cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers

This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total 5-ASA percent of dose excreted (A'e \[%\]) over the 24-hour period on Day 7.


Eligibility Criteria:
Inclusion Criteria:

* Males or females between 18 and 45 years of age, inclusive, at screening and in good general health based on medical history, physical examination, and laboratory evaluation;
* If female, must be (as documented by patient reported medical history):
* postmenopausal (at least 1 year without spontaneous menses), or
* surgically sterile (tubal ligation or hysterectomy), or
* using acceptable contraception \[e.g., sexual partner with non-reversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intra-uterine device\];
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive;
* Able to swallow the assigned study medication tablet whole; and,
* Able to fulfill the requirements of the protocol and provide written informed consent.

Exclusion Criteria:

* History or presence of any condition or gastrointestinal (GI) surgery causing malabsorption or an effect on GI motility;
* Any uncontrolled acute disease or major surgical operation requiring hospitalization within 1 month of screening;
* History of diabetes, syncope, cardiovascular, hepatic, or renal disease;
* Uncontrolled chronic diseases such as hypertension, systemic lupus erythematosus, or rheumatoid arthritis;
* History of cancer within the last 5 years (except for basal cell carcinoma with a documented 6-month remission);
* Any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of treatment;
* Any prescription drug or herbal remedy within 14 days prior to scheduled dosing
Neuropsychiatric Symptoms in Spontaneous Intracerebral Hemorrhage Survivors

Compared to the United Kingdom and the United States, Spontaneous non-traumatic intracerebral hemorrhage (ICH) is more common among people in Taiwan. The prevalence rate of ICH was 14.0% for people aged 36 years or older in Taiwan. Primary ICH originates from the spontaneous rupture of small vessels damaged by chronic hypertension or cerebral amyloid angiopathy (CAA). Emotional disturbances are frequent symptoms in stroke survivors and negatively impact on functional recovery, the patient's quality of life and are distressing for both the patients and their caregivers. Furthermore, the emotional disturbances are associated with impaired cognitive. However, these issues are often unnoticed and most of the studies had been performed in ischemic stroke survivors rather than in patients with ICH.

In this study, we will be recruited participants from National Taiwan University Hospital Bei-Hu branch and National Taiwan University Hospital. We aim to enroll respectively maximum number of 60 patients who had previous spontaneous ICH. Each participant will receive neuropsychiatric assessment, cognitive screening tests, domain-specific cognitive tests, a questionnaire for their quality of life and blood drawing for ApoE genotyping. The main aims of this study include (1) To investigate the prevalence of distinct neuropsychiatric symptoms in ICH survivors (2) To investigate the impact of non-cognitive neuropsychiatric issues on the cognitive functions and quality of life in ICH survivors. Our results may remind clinicians to pay more attention to the early diagnosis and effective management of neuropsychiatric symptoms to improve clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is older than 20-year-old (older than 18-year-old from Jan 1st, 2023) with a past medical history of spontaneous intracerebral hemorrhage.
2. The weight of patient is over 50 Kilograms
3. Patient agrees to participate in the study

Exclusion Criteria:

1. Patients who experience acute phase of stroke or neurological disorders, or vision loss and hearing impairment
2. Patient cannot cooperate with the interview including those with aphasia, conscious disturbance or bedridden status
Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study

This study is an open label trial designed to test the effectiveness of the Tennant Biomodulator® PRO electrical stimulation device (Avazzia), which uses BEST™ (Bio-Electric Stimulation Technology), on hospital in-patients to improve perfusion in the treated and contralateral limb.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide Informed Consent
* Ankle Brachial Index (ABI) ≥ 0.5 (bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to therapy)
* Participant is a hospital in-patient for the duration of study procedures
* One or more chronic lower extremity wounds that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit
* 18 years of age or older

Exclusion Criteria:

* Unable to provide informed consent
* \<18 years of age
* Participant has a demand-type cardiac pacemaker, implanted defibrillator or other implanted metallic or electronic device.
* Participant has untreated osteomyelitis
* Participant has active cellulitis
* Participant has active charcot
* Is pregnant or plans to become pregnant
* Is nursing or actively lactating
* Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the participant's ability to provide informed consent, participate in the study protocol including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
Treatment of the Hutchinson-Gilford Progeria Syndrome With a Combination of Pravastatin and Zoledronic Acid

We suggest treating the Hutchinson-Gilford Progeria Syndrome by two molecules (zoledronic acid and pravastatin).The therapeutic approach which we propose has for objectives to reduce, to prevent or to delay the gravest infringements of the disease, to prolong the life of the children, and in a more general way, aim at improving their living conditions.


Eligibility Criteria:
Inclusion Criteria:

* Molecularly characterised patients with a known mutation of their LMNA gene leading to the production of a farnesylated prelamin A, whether truncated or not
* Patients must be able to travel and consult in Marseille, France for necessary explorations planned at the inclusion step, then following the protocol flow
* chart for zoledronic acid injections and follow-up visits
* Patient older than 3 years
* Patients affiliated or beneficiary of a legal medical insurance
* Adult patients certifying they have been properly informed about the protocol, and they signed a written consent form. Children and/or disabled patients whose parents/legal tutor have been informed and have signed a written consent form

Exclusion Criteria:

* Known hypersensitivity to pravastatin or zoledronic acid
* Seric transaminase levels higher than 3 times of normal value
* CPK level higher than 5 times of normal value
* Creatininemia higher than 0.5mg/dl or 44mM, or creatinin clearance lower than 70ml/min/1.73m3
* Presence of dental troubles, or recent dental trouble
* Maxillary osteonecrosis or bone nakedness antecedent
* Congenital galacosemia, glucose or galactose maladsorption syndrome, lactase deficiency
* Every other pathology thought to be incompatible with proposed treatment by the investigator
* Under treatment that can interfere with pravastatin and/or zoledronate metabolisms
The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study

This project uses a hybrid trial design to evaluate two biomedical interventions targeting the gut-brain axis. One intervention is portable Transcutaneous Vagus Nerve Stimulator, tVNS, that is hypothesized to stimulate the autonomic nervous system, resulting in decreased inflammation and improved cognition. The second intervention is a probiotic supplement intended to replace gut bacteria that are associated with dysbiosis in persons with HIV and alcohol consumption.


Eligibility Criteria:
Inclusion Criteria:

* Age 35-70 years
* English or Spanish speaking
* Alcohol users
* Cognitive impairment
* Current CD4\>350

Exclusion Criteria:

* Diagnosed major psychiatric illness
* Consumption of over 300 drinks in the past 30 days
* Recent opioid use
* Lifetime history of medically-assisted alcohol detoxification
* Inpatient or intensive treatment for addictive behaviors in the past 12 months
* MRI contraindications
* Current antibiotic treatment
* Current probiotic use
* Physical impairment precluding motor response or lying still.
Arteriovenous Fistula Maturation Evaluation Study. FAME Study

Study of the features of hemodynamic and clinical maturation of the native arteriovenous fistula for hemodialysis.

This is a prospective, single-center, observational study, investigating the clinical and hemodynamic features of maturation of hemodialysis native arteriovenous fistula (AVF). Hemodynamic features under investigation are the diameter of the feeding brachial artery, volume of flow (VF) measured with transcutaneous Duplex ultrasound (DUS), resistivity index (RI), diameter and wall thickness of the efferent vein, measured at days 1, 2, 3, 4, 5, 6, 7, 14, 21, 30, 60 and 90 post creation. Clinical features of maturation are the time of first access successful cannulation and the performance of three consecutive adequate dialysis sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Hemodialysis patients
2. new native arteriovenous fistula (AVF)

Exclusion Criteria:

1. Patients not eligible for AVF creation
2. Patients with non compensated heart failure New York Heart Association stages 3 and 4
A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System

This postmarket surveillance study is being conducted to evaluate the TRANSITION Stabilization System as an adjunct to fusion in the treatment of acute or chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The study will involve up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION Stabilization System. The data from this postmarket surveillance study will be provided to FDA in accordance with the 522 order.


Eligibility Criteria:
Inclusion Criteria:

* Any of the following acute or chronic instabilities or deformities of the thoracic, lumbar or sacral spine:
* degenerative spondylolisthesis with objective evidence of neurologic impairment,
* kyphosis, or
* pseudoarthrosis (failed previous fusion)
* Age 18 or older at the time of consent
* Able to understand and sign informed consent form
* Psychosocially, mentally and physically able to comply with protocol
* Able to meet the proposed follow-up schedule at 6 mo, 12 mo, and 24 mo

Exclusion Criteria:

* Prior fusion surgery or another spinal device implanted in the thoracic, lumbar or sacral spine
* Requires treatment of more than two vertebral levels
* Lytic spondylolisthesis at the index level(s)
* Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
* Sustained pathologic fractures of the spine or hip, including prior fracture or trauma to vertebral structures at any thoracic, lumbar, or sacral level
* Morbid obesity defined as a body mass index \> 40, or a weight more than 100 lbs over ideal body weight
* Pregnant or interested in becoming pregnant within the next 2 years
* Active systemic or local infection
* Known allergy to device materials titanium, polycarbonate (PCU), polyethylene terepthalate (PET), or hydroxyapatite (HA).
* Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids, excluding routine NSAIDs)
* Systemic disease including AIDS, HIV, Hepatitis C
* Has an active malignancy defined as a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years
* Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc.
* Participation in an investigational device or drug clinical trials within 30 days of surgery
* Acute mental illness or substance abuse
* Prisoners
Early Diagnosis of Postoperative Acute Renal Failure-using Biomarker to Predict Outcome of Cardiac Surgery Associated Acute Kidney Injury

The purpose of this study is to determine soluble HJV could be an early diagnosis urinary biomarker of ischemia/reperfusion injury in post CPB-patients.

Acute kidney injury (AKI) is a common syndrome on Intensive Care Unit, and renal dysfunction would result in a further morbidity and mortality. Critical ills complicated with acute kidney injury are usually accompanied with multi-organ failure. Therefore, National Taiwan University Hospital Study group of Acute Renal Failure (NSARF) realizes that the characteristics of AKI is resulted from the perfusion less of body fluid and attempt to develop therapies to prevent or attenuate AKI, which have had limited success. We attempt to use the novel biomarker soluble hemojuvelin (sHJV) to evaluate the iron homeostasis on acute kidney injury and develop new strategies and therapies such as protease inhibitors on kidney function, as safety markers to monitor toxicity and as measures of treatment effect. Besides, we will focus on validation the sensitivity and specificity of sHJV on the clinical specimen of post-operative patients from NSARF data-bank. Merge the renal function and other types of biomarkers as panel to predict the post-operative outcome. Based on the different expression of these markers, using a panel of serum and urine markers may potentially help us to distinguish between various types of insults, establish the duration and severity of injury, predict the clinical outcome and help to monitor response to treatment in AKI.

Eligibility Criteria:
Inclusion Criteria:

* AKI is defined as a serum creatinine level greater that 50% more than baseline during the first 3 postoperative days (PODs), and non-AKI, as a less than 10% increase.

Exclusion Criteria:

* Patients with chronic kidney disease (baseline estimated glomerular filtration rate \< 60 mL/min/1.73 m2 as calculated by using the 4-variable Modification of Diet in Renal Disease Study equation, or protein-creatinine ratio \> 100 mg/mmol) are excluded.
Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients

The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for sedation in mechanically ventilated ICU patients.

This is a randomized, open-label, small sample study using fospropofol disodium and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to different treatment groups (including 1 for fospropofol disodium and 1 for propofol). Remifentanil is co-administered with fospropofol or propofol. Efficacy and safety profiles of fospropofol disodium are to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>= 18 and \<= 75 years; Endotracheal intubated; Patients currently on mechanical ventilation \<= 96 hours and expected to be mechanically ventilated \>= 24 hours; Demand for light/moderate sedation (a RASS score of -3 to 0).

Exclusion Criteria:

* Informed Consent is unsigned； Participated in any other interventional research within 3 months; Tracheostomy; BMI \<= 18 and \>= 35 kilograms per square meter Pregnant; Lactant; Known or suspected allergy to various components of the study drug or to opioids and their salvage drugs, or other diseases (such as pancreatitis associated with hyperlipidemia) for which lipid emulsion should not be used; Patients who cannot be evaluated for RASS for various reasons (such as mental illness, acquired or congenital mental retardation, deafness, severe neuromuscular disease, Parkinson's disease, Huntington's disease, Alzheimer's disease, cerebrovascular disease, coma, or severe cognitive impairment due to structural diseases such as stroke, intracranial hemorrhage, head injury, malignancy, hypoxic brain injury, or cerebral edema); Patients with an expected survival period of less than 48 hours; Severe hepatic insufficiency (CTP score is 10-15 points); Chronic kidney disease (CKD grade 3 above); Unstable angina pectoris or acute myocardial infarction; Left ventricular ejection fraction \<= 30%; Heart rate \< 50bpm(intravenous pumping of isoproterenol \<4ug/min, heart rate ≥50bpm may not be excluded); Type 2 second-degree or third-degree atrioventricular block (except those implanted a pacemaker); Two vasoconstrictors are used to maintain SBP above 90mmHg after sufficient fluid resuscitation; Myasthenia gravis; Patients with a history of drug abuse, drug abuse, alcohol abuse and long-term use of psychotropic drugs within 2 years before the screening period. Binge drinking is defined as regular drinking more than 14 times per week (1 time = 150ml of wine or 360ml of beer or 45ml of spirits);
The Effects of Acupuncture on the Risk of AD After TBI

Traumatic brain injury (TBI) is a severely disabling injury which affects 150-200 people per million annually. Increasing evidence suggests that TBI may be a major risk of dementia, Alzheimer's disease (AD) in particular. Postmortem evidence has shown that beta-amyloid (Aβ) deposits, one of the most validated pathological biomarkers of AD, are present in the brains of severe TBI patients. Although the underlying mechanisms remain unclear, the axonal injury may play a role. Imaging investigations have revealed Aβ density maps of TBI patients overlapped with those of AD patients, and increased Aβdensity not only associated with prolonged TBI duration but also associated with decreased white matter integrity. Hence, the increasing accumulation in Aβ due to TBI may contribute to the initiation of the pathological alterations seen in AD. Treatment of TBI may not only be of benefit for the injury itself but also act to block the pathological changes in AD.

As a part of the clinical arm of the project, in this subproject investigators will conduct a single-blind, block-randomized clinical trial to investigate the efficacy of acupuncture in TBI. More specifically, investigators hypothesize that acupuncture intervention will elicit neuroprotective processes and thereby reduce axonal damage in TBI, manifested as (1) decreased plasma levels of Aβ peptide, tau, and glial fibrillary acidic protein (GFAP) and (2) increased white matter integrity after acupuncture. Ninety-six participants will be randomly allocated to the acupuncture intervention (verum acupuncture) or control group (sham acupuncture) in a 1:1 ratio. All participants will receive 20 minutes of acupuncture treatment twice a week for 2 weeks. A set of commonly used acupoints for TBI treatment will be manually stimulated every 10 minutes. The multi-modality magnetic resonance imaging (T1, T2, and diffusion tensor imaging) and blood sample will be taken before and after the acupuncture session to measure the white matter integrity in brain and plasma levels of Aβ peptide, tau, and GFAP, respectively. After integrate these data with other subprojects, we can provide synergic and integrative mechanisms of the effects of acupuncture on the risk of AD after TBI.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 20 years old
2. GCS score \> 13
3. LOC \< 30 minutes
4. hospital admission \< 7 days
5. having adequate competency for understanding the study and a willingness to sign the written informed consent forms
6. be able to commence the acupuncture intervention within 2 weeks after TBI diagnosis

Exclusion Criteria:

1. medical history of neurological, cardiovascular events, or mental disorder, e.g., epilepsy, stroke, major depression or anxiety
2. other major medical conditions, e.g., active cancer, uncontrolled diabetes, pregnancy
3. surgery for TBI
4. receipt of acupuncture within the 6 months prior to study entry
5. patients with pacemaker, metal graft, or claustrophobia
6. preparing for pregnancy during the trial
Tomographic and Histologic Assessment on the Influence of the Use of a Collagen Membrane to Protect the Antrostomy After Maxillary Sinus Floor Augmentation.

the aim of the present study was to evaluate the dimensional variation and osseointegration of mini-implants at augmented sinus with the antrostomy left unprotected or protected with a collagen membrane.

The Schneiderian mucosa will be elevated and the created space will be filled with a natural bovine bone grafting material (Cerabone® 1-2 mm, Botiss Biomaterials GmbH). In ten patients randomly selected (control sties), a native collagen membrane made of porcine dermis (Collprotect®, Botiss Biomaterials GmbH) will be placed on the antrostomy. In another ten patients of the test group, the antrostomy will be left without the membrane. The flaps will be sutured and anti-inflammatory drugs and antibiotics will be administrated to the patients. The sutures will be removed after 7 days. After 6 months of healing, two mini-implants with different surface will be installed and retrieved after further 3 months for histomorphometric evaluations.

CBCTs will be taken for all patients before surgery (T0), after 1 week from sinus floor augmentation (T1) and after 9 months of healing (T2) and evaluation of dimensional variations over time of soft and hard tissues will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Presence of an edentulous atrophic zone in the posterior segment of the maxilla
* Height of the sinus floor ≤4 mm.
* Desiring a prosthetic restoration of the zone using a fix prosthesis supported by implants
* ≥ 21 years of age
* Good general health
* No contraindication for oral surgical procedures
* Not being pregnant.

Exclusion Criteria:The patients will be excluded if they present:

* A systemic disordered.
* Had a chemotherapic or radiotherapeutic treatment.
* Are smokers \>10 cigarettes per day
* Have an acute or a chronic sinusitis.
* Had a previous bone augmentation procedures in the zone of interest.
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)

The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant recipients.

In this study, the whole target area defined by the investigator will be treated by Metvix PDT: this means that both lesions and sub-clinical lesions will be exposed to Metvix PDT. Biopsies will be performed in both regions: lesional and peri-lesional ones. This will allow us to compare pre and post treatment molecular changes that occurred in these regions and so to evaluate if Metvix PDT acts on the sub-clinical lesions.

Eligibility Criteria:
Inclusion Criteria:

* Renal transplant with an history of immunosuppression from 5 to 15 years,
* Presenting at least 4 discrete AK lesions, mild or moderate, either on the face, the scalp, forearms or the chest.

Exclusion Criteria:

* At risk in terms of precautions, warnings, and contra-indication referred in the package insert of Metvix®,
* AK lesions clinically atypical or suspicious for malignancy on the target field,
* Any of the following topical treatments within the specified washout period at Screening:

  * 5-FU, Imiquimod, Diclofenac sodium: 3 months,
  * Cryotherapy: 3 months,
  * PDT: 3 months,
  * Other less common AK treatments: 3 months.
* Systemic retinoids within the last month prior to Screening visit.