cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Tolerability, PK and PD of AM1030-CREAM in Patients With Atopic Dermatitis

This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Males and/or females of any ethnic origin between 18 and 65 years of age
* Body mass index between 18.0 and 35.0 kg/m2
* Subjects with AD as defined by the Hanifen and Rajka criteria and with mild to severe disease activity (IGA 2-4)
* AD lesions amenable to cutaneous treatment located on the trunk and/or limbs

Exclusion Criteria:

* Subjects with scars, moles, tattoos, sunburn or other blemishes in test areas
* Systemic treatment with immunosuppressants, immunomodulators or corticosteroids within 2 weeks prior to dosing
* Topical treatment with corticosteroids, antibiotics and/or immunomodulators within 4 days prior to dosing
* Treatment with systemic antihistamines within 24 hours of the first dose administration
* Treatment with SSRIs within 2 weeks of the first dose administration
* Subjects who have received phototherapy within 4 weeks prior to dosing
Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department

To investigate the role of initial venous lactate in predicting the severity progression to overt septic shock and 30-day mortality in non-elderly patients without hemodynamic shock who suspected to have acute infections.

Blood lactate is one of the markers that can predict the organ failures and mortality in emergency department (ED) patients with sepsis. Regarding its predictive role in the clinical deterioration in normotensive sepsis patients, a recent prospective observational study of the patients with moderately-high serum lactate (2.0-3.9 mmol/L) showed that one-forth of the patients eventually developed progressive organ dysfunctions or required vasopressor or mechanical ventilator. Unfortunately, low serum lactate (\< 2.5 mmol/L) was still found up to 50% of overt septic shock patients, even in vasopressor-dependent cases. For the prognostic role on mortality, numbers of articles showed that blood lactate can also predict death in sepsis patients, especially in those who are elderly and critically-ill. However, no previous study was done in younger patients since lactate kinetics in the body may differ among the age groups. The primary aim of our study is to investigate the role of initial venous lactate levels in predicting the chance of severity progression to overt septic shock especially in non-elderly patients who suspected to have acute infections and without hemodynamic shock in ED. The secondary outcomes are to evaluate its prognostic role on hospital length of stay and 30-day mortality of this target population.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* Confirmed or suspected diagnoses of acute infections (within 7 days)
* Major infections (e.g. Acute pyelonephritis, Acute bronchitis/pneumonia, Acute hepatobiliary tract infections, intrabdominal abscesses, meningitis and other central nervous system infections, soft tissue infections involving more than 10 square centimeters of the skin surface or deeper down beyond the dermis, significant tropical infections; dengue fever, leptospirosis, typhus fevers, or high fever from any infectious sources)
* Systolic blood pressure more than 90 mmHg at presentation
* Mean arterial pressure more than 70 mmHg at presentation

Exclusion Criteria:

* Duplicated cases that have participated in this study during the study period
* Overt organ hypoperfusion (e.g. cold, clammy or mottling skin, altered mental status; Glasgow Coma Scale equal to or less than 12 or decrease \> 1 compared with the baseline)
* Pulse oximetry equal to or less than 90% at ambient air
* received intravenous fluid more than 10 ml/kg prior to the venous blood sampling
* received intravenous antibiotics for more than 1 hours prior to the venous blood sampling
* Minor infections (e.g. uncomplicated upper respiratory tract infections, gastroenteritis, minor skin infections)
* currently taking antiretroviral drugs
* having or suspicious of having seizures in the past 72 hours
A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune responses of CNTO 6785 after administration to healthy adult volunteers.

This is a randomized (study drug will be assigned by chance), double-blind (neither the volunteer, physician, or study staff will know the identity of the assigned treatment), study to evaluate the safety, tolerability, pharmacokinetics (blood levels of drug) and immunogenicity (development of antibodies to the drug) of a single dose of CNTO 6785 administered to healthy adult volunteers intravenously (in the vein) or by subcutaneous (under the skin) administration to healthy adult volunteers.This will be the first administration of CNTO 6785 to humans; therefore, no clinical experience is available. Healthy volunteers will receive a single dose of 1, 3, or 10 mg/kg of CNTO 6785 or placebo as a 30-minute intravenous (IV) (injection into a blood vessel) infusion or a single dose of 3 mg/kg of CNTO 6785 administered in up to 3 subcutaneous (under the skin) (SC) injections.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteer with no clinically significant abnormalities as determined by the investigator (study physician)
* Have a body mass index (BMI) between 19-30 kg/m2
* Be a non-smoker for at least 6 months prior to study participation
* Women must be postmenopausal or surgically sterile

Exclusion Criteria:

* Currently have or have a history of any clinically significant medical illness or medical disorders (includes malignancies or serious infections) that the investigator (study physician) considers should exclude the volunteer from the study
* Major surgery or significant trauma within 12 weeks of screening
* Any volunteer who plans to undergo elective surgery within 4 weeks prior to study agent administration and through the end of the study
* Consumes, on average, more than approximately 500 mg/day of caffeine (as contained in 5 cups of tea or coffee or 8 cans of soda or other caffeinated products per day).
Giant Cell Tumor of the Bone in Young Patients

single institution cases series review of histological and clinical data of young patient with Giant Cell Tumors


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients under 15 years old treated at Rizzoli Institute from 01 January 1982 to 31 December 2018.
2. Diagnosis of giant cell tumor of bone, aneurysmatic bone cysts with solid features and giant cell reparative granuloma.
3. Histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis
4. Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

1. Patients with histological diagnosis different from diagnosis of giant cell tumor, aneurysmatic bone cysts with solid features, and giant cell reparative granuloma.
2. Patients with no available material for additional immunohistochemical and molecular analysis
Effectiveness of a 12-week Movement Intervention on Heart Rate Variability and Self-compassion Among New Mothers

This is a mixed-methods randomized controlled trial assessing the effects of an online and in person 12-week movement intervention compared to an education only control group on heart rate variability, self-compassion, psychological well-being, fatigue, exercise self-efficacy, physical activity identity, and body image in postpartum women.

This is a mixed-methods randomized controlled trial assessing the effects of an online and in person 12-week movement intervention compared to an education only control group on heart rate variability, self-compassion, psychological well-being, fatigue, exercise self-efficacy, physical activity identity, and body image in postpartum women.

Participants will be randomized into one of three groups: 1) in person yoga movement intervention, 2) online yoga movement intervention, 3) education group. Heart rate variability will be measured using a chest strap at the beginning and end of the 12 week intervention. At the beginning and end of the 12 week intervention, and at 3-months post-intervention, questionnaires will be completed online to assess self-compassion, psychological well-being, fatigue, exercise self-efficacy, physical activity identity, and body image.

Eligibility Criteria:
Inclusion Criteria:

* Women who have given birth to a child within the past 6 months and who are cleared for physical activity by their health care provider.

Exclusion Criteria:

* Participants who have a medical condition that precludes them passing the Get Active questionnaire
* Women not clear for physical activity by a health care provider
* Participants who are not able to attend classes at pre-specified times
Hemodynamic Effects of Delayed Umbilical Cord Clamping in Full-term Newborns

The sequence of events at the time of delivery includes delivery of the infant, clamping of the umbilical cord, and lastly delivery of the placenta. There are some benefits for delayed cord clamping. This study aims to compare the effects of two different duration of delayed cord clamping.

Infants will be randomized into two groups based on the duration of delayed cord clamping: 30 seconds vs 120 seconds. Different hemodynamic effects will be measured in each group at different time intervals. The hypothesis of the study is that delayed cord clamping for 120 seconds is associated with better cardiac output and with other hemodynamic advantages.

The study will include full term infants delivered via cesarean section. Written informed consent for participation in the study will be obtained from parents prior to delivery. Newborns will be randomly assigned into two groups according to the duration of cord clamping: Group 1: the cord will be clamped at 30 seconds, and Group 2: the cord will be clamped at 120 seconds of life. Stopwatch will be started when infants buttocks (or head if breech) are delivered from the uterus. The time elapsed will be counted aloud by the investigator in 10-second intervals. During this time, the infant will be held in linen on the mothers legs. Care will be taken not to apply traction on the cord. Milking of the cord will not be allowed. Immediately after resuscitation, infants will be attached to the leads of the electrical cardiometry device. Device output will be imported at 5, 10, and 15 minutes after birth in both groups. A follow up measurement will be imported later at 24 hours of age. In addition, a peripheral blood sample will be obtained at 24 hours of age for assessment of hemoglobin, glucose and bilirubin concentrations. .

The calculated sample size is 31 newborns in each group. This number will be adequate to detect an effect size of 10% in the mean cardiac output between the two groups with 95% confidence and 80% power. The study plans to recruit 34 infants in each group (10% attrition rate).

Eligibility Criteria:
Inclusion Criteria:

* Normal full term newborns ≥37 weeks gestational age
* Both genders are included
* Singleton
* Delivered by elective cesarean section due to previous cesarean section, cephalo-pelvic disproportion, or mal-presentation
* Successfully transitioned without need for respiratory or medication support

Exclusion Criteria:

* Neonates needing any active resuscitation
* In-utero fetal distress
* Suspected perinatal asphyxia
* Major congenital malformations
* Twin or multiple gestation
* Intrauterine growth restriction
* Placenta previa
* Mothers with cardiac disorders
Ventilation Strategies Impact on Oxygenation and Postoperative Pulmonary Complications in Lung Surgery Patients

The purpose of this clinical trial was to understand the effects of variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), pressure-controlled ventilation (PCV), and open surgery (Open Surgery). controlled ventilation (C-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) for open surgery, video-assisted thoracoscopic surgery, and segmental lung resection. VATS), segmentectomy (Segmentectomy), lobectomy (Lobectomy), and pneumonectomy (Pneumonectomy) on oxygen saturation and pulmonary complications, and length of hospitalization.

The main question it aims to answer is: variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV).Does it decrease patient oxygen saturation, and does it increase pulmonary complications, length of hospitalization? Researchers compared variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) to compare them to see which mode of ventilation has the least physiologic disruption for the patient.

Participants will:

Select the appropriate surgical procedure according to the condition and be randomized to variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume- controlled ventilation (C-VCV), pressure-controlled ventilation (PCV), and were checked after surgery.

Patients' oxygen saturation, pulmonary complications, length of hospitalization were recorded


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring any of open surgery, television-assisted thoracoscopic surgery (VATS), segmental lung resection (Segmentectomy), lobectomy, and total lung resection (Pneumonectomy).
* Patients who are able to receive any of the ventilation modes of controlled ventilation (C - VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C - VCV), pressure-controlled ventilation (PCV), and variable tidal volume ventilation (V - VCV).

Exclusion Criteria:

* Patients with severe cardiac, hepatic, renal, and other vital organ dysfunction
* Patients with mental illness or cognitive disorders that prevent them from understanding the study and cooperating with the study process.
* Patients with hematologic disorders
* Pregnant or breastfeeding females
The Impact of Esmolol Administration on Postoperative Recovery

The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain

Contemporary anaesthesiology requires the quest of ways to restrict the use of opioids, which aim at the alleviation of severe postoperative and chronic pain. This is not only due to the side effects involved but also to the epidemic dimensions their use entails. Esmolol, an extremely short-acting cardioselective antagonist of β1 adrenergic receptors, is effectively used in order to attenuate the stress response and minimize undesirable perioperative hemodynamic changes. More specifically, esmolol has been used effectively to reduce pain during induction of anesthesia with propofol and treat tachycardia and hypertension during laryngoscopy. However, recent studies also highlight a possible antinociceptive and/or analgesic effect of esmolol. Therefore, The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* American Society of Anesthesiologists (ASA) classification I-II
* elective inguinal hernia repair

Exclusion Criteria:

* body mass index (BMI) \>35 kg/m2
* β-blocker administration preoperatively
* systematic use of analgesic agents preoperatively
* chronic pain syndromes preoperatively
* neurological or psychiatric disease on treatment
* pregnancy
* severe hepatic or renal disease
* history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
* hemodynamic instability
* drug or alcohol abuse
* language or communication barriers
* lack of informed consent
* bilateral inguinal hernia repair
Impact of Front-of-package Labels on Weight Bias Among Latines

The goal of this experiment is to examine the effects on explicit weight bias of a selection task using 4 different types of front-of-package food labels to select healthy or unhealthy foods among a sample of Latine and low English proficiency adults. The main questions this experiment aims to answer are:

* Does the use of different front-of-package label designs in a selection task lead to different effects on explicit weight bias among Latine and low English proficiency consumers?
* Does the use of different front-of-package label designs in a selection task lead to different effects on attribution of personal responsibility for body weight among Latine and low English proficiency consumers?

Participants will be randomly assigned to 1 of 4 types of front-of-package label designs. They will view 3 sets of products (frozen meals, frozen pizzas, and frozen desserts), shown in random order. For each product set, participants will view 3 products shown in random arrangement, each with participants' randomly assigned label shown on the front of package. After viewing all 3 product types, participants will answer questions about explicit weight bias and attribution of responsibility for body weight. Researchers will compare results across label designs.

This study aims to determine if the use of different front-of-package label types in a selection task leads to different effects on explicit weight bias and attribution of responsibility for body weight among Latine and low English proficiency (LEP) consumers. A Latine-focused panel company will recruit 4,000 US Latine adults of parental age (18-55 years), approximately 50% of whom will have low English proficiency (LEP). In a between-subjects experiment, researchers will randomize participants to 1 of 4 types of front-of-package labels: a numerical label, an interpretive text-only label, an interpretive label with a magnifying glass icon, or separated interpretive labels with a magnifying glass icon. Participants will first perform a selection task for a parent study in which they will view their assigned label on 3 sets of products (with 3 products per set) and select the product they believe is most and least healthy and the product they most want to purchase. After this selection task, participants will answer questions measuring this study's outcomes: explicit weight bias (primary outcome) and attribution of personal responsibility of body weight (secondary outcome).

Eligibility Criteria:
Inclusion Criteria:

* Identifying as Latine or Hispanic
* Ages 18-55 years old
* Residing in the United States

Exclusion Criteria:

* Not identifying as Latine or Hispanic
* Less than 18 or greater than 55 years old
* Not residing in the United States
A Study of EXG102-031 in Patients With wAMD (Everest)

In neovascular (wet) age-related macular degeneration (nAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with nAMD.

Age-related macular degeneration (AMD) is a major cause of blindness and visual impairment in older adults. The wet form of AMD, also called neovascular AMD (nAMD) usually causes faster vision loss than the dry form. The most common current treatments of nAMD are products that inhibit vascular endothelial growth factor (VEGF) (including ranibizumab (LUCENTIS®, Genentech) and aflibercept (EYLEA®, Regeneron) and are delivered by intravitreal injections at 4 to 16 week intervals and continued indefinitely. This Phase I, open-label, multiple-cohort, dose-escalation study is designed to evaluate the safety and tolerability of EXG102-031 gene therapy in subjects with previously treated nAMD. Safety will be assessed over 52 weeks after the administration of EXG102-031.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥ 50 years of age;
2. Diagnosis of nAMD and current active lesion in the study eye at Screening;
3. An ETDRS BCVA letter scores between 73 and 19 letters in the study eye;
4. Response to anti-VEGF treatment during Screening;
5. The study eye must be a pseudophakic lens (post-cataract surgery status); and
6. Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening.

Exclusion Criteria:

1. Presence of any ocular disease or history of disease in the study eye other than nAMD that may affect central visual acuity and/or macular detection, including retinal detachment, or in the opinion of the investigator could limit VA improvement in the study eye;
2. Presence in the study eye of CNV or macular edema due to causes other than AMD;
3. Presence in the study eye of scarring, fibrosis or atrophy involving the macula;
4. Subretinal hemorrhage accumulating in the center of the macula of the test eye, with an area of hemorrhage ≥ 4 optic disc diameters;
5. Active ocular infection in either eye;
6. Presence of advanced glaucoma or uncontrolled glaucoma in the study eye;
7. History of intraocular surgery in the study eye within 90 days of screening; or
8. Prior receipt of any ocular or systemic gene therapy agent.