cyrilzakka/clinical-trials huggingface dataset:
Microcirculatory Alteration by a Vascular Occlusion Test Using Near-infrared Spectroscopy in Pediatric Cardiac Surgery

Cardiopulmonary bypass cause microcirculatory alterations. Near infrared spectroscopic measurement of tissue oxygen saturation and vascular occlusion test are novel technologies for assessing the microcirculatory function of peripheral tissue specifically in patients undergoing cardiac surgery with cardiopulmonary bypass

Cardiac surgery and cardiopulmonary bypass (CPB) procedures cause microcirculatory alterations, and microvascular alterations and the impairment of tissue oxygen saturation (StO2) after cardiac surgery with CPB have been associated with adverse patient outcomes. It has been shown that contact with foreign surfaces causes transient microcirculatory dysfunction and activation of the inflammatory and hemostatic systems and that tissue trauma and anesthesia also affect microcirculation. Although microcirculation is affected by surgery with CPB, monitoring of the microcirculatory function is still not part of routine practice. Continuous real-time monitoring may aid in the early detection of tissue malperfusion.

StO2 measurement using NIRS and vascular occlusion testing (VOT) are novel techniques for assessing the microcirculatory function of peripheral tissue, specifically in patients undergoing cardiac surgery with CPB. The level of StO2 is determined by the amount of oxygen delivered and consumed. The deoxygenation rate, minimum rSO2, and reoxygenation rate measured using VOT may indicate tissue perfusion, the local metabolic rate, the oxygen reserve, and microvascular reactivity. It has been shown that prolonged exposure to CPB is associated with abnormal vasomotor responses and end-organ dysfunction. Although the INVOS system is not commonly used for VOT in children undergoing cardiac surgery with CPB, we hypothesized that using this noninvasive method to measure StO2 would allow detection of the local metabolic rate and local tissue perfusion adequacy change and that StO2 changes would reflect the preexisting cardiovascular reserve.

Eligibility Criteria:
Inclusion Criteria:

Elective cardiac surgery with CPB

Exclusion Criteria:

* Skin and peripheral vascular disease,
* Taking medicine for vascular disease,
* Emergency procedures
Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth

The purpose of this study is to evaluate the effectiveness of silver diamine fluoride (SDF) compared to chlorhexidine (CHX) as a cavity disinfectant in primary molars after Atraumatic Restorative Treatment approach (ART).

This study is a three arm randomized controlled clinical trial, where children with an age range of 4-6 years indicated for Atraumatic Restorative Treatment (ART) are selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. Sixty teeth are randomly allocated into 3 groups of Atraumatic restorative treatment approaches. Group I is assigned to silver diamine fluoride as an antibacterial agent, Group II is assigned to chlorhexidine as an antibacterial agent, and Group III serves as a negative control.

Eligibility Criteria:
Inclusion Criteria:

* Children free of any systemic disease or special health care needs.
* Class I cavity involving dentin in primary molars.
* Lesion wide enough to allow access of instruments.
* Informed consent fulfilled.

Exclusion Criteria:

* Signs of irreversible pulpitis or pulp necrosis.
* Patients allergic to silver products.
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement

The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach).

The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement during treatment.

Phase 1 (Titration):

Participants will provide written informed consent and receive the first dose of osilodrostat (1-2 mg) in the evening. The following morning, participants will add treatment with at least a physiologic replacement dose of methylprednisolone (4-6 mg/d based on body size in not more than 2 divided doses) and concurrently continue 1-2 mg BID of osilodrostat. Frequent communication is maintained with each participant, at least twice weekly for the first 3 months and weekly thereafter until target osilodrostat dose is reached. Study personnel will ask targeted questions related to the primary endpoint with parameters to notify the study physicians for early signs of adrenal insufficiency. Participants are instructed to double their methylprednisolone dose for intercurrent illness and for symptoms of cortisol deficiency or withdrawal that do not resolve with pausing osilodrostat dosing. Every 4-12 weeks, an AM cortisol, as well as a research sample for steroid profiling (including 11OHA4), is obtained prior to the first doses of methylprednisolone and osilodrostat. The osilodrostat dose is up-titrated as necessary to achieve an AM cortisol goal of \<5 µg/dL. Once the AM cortisol is at goal, a late-night saliva cortisol (LNSC) and 24 h urine free cortisol (UFC) is obtained per standard of care. Osilodrostat titration is continued if necessary until the UFC is also at goal of \<10 µg/24h. Once the AM cortisol and UFC are at goals (\<5 µg/dL and \<10 µg/24h, respectively), the primary endpoint measures are completed, and the participant enters Phase 2.

Phase 2 (Maintenance):

Once the participant reaches what the investigator considers the maintenance doses of osilodrostat and methylprednisolone, participants are followed for a total of 48 weeks from the first osilodrostat dose before being considered at the end of study. The AM serum cortisol, UFC, and LNSC are repeated at the end of the 48-week period and as clinically indicated throughout Phase 2, generally every 3-6 months.

Eligibility Criteria:
Inclusion Criteria:

* Endogenous Cushing syndrome, either following surgery or not candidates for surgery
* Under consideration to receive osilodrostat as part of their clinical care
* Able to provide informed consent.

Exclusion Criteria:

* Treatment with other investigational drugs within 30 days or five half-lives (whichever is longer).
* A history of hypersensitivity to osilodrostat or therapies of a similar chemical class.
A Pharmacist-led Transitions of Care Program

This study was to show the value of pharmacists in providing transitions of care to and improving health outcomes of uninsured populations. It also aimed to demonstrate the feasibility of implementing a transitions of care program in an indigent care clinic with limited resources. We hypothesized that a pharmacist-led transitions of care program will reduce 30-day hospital readmission rates among the uninsured discharged from a community hospital.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or older
* Uninsured
* English speaking
* Discharged from East Alabama Medical Center within the past 16 days

Exclusion Criteria:

* Patients who did not show up for the first follow-up visit with the study pharmacist after being referred by the care coordinator at East Alabama Medical Center
Dexamethasone Vs. Dexmedetomidine for ESPB in Pain Management After Knee Arthroplasty

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for knee arthroplasty

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery.

After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

Local anaesthesia's much lower toxicity threshold makes it essential for its safety. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.

There is considerable research comparing intravenous and perineural dexamethasone and Dexmedetomidine use in orthopaedic surgeries. However, there is a massive lack of research regarding knee surgery and the Erector Spine Plane Block.

In this study, investigators compare perineural Dexamethasone and Dexmedetomidine.

The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing primary hip arthroplasty
* aged \>18 years and \<100 years
* ASA physical status 1, 2 or 3.

Exclusion Criteria:

* if they refused to participate,
* had a history of opioid abuse,
* had an infection of the site of needle puncture,
* were less than 18 years of age,
* were postponed as having ASA 4 or 5,
* had an allergy to any of the drugs used in the study,
* renal failure (estimated glomerular filtration rate \<15ml/min/1.73m2),
* liver failure,
* known or suspected coagulopathy,
* pre-existing anatomical or neurological disorders in the lower extremities,
* intellectual disability with problems in pain evaluation,
* severe psychiatric illness.
The Outcomes of NRICM101 on SARS-COV-2 (COVID-19) Infection

Traditional Chinese medicine is regarded as a dietary supplement in many countries around the world. Dietary supplement, NRICM101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (COVID-19) in September 2020. It is expected to help people not to progress to severe illness, and reduce lung damage and mortality. The investigators gather the effects of people who taking NRICM101 using the Real-World Big Data Study and the network feedback information collection model. This study can be used as a reference for global prevention and control of coronavirus disease 2019 (COVID-19).

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is raging around the world. Because of its strong spread, variability, survivability, and invisibility, the number of infected people rise rapidly. On March 11, 2020, the WHO officially declared COVID-19 as a pandemic disease. As of October 3, 2020, the number of confirmed cases has exceeded 34 million, and the cumulative deaths have exceeded 1 million. There are still no drugs to treatment the coronavirus disease 2019 (COVID-19). Due to the mutation of virus rapidly, vaccine development cannot be completed in a short period of time. At the beginning of the infection outbreak, the governments of China and South Korea, adopted a cooperative of Chinese and Western medicine to treatment the coronavirus disease 2019 (COVID-19). In addition to the reported good clinical effects, Chinese medicine prescriptions have included in diagnosis and treatment guideline of these two countries.

Traditional Chinese medicine is regarded as a dietary supplement in many countries around the world. Dietary supplement, NRICM101, has been available for people who diagnosed, suspected or prevented for coronavirus disease 2019 (COVID-19) in September 2020. It is expected to help people not to progress to severe illness, and reduce lung damage and mortality. The investigators gather the effects of people who taking NRICM101 using the Real-World Big Data Study and the network feedback information collection model. This study can be used as a reference for global prevention and control of coronavirus disease 2019 (COVID-19).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who confirmed, suspected or prevented infected of COVID 19 disease and take dietary supplement NRICM101

Exclusion Criteria:

* Those who refuse to participate in observational research.
Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials

Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability. Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.

One objective of implant dentistry is to provide excellent esthetics and soft-tissue profiles in the esthetic zone. Esthetic requirements have focused primarily on the position, inclination, shape, and color of the restoration. However, the peri-implant soft tissue also plays a major role in the esthetics of an implant-supported restoration especially in the anterior region.

Eligibility Criteria:
Inclusion Criteria:

* No systemic diseases that might alter the tissue response to implantation.
* Mobility grade 3 at the site of the 4 lateral incisors.
* sufficient available inter-arch space
* normal maxillomandibular relation.
* no temporomandibular joint

Exclusion Criteria:

* Grade 1 or 2 mobility at the incisor's region.
* Patients with systematic diseases that contraindicate implant placement.
A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF

The purpose of this phase Ib/II clinical trial was to: a) evaluate the safety of the co-administration of LDE225 and INC424 in myelofibrosis patients and establish a maximum tolerated dose and/or Recommended Phase II dose of the combination and b) to assess the efficacy of the co-administration of LDE225 and INC424 on spleen volume reduction.

The study is considered to have been completed because the participants completed the study as per study design at the time of trial termination. If participants were already in extension phase until discontinuation criteria were met or alternative setting was available, they were considered as completed. The study was terminated due to one of the compounds being divested.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PMF per 2008 WHO criteria, post-PV MF or post-ET MF per IWG-MRT criteria.
* Ineligible or unwilling to undergo stem cell transplantion.
* PLT counts \> or = 75X 10\^9/L not reached with the aid of transfusions.
* ECOG performance status ≤ 2.
* Palpable splenomegaly defined as ≥ 5 cm below the left costal margin.
* Intermediate risk level 1 (1 prognostic factor which is not age), Intermediate risk level 2, or high risk.
* Active symptoms of MF as demonstrated by one symptom score of at least 5 (0 to10 point scale) or two symptom scores of at least 3 (0 to 10 point scale) on the MF Symptom Assessment Form (MFSAF).

Exclusion Criteria:

* Previous therapy with JAK or Smoothened inhibitors.
* Patient is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg) and LMWH.
* Impairment of GI function or GI disease that may significantly alter the absorption of INC424 or LDE225 (e.g., uncontrolled nausea, vomiting, diarrhea; malabsorption syndrome; small bowel resection).
* Splenic irradiation within 12 months prior to Screening.
* Pregnant or nursing women.
* WOCBP not using highly effective methods of contraception
* Sexually active males who refuse condom use
* Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as HMG CoA inhibitors (statins), clofibrate and gemfibrozil. Pravastatin may be used if necessary, with extra caution.
Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease

The purpose of this research is to evaluate changes in cholinergic brain activity over time in subjects with Parkinson disease.

The project will apply positron emission tomography (PET) of acetylcholinesterase to study non-dopaminergic (i.e. cholinergic) brain changes over time in subjects with Parkinson disease. Acetylcholinesterase PET imaging was used to assess cholinergic changes over time in this study. Acetylcholinesterase PET imaging is a diagnostic test as the investigator does not assign specific interventions to the subjects of the study based on the acetylcholinesterase PET. Therefore, this is an observational study as defined as following: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria for PD.
* Hoehn and Yahr stages 1-2.5 at initial recruitment in baseline study.
* Absence of dementia confirmed by neuropsychological testing at initial recruitment in baseline study.

Exclusion Criteria:

* contra-indication for magnetic resonance study
* Pregnancy or breastfeeding
Microcirculation Evolution in Patients After Cardiac Surgery

We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients after cardiac surgery and compared the evolutions of those parameters between patients with tissue hypoperfusion and normal perfusion. Consecutive patients after cardiac surgery who required mechanical ventilation and for whom sublingual microcirculation measurements were possible enrolled.

We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients after cardiac surgery and compared the evolutions of those parameters between patients with tissue hypoperfusion and normal perfusion.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients after cardiac surgery.
* Patients whom sublingual microcirculation measurements were possible.

Exclusion Criteria:

* moribund patients
Prospective Evaluation of Performance of Disposable Elevator Cap Duodenoscope During ERCP in Clinical Practice

Purpose: To evaluate overall performance of disposable TIP duodenoscopes and get insight from end-users regarding its performance during various steps of ERCP procedure as well as ease and feasibility of pre-procedure duodenoscope set up and post procedure manual cleaning as well as reprocessing.

Research design: This is a prospective observational multi-center study. Procedure used: During ERCP

Risks and potential benefits: There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future.

Importance of knowledge that may reasonably be expected to result: The quality of health care which will be crucial to identify patterns of competence and identify areas of continued improvement. More specifically in the quality metrics sector we will be able to see what is already in place and steps we will undertake that will be beneficial for physicians.

This is a prospective study to evaluate performance of disposable TIP duodenoscopes. Scope is designed to facilitate effective reprocessing of duodenoscope and thus prevent future outbreaks related to contaminated duodenoscope despite standard reprocessing.

This is a multi-center study being performed at the University of Texas Health Science Center, Wake Forest Baptist Health and Institute of Gastroenterology in Ecuador. The study will enroll a total of 100 patients who undergo ERCP. The study is purely observational as it will collect clinical success and information of the TIP duodenoscope.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patients undergoing ERCP.
* Patient has a clinical indication for ERCP.

Exclusion Criteria:

* Any patients less than 18 years old undergoing ERCP as medical necessary procedure.
* Patients who refuse to consent for ERCP procedure.
Comparison of Different Functional Capacity Tests in Cystic Fibrosis Patients With Acute Pulmonary Exacerbation

The aim of this study to investigate and compare functional capacity with different tests and to evaluate the relationship between functional capacity and quality of life during acute pulmonary exacerbation in children with cystic fibrosis.

Exercise tests associated with prognostic values in CF patients and decreased exercise capacity has been correlated with a reduction in health-related quality of life. Pulmonary functions, functional capacity and quality of life will examine in this study.

This study will be participated children with cystic fibrosis who will diagnosed acute pulmonary exacerbation. Patients' pulmonary function test, functional capacity will be assess and record at hospital admission and hospital discharge and outpatient clinic control. Quality of life will be evaluated at only outpatient clinic control .

Pulmonary function test will be assessed with spirometry, functional capacity will be evaluated with 1-minute sit to stand test and 3-minute step test. And quality of life will be evaluated Cystic Fibrosis Questionnaire-Revised (CFQ-R).

Eligibility Criteria:
Inclusion Criteria:

* Childrens with CF diagnosed between 7-18 years of age and hospitalized due to acute pulmonary exacerbation will be included in the study.The diagnosis of acute pulmonary exacerbation will be established by Fuchs criteria.

Exclusion Criteria:

* Patients with allergic bronchopulmonary aspergillosis (ABPA) who were treated with systemic steroid therapy and noninvasive mechanical ventilation support will not be included in the study.
The Association Between Post-ERCP Acute Pancreatitis and Various Genetic Mutations

Pancreatitis remains the most common complication of ERCP, with the reported incidence ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may develop severe pancreatitis, that means additional morbidity and risk for death. ERCP, despite the development of new diagnostic tools, remains a widely used procedure, so post-ERCP pancreatitis is a problem with significant impact. Several studies and meta-analyses helped us to recognize special factors that put an individual in high risk for the development of post-ERCP pancreatitis. Among these factors special interest presents the history of post-ERCP pancreatitis as an independent risk factor for a new episode of post-ERCP pancreatitis. It seems that some individuals have a genetically predisposed susceptibility in this particular complication. The aim of the present study is to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing.

This study includes patients who are at high risk of post-ERCP pancreatitis. Blood samples will be gathered to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing. DNA for whole genome sequencing will be extracted using DNA extraction kit (Qiagen Inc., Hinden, Germany) and the concentration \& purity of DNA will be measured using Nanodrop (Nano Drop Technologies, Wilmington, DE, USA) or fluorometric quantitation(Qubit fluorometer). Genetic variations which are associated with acute pancreatitis will be searched using whole genome sequencing. Post-ERCP pancreatitis is the primary outcome. Medical records and data of genetic variations will be reviewed for identifying possible risk factors and genetic variations associated with post-ERCP pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo ERCP with high risk factors of post-ERCP pancreatitis

Exclusion Criteria:

* \<18 years old
* current pancreatitis (\<72hrs before ERCP)
* pregnant woman, breast-feeding woman
* patient refusal
* contraindication of ERCP
* patients who would only be treated of bile duct such as a change of stent with previous endoscopic sphincterotomy
* chronic pancreatitis
* patients who underwent gastrectomy (Billroth II or Roux-en Y anastomosis)
* patients who have pancreatic or distal bile duct cancer