cyrilzakka/clinical-trials huggingface dataset:
Evalutation of Insulin Sensitivity Through Hyperinsulinemic Clamp in Children With GH Deficiency

Data about the impact of growth hormone treatment on insulin sensitivity in children are quite controversial, due to the different surrogate indexes that have been used, like Homa-IR, QUICKI, ISI-Matsuda or adipokine levels.

The investigators aimed to evaluate insulin sensitivity through the euglycemic hyperinsulinemic clamp, considered the gold standard technique, in children affected by growth hormone deficiency and to compare the M-value with the most commonly used surrogate indexes of insulin sensitivity.

The investigators aimed of this study was to use the hyperinsulinemic clamp to evaluate the impact of GH treatment on insulin-stimulated glucose utilization (M-value) in a group of children affected by GH deficiency and to compare the clamp-derived index with the most commonly used surrogate indexes of insulin sensitivity.

In all patients the auxological and metabolic evaluation was performed at baseline and after 12 months of GH treatment, while in controls these evaluations were only performed at baseline. In all children the investigators measured body height, body mass index (BMI) and waist circumference (WC). A blood sample was drawn after an overnight fast for the measurement of glucose, insulin, Hemoglobin A1c (HbA1c) and IGF-I. This sample served as the baseline for the oral glucose tolerance test (OGTT). Blood samples were collected every 30 min for 120 min for glucose and insulin measurements. As surrogate estimates of insulin sensitivity the investigators used the insulin sensitivity index, a composite index derived from the OGTT and validated by Matsuda and DeFronzo (ISI-Matsuda). On a different day, as a gold standard measurement of insulin sensitivity the investigators performed the euglycemic hyperinsulinemic clamp. As other insulin sensitivity markers, the serum levels of adiponectin and resistin after an overnight fast were also measured.

Eligibility Criteria:
Inclusion Criteria:

* Isolated idiopathic GH deficiency diagnosed by the auxological and biochemical criteria of the GH Research Society in prepubertal children
* Prepubertal children

Exclusion Criteria:

* Children with multiple hormone deficiency
* Children receiving other hormonal replacement treatment
* Pubertal children
Remifentanil And Local Anesthesia Compared With Local Anesthesia For The Insertion Of Central Venous Catheters

At present, there is no reference protocol for Central Venous Catheter (CVC) insertion assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and anesthesia to realize this gesture, from single local anesthesia to general anesthesia. Remifentanil has been shown to decrease pain scores for insertion and removal of long-term central venous access. Remifentanil is also often employed for pediatric or labor analgesia for short acts as procedural sedation.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* eligible for CVC insertion

Exclusion Criteria:

* pregnancy
* patients who can't give their consent
* contra-indications to remifentanil infusion
Single Scope Staging of Lung Cancer With Endosonography

Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most frequent cause of cancer death. Accurate staging is important because it directs treatment and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two techniques have a complementary diagnostic range and the combined procedure is suited for assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the combined procedure). Second, frequently only one or two, by imaging suspected lymph node stations, are sampled (ie. targeted approach).

Objectives: main and secondary:

1. Complete endosonographic (combined endobronchial and esophageal) staging using a single EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.
2. Systematic mediastinal staging results in improved locoregional staging compared to PET-CT directed assessment of the mediastinum (ie targeted approach).

Study population: Patients with potentially operable and resectable NSCLC are eligible if there is an indication for mediastinal nodal sampling. Patients have an indication for EBUS-TBNA.

Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET imaging and on subsequent ultrasound are sampled.

Main study endpoint: The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone.


Eligibility Criteria:
Inclusion Criteria:

* (Suspected) NSCLC;
* Indication for mediastinal nodal assessment;
* Suspected mediastinal lymph nodes within reach of EBUS;
* Age 18 years or older;
* Clinically fit to undergo surgical resection of the lung tumor;
* Provision of a written informed consent;

Exclusion Criteria:

* Mediastinal re-staging after neo-adjuvant treatment;
* Indication for EUS other than mediastinal staging, eg a for malignancy
* suspected left adrenal;
* Active malignancy with a life expectancy of less than two years;
* Former therapy for lung cancer (chemotherapy, radiotherapy or surgery);
* Technical contraindication for EBUS or EUS (eg, esophagus stenosis);
* Pregnancy;
* Inability to consent;
The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder

There is limited guidance on the optimal management of buprenorphine perioperatively and both buprenorphine discontinuation and continuation are acceptable standards of care. Buprenorphine continuation at low analgesic dosing is also accepted, however is not provided as a potential treatment strategy by the Substance Abuse and Mental Health Services Administration (SAMHSA). There is the risk of inadequate pain control necessitating opioid escalation when buprenorphine is continued. Preliminary clinical observations support buprenorphine continuation at low analgesic doses (8mg) as it adequately facilitates postoperative pain management without interrupting opioid use disorder (OUD) treatment, however to date, no prospective trial has investigated this treatment strategy in comparison to full dose buprenorphine continuation. Since optimal perioperative dosing strategies remain unknown, the purpose of this study is to investigate if buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery.

The purpose of this study is to investigate whether buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery. Adults scheduled for elective surgery who are taking ≥12mg buprenorphine for OUD treatment will be eligible for this study. Enrolled participants will be randomized to receive either a reduced analgesic dose of buprenorphine (8mg) or to continue buprenorphine on the day of surgery without dose reduction. The primary outcome of interest is postoperative pain scores. The secondary outcomes of interest are opioid consumption, opioid dispensing up to 30 days following the surgical procedure and OUD related symptoms, including opioid withdrawal, cravings and relapse. The investigators hypothesis is that there will be a clinically significant increase in pain scores when buprenorphine is continued in full compared to when it is continued at a lower analgesic dose. Clinical significance will be defined as a difference in composite pain scores of greater than 20% between groups. The investigators also hypothesize that opioid consumption and opioid dispensing will be greater with full dose buprenorphine continuation compared to low-dose continuation.

Eligibility Criteria:
Inclusion Criteria:

* age 18 and older
* American Society of Anesthesia health class I-III
* Currently taking buprenorphine formulation equivalent to 12mg or greater for at least 30 days for treatment of Opioid Use Disorder
* Scheduled for surgery at Maine Medical Center for a procedure with a greater than 4/10 pain intensity is expected on post-op day one.

Exclusion Criteria:

* unable to consent to the study
* currently pregnant
* current major medical illness that could limit the ability to utilize medications within our protocol driven multimodal analgesic plan (e.g. cancer, severe end-stage organ disease, or dementia)
Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients

* To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation
* To estimate the incidence rates of PTLD in adult, EBV seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation
* To compare the PTLD incidence rates in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept to the rates in adult, EBV seropositive, kidney alone transplant recipients treated with CNI-based regimens at the time of transplantation


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Adult,
* EBV seropositive, Kidney only transplant recipients initiated on belatacept and adult,
* EBV seropositive, kidney only transplant recipients initiated on CNIs reported to the United Network for Organ Sharing (UNOS) during the period of recruiting belatacept users
Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology

Prospective Feasibility Study:

Fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during their surgical evaluation of infertility. Of note, these patients are already scheduled to undergo surgery as part of their standard of care.

The surgical technique will involve laparoscopic brush and tissue biopsies of the fallopian tube lumen. A small piece of the fallopian tube lining will be removed during the surgery.The biopsy is a minimally invasive and relatively pain free procedure. Co culture blood serum will be drawn at least one day prior to the biopsy and during the IVF cycle. The fallopian tube sample is sent to the Center for Reproductive Medicine (CRM) lab where it is treated, purified and frozen. The next month or whenever the physician deems appropriate, the patient will then undergo a typical IVF cycle and will be given standard medication protocol determined by her physician to stimulate egg growth in her ovaries. The patient's eggs will be retrieved and mixed with sperm. At this time, the lab will begin to thaw and grow the fallopian tube cells. Once fertilization is confirmed, the patient's embryos will be placed on top of her own (now thawed) fallopian tube cells and allowed to grow. Subsequently, the embryos will be placed on top of her uterus for implantation and pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing assisted reproductive technology at Weill Cornell Medical College (WCMC) and are scheduled to undergo surgery as part of their standard of care
* Women who had a prior failed IVF cycle
* Women with normal Hysterosalpingogram (HSG) or a prior laparoscopy confirming normal tubal status
* Both the patient (potential subject) and her partner must sign the consent form

Exclusion Criteria:

* Pregnancy
* Undiagnosed vaginal bleeding
* Fallopian tube disease
Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease

This pilot clinical trial studies continuous intraventricular methotrexate in treating patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the ventricles may be an effective treatment for patients with leptomeningeal disease

PRIMARY OBJECTIVES:

I. Determine the pharmacokinetics and efficacy of continuous intraventricular methotrexate infusion in the treatment of leptomeningeal disease.

SECONDARY OBJECTIVES:

I. Describe the dose limiting toxicities. II. Describe the pharmacodynamics of continuously delivered intraventricular methotrexate.

III. Assess for response.

OUTLINE:

Patients receive intraventricular methotrexate continuously on days 1-14. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with leptomeningeal carcinomatosis (from solid tumors)
* Subjects with lymphomatous or leukemic meningitis
* The effects of methotrexate on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following the conclusion of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she will be excluded from the study and should inform her treating physical immediately
* Karnofsky Performance Status greater than 70%
* All subjects must have the ability to understand and the willingness to sign a written informed consent
* We will exclude subjects who have had prior intrathecal/intraventricular therapy with methotrexate within 6 months

Exclusion Criteria:

* Prior therapy with methotrexate for management of leptomeningeal disease
* Subjects with evidence of hydrocephalous
* Subjects with intraparenchymal lesions or bulky disease
* Subjects with ventriculoperitoneal shunt in place
* Previous history of whole brain radiation therapy
* Subjects who, in the opinion of the principal investigator, may not be able to comply with the safety monitoring requirements of the study will not be included in this trial
Effects of Abatacept in Patients With Early Rheumatoid Arthritis

The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

Subcutaneous (SC)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Rheumatoid arthritis (RA) diagnosis less than 6 months
* CRP \> 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h
* At least 3 swollen and 3 tender joints
* Anti-citrullinated protein antibodies (ACPA) positive

Exclusion Criteria:

* At risk for tuberculosis
* Have acute infection
* Have chronic or recurrent bacterial or serious latent viral infection
* History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
* Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)
Optimization of Cardiac Pacing Using CardioMEMS

This study is designed to determine if a simplified technique for cardiac device reprogramming using pulmonary artery pressure (PAP) data in the acute setting holds promise to improve subjective assessments of patient quality of life (QOL), objective measurements of functional capacity, and specific systolic and diastolic echocardiographic indices.

The present study is designed to determine if a simplified technique for cardiac device( CRT) reprogramming using pulmonary artery pressure (PAP) via implanted CardioMEMS device data in the acute setting holds promise to improve subjective assessments of patient quality of life (QOL), objective measurements of functional capacity, and specific systolic and diastolic echocardiographic indices. The protocol requires prospective collection and analysis of echocardiographic data, subjective symptoms (Minnesota Living with Heart Failure Questionnaires), and 6-minute walk distance measurements in patients with implanted biventricular pacemakers / defibrillators who are predominantly ventricularly paced, in normal sinus rhythm, have documented NYHA class 3 Heart Failure, and have implanted pulmonary artery pressure monitors (CardioMEMS, St. Jude Medical CRMD, St. Paul, MN). Data collection will occur at presentation (rest and with ambulation), one month post-reprogramming, and two months after evaluation and / or reprogramming.

Eligibility Criteria:
Inclusion Criteria:

1. Patients have implanted PPM, ICD, or CRT devices and CardioMEMS
2. Patients can ambulate for 6 minutes and lay on a flat surface
3. Patients are paced \> 95% of the time
4. Patients are not in acute CHF and are on a stable medication regimen
5. Patients have adequate echocardiographic windows
6. Patients can consent independently

Exclusion Criteria:

1. Patients with poor echocardiographic acoustical resolution.
2. Patients with congenital heart disease.
3. Patients with mechanical aortic or mitral valve replacements.
4. Patients with significant mitral annular calcification.
5. Patients with irregular heart rates: atrial fibrillation, supraventricular tachycardia, atrial premature contractions, and ventricular arrhythmia that would preclude data acquisition.
6. Patients unable to remain still secondary to movement disorders or agitation.
7. Inpatient status
8. Patients with poorly controlled HTN (SBP\>160/90
PRF Therapy for Pocket Reduction

Periodontal regenerative therapy has focused on various non-surgical and surgical treatment methods. Platelet-rich fibrin (PRF) has shown to possess multiple uses, including properties that promote healing of both soft and hard tissues. In the present study, we hypothesized that the addition of PRF into periodontal pockets, as an adjunct to conventional scaling and root planing (SRP), would enhance the outcomes of non-surgical periodontal therapy. This split-mouth randomized controlled clinical trial included 26 periodontal pocket sites in 13 patients with periodontitis. The pockets were randomly assigned as either test or control sites. In the test group, PRF was placed as an adjunct to SRP, while the control group received SRP alone. Probing pocket depths (PPD), clinical attachment levels (CAL), gingival recession (GR), plaque index (PI), and gingivitis index (GI) were measured at baseline and at six weeks. The wound healing index was measured during the six-week follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* either gender,
* aged 18 years or older,
* patients without a medical history of systemic diseases,
* patient with chronic periodontitis
* patient with 5 or 6 mm of probing depth

Exclusion Criteria:

* patients with medical history of systemic disease or bleeding disorders
* presence of other gingival diseases (such as leukoplakia, lichen planus, pemphigoid disorders, pemphigus vulgaris, herpetic lesions, Necrotizing Ulcerative Periodontitis (NUP)
* pregnancy
* history of any drug usage affecting the periodontium for the past six months (such as systemic antibiotic therapy)
* previous periodontal treatment in the last six months
* smoking
* teeth with untreated caries
* endodontic lesions and grade II or more mobility
* subjects with acute exacerbation of periodontitis
* patients with systemic
* disease or condition that could affect tissue healing (e.g., autoimmune disease)
* severe furcation involvement (grade II and III)
* abutment for prosthetic rehabilitation
* active orthodontic therapy
Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy

Hepatectomy induces moderate to severe postoperative pain. Patient-controlled intravenous analgesia has been used in many medical centers for post-hepatectomy analgesia, but the effects are limited and often cause undesirable adverse effects.

Regional Block has been used for postoperative analgesia in many surgeries. Some studies suggest that regional analgesia has an opioid-sparing effect and can reduce the incidence of chronic pain. Also, the programmed intermittent bolus infusion is better than continuous infusion, with less analgesic consumption and fewer adverse effects.

Studies on the early and late postoperative analgesia and recovery effects of paravertebral block for open hepatectomy are scarce. Therefore, the investigators aim to conduct a prospective, randomized, subject and assessor-blinded, parallel-group, placebo-controlled study to test the hypothesis that the programmed intermittent bolus infusion of right thoracic paravertebral block reduces postoperative intravenous analgesic use and pain scores and improved patients' satisfaction.

This study aims to compare the early postoperative morphine consumptions, pain scores, rescue analgesics, adverse effects and recovery indices, and the late postoperative life quality between patients with and without paravertebral block.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo hepatectomy with J-shape subcostal incision
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Unable to cooperate, eg. inability to properly describe postoperative pain to investigators
Sodium-Glucose Cotransporter-2 Inhibitors: A Potential Novel Treatment for Epilepsy

About 30% of persons with epilepsy have seizures that do not respond to drugs. The ketogenic diet is an effective treatment option for them, but this high fat diet is strict and difficult to maintain. The properties of gliflozins, which often are used to treat type 2 diabetes, make them a potential replacement for the ketogenic diet. This pilot study will determine whether gliflozins induce ketosis and could be used to treat adults with epilepsy safely.

The 30% of persons with epilepsy who are drug-resistant bear most of the financial and psychosocial costs of this common neurological disorder. An effective, clinically used treatment for these individuals is the ketogenic diet, a high fat, low carbohydrate diet. Newer variants of the ketogenic diet including the modified Atkins diet (MAD) and low glycemic index treatment (LGIT) are more palatable than the older versions but are challenging to maintain because they are strict. The MAD and LGIT lower blood glucose and produce mild ketosis. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) such as empagliflozin have become important additions to the armamentarium for treating type 2 diabetes. SGLT2i decrease blood sugar by causing glucosuria, and they induce mild ketosis. These actions raise the possibility that SGLT2i can replace the MAD and LGIT as epilepsy treatments. This pilot, phase 1 study will determine the feasibility, safety, and tolerability of the SGLT2i empagliflozin in adults with epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years
* Focal, generalized, combined generalized and focal, or unknown epilepsy type
* Drug-responsive or drug-resistant epilepsy

Exclusion Criteria:

* Seizure frequency \>2 seizures per day during the 6 months prior to enrollment
* Status epilepticus during the 2 years prior to enrollment
* Taking a gliflozin
* Allergy to gliflozins
* Taking a carbonic anhydrase inhibitor such as acetazolamide
* On any ketogenic diet variant
* Having an absolute contraindication to a ketogenic diet
* Type 1 or type 2 diabetes
* Pregnancy
* Moderate to severe intellectual disability,
* Significant cardiovascular disease
* Renal insufficiency
* Body mass index \<18.5 or ≥30
* Hemoglobin A1c ≥5.7%