cyrilzakka/clinical-trials huggingface dataset:
Promoting Stress Management and Resilience Among Individuals with Von Hippel- Lindau Disease

The Relaxation Response Resiliency Program (3RP) has shown efficacy in improving coping and resilience across diverse populations; however, little is known about how it helps individuals manage the challenges of living with a chronic illness. This study proposes to pilot test an adapted version of the 3RP among patients living with VHL.

The 3RP has not been carried out with VHL patients. As such, the investigators are looking to see if an adapted program, tailored to the needs of patients with VHL, is feasible, acceptable, and helpful in improving coping among individuals living with VHL.

This study is a two phase trial. Phase I is descriptive. It is comprised of conducting interviews with patients and caregivers to understand the challenges of living with VHL and patient's programatic needs. This information will be used to tailor the program for patients living with VHL. Phase II is a single-arm feasibility trial that will examine if the adapted program is feasible, acceptable, and helps promote stress management among VHL patients. To these means, we will test the adapted 3RP (3RP-VHL) in up to 40 patients living with VHL. Participants will complete surveys at baseline and post 3RP-VHL program completion. This record will reflect the trial component (Phase II) only, as feasibility and acceptability outcomes will be collected for this phase.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18+
* Confirmed diagnosis of VHL

Exclusion Criteria:

* Is medically, psychiatrically, or otherwise unable to participate (as determined by a physician or study PI).
* Unwilling or unable to participate in study sessions delivered via Partners Telehealth videoconferencing.
* Participated in Phase 1 qualitative interview.
Blood Loss Measurement During Cesarean Delivery

The aim of this study is to assess the ability of the Triton Device to measure blood loss among women undergoing elective and non-elective cesarean delivery. This patient population often experiences significant blood loss during surgery, and measurements of surgical blood loss are often inaccurate.

This is an observational study. Potential participants will be approached by a member of the research team prior to surgery. Healthy ASA 1, 2, or 3 patients undergoing uncomplicated Cesarean delivery will be recruited. The Triton device will be used during the surgery to estimate blood loss. Specifically, the device takes pictures of the blood saturated laps and fluid collection canister and calculates hemoglobin loss and overall blood loss.

Serum hemoglobin samples will be collected at baseline on presentation to the pre-operative area, within 15 mins of arrival in PACU and at 24 hrs post cesarean delivery. Blood sampling will take place by venipuncture technique from a vein in the arm. Maternal vital signs during the perioperative period (heart rate, maternal mean arterial blood pressure, anesthetic technique, fluid administration, and surgical data will be recorded.

All patient will have a neuraxial anesthetic of a spinal or combined spinal/epidural. Fluid administration will be under the discretion of the anesthesiologist and will follow standard guidelines including 1L of Lactated Ringers co-load at time of spinal and 1-2L of crystaloid intraoperatively.

At the end of the cesarean section, the following measurements will be made:

1. tEBL: Triton device will be used to measure blood loss on wet and dry soaked laps and in the suction canister. These measurements will be used to calculate tEBL.
2. vEBL: The attending obstetrician and anesthesiologist will independently be asked to provide estimates for total blood loss (vEBL). We will use both values in separate regression analyses
3. qEBL: Blood loss will be measured by cumulative measurement of the following: the volume of blood in the suction chamber at the end of surgery (and subtracting the estimated amniotic fluid from the suction chamber; weight of blood soaked laps; estimated spillage of blood (in ml) in and around the surgical field (not collected on laps or in suction chamber).

Using mixed effects modeling, we will determine whether estimated blood loss measurements using Triton (tEBL) can be used to predict postpartum hemoglobin (Hb) levels, after accounting for the predelivery Hb level, intraoperative intravenous fluids and patient/operative factors.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status class I-III
* undergoing Cesarean delivery under neuraxial anesthesia
* age between 18 and 50
* gestational age greater than or equal to 37 completed weeks
* all ethnicities

Exclusion Criteria:

* contraindication for epidural or spinal analgesia (bleeding diathesis, neuropathy, severe scoliosis, local anesthetic allergy)
* inability to adequately understand the consent form
Understanding Immunity to SARS-CoV-2, the Coronavirus Causing COVID-19

The purpose of this study is to test over time immunity to SARS-CoV-2, a recently identified coronavirus responsible for the 2019 world-wide pneumonia outbreak known as COVID-19. Adults and children diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older) and children with confirmed COVID-19 (RT-PCR diagnosis).
* Adults (18 years and older) and children without COVID-19 for controls (who test negative for COVID-19 but may have viral symptoms)

Exclusion Criteria:

* Patients with special risks attendant to venipuncture will be excluded.
A Study to Collect Bone Marrow for Process Development and Production of BM-MSC to Treat Severe COVID19 Pneumonitis

The COVID-19 pandemic, commonly referred to as "coronavirus", first began in the city of Wuhan, China in December 2019. This virus has since spread globally, with infections reported in nearly every country. COVID-19 targets the body's respiratory system, where infections can be found in the nose, throat and lungs. The effect of COVID-19 infection is very variable, where many people might not know that they have been infected and have recovered from COVID-19. However, COVID-19 infection can cause people to have difficulty breathing. This can be severe enough to require hospitalisation and potentially intensive care treatment.

While they are being treated in hospital, COVID-19 infected patients can be found to have inflamed tissue in their lungs (referred to medically as "pneumonitis"). This inflammation is thought to be caused by their body's immune systems overacting to the infection rather than the COVID-19 virus itself. By potentially dampening down this overreaction of their immune system, it is hoped that COVID-19 patients with inflamed lungs have better and quicker chance to survive.

Mesenchymal stromal cells (MSCs) have been shown to have anti-inflammatory and healing properties on injured tissue. MSCs have been trialled in various diseases but have not yet been tested on patients with COVID-19. In this study, the investigators will obtain bone marrow from healthy volunteers to develop a cell-based treatment for COVID-19-related pneumonitis. The investigators will also determine whether it is feasible to recruit bone marrow donors in a clinically useful timeframe to treat COVID-19 patients. A future trial, COMET20, will use the bone marrow-derived MSCs (BM-MSCs) manufactured in COMET20d to treat COVID-19 patients suffering with pneumonitis, to determine whether the BMMSCs can reduce the likelihood for mechanical ventilation and reduce hospitalisation.


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent to participate
* Be aged between 18 and 40 years old
* Have Eastern Cooperative Oncology Group (ECOG) performance status 0
* Be negative for mandatory infectious disease markers (IDM) as per World Marrow Donor Association (WMDA) guidelines
* Present a negative SARS-CoV2 screen
* Show absence of clinical symptoms of COVID-19 (Not have been in known COVID-19 contact within the previous 14 days, Adherence to national social distancing guidelines for 14 days)
* Have a BMI \<35kg/m\^2
* Women of childbearing potential need a negative pregnancy test (urine or blood) within 7 days prior to the marrow collection

Exclusion Criteria:

* Any major disease which would represent a contraindication to bone marrow donation based on WMDA guidelines
* Presence of any previous or active malignancy (other than non-melanoma skin cancer)
* Any other concurrent severe and/or uncontrolled medical condition
* Women who are pregnant or breast-feeding
* Any acute or chronic back complaint
* Presence of anaesthetic risk factors
Tri-split Face Study of Skin Resurfacing Modalities for the Treatment of Melasma

Tri-split face study of skin resurfacing modalities for the treatment of melasma, comparing the medium depth trichloroacetic acid peel, CO2 laser and Qs-NdYag laser.

Melasma is an acquired chronic and relapsing hyperpigmentation disorder, with a significant negative impact on the quality of life of patients. Melasma is more common in patients with skin of color and has also been linked to chronic ultraviolet (UV) and heat exposure, family history and hormonal factors. There are several studies in the literature using various therapies for melasma, including sun protection, topical therapies, lasers and chemical peels. However, many of these studies vary greatly in their efficacies and side effect profiles, due to varying and undelineated pre and post-op procedure regimens. Side effects of post-inflammatory hyper and hypopigmentation and rebound are reported in these studies. The investigators would like to conduct a tri-split face study that compares a 22% trichloroacetic acid (TCA) deep medium peel with an ablative fractionated CO2 laser and more pigment selective Q-switched (Qs) Nd:YAG laser. To minimize possible post-procedure side effects and melasma rebound, the investigators will perform above treatments in conjunction with an optimal skincare regimen, starting 6 weeks before and continuing after the treatments. The investigators will perform the 22% TCA chemical peel, CO2 laser and Qs-Nd:YAG at 6 weeks after the start of the skincare regimen, and repeat treatments with Qs-Nd:YAG at weeks 8, 10, and 12. The investigators will assess participants using standardized photos in conjunction with UV imaging (Visia CR) at weeks 0, 6, 16, 20 and 24 (6 months), by measuring the modified melasma area and severity index (mMASI) scores and visual analog scale (VAS) scores as graded by participants as well as by blinded physicians based on photos and UV imaging.

Eligibility Criteria:
Inclusion Criteria:

* male or female participants
* 20 to 60 years old
* participants with melasma on forehead and both cheeks
* participants who failed topical therapy for melasma
* participants who have never tried other therapies for melasma

Exclusion Criteria:

* pregnancy
* lactation
* use of oral contraceptive (OCP) within 3 months of starting the study
* hormonal therapy within 3 months of starting the study
* hormonal intrauterine device (IUD) within 3 months of starting the study
* history of poor wound healing or abnormal scarring
* history of lip or face herpes simplex virus infections
* active facial skin infection
* history of connective tissue disorders (such as lupus or scleroderma)
* history of isotretinoin therapy within 6 months of starting the study
* history of chemical peels, dermabrasion, laser therapy or intense pulse light (IPL) within 6 months before enrollment into the study
Right Ventricular Dysfunction Incidence After Major Lung Resection

This study aims to describe incidence of right ventricular dysfunction after major lung resection with echocardiography criteria.

Few clinical trial studied the incidence of right ventricular dysfunction after major lung resection and time frame of occurrence.

In this prospective observational study the right ventricular function will be mesure with echocardiographic criteria. Echocardiographic exam will be standardised and be realised day before surgery (at the same time that inclusion), day 1, day 2 and day 3 after surgery.

In order to assess prognostic value of right dysfunction after lung resection, data as hospitalization stay, complications and survival will be collected at 6 months.

Cardiac cycles will be recorded and be analysed by a single observer blind to the clinical finding and other echocardiographic measurements.

Eligibility Criteria:
Inclusion Criteria:

* Written consent
* Patient older than 18 years
* Major lung surgery (pneumonectomy, lobectomy)

Exclusion Criteria:

* Pre-existing pulmonary arteria hypertension
* Post-operative surgical complication on day 1 to 3 (bleeding, revision surgery)
* Technical difficulty preventing adequate echocardiographic assessment
* Patient refusal
MRI Brain Changes Induced by Hyperbaric Oxygen Therapy in Brain Injury Patients

In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging studies before and after treatment.

The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI in addition to the cognitive tests before and after the treatment.

Retrospective analysis of patients suffering from chronic neuro-cognitive damage due to TBI treated at Sagol center for hyperbaric medicine and research, Assaf Harofeh Medical Center, Israel

Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). The study was approved by the institutional review board of the hospital.

Patients are treated with 50-70 daily hyperbaric sessions, 5 days per week. Each session consists of 60 minutes exposure to 100% oxygen at 1.5 ATA.

All patients that underwent MRI before and after HBOT. The MRI protocol included DSC, DCE, DTI, FLAIR, T2 and SWI.

MRI scans sequences parameters:

\* DSC: 50 T2\*-weighted gradient-echo echo planar imaging (EPI) volumes were acquired, 2 repetitions before a bolus injection of Gadolinium-DTPA (Gd-DTPA), 48 repetitions after injection of Gd-DTPA. Sequence parameters: TR=2,300 ms, TE= 40ms, flip angle = 30°, voxel size = 1.8 x1.8, Matrix = 128x128, No. of slices = 25, Slice thickness = 3.9 mm.

* DCE: three T1 weighted Fast Low Angle SHot (FLASH) volumes were acquired with different flip angles (2, 7 and 15 degrees) followed by 70 dynamic T1 weighted FLASH volumes with flip angle of 15 degrees after bolus injection of Gd-DTPA. Sequence parameters: before injection: TR=4.09, after injection - TR=4.86 ms, TE= 1.76 ms, Voxel size = 1.5x1.5, Matrix = 192X192, No. of slices = 26, Slice thickness = 3.5mm.
* DTI: 30 diffusion weighted images were scanned with different gradient directions (b=1000) and one volume without diffusion weighting, with the following parameters: TR=10,300 ms, TE=89 ms, Voxel size = 1.8X1.8, Matrix = 128 X 128, No. of slices = 63, Slice thickness = 2.2mm

Eligibility Criteria:
Inclusion Criteria:

* Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT).

Exclusion Criteria:

* did no complete treatment or did not complete examinations.
Effects of Exercise Training on Endothelial Function, Inflammation, Arterial Stiffness and Autonomic Function in CAD

The main purposes of this study is to analyze, in a randomized controlled trial, the effects of an exercise-based cardiac rehabilitation program (i) on biomarkers of endothelial function, (ii) on biomarkers of inflammation, (iii) on autonomic function, and (iv) on arterial stiffness in coronary artery disease patients (CAD). Additionally, the investigators aim to analyze the (v) contribution of age and the changes in traditional risk factors to the modification of the endothelial dysfunction and inflammation, and (vi) the contribution of the changes in inflammatory and endothelial function biomarkers to the modification of autonomic function and arterial stiffness.

The investigators hypothesize that exercise training will improve the autonomic function, arterial stiffness and mitigate the endothelial dysfunction and inflammation in CAD patients even in the absence of significant changes in traditional risk factors. Thus, the investigators expect with the present study to promote, develop and expand the knowledge in this field by assessing the impact of exercise on a pool of markers that provide a wide picture of the pathophysiological processes underlying CAD.


Eligibility Criteria:
Inclusion Criteria:

* acute myocardial infarction

Exclusion Criteria:

* ventricular tachyarrhythmia
* uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg)
* significant valvular disease
* unstable angina pectoris
* reduced left ventricular function (ejection fraction \< 45%)
* abnormal hemodynamic response
* myocardial ischemia and/or severe ventricular arrhythmias during baseline exercise testing
* uncontrolled metabolic disease (e.g. uncontrolled diabetes or thyroid disease)
* presence of pulmonary and renal co-morbidities
* peripheral artery disease and/or orthopedic limitations
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening.

Note: For subjects taking any prophylactic HAE therapy during the 3 months before Screening, ≥ 3 HAE attacks may be documented over 3 consecutive months before commencing the prophylactic therapy.

Exclusion Criteria:

* Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3
Measurement of Bispectral Index and Awareness in Patients Undergoing Electrophysiology Studies With Isoproterenol

Isoproterenol is used as a cardiac stimulant in electrophysiology studies (EP). Preliminary data suggests that administration of isoproterenol increases the Bispectral index (BIS). BIS is used to monitor neuronal signals under anesthesia. The BIS level is suggested to correspond to the level of consciousness. We hypothesize that isoproterenol increases BIS values because it increases the patient's level of consciousness through its central nervous system (CNS) stimulatory effects. In this study, we will administer increasing doses of isoproterenol to EPS patients. We will measure the BIS levels continuously before and after isoproterenol administration. In addition, we will test the level of awareness of patients by their response to a modified isolated forearm technique.

Isoproterenol is a direct acting Beta-1 and Beta-2 agonist useful for its effects on bronchodilation and myocardial contractility. Its CNS side effects include nervousness, headache, dizziness, restlessness, insomnia, anxiety, tension, blurring of vision, fear, and excitement. In addition to our preliminary data, two case reports show an increase in BIS with administration of isoproterenol. Our hypothesis is that administration of isoproterenol will increase the level of consciousness of the patient as reflected in the BIS reading.

The BIS Vista Monitor is a non-invasive device that measures the electrical activity of the brain. It computes a number between 0 and 100 which corresponds to a level of consciousness which is known as the Bispectral (BIS) value. Using the BIS value to guide administration of anesthetic medication, clinicians can make informed decisions for optimal anesthesia. This technology has the potential to prevent over sedation, but is currently not a standard monitoring device.

Another approach to evaluating the level of consciousness of anesthetized patients is to assess their ability to form memories or recall events which occurred while under anesthesia. Conscious recall is the first to disappear with decreasing levels of consciousness. A BIS of 60 or less has been shown in various studies to be sufficient to prevent conscious recall in the vast majority of patients. We propose to use a modified isolated forearm technique test in which the patient is asked to squeeze an observer's hand during anesthesia to ascertain if awareness can occur without recall at a BIS of 60 to 70. (6) Implicit memory in which there is no conscious recall or evaluation of awareness can be assessed by word stem completion tests and has been shown to occur with a BIS as low as 40 - 60 although these results are not consistent across all studies. (7)

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for EP studies for catheter ablation of atrial fibrillation under general anesthesia will participate in the study

Exclusion Criteria:

* Patients with neuromuscular disease precluding the use of succinylcholine will be excluded.
* Patient or cardiologist refusal
The Influence of Overfeeding Different Macronutrients on Whole-body Insulin Sensitivity

This study will investigate the effect of high-carbohydrate vs. high-fat overfeeding (130% of energy requirements) on whole body insulin sensitivity.

Following habitual diet, participants will be randomly allocated to either a high-carbohydrate or a high-fat diet intervention for 14-days. On days 0, 7 and 14 participants will undergo anthropometric and metabolic testing (primarily an oral glucose tolerance test \[OGTT\]).


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* BMI = 18.5-29.9 kg/m2
* Male or female
* Physically active (\> 3 x 30 min moderate exercise per week)
* Non-smoker (including the use of vaporisers and e-cigarettes)
* Healthy (determined by the School's standard health questionnaire)
* No cardiometabolic or inflammatory illness

Exclusion Criteria:

* Outside of age-range
* Outside BMI range
* Inactive (\< 3 x 30 min moderate exercise per week)
* Smoker
* Taking medication
* History of cardiometabolic or inflammatory illness
* Vegetarian/ vegan (as the high-fat diet is based on animal fats)
* Other dietary restrictions which prevent consumption of the experimental diet
* Consumption of probiotics within last 3 months (these influence the gut microbiota)
* Participation in another clinical trial
* Those with known or suspected food intolerances, allergies or hypersensitivity
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study