cyrilzakka/clinical-trials huggingface dataset:
Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in DSAEK

The Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Busin glide.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation.
* Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma.
* Ability to understand the nature of the procedure and give full informed consent.
* Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital.

Exclusion Criteria:

* Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty.
* Patients with complex anterior segment pathology precluding successful DSAEK procedure.
* Patients not giving full informed consent to participate in the trial
Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome

Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for the study of glandular architecture and functions are limited and include analysis of tear constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and histopathological evaluation of lacrimal gland biopsy specimens. Confocal microscopy is a new emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment of anterior-segment disorders.The use of in vivo confocal microscopy in a comparative study of the microscopic morphology of the salivary/lacrimal glands have not been reported up to date. In this study, we employ laser scanning confocal microscopy to evaluate the morphological changes of the salivary/lacrimal glands in patients with primary Sjögren's syndrome and compare the results with those of healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* The Sjögren's syndrome diagnosis was made according to the revised American-European consensus criteria.
* Briefly, the patients had to have ocular and oral symptoms of dryness,
* clinically diagnosed dry eye and dry mouth disease,
* serum rheumatoid factor and antinuclear antibody levels ≥1:160,
* positive serology for anti SS-A or anti SS-B antibodies,
* labial salivary gland inflammatory infiltration focus score ≥2 and consents for lacrimal gland biopsy to be included into this study.

Exclusion Criteria:

* Patients with any history of ocular surgery including punctal occlusion,
* other ocular or systemic disease
* or a history of topical/ systemic drug use or contact lens wear or
* other systemic disorders that would cause dry eyes or that would alter the ocular surface.
Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women

The investigators investigated the effect of vitamin D3 supplementation on metabolic profile (anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices) in overweight or obese women.

Vitamin D deficiency is a worldwide health problem and is determined as a risk factor in Cardiometabolic disorders including Cardiovascular disease, Metabolic syndrome, and type 2 diabetes mellitus. The investigators investigated the effect of vitamin D3 supplementation on metabolic profile in overweight or obese women.

A double blind randomized clinical trial was conducted in 77 premenopause overweight or obese women. Participants were classified into two groups : vitamin D supplementation \[1000 IU/day as cholecalciferol tablets (n=39)\] or placebo (n=38). Vein blood samples were taken after at least 12 hours overnight fasting. Selected anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices were measured at baseline and after 12 weeks. Body fat mass was determined using BIA. Also the investigators assessed dietary intake using 24 hours food recall and semi-quantitative food frequency and physical activity using IPAQ questionnaires.

The investigators conducted the study between October 2009 and March 2010 at the Medical school, Tehran, Iran. Recruitment began in October 2009 via advertisements and was terminated in October 2009. The investigators excluded patients with a history of Cardiovascular disease, Liver disease, Gastrointestinal disease, Kidney disease, diabetes mellitus, and Osteoporosis. Moreover, pregnancy, lactation, vegetarianism, and intake of dietary supplements were the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-50 years old
* Premenopause
* BMI ≥25

Exclusion Criteria:

* Cardiovascular disease
* Liver disease
* Gastrointestinal disease
* Kidney disease
* Diabetes mellitus
* Osteoporosis
* Pregnancy
* Lactation
Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds

The purpose of this study is to compare the effectiveness and safety of Emervel Classic Lidocaine versus Juvederm® Ultra in the treatment of moderate to severe facial wrinkles and folds.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a male or female 18 years of age or older
* The subject has bilateral nasolabial folds that, in the opinion of both the Blinded Evaluating Investigator and the Unblinded Injecting Investigator, can be corrected with an injectable dermal implant
* The subject has the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold

Exclusion Criteria:

* The subject has active skin disease or inflammation on or near a nasolabial fold that, in the Principal Investigator's opinion, would interfere with the study device injections and/or study assessments.
* The subject has a history of sensitivity to hyaluronic acid
* The subject has a history of sensitivity to lidocaine or other amide type anesthetics
* The subject is, in the Principal Investigator's opinion, at undue risk based on the precautions, warnings and contraindications for local lidocaine anesthetics.
Investigation of the Uterine Cervix Using CervicalMD

The purpose of this study is to demonstrate the CervicalMD device's ability to collect digital imagery suitable for a colposcopy examination.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Negative Pregnancy test
* Abnormal Pap smear
* 18 years and older
* Presence of a cervix

Exclusion Criteria:

* Pregnant
* Absence of a cervix
* Less than 18 years old
* Male
Optical Biopsy for Distal Margin in Low Rectal Cancer

This is a multi-center prospective randomized controlled study. In this study, the investigators will use confocal laser endomicroscopy to make real-time in vivo optical biopsy of distal margin in rectal cancer surgery and help surgeons to make surgical decision.The investigators also assess the accuracy of CLE optical biopsy, compared with intra-operative frozen section.

In low rectal cancer surgery, how to select the precise dissection plane and optimal surgical procedure is an important challenge for surgeons. In current clinic, surgeons select dissection plane by a comprehensive judgment of pre-operative pelvis MRI, colonoscopy and digital rectal examination, then through submitting the "doughnut" after cutting and anastomosis to intra-operative frozen section (IFS) to definite whether there is residual tumor in distal margin (DM). However, IFS can only make diagnosis using the tissue specimen in vitro and time-consuming. Once the IFS confirm positive margin, it always means anal resection should be implemented to ensure radical treatment. Therefore, if there is a real-time in situ examination method to evaluate DM in vivo, it will bring great benefits to both surgeons and patients.

Confocal laser endomicroscopy (CLE) had been widely used in medical field to diagnose colorectal disease, but it is seldom applied in surgical filed especially in rectal cancer to make optical biopsy and help surgical decision-making. Therefore, the investigators hypothesize that CLE can real-time in situ evaluate DM during surgery in rectal cancer and its accuracy is non-inferior to intra-operative frozen section.

In this study, the investigators will randomly assign patients to the experimental group (CLE optical biopsy) and control group (IFS). Using H-E staining pathological diagnosis as golden standard, the accuracy, sensitivity and specificity of both CLE optical biopsy and IFS will be evaluated and compared. And the investigators will also evaluate patients' postoperative urinary function, defection function and quality of life through a year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Ages from 18 to 70 years.
* Rectal tumor confirmed pathologically by endoscopic biopsy.
* The distance from lower edge of tumor to the dentate line is less than 5cm.
* Plan to perform curative resection.
* ASA(American Society of Anesthesiology)score class I,II,or III.
* Able to provide written informed consent.

Exclusion Criteria:

* Intestinal perforation or acute intestinal obstruction.
* Multiple distant metastasis and can not R0 resection.
* T4b according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
* Pregnancy or breastfeeding.
* Impaired renal function
* American Society of Anesthesiology score (ASA) class IV or V.
* Unable or refuse to provide written informed consent.
Study of the Ability of Betaine Hydrochloride to Increase Stomach Acid in Healthy Volunteers

In this study the investigators will test a nutritional supplement called betaine hydrochloride to see if it can temporarily increase the stomach acid in healthy volunteers who have decreased stomach acid because they take a medicine called rabeprazole.

Investigators will evaluate the extent and time course of gastric re-acidification after oral betaine HCl in healthy volunteers with pharmacologically-induced hypochlorhydria. After betaine HCl dose, gastric pH will be continuously monitored for 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam;
* BMI between 18.5 - 35 kg/m2;
* Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or OTC medications (except acetaminophen);
* Subjects must be able to maintain adequate birth control during the study independent of hormonal contraceptive use;
* Be able to provide written informed consent and comply with requirements of the study;
* Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until completion of the entire study;
* Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of that study day;
* Fast from food and beverages at least 8 hours prior to the study day;
* Be able to read, speak and understand English

Exclusion Criteria:

* Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia.
* Subjects with a fasting gastric pH of \> 4 (i.e. hypochlorhydria)
* Subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills.
* Subjects on prescription or chronic over-the counter medications (including hormonal contraceptives);
* Subjects with known allergy to study interventions;
* Subjects who smoke tobacco;
* Subjects with ongoing alcohol or illegal drug use;
* Subjects who are pregnant, lactating or attempting to conceive;
* Subjects unable to maintain adequate birth control during the study;
* Subjects unable to follow protocol instructions or protocol criteria.
HMW-Adiponectin is Raised in Newborns

Cross sectional, hospital-based study dealing with adiponectin levels in newborns to mothers with pre-eclampsia. Venus cord blood samples were collected immediately after birth; 30 cases and 62 controls were enrolled into the study. The study was approved by the local ethics committee and all participants gave written consent.


Eligibility Criteria:
Inclusion Criteria:

* Pre-eclampsia
Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement

Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders.

The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide™) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.


Eligibility Criteria:
Inclusion Criteria:

* Primary symptomatic severe aortic valve stenosis
* Accepted for TAVR, either by transfemoral, transsubclavian or transapical access
* Plan to implant one of the following transcatheter heart valves for which FEops HEARTguide™ is available (CoreValve™ Evolut™ R, and Evolut™ PRO and Evolut™ PRO+ (Medtronic, Minnesota, USA), ACURATE neo™ and ACURATE neo 2™ (Boston Scientific, Marlborough, MA, USA)
* Informed consent

Exclusion Criteria:a potential subject who meets any of the following criteria will be excluded from participation in this study before randomization:

* Previous surgical aortic valve replacement
* Permanent pacemaker at baseline
* Emergency procedure
* Poor CT image quality (disabling computer-simulation, i.e. generation of 3D anatomical models will not be possible with poor CT image quality), for example because of motion artifacts due to the presence of other implanted devices affecting the region of interest
* Patient who did not agree to the informed consent and/or refused to participate
* Patient unable to understand the informed consent/study
Prognostic Factors of Patients Undergoing Redo Cardiac Surgery

This study aims to investigate the prognostic significance of baseline characteristics for patients undergoing redo cardiac surgery.

Redo cardiac surgery is associated with an increased risk of postoperative morbidity and mortality. Patients undergoing redo cardiac surgery are becoming increasingly complex due to multiple comorbidities, adherence of mediastinal structures to the undersurface of the sternum as well as the spatial location of patent bypass grafts relative to the route of entry. Association estimates between baseline characteristics and outcomes in those cohort are imprecise. The aim of this study is to identify prognostic factors associated with redo cardiac surgery which may help physicians predict clinical outcomes and guide their treatment decision.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing redo cardiac surgery

Exclusion Criteria:

* Age \<18 years;
* Patients with a DNR order or "do not escalate care" order.
The Cardiovascular Benefits of Resistance Training and Dark Chocolate in Female Adults

This study investigates the effects of 85% dark chocolate supplementation on vascular function and nitric oxide (NO) levels during high-intensity resistance exercise in healthy women across menstrual phases. Using a randomized crossover design, 31 women consumed either dark chocolate or milk chocolate before exercising during the early follicular and mid-luteal phases. Vascular markers, including pulse wave velocity (ftPWV), arterial stiffness, blood pressure, and plasma NO levels, were measured at multiple time points.

Background:

Dark chocolate, rich in flavanols, may support vascular health by reducing arterial stiffness and blood pressure across menstrual phases. This study examined the effects of 85% dark chocolate on nitric oxide (NO) levels and vascular function during high-intensity resistance exercise in healthy women across the early follicular and mid-luteal phases.

Methods:

Thirty-one healthy women (aged 20-30 years) with regular menstrual cycles completed a randomized, crossover study (conducted at National Chung Cheng University, Sep-Dec 2023). Participants consumed either 85% dark chocolate or milk chocolate (1g/kg body weight) before high-intensity resistance exercise during the early follicular (days 2-5) and mid-luteal (days 18-24) phases of two menstrual cycles. Finger-toe pulse wave velocity (ftPWV), arterial stiffness, blood pressure, and plasma NO levels were measured at rest, 2 hours after chocolate consumption (baseline), immediately post-exercise (T0), and at 60 (T60) and 120 (T120) minutes post-exercise.

Eligibility Criteria:
Inclusion Criteria:

* the healthy adult women,
* aged 20-30 years, from a local university campus,
* had a regular menstrual cycles in the past three months.

Exclusion Criteria:

* (1) irregular menstrual cycles (menstrual cycle length \< 21 or \> 35 days in the past three months),
* (2) pregnancy or lactation in the past year,
* (3) history of cardiovascular or uterine surgery in the past six months,
* (4) use of contraceptives or other female hormone medications,
* (5) smoking or alcohol consumption habits,
* (6) hypertension (blood pressure \> 140/90 mmHg), chronic diseases, heart disease, or other cardiovascular conditions, (7) allergy to cocoa products, nuts, or fruits.
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway

The protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway:

* POMC or PCSK1 (Sub-study 035a)
* LEPR (Sub-study 035b)
* SRC1 (Sub-study 035c)
* SH2B1 (Sub-study 035d)

The objectives and endpoints are identical for these sub-studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a pre-identified:

  * Heterozygous genetic variant in the POMC gene or PCSK1 gene
  * Heterozygous genetic variant in the LEPR gene
  * Homozygous, heterozygous, or compound heterozygous variant in the NCOA1 (SRC1)
  * Homozygous, heterozygous, or compound heterozygous variant in SH2B1 gene, or chromosomal 16p11.2 deletion encompassing the SH2B1 gene
* Between 6 and 65 years of age at the time of provision of informed consent/assent
* Obesity, defined as BMI ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and gender for patients 6 up to 17 years of age
* Patient and/or parent or guardian is able to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent
* Patient and/or parent or guardian reports that patient experienced childhood obesity, defined as the patient and/or parent or guardian reporting that the patient was significantly overweight during childhood
* Agree to use a highly effective form of contraception throughout the study and for 90 days following the study
* Reported history of lifestyle intervention of diet and exercise
* Reported history of hyperphagia

Key Exclusion Criteria:

* Weight loss of 2% or greater in the previous 3 months
* Recent history of bariatric surgery
* Significant psychiatric disorder(s)
* Suicidal ideation, attempt or behavior
* Clinically significant pulmonary, cardiac, endocrine/metabolic, hepatic or oncologic disease
* Glycated hemoglobin (HbA1C) \>10% at Screening
* History of significant liver disease or severe kidney disease
* History or close family history (parents or siblings) of melanoma, or patient history of oculocutaneous albinism
* Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
* Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing
* Previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide
* Significant hypersensitivity to any excipient in the study drug
* If female, pregnant or breastfeeding
A Pharmacist Intervention to Improve Mother and Child Health

The goal of this clinical trial is to learn if a research pharmacist can improve the health of new mothers and their babies. The main questions it aims to answer are:

* Will postpartum women who had elevated blood pressure during pregnancy be willing to participate in the study, talk to a pharmacist about their health and the health of their child, and text us their blood pressure measurements?
* Will contact with the pharmacist improve the health of the mother and/or the child?

Participants will:

* complete a baseline demographic survey,
* be given a blood pressure cuff and taught how to use it,
* be asked to text us their blood pressure values 2 times per day for 7 days after enrollment,
* complete a phone call with a pharmacist discussing their health and the health of their baby,
* text us their blood pressure 1 time per day for 3 days 1 month after enrollment,
* have a 1 month follow-up phone call with the research pharmacist, and
* complete an exit survey to provide feedback about the study.


Eligibility Criteria:
Inclusion Criteria:

* biological mother of a baby attending a 1-week to 6-month well-child visit,
* received prenatal care at University of Iowa Hospitals and Clinics,
* had at least 2 elevated blood pressures (\>= 130 mmHg systolic or \>= 80 mmHg diastolic) during pregnancy,
* owns a smartphone

Exclusion Criteria:

* arm circumference \> 17 inches,
* prisoner status
* unable to provide own written informed consent