cyrilzakka/clinical-trials huggingface dataset:
Effect of Dexmedetomidine on Plasmatic Cortisol Response in Transsphenoidal Surgery

Use of dexmedetomidine in pituitary tumor resection surgery as adjuvant drug and its relation to cortisol levels during postoperative period.

Transsphenoidal resection of pituitary tumors is the neurosurgical procedure of choice to remove most of the tumors of the sellar region. Sometimes the intervention produces dysfunction of the hypothalamic-pituitary axis, and although most are transient, the risk associated with post-operative hypocortisolism determines its evaluation early in the postoperative period and the possibility of steroidal supplementation posteriorly. It is described that dexmedetomidine can be used as an adjuvant drug in this type of surgery being useful in reduction of total consumption of opioids and anesthetic gases, maintain hemodynamic stability and less time to recovery from anesthesia. Due to its sympatholytic effect, dexmedetomidine has been found to alter the intraoperative common neuroendocrine response generating lower levels of cortisol in the postoperative period than patients in which is not used.

The main objective of this study is to evaluate corticosteroid axis response (cortisol and adrenocorticotropic hormone) in patients undergoing transsphenoidal surgery under anesthesia with dexmedetomidine. A single-center randomized double-blind clinical trial will be conducted that will compare two groups of patients, one of which will be given dexmedetomidine (Dex group) and another group who will receive a placebo (control group). In addition the incidence of perioperative complications (nausea, vomiting, diabetes insipidus), intraoperative hemodynamics and patient comfort. The investigators expect that the normal stress response to surgery measured by cortisol and adrenocorticotropic hormone in the postoperative period will be reduced in the dexmedetomidine arm. This effect should be transient and attributed to use of dexmedetomidine and not to surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I or II.
* Pituitary tumour: non-functional macroadenoma, Rathke's cleft cyst, acromegaly.
* Normal hypothalamic-pituitary-adrenal axis by hormone levels measurement previous to surgery.

Exclusion Criteria:

* Cushing disease.
* Pituitary apoplexy.
* Craniopharyngioma.
* Chronic corticosteroid use.
* Hemodynamic instability.
* Altered consciousness (Glasgow Coma Scale score less than 15).
* Atrioventricular block in any degree.
* Preoperative bradycardia.
* Alpha 2 agonist use (clonidine, alpha-methyldopa)
* Pregnancy or breast feeding.
* Known allergy to any of the study drugs.
Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis

This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.

Proteasome inhibitor and immunmodulators have synergistic effect for plasma cell dyscrasia. Due to the fact that more than 70-80% of patients with amyloidosis have renal involvement, the application of lenalidomide is limited. Thus, the investigators designed this open-label, multicenter, phase 2 study for newly diagnosed or previously treated systemic AL amyloidosis with bortezomib, pomalidomide and dexamethasone regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.
2. Newly diagnosed or previous treated AL amyloidosis
3. Patients must be ≥ 18 years of age.
4. ECOG performance status 0, 1 or 2.
5. Measurable disease defined by at least one of the following:

   ① serum free light chain (FLC) ≥2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg/dL (20 mg/L).

   ②. presence of a monoclonal spike that is ≥5 g/l.
6. Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).
7. Absolute neutrophil count (ANC) ≥1.0 X 10\^9/L, Hemoglobin ≥70 g/L, Platelets ≥50 X 10\^9/L
8. eGFR ≥20 mL/min/ 1.73 m\^2
9. Written informed consent in accordance with local and institutional guidelines.
10. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
3. Severe or persistent infection that cannot be effectively controlled;
4. Presence of severe autoimmune diseases or immunodeficiency disease;
5. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
6. Patients with HIV infection or syphilis infection;
7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
A Substantial Equivalence Study of RD04723 and Predicate Device

The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent and release health information
* Ability to follow study instructions and study requirements
* Have a hypertrophic or keloid scar accessible for treatment and evaluation
* Negative pregnancy test for women of childbearing potential
* Agreement to use effective birth control method for study duration

Exclusion Criteria:

* History of allergy or sensitivity to components
* History of diabetes
* History of collagen vascular disorders
* Anticipated need for surgery or hospitalization during the study
* Pregnant, nursing, or planning a pregnancy during the study
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)
Polygenic Risk Score to Predict Weight Loss Intervention in Children With Obesity

Children with obesity are prone to suffering from metabolic diseases, which undoubtedly increases the burden of public health. Since obesity is a multiple gene disease, a comprehensive approach using polygenic risk scores (PRS), rather than individual genetic variant, may be a more appropriate method. The aim of the study was to establish a polygenic risk score model to assess differences to assess differences in weight loss treatment outcomes.

The investigators hypothesize that obesity gene variants can predict the efficacy of weight loss intervention in obese children. The aim of the study was to establish a polygenic risk score model to assess differences to assess differences in weight loss treatment outcomes. The investigators will also analyze whether these gene variants have an effect on obesity comorbidities (hypertension, hyperlipidemia, non-alcoholic fatty liver disease, type 2 diabetes, obstructive sleep apnea, polycystic ovary syndrome, etc.). For participants with non-simple obesity, the investigators will collect their complete family history, and perform whole exome sequencing to identify possible rare disease-causing genes.

The experimental design is as follows:

Obese children and adolescent subjects will undergo a 6-month weight loss intervention program and be followed for 12-18 months. The investigators will analyze obesity and fatty liver-related genes in these adolescents using next-generation gene sequencing and/or gene chips, perform polygenic risk score analysis, and use an additive model to total the number of variant loci weighted by effect size. Whole exome gene sequencing refers to the human DNA map (hg19), and Sanger sequencing will be used to confirm the correctness of the variant site.

Eligibility Criteria:
Inclusion Criteria:

* Age \<18 years old
* Obesity definition: BMI \> 95% according to the age- and gender-specific standard by National Health Institute in Taiwan
* Willing to give written informed consent

Exclusion Criteria:

* Alcohol consumption
* Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and major psychotic disorder
Study of the Colonic Carriage of Staphylococcus Aureus in a Prospective Cohort of Patients Undergoing Endoscopic Screening for Digestive Cancer in the University Hospital of Saint-Etienne

Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and colonic) of S. aureus in patients without chronic digestive disease who are going to have a colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity of strains isolated from each site will be analyzed using molecular tools. The aim of this study is to better estimate the digestive reservoir of S. aureus to better prevent endogenous infections due to this bacterium.


Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated to French social security
* Written consent of the patient
* Patient needing a colonoscopy in the University Hospital of Saint-Etienne, France

Exclusion Criteria:

* Patient who decline to participate to the study
* Patient in the incapacity to give consent
* Patient receiving treatment with anticoagulant or antiaggregant platelets
* Patients with a known haemostatic disorder
* Pregnant woman
* Patients with a chronic disease of the gastrointestinal tract
* Patients receiving long-term corticosteroid
* Patient receiving anti staphylococcal antibiotics
Open-label Clinical Trial of Lacosamide in ALS

Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS).

Lacosamide is administered for patients with amyotrophic lateral sclerosis (ALS). This clinical trial is open-label, single group and before and after comparison study. Dosage of lacosamide is increased from 100mg to 400mg for 4 weeks. Safety of lacosamide administration in ALS is primary endpoint. Nerve excitability, fasciculation and muscle cramp are investigated before and after administration for secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Over 20 year old
* Probable or definite ALS disease evaluated by Awaji electrophysiological criteria
* Subjects provided informed consent.

Exclusion Criteria:

* Patient without ability to comprehend informed consent
* Patient with uncompensated medical illness
* Patient with cardiac disease (myocardial infarction, valvular disease and cardiomyopathy etc.)
* Patient with arrhythmia (incomplete atrioventricular block and bundle branch block etc.)
* Patient with sodium channel disorders, such as Brugada syndrome
* Patient already administered anti-arrhythmic drug which prolongs PR interval (interval between arterial and ventral contraction measured by ECG)
* Pregnant or breast-feeding woman
* Patient with forced vital capacity of \< 60% predicted
* Patient already performed tracheotomy or tube feeding
* Patient who takes any other experimental agents 3 months before.
* Not enough compound muscle action potential amplitude in the median nerve to be performed nerve excitability test
* Patient who plans to change medicine which affects nerve excitability during this trial 4 weeks
* Familial ALS
* Patient who is judged inappropriate for this trail by doctors responsible for this trial
Genetic Predictors of Responsiveness to Radiofrequency Denervation in Chronic Low Back Pain

The Investigators have designed this exploratory study in patients suffering from zygapophysial joint mediated pain to investigate if a correlation exists between inter-individual genetic variability (genotype) with treatment response (phenotype). More specifically, the investigators aim to identify any form of correlation between a specific SNP of the BDNF gene (Val66Met) and the effectiveness and/or duration of radiofrequency facet joint neurotomy. The study population is patients suffering from chronic low back pain who have been scheduled for radiofrequency neurotomy following the diagnosis of facet joint mediated pain (using medial branch block test). The investigators will evaluate if a common variant of BDNF gene (Val66Met) can be directly correlated to a significant degree of pain relief following RF treatment, and whether the result of such a procedure can be predicted from a specific genetic profile.

Study Hypothesis It is possible to predict individual responsiveness to radiofrequency denervation for zygapophysial (facet) joint mediated pain on the basis of a specific genetic pattern (Single Nucleotide Polymorphism, \[SNP\])?

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic low back pain which is unresponsive to conservative treatment (including suitable analgesics and physical therapy);
* Willing to provide consent
* Subject is capable of comprehending the patient information sheet and has the capacity to give their informed consent to all study procedures in English
* Be 18 years or older at the time of enrolment;
* Have specific low back pain that is aggravated by hyperextension and rotation of the spine, with or without hip, buttock or leg pain that does not follow a known dermatomal distribution
* Paraspinal Tenderness
* A "positive" response to a uni/bi-lateral MBB\* (a response is considered positive when a subject experiences at least 50% reduction in pain scores after the block, regardless of the duration of pain relief)

Exclusion Criteria:

* Patients who had had any previous back surgery
* Patients who had previous RF treatments for facet joints mediated pain
* Patients with another significant cause of low back pain (like spinal stenosis, disc herniation, spondylolisthesis, malignancy, infection or trauma);
* Radicular pain (pain with neuropathic characteristics following one or more nerve root distribution)
* Patients with bleeding complications or coagulopathy issues;
* Concurrent participation in other experimental trials;
* Known history of adverse reactions to local anesthetics;
* Pregnant or lactating women;
* Refusal to provide informed consent for blood banking
* Any other complication which in the view of the investigator may interfere with the study procedures or the measurement of the accurate study outcomes
Perineural Injection Therapy for Ulnar Neuropathy at Elbow

Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy. Although many conservative managements of UNE, the effectiveness of these methods are unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment for entrapment neuropathy. However, current studies have not proved the effects of PIT on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. We design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.

After obtaining written informed consent, 40 patients, clinically diagnosed with mild or moderate UNE were randomized into intervention or control group. Participants in intervention group received one-session of ultrasound-guided PIT injection with 5cc. 5% dextrose and control group received 2cc 0.9% normal saline+3cc Triamcinolone (30mg) (total 5 cc) ultrasound-guided PIT injection. The primary outcome is Disabilities of the Arm, Shoulder and Hand (DASH) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity of the ulnar nerve, and strength of palmer finger pinch and grasp. The evaluation was performed pretreatment as well as on the 1st, 3rd and 6th month after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old.
* Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

* Cancer
* Coagulopathy
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for ulnar neuropathy
Study of AAVrh10-h.SGSH Gene Therapy in Patients With Mucopolysaccharidosis Type IIIA (MPS IIIA)

MPS IIIA is predominantly a central nervous system disease causing cognitive disability, progressive loss of acquired skills, behavioral and sleep disturbance. LYS-SAF302 is a gene therapy which is intended to deliver a functional copy of the SGSH gene to the brain. This is a phase 2-3 study to assess the efficacy in improving or stabilizing the neurodevelopmental state of MPS IIIA patients.

The study is interventional, single arm and multi-center. Evolution under treatment will be compared to expected natural evolution based on natural history studies.

Eligibility Criteria:
Inclusion Criteria:

* Documented MPS IIIA diagnosis based on genotyping confirming the SGSH gene mutations
* Cognitive DQ score on BSID-III: 50% and above

Exclusion Criteria:

* Homozygous for the S298P mutation or non-classical severe form of MPS IIIA, based on investigator's judgement.
* Participation in another gene or cell therapy clinical trial.
* Past use of SGSH enzyme replacement therapy for a period exceeding 3 months. A washout period of at least 2 months is required prior to screening.
* Current participation in a clinical trial of another investigational medicinal product.
* History of bleeding disorder or current use of medications that, in the opinion of the investigator, place them at risk of bleeding following surgery.
* Any condition that would contraindicate treatment with immunosuppressants such as tacrolimus, mycophenolate mofetil or steroids.
Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations

The purpose of this study is to understand best strategies for engaging high risk populations in a primary care setting to improved adherence to colorectal cancer screening guidelines. The results will be used to identify best practices that are scalable to other high-risk populations who are due or overdue for colorectal cancer (CRC) screening.

This is a prospective implementation science study that will test 4 different approaches to increase colorectal cancer screening in a local primary care setting that provides services to individuals who are under-resourced. The interventions will include reminders from primary care providers with and without additional information and/or services to help complete colorectal cancer screening. A review of electronic medical records will be used to identify baseline information assessing risk factors and personal and family CRC history. For arm 3 of the study, participants may elect to enroll in our existing health navigation program. If so, additional baseline information will be collected, including information on Social Determinants of Health (SDOH). For arm 4 of the study, a questionnaire will be used to assess knowledge about colorectal cancer screening. The questionnaire will be repeated after the intervention (informational video). For all arms of the study, the primary outcome (engagement on CRC screening, receipt of CRC screening, results of CRC screening) will be collected through EPIC.

Eligibility Criteria:
Inclusion Criteria:

* be 50-74 years of old at the time of enrollment
* have one valid medical encounter with CSHHC Columbus Ave. location or Dixwell location between the dates of 11/01/2019 and 11/30/2020

Exclusion Criteria:

• Documented history of colorectal cancer
Gastric Ischemic Preconditioning Before Esophagectomy

The aim of the study is to investigate the impact of left gastric artery embolization before esophagectomy on postoperative complications, particularly anastomotic leaks and necrosis of the gastric conduit.


Eligibility Criteria:
Inclusion Criteria:

Patient with operable esophageal cancer who underwent embolization of the left gastric artery prior to surgery.

Exclusion Criteria:

Patient with no operable esophageal cancer
A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain

This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients will receive 1 injection under the skin of either active or placebo REGN475, and be followed over 10 visits for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Pain present for at least 2 weeks, but not lasting for more than 16 weeks prior to the screening visit.
2. A confirmed diagnosis of sciatica at the screening visit.
3. Weight less than 120 kg

Exclusion Criteria:

1. Back surgery within 6 months prior to the screening visit
2. Neurological deficit (muscle weakness and/or reflex loss; loss of bowel or bladder function) from any cause including sciatica
3. Other conditions which may confound the interpretation of the study, such as carpal tunnel syndrome, MS, rheumatoid arthritis, spinal stenosis, etc.
4. Allergy to doxycycline or related compounds
5. Women who are pregnant or nursing
Joint Inflation With Nominal-pressure and Stability Approach in DES Optimization

To achieve the stent optimization following "Keep It Simple and Safe" coronary intervention is recommended. A protocol of Joint Inflation with Nominal-pressure and Stability (JINS) approach in coronary drug-eluting stent (DES) implantation by intracoronary imaging (ICI) guidance could provide additional benefits in reducing unnecessary radiation exposure, and post-dilatation balloon angioplasty-related complications.

Variable types of stent inflation protocol to achieve evidence and consensus-based coronary drug-eluting stent (DES) optimization could improve clinical outcomes. The investigators aim to evaluate whether the JINS approach could be adopted in Chinese daily practice.

The investigators will perform ICI (OCT or IVUS)-guided DES implantation in coronary de novo lesions by JINS protocol, described as inflating stent balloon with nominal-pressure (+1\~2atm) without decay for at least 30 seconds.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute coronary syndrome (UA/NSTEMI/STEMI) plan to undergo OCT- or IVUS-guided DES implantation in de novo lesion.
* Patients provide written informed consent prior to enrollment.

Exclusion Criteria:

* Left main, ostial right coronary artery lesion.
* High thrombus burden at the index primary percutaneous coronary intervention.
* Active bleeding or bleeding diathesis, thrombocytopenia (platelet \<100,000/mL), or hemoglobin \<10 g/dL
* Hepatic dysfunction (serum liver enzyme\>3 times the normal limit)
* Renal failure (eGFR \<15 ml/min/1.73m2 or requiring dialysis)
* Life expectancy \< 1 year