of less than 15%,
* Individuals who have not undergone periodontal treatment (subgingival curettage, gingivectomy, crown lengthening, etc.) in the last 6 months,
* Absence of dental compensations of skeletal malocclusion.

Exclusion Criteria:

* Individuals who smoke and have a history of smoking,
* Individuals who have undergone orthodontic treatment,
* Individuals using drugs that may cause gingival hyperplasia (immunosuppressive drugs, calcium channel blockers, anticonvulsant drugs, etc.)
* Individuals who are in pregnancy or lactation period,
* Presence of structural defects, crowns or large restorations in the maxillary anterior teeth to be measured,
* The presence of missing or supernumerary teeth in the maxillary anterior teeth to be measured,
Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients

Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems. Malnutrition is associated with lower physical functioning, lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired quality of life (QoL), and increased mortality. Although the international guidelines recommend early nutritional support in the presence of nutritional risk, the best type of nutritional intervention is still unclear. Individualized dietary counseling showed beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most acceptable in Chinese NPC patients. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials for Chinese NPC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed、pathologically proven nasopharyngeal carcinoma（Stage III/IV）
2. Concurrent radiation and chemotherapy(platinum )
3. Karnofsky score over 60
4. No evidence of metastatic disease
5. No significant cardiac, chest, gastrointestinal or renal morbidities

Exclusion Criteria:

1. age \<18 years
2. ongoing artificial nutrition
3. refusal
Exercise Controls Tumor Cell Growth Through AMPK Activation

The study investigates the explanation for the positive relation found between exercise and breastcancer.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Females age 18-30
* BMI 18-25
* Regular period

Exclusion Criteria:

* Ingestions of any hormones
* Pregnancy
* Chronic inflammation
* Elite athletes
A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs

This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and target sample size is \<100.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=18 years of age
* moderate to severe rheumatoid arthritis of \>/=6 months duration
* synovitis (swollen and tender joint) in the wrist of the dominant hand
* non-biologic DMARDs at stable dose for \>/=12 weeks prior to baseline
* oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline

Exclusion Criteria:

* rheumatic autoimmune disease other than RA
* history of or current inflammatory joint disease other than RA
* functional class IV (ACR classification)
* intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* previous treatment with a biologic agent for RA