cyrilzakka/clinical-trials huggingface dataset:
Changes of Optic Nerve Sheath Diameter Between Obese and Non-obese Patients Undergoing Laparoscopic Gynecological Surgery

This study aims to compare the change of optic nerve sheath diameter in obese and non-obese patients undergoing laparoscopic gynecological surgery in a steep Trendelenburg position.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic gynecological surgery

Exclusion Criteria:

* Ophthalmic diseases
* Previous history of ophthalmic surgery.
* Neurological disorders
* History of head surgery.
Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)

A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \>=18 years of age;
* ASA Class 1-3;
* Subjects with a Body Mass Index (BMI) of \< 35 kg/m\^2 ;
* Subjects scheduled to undergo an elective short procedure with general anesthesia requiring neuromuscular relaxation and endotracheal intubation in outpatient surgicenters;
* Subjects scheduled to undergo an elective surgical procedure expected to last 1.5 hours or less (from end of intubation to end of suturing/stapling of skin);
* Subjects who are scheduled to undergo an elective surgical procedures that allows access to the arm for TOF-Watch® SX monitoring;
* Subjects who have given written informed consent.

Exclusion Criteria:

* Subjects known to have ischemic heart disease or a history of myocardial infarction;
* Subjects in whom a difficult intubation is expected because of anatomical malformations;
* Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemakers);
* Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis);
* Subjects who would require the use of pneumatic tourniquet during the surgical procedure;
* Subjects known or suspected to have significant renal dysfunction (e.g., creatinine clearance \< 30 mL per min);
* Subjects known or suspected to have significant hepatic dysfunction;
* Subjects known or suspected to have a (family) history of malignant hyperthermia;
* Subjects known or suspected to be hypersensitive to sugammadex or other cyclodextrins or rocuronium or any of its excipients;
* Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants, or other medications used during general anesthesia;
* Subjects for whom a pre-established need for post operative intensive care admission and/or hospital admission is expected;
* Subjects for whom an intra operative IV administration of fluids that contain potassium is expected;
* Female subjects who are pregnant;
* Female subjects who are breast-feeding;
* Subjects who have participated in a previous sugammadex trial;
* Subjects who have participated in another investigational drug trial within 30 days before entering into clinical trial (CT) 19.4.319 (P05700) unless pre-approved by the sponsor.
Metabolomic in Critical Ill Patients

Analysis of blood, urinary, and intrathecal metabolites of critical ill patients will be checked for possible correlations between metabolomics patterns and patients' outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients with severe left or right ventricular dysfunction undergoing cardiac surgery
* patients undergoing ablation of ventricular tachycardia
* patients with febrile neutropenia after chemotherapy or allogeneic transplant for haematological diseases
* patients undergoing thoracoabdominal vascular surgery

Exclusion Criteria:

* pregnant women
* no written consent
Prevalence, Severity and Natural Course of Sleep Apnea After Cardiac Surgery

Sleep disordered breathing (SDB) is common in cardiovascular patients. Patients after cardiac surgery will be screened for SDB with the ApnoeLink device at the beginning of cardiac Rehabilitation and then after 3 weeks and 3 months.

Objective(s) of the project

* Evaluate the prevalence of sleep apnea after cardiac surgery
* Compare results interindividually (group A vs. group B) and intraindividually (longitudinal assessment after 3 months)

Outcome(s)

* Prevalence of sleep apnoe at day 1 and 20 of rehabilitation and 3 months after cardiac surgery
* composite endpoint of events at 3 months (cardiovascular death, non-fatal myocardial infarction, non-fatal cardiac arrest, revascularisation procedure, new atrial fibrillation and stroke)
* change in 6-minute walking test (6-MWT)
* impact of heart surgery on sleep apnoe

Eligibility Criteria:
Inclusion Criteria:

* cardiac surgery or orthopedic surgery \<2 weeks

Exclusion Criteria:

* known SDB
Thyroid Function and Structure in Klinefelter Syndrome

This is a longitudinal retrospective study for the evaluation of thyroid function and structure in patients with Klinefelter syndrome compared to healthy controls and patients affected by chronic lymphocytic thyroiditis.

This is a longitudinal retrospective study for the evaluation of thyroid function and structure in patients with Klinefelter syndrome compared to healthy controls and patients affected by chronic lymphocytic thyroiditis (CLT).

The investigators will retrospectively enroll patients with Klinefelter syndrome followed at the host institution and will retrieve data with regards to peripheral hormone levels (thyroid function) and ultrasonographic appearance (thyroid structure) according to pubertal status and gonadal status. Data will be compared with male age- and pubertal stage-matched euthyroid controls, as well as with male patients affected by CLT.

The primary outcome will be the thyroid function compared to healthy controls, by the assessment of peripheral blood TSH, free T3 (fT3) and free T4 (fT4) levels according to pubertal status (pre-pubertal, pubertal and adult subjects) as well as according to gonadal status (eugonadal subjects, hypogonadal subjects and subjects receiving testosterone replacement therapy \[TRT\]).

Secondary Outcome Measures will be:

Thyroid function indexes (fT3/fT4 ratio, fT4/TSH ratio, TSH\*fT4 product)

Quantitative ultrasonographic thyroid structure parameters, comprising: thyroid volume and echogenicity index, as well as the echotexture parameters of homogeneity and entropy evaluated by Gray Levels Co-occurrence Matrices (GLCM).

In vitro assay of testosterone and estradiol effects on deiodinase type 2 (DIO2) activity in a rat pituitary cell line.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of classic, non-mosaic 47,XXY Klinefelter syndrome based on a peripheral blood 97 karyotype analysis;
* Availability of thyroid function test results (TSH, fT3, and fT4) and/or thyroid US imaging;
* Availability of concurrent clinical data.

Exclusion Criteria:

* Presence of other known genetic conditions or chromosomal abnormalities;
* Use of levothyroxine or other drugs that are either active on the hypothalamic-pituitary-thyroid (HPT) axis or that may interfere with thyroid function tests;
* History of previous surgery or radiotherapy on the thyroid or pituitary glands;
* Current or previous T therapy (for the pre-pubertal and pubertal groups).
A Randomized Trial of Letters From Family Physicians to Encourage Screening Mammography in Overdue Women

A randomized, double-blinded study conducted in British Columbia, Canada, where there is a publicly funded, organized screening program and screening mammography is recommended at 24-month intervals. Eligible women aged 51-73 years old and overdue for their screening mammogram by 6-24 months are identified in the database of the Screening Mammography Program of BC (SMPBC). Family physicians are recruited by mail and asked to sign letters to the overdue women in their practices. The overdue women are randomized and mailed either the signed reminder letter and the standard reminder postcard, or the standard reminder postcard alone. The primary endpoint is the proportion of overdue women attending a screening mammogram appointment 6 months after the mailing.


Eligibility Criteria:
Inclusion Criteria:

Active family physicians (family physicians, general practitioners or primary care physicians) who have overdue women in their practice that meet the following criteria:

* Previously been enrolled in the SMPBC and had a previous normal screening mammogram.
* Have agreed to being contacted for research on the SMPBC questionnaire
* Are 6-24 months overdue from their last screening mammogram
* Live in BC
* Have listed an active family physician as the contact to receive their mammography results

Exclusion Criteria:

* Family physicians who do not work in primary care
* Family physicians who do not have overdue women in their practice
Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis

Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. This study aims to analyze the clinical characteristics and demographic data of GLM patients and to compare the overall effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy, with the goal of providing new insights for clinical treatment.

In recent years, the incidence of this disease has been increasing annually. The incidence of GLM is region-specific, being higher in Mediterranean regions and Asian countries. The etiology is currently unclear, but many studies suggest that GLM is associated with autoimmune disorders, hormonal imbalances, and microbial infections . GLM has a long course, is difficult to treat, and prone to recurrence, causing significant trauma to the patient's breast appearance and overall well-being. Currently, the main treatment methods for GLM include surgical treatment, drug therapy, combined surgery with drug therapy, and close observation. Surgical treatment options mainly include abscess incision and drainage, segmental resection, subcutaneous mastectomy, mastectomy, and breast reconstruction. Although surgical treatment can rapidly improve the condition, the recurrence rate reported in the literature ranges from 5% to 50% . Although GLM is a benign disease, it can severely impact the patient's normal life, causing physical and psychological trauma. However, few studies have included patients' subjective treatment experiences in the evaluation of treatment outcomes.

To date, there have been no studies comparing the efficacy of three treatment methods (surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy) in the same population of GLM patients. This study aims to compare the efficacy and patient satisfaction of these three treatment methods, with the hope of providing new insights for clinical treatment options.

Eligibility Criteria:
Inclusion Criteria:

* non-lactating and aged 15-65 years
* histopathological confirmation of GLM
* normal liver and kidney function

Exclusion Criteria:

* lactating and pregnant women
* allergies to rifampin, isoniazid, or ethambutol
* concurrent malignant breast tumors
* severe underlying diseases
* other conditions deemed unsuitable by the investigator and
* refusal to participate in the study
PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study

The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype in subjects who have confirmed disease progression following treatment with vorinostat in the SOLAR clinical study (MRG106-11-201). Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells.

The effects of treatment will be measured based on changes in skin lesion severity, disease-associated symptoms, and quality of life, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.

Study Design:

Up to 60 subjects are expected to be enrolled after discontinuation from the SOLAR clinical study (MRG106-11-201). Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated.

Eligibility Criteria:
Key Inclusion Criteria:

* Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression).

Key Exclusion Criteria:

* Sézary syndrome or mycosis fungoides with B2 involvement, defined as documented history of B2 and/or B2 staging at screening.
* Evidence of large cell transformation.
* Visceral involvement related to MF at screening.
* Unresolved toxicities from prior vorinostat treatment, defined as having not resolved to CTCAE v5.0 grade 0 or 1.
* Any CTCL systemic therapy after completion of the SOLAR study and prior to Day 1 for PRISM.
Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit at University of Virginia

The purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU. Babies will be weighed prior to breastfeeding and again after breastfeeding. The weight gain of the baby will be compared to the volume measured using FEEDBACK. The study will also evaluate the device safety and ease of use.

Researchers have long stated that accurate assessment of infant milk intake while breastfeeding is needed for clinical practice and research. Many methods for measuring milk intake have been studied. While the intake of formula fed infants can be directly measured based on the amount of fluid in the bottle, determining the actual milk intake for breastfed infants is more difficult. Precise feed volumes are especially important for infants in the NICU. Most premature infants are unable to breastfeed because they are not able to coordinate suckling and swallowing.

The FEEDBACK system includes a nipple shield and a monitoring unit. It helps protect the nipple of a breastfeeding mother as well as measures and displays the volume of milk, in mL or oz, that an infant consumes during a breast feeding session. Based on this information, a mother has quantitative data regarding her infant's milk intake for her own use or to share with her health care provider.

This study is designed in two phases. First, data will be collected from breastfeeding mothers of pre-term infants to develop an algorithm that can identify feeding patterns in the pre-term infant. Once established, accuracy of FEEDBACK will be assessed comparing pre and post weights of the breastfed infant to the volume intake measured by FEEDBACK.

Eligibility Criteria:
Inclusion Criteria:

1. Mother willing and able to provide informed consent for herself and her infant to participate in the study
2. Mother / infant dyad has an indication for and is currently using a nipple shield as per Licensed Independent Practitioner (LIP) or UVA lactation consultant assessment and recommendation.
3. FEEDBACK Smart Nipple Shield 'fit' assessment has been done by a study team member. Size to be comparable to the Smart Nipple Shield sizes (20mm or 24mm)
4. Infant is \<37 weeks corrected gestational age at time of first planned FEEDBACK feed and in the NICU
5. Infant must be medically cleared for PO feeding as determined by presence of a milestone feeding order documented in EPIC.
6. Mother willing to be present for PO feeding sessions per study requirements.

Exclusion Criteria:

1. Infant with an oral, pharyngeal or mandibular abnormality where the use of a nipple shield would be contraindicated.
2. Mother / infant dyad deemed ineligible based on LIP or lactation consultant assessment.
3. Mother's with multiples \> than 2. For example, if mother has triplets only 2 of the 3 infants are allowed to be in the study.
4. Infant on any isolation precautions.
5. Infant receiving any IV fluids.
Evaluating MMPs in Burns

The objective of this study is to determine whether our chemical assay can be used to reliably predict graft take or failure in patients undergoing autologous skin grafting for treatment of acute burn injury.

This is an observational pilot study of patients treated at UF Health Shands Burn Center adult service. This is a study to determine the predictive value of quantifying concentrations of specific MMPs. Coupling this with a specialized collection sample collection system and a calibrated fluorimetry allows for the rapid assessment of MMP concentrations. This assay has been validated as a predictor of failed wound healing in a published clinical study involving chronic open wounds.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Admitted with acute burns injuries (flame, contact or scald) requiring at least one surgical excision and grafting operation will be considered for inclusion
* Burn injury less than one week old

Exclusion Criteria:

* Electrical, chemical or cold-induced burn injury
* Total body surface area burn \>50 %
* Pre injury diagnosis of chronic renal insufficiency, liver failure, refusal to accept blood transfusion or withdrawal of care within three days of admission will also be exclusion criteria
* Patients not expected to survive
* Patients presenting with re-injury to previously burned and treated areas.
* Patients who present after receiving burn excision surgery out an outside facility for the current acute injury
The Smart-phone as a Physical Fitness Monitor - Validity, Sensitivity and Motivation InterWalk

Low physical fitness may cause several life style related diseases e.g. cardiovascular disease, cancer and type 2 diabetes. It is important to develop reliable methods for measurement which can be used to follow the development of the physical shape both on an individual level and on at population level.

Associated with the development of new training method known as Interval Walking we developed an application for smartphones. The use of the application InterWalk was meant to increase physical activity in patients with type 2 diabetes. The application should both be able to, 1) be a personal trainer when doing interval walking, and 2) measure the individual physical fitness performed as a walking test. The latter function was developed to make the training more personal and individal adapted, so that the training was neither too hard or too easy.

It is necessary to test the walking test against a golden standard for measuring physical fitness and that the test in the application is able to measure and register changes in physical fitness.

Our hypothesis is that the individual test, in the InterWalk Application is reliable and able to register changes in physical fitness in patients with type 2 diabetes. The purpose of this project is investigate the reliability of a smartphone-based test of physical fitness, and to investigate whether the test is able to register changes in physical fitness during the project time (3 month). A secondary aim is to investigate whether individual support during the training period, affect the individual effort and time of interval walking per week.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, age 30-80 y, BMI \>18 but \<40 kg/m2 and confirmed T2D diagnose

Exclusion Criteria:

* Pregnancy, smoking, contraindication to increased levels of physical activity, insulin dependence, evidence of thyroid, liver, lung, heart or kidney disease
Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients

This study examines patients on chronic hemodialysis with non-valvular atrial fibrillation, who have a CHA2DS2-VASc Score of ≥ 2 and therefore are candidates for or already receive a vitamin K antagonist.

The first question is whether replacement of the vitamin K antagonist by rivaroxaban is able to slow progression of vascular calcification. The second question is whether addition of vitamin K2 to rivaroxaban can further slow down or even halt the progression of vascular calcification.

The present study targets dialysis patients with non-valvular atrial fibrillation requiring treatment with vitamin K antagonists. It addresses the question whether replacement of the vitamin K antagonist by rivaroxaban is able to slow progression of vascular calcification (VC). The second research question is whether addition of vitamin K2 to rivaroxaban can further beneficially affect the progression of VC. Two non-invasive methods are used to evaluate the impact of interventions on the progression of VC: i.e. coronary artery calcification (CAC) and pulse wave velocity (PWV) measurements. The detection of CAC is predictive for the presence of obstructive coronary artery disease and future coronary events. VC and stiffening of the central elastic-type arteries are independent predictors of cardiovascular morbidity and mortality in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* end stage renal failure treated with chronic hemodialysis
* atrial fibrillation
* CHA2DS2-VASc Score ≥ 2
* ability to provide informed consent

Exclusion Criteria:

* known intestinal malabsorption or inability to take oral medication
* inability to stop co-medication that causes major interactions with rivaroxaban (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, rifampicin, phenytoin, carbamazepine, phenobarbital or St John's wort)
* investigator's assessment that the subject's life expectancy is less than 1 year
* prosthetic mechanical heart valve
* contraindication for anticoagulation
* liver dysfunction Child-Pugh grade B-C
* pregnancy, breastfeeding, inadequate contraception
* incompliance with medication and scheduled investigations