cyrilzakka/clinical-trials huggingface dataset:
Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]

To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.

A cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Gluten-free diet for at least 1 year
2. Clinical endoscopy within the past month
3. Biopsies must show no villous atrophy or villous blunting
4. Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater

Exclusion Criteria:

1. 1st degree relative with Celiac Disease
2. Positive tTG IgA, already on simvastatin or statin agent
3. Unable to stop non-steroidal or anti-inflammatory drugs
4. Prior history of GI surgery other than appendectomy or cholecystectomy
5. Taking drugs know to inhibit or activate CYP3A4
6. Unable to avoid food known to inhibit CYP3A4
7. History of a reaction to statin drugs in the past
8. Pregnant or nursing women
Continuous Versus Bolus Administration of G-CSF in Children With Cancer

The investigators hypothesized that in terms of granulocyte colony-stimulating factor (G-CSF) administration, the route of continuous infusion would lead to a faster neutrophil recovery compared to that of bolus administration

The investigators aimed to enroll 40 hospitalized patients in this phase 4 clinical trial. Patients with an ANC lower than 500 cells/mm3 will be randomly categorized into experimental and controlled arms. The experimental arm was designed to receive G-CSF intravenous infusion for 5 hours at a dose of 5 mcg/kg. The controlled arm was designed to receive a G-CSF bolus injection within one minute at a dose of 5 mcg/kg. Three days after treatment initiation, serum white blood cell and differential counts will be followed daily to determine the timing of steady neutrophil recovery. In the following time of another neutropenia event, the experimental arm would cross-switch to the controlled arm and receive corresponding G-CSF according to the study design

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with an age between 0 to 18 years old will be included
* Hematologic and oncologic malignancies

Exclusion Criteria:

* Patients with a diagnosis of myelodysplastic syndrome or severe aplastic anemia will be excluded
* Patients receiving G-CSF treatment 7 days before enrollment will be excluded
* Patients concurrently receiving cytokine therapy or thrombopoietin receptor agonist therapy will be excluded
Tacrobell tab_Phase1_PK

A randomized, open-label, two-way crossover study to assess the tolerability and pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Understand the requirements of the study and voluntarily consent to participate in the study.
2. Healthy male volunteer in the age between 20 and 45 years old.
3. Body weight ≥ 55 kg and 30.0kg/m2 ≥ BMI ≥ 18.0kg/m2

Exclusion Criteria:

1. presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
2. any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug, or major surgery of the gastrointestinal tract except for appendectomy
3. any history of drug hypersensitivity (especially to the active and inactive ingredients of the tacrolimus preparation)
4. administration of cyclosporine or Bosentan
5. administration of potassium sparing diuretic
6. Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
7. SBP \> 150 mmHg or\< 90 mmHg
8. DBP \> 100 mmHg or \< 50 mmHg
9. positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies, RPR
10. AST or ALT \> 1.5\*ULN, e-GFR \< 80 mL/min
11. history of drug abuse or positive drug screening test
12. intake or administration of any ethical or herbal medication medication within 2 weeks, intake or administration of any OTC or vitamin preparations
13. medication with metabolizing enzyme inducers or inhibitors such as barbitals within 1 month before first dosing
14. administration of another study medications within 3 months before first dosing
15. blood donation in 2 months, component blood donation within 1 month or blood transfusion before first dosing
16. Alcohol \> 21 units/week or cannot stop drinking during the study
17. Cigarette \> 10 cigarettes/day or cannot stop smoking during hospitalization
18. consumption of beverages or food containing caffeine(e.g.coffee, tea) during hospitalization
19. consumption of grapefruit or food containing grapefruit during hospitalization
20. Not eligible to participate for the study at the discretion of investigator.
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia

The primary aims of this randomized, single-blinded, 2x2 sham-controlled trial are to 1) evaluate synergistic impact of 8-weeks of transcutaneous auricular vagus nerve stimulation (taVNS) + cognitive-behavioral therapy (CBT) on post-meal gut-brain communication; 2) determine the sequential relationship between treatment-associated changes in gastrointestinal-related anxiety and both clinical functional dyspepsia (FD) improvements and meal-induced physiological outcomes; 3) investigate whether post-treatment changes in gut-brain physiology mediate improvements in FD clinical outcomes. Using a fully non-invasive framework including gastric and brain magnetic resonance imaging (MRI) and taVNS, the investigators aim to evaluate the potential synergy of taVNS and CBT in FD, by assessing the gut-brain physiological response to prandial challenge, linking physiological with symptom improvements.


Eligibility Criteria:
Inclusion Criteria:

Age 18-65 years old (inclusive)

* Ability to give written consent and participate in behavioral intervention in English
* Willingness to attend weekly treatment sessions over live video, daily self-administered transcutaneous auricular vagus nerve stimulation (taVNS) sessions, and engage in homework during treatment
* Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session
* Diagnosis according to the Rome IV criteria for both epigastric pain syndrome and postprandial distress syndrome subtypes
* Stable medical treatment for functional dyspepsia (FD) during 1 month before the study and during the study period

Exclusion Criteria:

* Previous receipt of cognitive behavioral therapy (CBT) for gastrointestinal symptoms
* Enteral or parenteral feeding
* Previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency, or iron overload disorders
* Estimated Glomerular Filtration Rate (eGFR) \< 60
* Medications that affect gastrointestinal motility in addition to medications or products containing tetrahydrocannabinol (THC) will be stopped at least 7 days prior to the start of the study and for the duration of the study. However, anti-depressants (SSRI's, TCA's) may be allowed in order to reduce the risk of worsening neuropsychiatric disease, though it will be up to the study team and the Principal Investigator whether subjects on anti-depressants will be able to participate in the study
* Intellectual disability by history
* Diabetes, mitochondrial disease, severe autonomic dysfunction, and small fiber polyneuropathy
* No active clinical acupuncture therapy
* Illicit drugs or opioid usage
* History of arrhythmias
* Current pregnancy/breastfeeding
* Contraindications for magnetic resonance imaging (MRI) (implanted ferromagnetic objects, claustrophobia)
* Weight \> 450 lbs. (limit of the MRI table)
* Allergy to pineapple (used in the test meal during MRI)
* Any other condition interfering with study requirements, according to the Investigator
Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain

Up to our knowledge there is no study focused upon the incidence of post VATS chronic pain when dexmedetomidine is used.

Most Video-Assisted Throcoscopy Surgery (VATS) procedures are considered low-risk interventions requiring short hospital stays or even outpatient settings. Because of these factors, VATS did not raise as much interest as thoracotomy in its postoperative pain management. However, it is a fact that pain following VATS can be severe and long-lasting .According to Richardson and colleagues, 38% of VATS procedures present persistent pain two months after surgery as a result of acute nerve damage during the surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* ASA II-III
* Adult
* Video-assisted thoracic surgery

Exclusion Criteria:

* Patient refusal
* Allergy to medication
* Coagulopathy
* Malformation
The Influence of day-to Day BPV on Long-term Adverse Outcomes in Patients Ischemic Stroke

Stroke is one of the most devastating disorder worldwide. Hypertension has been confirmed to be a major modifiable risk factor for stroke.Even the casual visit hypertension has been managed ideally,there is still surplus risk for stroke re-attack.The purpose of this study is to explore whether variation of 24-hour ambulatory and visit-to-visit blood pressure variability (BPV) contribute to recurrent stroke.

System hypertension has been reported to play the most important role in the development of stroke,and the anti-hypertension therapy is regarded as the cornerstone for stroke secondary prevention. However, even though some proper measures have been taken,there is still surplus risk for recurrent stroke. Recently the variation of system blood pressure has been focused as the candidate of another risk factor.Up to date,this hypothesis remains an intense debate and few studies has been done to clarify it.Besides, the definition of BPV and measurement of BPV parameters are still beyond conformity.In the current study, the long-term and short-term BPV will be taken respectively for patients with prior stroke. Bsed on these parameters, the cohort will be followed up for average 2 years. The predefined outcome include composite cardiovascular events, neuropsychiatric wording, and mortality during followup.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* comorbidity of dementia ( including AD, PDD, FTLD, VaD and so on )
* coexisting severe systematic diseases on admission such as acute coronary syndrome, malignant tumor, plasma dialysis therapy for renal failure, cirrhosis, rheumatic disease that would influence mortality.
* discharge with severe sequelae with mRS\>5
Continous Popliteal Block for Microvascular Free Flap Reconstruction in Ear, Nose and Throat Surgery

The aim of the study is to assess the effects of a continuous popliteal block on postoperative pain and recovery after major ear, nose and throat surgery with microvascular free flap reconstruction using a fibula graft.

Tumors of the head and neck is one of the most common cancer types, and the incidence is increasing. Management of these tumors is complex, and treatment can include surgery with extensive resection of the mandible or maxilla, which requires reconstruction using a microvascular free flap, oftentimes a part of the fibula. The injury to the operated leg can cause significant postoperative pain, which in these patients traditionally has been treated with intravenous opioids. These drugs have good analgesic properties, but also several side effects, such as fatigue, nausea and respiratory depression. The experience at Skåne University hospital in Lund has also been that the analgesic effect in the leg has been insufficient. The investigators would therefore like to evaluate the effect of adding a continuous popliteal block on postoperative pain and opioid consumption, as well as postoperative recovery. This type of block is regularly used for orthopedic surgery of the fibula, but its effects and significance have not been evaluated for the patient group in question.

Patients will receive information about the study and, if they opt to participate, be included during the routine preoperative visit. All patients included in the study will preoperatively receive a popliteal nerve block catheter in technical accordance with local procedure guidelines, and be randomized to either active substance (local anesthetic) or placebo (saline solution). They will receive a bolus injection of the allotted substance (blinded to both patient, care provider and investigator) at the start of surgery, followed by continuous infusion during the first, maximally, seven days. During this period pain, nausea and vomiting, as well as sensory and motor function in the operated leg will be recorded regularly. Opioid consumption, need for other analgesics and ability to mobilize will also be noted. Follow up of above mentioned parameters will be made at the first routine office visit at three months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients at Skåne University hospital department of ear, nose and throat surgery undergoing major resection of maxilla or mandible and reconstruction using free fibula graft.
* Preoperatively able to walk (with or without aid).

Exclusion Criteria:

* Neurological disease or peripheral neuropathy affecting the donor leg of the fibula graft.
* Conditions of coagulopathy, or treatment with anticoagulant drugs, that contraindicates peripheral nerve block according to local guidelines.
* Local anesthetic allergy.
* Inability to understand study information or answer questions.
Optimal Neck Angle for Internal Jugular Cannulation

Measurements will be made between the internal jugular vein and the carotid artery using an ultrasound machine as the subjects is asked to move and position his or her neck in various positions.

It is hypothesized that by movements of the neck the investigators can maximize the distance between the internal jugular vein and the carotid artery to decrease inadvertent cannulation of the carotid artery to improve patient safety

Patients will be asked to participate in this trial if they are scheduled for surgery and they will have their neck repositioned in several ways using an ultrasound machine to measure the distance between the internal jugular vein and the carotic artery to determine maximal distance in order to insert a catheter prior to surgery

Eligibility Criteria:
Inclusion Criteria:

Male and Females 18 years through 98 Scheduled for cardiac surgery Requires internal cannulation for their scheduled operative procedure -

Exclusion Criteria:

Individuals who refuse participation Subjects who already have had the internal jugular cannulated (line already present) History of carotid surgery History of Neck Surgery Individuals under 18 years of age

-
Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction Pair

The aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction pair Biolox® Delta Ceramic.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient implanted with a primary total hip replacement using a ceramic friction pair including Meije Duo® stem associated with a Dynacup® cup.
* Aged of more than 18 years at the time of the surgery.
* Patient with a follow-up of at least 2 years after surgery based on a consecutive and exhaustive series of patients operated within the inclusion period.
* Able to understand information to participate to the study.

Exclusion Criteria:

* Patient having a tumoral pathology.
* Patient having expressed opposition to the study participation.
Trial of Linaclotide in Patients With Chronic Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.


Eligibility Criteria:
Inclusion Criteria:

* Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
* Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
* Patient meets protocol criteria for CC: reports \< 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs
* Patient demonstrates continued chronic constipation through Pretreatment Period
* Patient is compliant with IVRS

Exclusion Criteria:

* Patient has history of loose or watery stools
* Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Indocyanine Green (ICG) in the ex Vivo Detection of Sentinel Lymph Node (SLN)in Colon Cancer

Evaluation of the possibility to detect sentinel lymph node(s) after ex vivo Indocyanine Green injections around the tumour in pieces of colectomy from patients with colon cancer.

Primary objective Feasibility study of ex vivo injections of ICG to image and detect the sentinel lymph nodes in patients with colon cancer.

Secondary objectives:

To determine the sensitivity of ICG in the dissected piece of colon cancer compared with the blue dye.

Tertiary objectives:

Evaluation of the influence of this approach on the up-staging of the patients

Microscopic study of the ICG distribution in the lymph nodes (in the lymphatic sinuses, in specific cells, in cancerous foci...)

Methodology:

In the operating room:

Patients will undergo standard surgical resection. Immediately after removal of the colon and node-bearing mesentery, using different 29 Gauge insulin syringes, blue dye (2 ml blue dye: 0.5 ml per injection) and ICG (2 ml with 0,5 mg ICG per ml: 0.5 ml per injection) will be injected in the fresh specimen beside each other submucosally around the tumour in at least four sites (as many injections needed to cover all the perimeter of the tumour) for each agent. The injection sites will be then gently stretched and massaged for 3-5 min to stimulate the tracers to flow along the lymphatic channels. Fluoroscopic imagings of the mesentery will be performed during the injections and during these manoeuvers.

The research and identification of the sentinel lymph nodes will be then performed as follows:

1. he will first localize the blue colored lymph vessels (if visible) as well as the palpable and/or blue colored lymph nodes. These last ones will be marked for dissection with a blue suture.
2. using the PDE camera, he will thereafter localize the fluorescent lymph vessels (if visible) as well as the palpable and/or fluorescent lymph nodes. These last ones will be marked for dissection with a green suture.

Histopathology in the Laboratory of Pathology:

When all SLN are identified, they will be dissected and classified as follows:

* SLN first seen as blue and confirmed also as fluorescent using PDE
* SLN seen as blue but not confirmed to be fluorescent using PDE
* SLN not directly visible as blue but seen fluorescent using PDE (the LN in this group will be controlled for their blue or not character when dissected)
* LN identified by the pathologist as pathological but not blue and not fluorescent.

After the dissection of these SLN, the specimen will be processed as usual using routine procedure for further examination of the non SLN by the pathologists. Once these lymph nodes are dissected, they will be tested for the emitted fluorescence.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histo-pathological diagnosis of colon cancer who are candidate for laparoscopic colectomy,
* Informed consent form signed.

Exclusion Criteria:

* Definite lymph node metastases diagnosed either pre-operatively, or per-operatively
* Inability to give informed consent,
* Age \< 18 years old,
* Pregnancy.
Thromboelastographic Methods in Deciding Therapy on Moderate to Severe COVID-19 Patients

This study is a prospective observational study that compares the anticoagulant therapy decision time among moderate and severe COVID-19 patients whose coagulation profiles were tested with thromboelastography (TEG) to those with a standard coagulation profile laboratory examination.

A prospective observational study was conducted among moderate to severe COVID-19 patients in the High Care Unit and Intensive Care Unit at Kiara Ultimate, Cipto Mangunkusumo Hospital, Indonesia. We consecutively recruited 100 moderate and severe COVID-19 patients in the high and intensive care units.

Baseline characteristic data collection was carried out when the patient was admitted to the ICU or HCU. Venous blood was taken by nurses within 30 min of admission. The samples were sent to the centralized hospital laboratory for a standard hemostasis panel which consisted of platelets, PT/APTT, fibrinogen, and D-dimer. The hospital used Sysmex® CS-2500 and 5100 (Sysmex Corp., Japan) for coagulation tests by using plasma derived from centrifuged whole blood samples. Bedside TEG examination was done by using TEG 5000 Hemostasis Analyzer (Haemonetics Corp., USA) with 2.5 ml of a whole blood sample. Samples of patients with heparin thromboprophylaxis were given heparinase, which binds to heparin so that the coagulation profile can be assessed. Except for TEG, all patients received equal diagnostic tests and treatment, including anticoagulant therapy, as indicated according to the national guideline. A trained doctor from the research team recorded time from blood samples taken until the coagulation panel or TEG results were obtained. Test result timestamp, anticoagulation decision timestamp, mortality, and length of stay in higher care were objectively retrieved through online medical records.

We compared the result turnaround time, time to decision of anticoagulant therapy, and clinical outcomes (length of stay and 30-day mortality) between those who had TEG examination in addition to standard coagulation profile examination (thrombocyte count, PT, APTT, D-dimer, and fibrinogen) and those who had a standard coagulation profile laboratory examination only.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed COVID-19 (Positive SARS-CoV-2 PCR test), 3. Moderate or severe symptoms (We defined moderate COVID-19 as patients with clinical signs of pneumonia with SpO2 \>93% in room air and severe COVID-19 as pneumonia with SpO2 ≤93% in room air or ventilator support requirement), and 4. The family signed the informed consent

Exclusion Criteria:

1. History of blood clotting disorders (eg, hemophilia and Von Willebrand's disease),
2. Have contraindications to the administration of anticoagulants, for example:

   1. Platelet count \< 25,000
   2. Has bleeding manifestations
   3. History of heparin allergy or heparin-induced thrombocytopenia
3. Pregnant